Clamping locking element for linear surgical sutures

Abstract

A device includes a housing, a locking arm, and a spring, and is configured for use with a linear surgical stapler having a first stapler half and a second stapler half, the first stapler half having a frame and a clamping lever, and the second stapler half having a latching protrusion. The locking arm is rotatable between a locked position and a bypass position and is biased toward the locked position by the spring. In the locked position, the locking arm prevents the proximal end of the clamping lever, which is in a closed state, from engaging with the proximal end of the frame. In the bypass position, the locking arm allows the proximal end of the clamping lever, which is in a closed state, to engage with the proximal end of the frame. The locking arm changes from the locked position to the bypass position only when the latching protrusion is properly engaged by the clamping lever, which is in a closed state.

Description

Background Technology

[0001] 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 also 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 positioned 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.

[0002] 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

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

[0004] Figure 1 A perspective view of an exemplary linear surgical stapler is shown, 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 1 An 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 1A 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 9A 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 9B It shows Figure 1 A side front view of a straight surgical stapler, showing that when the clamping lever is in the open position, the proximal ends of the stapler halves are joined together to provide the stapler in a “suspended open” state; Figure 9C 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 9D 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 9E It shows Figure 1 A side front view of a straight surgical stapler, showing the distal actuation of the firing assembly when the stapler half is fully clamped; Figure 10 It shows Figure 1 A side front view of a linear surgical stapler equipped with interlocking components, showing the clamping lever in the fully closed, unlatched position; Figure 11 It shows Figure 10 A straight surgical stapler, showing the clamping lever in the fully closed latch position; Figure 12 It shows Figure 10 A perspective view of the interlocking components; Figure 13 It shows Figure 12 A perspective view of the housing of the interlocking assembly; Figure 14 It shows Figure 12 A perspective view of the locking arm of the interlocking assembly; Figure 15 It shows Figure 1 Enlarged top front view of a linear surgical stapler, in which the interlocking assembly is installed inside the linear surgical stapler; Figure 16A It shows Figure 10 A perspective view of the chamber half of a straight surgical stapler, showing the interlocking assembly not installed and spaced apart from the chamber half; Figure 16B It shows Figure 16A A perspective view of the compartment half, showing the interlocking components installed inside the compartment half; Figure 17 It shows Figure 10 An enlarged side front view of the proximal portion of a linear surgical stapler, showing the locking arm of the interlocking assembly in the locked position and preventing the latching member of the clamping lever from fully closing. Figure 18 It shows Figure 17 An enlarged side front view of the proximal portion of a straight surgical stapler, showing the locking arm of the interlocking assembly in the bypass position and pivoted away from the clamping lever latch member; Figure 19 It shows Figure 1 A side front view of a linear surgical stapler equipped with an interlocking spring, showing the clamping lever in the open position; Figure 20 It shows Figure 19 A side view of a straight surgical stapler, showing the clamping lever in the fully closed latch position; Figure 21A It shows Figure 19 An enlarged perspective view of the chamber half of a linear surgical stapler, in which the interlocking spring is shown as spaced apart from the chamber half; Figure 21B It shows Figure 19 An enlarged perspective view of the compartment half, showing the interlocking springs installed to the compartment half; Figure 22A It shows Figure 19 An enlarged side front view of a straight surgical stapler, showing the stapler halves approaching each other, with the clamping lever in the open position and the ramp of the anvil half aligned with the interlocking spring of the chamber half; Figure 22B It shows Figure 19 An enlarged side front view of a straight surgical stapler, showing that when the clamping lever is in the open position, the interlocking spring is initially engaged by the ramp of the anvil half; Figure 22C It shows Figure 19An enlarged side front view of a straight surgical stapler, showing that as the stapler half approaches further from the open position toward the partially closed position via the clamping lever, the interlocking spring deploys laterally via the ramp of the anvil half; and Figure 22D It shows Figure 19 An enlarged side front view of a straight surgical stapler, showing the interlocking spring fully deployed via the ramp of the anvil half with the clamping lever in the closed position.

[0005] 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 form 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

[0006] 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.

[0007] 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.

[0008] 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.

[0009] I. Exemplary linear surgical suture device A. Overview of Linear Surgical Staplers Figures 1 to 2 An exemplary linear surgical stapler (10) (also referred to 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 referred to 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. The linear surgical stapler (10) may be further constructed in accordance with the teachings of the following patent application: U.S. Patent Application No. 18 / 316,635, filed May 12, 2023, entitled “Linear Surgical Stapler,” the disclosure of which is incorporated herein by reference.

[0010] 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) also 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 the proximal and distal positions. (The following is in conjunction with...) Figure 8 The firing assembly (110) is described in more detail.

[0011] 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 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 accommodating a plurality of staples (not shown) and corresponding staple drivers (not shown).

[0012] The compartment half (12) also includes 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 substantially 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 the 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.

