Systems and methods for controlling a surgical stapling instrument

Abstract

To provide systems and methods for controlling 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 force, instructions cause the surgical stapling instrument to advance a pusher towards the anvil assembly from a first position to a second position, determine if the pusher stopped advancing towards the anvil assembly prior to the second position, measure a force of staple compression of a staple being ejected from an annular staple cartridge by the pusher, in response to the pusher having stopped advancing towards the anvil assembly, and determine if the force of staple compression is outside of a predetermined range.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 056,746, filed July 27, 2020, the entire contents of which are hereby incorporated by reference.

[0002] (Field) The present disclosure relates generally to powered surgical stapling instruments, and more particularly to a method for controlling a surgical stapling instrument based on staple formation range, and a surgical stapling instrument for performing the method. [Background technology]

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

[0004] In a circular anastomosis procedure, the remaining end portions of the organ are joined by a surgical stapling instrument that drives a circular array of staples through the remaining end portions and simultaneously hollows out any tissue interior to the driven circular array of staples to free a tubular passageway within the organ. The staples delivered during a circular anastomosis procedure should be shaped to prevent leakage of the contents of the digestive tract into the abdominal or thoracic cavity.

[0005] There is a continuing need for a stapling instrument that can distinguish between staple formations that are leak-proof and staple formations that are not sufficiently closed. Summary of the Invention [Means for solving the problem]

[0006] In accordance with the present disclosure, a computer-implemented method for controlling a surgical stapling instrument for stapling tissue includes advancing a pusher from a first position toward an anvil assembly of the surgical stapling instrument to a second position, the pusher being configured to eject staples from a staple cartridge of the surgical stapling instrument; determining whether the pusher stops advancing toward the anvil assembly prior to the second position; measuring a staple compression force of the staples ejected from the staple cartridge by the pusher; and determining whether the staple compression force is outside a predetermined range.

[0007] In one aspect, the method further includes engaging a tissue-cutting mode of the surgical stapling instrument in response to a staple compression force based on a predetermined acceptable staple compression range.

[0008] Alternatively, the staple compression force may be measured by a strain gauge.

[0009] In yet another aspect, the staple compression force may be measured based on the current of a motor configured to advance the pusher.

[0010] In one aspect, the method can further include preventing firing of the staples in response to the staple compression force being greater than a predetermined range.

[0011] In another aspect, the method may further include displaying a warning in response to the staple compression force being greater than a predetermined range.

[0012] In yet another embodiment, the displayed warnings may include warnings to inspect the surgical site and / or to unclamp the tissue.

[0013] In still yet another aspect, the method may further include retracting the pusher.

[0014] In still yet another aspect, the method may further include generating an audio alert in response to the staple compression force being greater than a predetermined range.

[0015] In still yet another aspect, the method may further include determining whether functionally closed staple formation has been achieved.

[0016] According to aspects of 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 a pusher, and an annular staple cartridge including a plurality of staples. The pusher is configured to eject the staples from the annular staple cartridge. The surgical stapling instrument further includes a processor and a memory. The memory includes instructions stored thereon that, when executed, cause the surgical stapling instrument to: advance the pusher toward the anvil assembly from a first position to a second position; determine whether the pusher has stopped advancing toward the anvil assembly prior to the second position; measure a staple compression force of staples ejected from the annular staple cartridge by the pusher in response to the pusher stopping advancing toward the anvil assembly; and determine whether the staple compression force is outside a predetermined range.

[0017] In one aspect, the instructions, when executed by the processor, may further place the surgical stapling instrument into a tissue cutting mode of the surgical stapling instrument in response to a staple compression force based on a predetermined allowable staple compression range.

[0018] In another embodiment, the staple compression force is measured by a strain gauge.

[0019] In yet another aspect, the staple compression force is measured based on the current of a motor configured to advance the pusher.

[0020] In still yet another aspect, the instructions, when executed by the processor, may further cause the surgical stapling instrument to prevent firing of staples in response to a staple compression force greater than a predetermined range.

[0021] In still yet another aspect, the instructions, when executed by the processor, may further cause the surgical stapling instrument to display a warning on a display if the staple compression force is greater than a predetermined range.

[0022] In still yet another embodiment, the displayed warnings may include warnings to inspect the surgical site and / or to unclamp the tissue.

