linear surgical suture

Abstract

An apparatus includes a first elongated member and a second elongated member having a first suture surface and a second suture surface and configured to be releasably coupled together. A clamping member is movable from a first position to a second position to bring the suture surfaces into contact with and clamp tissue. A latching member is movable from an unlatched state to a latched state to releasably retain the clamping member in the second position. A firing assembly is actuated from an original position to fire a pin into the clamped tissue. When the clamping member is in the second position and the firing assembly is in the original position, the latching member is movable from the unlatched state to the latched state. When the clamping member is in the second position and the firing assembly is displaced from the original position, the latching member is prevented from movable from the unlatched state to the latched state.

Description

priority

[0001] This application is a continuation-in-part of U.S. non-provisional application No. 18 / 316,635, entitled “Linear Surgical Stapler,” filed May 12, 2023, which claims the benefits of U.S. provisional application No. 63 / 352,093, filed June 16, 2022, and U.S. provisional application No. 63 / 423,300, filed November 7, 2022, the disclosures of which are incorporated herein by reference in their entirety. Background Technology

[0002] In some surgical procedures, such as gastrointestinal anastomosis, it may be desirable to clamp one or more layers of tissue, cut through the clamped layers, and simultaneously drive staples through the layers to substantially seal the cut layers together near the cut ends of the tissue layers. One such instrument that can be used in such procedures is a linear surgical stapler, also known as a “linear cutter.” A linear surgical stapler typically comprises a first half (called the “cabin half” or “reloading half”) and a second half (called the “anvil half”), the first half having distal jaws configured to support the staple cartridge (or “reloading”), and the second half having distal jaws supporting the anvil surface with staple-forming features. The stapler further includes movable clamping levers configured to releasably clamp these stapler halves together. These stapler halves are configured to releasably engage together and pivot relative to each other to clamp tissue located between the two distal jaws when the clamping levers are closed. The firing assembly of the stapler is configured to be actuated to cut the clamped layer and simultaneously drive the staples through the tissue on either side of the cut line. After the stapler is fired, the clamping levers can be opened and the stapler half separates to release the cut and sutured tissue.

[0003] Although various surgical suturing instruments and associated components have been manufactured and used, it is believed that no one had manufactured or used the invention described in the appended claims prior to the inventors. Attached Figure Description

[0004] 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.

[0005] Figure 1 A perspective view of an exemplary linear surgical stapler is shown, illustrating that the stapler's chamber half and anvil half are joined together, with the clamping lever of the chamber half in a fully closed position. Figure 2 It shows Figure 1An exploded perspective view of a straight surgical stapler, also showing the staple cartridge; Figure 3 It shows Figure 1 A perspective view of the distal end portion of the anvil half of a straight surgical suture device; Figure 4 It shows Figure 2 A perspective view of the distal end portion of the staple cartridge; Figure 5 It shows Figure 1 A cross-sectional perspective view of the proximal portion of the chamber half of a linear surgical stapler, with the clamping lever in the open position, to show details of the firing and holding components of the chamber half; Figure 6 It shows Figure 5 The exploded perspective of the preserved components; Figure 7 It shows Figure 5 Another exploded perspective of the retaining component; Figure 8 It shows Figure 5 A perspective view of the firing component; Figure 9 It shows including Figure 2 A perspective view of the pinning device component; Figure 10 It shows Figure 9 An exploded perspective view of the pinning cartridge component; Figure 11 It shows Figure 9 A top-down plan view of the staple cartridge; Figure 12 It shows Figure 9 Rear front view of the staple cartridge; Figure 13 It shows Figure 9 An enlarged perspective view of the distal portion of the staple cartridge, showing the tissue gripping components formed on the platform of the staple cartridge; Figure 14 It shows Figure 9 An enlarged perspective view of the platform portion of the staple cartridge, which shows the bridge element of the tissue gripping member and the staple driver and staple of the staple cartridge in an actuated state; Figure 15 yes Figure 9 A perspective view of the staple driver unit of the staple cartridge and the corresponding pair of staples; Figure 16 It shows Figure 9 A side view of the staple cartridge; Figure 17 A side front view of another exemplary staple cartridge constructed for use with a straight surgical stapler is shown; Figure 18A side front view of another exemplary staple cartridge constructed for use with a straight surgical stapler is shown.

[0006] Figure 19A It shows Figure 1 A side view of a straight surgical stapler, showing the stapler halves separated from each other and the clamping lever in the open position; Figure 19B It shows Figure 1 A side front view of a straight surgical stapler, showing that with the clamping lever in the open position, the proximal ends of the stapler halves are joined together to provide the stapler in a "suspended open" state. Figure 19C It shows Figure 1 A side view of a straight surgical stapler, showing that the distal portion of the stapler half has approached, such that the distal pin of the anvil half is received by the clamping lever jaws of the chamber half. Figure 19D It shows Figure 1 A side view of a straight surgical stapler, showing the closure of the clamping levers completely clamping the stapler halves together; Figure 19E It shows Figure 1 A side front view of a straight surgical stapler, showing the distal actuation of the firing assembly while the stapler half is fully clamped. Figure 20 A perspective view of the proximal portion of another exemplary linear surgical stapler is shown, which shows the stapler's chamber half and anvil half connected together, wherein the clamping lever of the chamber half is in the fully closed position and the latching member of the clamping lever is in the latched state. Figure 21 It shows Figure 20 A perspective view of the clamping lever latch component of a linear surgical stapler; Figure 22 It shows Figure 20 A lateral sectional view of the proximal portion of a linear surgical stapler, showing details of the firing assembly, the retaining assembly, and the clamping lever latching member of the chamber half, showing the clamping lever in the fully closed position as the firing assembly is displaced from its proximal original position, with the latching member in the unlatched state. Figure 23 It shows Figure 20 A lateral sectional view of the proximal portion of a linear surgical stapler, showing the latching member in a latched state while the firing assembly is in its proximal original position; Figure 24 It shows Figure 20A side view of the proximal portion of a straight surgical stapler, showing a protrusion that, when the stapler is in the suspended open position, is located at the proximal end of the cover of the anvil half and contacts the retaining member of the chamber half to resist detachment of the proximal end of the stapler half. Figure 25A A side front view of a second exemplary linear surgical stapler is shown, illustrating the stapler's clamping lever in the open position; Figure 25B It shows Figure 25A A side view of a straight surgical stapler, showing the clamping lever in a partially closed, non-latched position; Figure 25C It shows Figure 25A A side view of a straight surgical stapler, showing the clamping lever in a fully closed, non-latched position; Figure 26A A side view of a third exemplary linear surgical stapler is shown, illustrating the clamping lever in a partially closed, non-latched position; Figure 26B It shows Figure 26A A side view of a straight surgical stapler, showing the clamping lever in another partially closed, non-latched position; Figure 27 A side view of the fourth exemplary linear surgical stapler is shown, illustrating the clamping lever in the fully closed, non-latched position; Figure 28 A side view of the fifth exemplary linear surgical stapler is shown, illustrating the clamping lever in the fully closed, non-latched position; Figure 29 A perspective view of the anvil half of another exemplary linear surgical suture is shown, which shows the two weld pins of the anvil half; Figure 30A It shows Figure 29 An enlarged side sectional view of the anvil half, showing the anvil cover and selected portions of the distal end member of the anvil half in their respective first longitudinal positions during assembly of the anvil half; Figure 30B It shows Figure 29 Another enlarged side sectional view of the anvil half shows each of the anvil cover and the distal end member in a corresponding second longitudinal position, which constrains the components of the anvil half relative to each other during assembly of the anvil half. Figure 31A It shows Figure 29 An enlarged side sectional view of another exemplary variant of the anvil half, showing the anvil cover and selected portions of the distal end member of the anvil half in the respective first longitudinal position during assembly of the anvil half; Figure 31B It shows Figure 31B Another enlarged side sectional view of the anvil half shows each of the anvil cover and the distal end member in a corresponding second longitudinal position, which constrains the components of the anvil half relative to each other during assembly of the anvil half. Figure 32 A perspective view of another illustrative anvil half of a linear surgical suture is shown; Figure 33A It shows Figure 32 A perspective view of the anvil channel and grooved latch pin of the anvil half, showing the grooved latch pin assembled with the anvil channel; and Figure 33B It shows Figure 32 A perspective view of the disassembled anvil half, showing Figure 33A The assembled anvil channel and grooved latch pin are aligned with the corresponding feature of the anvil cover for assembly.

