Systems and methods for clamping and stapling to a pressure with a surgical stapling instrument - Patents.com

Abstract

To provide systems and methods for clamping and stapling to a pressure by a surgical stapling instrument.SOLUTION: A surgical stapling instrument includes an anvil assembly, a reload assembly, an adapter assembly, a processor, and a memory. When clamping to a target pressure, instructions cause the surgical stapling instrument to advance the anvil assembly in relation to a staple cartridge supported on the reload assembly to a first position to define a first tissue gap within a predetermined acceptable range of tissue gaps, measure a first force of tissue compression of tissue clamped within the first tissue gap with the anvil assembly in the first position, and enter a firing mode of the surgical stapling instrument if the first force of tissue compression is within a predetermined acceptable range of tissue compression.SELECTED DRAWING: None

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 052,571, filed on July 16, 2020, the entire content of which is hereby incorporated by reference into this specification.

[0002] This disclosure generally relates to surgical stapling instruments, and more particularly, to methods for controlling surgical stapling instruments based on tissue clamping pressure, and surgical stapling instruments for performing the methods.

Background Art

[0003] Anastomosis is the surgical joining of separate hollow organ parts. Typically, an anastomosis procedure follows surgery in which diseased or defective portions of an organ are removed and the remaining end portions of the organ are joined via a surgical stapling instrument. Depending on the desired anastomosis procedure, the remaining end portions may be joined, for example, by circular or side - to - side organ reconstruction methods.

[0004] In a circular anastomosis procedure, the remaining end portions of the organs are joined by a surgical stapling instrument that punches through any tissue within a circular array of staples driven through the remaining end portions to simultaneously release a tubular passage within the organ. Typically, these surgical stapling instruments include an anvil and a staple cartridge that are movable relative to each other between an open position and a clamping position to clamp the remaining end portions together before firing the staples to join the end portions together. In the clamping position, the anvil and the staple cartridge move to a position that defines a predetermined tissue gap. Depending on the thickness of the remaining end portions being clamped, the pressure applied to the remaining end portions can vary widely. Stapling tissue that is under-compressed can lead to blood leakage through the staple line formed by the surgical stapling instrument, increasing the risk of infection, and stapling tissue that is over-compressed can cut off the blood supply and cause tissue necrosis.

[0005] There is a continuing need for a stapling instrument that can apply a predetermined clamping pressure to tissue, regardless of the thickness of the tissue, before forming a staple line within the tissue.

SUMMARY OF THE INVENTION

MEANS FOR SOLVING THE PROBLEM

[0006] According to the present disclosure, a computer-implemented method for controlling a surgical stapling instrument for clamping and stapling tissue to a certain pressure includes advancing an anvil assembly to a first position relative to a staple cartridge to define a first tissue gap between the staple cartridge and the anvil assembly within a predetermined tissue gap tolerance, measuring a first tissue compression force of the tissue clamped within the first tissue gap with the anvil assembly in the first position, and entering a firing mode of the surgical stapling instrument when the first tissue compression force is within a predetermined tissue compression tolerance.

[0007] In one aspect, the method may further include measuring a second tissue compression force of tissue clamped within a second tissue gap where the anvil assembly is in a second position.

[0008] In another aspect, the method may further include entering a firing mode of a surgical stapling instrument when the second tissue compression force is within a predetermined tissue compression tolerance range.

[0009] In yet another aspect, the method may further include displaying a warning on a display when the second tissue compression force is not within a predetermined tissue compression tolerance range.

[0010] In one aspect, the method may further include preventing staple firing when the measured second tissue compression force is not within a predetermined tissue compression tolerance range and the tissue gap is within a predetermined acceptable tissue gap range.

[0011] In another aspect, the predetermined tissue gap tolerance range may include a maximum tissue gap and a minimum tissue gap.

[0012] In yet another aspect, the method may further include advancing the anvil assembly towards the staple cartridge to a minimum tissue gap when the measured first tissue compression force is not within a predetermined tissue compression tolerance range.

[0013] In yet another aspect, the method may further include stapling the tissue with a surgical stapling instrument to a target staple pressure within a predetermined staple pressure range.

[0014] In yet another aspect, stapling the tissue to the target staple pressure may include determining whether a plurality of staples are present in the reload assembly of the surgical stapling instrument, and determining at least one of whether the target staple pressure has been reached or whether advancing the staple pusher of the surgical stapling instrument to the first staple position has been achieved, and forming a plurality of staples based on the target staple pressure.

