Strain and compressive force measurement features for surgical staplers

Abstract

In one embodiment, an apparatus includes: a first elongate member and a second elongate member releasably coupleable together to cooperate to clamp and staple tissue; a latch member capable of latching the first elongate member and the second elongate member to grip tissue; the percussion assembly can be used for cutting off and suturing the clamped tissue; and a strain measurement assembly associated with the first elongate member. The strain measurement assembly is configured to measure a strain value on the first elongate member, compare the strain value to a predetermined limit associated with successful nail forming, and generate a signal in response to the comparison.

Description

Background Art

[0001] In some surgical procedures such as gastrointestinal anastomosis, it may be desirable to clamp one or more tissue layers, cut through the clamped layers, and simultaneously drive the nail through the layers to substantially seal the cut layers together near the cut ends of the tissue layers. A type of such instrument that can be used in such surgery is a linear surgical stapler, also referred to as a "linear cutter". A linear surgical stapler generally includes a first half (referred to as a "bin half" or "reload half") and a second half (referred to as an "anvil half"), the first half having a distal jaw configured to support a staple cartridge (or "reload"), and the second half having a distal jaw supporting an anvil surface with a staple forming feature structure. The stapler also includes a movable clamping lever, which is configured to releasably clamp these stapler halves together. These stapler halves are configured to releasably couple together and pivot relative to each other to clamp the tissue between the two distal jaws when the clamping lever is closed. The firing assembly of stapler is configured to be able to actuate to cut the clamped layer and drive nail to pass the tissue on either side of cutting line simultaneously.After stapler is fired, clamping lever can be opened and stapler half part separates to release the tissue of cutting off and stitching.

[0002] While various surgical stapling instruments and associated components have been made and used, it is believed that no one prior to the inventor has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0004] Figure 1 A perspective view of an exemplary linear surgical stapler is shown showing the cartridge half and the anvil half of the stapler coupled together with the clamping levers of the cartridge half in a fully closed position;

[0005] Figure 2 Shows Figure 1 An exploded perspective view of a linear surgical stapler, further showing a staple cartridge;

[0006] Figure 3 Shows Figure 1 A perspective view of a distal end portion of an anvil half of a linear surgical stapler;

[0007] Figure 4 Shows Figure 2 A perspective view of a distal end portion of a staple cartridge;

[0008] Figure 5 Shows Figure 1 A cross-sectional perspective view of a proximal portion of a cartridge half of a linear surgical stapler with a clamping lever in an open position to show details of a firing assembly and a retaining assembly of the cartridge half;

[0009] Figure 6 Shows Figure 5 An exploded perspective view of a retaining assembly;

[0010] Figure 7 Shows Figure 5 Another exploded perspective view of the retaining assembly;

[0011] Figure 8 Shows Figure 5 A perspective view of a firing assembly;

[0012] Fig.9A Shows Figure 1 A side elevation view of a linear surgical stapler of , showing the stapler halves separated from each other and the clamping lever in an open position;

[0013] Fig. 9B Shows Figure 1 A side elevation view of a linear surgical stapler of , showing the proximal ends of the stapler halves coupled together to provide the stapler in a "hanging open" state when the clamping lever is in an open position;

[0014] Fig. 9C Shows Figure 1 A side elevation view of a linear surgical stapler showing distal portions of stapler halves having been approximated such that a distal pin of anvil half is received by a clamping lever jaw of cartridge half;

[0015] Fig.9D Shows Figure 1 A side elevation view of a linear surgical stapler of , showing the closure of the clamping levers completely clamping the stapler halves together;

[0016] Fig.9E Shows Figure 1 A side elevation view of a linear surgical stapler of , showing distal actuation of the firing assembly when the stapler halves are in a fully clamped state;

[0017] Fig. 10A Shows Figure 1 A side elevation view of a linear surgical stapler showing the distal portion of the stapler half having been approximated, wherein tissue is present, and Fig. 9C The distal pin of is initially received by the clamping lever jaws of the cartridge half;

[0018] Fig. 10B Shows Figure 1A side elevation view of a linear surgical stapler of , showing closure of the clamping levers clamping the stapler halves together to grasp tissue therebetween;

[0019] Fig.11A Shows Figure 1 A side elevation view of a linear surgical stapler showing the distal portion of the stapler half having been approximated, wherein tissue is present, and Fig. 9C The distal pin of the cartridge is not aligned with the clamping lever jaws of the cartridge half;

[0020] Fig. 11B Shows Figure 1 A side elevation view of a linear surgical stapler showing the closure of the clamping lever while Fig. 9C The distal pin of is still not aligned with the clamping lever jaws of the cartridge half;

[0021] Fig.12 An exploded perspective view of an alternative linear surgical stapler having a cartridge half and an anvil half, wherein the anvil half has an anvil strain measurement assembly;

[0022] Fig.13 Shows Fig.12 a cross-sectional view of a portion of an anvil half;

[0023] Fig.14 A flow chart illustrating an exemplary method of using a linear surgical stapler having an anvil strain measurement assembly;

[0024] Fig.15 A perspective view of an alternative linear surgical stapler having a grip quality indicator is shown which indicates that the distal portion of the stapler half is properly gripping tissue such that the risk of poorly formed or split staples is low;

[0025] Fig.16 Shows Fig.15 A perspective view of a linear surgical stapler, wherein Fig.15 The grip quality indicator indicates that the distal portion of the stapler half is improperly grasping tissue, so that the risk of poorly formed or split staples is high;

[0026] Fig.17 A perspective view of an alternative linear surgical stapler having a grip quality indicator is shown which indicates that the distal portion of the stapler half is properly gripping tissue such that the risk of poorly formed or split staples is low;

[0027] Fig.18 Shows Fig.17 A perspective view of a linear surgical stapler, wherein Fig.17The grip quality indicator indicates that the distal portion of the stapler half is improperly grasping tissue, so that the risk of poorly formed or split staples is high;

[0028] Fig.19 shows a perspective view of an alternative linear surgical stapler having a grip quality indicator indicating that the distal portion of the stapler half is properly gripping tissue so that the chance of high quality staple formation is high;

[0029] Fig. 20 Shows Fig.19 A perspective view of a linear surgical stapler, wherein Fig.19 A grip quality indicator indicates that the distal portion of the stapler half is improperly gripping tissue such that the chance of high-quality staple formation is low;

[0030] Fig.21 A flow chart illustrating an exemplary method of using a linear surgical stapler having an anvil strain measurement assembly;

[0031] Fig. 22 Shows Fig.19 A perspective view of a linear surgical stapler of FIG. 1 showing the closing of the clamping lever while the distal pin of the anvil half is misaligned with the clamping lever jaws of the cartridge half, wherein Fig.19 A grip quality indicator indicates that the distal portion of the stapler half is improperly gripping tissue, making the chance of high-quality staple formation essentially zero;

[0032] Fig.23 A flow chart illustrating an example method of calibrating an anvil strain measurement assembly of a linear surgical stapler;

[0033] Fig.24A shows a cross-sectional view of an alternative linear surgical stapler having an anvil strain measurement assembly with a locking device, wherein the locking device is in a locked configuration;

[0034] Fig. 24B shows a cross-sectional view of an alternative linear surgical stapler having an anvil strain measurement assembly with a locking device, wherein the locking device is in an unlocked configuration;

[0035] Fig.25 showing a perspective view of a laparoscopic anvil with anvil strain measurement assembly; and

[0036] Fig.26 Shows that there is Fig.25 A perspective view of a laparoscopic end effector with an anvil showing the end effector grasping tissue.

[0037] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be performed in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; however, it should be understood that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION

[0038] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. According to the following description shown by way of example, other examples, features, aspects, embodiments and advantages of the present invention will be apparent to those skilled in the art, and a best mode is contemplated for implementing the present invention. As will be appreciated, the present invention can have other different and obvious aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered to be illustrative and non-restrictive in nature.