[0007] The accompanying drawings are not intended to be limiting in any way, and various embodiments of the invention can be conceived to be implemented in many other ways, including those not necessarily shown in the drawings. The 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 explicit arrangements shown. Detailed Implementation

[0008] The following description of certain examples of the invention is not intended to limit the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will be apparent to those skilled in the art from the following description, which is illustrated by way of example, and a preferred mode is contemplated for carrying out the invention. It will be appreciated that the invention can have other different and obvious aspects, all of which are not departing from the invention. Therefore, the drawings and descriptions should be regarded as substantially illustrative and not restrictive.

[0009] For clarity of disclosure, the terms "proximal" and "distal" are defined herein in relation to a surgeon or other operator holding a surgical instrument with a distal surgical end effector. The term "proximal" refers to a position where the element is positioned closer to the surgeon's placement, and the term "distal" refers to a position where the element is closer to the surgical end effector of the surgical instrument and further away from the surgeon's placement. Furthermore, the use of spatial terms such as "upper," "lower," "vertical," "horizontal," etc., with reference to the accompanying drawings, should be understood as being for illustrative purposes only and 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.

[0010] Furthermore, the terms “approximately” and “about” as used herein in relation to any numerical value or range indicate appropriate dimensional tolerances that allow the reference feature to function for the intended purposes described herein.

[0011] I. Exemplary linear surgical suture device A. Overview of linear surgical sutures Figures 1 to 2 An exemplary linear surgical stapler (10) (also known as a “linear cutter”) suitable for a variety of cutting and suturing procedures, such as gastrointestinal anastomosis, is shown. The linear surgical stapler (10) includes a chamber half (12) (also known as a “reloading half”) and an anvil half (14) configured to be releasably coupled together to hold tissue therebetween for simultaneous cutting and suturing of the held tissue.

[0012] The chamber half (12) includes a first elongated member in the form of an elongated chamber 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 notch (26) disposed at its proximal end. An outwardly projecting rigid rib (28) extends longitudinally between the distal slot (24) and the proximal notch (26) of each side flange (22) and is configured to provide enhanced rigidity to the side flange (22). An outwardly expanding upper section (30) defines the upper edge of the proximal portion of each side flange (22) and is configured to facilitate the receiving of the anvil half (14) by the chamber half (12). Each side flange (22) further includes an elongated firing slot (32) extending longitudinally along the underside of the side flange (22) between a proximal notch (26) and a distal slot (24). The elongated firing slot (32) is configured to guide the firing assembly (110) between a proximal position and a distal position. (The following is in conjunction with...) Figure 8 The firing assembly (110) is described in more detail.

[0013] The distal jaw portion (20) of the cartridge passage (16) is configured to releasably receive the staple cartridge (140) (or "reload"). For example... Figure 4 and Figures 9 to 16 As shown, the staple cartridge (140) includes a cartridge body (142) having an upper side defining a first suture surface in the form of a platform (156) having a plurality of staple openings (166) for receiving a plurality of staples (168) and corresponding staple drivers (172) (see See Figure 16 The exemplary features of the staple cartridge (140) are described below in conjunction with... Figures 9 to 16 To describe in more detail.

[0014] The compartment half (12) further includes a third elongated member and a clamping member (also referred to as a "clamping arm" or "latch lever") in the form of a clamping lever (40), which is pivotally connected to the compartment passage (16) by means of a clamping lever pivot pin (42), which is arranged to be generally aligned with a distal slot (24) of the compartment passage side flange (22). The clamping lever (40) includes an elongated lever arm (44) having a free proximal end (46) and a distal end, which is pivotally connected to a lower portion of the compartment passage (16) by means of a pivot pin (42). A pair of opposing jaws (48) extend distally from the distal end of the lever arm (44) beside the compartment passage 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 latching pin (68) of the anvil half (14), as described below.

[0015] The clamping lever (40) is operable to pivot relative to the storage channel (16) between an open position and a closed position, in which the proximal end (46) of the lever arm (44) is spaced apart from the storage channel frame portion (18) (as described below). Figures 19A to 19C As shown), in the closed position, the proximal end (46) faces the warehouse passage frame portion (18) (as described below). Figure 9 (As shown in D). The actuation of the clamping lever (40) from the open position to the closed position is used to capture the opposite side ends of the latching pin (68) within the clamping lever jaw slot (50), and thereby clamp the anvil half (14) against the chamber half (12), as described below. Figures 19C to 19D As shown and described. In this respect, 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 end of the latch pin (68) and pull it toward the compartment channel (16) when the clamping lever (40) is pivotally closed. An elastic member, shown in the form of a leaf spring (52), biases the lever arm (44) toward the open position. Thus, when the clamping lever (40) is initially advanced from the closed position toward the open position, the leaf spring (52) facilitates the disengagement of the clamping lever jaws (48) from the anvil half latch pin (68).

[0016] like Figure 2As best shown, the clamping lever (40) further includes a latching member (54) disposed at the proximal end (46) of the lever arm (44). The clamping lever latching member (54) is configured to resiliently and releasably engage the proximal end of the compartment channel frame portion (18), and thereby releasably hold the clamping lever (40) in the closed position, for example, when the suture (10) is fired. The clamping lever latching member (54) may be further constructed according to the teachings of U.S. Patent No. 11,278,285 entitled “Clamping Assembly for Linear Surgical Stapler”, published March 22, 2022, the disclosure of which is incorporated herein by reference. Exemplary variations of the clamping lever latching member (54) are incorporated below. Figures 20 to 23 To describe in more detail.

[0017] The anvil half (14) of the linear surgical stapler (10) includes a second elongated member in the form of an elongated anvil channel (60) having a proximal frame portion (62) and a distal jaw portion (64). The proximal frame portion (62) includes a pair of laterally opposed upright side flanges (66) configured to be received between the storage channel side flanges (22) when the anvil half (14) is engaged with the storage half (12). A distal latching protrusion in the form of a latching pin (68) extends laterally through the distal end of the anvil channel side flange (66), and a proximal pivoting protrusion in the form of a proximal pin (70) extends laterally through the proximal end of the anvil channel side flange (66). The anvil half pins (68, 70) are configured to facilitate engagement of the anvil half (14) with the storage half (12), as described below.

[0018] like Figure 2 and Figure 3As shown, the distal jaw portion (64) of the anvil half (14) supports the anvil plate (72), which defines a second suturing surface in the form of an anvil surface having a plurality of nail-forming recesses (74) configured to deform the legs of the nails ejected from the staple cartridge (140) when the stapler (10) is fired. The nail-forming recesses (74) of this example can be formed via an embossing process and configured to allow each nail in the staple cartridge (140) to form a three-dimensional shape, wherein the legs of each formed nail are laterally offset from each other to provide a non-planar shape for the formed nail, for example, as disclosed in U.S. Patent No. 11,229,433 entitled “Linear Surgical Stapler”, published January 25, 2022, the disclosure of which is incorporated herein by reference. The anvil channel (60), anvil plate (72), and stapling recess (74) may be formed in one or more of the manner 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”, published June 29, 2021; and / or U.S. Publication No. 2022 / 0142641, entitled “System and Method for Forming Pockets in Anvil of Surgical Stapler”, published 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 pre-formed along its length with a curvature that adapts to the deflection of the distal jaw portion (64) and the anvil plate (72) when the suture halves (12, 14) are held together by the clamping lever (40). The distal jaw portion (64) of the anvil half (14) also supports a tapered distal end member (76). In some embodiments, the distal end member (76) may extend selectively relative to the distal jaw portion (64), according to the teachings of U.S. Patent No. 11,033,266 entitled "Decoupling Mechanism for Linear Surgical Stapler," published June 15, 2021, the disclosure of which is incorporated herein by reference.

[0019] like Figure 2As shown, the linear surgical stapler (10) further includes a pair of covers (56, 78) that cover selected portions 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) such that the clamping lever cover (56) is configured to pivot relative to the storage channel (16) together with the clamping lever (40). Additionally, the anvil cover (78) is attached to and covers the outward-facing side of the anvil channel (60). In some configurations, the anvil cover (78) may be coupled to the anvil channel (60) via an interaction between pins (68, 70) and one or more inserts, ribs, or other structures disposed within the interior of the anvil cover (78) and including openings, slots, keyholes, or other features configured to receive a corresponding one of the pins (68, 70). By way of example only, the cover (56, 78) may be attached using one or more of the teachings of U.S. Patent No. 11,278,285, which is incorporated herein by reference. In other forms, the cover (56, 78) may be attached to the clamping lever (40) and the anvil channel (60) in a variety of other suitable manners readily understood by one of ordinary skill in the art in accordance with the teachings herein.

[0020] like Figure 2 and Figures 5 to 7 As best shown, the proximal end of the chamber half (12) includes a retaining assembly (80) configured to releasably retain portions of the anvil half (14) and 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 connected to the proximal end of the chamber passage (16) via a lateral extension pin (85) arranged proximal to the firing slot (32), and the members (82, 84) are elastically biased in opposite rotational directions by an elastic member in the form of a torsion spring (86) positioned between the members (82, 84).