[0023] In still yet another aspect, the instructions, when executed by the processor, may cause the surgical stapling instrument to further retract the pusher.

[0024] In still yet another aspect, the instructions, when executed by the processor, may further cause the surgical stapling instrument to generate an audio alert in response to the staple compression force being greater than a predetermined range.

[0025] According to another aspect of 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 comprising: advancing a pusher from a first position toward an anvil assembly of the surgical stapling instrument to a second position, the pusher being configured to eject staples from a staple cartridge of the surgical stapling instrument; determining whether the pusher has stopped advancing toward the anvil assembly prior to the second position; measuring a staple compression force of the staples ejected from the staple cartridge by the pusher; and determining whether the staple compression force is outside a predetermined range.

[0026] The present invention provides, for example: (Item 1) 1. A computer-implemented method for controlling a surgical stapling instrument, comprising: advancing a pusher toward an anvil assembly of the surgical stapling instrument from a first position to a second position, the pusher configured to eject staples from a staple cartridge of the surgical stapling instrument; determining whether the pusher has stopped advancing toward the anvil assembly prior to the second position; measuring a staple compression force of staples ejected from the staple cartridge by the pusher; and determining whether the staple compression force is outside a predetermined range. (Item 2) The computer-implemented method of the preceding paragraph, further comprising entering a tissue-cutting mode of the surgical stapling instrument in response to the staple compression force based on a predetermined acceptable staple compression range. (Item 3) 2. The computer-implemented method of claim 1, wherein the staple compression force is measured by a strain gauge. (Item 4) 10. The computer-implemented method of claim 1, wherein the staple compression force is measured based on a current of a motor configured to advance the pusher. (Item 5) 20. The computer-implemented method of claim 19, further comprising: preventing staples from firing in response to the staple compression force being greater than the predetermined range. (Item 6) 20. The computer-implemented method of claim 19, further comprising displaying a warning in response to the staple compression force being greater than the predetermined range. (Item 7) The computer-implemented method of any preceding item, wherein the displayed warning includes at least one of a warning to inspect the surgical site or to unclamp tissue. (Item 8) 2. The computer-implemented method of any preceding claim, further comprising retracting the pusher. (Item 9) 20. The computer-implemented method of claim 19, further comprising generating an audio alert in response to the staple compression force being greater than the predetermined range. (Item 10) The computer-implemented method of any preceding item, further comprising determining whether functionally closed staple formation has been achieved. (Item 11) 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 a pusher and an annular staple cartridge containing a plurality of staples, the pusher configured to eject the staples from the annular staple cartridge; a processor; a memory containing stored instructions that, when executed, cause the surgical stapling instrument to: advancing the pusher toward the anvil assembly from a first position to a second position; determining whether the pusher has stopped advancing toward the anvil assembly prior to the second position; measuring a staple compression force of staples ejected from the annular staple cartridge by the pusher in response to the pusher ceasing to advance toward the anvil assembly; and determining whether the staple compression force is outside a predetermined range. (Item 12) 10. The surgical stapling instrument of claim 9, wherein the instructions, when executed by the processor, further place the surgical stapling instrument into a tissue cutting mode of the surgical stapling instrument in response to the staple compression force based on a predetermined allowable staple compression range. (Item 13) Item 10. The surgical stapling instrument of any preceding item, wherein the staple compression force is measured by a strain gauge. (Item 14) 10. The surgical stapling instrument of claim 1, wherein the staple compression force is measured based on a current of a motor configured to advance the pusher. (Item 15) 10. The surgical stapling instrument of claim 1, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to prevent firing of staples in response to the staple compression force being greater than the predetermined range. (Item 16) 10. The surgical stapling instrument of claim 1, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to display a warning on a display if the staple compression force is greater than the predetermined range. (Item 17) Item 10. The surgical stapling instrument of any preceding item, wherein the displayed warning includes at least one of a warning to inspect the surgical site or to unclamp tissue. (Item 18) 10. The surgical stapling instrument of any preceding item, wherein the instructions, when executed by the processor, cause the surgical stapling instrument to further retract the pusher. (Item 19) 10. The surgical stapling instrument of claim 1, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to generate an audio warning in response to the staple compression force being greater than the predetermined range. (Item 20) 1. 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 instructions comprising: advancing a pusher toward an anvil assembly of the surgical stapling instrument from a first position to a second position, the pusher configured to eject staples from a staple cartridge of the surgical stapling instrument; determining whether the pusher has stopped advancing toward the anvil assembly prior to the second position; measuring a staple compression force of staples ejected from the staple cartridge by the pusher in response to the pusher ceasing to advance toward the anvil assembly; and determining whether the staple compression force is outside a predetermined range. (Summary) The surgical stapling instrument includes an anvil assembly, a reload assembly, an adapter assembly, a processor, and a memory. When clamping to a target force, the instructions cause the surgical stapling instrument to advance a pusher toward the anvil assembly from a first position to a second position, determine if the pusher stops advancing toward the anvil assembly prior to the second position, measure a staple compression force of staples ejected from the annular staple cartridge by the pusher in response to the pusher stopping advancing toward the anvil assembly, and determine if the staple compression force is outside a predetermined range. [Brief explanation of the drawings]

