Atrial appendage exclusion device

Abstract

A surgical applicator for a fastener, the surgical applicator comprising: a handle; a trigger that can move relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; and a locking mechanism that can move relative to the trigger between a locked position and an unlocked position, the locking mechanism being operatively arranged to: lock the trigger at the intermediate position when the trigger moves from the initial position to the actuated position; and allow the trigger to move from the intermediate position to the initial position or the actuated position when the locking mechanism moves from the locked position to the unlocked position.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 649,455, filed on March 28, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present invention relates broadly to the field of fasteners and / or applicators. More specifically, the present invention relates to surgical applicators for implants and / or fasteners, including but not limited to sterile fasteners such as staples. Background Art

[0004] Atrial fibrillation is a relatively common condition characterized by very rapid heartbeats in the left and right atria. Although atrial fibrillation itself is not usually fatal, it is associated with an increased risk of stroke. It is thought that the rapid heartbeat causes blood to pool in the left atrial appendage (LAA), which results in emboli being released into the left atrium, from where they travel to the cerebral blood vessels, causing a stroke. In addition to stroke, emboli may travel to the coronary circulation, potentially causing a myocardial infarction, or may travel to the peripheral circulation, potentially causing peripheral vascular disease.

[0005] The risk of stroke in patients with atrial fibrillation can be reduced in a number of ways. For example, blood thinning medications can be used to reduce the risk of blood clot formation. However, blood thinners are contraindicated in patients at risk for bleeding disorders. More aggressive treatment options have been proposed, including closure of the LAA. Closure and resection can be performed in an open surgical procedure, typically requiring the patient to be placed on a bypass and the chest to be opened through the sternum. Alternatively, thoracoscopic surgery and other less invasive surgical procedures have been proposed. These tools are used to ablate or melt the LAA from the inside using energy, adhesives, etc.

[0006] In some examples, a compliant closure structure can be used to close the LAA. Such a compliant structure can have an elastomer having a pair of opposing legs that can be arranged in an elliptical or U-shaped configuration to define an opening therebetween. The compliant closure structure can be closed to provide a desired LAA seal by placing the opening between the legs above the LAA and aligning it with the base of the LAA. In order to keep the compliant closure structure closed, a number of discrete, axially spaced tissue penetrating fasteners are arranged along the length of each leg. By compressing the legs together to press fit with the closure device, the compliant closure structure can be closed to provide a compliant seal that effectively isolates the LAA.

[0007] The compliant closure structure is closed using a manually operated delivery tool having jaws that can be inserted into the legs of the closure structure and actuated to close the jaws in the legs above the LAA. The jaws also include comb-like studs that engage and press-fit with the closure device to hold the compliant closure structure in its closed, sealed configuration. The studs are intended to be retracted to allow removal of the delivery tool.

[0008] Existing delivery tools have certain drawbacks. For example, the actuation of the jaws and the retraction of the comb studs can be chaotically executed, thereby increasing the risk of failure in the delivery of the compliant structure. In addition, existing delivery tools do not allow for repeated "rehearsal" placement of the compliant closure structure on the LAA without closure tissue penetrating fasteners. Furthermore, positioning and orientation of the delivery tool can be difficult, especially when the tool is introduced through an intercostal puncture to access the LAA. Summary of the invention

[0009] For these reasons, it is desirable to provide an improved delivery tool for use with a compliant closure device for sealing the LAA. It is also desirable if the delivery tools and methods of their use are compatible with the delivery of other tissue closure devices and also for surgical procedures other than closure of the LAA.

[0010] According to some non-limiting examples, a surgical applicator for a fastener may include: a handle; a trigger that is movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; and a locking mechanism that is movable relative to the trigger between a locked position and an unlocked position. The locking mechanism may be operatively arranged to lock the trigger at the intermediate position when the trigger moves from the initial position to the actuated position; and to allow the trigger to move from the intermediate position to the initial position or the actuated position when the locking mechanism moves from the locked position to the unlocked position.

[0011] According to some non-limiting examples, the locking mechanism may also be operatively arranged to allow the trigger to move from the initial position to the actuated position when the locking mechanism moves from the locked position to the unlocked position before the trigger moves from the initial position. The trigger may be movable relative to the handle from the initial position by applying a compressive force on the trigger in a direction toward the handle. The trigger may have a distal side, the distal side being opposite to a proximal side facing the handle, and at least a portion of the locking mechanism may be located at the distal side of the trigger.