[0021] The anvil latch member (82) includes a central body (88), latch fingers (90) extending upward from the central body (88), and a release button (92) extending downward from the central body (88) through the base wall of the proximal frame portion (18) of the compartment passage (16). The upper end of the latch fingers (90) tapers distally and is configured to releasably capture the proximal anvil pin (70) of the anvil half (14) using an angled latch surface (94) that covers the proximal anvil pin (70) once captured. The anvil latch member (82) further includes a pin ejection feature in the form of an angled protrusion (96) extending distally from the base portion of the latch fingers (90) and defining an ejection cam ramp (98) proximal to the latch fingers (90).

[0022] The stop member (84) of the proximal holding 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 its proximal original 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) translates distally from its proximal original position, thereby preventing the clamping lever (40) from opening during the firing stroke, for example, as described in more detail in U.S. Patent No. 11,278,285, which is incorporated herein by reference.

[0023] In use, with the suture halves (12, 14) joined together at their proximal ends such that the proximal anvil pin (70) is held 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 ejection cam ramp (98) to advance proximally to drive the proximal tapered notch (26) of the ejection channel (16) upwards towards the proximal anvil pin (70). The chamber half (12) of this type further includes a stationary finger gripping protrusion (106) that extends downwards from the base wall of the proximal frame portion (18) of the chamber channel (16) at a position distal to the lower release button (92) and is configured to facilitate actuation of the release button (92). Specifically, the user may 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 grip protrusion (106), and then squeeze the release button (92) distally toward the stationary finger grip protrusion (106) to cause the latch finger (90) to rotate out of engagement with the proximal anvil pin (70) and eject the pin (70) upward from the compartment channel (16) using the ejection cam ramp (98).

[0024] The relevant components of the retaining assembly (80) and the compartment half (12) may be constructed and operated in accordance with the teachings of one or more of the following patents: U.S. Patent No. 10,898,187 entitled “Firing System for Linear SurgicalStapler”, issued January 26, 2021; and / or U.S. Patent No. 11,033,266, which is incorporated herein by reference.

[0025] like Figure 8 As shown, the firing assembly (110) of the magazine (12) includes a slider (112), a pair of actuators (114, 116) (or “firing knobs”) pivotally coupled to the slider (112), and a set of elongated beams (118, 122) extending distally from the slider (112). The pair of side beams (118) are coupled to the distal end of the slider (112) at their proximal ends and terminate distally in a pair of cam ramps (120). The cam ramps (120) are configured to engage a nail actuator (172) housed within the nail cartridge (140) (see...). Figure 10 and Figure 15The staple driver (172) is actuated upwards from the lower side of the staple cartridge (130), thereby driving (or “firing”) the staples from the cartridge (130) into the tissue held between the staple cartridge (140) and the anvil plate (72). The central beam (122) is connected to the side beam (118) via a bridging member (124) (or “blade block”) spaced distally from the slider (112). The central beam (122) terminates distally in a distally angled blade member (126) having a distal cutting edge (128) configured to cut tissue held between the distal portions of the stapler halves (12, 14).

[0026] Each actuator (114, 116) of the firing assembly (110) is configured to rotate relative to the slider (112) between a deployment position and a retracted position, such that only one actuator (114, 116) can be deployed at a time, for example, as disclosed in U.S. Patent No. 10,898,187, which is incorporated herein by reference above. In the deployment position, the actuators (114, 116) can be driven distally by the operator to actuate the firing assembly (110) distally past the suture (10), thereby simultaneously cutting and suturing the tissue held between the suture halves (12, 14).

[0027] B. Illustrative bin Figures 9 to 16 An exemplary staple cartridge assembly (130) configured for use with a linear surgical suture device (10) is shown. The staple cartridge assembly (130) includes a staple cartridge (140) and a retainer (132) configured to be releasably coupled to the staple cartridge (140) to retain staples (168) in the staple cartridge (140) prior to use.

[0028] The staple cartridge (140) includes a cartridge body (142) extending linearly along a longitudinal axis between a proximal end and a distal end. The proximal end has a cartridge channel connection feature in the form of a plurality of downwardly extending connecting legs (144, 146) (also referred to as “teeth”), and the distal end has a tapered nose (150). The connecting legs (144, 146) are configured to releasably capture a clamping lever pivot pin (42) and extend downward through corresponding openings formed in the base plate of the cartridge channel (16) when the staple cartridge (140) is located within the distal jaw portion (20) of the cartridge channel (16). A pair of oscillating tabs (152) located on the side of the cartridge body (142) near the proximal end are configured to facilitate insertion and removal of the staple cartridge (140) relative to the distal jaw portion (20). Figure 20As shown, the inner side of each swing insert (152) includes a bevel (154) at its proximal end, which serves as a release feature to provide clearance to the sidewall of the distal jaw portion (20) to facilitate the installation and removal of the staple cartridge (140) without interference.

[0029] The upper side of the cartridge (142) defines a platform (156). An elongated blade slot (158) extends longitudinally through the platform (156) along the longitudinal axis of the cartridge (140) and is configured to receive its blade member (126) slidably through it in response to distal actuation of the firing assembly (110), as described above. A firing locking bypass feature in the form of a swivel insert (160) is rotatably connected to the cartridge (142) at the proximal end of the blade slot (158). The swivel insert (160) is configured to rotate between a deployed position and a retracted position. In the deployed position, the swivel insert (160) extends vertically across the proximal end of the blade slot (158), and in the retracted position, the swivel insert (160) extends parallel to the blade slot (158). The oscillating insert (160) in the deployment position is configured to push the firing assembly (110) from the locked state to the firing state. In the firing state, the firing beam (118, 122) can be translated distally through the staple cartridge (140) to suture and cut the tissue held by the stapler (10).

[0030] A rigid tissue gap column (162) is fixed at the distal end of the scalpel slot (158) and protrudes upward away from the storage platform (156). The circular upper end of the tissue gap column (162) is configured to contact the distal end of the anvil plate (72), thereby defining a tissue gap of a predetermined size between the storage platform (156) and the anvil plate (72) when the suture halves (12, 14) are clamped together in the manner described above.

[0031] A pair of elongated ribs (164) extend along opposite sides of the blade slot (158) and protrude away from the platform (156) to define a raised surface. The elongated ribs (164) terminate at the proximal and distal ends of the blade slot (158) and are configured to facilitate enhanced gripping of tissue along the blade slot (158), thus stabilizing tissue during cutting by the blade member (126).

[0032] The cartridge body (142) of the staple cartridge (140) further includes a plurality of staple openings (166) extending laterally through the cartridge body (142) and opening onto the platform (156). In this example, the staple openings (166) are arranged in parallel first and second rows along each side of the blade slot (158), such that the staple openings (166) in each row are longitudinally staggered relative to the staple openings (166) in adjacent rows. It should be understood that various suitable arrangements and numbers of staple openings (166) can be provided in other types of staple cartridges (140). Each staple opening (166) is configured to accommodate a corresponding staple (168) and staple driver (172). As described above, the cam ramp (120) of the firing assembly (110) is configured to engage the underside of the nail driver (172) and actuate the nail driver (172) upward within the nail opening (166) to drive (or “fire”) the nail (170) from the nail opening (166) into the tissue and abut against the anvil plate (72).

[0033] like Figures 13 to 14 As shown, the staple cartridge (140) further includes a plurality of tissue gripping members (180) arranged on and projecting upward from the cartridge platform (156). The tissue gripping members (180) are distributed along the length of the platform (156) and laterally offset from the blade slot (158) and elongated ribs (164) to align with and open toward a corresponding one or more staple openings (166). The tissue gripping members (180) are configured to grip and thereby stabilize tissue when the platform (156) and the anvil plate (72) are clamped together; and furthermore, tissue compression at the staple location is optimized to facilitate effective suturing and cutting of the tissue. In this configuration, the tissue gripping members (180) are integrally connected to the cartridge body (142).

[0034] Each tissue gripping member (180) includes a first end feature (182) and an opposing second end feature (182), the first end feature being partially wound around a first end portion of a pin opening (166), and the second end feature being partially wound around an opposing second end portion of the same pin opening (166). A pair of bridge elements (184) extend along opposing sides of the pin opening (166) between the first end feature (182) and the second end feature (182) and are recessed relative to the first end feature (182) and the second end feature (182). Thus, each bridge element (184) has a maximum height relative to the platform (156) that is less than the maximum height of each of the first end feature (182) and the second end feature (182). Each pair of bridge elements (184) is configured to cooperate with the corresponding end features (182) to compress and grip tissue surrounding the corresponding staple opening (166) and guide the corresponding staple driver (172) toward the anvil plate (72) during staple leg formation without contacting the legs of the corresponding staple (168). This compression of the tissue by the end features (182) and bridge elements (184) facilitates gripping and stabilizing the tissue while minimizing the compression of the tissue by the staple driver (172) itself, which in turn minimizes the user input force required to fire the suture device (10). In addition, at least one end feature (182) associated with each staple opening (166) is integrally connected to an adjacent end feature (182) associated with a longitudinally adjacent staple opening (166), wherein a recessed region (186) is located between each pair of integrally connected end features (182).