[0027] A system and method for controlling a surgical stapling instrument for clamping and stapling is disclosed herein with reference to the drawings. [Figure 1] FIG. 1 is a perspective view of a surgical stapling instrument in accordance with the present disclosure; [Figure 2A] 2 is a side cross-sectional view of a proximal portion of the adapter assembly of the surgical stapling instrument shown in FIG. 1; FIG. [Figure 2B] 2 is a cross-sectional view of a distal portion of the adapter assembly and the tool assembly of the surgical stapling instrument shown in FIG. 1; [Figure 2C] 2 is a cross-sectional view of a distal portion of the handle assembly of the surgical stapling instrument shown in FIG. 1; [Figure 3A] 2 is a block diagram of a controller provided in accordance with the present disclosure and configured for use with the surgical system of FIG. 1; [Figure 3B] FIG. 2 is a block diagram of a handle assembly, an adapter assembly, and a reload assembly of the surgical system of FIG. 1 in accordance with the present disclosure. [Figure 4] 10 is a flowchart of a method for controlling a surgical stapling instrument for stapling in accordance with the present disclosure. [Figure 5A] 2 is a diagram of a staple configured for use with the surgical system of FIG. 1 in accordance with the present disclosure; [Figure 5B] 2 is a diagram of a staple configured for use with the surgical system of FIG. 1 in accordance with the present disclosure; DETAILED DESCRIPTION OF THE INVENTION

[0028] The disclosed surgical device will now be described in detail with reference to the drawings, in which like reference numerals indicate identical or corresponding elements in each of the several views. However, it should be understood that aspects of the present disclosure are merely exemplary of the present disclosure and may be embodied in various forms. Known functions or configurations will not be described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art how to vary the present disclosure to substantially any suitable detailed structure. Additionally, directional terms such as anterior, posterior, superior, inferior, top, bottom, distal, proximal, and similar terms are used to aid in understanding the description and are not intended to limit the present disclosure.

[0029] The present disclosure is directed to a surgical stapling instrument that controls the stapling of tissue based in part on determining the closure state of the staples, and in particular, that distinguishes between sufficient staple formation and prevents leaks and insufficient staple formation.

[0030] FIG. 1 illustrates a surgical stapling instrument, generally designated as stapling instrument 10. Stapling instrument 10 is a circular stapling instrument and includes a handle assembly 20, an adapter assembly 100 extending distally from handle assembly 20, a reload assembly 16 supported on a distal portion of adapter assembly 100, an anvil assembly 50 operably coupled to adapter assembly 100, and a controller 300 (FIG. 3A) supported within handle assembly 20. Reload assembly 16 supports an annular staple cartridge 48 containing a plurality of staples (not shown). Anvil assembly 50 includes an anvil head 28 including a staple-forming surface 29 (FIG. 2B) that defines staple-forming pockets 48a (FIG. 2B) and is movable relative to staple cartridge 48 between an open position and a clamped position.

[0031] Handle assembly 20 is shown as a powered assembly and includes a grip 22, an actuation button 24 for controlling the firing of staples (not shown) from annular staple cartridge 48 of reload assembly 16, and approximation buttons 26a, 26b for controlling the axial displacement of anvil assembly 50 toward and away from 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 may be made to U.S. Patent Application Publication Nos. 2020 / 0015820 and 2019 / 0343517. While the present disclosure illustrates a powered assembly, it is contemplated that the benefits of the present disclosure are also applicable to robotically operated surgical instruments, as described in detail below.

