Firing lockout for linear surgical stapler

Abstract

An apparatus includes: a first suture half and a second suture half, the first suture half and the second suture half being selectively coupled together and separated from each other; and a clamping member actuable to bring the suture halves into contact with tissue for clamping. A firing assembly is actuable through a firing stroke to fire the suture assembly onto the clamped tissue. The firing assembly includes a firing actuator and a firing locking member, the firing actuator being movable between a retracted position and a deployed position, in which the firing actuator is configured to actuate the assembly through a firing stroke, and the firing locking member being movable between an engaged position and a disengaged position, in which the firing locking member inhibits the advance of the firing assembly through the firing stroke, and in the disengaged position, the firing locking member allows the firing assembly to advance through the firing stroke. The firing locking member is configured to take the disengaged position only when the firing actuator is in the deployed position.

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 a movable clamping lever configured to releasably clamp the stapler halves together. These stapler halves are configured to releasably engage and pivot relative to each other to clamp tissue positioned between the two distal jaws when the clamping lever is 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 A perspective view of the proximal portion of an exemplary linear surgical stapler with a firing locking member is shown, showing the firing assembly in its proximal original position and the firing actuator of the firing assembly in its retracted position. Figure 11 The section cut along line 11-11 is shown. Figure 10 A cross-sectional perspective view of the proximal portion of a linear surgical stapler, showing the firing assembly in its proximal original position with the two firing actuators in their retracted positions, such that the firing locking member is in an engaged position that inhibits distal actuation of the firing assembly through the firing stroke. Figure 12A It shows Figure 10 A cross-sectional side view of the proximal portion of a straight surgical stapler, showing the firing locking member in the engaged position and the two firing actuators in the retracted position. Figure 12B It shows Figure 10 Another cross-sectional side view of the proximal portion of the linear surgical stapler, showing the firing locking member moving to the disengaged position by a firing actuator in the deployed position; Figure 12C It shows Figure 10 Another cross-sectional side view of the proximal portion of the linear surgical stapler, showing the firing assembly advancing distally through the firing stroke, with the firing actuator in the deployed position and the firing locking member in the disengaged position. Figure 13A A cross-sectional side view of the proximal portion of another exemplary linear surgical stapler with a firing locking member is shown, which shows the firing assembly in its proximal original position, with the two firing actuators in the retracted position and the firing locking member in the engaged position, which inhibits the firing assembly from being actuated distally through the firing stroke. Figure 13B It shows Figure 13A Another cross-sectional side view of the proximal portion of the linear surgical stapler, showing the firing locking member moving to the disengaged position by a firing actuator in the deployed position; Figure 13C It shows Figure 13A Another cross-sectional side view of the proximal portion of the linear surgical stapler shows the firing assembly advanced distally through the first part of the firing stroke, with the firing actuator in the deployed position, allowing the firing locking member to return to its... Figure 13A Location; Figure 13D It shows Figure 13A Another cross-sectional side view of the proximal portion of the straight surgical stapler, with the firing assembly retracting proximally on the firing locking member; Figure 14 A top front view of the firing assembly of another exemplary linear surgical suture is shown, which shows a slider, a pair of firing actuators and a firing locking member, wherein some other features of the firing assembly are omitted; Figure 15A It shows including Figure 14 A cross-sectional side view of the proximal portion of the linear surgical stapler for the firing assembly, showing the firing assembly in its proximal original position with the two firing actuators in the retracted position and the firing locking member in the engaged position, which inhibits the firing assembly from being actuated distally through the firing stroke. Figure 15B It shows Figure 15A Another cross-sectional side view of the proximal portion of the linear surgical stapler, showing the firing locking member moving to the disengaged position by a firing actuator in the deployed position; Figure 16A A frontal view of another exemplary linear surgical stapler with a firing locking member is shown, showing the stapler half fully approaching with the clamping lever in the closed position, such that the firing locking member is configured to allow the firing assembly to be actuated distally through the firing stroke. Figure 16B It shows Figure 16A Another frontal view of the linear surgical stapler shows that only half of the stapler is approaching, such that the firing locking member is configured to inhibit the firing assembly from actuating distally through the firing stroke. Figure 17A It shows a state of near-perfect proximity. Figure 16A A perspective view of the proximal portion of a linear surgical stapler, showing the firing locking member aligned with a slot in the deployed firing actuator of the firing assembly, thereby allowing the firing assembly to be actuated distally through the firing stroke. Figure 17B It shows a state of partial proximity. Figure 16B A perspective view of the proximal portion of a linear surgical stapler, showing misalignment between the firing locking member and the slot in the deployed firing actuator of the firing assembly, thereby inhibiting distal actuation of the firing assembly during the firing stroke; and Figure 18 A perspective view of the proximal portion of another exemplary linear surgical stapler with a firing locking member is shown, which shows that the stapler half is only partially approaching, such that the firing locking member inhibits the deployment of the firing actuator, and thus inhibits the firing assembly from being actuated distally through the firing stroke.

[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 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.

[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 2 As 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) further supports the anvil insert (76). In some models, the anvil insert (76) can be removed from the distal jaw portion (76) and replaced with a different anvil insert (76). In some models, according to the teachings of U.S. Patent No. 11,033,266 entitled "Decoupling Mechanism for Linear Surgical Stapler" issued June 15, 2021, the anvil insert (76) can be selectively extended relative to the distal jaw portion (64), 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 facilitate effective gripping and manipulation of the stapler (10) by the operator 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 a pin (68, 70) and one or more tabs, ribs, or other structures disposed within the interior of the anvil cover (78) and including an opening, slot, keyway, or other feature 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 in the nail cartridge (140) and actuate the nail driver (not shown) upward, thereby driving (or “firing”) nails from the nail 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... Figure 5 As shown and described above. 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 stapler 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 to be able to be positioned within the stapler (10). Figure 9D The distal end of the contact anvil plate (72) is in the fully clamped state. 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 thereby take a latched state in which the clamping lever latch 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 the corresponding channels formed in the staple cartridge (140), thereby firing staples into the clamped tissue via the cam ramp (120) and staple driver, while simultaneously cutting the clamped tissue using the blade member (126). After completing the firing stroke, 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. The suture (10) may be further constructed and operated in accordance with the teachings of U.S. Patent Application No. 18 / 316,635, entitled “Linear Surgical Stapler,” filed May 12, 2023, the entire disclosure of which is incorporated herein by reference. Additionally, 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 also incorporated herein by reference.