[0015] In yet another aspect, the method may further include compensating for the stapling stroke of the surgical stapling instrument based on the continuous non-linear backlash loss of the reload assembly of the surgical stapling instrument. Compensating for the staple stroke may include adjusting the first staple position and / or the second staple position.

[0016] 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 staple cartridge including a plurality of staples, a processor, and a memory. The memory includes instructions stored thereon that, when executed, cause the surgical stapling instrument to advance the anvil assembly to a first position relative to the staple cartridge to define a first tissue gap within a predetermined tissue gap tolerance, measure a first tissue compression force of the tissue clamped within the first tissue gap with the anvil assembly in the first position, and enter a firing mode of the surgical stapling instrument when the first tissue compression force is within a predetermined tissue compression tolerance.

[0017] In one aspect, the instructions may further cause the surgical stapling instrument to advance the anvil assembly from the first position to a second position to define a second tissue gap within the tissue gap tolerance when executed.

[0018] In another aspect, when the instructions are executed, the surgical stapling instrument may be further caused to measure a second tissue compression force of the tissue clamped in the second tissue gap with the anvil assembly in the second position.

[0019] In yet another aspect, when the instructions are executed, the surgical stapling instrument may be further caused to enter a firing mode when the second tissue compression force is within a predetermined tissue compression tolerance range.

[0020] In yet another aspect, when the instructions are executed, the surgical stapling instrument may be further caused to display a warning on a display when the second tissue compression force is not within a predetermined tissue compression tolerance range.

[0021] In yet another aspect, when the measured second tissue compression force is not within a predetermined tissue compression tolerance range and the anvil assembly has advanced beyond the second tissue gap, when the instructions are executed, the surgical stapling instrument may be further caused to prevent staple firing.

[0022] In yet another aspect, the predetermined tissue gap tolerance range may include a maximum tissue gap and a minimum tissue gap.

[0023] In yet another aspect, when the measured first tissue compression force is not within a predetermined tissue compression tolerance range, when the instructions are executed, the surgical stapling instrument may be further caused to advance the anvil assembly to the minimum tissue gap relative to the staple cartridge.