[0032] The handle assembly 20 may include an electrical assembly including a strain gauge 51 (FIG. 2B) configured to measure the strain applied to the lead screw 125, which also indicates the mechanical load on the motors (e.g., motors 152, 154, 156 in FIG. 2C) of the stapling instrument 10 resulting from staple formation when the staples "S" are fired from the staple cartridge 48 of the reload assembly 16 against the anvil assembly 50.

[0033] FIG. 2A shows adapter assembly 100 including first drive shaft 106, second drive shaft 108, and third drive shaft 110 coupled to drive shafts 152a, 154a, 156a of motors 152, 154, 156 (FIG. 2C) supported within handle assembly 20 (FIG. 1) for controlling various functions of stapling instrument 10 (e.g., clamping, stapling, and / or cutting tissue) when adapter assembly 100 is coupled to handle assembly 20. Drive shaft 106 within adapter assembly 100 is coupled by gears to drive assembly 114 to control movement of anvil assembly 50 between open and clamped positions relative to staple cartridge 48. Drive shaft 108 of adapter assembly 100 is coupled by gears to drive assembly 119 to control movement of pusher assembly 61 (FIG. 2B) within reload assembly 16 (FIG. 1) to control firing of staples from staple cartridge 48 (FIG. 1). Drive shaft 110 of adapter assembly 100 is coupled by gears to drive assembly 116 for controlled tissue cutting. Each of drive assemblies 114, 116, 119 (FIG. 2A) includes a screw and nut, not described in detail herein, where the nut is driven relative to the screw to effect longitudinal movement of the screw.

[0034] 1 illustrates a reload assembly 16 that includes a shell housing 46 supported on a distal portion of an outer tube 122 of an adapter assembly 100 and that supports a staple cartridge 48. In embodiments of the present disclosure, the staple cartridge 48 defines an annular array of staple-receiving pockets 48a that receive staples S. In some embodiments of the present disclosure, the reload assembly 16 is releasably coupled to a distal portion of a tubular shaft (not shown), facilitating replacement of the annular staple cartridge 48 after each use and promoting reuse of the surgical instrument 10. For a detailed description of exemplary embodiments of a powered handle assembly and a releasable adapter assembly, reference may be made to U.S. Pat. No. 10,085,744.

[0035] Each of staple-receiving pockets 48a (FIG. 2B) of staple cartridge 48 supports a staple (not shown) that can be fired from staple cartridge 48 via actuation of actuator button 24 of handle assembly 20. Shell housing 46 of reload assembly 16 defines an annular cavity 60. Annular cavity 60 supports a staple pusher 61 (FIG. 2B) and an annular knife 62 coupled to knife driver nuts 264 of drive assemblies 119 (FIG. 2A) and 116 (FIG. 2A), respectively, such that staple pusher 61 and annular knife 62 are movable relative to staple cartridge 48 to eject staples "S" from staple cartridge 48 and to cleave or cut tissue positioned within the annulus defined by staple cartridge 48. When staples "S" are fired from staple cartridge 48, staples "S" are driven into and formed in staple forming pockets 29a (FIG. 2B) of staple forming surface 29 of anvil head 28 of anvil assembly 50.

[0036] As noted above, the first, second, and third shafts are 106, 108, and 110 of the adapter assembly 100, which are coupled to the power handle assembly 20 by motor shafts 152a, 154a, 156a, which are coupled to motors 152, 154, 156 (FIG. 2C) within the handle assembly 20 by gear assemblies (not shown). Rotation of motor shafts 152 a, 154 a, 156 a by motors 152, 154, 156 is controlled by controller 300 such that motors 152, 154, 156 drive movement of shafts 106, 108, and 110 to move drive assembly 114, drive assembly 119, and drive assembly 116 a predetermined stroke to move anvil assembly 50 from an open position to a clamping position relative to staple cartridge 48 to define a predetermined tissue gap between anvil assembly 50 and staple cartridge 48, advance pusher 61 within shell housing 46 to eject staples "S" from staple cartridge 48, and advance knife carrier (not shown) within shell housing 46 to sever tissue. The predetermined stroke is calculated from a reference position based on the rotational position of motor drive shafts 152 a, 154 a, 156 a within handle assembly 20.