[0012] According to some non-limiting examples, the locking mechanism may have a release button connected to the trigger, the release button being movable between a first position and a second position relative to the trigger. The locking mechanism may also have a trigger stopper connected to the handle, the trigger stopper being movable between a first position and a second position relative to the handle. The release button may be pivotally movable relative to the trigger, or may be linearly movable in a direction transverse to the trigger. The release button may be biased to the first position by a release button biasing member. The trigger stopper may be biased to the first position by a trigger stopper biasing member. The movement of the trigger from the initial position to the actuated position may cause the trigger to engage with the trigger stopper to automatically lock the trigger at the intermediate position. The movement of the release button from the first position to the second position when the trigger is in the intermediate position may allow the trigger to disengage from the trigger stopper.

[0013] According to some non-limiting examples, a ratchet mechanism may be provided to engage with the trigger when the trigger moves from the intermediate position to the post-actuation position to prevent the trigger from moving to the initial position. The ratchet mechanism may be disengaged from the trigger when the trigger moves to the post-actuation position. The ratchet mechanism may have a ratchet rod and a ratchet wheel, and the ratchet wheel engages with the ratchet rod when the trigger moves from the intermediate position to the post-actuation position. The ratchet mechanism may be actuated when the trigger moves a predetermined distance from the intermediate position to the post-actuation position.

[0014] According to some non-limiting examples, the surgical applicator may also have a jaw assembly that is selectively movable between an open position and a closed position by movement of the trigger from the initial position to the actuated position. The jaw assembly may have a pair of jaws movably attached to each other, each jaw having a pair of sides, wherein a plurality of side grooves extend through each side. The outer surface of at least one of the sides of each jaw may have a recess that receives a covering element that is used to enclose at least a portion of the plurality of side grooves. The covering element may be adhesively fixed in the recess. The jaws may be pivotally attached to each other by a pin. The surgical applicator may also include a damping mechanism that is operatively arranged with the trigger to inhibit changes in the compressive force applied to the trigger during movement between the initial position and the actuated position. The damping mechanism may have a spring and a damper.

[0015] According to some non-limiting examples, a surgical applicator for a fastener may have: a handle; a trigger that is movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; and a locking mechanism. The locking mechanism may include a release button connected to the trigger and a trigger stop connected to the handle. Movement of the trigger from the initial position to the actuated position may cause the trigger stop to engage with the trigger to lock the trigger at the intermediate position, and movement of the release button relative to the trigger when the trigger is in the intermediate position may cause the trigger to disengage from the trigger stop to allow the trigger to move from the intermediate position to the initial position or the actuated position. The surgical applicator may also have a ratchet mechanism that engages with the trigger when the trigger moves from the intermediate position to the actuated position to prevent the trigger from moving to the initial position. The ratchet mechanism may disengage from the trigger when the trigger moves to the actuated position.

[0016] According to some non-limiting examples, a surgical applicator for fasteners may have: a handle; a trigger that is movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; and an elongated body that extends distally from the handle. The elongated body may have: a distal portion; a jaw assembly at the distal portion, the jaw assembly selectively movable between an open position, a closed position, and an intermediate position between the open position and the closed position by movement of the trigger. The surgical applicator may also have a locking mechanism that is operatively arranged to: lock the trigger and the jaw assembly at the intermediate position when the trigger moves from the initial position to the actuated position; and allow the trigger to move from the intermediate position to the initial position or the actuated position to move the jaw assembly from the intermediate position to the open position or the closed position, respectively.

[0017] According to some non-limiting examples, a method of operating a fastener applicator may include: moving a trigger of the fastener applicator from an initial position to an actuated position by applying a compressive force on the trigger in a direction toward a handle of the fastener applicator; closing a jaw assembly of the fastener applicator from an open position to a closed position by movement of the trigger; and locking the trigger and the jaw assembly in an intermediate position by a locking mechanism. The method may also include: moving the locking mechanism from a locked position to an unlocked position; moving the trigger from the intermediate position to the actuated position; and closing the jaw assembly from the intermediate position to the closed position by movement of the trigger. Closing the jaw assembly to the closed position may close the fastener from an unsecured position to a secured position.