[0024] According to the present disclosure, a non-transitory computer-readable medium storing instructions that, when executed by a processor, cause the processor to execute a method of controlling a surgical stapling instrument for clamping and stapling tissue to a certain pressure, the method comprising: advancing an anvil assembly to a first position relative to a staple cartridge to define a first tissue gap within a predetermined tissue gap tolerance; measuring a first tissue compression force of the tissue clamped within the first tissue gap with the anvil assembly in the first position; and entering a firing mode of the surgical stapling instrument when the first tissue compression force is within a predetermined tissue compression tolerance. For example, the present application provides the following items. (Item 1) A computer-implemented method for controlling a surgical stapling instrument for clamping and stapling tissue to a certain pressure, the method comprising: advancing the anvil assembly to a first position relative to the staple cartridge to define a first tissue gap within a predetermined tissue gap tolerance; measuring a first tissue compression force of the tissue clamped within the first tissue gap with the anvil assembly in the first position; and entering a firing mode of the surgical stapling instrument when the first tissue compression force is within a predetermined tissue compression tolerance. (Item 2) The computer-implemented method according to the above item, further comprising advancing the anvil assembly from the first position to a second position to define a second tissue gap within the predetermined tissue gap tolerance. (Item 3) The computer-implemented method according to any one of the above items, further comprising measuring a second tissue compression force of the tissue clamped within the second tissue gap with the anvil assembly in the second position. (Item 4) The computer-implemented method according to any one of the above items, further including entering the firing mode of the surgical stapling instrument when the second tissue compression force is within the predetermined tissue compression allowable range. (Item 5) The computer-implemented method according to any one of the above items, further including displaying a warning on a display when the second tissue compression force is not within the predetermined tissue compression allowable range. (Item 6) The computer-implemented method according to any one of the above items, further including preventing staple firing when the measured second tissue compression force is not within the predetermined tissue compression allowable range and the tissue gap is within the predetermined tissue gap allowable range. (Item 7) The computer-implemented method according to any one of the above items, wherein the predetermined tissue gap allowable range includes a maximum tissue gap and a minimum tissue gap. (Item 8) The computer-implemented method according to any one of the above items, further including advancing the anvil assembly towards the staple cartridge to the minimum tissue gap when the measured first tissue compression force is not within the predetermined tissue compression allowable range. (Item 9) The computer-implemented method according to any one of the above items, further including stapling the tissue to a target stapling pressure within a predetermined stapling pressure range using the surgical stapling instrument. (Item 10) Stapling the tissue to the target stapling pressure is determining whether a plurality of staples are present in the reload assembly of the surgical stapling instrument, and determining at least one of whether the target stapling force has been reached or whether advancing the staple pusher of the surgical stapling instrument to a first staple position has been achieved. Forming the plurality of staples based on the target staple fastening pressure, and the computer-implemented method according to any one of the above items. (Item 11) Further comprising compensating for a staple fastening stroke of the surgical staple fastening instrument based on a continuous non-linear backlash loss of a reload assembly of the surgical staple fastening instrument, Compensating for the staple stroke includes at least one of adjusting a first staple position or a second staple position, and the computer-implemented method according to any one of the above items. (Item 12) A surgical staple fastening instrument, 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 containing a plurality of staples, A processor, A memory containing instructions stored thereon, which when executed cause the surgical staple fastening instrument to, Advance the anvil assembly to a first position relative to the staple cartridge to define a first tissue gap between the staple cartridge and the anvil assembly within a predetermined tissue gap tolerance range, Measure a first tissue compression force of the tissue clamped within the first tissue gap with the anvil assembly in the first position, Enter a firing mode of the surgical staple fastening instrument when the first tissue compression force is within a predetermined tissue compression tolerance range, and a memory. A surgical staple fastening instrument comprising. (Item 13) The surgical staple fastening instrument according to the above item, wherein the instructions, when executed, further cause the surgical staple fastening instrument to advance the anvil assembly from the first position to a second position to define a second tissue gap within the tissue gap tolerance range. (Item 14) When the above command is executed, the surgical stapling instrument is further caused to measure the second tissue compression force of the tissue clamped in the second tissue gap with the anvil assembly in the second position. The surgical stapling instrument according to any one of the above items. (Item 15) When the above command is executed, the surgical stapling instrument is further caused to enter the firing mode of the surgical stapling instrument when the second tissue compression force is within the predetermined tissue compression tolerance range. The surgical stapling instrument according to any one of the above items. (Item 16) When the above command is executed, the surgical stapling instrument is further caused to display a warning on the display when the second tissue compression force is not within the predetermined tissue compression tolerance range. The surgical stapling instrument according to any one of the above items. (Item 17) When the measured second tissue compression force is not within the predetermined tissue compression tolerance range and the anvil assembly has advanced beyond the second tissue gap, when the above command is executed, the surgical stapling instrument is further caused to prevent staple firing. The surgical stapling instrument according to any one of the above items. (Item 18) The surgical stapling instrument according to any one of the above items, wherein the predetermined tissue gap tolerance range includes a maximum tissue gap and a minimum tissue gap. (Item 19) When the measured first tissue compression force is not within the predetermined tissue compression tolerance range, when the above command is executed, the surgical stapling instrument is further caused to advance the anvil assembly to the minimum tissue gap with respect to the staple cartridge. The surgical stapling instrument according to any one of the above items. (Item 20) A non - transitory computer - readable medium storing instructions that, when executed by a processor, cause the processor to execute a method for controlling a surgical stapling instrument for clamping and stapling tissue to a certain pressure, the method comprising: Advancing the anvil assembly to a first position relative to a staple cartridge to define a first tissue gap between the staple cartridge and the anvil assembly within a predetermined tissue - gap tolerance range; Measuring a first tissue compression force of the tissue clamped within the first tissue gap with the anvil assembly in the first position; Entering a firing mode of the surgical stapling instrument when the first tissue compression force is within a predetermined tissue - compression tolerance range. (Abstract) A surgical stapling instrument includes an anvil assembly, a reload assembly, an adapter assembly, a processor, and a memory. When clamping to a target pressure, the instructions cause the surgical stapling instrument to advance the anvil assembly to a first position relative to a staple cartridge supported on the reload assembly to define a first tissue gap within a predetermined tissue - gap tolerance range, measure a first tissue compression force of the tissue clamped within the first tissue gap with the anvil assembly in the first position, and enter a firing mode of the surgical stapling instrument when the first tissue compression force is within a predetermined tissue - compression tolerance range.