[0029] II. An exemplary firing latch requiring full deployment of the firing actuator As described above, the firing assembly (110) of the linear surgical stapler (10) is actuated distally through a firing stroke by one of the firing actuators (114, 116) in the deployed position, which is driven by the user. To better prevent potential misuse of the stapler (10) by the user, it may be desirable to equip the stapler (10) with a firing locking member that prevents the user from firing unless one of the firing actuators (114, 116) is fully deployed. Figures 10 to 15B An exemplary form of a straight surgical stapler constructed in this manner is shown. It should be understood that the features discussed below can be readily combined with the features of the stapler (10). For this purpose, similar reference numerals below indicate similar features described in more detail above.

[0030] A. Leaf spring used to selectively suppress the firing of the firing assembly. Figures 10 to 12C Another exemplary suture (210) that is generally similar to the suture (10) described above, except as otherwise described below, is shown. Figure 10 As shown, the suture device (210) includes a storage compartment half (212) (or "reloading half") and an anvil half (214), which are configured to be releasably coupled together to hold tissue therebetween for simultaneous cutting and suturing of the held tissue. Figure 11 As shown, the chamber half (212) includes a clamping member in the form of a clamping lever (240) pivotally connected to the chamber passage (216). The clamping lever (240) can be actuated by a user from an open position to a closed position to bring the chamber half (212) and the anvil half (214) closer together, thereby clamping the tissue between the distal jaw portions (e.g., 20, 64). The chamber passage (216) includes a pair of elongated beams (318). A firing assembly (310) is provided as part of the chamber half (212) and can be actuated by a user, moving from the original position through a firing stroke ( Figure 10 and Figure 11 (as shown) to the firing position (e.g., Figure 9E As shown), to fire a suture assembly onto the held tissue. The firing assembly (310) includes a slider (312) and a pair of firing actuators (314, 316) pivotally coupled to the slider (312). An elongated beam (318) extends distally from the slider (312) and adapts to sliding of the slider (312) such that the slider (312) and the firing actuators (314, 316) are configured to translate together relative to the elongated beam (318) between an initial position and a firing position. In one example, the initial position includes a proximal position and the firing position includes a distal position, such that the firing assembly (310) can be actuated distally from the initial position to the firing position by one of the firing actuators (314, 316) to fire the suture assembly.

[0031] Each firing actuator (314, 316) is pivotally connected to a slider (312) via a pin (330), the pin defining a pivot axis P1 for the firing actuator (314, 316) extending transversely to the direction of travel of the slider (312). Each firing actuator (314, 316) is capable of retracting in a retracted position around the pin (330) and relative to the slider (312) and relative to each other. Figure 11 (as shown) and deployment location (e.g., Figure 8Pivoting between the actuators (314, 316) shown. In one example, only one of the firing actuators (314, 316) is pivotable to the deployment position at a time. When either of the firing actuators (314, 316) is in the deployment position, the deployed firing actuator (314, 316) can be driven distally by the operator to actuate the firing assembly (310) distally past the suture (210), thereby simultaneously cutting and suturing the tissue held between the chamber half and the anvil half (212, 214). It should be understood that although the firing actuators (314, 316) are described as being able to pivot relative to the slider (312), the firing actuators (314, 316) can be configured to make any suitable type of movement relative to the slider (312) between the retracted position and the deployment position.

[0032] like Figures 11 to 12B As shown, a firing locking member in the form of a leaf spring (332) can be provided, which is longitudinally fixed relative to the magazine passage (216) and inhibits the advance of the firing assembly (310) to the firing position until one of the firing actuators (314, 316) is pivoted to the deployment position, as will be described in further detail below. The leaf spring (332) includes a distal end (334) coupled to the magazine passage (216) and disposed between elongated beams (318). A proximal end (336) extends upward and distally from the distal end (334) and selectively intersects with a slider (312). The slider (312) defines a channel (338) that receives the proximal end (336) of the leaf spring (332).

[0033] like Figure 12A and Figure 12B As shown, the proximal end (336) of the leaf spring (332) can be in the engagement position ( Figure 12A ) and disengagement position ( Figure 12B The proximal end (336) moves between the two sides. When the proximal end (336) is in the engagement position, as... Figure 12A As shown, it is configured to be adjacent to a stop surface (344) located at the proximal end of the channel (338). If the firing assembly (310) is subsequently pushed from its original position toward the firing position, the proximal end (336) contacts the stop surface (344) to inhibit the firing assembly (310) from advancing toward the firing position. When the proximal end (336) is in the disengaged position, as Figure 12B As shown, it is positioned below the stop surface (344), and therefore no longer inhibits the firing assembly (310) from firing to the firing position.

