Smart anvil insert for linear surgical stapler

Abstract

The invention discloses a surgical stapler. The surgical stapler includes an elongate cartridge channel, an anvil assembly, a gripping member, and a deflection sensor. The elongate cartridge channel includes a proximal frame portion and a distal jaw portion. The distal jaw portion is configured to releasably receive a staple cartridge. The anvil assembly includes an elongate anvil channel and an anvil insert. The elongate anvil channel includes a proximal frame portion and a distal jaw portion. The anvil insert is disposed at the distal jaw portion. The deflection sensor is associated with the anvil assembly and is configured to detect deflection of the anvil assembly to facilitate generating a notification based on the detected deflection.

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. The stapler also includes a movable clamping lever, which is configured to releasably clamp the 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 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.10 A perspective view of a distal end of another exemplary linear surgical stapler is shown showing an anvil insert associated with a distal jaw portion of a cartridge half;

[0018] Fig.11 Shows Fig.10 A perspective view of an anvil insert;

[0019] Fig.12 Shows Fig.10 A side elevation view of a linear surgical stapler showing the cartridge half and anvil half of the stapler having been approximated such that a distal pin of the anvil half is received by a clamping lever jaw of the cartridge half;

[0020] Fig.13 Shows Fig.10 A side elevation view of a linear surgical stapler of , showing the closure of the clamping levers completely clamping the stapler halves together over tissue;

[0021] Fig.14 Shows Fig.10 A side elevation view of a linear surgical stapler of , showing closure of the clamping levers clamping the stapler halves together over tissue, but wherein the stapler halves are pushed apart by tissue;

[0022] Fig.15 Shows Fig.10 An enlarged side elevation view of a distal jaw portion of a linear surgical stapler;

[0023] Fig.16 shows a partial schematic enlarged bottom plan view of the distal end of another exemplary linear surgical stapler, with an anvil insert shown partially installed;

[0024] Fig.17 Shows Fig.16 A partial schematic enlarged bottom plan view of a linear surgical stapler of , but with the anvil insert fully installed;

[0025] Fig.18 A perspective view of the distal end of another exemplary linear surgical stapler is shown showing an anvil insert having a pair of feedback generators;

[0026] Fig.19 An enlarged side elevation view of a distal jaw portion of another exemplary linear surgical stapler is shown;

[0027] Fig. 20 An enlarged side elevation view of a distal jaw portion of another exemplary linear surgical stapler is shown;

[0028] Fig.21 An enlarged side elevation view of a distal jaw portion of another exemplary linear surgical stapler is shown;

[0029] Fig. 22 illustrates an enlarged cross-sectional view of a distal jaw portion of another exemplary linear surgical stapler having a knife member in a retracted position; and

[0030] Fig.23 Shows Fig. 22 An enlarged cross-sectional view of the distal jaw portion of a linear surgical stapler of FIG. 1 , but with the knife member in an extended position.

[0031] 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

[0032] 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.

[0033] 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.

[0034] 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.

[0035] I. Exemplary Linear Surgical Stapler

[0036] A. Overview of Linear Surgical Staplers

[0037] Figure 1 to Figure 2An 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.

[0038] 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.

[0039] 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 suturing surface in the form of a platform (156) having a plurality of staple openings (166) for accommodating a plurality of staples (168) and corresponding staple drivers (172).

[0040] 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.

[0041] 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).

[0042] like Figure 2As 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.

[0043] 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.

[0044] 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" published 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 an anvil insert (76). In some versions, the anvil insert (76) can be removed from the distal jaw portion (76) and replaced with a different anvil insert (76). In some versions, the anvil insert (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.

[0045] 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. Pat. 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.

[0046] 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).

[0047] 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.

[0048] 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 clamping lever latch member (54) when the clamping lever (40) is fully closed and the firing assembly (110) is translated distally from its proximal home position, thereby preventing the clamping 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.

[0049] 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).

[0050] 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.

[0051] 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 in a pair of cam ramps (120) distally. The cam ramps (120) are configured to engage the underside of a staple driver (172) contained in the staple cartridge (140) and actuate the staple driver (172) upward, thereby driving (or "firing") staples from the staple cartridge (130) 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).

[0052] 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).

[0053] B. Exemplary Use of a Linear Surgical Stapler

[0054] 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 shown in FIG. Figure 5As shown and described above. At 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).

[0055] 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.

[0056] 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.

[0057] 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 (172), while the clamped tissue is cut by 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 holding assembly (80) can be pressed to release the anvil half (14) from the bin half (12), so that the stapler half (12, 14) can be separated from each other, thereby releasing the newly sutured and cut tissue. The stapler (10) can be further constructed and operated according to the teachings of the following patents: U.S. Patent Application No. 18 / 316,635, entitled "Linear Surgical Stapler" filed on May 12, 2023, the disclosure of which is incorporated herein by reference in its entirety. In addition, it should be understood that in some versions, the stapler (10) may include additional features that facilitate the disengagement of the stapler half (12, 14), for example, as disclosed in U.S. Patent No. 11,033,266, which is incorporated by reference as above.