[0018] According to some non-limiting examples, the method may further include: after the trigger moves from the intermediate position to the post-actuation position, blocking the trigger from moving to the initial position by a ratchet mechanism. When the trigger moves to the post-actuation position, or after the trigger moves to the post-actuation position, the jaw assembly may move from the closed position to the open position. The method may further include: when the trigger moves to the post-actuation position, unlocking the trigger.

[0019] Other examples of the invention are set forth in the following numbered items.

[0020] Item 1: A surgical applicator for a fastener, the surgical applicator comprising:

[0021] handle;

[0022] a trigger movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; and

[0023] A locking mechanism movable between a locked position and an unlocked position relative to the trigger, the locking mechanism being operatively arranged to:

[0024] locking the trigger in the intermediate position when the trigger moves from the initial position to the actuated position; and

[0025] The trigger is allowed to move from the intermediate position to the initial position or the post-actuation position when the locking mechanism moves from the locked position to the unlocked position.

[0026] Item 2: A surgical applicator according to Item 1, wherein the locking mechanism is also operatively arranged to allow the trigger to move from the initial position to the actuated position when the locking mechanism moves from the locked position to the unlocked position before the trigger moves from the initial position.

[0027] Item 3: The surgical applicator of item 1 or item 2, wherein the trigger is movable relative to the handle from the initial position by applying a compressive force on the trigger in a direction toward the handle.

[0028] Item 4: The surgical applicator of any of Items 1-3, wherein the trigger has a distal side opposite a proximal side facing the handle, and wherein at least a portion of the lockout mechanism is located on the distal side of the trigger.

[0029] Item 5: The surgical applicator of any one of Items 1-4, wherein the locking mechanism comprises:

[0030] a release button coupled to the trigger, the release button being movable relative to the trigger between a first position and a second position, and

[0031] A trigger stop is coupled to the handle, the trigger stop being movable relative to the handle between a first position and a second position.

[0032] Item 6: The surgical applicator of Item 4, wherein the release button is pivotally movable relative to the trigger.

[0033] Item 7: The surgical applicator of Item 4, wherein the release button is linearly movable in a direction transverse to the trigger.

[0034] Item 8: The surgical applicator of Item 4, wherein the release button is biased to the first position by a release button biasing member.

[0035] Item 9: The surgical applicator of Item 4, wherein the trigger stop is biased to the first position by a trigger stop biasing member.

[0036] Item 10: The surgical applicator of Item 4, wherein movement of the trigger from the initial position to the actuated position causes the trigger to engage the trigger stop to automatically lock the trigger in the intermediate position.

[0037] Item 11. The surgical applicator of Item 4, wherein movement of the release button from the first position to the second position when the trigger is in the intermediate position allows the trigger to disengage from the trigger stop.

[0038] Item 12: The surgical applicator of any one of Items 1-11, further comprising a ratchet mechanism that engages the trigger when the trigger moves from the intermediate position to the actuated position to prevent the trigger from moving to the initial position.

[0039] Item 13: The surgical applicator of Item 10, wherein the ratchet mechanism disengages from the trigger when the trigger is moved to the post-actuated position.

[0040] Item 14: The surgical applicator of Item 10, wherein the ratchet mechanism comprises a ratchet lever and a ratchet wheel, the ratchet wheel engaging the ratchet lever when the trigger moves from the intermediate position to the actuated position.

[0041] Item 15: The surgical applicator of Item 10, wherein the ratchet mechanism is actuated when the trigger moves a predetermined distance from the intermediate position to the actuated position.

[0042] Item 16: The surgical applicator of any of Items 1-15, further comprising a jaw assembly selectively movable between an open position and a closed position by movement of the trigger from the initial position to the actuated position.

[0043] Item 17: The surgical applicator of Item 16, wherein the jaw assembly comprises a pair of jaws movably attached to one another, each jaw having a pair of sides, wherein a plurality of side slots extend through each side.

[0044] Item 18: The surgical applicator of Item 17, wherein an outer surface of at least one of the sides of each jaw has a recess.

[0045] Item 19: The surgical applicator of Item 18, wherein the recess receives a covering element that surrounds at least a portion of the plurality of side grooves.