[0034] The leaf spring (332) is configured to change from an engaged position to a disengaged position in response to a change in one of the firing actuators (314, 316) from a retracted position to a deployed position. The operation of the firing actuator (314) to facilitate the firing of the firing assembly (310) will now be described, but can be understood as referring to the operation of the firing actuator (316). The firing actuator (314) includes fingers (346) that include chamfered surfaces (348). Pivoting of the firing actuator (314) between the deployed and retracted positions allows the fingers (346) and chamfered surfaces (348) to engage and disengage with the proximal end (336) of the leaf spring (332) to facilitate movement of the distal end between the disengaged and engaged positions. For example, as... Figure 11 and Figure 12A As shown, when the firing actuator (314) is in the retracted position, the fingers (346) and the chamfered surface (348) are spaced apart from the proximal end (336) and the channel (338), such that the proximal end (336) is positioned in the engaged position and in direct contact with the stop surface (344) to inhibit the sliding of the slider (312) and thus the firing assembly (310) from the original position toward the firing position. When the firing actuator (314) subsequently pivots to the deployed position, the fingers (346) correspondingly pivot to a position above the proximal end (336). This pivoting of the fingers (346) allows the chamfered surface (348) to engage the proximal end (336) and correspondingly move the proximal end (336) to the disengaged position (e.g., in the direction of arrow A1), as... Figure 12B As shown, this effectively releases direct contact between the proximal end (336) and the stop surface (344) to allow the firing assembly (310) to fire from its original position to the firing position. Therefore, the proximal end (336) of the leaf spring (332) is configured to take a disengaged position only when the firing actuator (314) is in the deployed position. This prevents the firing assembly (310) from firing unless and until the firing actuator (314) pivots to the retracted position, thus preventing accidental firing of the firing assembly (310) until the firing actuator (314) is correctly positioned in the deployed position.

[0035] Refer again Figure 12B When the firing actuator (314) is in the retracted position and the proximal end (336) is in the disengaged position, the finger (346) can simultaneously position the proximal end (336) adjacent to the inclined bottom surface (350) of the slider (312). When the firing assembly (310) is subsequently fired, the inclined bottom surface (350) interacts with the proximal end (336) to push the proximal end (336) below the slider (312), as... Figure 12CAs shown, this allows the slider (312) to travel on the leaf spring (332) (e.g., in the direction of arrow A2) as the firing assembly (310) advances further toward the firing position. The proximal end (336) of the leaf spring (332) is biased toward the engaged position. Thus, when the firing assembly (310) returns from the firing position to the original position, if the firing actuator (314) subsequently changes away from the deployment position before the next firing, the proximal end (336) automatically re-inserts into the channel (338) to restore the proximal end (336) from the disengaged position to the engaged position. Thus, the leaf spring (332) is configured to change between the retracted position and the deployment position only when the firing assembly (310) is in the original position.

[0036] When transitioning between the engaged and disengaged positions, the leaf spring (332) is shown to be movable within the channel (338) and in a direction transverse to the longitudinal axis of the sewing device (210). Thus, when in the engaged position, the leaf spring (332) can be considered to be in an upward position relative to the slider (312), and when in the disengaged position, the leaf spring can be considered to be in a lowered position relative to the slider (312). However, it should be understood that the leaf spring or other locking member can be provided in any kind of suitable alternative configuration that allows movement relative to the slider to facilitate selectively inhibiting the advance of the firing assembly to the firing position. For example, the leaf spring can be positioned on one of the elongated beams (318) and is laterally movable relative to the slider (312) between the engaged and disengaged positions.

[0037] B. A rotatable member having an arm for selectively suppressing the firing of the firing assembly. Figures 13A to 13D Another exemplary suture (410) is shown, which is generally similar to the sutures (10, 210) described above, except as otherwise described below. Figure 13AAs shown, the suture device (410) includes a chamber half (412) comprising a chamber channel (416) and engaging with an anvil half (not shown) for releasable connection to hold tissue therebetween for simultaneous cutting and suturing of the held tissue. The chamber channel (416) includes a pair of elongated beams (518) (one shown). The firing assembly includes a slider (512) and a firing actuator (514) pivotally connected to the slider (512) via a pin (530). Another firing actuator (not shown) may be positioned on the opposite side of the chamber half (412) in a manner similar to the firing actuator (316) described above. For illustrative purposes, the operation of the firing actuator (514) will be described, but it can be understood as representing the operation of both firing actuators. A slender beam (518) extends distally from the slider (512) and adapts to the sliding of the slider (512), such that the slider (512) and the firing actuator (514) are configured to translate together between the original position and the firing position.

[0038] like Figure 13A and Figure 13B As shown, the firing actuator (514) is able to retract around the pin (530) and relative to the slider (512) in the retracted position. Figure 13A ) and deployment location ( Figure 13B The firing assembly pivots between the two sections. A rotatable member in the form of a stop member (484) is located at the proximal end of the chamber half (412) and is configured to selectively hold the firing assembly in its original position via a distal finger (502). A firing locking member in the form of an arm (532) extends distally from the distal finger (502) and inhibits the firing assembly from advancing to the firing position until the firing actuator (514) pivots to the deployment position, as will be described in further detail below. The arm (532) is located between the elongated beams (518) and includes a distal latch (536) that selectively intersects with the slider (512). The slider (512) defines a channel (538) that receives the distal latch (536) of the arm (532).

[0039] like Figure 13A and Figure 13B As shown, the arm (532) can be in the engagement position ( Figure 13A ) and disengagement position ( Figure 13B The arm (532) moves between the two positions. When the arm (532) is in the engaged position, as... Figure 13A As shown, the distal latch (536) is configured adjacent to a stop surface (544) located at the proximal end of the channel (538). If the firing assembly (e.g., 310) is subsequently pushed from its original position toward the firing position, the distal latch (536) contacts the stop surface (544) to inhibit the firing assembly from advancing toward the firing position. When the arm (532) is in the disengaged position, as Figure 13B As shown, the distal latch (536) is located below the stop surface (544) and therefore no longer inhibits the firing assembly from firing to the firing position.