Brief Description of the Drawings

[0025] A system and method for controlling a surgical stapling instrument for clamping and stapling tissue to a certain pressure are disclosed herein with reference to the drawings.

[0026]

Figure 1

Figure 2A

Figure 2B

Figure 3

Figure 4

Figure 5

Figure 6

DETAILED DESCRIPTION OF THE INVENTION

[0027] Here, the disclosed surgical device will be described in detail with reference to the drawings, in which like reference numerals indicate the same or corresponding elements in each of several figures. However, it should be understood that the aspects of the present disclosure are merely illustrative of the present disclosure and can be embodied in various forms. Well-known functions or configurations are not described in detail so as not to obscure the present disclosure with unnecessary details. Therefore, the specific structural and functional details disclosed herein should not be construed as limitations, but rather as a basis for the claims and as a representative basis for teaching those skilled in the art to use the present disclosure in substantially any suitable detailed structure. In addition, terms indicating directions such as front, rear, upper, lower, top, bottom, distal, proximal, and similar terms are used to assist in understanding the description and are not intended to limit the present disclosure.

[0028] The present disclosure is directed to a surgical stapling instrument that controls the stapling of tissue based in part on the clamping pressure applied to the tissue clamped between an anvil assembly and a cartridge assembly of a stapling instrument. In aspects of the present disclosure, the surgical stapling instrument controls the approach of the anvil and cartridge assemblies such that they are within a predetermined tissue gap range. The predetermined tissue gap range is selected based on the size of the staples and ensures that the anvil and cartridge assemblies are sufficiently close to each other to achieve proper staple formation. The predetermined tissue gap range includes a maximum tissue gap (where the tissue gap is maximum within the predetermined tissue gap range) and a minimum tissue gap (where the tissue gap is minimum within the predetermined tissue gap range). To prevent over-compression of the tissue within the predetermined tissue gap range that can lead to tissue necrosis, or under-compression of the tissue within the predetermined tissue gap range that can lead to blood leakage through the staple line formed by the stapling instrument, the surgical stapling instrument measures the clamping pressure on the tissue when the anvil and cartridge assemblies approach through the predetermined tissue gap range and ensures that stapling occurs only when the tissue is compressed within a predetermined compression range. The disclosed surgical stapling instrument and method of use enable the surgical stapling instrument to adapt to the thickness, type, and disease of the tissue and enable more consistent staple formation. Instead of using several different stapler sizes, the disclosed surgical stapling instrument and method of operation enable a universal stapler that reduces the medical provider's stock keeping unit (SKU). Clamping and stapling to a certain pressure increases surgical efficiency and saves time during surgery. FIG. 1 shows a surgical stapling instrument generally shown as surgical stapling instrument 10.The surgical stapling instrument 10 is a circular stapling instrument and includes a handle assembly 20, an adapter assembly 100 extending distally from the handle assembly 20, a reload assembly 16 supported on the distal portion of the adapter assembly 100, an anvil assembly 50 operably coupled to the adapter assembly 100, and a controller 300 (FIG. 3) supported within the handle assembly 20. The reload assembly 16 supports an annular staple cartridge 48 that includes a plurality of staples (not shown). The anvil assembly 50 includes an anvil head 28 that includes a staple forming surface 29 (FIG. 2A).

[0029] The handle assembly 20 is shown as an electric assembly and includes a fixed grip 22, an actuation button 24 for controlling the firing of staples (not shown) from the staple cartridge 48 of the reload assembly 16, and approach buttons 26a, 26b for controlling the axial displacement of the anvil assembly 50 toward and away from the staple cartridge 48 of the reload assembly 16 between an open position and a clamped position. For a detailed description of the structure and function of an exemplary electric handle assembly, reference can be made to U.S. Patent Application Publication Nos. 2020 / 0015820 and 2019 / 0343517. Although the present disclosure illustrates an electric assembly, the advantages of the present disclosure are contemplated to be applicable to robotic-operated surgical instruments and / or manually operated staplers (e.g., including a pressure sensor indicating that an acceptable clamping pressure has been reached when manual approach is being performed), as will be described in detail below.