[0039] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator grasping a surgical instrument having a distal surgical end effector. The term "proximal" refers to a position where an element is disposed closer to the surgeon, and the term "distal" refers to a position where an element is disposed closer to the surgical end effector of the surgical instrument and further away from the surgeon. In addition, to the extent that spatial terms such as "upper," "lower," "vertical," "horizontal," and the like are used herein with reference to the accompanying drawings, it should be understood that such terms are used for illustrative descriptive purposes only and are not intended to be limiting or absolute. In this regard, it should be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.

[0040] Additionally, the terms "about" and "approximately" as used herein in connection with any numerical values ​​or ranges represent a suitable dimensional tolerance that allows the referenced features to function for the intended purpose described herein.

[0041] I. Exemplary Linear Surgical Stapler

[0042] A. Overview of Linear Surgical Staplers

[0043] Figure 1 to Figure 2 An exemplary linear surgical stapler (10) (also referred to as a "linear cutter") suitable for use in a variety of cutting and stapling procedures (such as gastrointestinal anastomosis procedures) is shown. The linear surgical stapler (10) includes a cartridge half (12) (also referred to as a "reloading half") and an anvil half (14), which are configured to be releasably coupled together to clamp tissue therebetween for simultaneous cutting and stapling of the clamped tissue.

[0044] The cartridge half (12) includes a first elongated member in the form of an elongated cartridge channel (16) having a proximal frame portion (18) and a distal jaw portion (20). The proximal frame portion (18) slidably holds the firing assembly (110) and includes a pair of laterally opposed upright side flanges (22). Each side flange (22) includes a vertical slot (24) disposed at its distal end and a tapered recess (26) disposed at its proximal end. An outwardly projecting rigid rib (28) extends longitudinally between the distal slot (24) and the proximal recess (26) of each side flange (22) and is configured to provide enhanced rigidity to the side flange (22). An outwardly flared upper section (30) defines an upper edge of the proximal portion of each side flange (22) and is configured to facilitate the cartridge half (12) to receive the anvil half (14). Each side flange (22) also includes an elongated firing slot (32) extending longitudinally along the underside of the side flange (22) between the proximal notch (26) and the distal slot (24). The elongated firing slot (32) is configured to guide the firing assembly (110) between a proximal position and a distal position. Figure 8 Firing assembly (110) is described in greater detail.

[0045] The distal jaw portion (20) of the cartridge channel (16) is configured to releasably receive (or "reload") a staple cartridge (140). Figure 4 As shown, staple cartridge (140) includes a cartridge body (142) having an upper side defining a first stapling surface in the form of a deck (156) having a plurality of staple openings (166) for accommodating a plurality of staples and corresponding staple drivers.

[0046] The bin half (12) further includes a clamping member (also referred to as a "clamping arm" or "latch lever") in the form of a clamping lever (40) pivotably coupled to the bin channel (16) using a clamping lever pivot pin (42) disposed generally aligned with the distal slot (24) of the bin channel side flange (22). The clamping lever (40) includes an elongated lever arm (44) having a free proximal end (46) and a distal end pivotably coupled to a lower portion of the bin channel (16) using the pivot pin (42). A pair of opposed jaws (48) extend distally from the distal end of the lever arm (44) beside the bin channel side flange (22). Each jaw (48) includes a curved slot (50) having a closed proximal end and an open distal end configured to receive a latch pin (68) of anvil half-section (14), as described below.

[0047] The clamping lever (40) is operable to pivot relative to the cartridge channel (16) between an open position and a closed position, wherein the proximal end (46) of the lever arm (44) is spaced apart from the cartridge channel frame portion (18) (as described below). 9A to 9C In the closed position, the proximal end (46) faces the bin channel frame portion (18) (as described below). Fig.9D Actuation of the clamping lever (40) from the open position to the closed position serves to capture the opposite side ends of the latch pin (68) within the clamping lever jaw slot (50) and thereby clamp the anvil half (14) against the cartridge half (12), as described below in conjunction with FIG. 9C to FIG. 9D As shown and described. In this regard, the curvature of each jaw slot (50) defines a corresponding upper cam surface and a lower cam surface, which are configured to engage the corresponding side ends of the latch pin (68) and pull it toward the bin channel (16) when the clamping lever (40) is pivotally closed. A resilient member shown in the form of a leaf spring (52) biases the lever arm (44) toward the open position. Therefore, when the clamping lever (40) is initially advanced from the closed position toward the open position, the leaf spring (52) promotes the clamping lever jaws (48) to disengage from the anvil half latch pin (68).

[0048] like Figure 2 As best shown, the clamping lever (40) further includes a latch member (54) disposed at the proximal end (46) of the lever arm (44). The clamping lever latch member (54) is configured to resiliently and releasably engage the proximal end of the bin channel frame portion (18), and thereby releasably retain the clamping lever (40) in a closed position, for example, when the stapler (10) is fired. The clamping lever latch member (54) may also be constructed in accordance with the teachings of U.S. Patent No. 11,278,285, entitled “Clamping Assembly for Linear Surgical Stapler,” issued on March 22, 2022, the disclosure of which is incorporated herein by reference.

[0049] The anvil half (14) of the linear surgical stapler (10) includes a second elongated member in the form of an elongated anvil channel (60), the elongated anvil channel having a proximal frame portion (62) and a distal jaw portion (64). The proximal frame portion (62) includes a pair of transversely opposite upright side flanges (66), which are configured to be received between the chamber channel side flanges (22) when the anvil half (14) is connected to the chamber half (12). A distal latch projection in the form of a latch pin (68) extends transversely through the distal end of the anvil channel side flange (66), and a proximal pivot projection in the form of a proximal pin (70) extends transversely through the proximal end of the anvil channel side flange (66). The anvil half pins (68, 70) are configured to facilitate the connection of the anvil half (14) with the chamber half (12), as described below.

[0050] like Figure 2 and Figure 3As shown, the distal jaw portion (64) of the anvil half (14) supports an anvil plate (72), which defines a second suturing surface in the form of an anvil surface having a plurality of staple forming recesses (74), which are configured to deform the legs of the staples ejected from the staple cartridge (140) when the stapler (10) is fired. The staple forming recesses (74) of this example can be formed via an embossing process and are configured to enable each staple in the staple cartridge (140) to form a three-dimensional shape, wherein the legs of each formed staple are laterally offset from each other to provide a non-planar shape for the formed staples, for example, as disclosed in U.S. Patent No. 11,229,433, entitled “Linear Surgical Stapler”, published on January 25, 2022, the disclosure of which is incorporated herein by reference. The anvil channel (60), anvil plate (72) and staple forming pockets (74) may be formed in one or more of the ways disclosed in the following patents: U.S. Patent No. 11,229,433; U.S. Patent No. 11,045,193, entitled "Anvil Assembly for Linear Surgical Stapler" issued on June 29, 2021; and / or U.S. Publication No. 2022 / 0142641, entitled "System and Method for Forming Pockets in Anvil of Surgical Stapler" issued on May 12, 2022, the disclosures of which are incorporated herein by reference. For example, the distal jaw portion (64) of the anvil half (14) may be preformed with a certain curvature along its length, which accommodates the deflection of the distal jaw portion (64) and the anvil plate (72) when the stapler halves (12, 14) are clamped together by the clamping lever (40). The distal jaw portion (64) of the anvil half (14) further supports a tapered distal tip member (76). In some versions, the distal tip member (76) can be selectively extended relative to the distal jaw portion (64) in accordance with the teachings of U.S. Patent No. 11,033,266, entitled "Decoupling Mechanism for Linear Surgical Stapler," issued on June 15, 2021, the disclosure of which is incorporated herein by reference.