[0046] Item 20. The surgical applicator of Item 17, wherein the covering element is adhesively secured in the recess.

[0047] Item 21. The surgical applicator of Item 17, wherein the jaws are pivotally attached to each other by a pin.

[0048] Item 22: The surgical applicator of any of Items 1-21, further comprising a damping mechanism operatively arranged with the trigger to dampen changes in compressive force applied to the trigger during movement between the initial position and the actuated position.

[0049] Item 23. The surgical applicator of Item 22, wherein the damping mechanism comprises a spring and a damper.

[0050] Item 24: A surgical applicator for a fastener, the surgical applicator comprising:

[0051] handle;

[0052] a trigger movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; and

[0053] a lockout mechanism including a release button connected to the trigger and a trigger stop connected to the handle,

[0054] wherein movement of the trigger from the initial position to the actuated position causes the trigger stop to engage the trigger to lock the trigger in the intermediate position, and

[0055] Wherein movement of the release button relative to the trigger when the trigger is in the intermediate position disengages the trigger from the trigger stopper to allow the trigger to move from the intermediate position to the initial position or the actuated position.

[0056] Item 25: The surgical applicator of Item 24, further comprising a ratchet mechanism that engages the trigger when the trigger moves from the intermediate position to the actuated position to prevent the trigger from moving to the initial position.

[0057] Item 26: The surgical applicator of item 24 or item 25, wherein the ratchet mechanism disengages from the trigger when the trigger is moved to the post-actuated position.

[0058] Item 27: A surgical applicator for a fastener, the surgical applicator comprising:

[0059] handle;

[0060] a trigger movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position;

[0061] an elongated body extending distally from the handle, the elongated body having a distal portion;

[0062] a jaw assembly at the distal portion of the elongated body, the jaw assembly being selectively movable between an open position, a closed position, and an intermediate position between the open position and the closed position by movement of the trigger; and

[0063] A locking mechanism operatively arranged to:

[0064] locking the trigger and the jaw assembly in the intermediate position as the trigger moves from the initial position to the actuated position; and

[0065] The trigger is allowed to move from the intermediate position to the initial position or the actuated position to move the jaw assembly from the intermediate position to the open position or the closed position, respectively.

[0066] Item 28: A method of operating a fastener applicator, the method comprising:

[0067] moving a trigger of the fastener applicator from an initial position to an actuated position by applying a compressive force on the trigger in a direction toward a handle of the fastener applicator;

[0068] closing the jaw assembly of the fastener applicator from an open position to a closed position by movement of the trigger;

[0069] locking the trigger and the jaw assembly in an intermediate position by a locking mechanism;

[0070] moving the locking mechanism from a locked position to an unlocked position;

[0071] moving the trigger from the intermediate position to the actuated position; and

[0072] The jaw assembly is closed from the intermediate position to the closed position by movement of the trigger.

[0073] Item 29: The method of Item 28, wherein closing the jaw assembly to the closed position closes the fastener from an unsecured position to a secured position.

[0074] Item 30: The method according to Item 28 or Item 29 further includes: after the trigger moves from the intermediate position to the actuated position, blocking the trigger from moving toward the initial position by a ratchet mechanism.

[0075] Item 31: The method of any one of Items 28-30, wherein the jaw assembly moves from the closed position to the open position when or after the trigger moves to the post-actuated position.

[0076] Item 32: The method according to any one of Items 28-31 further includes: unlocking the trigger when the trigger moves to the actuated position.

[0077] These and other features and characteristics of the present invention, as well as methods of operation and function of the related elements of structure and combination of parts and manufacturing economies, will become more apparent from consideration of the following description and appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals represent corresponding parts in the various drawings. It is to be expressly understood, however, that the drawings are for purposes of illustration and description only and are not intended as a definition of the limits of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0078] Further advantages and details of the invention are explained in more detail below with reference to the exemplary examples shown in the accompanying drawings, in which:

[0079] Figure 1 is a side view of a fastener applicator constructed in accordance with an example of the present invention;

[0080] Figure 2 is a perspective view of a tissue closure device according to an example of the present invention;

[0081] Figure 3 yes Figure 1 An exploded perspective view of the fastener applicator is shown:

[0082] Figure 4A yes Figure 1 A perspective view of a pull rod assembly of a fastener applicator is shown;