[0030] Figures 2A and 2B show the surgical stapling instrument 10 in the open position and the clamped position. In the open position (Figure 2A), the anvil assembly 50 is spaced from the staple cartridge 48 of the reload assembly 16 to facilitate the placement of tissue between the staple forming surface 29 of the anvil head 28 of the anvil assembly 50 and the staple cartridge 48 of the reload assembly 16. In the clamped position, the anvil assembly 50 moves to an alignment juxtaposed with the staple cartridge 48, defining a tissue gap "G" between the staple forming surface 29 of the anvil head 28 of the anvil assembly 50 and the staple cartridge 48 of the reload assembly 16. In both current 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. This predetermined range is determined in part based on the size of the staples to be formed, ensuring that the anvil head 28 of the anvil assembly 50 is sufficiently close to the staple cartridge 48 to properly form the staples. The predetermined tissue gap range is the maximum allowable and the allowable minimum tissue gap G 最大 defined by 最小 the maximum value allowable in G and the allowable minimum tissue gap G

[0031] The handle assembly 20 may include an electrical assembly such as a strain gauge 360 (Figure 3) configured to communicate with a controller 300 (Figure 3) and determine the load on a motor (not shown) of the surgical stapling instrument 10 resulting from tissue being clamped between the anvil assembly 50 and the staple cartridge 48. This determination can be used to determine the compressive force on the tissue clamped between the anvil assembly 50 and the staple cartridge 48.

[0032] Continuing to refer to FIG. 1, the adapter assembly 100 includes an interface portion 232 removably coupled to the handle assembly 20, a tubular shaft 234 extending distally from the interface portion 232, a drive coupling assembly (not shown) movably supported within the adapter assembly 100, and a drive shaft (not shown) coupled to the anvil shaft 52 of the anvil assembly 50. The drive coupling assembly (not shown) engages and is thereby driven by the handle assembly 20 to control the axial displacement of the drive shaft to move the anvil assembly 50 between an open position and a clamping position relative to the staple cartridge 48.

[0033] The reload assembly 16 is supported on the distal portion of the adapter assembly 100 and includes a shell housing 46 that supports the staple cartridge 48. In aspects of the present disclosure, the staple cartridge 48 defines an annular array of staple receiving pockets 48a (FIG. 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 each spent annular staple cartridge 48.

[0034] Each of the staple receiving pockets 48a of the staple cartridge 48 supports a staple (not shown) that can be fired from the staple cartridge 48 via actuation of the actuation button 24 of the handle assembly 20. The shell 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 staples from the staple cartridge 48 and to sever or cut tissue positioned within the annulus defined by the staple cartridge 48. When a staple (not shown) is fired from the staple cartridge 48, the staple is driven into and formed within the staple forming pocket of the staple forming surface 29 of the anvil head 28 of the anvil assembly 50.

[0035] FIG. 3 shows a controller 300 including a processor 320 connected to a computer-readable storage medium or memory 330 according to the present disclosure. The computer-readable storage medium or memory 330 may be of a volatile type of memory such as RAM, or a non-volatile type of memory such as flash media, disk media, etc. In various aspects of the present disclosure, the processor 320 may 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, in contrast to the processor, network inference with weights implemented chemically or as other inferential calculations as a memristor may also be achieved within the system.

[0036] In aspects of the present disclosure, the memory 330 can be random access memory, read-only memory, magnetic disk memory, solid-state memory, 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 communicate with the processor 320 through a communication bus of the 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 executable by the processor 320 to operate the controller 300. In other aspects of the present disclosure, the controller 300 may include a network interface 340 for communicating with other computers or servers. A storage device 310 may be used to store data.

[0037] In aspects of the present disclosure, a strain gauge (not shown) is coupled to the processor and the disclosed method is executed on the controller 300 or on a user device including, for example, on a mobile device, an IoT device, or a server system.

[0038] FIG. 4 includes a diagram showing the clamp position from the hard stop of the surgical stapling instrument. The hard stop is a mechanical end stop where the nut on the drive assembly is at the bottom of the screw flange. This is achieved by moving each function proximally until a torque threshold is reached.

[0039] In the stapling instrument, the handle assembly is programmed to advance the drive member through a predetermined stroke to move the anvil assembly 50 from the open position to the clamp position to define a predetermined tissue gap between the staple cartridge 48 and the anvil assembly 50. According to the present disclosure, the drive member is controlled by the handle assembly 20 to move the anvil assembly 50 toward the clamp position to compress the tissue clamped between the anvil assembly 50 and the staple cartridge 48 within a predetermined compression range. However, the tissue gap "G" (FIG. 2B) must also be within a predetermined range so that proper staple formation can be achieved. The systems and methods of the present disclosure perform stapling at a target clamp pressure within a predefined range while allowing clamping with a target minimum force based on adjustable and configurable parameters.