[0035] like Figure 15 As shown, each pair of nail drivers (172) of the nail cartridge (140) is integrally formed as a nail driver unit (170), which has a bridge feature (174) that interconnects the nail drivers (172) at their lower ends. The nail drivers (172) of the driver unit (170) are arranged in a staggered manner, wherein the nail drivers (172) are laterally and longitudinally offset from each other relative to the longitudinal axis of the nail cartridge (140), such that the nail drivers (172) are configured to align with the corresponding nail opening (166) of the cartridge body (142). Each nail driver (172) includes a groove 176 at its upper end, which is configured to receive and support the crown of the corresponding nail (168). Additionally, each nail driver (172) includes a nail leg receiving feature at its upper end in the form of a recess (178), the recess being defined by a corresponding chamfered surface and configured to receive the end of the nail leg of the corresponding nail (168) during nail formation on the anvil plate (72) when the stitcher (10) is fired. Such features are described in more detail in U.S. Patent No. 11,229,433, which is incorporated herein by reference.

[0036] As described above, the connecting legs (144, 146) formed at the proximal end of the staple cartridge (140) facilitate the connection of the staple cartridge (140) to the distal jaw portion (20) of the cartridge channel (16). More specifically, each side of the staple cartridge (140) includes a longer distal connecting leg (144) and a shorter proximal connecting leg (146) separated by a gap (148). The gap (148) is appropriately positioned and shaped, for example having a quasi-elliptical shape, to provide a proximal connecting leg (146) with a minimum thickness in the longitudinal direction smaller than that of the distal connecting leg (144), thus making the proximal connecting leg (146) have appropriate flexibility relative to the cartridge body (142). Therefore, during the installation of the staple cartridge (140) into the distal jaw portion (20), the proximal connecting leg (146) is configured to deflect relative to the distal connecting leg (144) so ​​that the clamping lever pivot pin (42) can engage in a snap-fit ​​and be received into the gap (148) with an appropriate degree of installation force from the user.

[0037] The distal connecting leg (144) of the staple cartridge (140) can also be used as a foolproof feature, the size and shape of which are set so that the staple cartridge (140) can be used only with a predetermined type of straight surgical suture, such as a suture configured to apply a staple pattern and a cut line of a predetermined length (e.g., 60 mm) to the tissue. Figure 17 Another exemplary staple cartridge (190) is shown that is generally similar to the staple cartridge (140), except that the staple cartridge (190) is longer and has a uniquely shaped distal connecting leg (192) that allows the staple cartridge (190) to be used only with another predetermined type of straight surgical suture, such as a suture configured to apply longer (e.g., 80 mm) staple patterns and cutting lines to the tissue. Figure 18 Another exemplary staple cartridge (200) is shown that is generally similar to the staple cartridges (140, 190), except that the staple cartridge (200) is even longer and has a uniquely shaped distal connecting leg (202) that allows the staple cartridge (200) to be used only with another predetermined type of straight surgical suture, such as a suture configured to apply even longer (e.g., 100 mm) staple patterns and cutting lines to the tissue.

[0038] Staple containers (140, 190, 200) may be further constructed based on the teachings of the following patent application: U.S. Patent Application No. 29 / 842,580, filed June 14, 2022, entitled “Staple Cartridge for Linear Surgical Stapler,” the disclosure of which is incorporated herein by reference.

[0039] C. Illustrative use of linear surgical sutures Figures 19A to 19E An illustrative connection of the suture halves (12, 14) and the subsequent firing of the assembled suture (10) during surgical procedures are shown. Figure 9 As shown in Figure A, the clamping lever (40) of the chamber half (12) is positioned in the open position, such that the jaw slot (50) is aligned with the vertical slot (24) of the chamber passage side flange (22). Furthermore, the firing assembly (110) is held in its proximal original position by the stop member (84) of the holding assembly (80), as described above. Figure 5 As shown. At this stage, the tissue portion to be sutured and cut (not shown) can be positioned above the top of the staple cartridge (140) located in the distal jaw portion (20) of the cartridge half (12). Alternatively, after the proximal ends of the stapler halves (12, 14) are joined, as described below, the tissue can be positioned above the staple cartridge (140).

[0040] like Figures 19A to 19B As shown, the proximal ends of the stapler halves (12, 14) are aligned with each other, and the proximal anvil pin (70) is guided downward into the proximal conical notch (26) of the compartment channel (16) to engage the latch finger (90) of the anvil latch member (82). This engagement forces the anvil latch member (82) to rotate elastically clockwise, thereby enabling the latch finger (90) to capture the anvil pin (70), and thus releasably connecting the proximal ends of the stapler halves (12, 14) together, as shown. Figure 19B As shown. While the clamping lever (40) remains in the position as... Figure 19B In the open position shown, the suture (10) is set to a "suspended open" state, allowing the suture (10) to be held by one hand via the anvil half (14), while the storage half (12) remains connected to the anvil half (14). Figure 9 As shown in C, and with the clamping lever (40) held in the open position, the anvil half (14) rotates about the proximal anvil pin (70) toward the anvil half (14), such that the distal latching pin (68) of the anvil half (14) is received in the vertical slot (24) of the compartment channel side flange (22) and the jaw slot (50) of the clamping lever (40). The distal jaw portions (20, 64) of the suturer half (12, 14) are now in a partially proximal state, allowing for a final adjustment of the tissue received therein before clamping.

[0041] like Figure 19DAs shown, the clamping lever (40) closes to abut against the proximal end of the closed jaw slot (50), pulling the anvil latch pin (68), and thereby abutting against the cartridge half (12) to fully clamp the anvil half (14), wherein tissue (not shown) is clamped between the suture surface defined by the cartridge (140) and the anvil plate (72). The tissue gap column (162) of the cartridge (140) defines a small transverse gap between the cartridge (140) and the anvil plate (72), thus containing the tissue therein with a predetermined degree of tissue compression. Figure 19A and Figure 19B As shown, the interstitial column (162) is located at the distal end of the staple cartridge (140) and is configured such that when the stapler (10) is in Figure 19D In the fully clamped state shown, the distal end of the anvil plate (72) can be contacted. 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 compartment channel (16), and thus present a latched state in which the clamping lever latch member (54) holds the clamping lever (40) in the closed position.

[0042] like Figure 19E As shown, when fully clamped, the stapler (10) can be fired by driving the deployed actuators (114, 116) of the firing assembly (110) distally along the proximal frame portion (18) of the cartridge half (12). This action causes the elongated beams (118, 122) of the firing assembly (110) to translate distally through corresponding channels formed in the staple cartridge (140), thereby firing staples into the clamped tissue via the cam ramp (120) and staple driver (172), while simultaneously cutting the clamped tissue using the blade member (126). After the firing stroke is completed, the firing assembly (110) returns to its proximal original position via the actuators (114, 116). The clamping lever latch member (54) can then be depressed to release the proximal end of the clamping lever (40) from the cartridge channel (16), thereby allowing the clamping lever (40) to reopen. Then, the release button (92) of the retaining assembly (80) can be pressed to release the anvil half (14) from the chamber half (12), allowing the suture halves (12, 14) to separate from each other, thereby releasing the newly sutured and cut tissue. It should be understood that in some embodiments, the suture (10) may include additional features that facilitate the disengagement of the suture halves (12, 14), for example, as disclosed in U.S. Patent No. 11,033,266, which is incorporated herein by reference as above.

[0043] D. A linear surgical stapler with a suspension opening feature and a clamping lever latching inhibition feature. As described above in conjunction with the linear surgical stapler (10), a pivotable connection is established between the proximal ends of the stapler halves (12, 14) when the anvil pin (70) is captured by the anvil latch member (82). Additionally, the clamping lever latch member (54) is configured to releasably capture the proximal end of the base wall of the chamber channel (16) to hold the clamping lever (40) in its closed position during firing.