[0013] 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 9A to 9C As shown), in the closed position, the proximal end (46) faces the warehouse passage frame portion (18) (as described below). Figure 9D (As shown). 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 9C to 9D 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).

[0014] like Figure 2As best shown, the clamping lever (40) also 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) can also be constructed according to the teachings of U.S. Patent No. 11,278,285, entitled “Clamping Assembly for LinearSurgical Stapler,” published March 22, 2022, the disclosure of which is incorporated herein by reference.

[0015] 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.

[0016] 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 LinearSurgical Stapler," published June 15, 2021, the disclosure of which is incorporated herein by reference.

[0017] like Figure 2As shown, the linear surgical stapler (10) also 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 tabs, 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.

[0018] 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).

[0019] 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) also 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).

[0020] 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 hold 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.

[0021] 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 also 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).

[0022] 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.

[0023] like Figure 8As shown, the firing assembly (110) of the cartridge half (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 the underside of a nail driver (not shown) housed within the nail cartridge (140) and actuate the nail driver upward to thereby drive (or “fire”) the nail from the cartridge (130) into the tissue held between the nail 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 suturer halves (12, 14).

[0024] 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).

[0025] B. Illustrative use of linear surgical sutures Figures 9A to 9E An illustrative connection of the suture halves (12, 14) and the subsequent firing of the assembled suture (10) during surgical procedures are shown. Figure 9A As shown, 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).

[0026] like Figures 9A to 9B As shown, the proximal ends of the stapler halves (12, 14) are aligned with each other, and the proximal anvil pin (70) is guided downward into the proximal tapered 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 9B As shown. While the clamping lever (40) remains in the position as... Figure 9B 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 9C As shown, 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.

[0027] like Figure 9D As 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 held 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 9A and Figure 9B 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 9D In the fully clamped state shown, it can contact the distal end of the anvil plate (72). In response to the clamping lever (40) reaching the fully closed position, the clamping lever latching member (54) can rotate to capture the proximal end of the base wall of the compartment channel (16), and thus present a latching state in which the clamping lever latching member (54) holds the clamping lever (40) in the closed position.

[0028] like Figure 9EAs 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), so that the suture halves (12, 14) can separate from each other, thereby releasing the newly sutured and cut tissue. It should be understood that in some types, 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 above.

[0029] II. Exemplary clamping locking element As described above, when the latching pin (68) of the linear surgical stapler (10) is properly aligned with the jaw slot (50), the clamping lever (40) is actuated from the open position to the closed position (see Figures 9C to 9D The latching member (54) is used to cam-drive the opposing side ends of the latching pin (68) proximally within the jaw slot (50), thereby clamping the stitcher halves (12, 14) together to bring the stitching surfaces (72, 140) close together. In the fully closed position of the clamping lever (40), the latching member (54) is configured to releasably engage the proximity end of the compartment channel frame portion (18), thereby holding the clamping lever (40) in the fully closed position.

[0030] In some cases, the surgeon may have difficulty adequately bringing the stapler halves (12, 14) close to properly align the latch 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 latch pin (68), resulting in the stapler halves (12, 14) not being properly latched together. Therefore, it may be desirable to configure the stapler (10) to inhibit the closing and / or latching of the clamping lever (40) to provide the surgeon with a clear indication when the latch pin (68) has not yet been properly captured within the jaw slot (50), and to require readjustment of the clamping lever (40) or the stapler halves (12, 14) to achieve proper tissue clamping. Figures 10 to 18 and Figures 19 to 22D An exemplary form of this configuration is shown below in more detail.

[0031] A. A clamping locking mechanism with a housing and a pivotable arm. Figures 10 to 18 An exemplary linear surgical stapler assembly (200) is shown, which incorporates an exemplary clamping closure in the form of an interlocking assembly (202). The interlocking assembly (202) is configured to prevent the clamping lever latching member (54) of the clamping lever (40) from latching to the proximal frame portion (18) of the compartment half (12) when the latching pin (68) of the anvil half (14) is not properly aligned with and captured by the clamping lever jaws (48) when the clamping lever (40) is fully closed. In this respect, the interlocking assembly (202) is configured to function as a fault-prevention feature that prevents misuse of the linear surgical stapler (10) by mitigating the risk of the user firing the linear surgical stapler (10) onto the tissue before the stapler (10) has been properly clamped onto the tissue.