[0058] II. Exemplary Linear Surgical Stapler with Alternative Smart Anvil Insert

[0059] In general, when a linear stapler is used in a surgical procedure (such as a gastrointestinal anastomosis), it may be helpful to present information about tissue and / or the linear stapler to the user before and during the procedure, such as, for example, whether the tissue is properly clamped, whether the stapler cartridge exists, the type of stapler cartridge used, the position of the knife member during cutting, and the number of times the knife member has been fired. However, such functionality is usually incorporated into the linear stapler during manufacturing and is therefore often considered to be cost-prohibitive. In addition, incorporating the desired sensing capability into the linear stapler usually requires that a specific component be hardwired into the linear stapler, which may limit any future customization of the sensing capability of the linear stapler. Therefore, it may be desirable to provide such functionality in an intelligent anvil insert that can be selectively mounted on the linear stapler to upgrade the linear stapler to include the sensing capability provided by the intelligent anvil insert. It may also be desirable to provide different intelligent anvil inserts with different sensing capabilities to allow the user to customize the sensing capability of the linear stapler depending on the specific intelligent anvil insert selected for installation on the linear stapler. The following description relates to various examples of smart anvils that can be incorporated into a linear stapler. Although these examples are illustrated and described separately from each other, it should be understood that the features described in any of the following examples can be combined with the features described in other examples described below. Therefore, the following features can be combined in various arrangements, as will be apparent to those skilled in the art with reference to the teachings herein.

[0060] A. Smart anvil insert with sensors for detecting improper clamping

[0061] Reference again Figures 1 to 9EThe stapler (10) shown, generally speaking, when tissue is arranged between the magazine half (12) and the anvil half (14), the clamping lever (40) can be closed to prompt the magazine half (12) and the anvil half (14) to enter the fully clamped position around the tissue. The relative spacing between the tissue gap column (162) and the anvil plate (72) is intended to provide the surgeon with a visual indication of whether the tissue is actually properly fully clamped. However, this spacing can be easily ignored, and in some cases, may be blocked by tissue. Therefore, the surgeon may only rely on the closure of the clamping lever (40) to confirm that the tissue is properly clamped. If the tissue is improperly clamped after the clamping lever (40) is closed and the surgeon continues to fire the stapler, the resulting cutting and / or nail insertion may be impaired. Therefore, it may be desirable to detect improper clamping of the cartridge half (12) and the anvil half (14) and generate a notification to the surgeon to indicate when the cartridge half (12) and the anvil half (14) are not fully clamped together to prevent the surgeon from erroneously firing the stapler (10). It should be understood that the features discussed below may be easily combined with the surgical instrument (10) discussed above. To this end, similar reference numerals indicate similar features described in more detail above.

[0062] 1. Smart anvil insert with deflection sensor

[0063] Figures 10 to 15 Another exemplary linear surgical stapler (210) is shown, which is generally similar to the linear surgical stapler (10) described above, except as further described below. The linear surgical stapler (210) includes a cartridge half (212) (or "reloading half") and an anvil half (214), which are configured to be releasably coupled together to clamp tissue therebetween for simultaneous cutting and stapling of the clamped tissue.

[0064] like Fig.10 As shown, the cartridge half (212) includes an elongated cartridge channel (216) having a distal jaw portion (220). The distal jaw portion (220) of the cartridge channel (16) is configured to releasably receive a staple cartridge (340) ( Figure 12 to Figure 14). The distal jaw portion (264) of the anvil half (214) includes a pair of anvil plates (272) that cooperate to provide a second suturing surface in the form of an anvil surface having a plurality of staple forming recesses that are configured to deform the legs of staples ejected from the staple cartridge (340). The anvil plates (272) are spaced apart from one another to define a slot therebetween. The distal jaw portion (264) of the anvil half (214) supports an anvil insert (276) that is insertable into the distal jaw portion (264). The anvil insert (276) includes an elongated body (330) and a contoured end (332) that extends distally from the elongated body (330). The elongated body (330) is configured to fit within the distal jaw portion (264). The contoured tip (332) is configured to abut against and extend distally from the distal jaw portion (264) such that the contoured tip acts as a leading edge of the anvil half (214) during a surgical procedure. Fig.11 As shown, the anvil insert (276) defines a slot (334) that extends longitudinally along the elongated body (330) and is disposed between the anvil plates (272). The slot (334) is configured to accommodate a knife member (e.g., Figure 8 126), as will be described in further detail below. The distal jaw portion (264) and the anvil insert (276) are configured to be capable of a releasable connection therebetween, such that the anvil insert (276) can be removed from the anvil half (14) and replaced with a different anvil insert. The distal jaw portion (264) and the anvil insert (276) are configured to have a cooperative retention feature (such as a detent) that facilitates the anvil insert (276) to remain in the distal jaw portion when the anvil insert (276) is installed in the distal jaw portion (264).