[0051] like Figure 2As shown, the linear surgical stapler (10) also includes a pair of covers (56, 78), which cover the selected portion of the stapler (10) and enhance the operator's effective grip and manipulation of the stapler (10) during use. In this example, the clamping lever cover (56) is attached to and covers the outward-facing side of the clamping lever (40), so that the clamping lever cover (56) is configured to pivot relative to the bin channel (16) with the clamping lever (40). In addition, the anvil cover (78) is attached to and covers the outward-facing side of the anvil channel (60). In some versions, the anvil cover (78) can be connected to the anvil channel (60) via the interaction between the pin (68, 70) and one or more tabs, ribs or other structures, which are arranged in the interior of the anvil cover (78) and include an opening, a slot, a key hole or other feature configured to receive a corresponding one of the pins (68, 70). By way of example only, covers (56, 78) may be attached using one or more of the teachings of U.S. Patent No. 11,278,285, which is incorporated by reference above. In other versions, covers (56, 78) may be coupled to clamp lever (40) and anvil channel (60) in various other suitable ways as would be apparent to one of ordinary skill in the art in light of the teachings herein.

[0052] like Figure 2 and Figures 5 to 7 As best shown, the proximal end of the magazine half (12) includes a retaining assembly (80) that is configured to releasably retain the anvil half (14) and a portion of the firing assembly (110). The retaining assembly (80) of this example includes a first movable retaining member in the form of an anvil latch member (82) and a second movable retaining member in the form of a stop member (84). The anvil latch member (82) and the stop member (84) are rotatably coupled to the proximal end of the magazine channel (16) via a transversely extending pin (85) disposed proximal to the firing slot (32), and the members (82, 84) are resiliently biased in opposite rotational directions by a resilient member in the form of a torsion spring (86) positioned between the members (82, 84).

[0053] The anvil latch member (82) includes a central body (88), a latch finger (90) extending upwardly from the central body (88), and a release button (92) extending downwardly from the central body (88) through the base wall of the proximal frame portion (18) of the chamber channel (16). The upper end of the latch finger (90) tapers distally and is configured to releasably capture the proximal anvil pin (70) of the anvil half (14) with an angled latch surface (94) that covers the proximal anvil pin (70) once captured. The anvil latch member (82) also includes a pin ejection feature in the form of an angled protrusion (96) extending distally from the base portion of the latch finger (90) and defining an ejection cam ramp (98) facing the latch finger (90) proximally.

[0054] The stop member (84) of the proximal retention assembly (80) includes a generally cylindrical central body (100), a distal finger (102) extending distally from the central body (100), and a proximal hook (104) extending proximally from the central body (100). The distal finger (102) is configured to releasably engage the proximal end of the firing assembly (110) and thereby retain the firing assembly (110) in a proximal home position. The proximal hook (104) is configured to cover and capture the upper end of the clamp lever latch member (54) when the clamp lever (40) is fully closed and the firing assembly (110) is translated distally from its proximal home position, thereby preventing the clamp lever (40) from opening during the firing stroke, for example, as described in more detail in U.S. Pat. No. 11,278,285, which is incorporated by reference above.

[0055] In use, with the stapler halves (12, 14) coupled together at their proximal ends so that the proximal anvil pin (70) is retained by the anvil latch member (82), and with the clamping lever (40) in the open position, distal actuation of the lower release button (92) causes the anvil latch member (82) to rotate about the pin (85), causing the ejector cam ramp (98) to advance proximally to drive the proximal anvil pin (70) upwardly out of the proximal tapered recess (26) of the cartridge channel (16). The cartridge half (12) of this version also includes a stationary finger gripping projection (106) extending downwardly from the base wall of the proximal frame portion (18) of the cartridge channel (16) at a location distal to the lower release button (92) and configured to facilitate actuation of the release button (92). Specifically, the user can apply his or her thumb to the proximal side of the release button (92) and one or more fingers to the distal side of the finger gripping protrusion (106), and then squeeze the release button (92) distally toward the stationary finger gripping protrusion (106) to rotate the latch finger (90) out of engagement with the proximal anvil pin (70) and eject the pin (70) upward from the magazine channel (16) using the ejection cam ramp (98).

[0056] The retaining assembly (80) and associated components of the cartridge half (12) may be constructed and operated in accordance with the teachings of one or more of: U.S. Patent No. 10,898,187, entitled “Firing System for Linear Surgical Stapler,” issued on January 26, 2021; and / or U.S. Patent No. 11,033,266, which are incorporated by reference above.

[0057] like Figure 8As shown, the firing assembly (110) of the cartridge half (12) includes a slide (112), a pair of actuators (114, 116) (or "firing knobs") pivotably coupled to the slide (112), and a set of elongated beams (118, 122) extending distally from the slide (112). A pair of side beams (118) are coupled to the distal end of the slide (112) at their proximal ends and terminate distally in a pair of cam ramps (120). The cam ramps (120) are configured to engage the underside of a staple driver (not shown) contained in the staple cartridge (140) and actuate the staple driver (not shown) upward, thereby driving (or "firing") staples from the staple cartridge (140) into tissue clamped between the staple cartridge (140) and the anvil plate (72). The central beam (122) is coupled to the side beams (118) via a bridging member (124) (or "knife block") that is distally spaced from the slide (112). The central beam (122) terminates distally in a distally angled knife member (126) having a distal cutting edge (128) configured to cut tissue clamped between the distal portions of the stapler halves (12, 14).

[0058] Each actuator (114, 116) of the firing assembly (110) is configured to be rotatable relative to the slide (112) between a deployed position and a retracted position so that only one actuator (114, 116) can be deployed at a time, for example, as disclosed in U.S. Pat. No. 10,898,187, which is incorporated by reference above. In the deployed position, the actuator (114, 116) can be driven distally by an operator to actuate the firing assembly (110) to pass distally through the stapler (10), thereby simultaneously cutting and suturing the tissue clamped between the stapler halves (12, 14).

[0059] B. Exemplary Use of a Linear Surgical Stapler

[0060] 9A to 9E An exemplary coupling of stapler halves (12, 14) and subsequent firing of the assembled stapler (10) during a surgical procedure is shown. Fig.9A As shown, the clamping lever (40) of the cartridge half (12) is set in the open position so that the jaw slot (50) is aligned with the vertical slot (24) of the cartridge channel side flange (22). In addition, the firing assembly (110) is retained in its proximal original position by the stop member (84) of the retaining assembly (80), as described above. Figure 5At this stage, the tissue portion to be stapled and cut (not shown) can be positioned above the top of the staple cartridge (140) disposed in the distal jaw portion (20) of the cartridge half (12). Alternatively, after the proximal ends of the stapler half (12, 14) described below are coupled, the tissue can be positioned above the staple cartridge (140).

[0061] like FIG. 9A to FIG. 9B As shown, the proximal ends of the stapler halves (12, 14) are aligned with each other, and the proximal anvil pin (70) is guided downwardly into the proximal conical recess (26) of the cartridge channel (16) to engage the latch finger (90) of the anvil latch member (82). This engagement forces the anvil latch member (82) to resiliently rotate clockwise, thereby enabling the latch finger (90) to capture the anvil pin (70) and thereby releasably couple the proximal ends of the stapler halves (12, 14) together, as shown in FIG. Fig. 9B As shown. When the clamping lever (40) is still in the Fig. 9B In the open position shown, the stapler (10) is arranged in a "hanging open" state so that the stapler (10) can be held by the anvil half (14) in one hand while the cartridge half (12) remains coupled to the anvil half (14). Fig. 9C As shown, and with the clamping lever (40) maintained in the open position, the anvil half (14) is rotated about the proximal anvil pin (70) toward the anvil half (14), so that the distal latch pin (68) of the anvil half (14) is received in the vertical slot (24) of the cartridge channel side flange (22) and the jaw slot (50) of the clamping lever (40). The distal jaw portions (20, 64) of the stapler half (12, 14) are now in a partially approximated state, allowing final adjustment of the tissue received therebetween before clamping.