[0037] Drive assembly 119 (FIG. 2A) includes a staple lead screw 253 and a staple driver nut 254, which is driven relative to staple lead screw 253 to effect longitudinal translation of staple lead screw 253. Drive assembly 116 (FIG. 2A) includes a knife lead screw 263 and a knife driver nut 264, which is driven relative to knife lead screw 263 to effect longitudinal translation of knife lead screw 263.

[0038] When surgical stapling instrument 10 is fired, staple legs 504 (FIGS. 5A and 5B) are received within recesses (not shown) defined in respective staple forming pockets 48a (FIG. 2B) of anvil assembly 50. As staple legs 504 move into the recesses, legs 504 engage and form staple forming surfaces (not shown) of staple forming pockets 48a (FIG. 2B).

[0039] Handle assembly 20 may include a sensor, such as a strain gauge 51 (FIG. 2B), in communication with controller 300 (FIG. 3A) and configured to determine the load on the motor of surgical stapling instrument 10 resulting from tissue clamped between anvil assembly 50 and staple cartridge 48. This determination is used to determine the compressive force on tissue clamped between anvil assembly 50 and staple cartridge 48.

[0040] 3A illustrates 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 a volatile type of memory, such as RAM, or a non-volatile type of memory, such as flash media, disk media, etc. In various embodiments 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 embodiments of the present disclosure, network inference may also be achieved within a system with weights implemented as memristors, chemically, or other inference computations, as opposed to a processor.

[0041] In embodiments of the present disclosure, the memory 330 may be random access memory, read-only memory, magnetic disk memory, solid-state memory, optical disk memory, and / or another type of memory. In some embodiments of the present disclosure, the memory 330 may be separate from the controller 300 and may communicate with the processor 320 through a communication bus on 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 executable by the processor 320 to operate the controller 300. The memory 330 may include volatile (e.g., RAM) and non-volatile storage configured to store data, including software instructions for operating the handle assembly 20. In other embodiments of the present disclosure, the controller 300 may include a network interface 340 for communicating with other computers or servers. The storage device 310 may be used to store data.

[0042] In an embodiment of the present disclosure, the strain gauge 51 (FIG. 2B) is coupled to a processor, and the disclosed method is executed on the controller 300 or on a user device, including, for example, a mobile device, an IoT device, or a server system.

[0043] 3B, a schematic diagram of handle assembly 20, adapter assembly 200, and reload assembly 16 is shown. For simplicity, only one of motors 152, 154, 156, namely motor 152, is shown. Motor 152 is coupled to battery 144. In embodiments, motor 152 may be coupled to any suitable power source configured to provide electrical energy to motor 152, such as an AC / DC transformer.

[0044] The battery 144 and motor 152 are coupled to a motor controller circuit board 142a having a motor controller 143 that controls the operation of the motor 152, including the flow of electrical energy from the battery 144 to the motor 152. The main controller 300 (FIG. 3A) controls the handle assembly 20. The motor controller 143 includes a plurality of sensors 408a, 408b, ... 408n configured to measure the operating conditions of the motor 152 and the battery 144. The sensors 408a-n may include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. The sensors 408a-408n can measure the voltage, current, and other electrical characteristics of the electrical energy supplied by the battery 144. The sensors 408a-408n can also measure the angular velocity (e.g., rotational speed) of the motor 152, such as revolutions per minute (RPM), torque, temperature, current draw, and other operating characteristics. Angular velocity can be determined by measuring the rotation of motor 152 or drive shafts 106, 108, 110 (FIG. 2A) coupled thereto and rotatable by motor 152. Additionally, the position of the various axially movable drive shafts may be determined using various linear sensors disposed in or near the shafts or estimated from RPM measurements. In embodiments, torque can be calculated based on the stabilized current draw of motor 152 at a constant RPM. In further embodiments, motor controller 143 and / or main controller 300 may measure time and process such values ​​as a function of time, including integration and / or differentiation, to determine, for example, the rate of change of the measurements. Main controller 300 is also configured to determine the distance traveled by various components of circular adapter assembly 200 and / or reload assembly 16 by counting rotations of motors 152, 154, and 156.