[0083] Figure 4B yes Figure 4A An exploded perspective view of the tie rod assembly is shown;

[0084] Figure 4C is a top view of the shaft of the tie rod assembly;

[0085] Figure 4D yes Figure 4C a top partial cross-sectional view of the shaft shown;

[0086] Figure 4E yes Figure 4C-4D A cross-sectional view of the axis shown taken along line AA:

[0087] Figure 5 yes Figure 1 an exploded perspective view of a trigger assembly of a fastener applicator is shown;

[0088] Fig. 6A is a detailed perspective view of a trigger release button and a trigger stop of a fastener applicator according to one example of the present invention;

[0089] Figure 6B is a detailed perspective view of a trigger release button and a trigger stop of a fastener applicator according to another example of the present invention;

[0090] Fig. 7A yes Figure 1 a side view of a trigger assembly of a fastener applicator, showing the trigger in an initial position;

[0091] Figure 7B yes Figure 1 A side view of a trigger assembly of a fastener applicator is shown showing the trigger in a determined or intermediate position and the release button in a first position:

[0092] Figure 7C yes Figure 1 a side view of a trigger assembly of a fastener applicator, showing the trigger in a determined or intermediate position, wherein a release button is moved from a first position to a second position;

[0093] Fig.7D yes Figure 1 a side view of a trigger assembly of a fastener applicator, showing the trigger in a position between an intermediate position and an actuated position;

[0094] Fig. 7E yes Figure 1 a side view of a trigger assembly of a fastener applicator, showing the trigger in a final or post-actuated position;

[0095] Figure 8A-8D illustrates the movement of the jaw assembly and its engagement with a tissue closure device according to one example of the present invention; Fig. 9 The use of a fastener applicator according to one example of the present invention is shown, wherein the fastener applicator is used to close a tissue closure device over the LAA:

[0096] Figure 10A-10C is a schematic diagram of a trigger and a trigger sub lever according to an example of the present invention, showing the movement of the trigger between an initial position and an actuated position;

[0097] Fig.11 is a perspective view of a trigger release button according to one example of the present invention;

[0098] Fig. 12A is a top perspective view of a trigger stop according to an example of the present invention;

[0099] Fig. 12B is a bottom perspective view of a trigger stopper according to an example of the present invention;

[0100] Fig.13A is a top perspective view of a ratchet lever according to one example of the present invention; and

[0101] Fig. 13Bis a bottom perspective view of a ratchet lever according to one example of the present invention.

[0102] exist Figure 1-13B 1 and 2. In the drawings, unless otherwise specified, like characters denote like parts and elements. DETAILED DESCRIPTION

[0103] Spatial or directional terms, such as "left", "right", "inner", "outer", "above", "below", etc., should not be considered limiting, as the invention can take various alternative orientations. For the purpose of the following description, the terms "end", "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the present invention as it is oriented in the accompanying drawings.

[0104] As used in the specification and claims, the singular form of "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0105] All numbers used in the specification and claims are to be understood in all instances as being modified by the term “about.” “About” means a range of plus or minus ten percent of the stated value.

[0106] Unless otherwise specified, all ranges or ratios disclosed herein should be understood to include any and all sub-ranges or sub-ratios encompassed therein. For example, a range or ratio set as "1 to 10" should be considered to include any and all sub-ranges between a minimum value of 1 and a maximum value of 10 (including 1 and 10); that is, all sub-ranges or sub-ratios start with a minimum value of 1 or greater and end with a maximum value of 10 or less, such as, but not limited to, 1 to 6.1, 3.5 to 7.8, and 5.5 to 10.

[0107] The terms "first", "second", etc. are not intended to indicate any particular order or sequence, but rather to indicate different conditions, properties or elements.

[0108] "At least" means "greater than or equal to". "Not greater than" means "less than or equal to".

[0109] The term "comprising" is synonymous with "including."

[0110] The terms "proximal" or "proximally" when used with respect to any portion of a fastener applicator refer to the portion of the fastener applicator that is closest to the body of a user manipulating the fastener applicator during use of the fastener applicator. Conversely, the terms "distal" or "distally" when used with respect to any portion of a fastener applicator refer to the portion of the fastener applicator that is farthest from the body of a user manipulating the fastener applicator during use of the fastener applicator.