[0032] It should be noted that the interlocking assembly (202) can be rearward integrated with existing linear surgical staplers (10) with little or no modification to the linear surgical stapler (10), thus having minimal impact on the assembly process of the linear surgical stapler (10). As described in more detail below, when the clamping lever (40) is improperly positioned by the user relative to the anvil half (14), such that the clamping lever (40) in the closed position cannot properly capture the latching pin (68), for example, Figure 10As shown, the interlocking assembly (202) is in a locked state, in which the proximal portion of the interlocking assembly (202) engages the clamping lever latch member (54), thereby preventing the clamping lever latch member (54) from being latched, thus preventing the clamping lever (40) from maintaining the closed position. This provides the user with a clear indication that the clamping lever (40) must be reopened and properly aligned with the latch pin (68) to achieve proper clamping of the tissue before firing. Figure 11 As shown, when the latching pin (68) is properly aligned with and captured by the clamping lever (40) in the closed position, the anvil half (14) engages the proximal portion of the interlocking assembly (202) to change it from a locked state to a bypass state, in which the proximal portion of the interlocking assembly (202) disengages from the clamping lever latching member (54), thereby allowing the clamping lever latching member (54) to be in a latched state and holding the clamping lever (40) in a closed state for subsequent firing on the clamped tissue.

[0033] Figure 12 An interlocking assembly (202) including a housing (204), an elongated locking arm (208), and a spring (206) is shown. The housing (204) and the elongated arm (208) can be constructed from polymers, plastics, or surgical safety materials known in the art to be rigid and having low production costs. The housing (204) and the elongated arm (208) are formed separately by injection molding or additive manufacturing and assembled together after molding. The spring (206) is fitted between the housing (204) and the elongated arm (208). As described in more detail below, the arm (208) is rotatable relative to the housing (204) between a locked position and a bypass position, in which the arm (208) inhibits the clamping lever latch member (54) from latching to the proximal frame portion (18) of the compartment passage, and in the bypass position, the arm (208) allows the clamping lever latch member (54) to latch to the proximal frame portion (18), and the spring (206) is configured to bias the arm (208) to the locked position in a first rotational direction.

[0034] like Figure 13As shown, the housing (204) includes a recessed portion (210), a pair of protruding portions (212), a pair of engaging features (214), a housing spring retainer (216), and a main shaft (218). The recessed portion (210) is positioned between the protruding portions (212). The protruding portions (212) are generally planar and include a first inner portion (220), a second inner portion (222), and a top portion (224). The top portion (224) is configured to fit flush with the proximal end of the side flange (22) of the compartment channel (16). The inner portion (220) defines the recessed portion (210) and extends laterally between the top portion (224) and the recessed portion (210). The first inner portion and the second inner portion (220, 222) are configured to engage a portion of the elongated arm (208) to limit the angular range of motion of the elongated arm (208). One of the protrusions (212) includes a spring retainer in the form of a spring hole (216), which is configured to retain the end of the spring (206) to the housing (204). Engaging features (214) are positioned on each top portion (224). Each engaging feature (214) includes an angled portion (232) and a straight portion (234). Each engaging feature (214) is configured to non-removably attach the housing (204) to the side flange (22) of the compartment passage (16). A spindle (218) extends laterally from the recess (210) and is configured to be rotatably coupled to and support the elongated arm (208).

[0035] Figure 14 An elongated arm (208) and a spring (206) are shown. The elongated arm (208) includes a proximal portion (240) and a distal portion (242). The distal portion (242) is slightly offset from the proximal portion (240) at a middle portion (244) to accommodate gaps as the elongated arm (208) rotates within the linear surgical stapler (10). The proximal portion (240) includes a pin hole (246), a first angled surface (248), a second angled surface (250), a spring hole (226), and a proximal tab (254). The spring hole (226) is configured to receive the end of the spring (206) opposite to the end captured by the spring hole (216) to rotatably bias the elongated arm (208) toward its locked position in a first direction. The spring (206) may include, for example, a compression spring, a tension spring, a torsion spring, or a helical spring. In this example, the spring (206) is shown as a compression spring, which is fixed to the elongated arm (208) within a spring hole (226), and the other end of the tension spring is fixed in a spring hole (216) positioned on the housing (204) (see Figure 12In the form of using a torsion spring or a coil spring, the spring hole (226) may be located near the pin hole (246), and the spring hole (216) may also be defined by a recessed portion (210) instead of a protrusion in the protrusion (212).

[0036] The pin hole (246) is sized and constructed to be rotatably connected to the spindle (218). A first angled surface (248) is configured to engage a first inner portion (220) to restrict the degree of freedom of travel of the elongated arm (208) in a first angular direction. A second angled surface (250) is configured to restrict the degree of freedom of travel of the elongated arm (208) in a second angular direction. A proximal tab (254) extends laterally downward relative to the pin hole (246) and aligns with the edge of the proximal portion (240). The proximal tab (254) is configured to engage the clamping lever latch member (54) when the arm (208) is in the locked position, as described below.

[0037] The distal portion (242) of the arm (208) includes an elongated member (256) that extends distally and terminates at a distal tab (258). The elongated member (256) is not limited to a rectangular or square cross-section as shown. The elongated member (256) may include, for example, a circular or hollow profile. The distal tab (258) extends laterally downward from the elongated member (256) and is configured to engage a portion of the anvil cover (78) when the suture half (12, 14) is properly clamped together with the clamping lever (40) in the closed position.