[0062] like Fig.9D As shown, the clamping lever (40) is closed to pull the anvil latch pin (68) against the closed proximal end of the jaw slot (50), and thereby completely clamp the anvil half (14) against the magazine half (12), wherein tissue (not shown) is clamped between the suturing surfaces defined by the staple magazine (140) and the anvil plate (72). The tissue gap column (162) of the staple magazine (140) defines a small lateral gap between the staple magazine (140) and the anvil plate (72), thereby accommodating the tissue therebetween at a predetermined degree of tissue compression. Fig.9A and Fig. 9B As shown, the tissue gap post (162) is disposed at the distal end of the staple cartridge (140) and is configured to be able to be stapled when the stapler (10) is in Fig.9DIn the fully clamped state shown, the distal end of the anvil plate (72) is in contact. In response to the clamping lever (40) reaching the fully closed position, the clamping lever latch member (54) can rotate to capture the proximal end of the base wall of the cartridge channel (16) and thereby assume a latched state in which the clamping lever latch member (54) maintains the clamping lever (40) in the closed position.

[0063] like Fig.9E As shown, when the fully clamped state is reached, the deployed actuator (114, 116) of the firing assembly (110) can be driven distally along the proximal frame portion (18) of the magazine half (12) to fire the stapler (10). This action causes the elongated beams (118, 122) of the firing assembly (110) to translate distally through the corresponding channels formed in the staple magazine (140), and thereby the staples are fired into the clamped tissue via the cam ramp (120) and the staple driver (not shown), while the clamped tissue is cut using the knife member (126). After completing the firing stroke, the firing assembly (110) returns to its proximal original position via the actuator (114, 116). The clamping lever latch member (54) can then be pressed down to release the proximal end of the clamping lever (40) from the magazine channel (16), thereby allowing the clamping lever (40) to reopen. Then, the release button (92) of the retaining assembly (80) can be depressed to release the anvil half (14) from the cartridge half (12), so that the stapler halves (12, 14) can be separated from each other, thereby releasing the newly sutured and severed tissue. It should be understood that in some versions, the stapler (10) may include additional features that facilitate the disengagement of the stapler halves (12, 14), for example, as disclosed in U.S. Patent No. 11,033,266, which is incorporated by reference above.

[0064] C. Linear surgical stapler with anvil strain measurement assembly

[0065] As described above, the anvil latch pin (68) of the anvil half (14) is received in the curved slot (50) of the jaws (48), so that the clamping lever (40) can be pivoted from the open position toward the closed position, thereby clamping the anvil half (14) toward the magazine half (12), thereby grasping and clamping tissue. In addition, the grasped tissue between the suturing surface of the staple cartridge (140) and the anvil plate (72) can be cut and sutured.

[0066] In some cases, such as FIG. 10A to FIG. 10B As shown in the figure, the tissue grasped and clamped between the staple cartridge (140) and the anvil plate (72) may be too thick, so that an undesirably large gap distance (d1) is defined between the staple forming recesses (74) of the anvil plate (72) and the platform (156) of the cartridge (140). Such gap distance (d1) may also increase toward the distal end, such as Fig. 10BIf the gap distance (d1) is too large, the nail fired from the nail magazine toward the anvil plate (72) may not be properly formed, either resulting in poorly formed nails or "open" nails, both of which may not properly engage the nail forming recesses (74) of the anvil plate (72). In addition, when the grasped tissue is too thick, the distal jaw portion (64) of the elongated anvil channel (60) may withstand a large closing force to clamp thicker tissue compared to the case of clamping an appropriate tissue thickness.

[0067] like FIG. 11A to FIG. 11B As shown in the figure, when the clamping lever (40) is pivoted from the open position to the closed position and the anvil latch pin (68) is not received in the curved slot (50) of the jaws (48), the tissue between the nail magazine (140) and the anvil plate (72) may never be properly clamped or grasped, leaving an undesirably large gap distance (d2). In the presence of an undesirably large gap distance (d2), the nails fired from the nail magazine toward the anvil plate (72) may be improperly formed due to reasons similar to those described above. In addition, when the anvil latch pin (68) is never received in the curved slot (50) of the jaws (48), the distal jaw portion (64) of the elongated channel (60) may experience little to no closing force because the clamping lever (40) is not properly engaged with the latch pin (68).

[0068] In the case where the clamping lever (40) provides a closing force to clamp the tissue via engagement with the latch pin (68), the closing force is transmitted to the distal jaw portion (64) via the latch pin (68). Therefore, during exemplary use according to the teachings herein, a portion of the distal jaw portion (64) adjacent to the latch pin (68) may cause a greater strain deformation value than a portion of the distal jaw portion (64) further away from the latch pin (68). The strain deformation value of the distal jaw portion (64) may indicate the closing force acting on the distal jaw portion (64) during exemplary use according to the teachings herein. As described above, if such a closing force is too high, this may indicate an excessive gap distance (d1) caused by excessively thick tissue. As also described above, if such a closing force is too low, this may also indicate that the gap distance (d2) caused by the anvil latch pin (68) never entering the curved slot (50) of the jaws (48) is too large. Therefore, it may be desirable to monitor the strain deformation of distal jaw (64), as such strain deformation may indicate an appropriate or inappropriate gap distance, which may affect the staple forming quality of the fired staples.

[0069] Fig.12An alternative exemplary linear surgical stapler (210) is shown, which is substantially similar to the above-mentioned linear surgical stapler (10), and the differences are described in detail below. Therefore, the linear surgical stapler (210) includes a cartridge half (12), an anvil half 14, an elongated cartridge channel (16), a clamping lever (40), an anvil channel (60), a firing assembly (110) and a replaceable staple cartridge (140). In addition, the linear surgical stapler (210) includes an anvil strain measurement assembly (220) contained in an inner cavity (79) defined by a cover (78) of the anvil half (14). As will be described in more detail below, the anvil strain measurement assembly (220) is configured to measure strain on a top surface (65) of an elongated anvil channel (60) adjacent anvil latch pin (68) during exemplary use of a surgical stapler (210), compare the measured strain to one or more predetermined limits, and based on the comparison determine / communicate a risk that a fired staple is poorly formed or open.

[0070] The anvil strain measurement assembly (220) includes a strain gauge (222), a control assembly (224), and a power source such as a battery (226). Fig.13 As best shown in , the strain gauge (220) is operatively connected to the control assembly (224) via the wire (228). Similarly, the control assembly (224) is operatively connected to the battery (226) via the wire (228). In the current example, the battery (226) and the control assembly (224) are suitably coupled to the cover (78) and housed within the inner cavity (79) defined by the cover (78). The battery (226) and the control assembly (224) may be coupled to the cover (78) via any suitable means, as will be apparent to those skilled in the art based on the teachings herein. As will be described in more detail below, the strain gauge (222) is attached to the top surface (65) of the elongated anvil channel (60).

[0071] The battery (226) is configured to be able to power the necessary components of the anvil strain measurement assembly (220). The battery (226) may include any appropriate components, as will be apparent to those skilled in the art based on the teachings herein. In some cases, the battery (226) may be connected to a switch (or other appropriate mechanism) that is configured to selectively activate the battery (226) so that the user can selectively activate the anvil strain measurement assembly (220). Such a switch may be present on the outer surface of the cover (78) or in any other appropriate location. Thus, the user may activate the anvil strain measurement assembly (220) prior to exemplary use. Of course, the battery (226) may be configured to be able to activate the anvil strain measurement assembly (220) in response to any other appropriate activation method, as will be apparent to those skilled in the art based on the teachings herein.