[0040] As described above, within the predetermined tissue gap tolerance range, i.e., G 最大 is the maximum tissue gap within the predetermined acceptable gap range, and G 最小 is the minimum tissue gap within the predetermined acceptable gap range, where G 最大 and G 最小To define the tissue gap "G" between, it is important that staples are not fired from the staple cartridge 48 into the anvil assembly 50 until the anvil assembly 50 moves toward the staple cartridge 48. For the reasons summarized above, it is also important that the tissue to be stapled is not overcompressed or undercompressed in order to provide effective stapling and joining of the tissue. Stapling the tissue compressed to an appropriate degree, i.e., within a predetermined compression range, enables the stapling instrument to adjust the amount of staple crimp according to the thickness of the tissue and minimize overcompression and undercompression of the tissue.

[0041] Figure 5 shows a flowchart of a computer-implemented method 500 for controlling a surgical stapling instrument for clamping tissue to a pressure within a predefined range. The method of forming an end-to-end anastomosis using the disclosed surgical stapling instrument 10 includes two clamping stages. During the first clamping stage, the anvil assembly 50 (FIG. 1) moves relative to the staple cartridge 48 from an open position to a clamping position within a predetermined acceptable gap range in which the tissue gap defined between the anvil assembly 50 and the staple cartridge 48 facilitates proper staple formation. More specifically, in the first clamping stage, the anvil assembly 50 approaches the staple cartridge 48 of the reload assembly 16 (step 502) to define the tissue gap of G 最大 In aspects of the present disclosure, G 最大 may be from about 0.037 inches to about 0.024 inches. However, the value of G 最大 varies depending on the size of the staples in the staple cartridge 48.

[0042] The anvil assembly 50 is at G 最大To define the tissue gap, as the staple cartridge 48 is moved relative thereto, the tissue compression force on the tissue clamped between the staple cartridge 48 and the anvil assembly 50 is measured (step 504). As described above, the clamping pressure of the tissue clamped between the anvil assembly 50 and the staple cartridge 48 of the shell assembly can be measured using a strain gauge 360 that communicates with the controller 300. Alternatively, other pressure measurement devices may be used to measure the clamping pressure of the tissue clamped between the anvil assembly 50 and the staple cartridge 48. When the compression force on the tissue is within a predetermined compression tolerance range, the surgical stapling instrument 10 enters the firing mode, enabling the surgeon to selectively fire the surgical stapling instrument 10 to staple the tissue (step 506). The predetermined compression tolerance range varies depending on the type of tissue being treated.

[0043] If the minimum compression force is G 最大 not found on the tissue at the position, the anvil assembly 50 moves towards the G 最小 position (step 508). As the anvil assembly 50 moves towards the G 最小 position towards the staple cartridge 48, the compression force on the tissue is continuously measured. If the compression force on the tissue enters the predetermined compression range before the anvil assembly 50 reaches the G 最小 position, the surgical stapling instrument 10 enters the firing mode, enabling the surgeon to selectively fire the surgical stapling instrument 10 to staple the tissue (step 506). If the anvil assembly 50 reaches the G 最小 position and the compression force on the tissue is not within the predetermined compression tolerance range, the surgical stapling instrument 10 does not enter the firing mode. Thus, the surgical stapling instrument 10 does not clamp the tissue to the pressure or force within the predetermined compression range, and the tissue gap "G" (Figure 2B) defined between the anvil assembly 50 and the staple cartridge 48 is within the predetermined tissue gap range, i.e., from G 最大 to G 最小Unless it does, entry into the firing mode is prevented. In some aspects of the present disclosure, the controller may provide a warning on a display on the handle assembly of the surgical stapling instrument, for example, to alert the surgeon that the compression force on the tissue is not within a predetermined compression range, so that the surgeon can reposition the surgical stapling instrument 10 on the tissue.