[0111] It should be understood that the specific devices and methods shown in the drawings and described in the following specification are merely exemplary examples or aspects of the invention. Therefore, specific dimensions and other physical characteristics related to the examples or aspects disclosed herein should not be considered limiting.

[0112] Various examples of the present invention provide alternative and improved devices, systems and methods for deploying one or more closure devices or fasteners to tissue.Exemplary tissue structures of patients at risk for stroke or other adverse events due to emboli released from the LAA into the circulation may include the LAA.

[0113] Now refer to Figure 1 A fastener applicator 10 (also referred to herein as a "surgical applicator" or "applicator") according to various exemplary configurations of the present invention has a shaft 12 having a handle assembly 17 at a proximal end 13 thereof and a jaw assembly 16 at a distal end 15 thereof, wherein separate jaws 18, 20 are adapted to carry a fastener 22 (e.g., Figure 2 The handle assembly 17 has a trigger 32 that can move relative to the handle 34 between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position. Figure 1 By applying a compressive force on the arrow A in FIG. 3 , trigger 32 can be moved relative to handle 34 from an initial position. In various examples of the present invention, fastener applier 10 is configured to introduce fastener 22 over a tissue structure.

[0114] Reference Figure 2, a fastener 22 is shown according to a non-limiting example of the present invention. The fastener 22 has a substantially U-shaped configuration for receiving a tissue structure, such as the LAA or other tissue structure, when the jaws 18, 20 of the fastener applicator 10 are open. The fastener 22 has a compressible body 24 and a pair of parallel legs 26 having two opposing compliant tissue engagement surfaces 28. The legs 26a can move between an open or unfixed position and a closed or fixed position. In some examples, each of the legs 26 is made of a soft biocompatible material. The fastener 22 also has a plurality of tissue penetrating fasteners 30 that are spaced apart along the legs 26 and are arranged to extend from a first tissue engagement surface in the tissue engagement surface 28 through the tissue at the puncture site to a second tissue engagement surface in the tissue engagement surface 28 to close the tissue structure therebetween. The plurality of tissue penetrating fasteners 30 apply a desired level of compressive force, which is determined by both the softness of the compressible body 24 and the distance between the tissue engaging surfaces 28 when the tissue engaging surfaces 28 are fully connected to the tissue structure. When connected to the tissue structure, the fasteners 22 remain in place to close and / or seal the tissue structure. Then, a portion of the tissue structure extending beyond the fasteners 22 can be cut, excised or otherwise removed, although this can be left to the physician to choose. A more detailed description of various fasteners suitable for use with the fastener applicator 10 of the present invention is described in U.S. Pat. No. 7,992,757, the entire disclosure of which is incorporated herein by reference.

[0115] Now refer to Figure 3 , showing Figure 1 1 is an exploded view of the fastener applicator 10 of FIG. The handle assembly 17 has a housing 36 that includes a first housing portion 36a and a second housing portion 36b that are coupled to each other and define an interior space for receiving the working components of the handle assembly 17. When assembled together, the first housing portion 36a and the second housing portion 36b define a handle 34 that is grasped by a user when manipulating the fastener applicator 10. In some examples, one or more handle fasteners 38 are used to couple the first and second portions 36a, 36b of the housing 36. In other examples, the first and second portions 36a, 36b of the housing 36 may be coupled using clips, grooves, adhesives, welding, or any other mechanical fastening arrangement. In various examples, the first and second portions 36a, 36b of the housing 36 may be removably or non-removably coupled to each other.

[0116] Continue to refer to Figure 3The interior space of the housing 36 receives various components for actuating the surgical applicator 10 between the initial position, the actuated position, and the intermediate position between the initial position and the actuated position. For example, the housing 36 can receive various gears, connecting rods, springs, etc. to move or actuate the trigger 32 between the initial position, the actuated position, and the intermediate position between the initial position and the actuated position. As discussed herein, the housing 36 receives at least a portion of the trigger 32 that is movable relative to the housing 36 in a pivoting movement around the trigger pivot pin 44. The trigger 32 can be biased to the initial position by a trigger biasing member (such as a trigger spring 38). The trigger spring 38 can be compressed as the trigger 32 moves from the initial position, thereby generating a restoring force in the trigger spring 38, which restores the trigger 32 to the initial position when the thrust on the trigger 32 is removed or reduced to a magnitude below the restoring force of the trigger spring 38. In some examples, the trigger 32 has a trigger stop 40 that is pivotally connected to at least a portion of the housing 36. The trigger stop 40 is movable between a first position and a second position relative to the handle 34. The trigger stop 40 is biased to the first position by a trigger stop biasing member, such as a trigger stop spring 50.