[0045] Motor controller 143 is coupled to main controller 300, which includes a number of inputs and outputs for interfacing with motor controller 143. Specifically, main controller 300 receives measured sensor signals from motor controller 143 regarding the operating conditions of motor 152 and battery 144, and then outputs control signals to motor controller 143 to control the operation of motor 152 based on the sensor measurements and specific algorithm instructions, which are described in more detail below. Main controller 300 is also configured to receive a number of user inputs from a user interface (e.g., switches, buttons, touchscreen, etc. coupled to main controller 300).

[0046] The main controller 300 is also coupled to the strain gauges 51 of the circular adapter assembly 200 using a wired or wireless connection and is configured to receive strain measurements from the strain gauges 51 used during operation of the handle assembly 20.

[0047] Reload assembly 16 includes memory device 405 (e.g., chip 464c). Adapter assembly 200 also includes memory device 407. Memory devices 405 and 407 include non-volatile storage media (e.g., EEPROM) configured to store any data related to reload assembly 16 and circular adapter assembly 200, including, but not limited to, number of uses, identification information, model number, serial number, staple size, stroke length, maximum actuation force, minimum actuation force, factory calibration data, etc. In embodiments, the data may be encrypted and decryptable only by a device (e.g., main controller 300) with the appropriate key. The data may also be used by main controller 300 to authenticate circular adapter assembly 200 and / or reload assembly 16. Memory devices 405 and 407 may be configured in read-only or read / write mode, allowing main controller 300 to read and write data to memory devices 405 and 407.

[0048] 4 shows a flow chart of a computer-implemented method 400 for controlling the surgical stapling instrument 10 to determine whether functionally closed staple formation has been achieved when a current or force limit is measured. A method of forming an end-to-end anastomosis using the disclosed surgical stapling instrument 10 includes clamping tissue and firing staples "S" into the tissue with the surgical stapling instrument 10. During the staple firing phase, the motor 154 drives the shaft 108 to move the drive assembly 119 a predetermined stroke (e.g., from a first position to a second position) to advance the pusher 61 within the shell housing 46 and eject the staples "S" from the staple cartridge 48 (step 402).

[0049] As the pusher 61 moves relative to the anvil assembly 50, if the controller 300 determines that the pusher 61 has stopped advancing toward the anvil assembly 50 before reaching the predetermined second position (step 404), the staple compression force on the staples "S" clamped between the staple cartridge 48 and the anvil assembly 50 is measured (step 406). As described above, the staple force of the staples "S" clamped between the anvil assembly 50 and the pusher 61 in the reload assembly 16 (FIG. 1) can be measured using a strain gauge 51 in communication with the controller 300. Alternatively, other force or strain measuring devices may be used to measure the clamping pressure of the staples clamped between the anvil assembly 50 and the pusher 61. In various embodiments, the current draw of the motor 154 can be used by the controller 300 to indicate the staple compression force.

[0050] The controller 300 determines whether the staple compression force is outside of a predetermined tolerance range, step 408. For example, the staple compression force may spike outside the range of forces measured during staple formation.

[0051] If the compression force applied to the staples is within the predetermined acceptable compression range, the surgical stapling instrument 10 enters a tissue cutting mode, allowing the surgeon to cut the tissue and complete the procedure (step 410). In embodiments, the predetermined acceptable staple compression range may vary depending on the type of tissue being treated and may be set automatically by the instrument 10 or the user. In various embodiments, the predetermined acceptable staple compression range may be based on the use of different reloads, different staple heights, and / or different types of surgical staplers.

[0052] If the compression force is greater than the predetermined allowable compression range, pusher 61 is retracted and surgical stapling instrument 10 exits the firing mode (step 412). In some aspects of the present disclosure, the controller may provide a warning, for example, on a display 146 (FIG. 1) disposed on the handle assembly of the surgical stapling instrument, to alert the surgeon that the compression force on the tissue is not within the predetermined compression range so that the surgeon can reposition surgical stapling instrument 10 on the tissue. In some aspects, the warning may be an audio warning, for example, a beep or a verbal warning to inspect the surgical site.

[0053] While the present disclosure is directed to a powered surgical stapling instrument, it is envisioned that the principles of the present disclosure are applicable to manual stapling instruments. For example, the clamping pressure on tissue clamped between the anvil assembly and staple cartridge of the stapling instrument can be measured as the stapling instrument moves through a predetermined acceptable tissue gap range. In such a device, an indicator, such as a light, can be provided with the instrument. When the tissue clamping pressure enters a predetermined acceptable compression range with the instrument within the predetermined acceptable gap range, the indicator can be activated to notify the surgeon that the instrument is ready to fire.