[0072] The strain gauge (222) is appropriately attached to the top surface (65) of the elongated anvil channel (60). Specifically, the strain gauge (222) is positioned along a portion of the top surface (65) adjacent to the anvil latch pin (68). According to the description herein, the strain gauge (222) is configured to measure the strain value at the corresponding portion of the anvil channel (60) in response to grasping and clamping the tissue. It should be understood that the greater clamping force required to properly grasp the tissue will result in a greater measured strain measurement value; while the smaller clamping force required to properly grasp the tissue will result in a smaller strain measurement value. The strain gauge (222) may include any appropriate components and geometries, as will be apparent to those skilled in the art based on the teachings herein. In addition, the strain gauge (222) may be attached to the top surface (65) of the elongated anvil channel (60) using any appropriate manner, as will be apparent to those skilled in the art based on the teachings herein.

[0073] As described above, because the jaws (48) of the clamping lever (40) apply a clamping force to the anvil channel (60) via the anvil latch pin (68), the deviation in strain of the anvil channel (60) in response to grasping and clamping tissue may be greatest (i.e., more significant) at the portion of the anvil channel (60) adjacent to the anvil latch pin (68). Therefore, a strain gauge (222) located at or around the portion of the elongated anvil channel (60) adjacent to the anvil latch pin (68) can provide the benefit of measuring strain deviations that are associated with or strongly indicative of the clamping lever (40) driving the anvil channel (60) into a clamped configuration during exemplary use as described herein.

[0074] As described above, the strain gauge (222) is in operative communication with the control assembly (224) via the wire (228). The strain gauge (222) is configured to communicate a strain signal indicative of a measured strain value to the control unit (224). The control assembly (224) is configured to compare the measured strain value with one or more predetermined predetermined limit values. The control assembly (224) may generate a communication signal in response to the comparison of the measured strain value with the one or more predetermined predetermined limit values.

[0075] For example, the first predetermined limit value may indicate that the clamping lever (40) applies the necessary clamping force to clamp tissue having a maximum acceptable tissue thickness associated with a generally acceptable maximum gap distance. If the measured strain value from the strain gauge (222) is above the first predetermined limit value, this may indicate that the platform 156 (see FIG. 10A to FIG. 11B) and the anvil plate (72) is too thick and produces a gap distance greater than the maximum gap distance that is generally acceptable. In other words, if the measured strain value is above the first predetermined limit, this may indicate that the fired nail has an unacceptable high risk of poorly formed or opened.

[0076] The control assembly (224) includes appropriate electrical components necessary to receive the strain signal from the strain gauge (222), compare the received strain signal to a predetermined limit, and generate a communication signal in response to such comparison. The control assembly (224) may include a printed circuit board (PCB), appropriate memory, and / or appropriate processing device to function as described herein.

[0077] Fig.14 An exemplary method (1000) of using a linear surgical stapler (210) is shown. First, a user may clamp tissue (1002) on a platform (156) of a staple cartridge (140) by utilizing a clamping lever (40) in accordance with the teachings herein (see FIG. 10A to FIG. 11B ) and the anvil plate (72) of the elongated anvil channel (60). In this case, the anvil latch pin (68) is driven into the clamping configuration via appropriate engagement with the curved slot (50) defined by the opposing jaws (48) of the clamping lever (40). As described above, generally, thicker clamped tissue results in greater clamping forces (and greater strain on the anvil channel (60)) and greater contact between the anvil plate (72) and the platform (156) (see FIG. 10A to FIG. 11B ) between the larger gap distance (d1, d2).

[0078] When the tissue is properly clamped, the strain gauge (222) of the anvil strain measurement assembly (220) measures (1004) the resulting strain on a portion of the top surface (65) adjacent to the anvil latch pin (68). A signal indicating the measured strain on the top surface (65) of the anvil channel (60) is transmitted to the control assembly (224), which then compares (1006) the measured strain from the strain gauge (222) to a predetermined limit value stored on the control assembly (224). In the current exemplary method, the control assembly (224) inquires whether the measured strain is greater than a predetermined limit value. Such a predetermined limit value can be compared to the platform (156) (see FIG. 10A to FIG. 11B ) and the maximum acceptable gap distance between the anvil plate (72).

[0079] If the measured strain is greater than a predetermined limit, the control assembly (224) then communicates (1008) a high risk of poorly formed and / or split nails if the device is fired. Additionally and / or alternatively, the control assembly (224) may prevent firing in accordance with the teachings herein. If the measured strain is less than a predetermined limit, the control assembly (224) then communicates (1010) a low risk of poorly formed and / or split nails if the device is fired. Additionally and / or alternatively, the control assembly (224) may allow firing in accordance with the teachings herein. It will be apparent to one skilled in the art, based on the teachings herein, that any suitable means of communicating such results may be used.

[0080] Figure 15 to Figure 16 An exemplary linear surgical stapler (210') is shown, which is substantially similar to the linear surgical stapler (210) described above, except that the anvil half (14') includes an alternative cover (278). The cover (278) is substantially similar to the cover (78) described above, but has the differences detailed herein. Therefore, it should be understood that the cover (278) accommodates the anvil strain measurement assembly (220). In addition, the cover (278) includes a visual clamping quality indicator (280) that is connected to the control assembly (224) via a wire (228). The visual clamping quality indicator (280) can also be appropriately connected to the battery (226) so that the battery (226) can power the visual clamping quality indicator (280).

[0081] As in Figure 15 to Figure 16 As best seen between the two, visual clamp quality indicator (280) may illuminate a first color to communicate that the measured strain is within an acceptable range (e.g., below a predetermined limit), thereby indicating an acceptable gap distance; while visual clamp quality indicator (280) may illuminate a second color to communicate that the measured strain is outside of the acceptable range (e.g., above a predetermined limit). Thus, during exemplary use, an operator may view visual clamp quality indicator (280) after clamping tissue but before firing staples and / or severing tissue to visually confirm that tissue is properly clamped as described herein.

[0082] Although in the current example, the visual clamping quality indicator (280) illuminates two different colors to communicate whether an acceptable gap distance exists between the anvil plate (72) and the nail platform (156), any other suitable means may be utilized as will be apparent to those skilled in the art in view of the teachings herein. For example, the visual indicator (280) may flash when the measured strain is outside the acceptable range during exemplary use, and continuously illuminate when the measured strain is within the acceptable range during exemplary use. In some cases, the visual indicator (280) may not provide visual confirmation, but may provide other suitable forms of feedback, such as auditory and / or tactile feedback.

[0083] Figure 17 to Figure 18 An exemplary linear surgical stapler (210") is shown that is substantially similar to the linear surgical staplers (210, 210') described above, except that the anvil half (14") includes an alternative cover (278'). The cover (278') is substantially similar to the covers (78, 278) described above, but has the differences detailed herein. It should be understood that the cover (278') houses the anvil strain measurement assembly (220). In addition, the cover (278') includes a visual clamping quality indicator (280') that is connected to the control assembly (224) via an electrical wire (228). The visual clamping quality indicator (280') is also appropriately connected to the battery (226) so that the battery (226) can power the visual clamping quality indicator (280').

[0084] As in Figure 17 to Figure 18 As best seen between the two, the visual clamp quality indicator (280') displays a properly formed "B" staple to convey that the measured strain is within an acceptable range (e.g., below a predetermined limit), thereby indicating an acceptable gap distance; while the visual clamp quality indicator (280') displays an open staple to convey that the measured strain is outside the acceptable range (e.g., above a predetermined limit). Thus, during exemplary use, an operator may view the visual clamp quality indicator (280') after clamping tissue but before firing staples and / or severing tissue to visually confirm that the tissue is properly clamped in accordance with the description herein.