[0038] Figure 15 Each engagement feature (214) of the housing (204) is shown, attached to the proximal end of the side flange (22) of the compartment channel (16) via a pair of channel holes (17). Figures 15 to 16BAs shown, the storage channel (16) includes a pair of pre-existing channel holes (17). It should be noted that two or more engagement features (214) can be used to secure the housing (204) to the storage channel (16). Each engagement feature (214) is configured to extend through the channel hole (17) and non-removably secure the housing (204) to the storage channel (16). The angled portion (232) is positioned further away from the top portion (224) than the straight portion (234). The engagement features (214) are elastically biased into a straight configuration and offset to the inside of each channel hole (17). The engagement features (214) are inserted from a first side of the channel hole (17) to a second side of the channel hole (17). The angled portion (232) is configured to straddle the channel hole (17), thereby causing the engagement feature (214) to deflect away from the inside of each channel hole (17) in a deflection configuration until the angled portion (232) passes through the channel hole (17) and reaches the second side of the channel hole (17). The engagement feature (214) quickly returns from the deflection configuration to a straight configuration. The angled portion (232) remains on the second side of the channel hole (17).

[0039] Figure 16A The interlocking assembly (2020) is shown spaced apart from a portion of the linear surgical stapler (10) before assembly, and Figure 16B The interlocking assembly (202) is shown after being assembled with the linear surgical stapler (10).

[0040] Figure 17 An interlocking assembly (202) is shown that prevents the clamping lever latch member (54) from rotating to capture the proximal end of the base wall of the compartment channel (16), thereby preventing the clamping lever (40) from remaining in a closed position if the clamping lever (40) fails to properly capture the latch pin (68). More specifically, the elongated arm (208) is biased and rotated about the main axis (218) via a spring (206) such that the proximal tab (254) directly contacts and pushes the lateral protrusion (53) of the clamping lever latch member (54) proximally, thereby causing the latch portion of the clamping lever latch member (54) to rotate proximally away from the compartment channel (16). Therefore, when the user releases pressure from the clamping lever (40), the clamping lever (40) is unable to maintain its closed position, thereby indicating to the user that the clamping lever (40) has not properly captured the latch pin (68) and the clamping lever (40) must be reopened to achieve proper clamping of the stitcher (10).

[0041] The interlocking assembly (202) prevents the latching lever (54) from latching unless the clamping lever (40) is actuated by the user to the fully closed latched position. By preventing the clamping lever (40) from being latched when it is in an incorrectly clamped state, this mitigates the risk of the user firing on tissue that has not been properly clamped, which could otherwise lead to nail deformity in the tissue.

[0042] Figure 18 The first and second stitcher halves (12, 14) are shown in a properly clamped state, in which the latching pin (68) has been properly captured in the closed position by the clamping lever (40). In this properly clamped state, the anvil cover (78) directly contacts the distal tab (258) of the arm (208) of the interlocking assembly (202) and pushes the distal tab downward against the bias of the spring (206) to rotate the arm (208) from its locked position to a bypass position. In the bypass position, the proximal tab (254) of the arm (208) disengages from the clamping lever latch member (54) and thus allows the clamping lever latch member (54) to rotate from its unlocked position to a latched position, thereby latching the proximal end of the clamping lever (40) to the proximal end of the compartment passage (16), thereby maintaining the clamping lever (40) in its closed position.

[0043] B. Clamping and locking mechanism with a spring arm Figure 19 Another exemplary linear surgical stapler assembly (300) is shown, having a clamping closure in the form of a resilient interlocking element (302) fitted within the linear surgical stapler (310), with the clamping lever (340) shown in the open position. The resilient interlocking element (302) is configured to function as a fault-prevention device, preventing the linear surgical stapler (310) from closing from its open position unless the stapler halves (312, 314) are properly aligned such that the latch pin (368) aligns with the jaw slot (350) of the clamping lever (340), thereby indicating to the user that the stapler halves (312, 314) are not yet adequately aligned. Thus, the resilient interlocking element (302) operates to mitigate the risk of improper clamping and therefore improper firing onto patient tissue. In some configurations, the interlocking assembly (302) can be backward integrated with an existing linear surgical stapler (310) with little or no modification to the existing one. In other configurations, the resilient interlocking element (302) can be supplied in the new linear surgical stapler (310) in an installed state.

[0044] The linear surgical stapler (310) comprises the same structure and arrangement as the linear surgical stapler (10), unless otherwise described below. The linear surgical stapler (310) comprises a clamping lever (340) having a pair of opposing jaws (348), each jaw having a curved slot (350) having a closed proximal jaw (348) that differs from the jaw (48) in that each jaw (348) defines an interlocking slot (353) located distal to the curved slot (350). The interlocking slot (353) is configured to overlap with and extend parallel to a latching pin slot (323) of the proximal frame portion (318) of the compartment passage when the clamping lever (340) is in the open position. As described below, each interlocking slot (353) accommodates a corresponding spring arm (304, 306) of the resilient interlocking member (302), and each latching pin slot (323) and its corresponding interlocking slot (353) are configured to receive at least partially a corresponding anvil ramp (361) on a corresponding side flange of the anvil passage positioned on the anvil half (314).