[0054] Although aspects of the present disclosure are illustrated in connection with a circular stapling instrument, it is envisioned that they are equally applicable to other types of stapling instruments, including linear stapling devices, vessel sealing devices, and other devices for joining tissue portions together.

[0055] Those skilled 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 400 may be operated in controller 300 (FIG. 3A), in a remote device, or in another server or system. Other variations are contemplated within the scope of the present disclosure. Although the operations of method 400 are described with respect to a controller, e.g., controller 300 (FIG. 3A) of surgical stapling instrument 10 (FIG. 3A), it will be understood that the illustrated operations are applicable to other systems and their components as well.

[0056] Those skilled in the art will understand that the apparatus and methods specifically described herein and illustrated in the accompanying drawings are non-limiting. It is contemplated that the elements and features may be combined with other elements and features without departing from the scope of the present disclosure. Likewise, those skilled in the art will recognize additional features and advantages of the present disclosure.

Claims

1. 1. A method for controlling a surgical stapling instrument, said method being executed by a processor of said surgical stapling instrument, said method comprising: advancing a pusher from a first position to a second position toward an anvil assembly of the surgical stapling instrument, the pusher configured to eject staples from a staple cartridge of the surgical stapling instrument when the pusher is advanced to the second position; determining whether the pusher has stopped advancing toward the anvil assembly prior to the second position; measuring a clamping pressure of a staple clamped between the anvil assembly and the pusher; determining whether the clamping pressure is outside a predetermined range; A method comprising:

2. The method of claim 1 , further comprising preventing staples from being ejected in response to the clamping pressure being greater than the predetermined range.

3. The method of claim 2 , further comprising displaying a warning in response to the clamping pressure being greater than the predetermined range.

4. The method of claim 3 , wherein the displayed warning includes at least one of a warning to inspect the surgical site or a warning to unclamp tissue.

5. The method of claim 2 , further comprising retracting the pusher if the clamping pressure is greater than the predetermined range.

6. The method of claim 1 , further comprising generating an audio warning in response to the clamping pressure being greater than the predetermined range.

7. 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 a pusher and an annular staple cartridge containing a plurality of staples, the pusher configured to advance from a first position to a second position and configured to eject the staples from the annular staple cartridge when the pusher advances to the second position; a processor; The memory where the instructions are stored Equipped with The instructions, when executed by the processor, advancing the pusher toward the anvil assembly from the first position to the second position; determining whether the pusher has stopped advancing toward the anvil assembly prior to the second position; measuring a clamping pressure of staples clamped between the anvil assembly and the pusher in response to the pusher ceasing to advance toward the anvil assembly; determining whether the clamping pressure is outside a predetermined range; A surgical stapling instrument that causes the surgical stapling instrument to perform the stapling.

8. 8. The surgical stapling instrument of claim 7, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to prevent staples from being ejected in response to the clamping pressure being greater than the predetermined range.

9. 9. The surgical stapling instrument of claim 8, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to display a warning on a display if the clamping pressure is greater than the predetermined range.

10. The surgical stapling instrument of claim 9, wherein the displayed warning includes at least one of a warning to inspect the surgical site or a warning to unclamp tissue.

11. The surgical stapling instrument of claim 8, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to retract the pusher if the clamping pressure is greater than the predetermined range.

12. 8. The surgical stapling instrument of claim 7, wherein the instructions, when executed by the processor, further cause the surgical stapling instrument to generate an audio alert in response to the clamping pressure being greater than the predetermined range.

13. 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 comprises: advancing a pusher from a first position to a second position toward an anvil assembly of the surgical stapling instrument, the pusher configured to eject staples from a staple cartridge of the surgical stapling instrument when the pusher is advanced to the second position; determining whether the pusher has stopped advancing toward the anvil assembly prior to the second position; measuring a clamping pressure of staples clamped between the anvil assembly and the pusher in response to the pusher ceasing to advance toward the anvil assembly; determining whether the clamping pressure is outside a predetermined range; a non-transitory computer-readable medium,

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