[0044] The present disclosure is directed to an electrosurgical stapling instrument, but the principles of the present disclosure are assumed to be applicable to manually operated stapling instruments. For example, as the stapling instrument moves through a predetermined acceptable tissue gap range, the clamping pressure on the tissue clamped between the anvil assembly of the stapling instrument and the staple cartridge can be measured. In such a device, an indicator such as a light can be provided on the instrument. When the clamping pressure of the tissue enters a predetermined compression tolerance range using the instrument within a predetermined gap tolerance range, the indicator can be activated to notify the surgeon that the instrument is ready to fire.

[0045] Aspects of the present disclosure are illustrated in connection with a circular stapling instrument, but are equally applicable to other types of stapling instruments, including linear stapling devices, vascular sealing devices, and other devices for joining tissue portions together.

[0046] One of ordinary skill in the art will recognize that one or more operations of method 500 may 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 may be operative in controller 300 (FIG. 3), in a remote device, or in another server or system. Other variations are also contemplated within the scope of the present disclosure. The operations of method 500 are described with respect to a controller, e.g., controller 300 (FIG. 3) of surgical stapling instrument 10 (FIG. 3), but it will be understood that the illustrated operations are equally applicable to other systems and their components.

[0047] When surgical stapling instrument 10 is used to perform a surgical procedure, surgical stapling instrument 10 is operated to position tissue between staple cartridge 48 and anvil assembly 50. Once the surgical instrument is properly positioned relative to the tissue to treat the tissue, handle assembly 20 is actuated to move anvil assembly 50 towards the clamp position to a G 最小 position.

[0048] FIG. 6 is a graph showing staple retention force versus staple position for a surgical stapling instrument. In aspects of the present disclosure, firing staples using surgical stapling instrument 10 is performed at a low speed and has three stages. The first stage is a staple detection process (from S0 to S1) in which software determines whether a staple is present in staple cartridge 48 of reload assembly 16. The second stage is an intermediate zone (from S1 to S2) where the staple contacts anvil assembly 50 and begins to bend. The third stage is staple formation (from S2 to S3) where stapling ends when the staple is fully formed and a predetermined target staple retention force is detected between a minimum staple position and a maximum staple position.

[0049] During surgery, an acceptable staple gap range (e.g., G 最大 and G 最小When a tolerable degree of compression (e.g., a target compression force) is reached within a predetermined tissue gap range between), staple firing can be initiated. To fire the staples, the surgeon activates the activation button 24 of the handle assembly 20. The method can determine whether staples are present in the reload assembly, and if so, the method can determine whether the target staple retention force has been reached.

[0050] Those skilled in the art will understand that the instruments and methods specifically described herein and illustrated in the accompanying drawings are non-limiting. It is envisioned that these elements and features can be combined with other elements and features without departing from the scope of the present disclosure. Similarly, those skilled in the art will understand further features and advantages of the present disclosure.

Claims

1. 1. A computer-implemented method for controlling a surgical stapling instrument to clamp and staple tissue to a pressure, comprising: determining whether a plurality of staples are present in an annular staple cartridge of a reload assembly; in response to determining that the plurality of staples are present, the surgical stapling instrument advances an anvil assembly to a first position relative to the annular staple cartridge thereby defining a first tissue gap between the annular staple cartridge and the anvil assembly that is within a predetermined tissue gap tolerance; measuring a first tissue compression force on the tissue clamped within the first tissue gap with the surgical stapling instrument and the anvil assembly in the first position; when the first tissue compression force is within a predetermined tissue compression tolerance range, the surgical stapling instrument enters a firing mode of the surgical stapling instrument.

23. A computer-implemented method comprising:

2. The computer-implemented method of claim 1, further comprising the surgical stapling instrument defining a second tissue gap within the tissue gap tolerance range by advancing the anvil assembly from the first position to a second position.

3. The computer-implemented method of claim 2, further comprising the surgical stapling instrument measuring a second tissue compression force on the tissue clamped within the second tissue gap with the anvil assembly in the second position.

4. The computer-implemented method of claim 3, further comprising: when the second tissue compression force is within the predetermined tissue compression tolerance range, the surgical stapling instrument entering the firing mode of the surgical stapling instrument.

5. The computer-implemented method of claim 4, further comprising the surgical stapling instrument displaying a warning on a display if the second tissue compression force is not within the predetermined tissue compression tolerance range.

6. The computer-implemented method of claim 3, further comprising the surgical stapling instrument preventing staple firing when the tissue gap is within the predetermined tissue gap tolerance range and the measured second tissue compression force is not within the predetermined tissue compression tolerance range.