[0065] like Figure 12 to Figure 14 As shown, the cartridge half (212) further includes a clamping member in the form of a clamping lever (240) pivotally coupled to the cartridge channel (216). The clamping lever (240) is operable to pivot relative to the cartridge channel (216) between an open position and a closed position, in which the proximal end (246) of the clamping lever (240) is spaced apart from the cartridge channel frame portion (218) (e.g., Fig.12 As shown), in the closed position, the proximal end (246) faces the bin channel frame portion (218) (as shown Fig.13 and Fig.14). A pair of opposing jaws (248) (one is shown) extend distally from the distal end of the clamping lever (240). Each opposing jaw (248) includes a curved slot (250) having a closed proximal end and an open distal end, the open distal end being configured to receive a latch pin (268) of the anvil half (214). The latch pin (268) extends laterally through the elongated anvil channel (e.g., 60). Actuation of the clamping lever (240) from an open position to a closed position serves to capture the opposing side ends of the latch pin (268) within the curved slot (250) and thereby pull the anvil half (214) and the cartridge half (212) together. Fig.12 As shown, when the clamping lever (240) is in the open position, the distal jaw portions (220, 264) are spaced apart to allow tissue (T) from a patient to be disposed therebetween. Fig.13 As shown, when the clamping lever (240) is subsequently moved to the closed position, the distal jaw portions (220, 264) are clamped together to clamp the tissue (T) therebetween. Once the tissue (T) is successfully clamped by the distal jaw portions (220, 264), the firing assembly (310) can be actuated to cut the tissue (T) with a knife member (e.g., 126) and simultaneously drive the staples through the tissue on either side of the cutting line. During cutting of the tissue T, the knife member slides within the slot (334) of the anvil insert (276), so that the anvil insert (276) acts as a cutting guide for the knife member.

[0066] The anvil insert (276) is configured as an intelligent device that is configured to measure the deflection that may be applied to the anvil half (214) when the tissue (T) is clamped between the cartridge half (212) and the anvil half (214). The deflection measured by the anvil insert (276) can be used to determine whether the tissue (T) is improperly clamped between the cartridge half (212) and the anvil half (214), as will be described in further detail below. Fig.10 and Fig.11 As shown, the anvil insert (276) includes a strain gauge (336) configured to detect deflection of the anvil insert (276). The strain gauge (336) includes a wire that is configured to detect the deflection of the anvil insert (276) based on the elongation of the material when the anvil insert (276) is flexed. It should be understood that the strain gauge (336) can be any of a variety of suitable alternative sensing arrangements that facilitate measuring deflection, such as, for example, a force sensor or a Hall effect sensor, and can be additionally or alternatively mounted at any location on the anvil insert (276).

[0067] The strain gauge (336) may be communicatively coupled to the microprocessor (338) and transmits the deflection data to the microprocessor (338), as will be described in more detail below. The microprocessor (338) may be embodied as any type of processor capable of performing the functions described herein. For example, the microprocessor (338) may be embodied as a single-core or multi-core processor, a digital signal processor, a microprocessor, a general-purpose central processing unit (CPU), a reduced instruction set computer (RISC) processor, a processor with a pipeline, a complex instruction set computer (CISC) processor, an application-specific integrated circuit (ASIC), a programmable logic device (PLD), a field programmable gate array (FPGA), or other processor or processing / control circuit or controller.

[0068] The microprocessor (338) is communicatively coupled to a wireless communication module (344) that facilitates wireless communication with a console (not shown) via any of a variety of wireless communication protocols, such as, for example, Wi-Fi, cellular, or wireless personal area network (WPAN) (e.g., IrDA, Bluetooth, Bluetooth low energy, Zigbee, wireless USB). The anvil insert (276) may additionally or alternatively be configured to support wired communication via a communication port (not shown) (such as, for example, a USB port). The console (not shown) may receive messages from the wireless communication module (344) and facilitate generating notifications to a user of the linear surgical stapler (210). By way of example only, the console may include a data processor and a display that collaborate to generate notifications. In addition, the console may be a component of a robotic electrosurgical system. In light of the teachings herein, various suitable forms that the console of the stapler (10) may take will be apparent to those skilled in the art.

[0069] The strain gauge (336), microprocessor (338), and wireless communication module (344) are powered by an onboard power supply (346), which may include a disposable battery, a rechargeable battery, a supercapacitor, or any of a variety of suitable alternative power storage arrangements. The strain gauge (336), microprocessor (338), wireless communication module (344), and onboard power supply (346) are embedded in the anvil insert (276) so that the strain gauge (336), microprocessor (338), wireless communication module (344), and onboard power supply (346) are hidden and not directly visible.