[0040] The arm (532) is configured to change from an engaged position to a disengaged position in response to the firing actuator (514) changing from a retracted position to a deployed position. The firing actuator (514) includes fingers (546). Figure 13B The finger-like structure includes a chamfered surface (not shown). For example... Figure 13A As shown, when the firing actuator (514) is in the retracted position, the finger (546) and the chamfered surface are spaced apart from the distal latch (536) and the channel (538), such that the arm (532) is positioned in the engaged position, where the distal latch (536) is in direct contact with the stop surface (544) to inhibit the sliding of the slider (512) and thus the firing assembly from the original position toward the firing position. When the firing actuator (514) subsequently pivots to the deployed position, the finger (546) correspondingly pivots to a position above the distal latch (536). This pivoting of the finger (546) allows the chamfered surface to engage the distal latch (536) and correspondingly moves the arm (532) to the disengaged position (e.g., in the direction of arrow A3), as... Figure 13B As shown, this simultaneously disengages the distal finger (502) from engagement with the firing assembly. The distal latch (536) is correspondingly released from direct contact with the stop surface (544), along with the distal finger (502), from the firing assembly, allowing the firing assembly to be fired from its original position to the firing position. In one example, pivoting the arm (532) in this manner to the disengaged position allows a portion of the distal latch (536) to protrude through the chamber passage (416) to provide a visual indication to the user that the firing actuator (514) is in the correct deployment position for firing the firing assembly. It should be understood that the arm (532) is therefore configured to take the disengaged position only when the firing actuator (514) is in the deployment position. Therefore, firing of the firing assembly is prevented unless and until the firing actuator (514) pivots to the retracted position, which prevents accidental firing of the firing assembly until the firing actuator (514) is correctly positioned in the deployment position.

[0041] Refer again Figure 13BWhen the firing actuator (514) is in the retracted position and the arm (532) is in the disengaged position, the finger (546) can simultaneously position the distal latch (536) adjacent to the inclined distal bottom surface (550) of the slider (512). When the firing assembly is subsequently fired, the inclined distal bottom surface (550) interacts with the distal latch (536) to push the distal latch (536) below the slider (512), which allows the slider (512) to travel on the distal latch (536) in the direction of arrow A4. Figure 13C The arm (532) is biased toward the engagement position such that once the slider (512) moves distally past the distal latch (536), as... Figure 12C As shown, arm (532) returns to the engaged position (e.g., in the direction of arrow A5). Figure 13C and Figure 13D As shown, the slider (512) includes an inclined proximal bottom surface (551). When the firing assembly returns from the firing position to its original position, as... Figure 13D As shown, the inclined proximal bottom surface (551) interacts with the distal latch (536) to push the distal latch (536) under the slider (512) in the direction of arrow A6. This allows the slider (512) to travel on the distal latch (536) in the direction of arrow A7 until the arm (532) returns to its original position. Figure 13A The shown joint position.

[0042] C. A plunger used to selectively suppress the firing of the firing assembly. Figures 14 to 15B Another exemplary suture (610) is shown, which is generally similar to the sutures described above (10, 210, 410), except as otherwise described below. Figure 14 and Figure 15A As shown, the suture device (610) includes a chamber half (612) that mates with an anvil half (not shown) to be releasably coupled together to hold tissue therebetween for simultaneous cutting and suturing of the held tissue. Figure 14 As shown, the suture device (610) includes a firing assembly (710) comprising a slider (712) and a pair of firing actuators (714, 716) pivotally connected to the slider (712) via a pin (730). Each firing actuator (714, 716) is pivotable about the pin (730) and relative to the slider (712) and relative to each other between a retracted position and a deployed position. When either of the firing actuators (714, 716) is in the deployed position, the deployed firing actuator (714, 716) can be driven distally by the operator to actuate the firing assembly (710) distally through the suture device (610), thereby simultaneously cutting and suturing the tissue clamped between the chamber half and the anvil half.

[0043] Now refer to Figure 15A and Figure 15B The chamber half (612) includes a chamber channel (616) comprising a pair of elongated beams (718) (one shown). The elongated beams (718) extend distally from the slider (712) and accommodate the sliding of the slider (712) such that the slider (712) and the firing actuators (714, 716) are configured to translate together between a home position and a firing position. A firing locking member in the form of a plunger (732) is disposed in the channel (738) defined by the slider (712) and is movable together with the firing assembly (710) between the home position and the firing position. The plunger (732) is configured to selectively inhibit the advance of the firing assembly (710) to the firing position until one of the firing actuators (714, 716) pivots to the deployment position, as will be described in further detail below.

[0044] like Figure 15A and Figure 15B As shown, the plunger (732) can be in the engaged position relative to the slider (712). Figure 15A ) and disengagement position ( Figure 15B Sliding (e.g., translation) between the plunger (732). When the plunger (732) is in the engaged position, as Figure 15A As shown, the lower portion (736) extends through the opening (772) in the chamber passage (616) and is positioned adjacent to the stop surface (744). If the firing assembly (710) is subsequently pushed from its original position toward the firing position, the lower portion (736) contacts the stop surface (744) to inhibit the advancement of the firing assembly (710) toward the firing position. When the plunger (732) is in the disengaged position, as Figure 15B As shown, the lower portion (736) is positioned above the stop surface (744) and therefore no longer inhibits the firing assembly (710) from firing to the firing position. The biasing member (774) is associated with the plunger (732) and is configured to bias the plunger (732) to the engagement position.

[0045] The plunger (732) is configured to change from an engaged position to a disengaged position in response to one of the firing actuators (714, 716) changing from a retracted position to a deployed position. The operation of the firing actuator (714) will now be described with respect to the plunger (732), but it can be understood that it also refers to the operation of the firing actuator (716). Figure 14As shown, the firing actuator (714) includes fingers (746) with chamfered surfaces (748). Pivoting of the firing actuator (714) between a deployed position and a retracted position allows the fingers (746) and chamfered surfaces (748) to engage and disengage with the plunger (732) to facilitate movement of the plunger (732) between a disengaged position and an engaged position. For example, as... Figure 15A As shown, when the firing actuator (714) is in the retracted position, the fingers (746) and the chamfered surface (748) disengage from the plunger (732), leaving the plunger (732) in the engaged position, where the lower portion (736) directly contacts the stop surface (744) to inhibit the sliding of the slider (712) and thus the firing assembly (710) from the original position toward the firing position. When the firing actuator (714) subsequently pivots to the deployed position, the fingers (746) correspondingly pivot to engage with the plunger (732), causing the chamfered surface (748) to engage the upper shoulder (776) of the plunger (732) to move the plunger (732) accordingly to the disengaged position (e.g., in the direction of arrow A9), as... Figure 15B As shown, this disengages the lower portion (736) from the stop surface (744) to allow the firing assembly (710) to fire from its original position to the firing position.