7. The computer-implemented method of claim 1 , wherein the predetermined tissue gap tolerance comprises a maximum tissue gap and a minimum tissue gap.

8. The computer-implemented method of claim 7, further comprising: when the measured first tissue compression force is not within the predetermined tissue compression tolerance range, the surgical stapling instrument advances the anvil assembly relative to the annular staple cartridge to the minimum tissue gap.

9. The computer-implemented method of claim 1, further comprising: the surgical stapling instrument stapling the tissue with the surgical stapling instrument to a target stapling pressure within a predetermined stapling pressure range.

10. The surgical stapling instrument stapling the tissue to the target stapling pressure, comprising: determining whether a plurality of staples are present in a reload assembly of the surgical stapling instrument; determining whether the surgical stapling instrument has reached at least one of a target stapling force or whether advancing a staple pusher of the surgical stapling instrument to a first staple position has been accomplished; forming the plurality of staples based on the target stapling pressure.

10. The computer-implemented method of claim 9, comprising:

11. The computer-implemented method further comprising compensating a stapling stroke of the surgical stapling instrument based on continuous non-linear backlash losses of a reload assembly of the surgical stapling instrument; The computer-implemented method of claim 10 , wherein compensating the staple stroke includes at least one of adjusting a first staple position or a second staple position.

12. 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; A memory in which instructions are stored Equipped with The instructions, when executed, determining whether a plurality of staples are present in said annular staple cartridge; in response to determining that the plurality of staples are present, advancing the anvil assembly to a first position relative to the annular staple cartridge thereby defining a first tissue gap between the annular staple cartridge and the anvil assembly that is within a predetermined tissue gap tolerance; measuring a first tissue compression force on tissue clamped within the first tissue gap with the anvil assembly in the first position; entering a firing mode of the surgical stapling instrument when the first tissue compression force is within a predetermined tissue compression tolerance range. causing said surgical stapling instrument to perform.

13. 13. The surgical stapling instrument of claim 12, wherein the instructions, when executed, further cause the surgical stapling instrument to advance the anvil assembly from the first position to a second position to define a second tissue gap within the tissue gap tolerance range.

14. 14. The surgical stapling instrument of claim 13, wherein the instructions, when executed, further cause the surgical stapling instrument to measure a second tissue compressive force on the tissue clamped in the second tissue gap with the anvil assembly in the second position.

15. 15. The surgical stapling instrument of claim 14, wherein the instructions, when executed, further cause the surgical stapling instrument to enter the firing mode of the surgical stapling instrument if the second tissue compression force is within the predetermined tissue compression tolerance range.

16. 16. The surgical stapling instrument of claim 15, wherein the instructions, when executed, further cause the surgical stapling instrument to display a warning on a display when the second tissue compression force is not within the predetermined tissue compression tolerance range.

17. 15. The surgical stapling instrument of claim 14, wherein the instructions, when executed, further cause the surgical stapling instrument to prevent staple firing if the second measured tissue compression force is not within the predetermined tissue compression tolerance range and the anvil assembly has advanced beyond the second tissue gap.

18. The surgical stapling instrument of claim 12, wherein the predetermined tissue gap tolerance includes a maximum tissue gap and a minimum tissue gap.

19. 20. The surgical stapling instrument of claim 18, wherein the instructions, when executed, further cause the surgical stapling instrument to advance the anvil assembly relative to the annular staple cartridge to the minimum tissue gap if the first measured tissue compression force is not within the predetermined tissue compression tolerance range.

20. A non-transitory computer readable medium having stored thereon instructions that, when executed by a processor, cause the processor to perform a method for controlling a surgical stapling instrument to clamp and staple tissue to a pressure; The method comprises: determining whether a plurality of staples are present in an annular staple cartridge of the reload assembly; in response to determining that the plurality of staples are present, advancing an anvil assembly to a first position relative to the annular staple cartridge thereby defining a first tissue gap between the annular staple cartridge and the anvil assembly that is within a predetermined tissue gap tolerance; measuring a first tissue compression force on the tissue clamped within the first tissue gap with the anvil assembly in the first position; entering a firing mode of the surgical stapling instrument when the first tissue compression force is within a predetermined tissue compression tolerance range. A non-transitory computer readable medium,

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