[0070] The microprocessor (338) is configured to detect improper clamping of tissue (T) based on the deflection of the anvil insert (276). When the linear surgical stapler (210) is clamped onto the tissue (T) by closing the clamping lever (240), the tissue (T) may be too thick and / or improperly positioned between the distal jaw portions (220, 264) to allow them to be properly clamped together, such as Fig.14 As shown. This improper clamping can cause excessive deflection of the anvil insert (276). Therefore, the microprocessor (338) can monitor the deflection of the anvil insert (276) via the strain gauge (336) to determine whether the tissue (T) is improperly clamped and thus causes excessive deflection of the anvil insert (276). If the microprocessor (338) determines that the anvil insert (276) is being excessively deflected by the tissue (T), the microprocessor (338) can send a message to the console via the wireless communication module (344), which causes the console to generate a notification warning the user that the tissue (T) is improperly clamped to prevent the user from firing the stapler. Then, the user can reposition the stapler on the tissue (T) until proper clamping is achieved. Once the tissue (T) is properly clamped, the microprocessor (338) can stop transmitting messages to terminate the notification on the console, thereby indicating to the user that the linear surgical stapler (210) is ready to fire. In one example, the microprocessor (338) may send different messages to the console, which causes the console to display a notification to the user indicating that the linear surgical stapler (210) is ready to fire. The notification presented by the console may be a visual notification (such as a message displayed on a screen or a flashing light), an audible notification (such as a chime or a recorded verbal message), or a combination thereof.

[0071] In one example, the microprocessor (338) may compare the deflection detected by the strain gauge (336) with a threshold value to determine whether the tissue (T) is improperly clamped. The threshold value may be understood as representing the minimum deflection that the anvil insert (276) can withstand before cutting and / or suturing will be adversely affected. If the detected deflection is lower than the threshold value, thereby indicating that the tissue (T) is properly clamped, the microprocessor (338) suppresses the transmission of a warning message to the console, or alternatively, transmits a permission message to the console to cause the console to notify the user that the linear surgical stapler (210) is ready to fire. In the case where the microprocessor (338) causes the console to notify the user that the linear surgical stapler (210) is ready to fire, the microprocessor (338) may delay the transmission of the permission message for a predetermined period of time (i.e., 15 seconds) after initially detecting the deflection to ensure that the tissue (T) is properly clamped. If the detected deflection is above a threshold, thereby indicating that the tissue (T) is improperly clamped, the microprocessor (338) transmits a warning message to the console, and in response, the console notifies the user to refrain from firing the linear surgical stapler (210) prior to releasing the tissue (T) and re-clamping.

[0072] In one configuration, the strain gauge (336) and the microprocessor (338) may be selectively activated in response to the clamping of the tissue (T) in an attempt to save power consumption. For example, prior to the clamping of the tissue (T), such as when the clamping lever (240) is opened, the strain gauge (336) and the microprocessor (338) are deactivated (i.e., in sleep mode). Once the tissue (T) is clamped between the distal jaw portions (220, 264), the strain gauge (336) and the microprocessor (338) may be activated to begin sensing the deflection of the anvil insert (276), as described above. The activation of the strain gauge (336) and the microprocessor (338) may be based on the position of the clamping lever (240). When the clamping lever (240) is opened, the strain gauge (336) and the microprocessor (338) may be deactivated. When the clamping lever (240) is closed to clamp the tissue (T), the microprocessor can identify the closure of the clamping lever (240) and can initiate the sensing of the deflection of the anvil insert (276) with the strain gauge (336). In one example, the microprocessor (338) can identify the state of the clamping lever (240) via a switch (not shown) associated with the clamping lever (240) and indicating whether the clamping lever (240) is open or closed. Additionally or alternatively, the anvil insert (276) can include a manual switch (such as a button or micro switch) that allows a user to manually control the activation of the strain gauge (336) and the microprocessor (338) through the activation of the switch.

[0073] Anvil insert (276) is intended to be configured as a replacement for conventional anvil inserts (e.g., Figure 2 and Figure 3 In some cases, the anvil insert (276) can be provided as an aftermarket solution to add the above-mentioned sensing functionality to an existing stapler (e.g., 10) equipped with a conventional anvil insert, such as a stapler that has been put into use. In these cases, the conventional anvil insert (76) can be removed from the stapler (10) and replaced with the anvil insert (276). In other cases, the anvil insert (276) can be incorporated into the linear surgical stapler (210) before being delivered to the consumer, so that the linear surgical stapler (210) and the anvil insert (276) can be sold together as a kit. In any case, the anvil insert (276) provides a cost-effective and simple solution for providing such functionality to a stapler that does not originally have the above-mentioned functionality.

[0074] Fig.15A configuration of a linear surgical stapler (210) is shown in which an anvil insert (276) is already incorporated into the linear surgical stapler (210) when it is delivered to the user (i.e., as a kit). For the purpose of this configuration, the onboard power supply (346) includes a battery. The anvil insert (276) is shown as being partially mounted in the distal jaw portion (264) so ​​that the contour end (332) is spaced apart from the distal jaw portion (264). The pull tab (348) is inserted between the distal jaw portion (264) and the contour end (332) and is configured to selectively interrupt the connection of the battery to the strain gauge (336), the microprocessor (338), and the wireless communication module (344), thereby preventing power from being supplied to them. When the linear surgical stapler (210) is initially put into use, the pull tab (348) can be removed from the anvil insert (276) to connect the battery to the strain gauge (336), the microprocessor (338) and the wireless communication module (344), thereby facilitating powering the same. The anvil insert (276) is biased proximally relative to the distal jaw portion (264) by an internal spring (not shown) so that when the pull tab (348) is removed, the anvil insert (276) automatically slides proximally and enters a fully installed position.