[0045] Figure 21A A linear surgical stapler (310) is shown with a clamping lever (340) in the open position, wherein a resilient interlocking element (302) is spaced apart from the linear surgical stapler (310) and aligned with a latching pin slot (323) and an interlocking slot (353). The resilient interlocking element (302) is constructed of a resilient surgical safety material, such as stainless steel or another resilient material known in the art with resilient properties. The resilient interlocking element (302) includes a first spring arm and a second spring arm (304, 306), which can be separated or interconnected. Each spring arm (304, 306) has an upper portion (308) and a lower portion (311). Each upper portion (308) includes an internal cam surface positioned at the upper end of the upper portion (308) and configured to engage a corresponding anvil ramp (361) of the anvil half (314). Each upper portion (308) also includes an internal curved surface configured to accommodate anvil ramp (361) when the clamping lever (340) is in the closed position. Each lower portion (311) extends proximally at an angle that matches the angle of the clamping lever (340) relative to the compartment passage when the clamping lever (340) is in the open position. Each lower portion (311) is configured to secure a corresponding spring arm (304, 306) between the lever arm and the clamping lever cover of the clamping lever (340).

[0046] Figure 21BA linear surgical stapler (310) is shown, wherein the clamping lever (340) is in the open position, and an elastic interlocking element (302) is mounted within an interlocking slot (353). The upper portion (308) of each spring arm (304, 306) is elastically biased laterally inward into a corresponding latching pin slot (323). When the clamping lever (340) is in the open position prior to the assembly of the stapler halves (312, 314), each upper portion (308) engages the facing slot wall of the corresponding latching pin slot (323), thereby locking the clamping arm (340) in the open position and preventing the clamping lever (340) from rotating from the open position to the closed position.

[0047] Figure 22A A linear surgical stapler (310) equipped with a resilient interlocking element (302) is shown. The resilient interlocking element (302) is positioned within a ramp channel (351) with the clamping lever (340) in the open position and the anvil half (314) spaced apart from the chamber half (312), such that the resilient interlocking element (302) is in a locked state in which the spring arms (304, 306) are in a non-expanding inwardly projecting state to thereby inhibit the closure of the clamping lever (340) in the manner described above. As shown, the latch pin (368) is aligned with the curved slot (350) such that the anvil half (314) is properly aligned with the chamber half (312), and the anvil half (314) approaches the chamber half (312).

[0048] Figure 22B A linear surgical stapler (310) is shown, wherein the anvil half (314) approaches the chamber half (312) further, wherein the latch pin (368) begins to approach the distal end of the opening of the curved jaw slot (350). Simultaneously, the upper portion (308) of the spring arms (304, 306) begins to engage the corresponding anvil ramp (361), which causes the spring arms (304, 306) to cam laterally outward away from each other to a partially extended state, in which the upper portion (308) is partially withdrawn laterally outward from the latch pin slot (323) of the chamber half (312).

[0049] Figure 22CA linear surgical stapler (310) is shown, wherein the anvil half (314) is brought closer to the chamber half (312), and the latch pin (368) enters the curved jaw slot (350). The engagement of the latch pin (368) and the curved jaw slot (350) further brings the anvil half (314) and the chamber half (312) closer together, while the resilient interlocking element (302) unfolds, so that the spring arms (304, 306) no longer obstruct the rotation of the clamping lever (340). In other words, the anvil ramp (361) fully engages the spring arms (304, 306) and causes the upper portions (308) to extend laterally outward away from each other, thereby placing both upper portions (308) in a fully extended state and withdrawing them from the latch pin slot (323). With the spring arms (304, 306) fully extended, the clamping lever (340) is allowed to rotate from the open position to the closed position, so that the linear surgical stapler (310) can be clamped onto the tissue.

[0050] Figure 22D A linear surgical stapler (310) is shown in the closed position after the anvil half (314) has come into full contact with the chamber half (312). In the closed position, the anvil ramp (361) is positioned within the latch pin slot (323) together with the latch pin (368), and the resilient interlock (302) remains in the fully extended position. The upper portion (308) in the extended position is driven across the outer surface of the chamber channel flange (366) until the clamping lever (340) stops in the closed position. Once the clamping lever (340) is in the closed position, the firing assembly (410) can be actuated to properly cut and suture the tissue.

[0051] III. 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.