[0117] Continue to refer to Figure 3 The housing 36 receives a ratchet mechanism 46 having a ratchet rod 120 and a ratchet 128, as discussed herein. When the trigger 32 moves from the intermediate position toward the post-actuation position, the ratchet mechanism 46 engages to prevent the trigger 32 from moving toward the initial position. In some examples, when the trigger 32 reaches the post-actuation position, the ratchet mechanism 46 disengages, so that when the ratchet mechanism 46 disengages or when the force applied to the trigger is released, the trigger 32 automatically moves toward the initial position. A damping mechanism 48 is received in the housing 36 and is operatively arranged with the trigger 32 to inhibit changes in the compressive force applied to the trigger 32 during movement between the initial position and the post-actuation position. In some examples, the damping mechanism 48 has a damping spring 50 received in a damper plunger 52, and a damper 54. In various examples, the damper 54 can be a friction damper, an elastic damper, a magnet damper, a viscous damper, or any combination thereof.

[0118] Reference Figure 4A , jaw assembly 16 is shown separated from the remaining components of fastener applicator 10 . Figure 4B yes Figure 4A Exploded view of the jaw assembly 16. As described herein, the jaw assembly 16 can be moved in the open position ( Figure 4A-4B shown) and closed position ( Figure 8B-Figure 8CThe jaw assembly 16 includes a pair of jaws 18, 20 movably attached to each other. In some examples, the jaws 18, 20 are pivotally attached to each other by a hinge pin 56 and a washer 58. In some examples, the hinge pin 56 and the washer 58 can be welded together, such as using laser welding, ultrasonic welding, or other types of welding. In other examples, the hinge pin 56 and the washer 58 are bonded to each other, threaded to each other, or connected by any other removable or non-removable mechanical connection.

[0119] Continue to refer to Figure 4A-4B , each jaw 18, 20 has a pair of sides 60, each side 60 having a plurality of side slots 62 extending therethrough. The side slots 62 define a channel for guiding the movement of a jaw cam pin 64. A single jaw cam pin 64 is received within each side slot 62 and is movable within the side slot 62 between a first position and a second position. In the first position, the jaw cam pin 64 in each jaw 18, 20 is positioned relative to a stud comb 66 so that the comb 66 is in an extended or exposed position within the jaws 18, 20. In the second position, the jaw cam pin 64 in each jaw 18, 20 is positioned so that the jaw cam pin 64 pushes the stud comb 66 in each jaw 18, 20 to a retracted or concealed position, wherein the comb 66 acts on the tissue penetrating fasteners 30 of the fasteners 22.

[0120] Continue to refer to Figure 4A-4B , the jaws 18, 20 are received in the clamp box 68. In some examples, the clamp box 68 has a pair of sides 68a, 68b defining a central opening 70 therebetween for receiving the jaws 18, 20. The sides 68a, 68b of the clamp box 68 can be removably or non-removably connected to each other, such as by one or more rivets 72. The movement of the jaws 18, 20 between the open position and the closed position is controlled by the guide slots 63 on each jaw 18, 20 and the corresponding guide pins 65 (such as rivets 72) on the clamp box 68. Figure 4B is guided by the interaction between the

[0121] The clamp box 68 receives the distal end 74 of at least a portion of the shaft 14 (such as the distal end of the clamp tube 76). Figure 4E , shaft 14 includes a clamp tube 76 slidably received within an ejection tube 77 and an inner tie rod 78 slidably received within the clamp tube 76, such that the clamp tube, ejection tube 77, and inner tie rod 78 are coaxially arranged relative to each other. Clamp tube 76 can be rotated about its longitudinal axis to rotate the clamp box 68 and jaws 18, 20 to facilitate the orientation of jaws 18, 20 relative to handle assembly 17 during use of fastener applicator 10. In some examples, shaft 14 can be adjusted with a positioning knob 88 (such as Figure 5 As shown in the figure, the rotatable member rotates around its longitudinal axis.