[0044] In some cases, it may be desirable to provide a linear surgical stapler capable of presenting an open state in which the corresponding elongated members of the stapler half are oriented at a predetermined maximum angle relative to each other and remain releasably connected together at the proximal ends of the stapler half (referred to as a “suspended open” or “open” state), such that the stapler in the assembled but open state can be easily manipulated by the operator with one hand. It may also be desirable to suppress the latching of the lever latching member when the firing assembly is displaced from its proximal original position, serving as an indication to the user that the staple cartridge may have been at least partially fired and is therefore unsuitable for use in surgical procedures. The following description provides an illustrative example of a variant of the linear surgical stapler (210) providing such functionality.

[0045] Figure 20 The proximal portion of another exemplary linear surgical stapler (210), comprising a chamber half (212) and an anvil half (214), is shown, which is similar to the chamber half (12) and anvil half (14) of the linear surgical stapler (10) described above, unless otherwise described below. Specifically, the chamber half (212) includes a clamping lever (240) having a clamping lever latching member (254) configured to prevent the proximal end of the clamping lever (240) from latching to the proximal end of the chamber channel (216) when the clamping lever (240) is closed, unless the firing assembly (310) is in its proximal original position. Figure 21 As shown, the clamping lever latching member (254) includes a latching member body (256) and a tapered protrusion (258) pivotally connected to the clamping lever (240), the tapered protrusion extending upward from the latching member body (256). The tapered protrusion (258) includes a lower edge (260) configured to hook onto the proximal end of the base wall of the compartment passage (216) of the compartment half (212), thereby holding the clamping lever (240) in a closed state. The tapered protrusion (258) further includes a convexly curved cam surface (262) facing distally.

[0046] like Figure 22As shown, when the firing assembly (310) shifts from its proximal original position to its distal position, the proximal end of the firing assembly slider (312) disengages from the distal finger (302) of the stop member (284). The stop member (284) rotates clockwise to a position where its proximal hook (304) is lowered, due to the elastic bias of the torsion spring (286). When the clamping lever (240) then moves from the open position to the closed position while the firing assembly (310) is in this distally shifted state, the proximal end of the proximal hook (304) contacts the cam surface (262) of the clamping lever latch member (254). This cam interaction drives the tapered protrusion (258) of the clamping lever latch member (254) away from the magazine passage (216), and thus prevents the clamping lever latch member (254) from latching onto the proximal end of the magazine passage (216). This result can alert the user that the firing assembly (310) has shifted from its proximal original position, meaning the cartridge (140) may have been partially fired and is therefore unsuitable for use on the patient. In response, the user can then return the firing assembly (310) to its proximal original position, replace it with a new cartridge (140), and continue the surgery. When the firing assembly (310) is in such a position... Figure 23 In the case of its proximal original position as shown, the stop member (284) is held by the slider (312) in a counterclockwise rotational position with the proximal hook (104) raised. Therefore, when the clamping lever (240) is closed, the clamping lever latching member (254) is prevented from contacting the proximal hook (304) and latched onto the proximal end of the compartment passage (216).

[0047] like Figure 24 As shown, the anvil half (214) of the suture device (210) further includes an anvil cover (278) having a protrusion in the form of a rib (279) extending downward from the proximal end of the anvil cover (278). The rib (279) includes a rounded end configured such that when the suture device (210) is held by the anvil half (214) in a position similar to Figure 19BIn the suspended open state, the proximal surface of the proximal hook (304) of the retaining assembly (280) of the compartment half (212) is accessible. In the suspended open state, the engagement between the rib (279) and the proximal hook (304) of the stop member (284) provides resistance to disengagement of the stitcher halves (212, 214). More specifically, in the suspended open state, the proximal anvil pin (270) applies an upward prying force against the lower latch surface (294) of the latch finger (290) of the anvil latch member (282), causing the anvil latch member (282) to rotate clockwise, releasing the anvil pin (270) and disengaging the stitcher halves (212, 214). The interaction between the rib (279) and the proximal hook (304) of the stop member (284) effectively counteracts and reduces the upward prying force, thereby providing resistance to the disengagement of the stapler halves (212, 214) and allowing the stapler (210) to remain more securely in the suspended open position without accidental disengagement. This configuration is particularly advantageous for staplers (210) of the type in which the weight of the bin half (212) is increased due to the choice of size and / or material, resulting in an increased prying force applied between the proximal anvil pin (270) and the anvil latch member (282) in the suspended open position.

[0048] E. A linear surgical stapler with a clamping lever and an unlatchable indicator feature. As described above in conjunction with the linear surgical stapler (10), when the latching pin (68) is properly aligned with the jaw slot (50), the clamping lever (40) moves from the open position to the closed position (see Figures 19C to 19D The actuation of the suture mechanism (10) is used to cam-drive the opposing lateral ends of the latching pin (68) proximally within the jaw slot (50), thereby clamping the suture halves (12, 14) together to bring the suture surfaces (72, 140) closer together. In some cases, the surgeon may have difficulty bringing the suture halves (12, 14) close sufficiently to properly align the latching pin (68) with the jaw slot (50), such as when clamping on thick tissue, and the surgeon may unknowingly close the clamping lever (40) without properly capturing the latching pin (68), resulting in the suture halves (12, 14) not being properly latched together. Therefore, it may be desirable to provide a suture mechanism (10) with one or more features configured to provide clear indication to the surgeon when the latching pin (68) has not been properly captured within the jaw slot (50), and to require readjustment of the clamping lever (40) to achieve proper clamping of the tissue.

[0049] Figures 25A to 25CAnother exemplary linear surgical stapler (410) is shown, comprising a storage compartment half (412) and an anvil half (414), which are similar to the storage compartment half (12) and anvil half (14) of the linear surgical stapler (10) described above, unless otherwise described below. Specifically, the clamping lever (440) of the storage compartment half (412) includes a pair of laterally opposed jaws (448) that are uniquely shaped to provide clear indication to the surgeon during the closure of the clamping lever (440) when the latching pin (68) has not yet been properly aligned with and captured by the jaw slot (450).

[0050] Brief reference Figure 25C Each jaw (448) includes a first pin engagement feature in the form of a curved slot (450) having a closed proximal end and an open distal end configured to receive a corresponding side end of a latching pin (68). Each jaw slot (450) divides its corresponding jaw (448) into an upper jaw portion (452) and a lower jaw portion (454) interconnected along the proximal side of the jaw (448). Each upper jaw portion (452) includes a second pin engagement feature at its distal end in the form of a recess (456) that is generally semi-circular in shape and sized to releasably capture the corresponding side end of the latching pin (68) when it is misaligned with the jaw slot (450), as further described below. Additionally, the upper jaw portion (452) has an angled outer profile such that the width of the upper jaw portion (452), measured laterally between the jaw slot (450) and the outer surface (458), increases proximally from the distal end of the jaw (448) toward the apex (460) of the upper jaw portion (452) which is approximately aligned with the midpoint of the slot (450) before gradually decreasing thereafter. Thus, the maximum such width of the upper jaw portion (452) is limited at the apex (460). As described in more detail below, each of the recess (456) and the outer surface (458) is configured to engage the latch pin (68) when it is misaligned with the jaw slot (450), thereby indicating to the surgeon that the latch pin (68) has not been properly captured by the jaw slot (450) and that the suture half (412, 414) needs to be readjusted.

[0051] Figure 25AAn exemplary scenario is shown in which the stapler halves (412, 414) are sufficiently close together such that the latch pin (68) is properly aligned with and can be captured by the jaw slot (450). The suture surfaces (472, 474) are in a partially close state, which defines a gap (G1) at the midpoint of the staple cartridge. In this scenario, the clamping lever (440) can then be closed to properly clamp the stapler halves (412, 414) together and fully bring the suture surfaces (472, 474) close together, such as... Figures 19C to 19D Combined with a linear surgical stapler (10) as shown.

[0052] Figure 25B An alternative scenario is illustrated in which the surgeon fails to adequately bring the stapler halves (412, 414) close during clamping, causing the latch pin (68) to be slightly misaligned with the jaw slot (450) and unable to be captured by it. When the surgeon then attempts to close the clamping lever (440), the latch pin (68) is captured by the jaw recess (456), causing the clamping lever (440) to be inhibited from closing and constrained to an intermediate position between its open and closed positions. This leaves the suture surfaces (472, 474) in a spaced-out state, in which they define a second gap (G2) at the midpoint of the staple cartridge, wherein the second gap (G2) is significantly larger than Figure 25A The first gap (G1). This provides the surgeon with a visual and tactile indication that the clamping lever (440) is not properly aligned with the latching pin (68) and must be reopened and adjusted to properly clamp the stapler halves (412, 414) together.