[0046] III. An exemplary firing locking mechanism requiring complete proximity of the sewing machine half. In some other cases, it may be desirable to equip the linear surgical stapler (10) with a firing locking member that prevents the user from firing unless the stapler halves (12, 14) are fully close together and the clamping lever (40) is in the closed position. Figures 16A to 18 An exemplary form of a straight surgical stapler constructed in this manner is shown. It should be understood that the features discussed below can be readily combined with features of any other stapler disclosed herein, such as stapler (10) . For this purpose, similar reference numerals below indicate similar features described in more detail above.

[0047] A. A protrusion that selectively interacts with a slot on the firing actuator. Figures 16A to 17B Another exemplary suture (810) is shown, which is generally similar to the sutures described above (10, 210, 410, 610), except as otherwise described below. Figures 16A to 17B As shown, the suture device (810) includes a storage compartment half (812) and an anvil half (814), which are configured to be releasably connected together to hold tissue therebetween for simultaneous cutting and suturing of the held tissue. Figure 16AAs shown, the compartment half (812) includes a clamping lever (840) pivotally coupled to the compartment channel (816). The clamping lever (840) can be actuated by a user from an open position to a closed position to bring the compartment half (812) and the anvil half (814) closer together, thereby clamping tissue between the distal jaw portions (e.g., 20, 64). The suture (810) also includes a pair of covers (856, 878) that cover selected portions of the suture (810) and facilitate effective gripping and manipulation of the suture (810) by the operator during use. In this example, the clamping lever cover (856) is attached to and covers the outward-facing side of the clamping lever (840) such that the clamping lever cover (856) is configured to pivot together with the clamping lever (840). Additionally, the anvil cover (878) is attached to and covers the outward-facing side of the anvil channel (860).

[0048] The firing assembly (910) is user-actuable, moving from its initial position to a firing position via a firing stroke to fire the suture assembly onto the held tissue. The firing assembly (910) includes a pair of firing actuators (914, 916) that are capable of firing in a retracted position (e.g., Figure 16A and Figure 16B The firing actuator (916) shown in the figure) and the deployment location (as shown in the figure) Figure 16A and Figure 16B The firing actuator (914) pivots between the two. When either of the firing actuators (914, 916) is in the deployed position, the deployed firing actuator (914, 916) can be driven distally by the operator to actuate the firing assembly (910) distally past the suturer (810), thereby simultaneously cutting and suturing the tissue held between the chamber half and the anvil half (812, 814).

[0049] To facilitate the clamping of tissue between the storage compartment half (812) and the anvil half (814), the storage compartment half (812) and the anvil half (814) are first set in a suspended open state (see Figure 9C This allows tissue to be positioned between the distal jaw portions (e.g., 20, 64). The chamber half (812) and the anvil half (814) are then pivoted toward each other to clamp the tissue between the distal jaw portions (e.g., 20, 64). The clamping lever (840) is then moved to the closed position to bring the chamber half (812) and the anvil half (814) close together. If the chamber half (812) and the anvil half (814) are properly engaged and the clamping lever (840) is moved to the closed position, the chamber half (812) and the anvil half (814) can be pulled to a fully close position, as shown. Figure 16A and Figure 17AAs shown, this allows the firing assembly (910) to properly cut and suture tissue. However, if the chamber half (812) and the anvil half (814) do not engage properly with each other (e.g., due to excessively thick tissue and / or incorrect positioning of the chamber half (812) and the anvil half (814) relative to each other) and the clamping lever (840) moves to the closed position, the chamber half (812) and the anvil half (814) may not be able to come into full contact, as... Figure 16B and Figure 17B As shown. When the chamber half (812) and the anvil half (814) are in close proximity, the firing of the firing assembly (910) may result in incorrect cutting and suturing of the tissue.

[0050] Therefore, a pair of firing locking members in the form of protrusions (958, 960) are provided, which are configured to selectively engage the firing actuators (914, 916) respectively, thereby inhibiting the firing assembly (910) from actuating through the firing stroke when the chamber half (812) and the anvil half (814) are not fully approaching and the clamping lever (840) is in the closed position. Figure 16A and Figure 16B As shown, each protrusion (958, 960) is disposed on the opposite side of the clamping lever cover (856) and extends outward therefrom, adjacent to the firing actuators (914, 916), respectively. Each firing actuator (914, 916) defines a slot (968, 970) configured to receive a corresponding protrusion (958, 960) when the chamber half (812) and the anvil half (814) are fully approaching.

[0051] The interaction between the firing actuator (914) and the protrusion (958) will now be described, but it can be understood as representing the interaction between the firing actuator (916) and the protrusion (960), which can be independent of the interaction between the firing actuator (914) and the protrusion (958). When the chamber half (812) and the anvil half (814) are completely close, as Figure 16A and Figure 17AAs shown, the protrusion (958) is aligned with the slot (968) of the firing actuator (914). When the firing actuator (914) is in the deployed position and the firing assembly (910) subsequently advances from its original position toward the firing position, the protrusion (958) is allowed to pass through the slot (968) to allow the firing assembly (910) to continue through the firing stroke. In one example, the slot (968) may extend through the entire length of the firing actuator (914) such that the firing assembly (910) can be fired regardless of whether the firing actuator (914) is in the deployed or retracted position. In another example, the slot (968) may extend only partially through the length of the firing actuator (914) such that the slot (968) is configured to allow the protrusion (958) to pass through it only when the firing actuator (914) is in the deployed position.