[0075] Fig.16 and Fig.17 Another exemplary linear surgical stapler (410) is substantially similar to the linear surgical stapler (210) described above, except that the difference is described in addition below. The linear surgical stapler (410) includes a distal jaw portion (464) and an anvil insert (476) slidably connected to the distal jaw portion (464). However, the anvil insert (476) includes an internal power circuit (550) terminating at the interface (552). The internal power circuit (550) is provided instead of the onboard power supply (346) and is configured to be able to selectively power a strain gauge (e.g., 336), a microprocessor (e.g., 338), and a wireless communication module (e.g., 344). The power port (554) may be provided within the distal jaw portion at the proximal end of the distal jaw portion (464). The power port (554) is powered from within the stapler, such as from a power source located on the linear surgical stapler (410) or from a remote power source connected to the linear surgical stapler (410) via a cable. Fig.16 As shown, anvil insert (476) is shown partially installed in distal jaw portion (464) such that interface (552) is physically separated from power port (554). When in this position, internal power circuit (550) is electrically disconnected from power port (554) to prevent power port (554) from being used to power anvil insert (476). When anvil insert (476) is fully installed in distal jaw portion (464), as shown, interface (552) is physically separated from power port (554). Fig.17As shown, internal power circuit (550) becomes electrically connected to power port (554), which facilitates powering anvil insert (476) with linear surgical stapler (410).

[0076] Fig.18Yet another exemplary linear surgical stapler (610) is shown, which is generally similar to the linear surgical stapler (210) described above, except that the difference is described in addition below. The linear surgical stapler (610) includes a distal jaw portion (620, 664) and an anvil insert (676) connected to the distal jaw portion (664). However, the anvil insert (676) includes a proximal feedback generator (756) and a distal feedback generator (758), each of which is configured to be able to provide at least one of an audible notification and a visual notification on the linear surgical stapler (610) relative to the clamping state of the linear surgical stapler (610). The proximal feedback generator (756) is located at the proximal end of the elongated body (e.g., 330) of the anvil insert (676), and the distal feedback generator (758) is located on the contour end (732). The distal jaw portion (664) defines an aperture (760) that is aligned with the proximal feedback generator (756) to allow any feedback generated thereby to be projected through the distal jaw portion (664) for easier viewing by the user. The proximal feedback generator and the distal feedback generator (756, 758) are communicatively coupled to a microprocessor (e.g., 338) that is configured to selectively activate the proximal feedback generator and the distal feedback generator (756, 758) based on the clamping state of the distal jaw portions (620, 664). For example, if the tissue (T) is properly clamped between the distal jaw portions (620, 664), the proximal feedback generator and the distal feedback generator (756, 758) are deactivated or alternatively generate a notification (such as a green light) to the user to indicate to the user that the linear surgical stapler (210) is ready to fire. If the tissue (T) is improperly clamped so that the deflection of the anvil insert (676) exceeds the threshold value, the proximal feedback generator and the distal feedback generator (756, 758) generate one or more of an audible notification and a visual notification (such as a red light) to indicate to the user that the tissue (T) is improperly clamped and suppress the firing of the linear surgical stapler (210) until the tissue (T) is released and re-clamped. In some cases, the anvil insert (676) is configured to generate a notification of the clamping state on a nearby console in conjunction with the notification generated by the proximal feedback generator and the distal feedback generator (756, 758). In these cases, the anvil insert (626) is configured to include a wireless communication module (e.g., 344) for communicating with the console. In other cases, the proximal feedback generator and the distal feedback generator (756, 758) can notify the user of the clamping state instead of generating an indicator on a nearby console. In these cases, anvil insert (626) may not include a wireless communication module (eg, 344).

[0077] 2. Smart anvil insert with alternative sensor arrangement

[0078] Fig.19 Yet another exemplary linear surgical stapler (810) is shown, which is generally similar to the linear surgical stapler (210) described above, except that the difference is described in addition below. The linear surgical stapler (810) includes a distal jaw portion (820, 864), a staple cartridge (940) supported by the distal jaw portion (820), and an anvil insert (876) supported by the distal jaw portion (864). However, the anvil insert (876) includes a Hall effect sensor (974) that is disposed in the contour end (932) and cooperates with a magnet (976) to facilitate measuring the distance between the contour end (932) and the staple cartridge (840). The anvil insert can therefore be configured to facilitate detecting improper clamping based on the distance between the contour end (932) and the staple cartridge (840). For example, when tissue is clamped between the distal jaw portions (820, 864), if the distance between the Hall effect sensor (974) and the magnet (976) exceeds a predetermined distance, the anvil insert (876) facilitates generating a notification to the user to inhibit firing the linear surgical stapler (810) prior to releasing the tissue (T) and re-clamping.