[0053] Figure 25CAnother alternative scenario is shown, in which the surgeon fails to adequately bring the suture halves (412, 414) close during clamping, resulting in a more significant misalignment of the latch pin (68) with the jaw slot (450) and its inability to be captured by the jaw slot. In this scenario, the clamping lever (440) has been allowed to pivot to its closed position, and the latch pin (68) has traveled proximally simultaneously along the outer surface (458) of each upper jaw portion (452) via the rotation of the jaws (448) relative to the latch pin (468), and finally rests at the apex (460) when the clamping lever (440) is fully closed. The angled outer contour of the upper jaw portion (452) acts as a cam feature that, when the clamping lever (440) is closed, pushes the distal end of the anvil half (412) away from the distal end of the cartridge half (412), causing the latch pin (68) to approach the apex (460) along the outer surface (458). This places the suture surfaces (472, 474) in a state of even further spacing, in which they define a third gap (G3) at the midpoint of the staple cartridge, wherein the third gap (G3) is significantly larger than... Figure 25B The second gap (G2). Thus, the surgeon is given a visual instruction: the stapler (410) is not properly latched and the clamping lever (440) must be reopened to properly bring the stapler halves (412, 414) close so that the latching pin (68) can be properly aligned with and received by the jaw slot (450) before the clamping lever (440) is reopened.

[0054] F. Alternative Unlatched Indicator Feature Figures 26A to 26B An exemplary linear surgical stapler (410) including different clamping levers (540) is shown. The clamping levers (540) are substantially similar to the clamping lever (440) but have the following differences. Similar to the clamping lever (440), the clamping lever (540) includes a pair of laterally opposed jaws (548) that are uniquely shaped to provide clear indication to the surgeon during the closure of the clamping lever (540) when the latching pin (468) has not yet been properly aligned with and captured by the jaw slots (550).

[0055] Figure 26AA latching pin (468) is shown positioned between a jaw slot (550) and a second latching pin engagement feature, which is in the form of a recess (556) formed on the upper side of the upper portion of the corresponding jaw (548). In this orientation, the clamping lever (540) cannot be converted to a fully closed configuration and therefore remains only partially closed. The recess (556) may include a semi-circular profile and be spaced apart from the jaw slot (550). The recess (556) may have the same or similar thickness as the jaw slot (550). Figure 26B As shown, the recess (556) is configured to capture the latch pin (468) during periods of misalignment between the latch pin (468) and the jaw slot (550), thereby preventing clamping and subsequent firing of the stitcher (410). As shown, once the latch pin (468) has been captured within the recess (556), the clamping lever (540) remains in a partially closed configuration. The latch pin (468) can then be released from the recess (556) and properly aligned in the jaw slot (550) by reopening the clamping lever (540), thereby allowing the stitcher (410) to transition from an unclamped state to a fully clamped state.

[0056] Figure 27 An alternative jaw (648) for the clamping lever (540) is shown. The alternative jaw (648) may be substantially similar to the alternative jaw (548) but with the following differences: The jaw (648) may include a second latching pin engagement feature in the form of a series of teeth (658) arranged longitudinally along the upper side of the jaw (648). By way of example only, the jaw (648) may include at least three teeth (658) of this series of teeth (658). This series of teeth (658) may collectively define a serrated profile and a corresponding recess between each tooth in the series of teeth (658). The size of each recess may be set to be the same as or smaller than the latching pin (468). During misaligned rotation of the clamping lever (540), the latching pin (468) may skip or undulate across the surface of each tooth (658) to thus provide the operator with tactile feedback that the clamping lever (540) is not properly clamped.

[0057] Figure 28 It shows Figure 27An alternative form of the suture (410) is provided, but with a triangular latching pin (468') instead of a round latching pin (468). When compared with a round latching pin (458), the triangular latching pin (468') can provide a greater amplitude or a sharper undulation during misaligned rotation of the clamping lever (540), thus providing greater tactile feedback to the operator. For example, the lower vertex of the triangular profile of the latching pin (468') can be configured to be positioned within a recess located between the teeth (658), thereby providing a ratchet-type engagement between the latching pin (468') and the teeth (658) when the latching pin (468') is misaligned with the jaw slot (450).

[0058] G. Pin secured to the anvil channel side flange Relative to the aforementioned anvil half (14), the anvil latch pin (68) and proximal pin (70) can be press-fitted to the anvil channel (60) and anvil cover (78). In some cases, alternative methods and features may be desired to secure one or both of the pins (68, 70) relative to the anvil channel and / or anvil cover (78). The following describes... Figures 29 to 33B An exemplary example of this configuration is shown and described.

[0059] Figure 29 It shows Figure 2 The anvil half (14) has a latching pin (68) and a proximal pin (70) welded to the anvil channel side flange (66). The latching pin (68) may be welded to the lateral side of the anvil channel side flange (66) (as shown) to thus allow the latching pin (68) to have a suitable clearance to capture the anvil plate (72) between the anvil channel side flanges (66). The proximal pin (70) may be welded to the inner or intermediate side of the anvil channel side flange (66) to thus provide clearance for the anvil (12) to be secured to the proximal pin (70) between the anvil channel side flange (66) and the anvil cover (78). The anvil cover (78) may snap-fit ​​onto the latching pin (68) and the proximal pin (70).

[0060] H. The anvil cover is fixed to the anvil channel. Figures 30A to 30B A first configuration (759) and method thereof for securing the anvil cover (778) to the anvil channel (766) using a latching pin (768) are shown. Figure 30A As shown, the anvil cover (778) may include a distal locking tab (791) and a proximal locking tab (793). Each locking tab (791, 793) may be configured to protrude through an opening in the base plate of the anvil channel (766) and offset proximally to lock the distal locking tab (791) onto the latch pin (768), as shown. Figure 30BAs shown. Then, the proximal end of the distal end member (772) with the cantilever locking arm can be translated proximally toward the distal locking tab (791). The cantilever locking arm can be biased to lock onto the anvil plate opposite the anvil channel base plate (766) to prevent distal movement relative to the anvil channel (766). Once locked, the distal end member (722) can abut the distal locking tab (791) of the anvil cover (778) to prevent the distal locking tab (791) from unlocking from the latch pin (768).

[0061] Figures 31A to 31B A second configuration (859) and method thereof for securing the anvil cover (878) to the anvil channel (866) using a latching pin (868) are shown. Figure 31A As shown, the anvil cover (878) may include a distal locking tab (891) and a proximal locking tab (893). Each locking tab (891, 893) may be configured to protrude through an opening in the base plate of the anvil channel (866) and offset proximally to partially engage with the base plate of the anvil channel (866), as shown. Figure 31B As shown. Then, the distal end member (872) with the cantilever locking arm can be translated proximally toward the distal locking tab (891). The cantilever locking arm can be biased to thus lock onto the anvil plate opposite the base plate of the anvil channel (866) to prevent distal movement relative to the anvil channel (866). Once locked, the lower arm of the distal end member (822) can abut against the distal locking tab (891) of the anvil cover (878) to prevent the distal locking tab (891) from unlocking from the anvil channel side flange (866).

[0062] I. Alternatively, pins can be used to secure the anvil cover. Figures 32 to 33B An alternative anvil half (914) is shown, which has a latching pin (968) that is engaged with a snap-fit ​​feature of the anvil cover (978). Figure 33A and Figure 33B As shown, the latch pin (968) may include an annular groove configured to laterally position a side flange beyond the anvil channel (966), thereby allowing the anvil cover (978) to snap onto the latch pin (968) via the annular groove. Once engaged, the anvil cover (978) can then laterally restrain the latch pin (968) relative to the anvil channel (966). The latch pin (968) may laterally project beyond the anvil cover (978) and can also be used to longitudinally restrain the distal end member (972) relative to the anvil channel (966), as... Figure 33B As shown.

[0063] Additionally, in any of the exemplary configurations shown and described above, the latch pin of the anvil half can be further laterally restrained relative to the corresponding anvil channel and anvil cover by one or more retaining clips (such as E-clamps).

[0064] II. Exemplary Combinations The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated by the inventor or a successor with an interest in the inventor at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0065] Example 1 An apparatus comprising: (a) a first elongated member having a distal portion configured to present a first suture surface; (b) a second elongated member having a distal portion configured to present a second suture surface, wherein the first elongated member and the second elongated member are configured to be releasably coupled together such that the first suture surface and the second suture surface cooperate to clamp tissue and suture the tissue with a plurality of staples; and (c) a clamping member wherein the clamping member is movable relative to the first elongated member and the second elongated member from a first position to a second position such that the first suture surface and the second suture surface... (d) a latching member configured to transition from an unlatched state to a latched state to releasably retain the clamping member in the second position; and (e) a firing assembly capable of actuating from its original position to fire the pin into the clamped tissue, wherein the latching member is configured to transition from the unlatched state to the latched state when the clamping member is in the second position and the firing assembly is in the original position, wherein the latching member is prevented from transitioning from the unlatched state to the latched state when the clamping member is in the second position and the firing assembly is displaced from the original position.