[0085] Figures 19 to 20 An exemplary linear surgical stapler (210'") is shown that is substantially similar to the linear surgical staplers (210, 210', 210") described above, except that the anvil half (14'") includes an optional cover (278"). The cover (278") is substantially similar to the covers (78, 278, 278') described above, but has the differences detailed herein. Therefore, it should be understood that the cover (278") houses the anvil strain measurement assembly (220). In addition, the cover (278") includes a visual clamping quality indicator (280") that is connected to the control assembly (224) via an electrical wire (228). The visual clamping quality indicator (280") is also appropriately connected to the battery (226) so that the battery (226) can power the visual clamping quality indicator (280").

[0086] As in Figures 19 to 20As best seen, the visual clamping quality indicator (280") displays an estimated percentage chance / probability that a properly formed nail can be formed based at least in part on measured strain (e.g., within an acceptable range associated with a 99% success rate, at a measured strain value associated with a 40% success rate, etc.). Thus, during exemplary use, an operator may view the visual clamping quality indicator (280") after clamping tissue but prior to firing the nail and / or severing the tissue in order to visually confirm that the tissue is properly clamped as described herein.

[0087] As described above, in some cases, the clamping lever (40) is pivoted from the open position toward the closed position without the anvil latch pin (68) being received in the curved slot (50) of the jaws (48). In the event that the anvil latch pin (68) is disengaged from the clamping lever (40) (e.g., the clamping lever (40) applies a clamping force to the anvil channel (60)), the measured strain on the top surface (65) of the anvil channel (60) may be substantially zero (providing a noisy measurement from the strain gauge (222) and / or negligible strain generated by the user manually closing the halves (12, 14) together, etc.). In such cases, tissue between the staple cartridge (140) and the anvil plate (72) may never be properly clamped or gripped, leaving an undesirably large gap distance (d2).

[0088] Fig.21 An exemplary method 1100 of using a linear surgical stapler (210, 210', 210", 210'") is shown in which an anvil strain measurement assembly (220) addresses the possibility of an anvil latch pin (68) being improperly received within the curved slot (50) of the jaws (48). First, a user may clamp tissue (1102) against the platform (156) of the staple cartridge (140) (see FIG. 10A to FIG. 11B ) between the anvil plate (72) of the elongated anvil channel (60). Next, the anvil strain measurement assembly (220) measures the strain (1104) on the top surface (65) of the anvil channel (60) as described herein. A signal indicating the measured strain on the top surface (65) of the anvil channel (60) is transmitted to the control assembly (224), which then compares (1106) the measured strain from the strain gauge (222) with a predetermined limit value stored on the control assembly (224).

[0089] If the measured strain is greater than a predetermined limit, this may indicate that the tissue being grasped is too thick, thereby leaving an undesirably large gap distance (similar to Fig. 10BThus, if the measured strain is greater than a predetermined limit, control assembly (224) communicates (1108) a high risk of poorly formed and / or split staples if the device is fired. Additionally and / or alternatively, control assembly (224) may prevent firing in accordance with the teachings herein.

[0090] If the measured strain is less than the predetermined limit, the control assembly (224) then compares (1110) the measured strain from the strain gauge (222) to see if the measured strain is substantially zero. If the measured strain is substantially zero, this may indicate that the anvil latch pin (68) is not properly received within the curved slot (50) of the jaws (48), thereby leaving an undesirably large gap distance (similar to Fig. 11B Thus, if the measured strain is substantially zero, the control assembly (224) communicates (1010) a high risk of poorly formed and / or split staples if the device is fired. Fig. 22 As shown, where a visual clamp quality indicator (280") is used, when the measured strain is substantially zero, the indicator (280") may display a 0% (or negligible) chance of successful staple formation. Additionally and / or alternatively, the control assembly (224) may prevent firing in accordance with the teachings herein.

[0091] If the measured strain is not greater than the predetermined limit and is not substantially zero, the control assembly (224) determines that the measured strain is below the predetermined limit and substantially above zero, thereby determining that the measured strain is within an acceptable range (1114). In such a case, the control assembly (224) communicates (1116) a low risk of poorly formed and / or split staples if the device is fired. Additionally and / or alternatively, the control assembly (224) may allow firing in accordance with the teachings herein. Any suitable means of communicating such results may be used, as would be apparent to one skilled in the art in light of the teachings herein.

[0092] Due to tolerance stacking during the manufacturing process of the linear surgical staplers (10, 210, 210', 210", 210'), the strain applied on a first linear surgical stapler (10, 210, 210', 210", 210') associated with a suitable gap distance may be different from the strain applied on a second linear surgical stapler (10, 210, 210', 210", 210') associated with the same suitable gap distance. Therefore, for a particular linear surgical stapler (10, 210, 210', 210", 210'), it may be desirable to customize the predetermined limits used by the above-mentioned anvil strain measurement assembly (220).

[0093] Fig.23An illustrative method (1200) for determining a predetermined limit used by an anvil strain measurement assembly (220) is shown. First, during the manufacturing process, an assembled linear surgical stapler (10, 210, 210', 210", 210') can be clamped on a force measuring element to measure the clamping force between the anvil plate (72) and the staple platform (156), thereby ensuring that such clamping force is within an acceptable range. In addition, when the linear surgical stapler (10, 210, 210', 210", 210') is clamped to the force measuring element, the anvil strain measured by the strain gauge (222) can also be measured (1204). It should be understood that any suitable component can be used to obtain the strain gauge (222) measurement in accordance with the teachings of this document, which will be apparent to those skilled in the art. Next, where the measured (1204) anvil strain obtained during an exemplary clamping of the stapler (10, 210, 210', 210", 210'") on the force measuring element ensures an acceptable clamping force, the measured (1204) anvil strain can be used to generate (1206) uniquely characterized device parameters (e.g., predetermined limits used by the anvil strain measurement assembly (220) in accordance with the teachings herein). Next, the uniquely characterized device parameters can be stored on a control assembly (224) of the anvil strain measurement assembly (220) and / or written (1208) to the control assembly of the anvil strain measurement assembly for exemplary use.

[0094] As described above, in some circumstances, control assembly (224) may prevent firing of stapler (10, 210, 210', 210", 210'") when anvil strain measurement assembly (220) determines that the measured anvil strain is outside of an acceptable anvil strain range associated with proper staple formation. FIG. 24A to FIG. 24B An exemplary linear surgical stapler (310) is shown that is configured to lockout the firing of staples until measured anvil strain is within an acceptable range associated with proper staple formation.

[0095] The stapler (310) is substantially similar to the staplers (10, 210, 210', 210", 210'") described above, but having the differences detailed herein. The stapler (310) includes an anvil strain measurement assembly (320), which is substantially similar to the anvil strain measurement assembly (220) described above, but having the differences detailed herein. The anvil strain measurement assembly (320) includes a strain gauge (322), a control assembly (324), a battery (326), and wires (328); which are substantially similar to the strain gauge (222), control assembly (224), battery (226), and wires (228) described above. In addition, the anvil strain measurement assembly (320) includes a solenoid locking member (330) that is connected to the control assembly (324) via the wire (328).

[0096] The solenoid latch (330) is configured to be capable of being in a locked configuration (see Fig.24A ) and unlocked configuration (see Fig. 24B ). In the locked configuration, the solenoid latch (330) is configured to selectively prevent distal actuation of the distal cutting edge (126). In the unlocked configuration, the solenoid latch (330) is configured to allow distal actuation of the distal cutting edge (126). The solenoid latch (330) is biased toward the locked configuration.