[0079] The anvil insert (876) may be further configured to utilize a Hall effect sensor (974) to facilitate detection of the presence of a staple cartridge (940) and / or the type of staple cartridge supported on the distal jaw portion (820). For example, each different type of staple cartridge (e.g., 840) that may be used with the linear surgical stapler (810) may include a magnet having a specific magnetic field or other characteristic that distinguishes one type of staple cartridge from other types of staple cartridges. When a particular type of staple cartridge is installed on the distal jaw portion (820), the anvil insert (876) may identify the type of staple cartridge installed based on the magnet detected by the Hall effect sensor (974). The anvil insert may accordingly notify the user of the type of staple cartridge installed to allow the user to confirm that the appropriate staple cartridge is being used for a given application. Furthermore, when a staple cartridge (840) is not installed on distal jaw portion (820), the Hall effect sensor (974) detects the absence of magnet (976), allowing anvil insert (876) to generate a notification to the user indicating that a staple cartridge needs to be installed.

[0080] Fig. 20Another exemplary linear surgical stapler (1010) is shown, which is generally similar to the above-mentioned linear surgical stapler (210), except that the difference is described in addition below. The linear surgical stapler (1010) includes a distal jaw portion (1020, 1064), a staple cartridge (1040) supported by the distal jaw portion (1020), and an anvil insert (1076) supported by the distal jaw portion (1064). However, the anvil insert (1076) includes a force sensor (1176) aligned with the tissue gap column (1162) disposed at the distal end of the staple cartridge (1040). The force sensor (1176) is configured to be able to detect contact with the tissue gap column (1162). Therefore, the anvil insert (1076) can be configured to be able to facilitate detection of improper clamping according to whether the tissue gap column (1162) contacts the force sensor (1176). For example, if the tissue gap post (1162) is not contacting the force sensor (1176), the anvil insert (1076) may advantageously generate a notification to the user to refrain from firing the linear surgical stapler (1010) prior to releasing the tissue (T) and re-clamping.

[0081] Fig.21 Yet another exemplary linear surgical stapler (1210) is shown, which is generally similar to the linear surgical stapler (210) described above, except that the difference is described in addition below. The linear surgical stapler (1210) includes a distal jaw portion (1220, 1264), a staple cartridge (1240) supported by the distal jaw portion (1220), and an anvil insert (1276) supported by the distal jaw portion (1264). However, the anvil insert (1276) includes a color sensor (1378) that is disposed in the contour end (1332) and is configured to detect the color of the staple cartridge (1240). When a particular type of staple cartridge is installed on the distal jaw portion (1220), the anvil insert (1276) can identify the type of staple cartridge installed based on the color detected by the color sensor (1378). Anvil insert (1276) may accordingly inform the user of the type of staple cartridge installed to allow the user to confirm that the appropriate staple cartridge is being used for a given application.

[0082] Fig.21Yet another exemplary linear surgical stapler (1210) is shown, which is generally similar to the linear surgical stapler (210) described above, except that the difference is described in addition below. The linear surgical stapler (1210) includes a distal jaw portion (1220, 1264), a staple cartridge (1240) supported by the distal jaw portion (1220), and an anvil insert (1276) supported by the distal jaw portion (1264). However, the anvil insert (1276) includes a color sensor (1378) that is disposed in the contour end (1332) and is configured to detect the color of the staple cartridge (1240). When a particular type of staple cartridge is installed on the distal jaw portion (1220), the anvil insert (1276) can identify the type of staple cartridge installed based on the color detected by the color sensor (1378). Anvil insert (1276) may accordingly inform the user of the type of staple cartridge installed to allow the user to confirm that the appropriate staple cartridge is being used for a given application.

[0083] Figure 22 to Figure 23 Yet another exemplary linear surgical stapler (1410) is shown, which is generally similar to the linear surgical stapler (210) described above, except as described further below. The linear surgical stapler (1410) includes a distal jaw portion (1420, 1464), a staple cartridge (1440) supported by the distal jaw portion (1420), and an anvil insert (1476) supported by the distal jaw portion (1464). However, the anvil insert (1476) includes an array of position sensors (1580) disposed in the narrow slot (1534) and distributed along the length of the anvil insert (1476). The position sensor (1580) is configured to detect the movement of the knife member (1526) along the way through the firing stroke ( Fig.23 Position sensor (1580) may be used to detect the position of blade member (1526) at various stages of the firing stroke (shown in Figure 1). In one example, position sensor (1580) may include a proximity sensor, although any of a variety of suitable sensors are contemplated. Position sensor (1580) may be used to detect the position of blade member (1526) during firing, the number of times blade member (1526) has been fired, or any of a variety of other clinically relevant information regarding the firing stroke of blade member (1526).

[0084] III. Exemplary Combinations

[0085] 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.