[0066] Example 2 According to the device of embodiment 1, the first engagement feature includes a slot having an open distal end and a closed proximal end, wherein the second engagement feature is configured to releasably capture the latch protrusion when the latch protrusion is misaligned with the slot, and thereby inhibit the clamping member from presenting the second position.

[0067] Example 3 According to the device of embodiment 2, the second engagement feature includes a semi-circular profile configured to contact the latch protrusion.

[0068] Example 4 According to any one of the foregoing embodiments, the recess of the second engagement feature opens away from the other of the first elongated member or the second elongated member.

[0069] Example 5 According to any one of the foregoing embodiments, the device, wherein the clamping member includes a lever portion and a distal jaw portion, wherein the first engagement feature and the second engagement feature are defined by the distal jaw portion, wherein the first engagement feature is positioned between the second engagement feature and the lever portion.

[0070] Example 6 According to the device of embodiment 5, the second engagement feature is positioned along the upper side of the distal jaw portion.

[0071] Example 7 According to any one of the foregoing embodiments, the device wherein the first engagement feature is configured to engage the latching protrusion when the clamping member is oriented at a first angle relative to the proximal end of the first elongated member or the second elongated member, wherein the second engagement feature is configured to engage the latching protrusion when the clamping member is oriented at a second angle less than the angle relative to the proximal end of the first elongated member or the second elongated member, wherein the second angle is less than the first angle.

[0072] Example 8 According to any one of the foregoing embodiments, the device wherein the second engagement feature is configured to capture the latch protrusion and thereby inhibit the clamping member from advancing to the second position, such that the first suture surface is inhibited from further approaching the second suture surface and is spaced apart from the second suture surface by a gap distance.

[0073] Example 9 According to the device of embodiment 8, the second engagement feature is further configured to release the latching protrusion when the clamping member returns to the first position, such that the first suture surface and the second suture surface are spaced further apart from each other by a distance greater than the gap distance.

[0074] Example 10 According to any one of the foregoing embodiments, the clamping member is configured to face the other of the first elongated member or the second elongated member while the latch protrusion is captured by the second engaging feature.

[0075] Example 11 According to any one of the foregoing embodiments, the recess is defined by a first tooth, and the second engagement feature further defines a second tooth, wherein the first tooth and the second tooth are configured to frictionally engage the latch protrusion to provide tactile indication to the operator.

[0076] Example 12 According to the device of embodiment 11, the second engagement feature further defines a third tooth, wherein the first tooth, the second tooth and the third tooth together define a sawtooth profile.

[0077] Example 13 According to any one of the foregoing embodiments, the latching protrusion includes a pin that extends laterally relative to the longitudinal axis of either the first elongated member or the second elongated member.

[0078] Example 14 According to the device of embodiment 13, the first engagement feature includes a curved slot having an open distal end and a closed proximal end, wherein when the pin is properly aligned with the curved slot, the pin is configured to be proximally advanced through the open distal end to the closed proximal end as the clamping member rotates from the first position to the second position, wherein when the pin is not aligned with the curved slot, the pin is configured to engage the second engagement feature as the clamping member rotates from the first position to the second position.

[0079] Example 15 According to the device of embodiment 14, the first suture surface and the second suture surface are configured to define a first gap distance between the first suture surface and the second suture surface when the pin is aligned with and captured by the curved slot, wherein the first suture surface and the second suture surface are configured to define a second gap distance between the first suture surface and the second suture surface when the latch pin is misaligned with the curved slot and is instead engaged by the second engagement feature, wherein the second gap distance is larger than the first gap distance by a gap difference that can be observed by the operator, wherein the indication includes the presence of the gap difference.

[0080] Example 16 According to any one of the foregoing embodiments, the device includes a first suture surface comprising a platform having a plurality of openings accommodating a plurality of nails, wherein the second suture surface comprises an anvil surface having a plurality of recesses configured to shape the nails when the device is fired, wherein the clamping member is pivotally coupled to the first elongated member, and the latching protrusion is coupled to the second elongated member, wherein the first position of the clamping member includes an open position and the second position includes a closed position, and the first suture surface and the second suture surface are configured to be separable to transfer the latching protrusion from the recess of the second engagement feature to the first engagement feature.

[0081] Example 17 An apparatus comprising: (a) a first elongated member having a latching protrusion and a distal portion configured to present a first suture surface; (b) a second elongated member having a distal portion configured to present a second suture surface, wherein the first elongated member and the second elongated member are configured to be hingedly connected together such that the first suture surface and the second suture surface cooperate to clamp tissue and suture the tissue with a plurality of staples; and (c) a clamping member pivotally connected to the first elongated member or the second elongated member. One of the second elongated members, wherein the clamping member includes: (i) a slot configured to releasably capture the latching protrusion as the clamping member is advanced from a first position to a second position, thereby bringing the first suture surface and the second suture surface close together to clamp tissue; and (ii) an engagement feature offset from the slot and including a recess, wherein the engagement feature is configured to engage the latching protrusion when it is misaligned with the slot, thereby providing an indication to the operator that the latching protrusion is misaligned with the slot.

[0082] Example 18 According to the device of embodiment 17, the recess is configured to releasably capture the latch protrusion when the latch protrusion is not aligned with the slot.

[0083] Example 19 According to any one of embodiments 17 to 18, the engagement feature is configured to engage the latch protrusion in order to prevent the clamping member from rotating to the second position.

[0084] Example 20 An apparatus comprising: (a) a first elongated member having a distal portion configured to present a first suture surface; and (b) a second elongated member having a distal portion configured to present a second suture surface, wherein the first elongated member and the second elongated member are configured to switch between an unclamped configuration and a clamped configuration, wherein in the unclamped configuration the first suture surface and the second suture surface are spaced apart from each other, and in the clamped configuration the first suture surface and the second suture surface face each other, wherein the first suture surface and the second suture surface in the clamped configuration are configured to hold tissue and suture with a plurality of staples. (c) a latching protrusion presented by one of the first elongated member or the second elongated member; and (d) a third elongated member pivotally coupled to one of the first elongated member or the second elongated member, wherein the third elongated member includes a first opening and a second opening, the first opening being configured to releasably capture the latching protrusion to provide the device in the clamping configuration, the second opening being spaced apart from the first opening and configured to releasably capture the latching protrusion when the latching protrusion is not aligned with the first opening, thereby providing a user with a visible and tactile indication that the device is not in the clamping configuration.

[0085] III. Miscellaneous It should be understood that any or more of the teachings, expressions, embodiments, examples, etc., described herein can be combined with any or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the aforementioned teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0086] Furthermore, 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," published April 28, 2020; U.S. Patent No. 10,667,818, entitled "Lockout Assembly for Linear Surgical Stapler," published June 2, 2020; U.S. Patent No. 10,932,781, entitled "Features to Align and Close Linear Surgical Stapler," published March 2, 2021; U.S. Patent No. 10,898,197, entitled "Releasable Coupling Features for Proximal Portions of Linear Surgical Stapler," published January 26, 2021; and U.S. Patent No. 10,898,197, entitled "Firing Lever Assembly for Linear Surgical Stapler," published December 29, 2020. U.S. Patent No. 10,874,398 entitled “Stapler”; U.S. Patent No. 10,687,819 entitled “Clamping Mechanism for Linear Surgical Stapler”, published June 23, 2020; U.S. Patent No. 10,898,187 entitled “Firing System for Linear Surgical Stapler”, published January 26, 2021; U.S. Patent No. 11,033,266 entitled “Decoupling Mechanism for Linear Surgical Stapler”, published June 15, 2021; U.S. Patent No. 11,045,193 entitled “Anvil Assembly for Linear Surgical Stapler”, published June 29, 2021; and U.S. Patent No. 10,045,193 entitled “Closure Assembly for Linear Surgical Stapler”, published February 2, 2021. U.S. Patent No. 10,905,419, entitled “Stapler”; and U.S. Patent No. 11,278,285, entitled “Clamping Assembly for Linear Surgical Stapler”, published on March 22, 2022.U.S. Patent No. 11,229,433, entitled "Linear Surgical Stapler," published January 25, 2022; U.S. Publication No. 2022 / 0142641, entitled "System and Method for Forming Pockets in Anvil of Surgical Stapler," published May 12, 2022; U.S. Patent No. 11,224,425, entitled "Surgical Linear Cutter Wishbone Separation Mechanism with Detent," published January 18, 2022; U.S. Patent No. 11,219,454, entitled "Pin Trap Mechanism for Surgical Linear Cutter," published January 11, 2022; and U.S. Patent No. 11,219,454, entitled "Separation Mechanism for Surgical Linear Cutter," published December 2, 2021. U.S. Patent Application No. 2021 / 0369272, entitled "Cutter"; U.S. Patent Application No. 17 / 489,879, entitled "Lockout Feature for Linear Surgical Stapler Cartridge", filed September 30, 2021; U.S. Patent Application No. 29 / 842,580, entitled "Staple Cartridge for Linear Surgical Stapler", filed June 16, 2022; and / or U.S. Patent Application No. 29 / 842,581, entitled "Linear Surgical Stapler", filed June 16, 2022. The disclosure of each of these references is incorporated herein by reference in its entirety.