[0052] When the storage half (812) and the anvil half (814) are only partially close, such as Figure 16B and Figure 17B As shown, the protrusion (958) is not aligned with the slot (968) of the firing actuator (914). Therefore, when the firing assembly (910) is propelled from its original position toward the firing position, the protrusion (958) contacts the portion of the firing actuator (914) adjacent to the slot (968) to prevent the firing assembly (910) from continuing distally toward the firing position. This can indicate to the user that the chamber half (812) and the anvil half (814) are misaligned and require further alignment to allow proper suturing and cutting of tissue. It should be understood that although the protrusions (958, 960) have been shown above, various suitable alternative firing locking member arrangements are contemplated that engage the firing assembly (910) to thereby inhibit the advance of the firing assembly through the firing stroke when the chamber half (812) and the anvil half (814) are not fully approached using the clamping lever (840).

[0053] B. A proximal-positioned protrusion that selectively interacts with a slot on the firing actuator. Figure 18Another exemplary suture (1010) is shown, which is generally similar to the sutures described above (10, 210, 410, 610, 810), except as otherwise described below. The suture (1010) includes a storage compartment half (1012) and an anvil half (1014) configured to be releasably connected together to hold tissue therebetween for simultaneous cutting and suturing of the held tissue. The storage compartment half (1012) includes a clamping lever (1040) actuated by a user from an open position to a closed position to bring the storage compartment half (1012) and the anvil half (1014) closer together, thereby clamping the tissue between distal jaw portions (e.g., 20, 64). The sewing device (1010) also includes an anvil cover (1078) attached to and at least partially covering the anvil half (1014). A firing actuator (1116) is provided to facilitate firing the firing assembly from its original position to the firing position. The firing actuator (1116) defines a slot (1170) that can be selectively aligned with the protrusion (1160) to selectively inhibit firing assembly actuation through the firing stroke when the chamber half (1012) and the anvil half (1014) are not fully approaching and the clamping member (1040) is in the closed position. However, with... Figures 16A to 17B Compared to the protrusions (958, 960) shown, the protrusion (1160) is shown positioned further proximally on the anvil cover (1078).

[0054] IV. 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.

[0055] Example 1 An apparatus comprising: (a) a first suture half having a first distal jaw portion configured to provide a suture assembly having a plurality of staples; (b) a second suture half having a second distal jaw portion configured to provide an anvil with a plurality of staple-forming recesses, wherein the first suture half and the second suture half are configured to selectively join together and separate from each other; (c) a clamping member provided by one of the first suture half or the second suture half, wherein the clamping member is actuable by a user to bring the first suture half and the second suture half into close proximity, thereby clamping tissue between the first distal jaw portion and the second distal jaw portion; and (d) a firing assembly provided by one of the first suture half or the second suture half. The firing assembly is actuated by a user from an initial position to a firing position via a firing stroke to fire the suture assembly on the held tissue. The firing assembly includes a firing actuator movable by the user between a retracted position and a deployed position, wherein the firing actuator is configured to actuate the firing assembly through the firing stroke in the deployed position; and (e) a firing locking member movable relative to the firing assembly between an engaged position and a disengaged position, wherein in the engaged position, the firing locking member is configured to inhibit the firing assembly from advancing toward the firing position from the initial position, wherein in the disengaged position, the firing locking member is configured to allow the firing assembly to advance toward the firing position from the initial position, wherein the firing locking member is configured to take the disengaged position only when the firing actuator is in the deployed position.

[0056] Example 2 According to the device of Embodiment 1, the firing locking member is configured to change from the engaged position to the disengaged position in response to the firing actuator changing from the retracted position to the deployed position.

[0057] Example 3 According to any one of the foregoing embodiments, the firing locking member is biased toward the engagement position such that the firing locking member is configured to return from the disengaged position to the engagement position in response to the firing actuator changing away from the deployment position.

[0058] Example 4 According to any one of the foregoing embodiments, the firing locking member is movable in a direction transverse to the longitudinal axis of the device when transitioning between the engaged position and the disengaged position.

[0059] Example 5 The device according to any one of the foregoing embodiments, wherein the firing actuator is configured to change between the retracted position and the deployed position only when the firing assembly is in the original position.

[0060] Example 6 The device according to any one of the foregoing embodiments, wherein the original position of the firing assembly includes a proximal position and the firing position includes a distal position, wherein the firing assembly is actuated distally from the original position to the firing position by the firing actuator to fire the suture assembly.

[0061] Example 7 According to any one of the foregoing embodiments, the device further includes a slider configured to translate between the original position and the firing position, wherein the firing actuator is coupled to the slider and movable relative to the slider between the retracted position and the deployed position, and wherein the firing locking member is movable relative to the slider between the engaged position and the disengaged position.

[0062] Example 8 According to the device of embodiment 7, the firing actuator is pivotally connected to the slider about a pivot axis extending transversely to the translational direction of the slider, wherein the firing actuator is capable of pivoting relative to the slider about the pivot axis between the retracted position and the deployed position.

[0063] Example 9 According to any one of embodiments 7 to 8, the firing locking member in the engaged position is configured to directly contact the slider, thereby suppressing translation of the slider from the original position to the firing position.

[0064] Example 10 According to any one of embodiments 7 to 9, the slider includes a channel, wherein the firing locking member is movable within the channel between the engaged position and the disengaged position.

[0065] Example 11 According to any one of embodiments 7 to 10, the engagement position of the firing locking member includes one of an elevated position or a lowered position relative to the slider, and the disengagement position includes the other of an elevated position or a lowered position relative to the slider.

[0066] Example 12 In the device according to any one of the foregoing embodiments, the firing locking member is longitudinally fixed relative to the firing assembly.

[0067] Example 13 In the device according to any one of the foregoing embodiments, the firing locking member includes a leaf spring.