[0052] Example 1 An apparatus comprising: (a) a housing configured to be securely coupled to a frame of a linear surgical stapler, wherein the linear surgical stapler includes a first stapler half and a second stapler half, the first stapler half having the frame and a clamping lever pivotally coupled to the frame, and the second stapler half having a latching protrusion configured to be captured by the clamping lever when the clamping lever is actuated to a closed state, thereby bringing the first stapler half and the second stapler half together to clamp tissue therebetween; and (b) a locking arm rotatably coupled to the housing, wherein the locking arm is capable of being positioned relative to the housing. The body rotates between a locked position and a bypass position, wherein the locking arm in the locked position is configured to prevent the proximal end of the clamping lever in the closed state from engaging with the proximal end of the frame, wherein the locking arm in the bypass position is configured to allow the proximal end of the clamping lever in the closed state to engage with the proximal end of the frame; and (c) a spring configured to elastically bias the locking arm toward the locked position, wherein the locking arm is configured to transition from the locked position to the bypass position only when the latch protrusion is properly captured by the clamping lever in the closed state.

[0053] Example 2 According to the device of embodiment 1, the first suture half has a distal end configured to receive a staple cartridge.

[0054] Example 3 According to any one of the foregoing embodiments, the housing is configured to be fixed to the frame sidewall of the frame.

[0055] Example 4 According to the device of embodiment 3, the housing includes one or more engagement features configured to engage the frame sidewalls to hold the housing in a fixed position relative to the frame.

[0056] Example 5 According to the device of embodiment 4, each engagement feature includes an angled portion and a recessed portion, wherein the angled portion is configured to resiliently deflect and pass through a hole in the sidewall of the frame such that the recessed portion resides within the hole, and wherein the angled portion is configured to prevent the housing from being removed from the frame.

[0057] Example 6 According to any one of embodiments 4 to 5, the device includes a recessed portion and at least one protruding portion, wherein the recessed portion is configured to receive a portion of the locking arm and allow the locking arm to rotate relative to the housing between the locked position and the bypass position.

[0058] Example 7 According to the device of embodiment 6, the at least one protrusion includes a pair of protrusions, wherein the protrusions are configured to be positioned against the frame sidewall to suppress lateral movement of the locking arm relative to the frame when the engagement feature engages with the frame sidewall.

[0059] Example 8 According to any one of the foregoing embodiments, the locking arm includes a proximal arm end, a distal arm end, and a pivot positioned between the proximal arm end and the distal arm end, wherein, in the locked position, the proximal arm end is configured to engage a latching member at the proximal end of the first stitcher half, and thereby inhibits the proximal end of the clamping lever from engaging with the proximal end of the frame when the latching protrusion is not properly captured by the clamping lever in the closed state.

[0060] Example 9 According to the device of embodiment 8, in the bypass position, the locking arm is configured to extend parallel to the longitudinal axis of the linear surgical stapler, and in the locked position, the locking arm is configured to extend obliquely relative to the longitudinal axis.

[0061] Example 10 According to any one of embodiments 8 to 9, the device wherein the distal arm end is configured to engage and be actuated by the second stitcher half to rotate the locking arm from the locked position to the bypass position against the bias of the spring when the latch protrusion is properly captured by the clamping lever in the closed state.

[0062] Example 11 According to the device of embodiment 10, the distal arm end includes a distal tab configured to engage a cover of the second stitcher half to rotate the locking arm from the locked position to the bypass position when the latching protrusion is properly captured by the clamping lever in the closed state.

[0063] Example 12 According to any one of Embodiments 10 to 11, the device includes a proximal tab at the proximal end of the proximal arm, the proximal tab being configured to engage a latching member at the proximal end of the first suture half, and thereby inhibiting the latching member from connecting the proximal end of the latching lever to the proximal end of the frame when the latching protrusion is not properly captured by the clamping lever in the closed state.

[0064] Example 13 In the device according to any one of the foregoing embodiments, the spring comprises a compression spring.

[0065] Example 14 A surgical instrument assembly comprising: (a) the device according to claim 1, and (b) a linear surgical suture device.

[0066] Example 15 According to the surgical instrument assembly of Embodiment 14, wherein the linear surgical suture includes: (i) a first suture half configured to receive a staple cartridge having a plurality of staples, and (ii) a second suture half having an anvil having a plurality of staple-forming recesses, wherein one of the first suture half or the second suture half includes a latching protrusion, wherein the other of the first suture half or the second suture half includes a clamping member movable from a first position to a second position to capture the latching protrusion and thereby bring the first suture half and the second suture half close together to clamp tissue therebetween, wherein the device is mounted to the other of the first suture half or the second suture half.

[0067] Example 16 An apparatus comprising: (a) a linear surgical stapler, the linear surgical stapler comprising: (i) a first stapler half having a distal portion configured to provide a first suture surface; (ii) a second stapler half having a distal portion configured to provide 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 using a plurality of staples; and (iii) a clamping member comprising one of the first stapler half or the second stapler half. Provided, wherein the clamping member is movable from a first position to a second position to bring the first suture surface and the second suture surface close together to clamp tissue; and (iv) 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 (b) an interlocking device configured to inhibit at least one of the following actions when the first suture half and the second suture half are not properly aligned with each other: (i) the clamping lever transitions from the first position to the second position, or (ii) the latching member transitions from the unlatched state to the latched state.