[0086] Example 1

[0087] A device comprising: (a) an elongated cartridge channel comprising a proximal frame portion and a distal cartridge jaw portion, the distal cartridge jaw portion being configured to releasably receive a staple cartridge; (b) an anvil assembly comprising an elongated anvil channel and an anvil insert, the elongated anvil channel comprising a proximal frame portion and a distal cartridge jaw portion, and the anvil insert being disposed at the distal cartridge jaw portion; (c) a clamping member pivotally connected to the elongated cartridge channel and capable of pivoting between a release position and an actuated position, wherein pivoting of the clamping member from the release position to the actuated position facilitates clamping patient tissue between the anvil assembly and the elongated cartridge channel; and (d) a deflection sensor associated with the anvil assembly and configured to detect deflection of the anvil assembly to facilitate generating a notification based on the detected deflection.

[0088] Example 2

[0089]

[00136] The apparatus of Example 1 wherein the deflection sensor is coupled to the anvil insert.

[0090] Example 3

[0091] A device according to Example 2, wherein the deflection sensor is embedded in the anvil insert.

[0092] Example 4

[0093] A device as described in embodiment 3, wherein the deflection sensor includes one of a strain gauge, a force sensor, or a Hall effect sensor.

[0094] Example 5

[0095] The apparatus according to any one of Examples 3 and 4, wherein the anvil assembly includes a power module configured to power the deflection sensor.

[0096] Example 6

[0097] The device according to embodiment 5, wherein the power module includes a battery.

[0098] Example 7

[0099]

[00136] The apparatus of Example 6, wherein the battery is coupled to the anvil insert.

[0100] Example 8

[0101] The device of any preceding embodiment, wherein the deflection sensor is configured to facilitate generating a notification when the detected deflection exceeds a threshold.

[0102] Example 9

[0103] A device according to any preceding embodiment, further comprising an indicator configured to generate the notification.

[0104] Example 10

[0105] A device as described in Example 9, wherein the indicator includes one or more of a light and a speaker.

[0106] Embodiment 11

[0107]

[0066] The apparatus of any of Examples 9 and 10 wherein the indicator is coupled to the anvil insert.

[0108] Example 12

[0109] A device as described in Example 11, wherein the elongated anvil channel defines a hole that is substantially aligned with the indicator.

[0110] Embodiment 13

[0111] According to any of the aforementioned embodiments, the device, wherein: (i) the clamping member includes a pair of opposing jaws extending distally from the distal end of the clamping member, (ii) each of the opposing jaws defines a curved slot, and (iii) pivoting of the clamping member from the release position to the actuation position facilitates capturing a pair of latch pins of the elongated anvil channel within the opposing jaws to facilitate clamping the anvil assembly against the elongated magazine channel.

[0112] Embodiment 14

[0113] According to any one of the aforementioned embodiments, the device also includes a gap spacing pin extending from the slender bin channel toward the anvil assembly, wherein the gap spacing pin is configured to space the anvil assembly and the elongated bin channel apart from each other by a predetermined distance when the anvil assembly is clamped against the elongated bin channel.

[0114] Embodiment 15

[0115] The apparatus of any of the preceding embodiments, wherein the elongated anvil channel is configured to interact with staples from the staple cartridge and wherein the anvil insert defines a slot configured to receive a knife.

[0116] Example 16

[0117] A device comprising: (a) an elongated cartridge channel, the elongated cartridge channel comprising a proximal frame portion and a distal cartridge jaw portion, the distal cartridge jaw portion being configured to releasably receive a cartridge; (b) an anvil assembly, the anvil assembly comprising an elongated anvil channel and an anvil insert, the elongated anvil channel comprising a proximal frame portion and a distal cartridge jaw portion, and the anvil insert being disposed at the distal cartridge jaw portion; and (c) a clamping member pivotally connected to the elongated cartridge channel and capable of pivoting between a release position and an actuation position. (a) a first actuated member adapted to engage the anvil insert and configured to engage the anvil insert to provide a first actuated position for clamping the patient tissue between the anvil assembly and the elongated chamber channel; (b) a second actuated member adapted to engage the anvil insert and configured to engage the anvil insert to provide a first actuated position for clamping the patient tissue between the anvil assembly and the elongated chamber channel; (c) a second actuated member adapted to engage the anvil insert and configured to engage the patient tissue to engage the anvil insert; (d) a second actuated member adapted to engage the anvil insert and configured to engage the patient tissue to engage the anvil insert; (e) a second actuated member adapted to engage the anvil insert and configured to engage the patient tissue to engage the anvil insert;

[0118] Embodiment 17

[0119] A device as described in embodiment 16, wherein the indicator is configured to generate a notification when the detected deflection exceeds a threshold.

[0120] Embodiment 18

[0121] The device of any one of embodiments 16 and 17, wherein the indicator comprises one or more of a light and a speaker.

[0122] Embodiment 19

[0123] A device as described in Example 18, wherein the elongated anvil channel defines a hole that is substantially aligned with the indicator.

[0124] Embodiment 20

[0125] An anvil insert for a linear surgical stapler, the anvil insert comprising: (a) an elongated body defining an elongated slot for accommodating a knife; (b) a tip disposed at a distal end of the elongated body; (c) a deflection sensor coupled to the elongated body and configured to detect a deflection of the elongated body; (d) an indicator coupled to the tip and configured to generate a notification when a detected deflection exceeds a threshold; and (e) a battery coupled to the anvil insert and configured to power the deflection sensor and the indicator.