[0097] As described above, the solenoid latch (330) is in communication with the control assembly (324). The battery (326) is configured to power the solenoid latch (330). When the control assembly (324) receives a measured strain from the strain gauge (322) within a predetermined range associated with suitable nail formation, the control assembly (324) instructs the solenoid latch (330) to actuate from a locked configuration to an unlocked configuration, thereby achieving distal actuation of the distal cutting edge (126) and the firing assembly (110). Therefore, the solenoid latch (330) inhibits the firing of the firing assembly (110) unless the measured strain from the strain gauge (322) is within an acceptable range associated with suitable nail formation.

[0098] It should be appreciated that while anvil strain measurement assembly (220, 320) is used in the context of linear surgical staplers (10, 210, 210', 210", 210'", 310), anvil strain measurement assembly (220, 320) may be readily incorporated into any other suitable surgical stapler. Figure 25 to Figure 26 An anvil strain measurement assembly (402) is shown associated with an anvil (410) of a laparoscopic surgical stapler (400) having an anvil (410) and staple magazine jaws (450) forming an end actuator attached to a distal end of an axis assembly (420) that is sized to be inserted laparoscopically into a patient's body.

[0099] The anvil (410) defines an elongated channel (414) on a lateral side of the anvil (410) that accommodates an array of strain sensors (404) connected to one another via wires (406) extending proximally from the anvil (410) and shaft assembly (420) to a control unit (408) (such as a surgeon's console or electrical control unit housed within an optional handle portion of a laparoscopic instrument or external to the instrument). When the anvil surface (412) of the anvil (410) grasps tissue (T) with the staple cartridge jaws (450), the strain sensors (404) measure the strain within the anvil (410) and communicate the strain to the control unit (408) via wires (406). The control unit (408) can use the measured strain in a manner similar to the control assembly (224, 324) described above, thereby enabling the control unit (408) to predict whether a suitable gap distance exists between the anvil surface (412) and the staple cartridge jaws (450) when the tissue is properly clamped. Control unit (408) may notify the user and / or prevent firing of the end effector in a manner similar to control assemblies (224, 324) described above.

[0100] II. Exemplary Combinations

[0101] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or in the subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided only for illustrative purposes. It is envisioned that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive unless otherwise explicitly indicated by the inventor or the successor with an interest in the inventor at a later date. If any claim proposed in this patent application or in the subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.

[0102] Example 1

[0103] A device, the device comprising: (a) a first slender member, the first slender member having a distal portion configured to present a first suturing surface; (b) a second slender member, the second slender member having a distal portion configured to present a second suturing surface, wherein the first slender member and the second slender member are configured to be releasably coupled together so that the first suturing surface and the second suturing surface can cooperate to clamp tissue and suturing the tissue with a plurality of staples; (c) a clamping member, wherein the clamping member can move from a first position to a second position relative to the first slender member and the second slender member to approach the first suturing surface and the second suturing surface to suturing the tissue. clamping tissue; (d) a latching member configured to transition from an unlatched state to a latched state to releasably hold the clamping member in the second position; (e) a firing assembly, wherein the firing assembly is actuable from an original position to fire the nail into the clamped tissue; and (f) a strain measurement assembly associated with the first slender member, wherein the strain measurement assembly is configured to: (i) measure a strain value on the first slender member, (ii) compare the strain value with a predetermined limit value associated with successful nail formation, and (iii) generate a signal in response to the comparison between the strain value and the predetermined limit value.

[0104] Example 2

[0105]

[0046] The apparatus of any one or more of the preceding embodiments, wherein the strain measurement assembly comprises a strain gauge attached to a top surface of the first elongated member.

[0106] Example 3

[0107] The device according to any one or more of the preceding embodiments, wherein the strain measurement assembly includes a control unit in communication with the strain gauge.

[0108] Example 4

[0109] The device according to any one or more of the preceding embodiments, wherein the strain measurement assembly comprises a battery configured to power both the strain gauge and the control unit.

[0110] Example 5

[0111] The device of any one or more of the preceding embodiments, further comprising a cover attached to the first elongated member, wherein the control unit and the battery are housed within an interior defined by the cover.

[0112] Example 6

[0113] According to any one or more of the aforementioned embodiments, the strain measurement assembly also includes a visual indicator associated with the cover, wherein the visual indicator is configured to display a first indicator when the strain value is outside the predetermined limit, and wherein the visual indicator is configured to display a second indicator when the strain value is within the predetermined limit.

[0114] Example 7

[0115] The apparatus of any one or more of the preceding embodiments, wherein the first elongated member comprises a latch pin, wherein the strain gauge is directly adjacent to the latch pin.

[0116] Example 8

[0117] A device as described in any one or more of the preceding embodiments, wherein the latch member includes a jaw defining a slot, wherein the slot is sized to accommodate the latch pin in the latched state.

[0118] Example 9

[0119] The device according to any one or more of the preceding embodiments, wherein the strain measurement assembly comprises a control unit, and the control unit comprises a PCB.

[0120] Example 10

[0121] The device according to any one or more of the preceding embodiments, wherein the PCB stores the predetermined limit value.

[0122] Embodiment 11

[0123]

[00136] The apparatus of any one or more of the preceding embodiments, wherein the first elongated member comprises an anvil plate.

[0124] Example 12

[0125]

[00136] The apparatus of any one or more of the foregoing embodiments, wherein the second elongated member comprises a cartridge receiving jaw sized to selectively receive a staple cartridge.

[0126] Embodiment 13

[0127]

[0013] The device according to any one or more of the foregoing embodiments further includes a lockout assembly configured to inhibit actuation of the firing assembly based on the measured strain value.

[0128] Embodiment 14

[0129] The device of any one or more of the preceding embodiments, wherein the latch assembly comprises a solenoid.

[0130] Embodiment 15

[0131]

[00136] The apparatus of any one or more of the preceding embodiments, wherein the first and second elongated members are configured to be releasably coupled at proximal ends.

[0132] Example 16

[0133] A device comprising: (a) a first elongated member having a distal portion configured to present a first suturing surface; (b) a second elongated member having a distal portion configured to present a second suturing surface, wherein the first elongated member and the second elongated member are configured to be releasably coupled together at their proximal ends so that the first suturing surface and the second suturing surface can cooperate to clamp tissue and suturing the tissue with a plurality of staples; (c) a clamping member, wherein the clamping member can move from an open position to a closed position relative to the first elongated member and the second elongated member to approach the first suturing surface and the second suturing surface to clamp tissue; and (d) a strain measurement assembly configured to measure a strain value associated with the first elongated member and generate a signal indicating whether a gap distance between the first suturing surface and the second suturing surface is within a predetermined range.

[0134] Embodiment 17

[0135] The device according to any one or more of the preceding embodiments, wherein the strain measurement assembly comprises a control unit configured to generate the signal.

[0136] Embodiment 18

[0137] The device according to any one or more of the preceding embodiments, wherein the strain measurement assembly comprises a battery configured to supply power to the control unit.

[0138] Embodiment 19

[0139]

[00136] The apparatus of any one or more of the preceding embodiments, wherein the first elongated member comprises an anvil surface defining a plurality of staple forming pockets.

[0140] Embodiment 20

[0141] A method for determining whether a gap distance between a first suturing surface and a second suturing surface is within a predetermined range, the method comprising: (a) measuring a strain value on the first slender member when the first slender member and the second slender member cooperate to clamp tissue; (b) comparing the measured strain value with a predetermined limit value; and (c) generating a comparison signal in response to the comparison of the measured strain value with the predetermined limit value.