[0068] Example 17 According to the device of embodiment 16, the interlocking device is mounted to one of the first suture half or the second suture half and includes a movable locking arm, wherein when the first suture half and the second suture half are properly aligned with each other, the movable locking arm can be actuated from the locked position to the bypass position by the other of the first suture half or the second suture half.

[0069] Example 18 According to the device of embodiment 17, the clamping member is provided by the first stitcher half, wherein the locking arm is configured to releasably engage a portion of the first stitcher half in the locked position.

[0070] Example 19 A method of operating a linear surgical stapler, the linear surgical stapler comprising: a first stapler half having a suture assembly with a plurality of staples; a second stapler half having an anvil with a plurality of staple-forming recesses; a clamping lever provided by one of the first stapler half or the second stapler half; and a latching protrusion provided by the other of the first stapler half or the second stapler half, the method comprising: (a) engaging a proximal end of the first stapler half with a proximal end of the second stapler half; (b) when the clamping lever is in an open position, bringing a distal end of the first stapler half and a distal end of the second stapler half together, such that the clamping lever is positioned to receive the latching protrusion; and (c) utilizing the other of the first stapler half or the second stapler half... The person actuates the locking arm of one of the first or second suture halves, causing the locking arm to move from a locked position to a bypass position, wherein the locking arm in the locked position is configured to prevent the clamping lever from performing at least one of the following actions: rotating from the open position to the closed position, or latching with the proximal end of one of the first or second suture halves; and (d) with the locking arm in the bypass position, rotating the clamping lever toward the closed position, in which the latching protrusion is captured by the clamping lever to further bring the distal ends of the first and second suture halves closer together, and in which the proximal end of the clamping lever latches with the proximal end of one of the first or second suture halves.

[0071] Example 20 According to the device of embodiment 19, the clamping lever and the locking arm are provided by the first stitcher half, the latching protrusion is provided by the second stitcher half, and actuating the locking arm from the locked position to the bypass position includes actuating the locking arm using the second stitcher half.

[0072] IV. 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.

[0073] 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. 11,045,193 entitled “Closure Assembly for Linear Surgical Stapler”, published February 2, 2021. U.S. Patent No. 10,905,419 for “Stapler”; U.S. Patent No. 11,278,285, issued on March 22, 2022, entitled “Clamping Assembly for LinearSurgical Stapler”.U.S. Patent No. 11,229,433, entitled "LinearSurgical 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.

[0074] 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.

[0075] 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 Auris Health (Redwood City, California) or IntuitiveSurgical (Sunnyvale, California).

[0076] 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.

[0077] 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.

[0078] 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 housing configured to be securely coupled to a frame of a linear surgical stapler, wherein the linear surgical stapler includes a first stapler half and a second stapler half, the first stapler half having the frame and a clamping lever pivotally coupled to the frame, and the second stapler half having a latching protrusion configured to be captured by the clamping lever when the clamping lever is actuated to a closed state, so as to bring the first stapler half and the second stapler half into close proximity, thereby clamping tissue therebetween; (b) A locking arm rotatably coupled to the housing, wherein the locking arm is rotatable relative to the housing between a locked position and a bypass position, wherein the locking arm in the locked position is configured to prevent the proximal end of the clamping lever in the closed state from engaging with the proximal end of the frame, and wherein the locking arm in the bypass position is configured to allow the proximal end of the clamping lever in the closed state to engage with the proximal end of the frame; and (c) A spring configured to resiliently bias the locking arm toward the locking position. The locking arm is configured to change from the locked position to the bypass position only when the latch protrusion is properly captured by the clamping lever in the closed state.

2. The device according to claim 1, wherein, The first suture half has a distal end configured to receive a staple cartridge.

3. The device according to claim 1 or claim 2, wherein, The housing is configured to be fixed to the frame sidewall of the frame.

4. The device according to claim 3, wherein, The housing includes one or more engagement features configured to engage the frame sidewalls to hold the housing in a fixed position relative to the frame.

5. The device according to claim 4, wherein, Each engagement feature includes an angled portion and a recessed portion, wherein the angled portion is configured to resiliently deflect and pass through a hole in the sidewall of the frame such that the recessed portion resides within the hole, and wherein the angled portion is configured to prevent the housing from being removed from the frame.

6. The device according to any of the preceding claims, wherein, The housing includes a recessed portion and at least one protruding portion, wherein the recessed portion is configured to receive a portion of the locking arm and allow the locking arm to rotate relative to the housing between the locked position and the bypass position.

7. The device according to claim 6, wherein, The at least one protruding portion includes a pair of protruding portions, wherein the protruding portions are configured to be positioned against the frame sidewall to suppress lateral movement of the locking arm relative to the frame when the engagement feature engages with the frame sidewall.