[0087] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with the existing definitions, statements, or other public materials listed in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference but conflicting with the existing definitions, statements, or other public materials listed herein, will be incorporated only to the extent that the incorporated material does not conflict with the existing public materials.

[0088] The aforementioned devices can be applied to both traditional medical treatments and surgeries performed by medical professionals and robot-assisted medical treatments and surgeries. By way of example only, the various teachings herein can be readily incorporated into robotic surgical systems, such as those provided by Intuitive Surgical in Sunnyvale, California, or Auris Health in Redwood City, California.

[0089] Devices of the types described above may be designed for single-use and disposal, or they may be designed for multiple uses. In either or both cases, these types may be repaired for reuse after at least one use. Repair may include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts, and subsequently reassembling. Specifically, some types of devices may be disassembled, and any combination may be used to selectively replace or remove any number of specific parts or portions of the device. While cleaning and / or replacing specific components, some types of devices may be reassembled at a repair facility or by the user prior to surgery for subsequent use. Those skilled in the art will appreciate that device repair can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repaired devices are within the scope of this application.

[0090] By way of example only, the types described herein can be sterilized before and / or after surgery. 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 can then be placed in a radiation field capable of penetrating the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art can also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

[0091] Various embodiments of the invention have been shown and described, and further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus comprising: (a) A first elongated member having a distal portion configured to present a first stitched surface; (b) A second elongated member having a distal portion configured to present a second suture surface, wherein the first elongated member and the second elongated member are configured to be releasably coupled together such that the first suture surface and the second suture surface cooperate to clamp tissue and suture the tissue with a plurality of staples. (c) A latching protrusion extending from one of the first elongated member or the second elongated member; and (d) A clamping member movably connected to another of the first elongated member or the second elongated member, wherein the clamping member comprises: (i) A first engagement feature configured to releasably capture the latching protrusion as the clamping member is advanced from a first position to a second position, thereby bringing the first suture surface and the second suture surface close together to clamp the tissue, and (ii) A second engagement feature offset from the first engagement feature and including a recess, wherein the second engagement feature is configured to engage the latch protrusion when the latch protrusion is misaligned with the first engagement feature, thereby providing an indication to the operator that the latch protrusion is misaligned with the first engagement feature.

2. The device according to claim 1, wherein, The first engagement feature includes a slot having an open distal end and a closed proximal end, wherein the second engagement feature is configured to releasably capture the latch protrusion when the latch protrusion is misaligned with the slot, thereby preventing the clamping member from presenting the second position.

3. The device according to claim 1 or claim 2, wherein, The second engagement feature includes a semi-circular profile configured to contact the latch protrusion.

4. The device according to any one of claims 1 to 3, wherein, The recessed portion of the second engagement feature opens away from the other of the first elongated member or the second elongated member.

5. The device according to any of the preceding claims, wherein, The clamping member includes a lever portion and a distal jaw portion, wherein the first engagement feature and the second engagement feature are defined by the distal jaw portion, and wherein the first engagement feature is positioned between the second engagement feature and the lever portion.

6. The device according to claim 5, wherein, The second engagement feature is positioned along the upper side of the distal jaw portion.

7. The device according to any of the preceding claims, wherein, The first engagement feature is configured to engage the latching protrusion when the clamping member is oriented at a first angle relative to the proximal end of the first elongated member or the second elongated member, wherein the second engagement feature is configured to engage the latching protrusion when the clamping member is oriented at a second angle relative to the proximal end of the first elongated member or the second elongated member, wherein the second angle is smaller than the first angle.

8. The device according to any of the preceding claims, wherein, The second engagement feature is configured to capture the latch protrusion and thereby inhibit the clamping member from advancing to the second position, such that the first suture surface is inhibited from approaching the second suture surface further and is spaced apart from the second suture surface by a gap distance.

9. The device according to claim 8, wherein, The second engagement feature is further configured to release the latching protrusion when the clamping member returns to the first position, such that the first suture surface and the second suture surface are spaced apart from each other by a distance greater than the gap distance.

10. The device according to any of the preceding claims, wherein, The clamping member is configured to face either the first elongated member or the second elongated member while the latch protrusion is captured by the second engagement feature.

11. The device according to any of the preceding claims, wherein, The recess is defined by a first tooth, wherein the second engaging feature further defines a second tooth, wherein the first tooth and the second tooth are configured to frictionally engage the latch protrusion to provide tactile indication to the operator.

12. The device according to claim 11, wherein, The second engagement feature further defines a third tooth, wherein the first tooth, the second tooth, and the third tooth together define a sawtooth profile.

13. The device according to any of the preceding claims, wherein, The latching protrusion includes a pin that extends laterally relative to the longitudinal axis of either the first elongated member or the second elongated member.

14. The device according to claim 13, wherein, The first engagement feature includes a curved slot having an open distal end and a closed proximal end, wherein when the pin is properly aligned with the curved slot, the pin is configured to advance proximally through the open distal end to the closed proximal end as the clamping member rotates from the first position to the second position, wherein when the pin is not aligned with the curved slot, the pin is configured to engage the second engagement feature as the clamping member rotates from the first position to the second position.

15. The device according to claim 14, wherein, The first and second suture surfaces are configured to define a first gap distance between the first and second suture surfaces when the pin is aligned with and captured by the curved slot, wherein the first and second suture surfaces are configured to define a second gap distance between the first and second suture surfaces when the latch pin is misaligned with the curved slot and is instead engaged by the second engagement feature, wherein the second gap distance is larger than the first gap distance by a gap difference observable by the operator, wherein the indication includes the presence of the gap difference.

16. The device according to any of the preceding claims, wherein, The first suture surface includes a platform with a plurality of openings that receive a plurality of nails, wherein the second suture surface includes an anvil surface with a plurality of recesses configured to shape the nails when the device is fired, wherein the clamping member is pivotally coupled to the first elongated member and the latching protrusion is coupled to the second elongated member, wherein the first position of the clamping member includes an open position and the second position includes a closed position.

17. An apparatus comprising: (a) A first elongated member having a latching protrusion and a distal portion, the distal portion being configured to present a first stitched surface; (b) A second elongated member having a distal portion configured to present a second suture surface, wherein the first elongated member and the second elongated member are configured to be hingedly connected together such that the first suture surface and the second suture surface cooperate to clamp tissue and suture the tissue with a plurality of staples; and (c) A clamping member pivotally connected to one of the first elongated member or the second elongated member, wherein the clamping member comprises: (i) a slot configured to releasably capture the latching protrusion as the clamping member is advanced from a first position to a second position, thereby bringing the first suture surface and the second suture surface close together to clamp the tissue, and (ii) An engagement feature offset from the slot and including a recess, wherein the engagement feature is configured to engage the latch protrusion when the latch protrusion is misaligned with the slot, thereby providing an operator with an indication that the latch protrusion is misaligned with the slot.

18. The device according to claim 17, wherein, The recess is configured to releasably capture the latch protrusion when it is not aligned with the slot.

19. The device according to claim 17 or claim 18, wherein, The engagement feature is configured to engage the latch protrusion in order to prevent the clamping member from rotating to the second position.

20. An apparatus comprising: (a) A first elongated member having a distal portion configured to present a first stitched surface; (b) A second elongated member having a distal portion configured to present a second suture surface, wherein the first elongated member and the second elongated member are configured to switch between an unclamped configuration and a clamped configuration, wherein in the unclamped configuration the first suture surface and the second suture surface are spaced apart from each other, and in the clamped configuration the first suture surface and the second suture surface face each other, wherein the first suture surface and the second suture surface in the clamped configuration are configured to clamp tissue and suture the tissue with a plurality of staples; (c) A latching protrusion, the latching protrusion being formed by one of the first elongated member or the second elongated member; and (d) A third elongated member pivotally connected to one of the first elongated member or the second elongated member, wherein the third elongated member includes a first opening and a second opening, the first opening being configured to releasably capture the latching protrusion to provide the device in the clamping configuration, and the second opening being spaced apart from the first opening and configured to releasably capture the latching protrusion when the latching protrusion is not aligned with the first opening, thereby providing a user with a visible and tactile indication that the device is not in the clamping configuration.

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