[0142] III. Miscellaneous

[0143] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered isolated from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art based on the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0144] In addition, any one or more of the teachings disclosed herein may be combined with any one or more of the teachings disclosed in the following patents: U.S. Patent No. 10,631,866, entitled “Release Mechanism for Linear Surgical Stapler”, issued on April 28, 2020; U.S. Patent No. 10,667,818, entitled “Lockout Assemblyfor Linear Surgical Stapler”, issued on June 2, 2020; U.S. Patent No. 10,932,781, entitled “Features to Align and Close Linear Surgical Stapler”, issued on March 2, 2021; U.S. Patent No. 10,898,197, entitled “Releasable Coupling Features for Proximal Portions of Linear Surgical Stapler”, issued on January 26, 2021; U.S. Patent No. 10,898,197, entitled “Firing Lever Assembly for Linear Surgical Stapler”, issued on December 29, 2020 No. 10,874,398, entitled “Clamping Mechanism for Linear Surgical Stapler”, issued on June 23, 2020; No. 10,687,819, entitled “Clamping Mechanism for Linear Surgical Stapler”, issued on January 26, 2021; No. 11,033,266, entitled “Decoupling Mechanism for Linear Surgical Stapler”, issued on June 15, 2021; No. 11,045,193, entitled “Anvil Assembly for Linear Surgical Stapler”, issued on June 29, 2021; and No. 11,045,193, entitled “Closure Assembly for Linear Surgical Stapler”, issued on February 2, 2021. No. 10,905,419, entitled “Clamping Assembly for Linear Surgical Stapler”; No. 11,278,285, issued on March 22, 2022;U.S. Patent No. 11,229,433, entitled “Linear Surgical Stapler,” issued on January 25, 2022; U.S. Publication No. 2022 / 0142641, entitled “System and Method for Forming Pockets in Anvil of Surgical Stapler,” issued on May 12, 2022; U.S. Patent No. 11,224,425, entitled “Surgical Linear Cutter Wishbone Separation Mechanism with Detent,” issued on January 18, 2022; U.S. Patent No. 11,219,454, entitled “Pin Trap Mechanism for Surgical Linear Cutter,” issued on January 11, 2022; U.S. Patent No. 11,219,454, entitled “Separation Mechanism for Surgical Linear Cutter,” issued on December 2, 2021; Cutter”; U.S. Patent Application No. 17 / 489,879, filed on September 30, 2021, entitled “Lockout Feature for Linear Surgical Stapler Cartridge”; U.S. Patent Application No. 29 / 842,580, filed on June 16, 2022, entitled “Staple Cartridge for Linear Surgical Stapler”; and / or U.S. Patent Application No. 29 / 842,581, filed on June 16, 2022, entitled “Linear Surgical Stapler”. The disclosure of each of these references is incorporated herein by reference in its entirety.;

[0145] In addition, any one or more of the teachings of this document may be combined with any one or more of the teachings of the following U.S. patent application No. [Agent Reference Number: END9511USNP2], entitled “Strain and Compression Force Measurement Features for Surgical Stapler,” filed on the same date as the present application, the disclosure of which is incorporated herein by reference in its entirety.

[0146] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials listed in the present disclosure. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof allegedly incorporated herein by reference but conflicting with existing definitions, statements, or other public materials listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public materials.

[0147] The above-described device versions may be used in conventional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into a robotic surgical system, such as the DAVINCI® by Intuitive Surgical, Inc. (Sunnyvale, California). TM system.

[0148] The devices of the types described above can be designed to be discarded after a single use, or they can be designed to be reusable. In either case or both, these types can be repaired to be reused after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can be disassembled, cleaned / replaced, and reassembled using a variety of techniques. The use of such technology and the resulting repair device are all within the scope of the present application.

[0149] By way of example only, the types described herein may be sterilized before and / or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0150] Various embodiments of the present invention have been shown and described, and further improvements of the methods and systems described herein may be achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those of skill in the art. For example, the embodiments, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Therefore, the scope of the present invention should be considered in light of the following claims, and should be understood not to be limited to the details of the structure and operation shown and described in the specification and drawings.

Claims

1. A device, comprising: (a) a first elongated member having a distal portion configured to present a first suturing surface; (b) a second elongated member having a distal portion configured to present a second suturing surface, wherein the first elongated member and the second elongated member are configured to be releasably coupled together so that the first suturing surface and the second suturing surface can cooperate to clamp tissue and suturing the tissue with a plurality of staples; (c) a clamping member, wherein the clamping member is movable from a first position to a second position relative to the first elongated member and the second elongated member to approximate the first suturing surface and the second suturing surface to clamp tissue; (d) a latch member configured to transition from an unlatched state to a latched state to releasably retain the clamping member in the second position; (e) a firing assembly, wherein the firing assembly is actuatable from an initial position to fire the staples into the clamped tissue; and (f) a strain measurement assembly associated with the first elongated member, wherein the strain measurement assembly is configured to: (i) measuring the strain value on the first elongated member, (ii) comparing the strain value to a predetermined limit value associated with successful nail formation, and (iii) generating a signal in response to a comparison between the strain value and the predetermined limit value.

2. The device according to claim 1, wherein: The strain measurement assembly includes a strain gauge attached to a top surface of the first elongated member.

3. The device according to claim 2, wherein: The strain measurement assembly includes a control unit in communication with the strain gauge.

4. The device according to claim 3, wherein: The strain measurement assembly includes a battery configured to power both the strain gauge and the control unit.

5. The apparatus of claim 4, further comprising a cover attached to the first elongated member, wherein The control unit and the battery are housed within an interior defined by the cover.

6. The device according to claim 5, wherein: The strain measurement assembly also includes a visual indicator associated with the cover, wherein the visual indicator is configured to display a first indicator when the strain value is outside the predetermined limit, and wherein the visual indicator is configured to display a second indicator when the strain value is within the predetermined limit.

7. The device according to claim 2, wherein: The first elongated member includes a latch pin, wherein the strain gauge is directly adjacent to the latch pin.

8. The device according to claim 7, wherein: The latch member includes a jaw defining a slot, wherein the slot is sized to receive the latch pin in the latched state.

9. The device according to claim 1, wherein: The strain measurement assembly includes a control unit including a PCB.

10. The device according to claim 9, wherein: The PCB stores the predetermined limit value.

11. The device according to claim 1, wherein: The first elongated member includes an anvil plate.

12. The device according to claim 11, wherein The second elongated member includes a cartridge receiving jaw sized to selectively receive a staple cartridge.

13. The apparatus of claim 1, further comprising a lockout assembly configured to inhibit actuation of the firing assembly based on the measured strain value.

14. The device according to claim 13, wherein: The latch assembly includes a solenoid.

15. The apparatus according to claim 1, wherein: The first and second elongated members are configured to be releasably coupled at proximal ends.

16. A device, comprising: (a) a first elongated member having a distal portion configured to present a first suturing surface; (b) a second elongated member having a distal portion configured to present a second suturing surface, wherein the first and second elongated members are configured to be releasably coupled together at their proximal ends so that the first and second suturing surfaces can cooperate to clamp tissue and suturing the tissue with a plurality of staples; (c) a clamping member, wherein the clamping member is movable from an open position to a closed position relative to the first elongated member and the second elongated member to approximate the first suturing surface and the second suturing surface to clamp tissue; and (d) a strain measurement assembly configured to measure a strain value associated with the first elongated member and generate a signal indicating whether a gap distance between the first suturing surface and the second suturing surface is within a predetermined range.

17. The device according to claim 16, wherein: The strain measurement assembly comprises a control unit configured to generate the signal.

18. The apparatus according to claim 17, wherein: The strain measurement assembly includes a battery configured to supply power to the control unit.

19. The apparatus according to claim 16, wherein: The first elongated member includes an anvil surface defining a plurality of staple forming pockets.

20. A method for determining whether a gap distance between a first suturing surface and a second suturing surface is within a predetermined range, the method comprising: (a) measuring a strain value on the first elongated member when the first elongated member and the second elongated member cooperate to clamp tissue; (b) comparing the measured strain value with a predetermined limit value; as well as (c) generating a comparison signal in response to said comparison of said measured strain value with said predetermined limit value.

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