[0126] IV. Miscellaneous

[0127] 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.

[0128] 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.

[0129] The surgical instrument systems described herein have been described in conjunction with the deployment and deformation of staples; however, the embodiments described herein are not limited thereto. For example, various embodiments are contemplated that deploy fasteners other than staples, such as clamps or tacks. In addition, various embodiments are contemplated that utilize any suitable device for sealing tissue. For example, an end effector according to various embodiments may include an electrode configured to heat and seal tissue. Additionally, for example, an end effector according to certain embodiments may apply vibration energy to seal tissue.

[0130] 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 operator 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.

[0131] 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.

[0132] 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) an elongated cartridge channel comprising a proximal frame portion and a cartridge distal jaw portion, the cartridge distal jaw portion being configured to releasably receive a staple cartridge; (b) an anvil assembly comprising an elongated anvil channel including a proximal frame portion and an anvil distal jaw portion and an anvil insert disposed at the anvil distal jaw portion; (c) a clamping member pivotally coupled to the elongated cartridge channel and pivotable between a release position and an actuated position, wherein pivoting of the clamping member from the release position to the actuated position facilitates clamping of patient tissue between the anvil assembly and the elongated cartridge channel; and (d) a deflection sensor associated with the anvil assembly and configured to detect deflection of the anvil assembly to facilitate generating a notification based on the detected deflection.

2. The device according to claim 1, wherein: The deflection sensor is coupled to the anvil insert.

3. The device according to claim 2, wherein: The deflection sensor is embedded in the anvil insert.

4. The device according to claim 3, wherein: The deflection sensor includes one of a strain gauge, a load cell, or a Hall effect sensor.

5. The device according to claim 2, wherein: The anvil assembly includes a power module configured to power the deflection sensor.

6. The device according to claim 5, wherein: The power module includes a battery.

7. The device according to claim 6, wherein: The battery is coupled to the anvil insert.

8. The device according to claim 1, wherein: The deflection sensor is configured to facilitate generating a notification when the detected deflection exceeds a threshold value.

9. The device of claim 1, further comprising an indicator configured to generate the notification.

10. The device according to claim 9, wherein: The indicator includes one or more of a light and a speaker.

11. The device according to claim 9, wherein: The indicator is coupled to the anvil insert.

12. The device according to claim 11, wherein The elongated anvil channel defines a hole that is substantially aligned with the indicator.

13. The apparatus of claim 1, wherein: (i) the clamping member comprises a pair of opposed jaws extending distally from a distal end of the clamping member, (ii) each of the opposing jaws defines a curved slot, and (iii) Pivoting of the clamping member from the release position to the actuated position facilitates capturing a pair of latch pins of the elongated anvil channel within the opposing jaws to facilitate clamping the anvil assembly against the elongated cartridge channel.

14. The apparatus of claim 1 further comprising a gap spacing pin extending from the elongated cartridge channel toward the anvil assembly, wherein: The gap spacing pin is configured to space the anvil assembly and the elongated cartridge channel a predetermined distance from each other when the anvil assembly is clamped against the elongated cartridge channel.

15. The apparatus according to claim 1, wherein: The elongated anvil channel is configured to interact with staples from the staple cartridge, and the anvil insert defines a slot configured to receive a knife.

16. A device comprising: (a) an elongated cartridge channel comprising a proximal frame portion and a cartridge distal jaw portion, the cartridge distal jaw portion being configured to releasably receive a staple cartridge; (b) an anvil assembly comprising an elongated anvil channel including a proximal frame portion and an anvil distal jaw portion and an anvil insert disposed at the anvil distal jaw portion; (c) a clamping member pivotally coupled to the elongated cartridge channel and pivotable between a release position and an actuated position, wherein pivoting of the clamping member from the release position to the actuated position facilitates clamping of patient tissue between the anvil assembly and the elongated cartridge channel; (d) a strain gauge embedded in the anvil insert and configured to detect deflection of the anvil insert; (e) an indicator coupled to the anvil insert and configured to generate a notification based on the detected deflection; and (f) A battery coupled to the anvil insert and configured to power the strain gauge and the indicator.

17. The device according to claim 16, wherein: The indicator is configured to generate a notification when the detected deflection exceeds a threshold value.

18. The apparatus according to claim 17, wherein: The indicator includes one or more of a light and a speaker.

19. The apparatus according to claim 18, wherein: The elongated anvil channel defines a hole that is substantially aligned with the indicator.

20. An anvil insert for a linear surgical stapler, the anvil insert comprising: (a) an elongated body defining an elongated slot for receiving a knife; (b) a tip disposed at a distal end of the elongated body; (c) a deflection sensor coupled to the elongated body and configured to detect a deflection of the elongated body; (d) an indicator coupled to the tip and configured to generate a notification when the detected deflection exceeds a threshold; and (e) A battery coupled to the anvil insert and configured to power the deflection sensor and the indicator.

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