8. The device according to any of the preceding claims, wherein, The locking arm includes a proximal arm end, a distal arm end, and a pivot positioned between the proximal arm end and the distal arm end, wherein, in the locked position, the proximal arm end is configured to engage a latching member at the proximal end of the first suture half, and thereby inhibit the proximal end of the clamping lever from engaging with the proximal end of the frame when the latching protrusion is not properly captured by the clamping lever in the closed state.

9. The device according to any of the preceding claims, wherein, In the bypass position, the locking arm is configured to extend parallel to the longitudinal axis of the linear surgical stapler, wherein, in the locked position, the locking arm is configured to extend obliquely relative to the longitudinal axis.

10. The device according to claim 8, wherein, The distal arm end is configured to engage and be actuated by the second stitcher half to rotate the locking arm from the locked position to the bypass position against the bias of the spring when the latch protrusion is properly captured by the clamping lever in the closed state.

11. The device according to claim 8 or claim 10, wherein, The distal arm end includes a distal tab configured to engage a cover of the second stitcher half to rotate the locking arm from the locked position to the bypass position when the latching protrusion is properly captured by the clamping lever in the closed state.

12. The device according to any one of claims 8, 9 or 10, wherein, The proximal arm end includes a proximal tab configured to engage a latching member at the proximal end of the first stitcher half, thereby preventing the latching member from connecting the proximal end of the latching lever to the proximal end of the frame when the latching protrusion is not properly captured by the clamping lever in the closed state.

13. The device according to any of the preceding claims, wherein, The spring includes a compression spring.

14. A surgical instrument assembly comprising: (a) The device according to any one of claims 1 to 13; and (b) Linear surgical suture device.

15. The surgical instrument assembly of claim 14, wherein, The linear surgical suture device includes: (i) A first stapler half, the first stapler half being configured to receive a staple cartridge having a plurality of staples, and (ii) A second suture half having an anvil with a plurality of staple-forming recesses, The first or second stitcher half includes a latching protrusion. The first or second suture device half includes a clamping member movable from a first position to a second position to capture the latching protrusion, thereby bringing the first and second suture device halves close together to hold tissue therebetween. The device is installed in the other of the first suture half or the second suture half.

16. An apparatus comprising: (a) A linear surgical stapler, said linear surgical stapler comprising: (i) A first suture half having a distal portion configured to provide a first suture surface. (ii) A second suture half having a distal portion configured to provide 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 using a plurality of staples. (iii) A clamping member provided by one of the first suture half or the second suture half, wherein the clamping member is movable from a first position to a second position to bring the first suture surface and the second suture surface into contact to clamp tissue, and (iv) A latching member configured to transition from a non-latched state to a latched state to releasably retain the clamping member in the second position; and (b) An interlocking device configured to inhibit at least one of the following actions when the first and second suture halves are not properly aligned with each other: (i) The clamping lever changes from the first position to the second position, or (ii) The latching member transitions from the unlatched state to the latched state.

17. The device according to claim 16, wherein, The interlocking device is mounted to one of the first or second stitcher halves and includes a movable locking arm, wherein, when the first and second stitcher halves are properly aligned with each other, the movable locking arm can be actuated from the locked position to the bypass position by the other of the first or second stitcher halves.

18. The device according to claim 16 or claim 17, wherein, The clamping member is provided by the first stitcher half, wherein the locking arm is configured to releasably engage a portion of the first stitcher half in the locked position.

19. A method of operating a linear surgical stapler, comprising: The first suture half has a suture assembly with a plurality of staples; The second stitcher half has an anvil with multiple nail-forming recesses; A clamping lever, wherein the clamping lever is provided by one of the first stitcher half or the second stitcher half; The method includes: a latching protrusion provided by the first stitcher half or the second stitcher half; and a latching protrusion provided by the first stitcher half or the second stitcher half. (a) The proximal end of the first suture half is fitted with the proximal end of the second suture half; (b) When the clamping lever is in the open position, the distal end of the first suture half and the distal end of the second suture half are brought close together, such that the clamping lever is positioned to receive the latch protrusion; (c) Actuating the locking arm of one of the first or second suture halves using the other of the first or second suture halves, such that the locking arm moves from a locked position to a bypass position, wherein the locking arm in the locked position is configured to prevent the clamping lever from performing at least one of the following actions: rotating from the open position to the closed position, or latching with the proximal end of one of the first or second suture halves; and (d) With the locking arm in the bypass position, the clamping lever is rotated toward the closed position, in which the latching protrusion is captured by the clamping lever to further bring the distal end of the first stitcher half and the distal end of the second stitcher half closer together, and in the closed position, the proximal end of the clamping lever is latched to the proximal end of either the first stitcher half or the second stitcher half.

20. The method according to claim 19, wherein, The clamping lever and the locking arm are provided by the first stitcher half, wherein the latching protrusion is provided by the second stitcher half, wherein actuating the locking arm from the locked position to the bypass position includes actuating the locking arm using the second stitcher half.

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