[0068] Example 14 The device according to any one of the foregoing embodiments further includes a rotatable member disposed at the proximal end of one of the first suture half or the second suture half, wherein the firing locking member includes an arm extending distally from the rotatable member.

[0069] Example 15 According to any one of the foregoing embodiments, the firing locking member is movable together with the firing assembly between the original position and the firing position, and is translatable relative to a portion of the firing assembly between the engaging position and the disengaged position.

[0070] Example 16 An apparatus comprising: (a) a first suture half having a first distal jaw portion configured to provide a suture assembly having a plurality of staples; (b) a second suture half having a second distal jaw portion configured to provide an anvil with a plurality of staple-forming recesses, wherein the first suture half and the second suture half are configured to selectively join together and separate from each other; and (c) a clamping member provided by one of the first suture half or the second suture half, wherein the clamping member is actuated by a user from a first position to a second position to bring the first suture half and the second suture half into close proximity, and thereby clamping tissue in the first distal jaw portion and the suture assembly. (d) a firing assembly provided by the first suture half, wherein the firing assembly is actuated by the user through a firing stroke to fire the suture assembly on the held tissue, wherein the firing assembly includes a firing actuator movable by the user between a retracted position and a deployed position, wherein the firing actuator is configured to actuate the firing assembly through the firing stroke in the deployed position; and (e) a firing locking member provided by the second suture half, wherein the firing locking member is configured to engage the firing assembly and thereby inhibit the advancement of the firing assembly through the firing stroke when the first suture half and the second suture half are not fully approaching and the clamping member is in the second position.

[0071] Example 17 According to the device of embodiment 16, the second stitcher half includes a cover, and the firing locking member includes a protrusion extending outward from the cover, wherein the protrusion is configured to engage the firing actuator, and thereby inhibit the firing assembly from actuating through the firing stroke when the first stitcher half and the second stitcher half are not fully close and the clamping member is in the second position.

[0072] Example 18 According to the device of embodiment 17, the firing actuator includes a slot configured to align with and receive the protrusion passing through it, thereby allowing at least one of the following conditions: the firing actuator is deployed or the firing assembly is actuated through the firing stroke when the first stitcher half and the second stitcher half are in full proximity and the clamping member is in the second position.

[0073] Example 19 An apparatus comprising: (a) a first suture half having a first distal jaw portion configured to provide a suture assembly having a plurality of staples; (b) a second suture half having a second distal jaw portion configured to provide an anvil with a plurality of staple-forming recesses, wherein the first suture half and the second suture half are configured to selectively engage and disengage from each other; (c) a clamping member provided by one of the first suture half or the second suture half, wherein the clamping member is actuable by a user from a first position to a second position to bring the first suture half and the second suture half into close proximity and thereby clamp tissue between the first distal jaw portion and the second distal jaw portion; and (d) a firing assembly provided by one of the first suture half or the second suture half. The firing assembly is actuated by a user through a firing stroke to fire the suture assembly on the held tissue, wherein the firing assembly includes: (i) a sliding member, and (ii) a firing actuator movable by the user relative to the sliding member between a retracted position and a deployed position, wherein in the deployed position the firing actuator is configured to actuate the firing assembly through the firing stroke; and (e) a firing locking member provided by one of the first suture half or the second suture half, wherein the firing locking member is configured to directly contact one of the sliding member or the firing actuator, and thereby inhibit the advancement of the firing assembly through the firing stroke when at least one of the following conditions occurs: (i) the firing actuator is not in the deployed position, or (ii) the first suture half and the second suture half are not fully close and the clamping member is in the second position.

[0074] Example 20 According to the device of embodiment 19, the device is configured to transition from a locked state to a firing state, wherein the locked state is when the firing locking member inhibits the firing assembly from actuating through the firing stroke, and the firing state is when the firing locking member allows the firing assembly to actuate through the firing stroke, wherein the firing locking member is configured to directly contact the firing actuator in at least one of the locked state or the firing state.

[0075] V. 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.

[0076] 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.

[0077] The surgical instrument system described herein has been described in conjunction with the deployment and variations of the staples; however, the embodiments described herein are not limited thereto. For example, various embodiments are contemplated for deploying fasteners other than staples, such as clamps or pins. Furthermore, various embodiments utilizing any suitable means for sealing tissue are contemplated. For example, the end effector according to various embodiments may include electrodes configured to heat and seal tissue. Additionally, for example, the end effector according to some embodiments may apply vibrational energy to seal tissue.

[0078] Devices of the types described above may be designed for single-use 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 operator prior to the procedure 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.

[0079] 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.

[0080] 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 suture half having a first distal jaw portion configured to provide a suture assembly having a plurality of staples. (b) A second stapler half having a second distal jaw portion configured to provide an anvil with a plurality of stapled recesses, wherein the first stapler half and the second stapler half are configured to be selectively joined together and separated from each other. (c) A clamping member provided by one of the first suture half or the second suture half, wherein the clamping member is actuable by a user to bring the first suture half and the second suture half into close proximity, and thereby clamping tissue between the first distal jaw portion and the second distal jaw portion. (d) A firing assembly provided by one of the first suture half or the second suture half, wherein the firing assembly is user-actuable to fire the suture assembly over a firing stroke from an initial position to a firing position, wherein the firing assembly includes a firing actuator movable by the user between a retracted position and a deployed position, wherein in the deployed position, the firing actuator is configured to actuate the firing assembly over the firing stroke; and (e) A firing locking member movable relative to the firing assembly between an engaged position and a disengaged position, wherein, in the engaged position, the firing locking member is configured to prevent the firing assembly from advancing from the original position toward the firing position, and wherein, in the disengaged position, the firing locking member is configured to allow the firing assembly to advance from the original position toward the firing position. The firing locking member is configured to take the disengaged position only when the firing actuator is in the deployed position.

2. The device according to claim 1, wherein, The firing locking member is configured to change from the engaged position to the disengaged position in response to the firing actuator changing from the retracted position to the deployed position.

3. The device according to claim 2, wherein, The firing locking member is biased toward the engagement position such that the firing locking member is configured to return from the disengaged position to the engagement position in response to the firing actuator changing away from the deployment position.

4. The device according to any of the preceding claims, wherein, When transitioning between the engaged position and the disengaged position, the firing locking member is capable of moving in a direction transverse to the longitudinal axis of the device.

5. The device according to any of the preceding claims, wherein, The firing actuator is configured to change between the retracted position and the deployed position only when the firing assembly is in the original position.

6. The device according to any of the preceding claims, wherein, The initial position of the firing assembly includes a proximal position, and the firing position includes a distal position, wherein the firing assembly is actuated distally from the initial position to the firing position by the firing actuator to fire the suture assembly.

7. The device according to any of the preceding claims, wherein, The firing assembly further includes a slider configured to translate between the original position and the firing position, wherein the firing actuator is coupled to the slider and movable relative to the slider between the retracted position and the deployed position, and wherein the firing locking member is movable relative to the slider between the engaged position and the disengaged position.

8. The device according to claim 7, wherein, The firing actuator is pivotally connected to the slider about a pivot axis extending transversely to the translational direction of the slider, wherein the firing actuator is capable of pivoting relative to the slider about the pivot axis between the retracted position and the deployed position.

9. The device according to claim 7 or claim 8, wherein, The firing locking member in the engagement position is configured to directly contact the slider, thereby inhibiting translation of the slider from the original position to the firing position.

10. The device according to any one of claims 7 to 9, wherein, The slider includes a channel in which the firing locking member is movable within the channel between the engaged position and the disengaged position.

11. The device according to any one of claims 7 to 10, wherein, The engaging position of the firing locking member includes one of an elevated or lowered position relative to the slider, and the disengaged position includes the other of an elevated or lowered position relative to the slider.

12. The device according to any of the preceding claims, wherein, The firing locking member is fixed longitudinally relative to the firing assembly.

13. The device according to claim 12, wherein, The firing locking component includes a leaf spring.

14. The device of claim 12, further comprising a rotatable member disposed at the proximal end of one of the first or second suture halves, wherein, The firing locking member includes an arm extending distally from the rotatable member.

15. The device according to any of the preceding claims, wherein, The firing locking member is movable together with the firing assembly between the original position and the firing position, and is translatable relative to a portion of the firing assembly between the engaged position and the disengaged position.

16. An apparatus comprising: (a) A first suture half having a first distal jaw portion configured to provide a suture assembly having a plurality of staples. (b) A second stapler half having a second distal jaw portion configured to provide an anvil with a plurality of stapled recesses, wherein the first stapler half and the second stapler half are configured to be selectively joined together and separated from each other. (c) A clamping member provided by one of the first suture half or the second suture half, wherein the clamping member is actuated by a user from a first position to a second position to bring the first suture half and the second suture half into close proximity and thereby clamp tissue between the first distal jaw portion and the second distal jaw portion. (d) A firing assembly provided by the first suture half, wherein the firing assembly is actuated by a user through a firing stroke to fire the suture assembly onto the held tissue, wherein the firing assembly includes a firing actuator movable by the user between a retracted position and a deployed position, wherein in the deployed position, the firing actuator is configured to actuate the firing assembly through the firing stroke; and (e) A firing locking member provided by the second stitcher half, wherein the firing locking member is configured to engage the firing assembly and thereby inhibit the advancement of the firing assembly through the firing stroke when the first stitcher half and the second stitcher half are not fully close and the clamping member is in the second position.

17. The device according to claim 16, wherein, The second stitcher half includes a cover, and the firing locking member includes a protrusion extending outward from the cover, wherein the protrusion is configured to engage the firing actuator, and thereby inhibit the firing assembly from actuating through the firing stroke when the first stitcher half and the second stitcher half are not fully close and the clamping member is in the second position.

18. The device according to claim 16 or claim 17, wherein, The firing actuator includes a slot configured to align with and receive the protrusion passing through it, thereby allowing at least one of the following conditions: the firing actuator is deployed or the firing assembly is actuated through the firing stroke when the first stitcher half and the second stitcher half are fully close together and the clamping member is in the second position.

19. An apparatus comprising: (a) A first suture half having a first distal jaw portion configured to provide a suture assembly having a plurality of staples. (b) A second stapler half having a second distal jaw portion configured to provide an anvil with a plurality of stapled recesses, wherein the first stapler half and the second stapler half are configured to be selectively joined together and separated from each other. (c) A clamping member provided by one of the first suture half or the second suture half, wherein the clamping member is actuated by a user from a first position to a second position to bring the first suture half and the second suture half into close proximity and thereby clamp tissue between the first distal jaw portion and the second distal jaw portion. (d) A firing assembly provided by one of the first suture half or the second suture half, wherein the firing assembly is user-actuable via a firing stroke to fire the suture assembly onto the held tissue, wherein the firing assembly comprises: (i) Sliding member, and (ii) a firing actuator, movable by the user relative to the sliding member between a retracted position and a deployed position, wherein in the deployed position the firing actuator is configured to actuate the firing assembly through the firing stroke; and (e) A firing locking member provided by one of the first stitcher half or the second stitcher half, wherein the firing locking member is configured to directly contact one of the sliding member or the firing actuator, and thereby inhibit the advancement of the firing assembly through the firing stroke when at least one of the following conditions occurs: (i) The firing actuator is not in the deployment position, or (ii) The first suture half and the second suture half are not fully close together and the clamping member is in the second position.

20. The device according to claim 19, wherein, The device is configured to transition between a locked state and a firing state, wherein the locked state is when the firing locking member inhibits the firing assembly from actuating through the firing stroke, and the firing state is when the firing locking member allows the firing assembly to actuate through the firing stroke, wherein the firing locking member is configured to directly contact the firing actuator in at least one of the locked state or the firing state.

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