[0122] The pull rod 78 can move axially relative to the clamp tube 76 with the movement of the trigger 32. For example, the pull rod 78 can move along its longitudinal axis in a direction extending between the proximal and distal ends of the shaft 14. Movement or closing of the trigger 32 from the initial position to the actuated position pulls the pull rod 78 proximally relative to the clamp tube 76 and the ejection tube 77 toward the proximal end 80 of the shaft 14, which in turn causes the jaws 18, 20 to close. The ejection tube 77 has at least one tendon 82 connected to its distal end. The at least one tendon 82 is operatively connected to the comb stud 66, so that movement of the trigger 32 to the activated position also pulls the at least one tendon 82 to cause the comb stud 66 to retract.

[0123] Reference Figure 4A-4B , the outer surface of at least one side 60 of each jaw 18, 20 has a recess 84. The recess 84 can be formed as a channel extending from the side 60 into the body of each jaw 18, 20 in the area surrounding the side groove 62. In some examples, the recess 84 receives a cover element 86 (also in Figure 3 84 ), the covering element 86 encloses at least a portion of the plurality of side grooves 62. The thickness of the covering element 86 can be selected so that the outer surface of the covering element 86 can be flush with the surface of the side 60. In other examples, the thickness of the covering element 86 can be selected so that its outer surface is recessed relative to the surface of the side 60, or so that the outer surface of the covering element 86 protrudes laterally from the surface of the side 60. In some examples, the covering element 86 can be adhesively fastened in the recess 84. In other examples, the covering element 86 can be transparent so that the side grooves 62 and the jaw cam pins 64 can be seen through the covering element 86. When located in the recess 84, the covering element 86 prevents the side grooves 62 and the jaw cam pins 64 from being contaminated during use of the fastener applicator 10, which may cause obstruction of one or more side grooves 62 and / or hinder the movement of one or more jaw cam pins 64 through the side grooves 62.

[0124] Reference Figure 5 , the trigger 32 includes a first trigger portion 32a and a second trigger portion 32b coupled to each other. When assembled together, the first trigger portion 32a and the second trigger portion 32b define a trigger 32 that is grasped by a user when manipulating the fastener applicator 10. In some examples, the first trigger portion 32a and the second trigger portion 32b are coupled using one or more trigger fasteners 90. In other examples, the first trigger portion 32a and the second trigger portion 32b can be coupled using a clip, a groove, an adhesive, a weld, a press fit, or any other mechanical fastening arrangement. In various examples, the first trigger portion 32a and the second trigger portion 32b can be removably or non-removably coupled to each other.

[0125] Continue to refer to Figure 5 Each trigger portion 32a, 32b has a first end 92, and the first end 92 is received in the housing 36 (such as Figure 3 The trigger 32 is provided with a first end 92 and a second end 94 extending opposite to the first end 92 and protruding outside the housing 36. The second free end 94 of the trigger 32 is configured to be grasped by a user during movement of the trigger 32 between the initial position and the activated position. The trigger 32 also has a distal side 111 opposite to the proximal side 108 facing the handle. As described herein, at least a portion of the locking mechanism is positioned on the distal side 110 of the trigger 32.

[0126] Continue to refer to Figure 5 The trigger 32 has a pivot pin opening 112 configured to receive the trigger pivot pin 44 (eg, Figure 3 14). The trigger 32 is pivotally movable about a longitudinal axis of a trigger pivot pin 44, the terminal end of which is secured to the housing 36. A trigger slot 114 extends through the body at the first end 92 of the trigger 32. The trigger slot 114 is configured to receive a closure trunnion 116 connected to a distal end of the pull rod 78. The trigger slot 114 serves as a cam mechanism for controlling movement of the pull rod 78 due to movement of the closure trunnion 116 within the trigger slot 114. In some examples, the shape of the trigger slot 114 is configured to cause linear movement of the pull rod 78 in the direction of the longitudinal axis 118 of the shaft 14 due to pivotal movement of the trigger about the trigger pivot pin 44. When the trigger 32 is in the initial position ( Fig. 7A ), the closing ear shaft 116 can be in contact with the first end of the trigger slot 114 or be positioned to be in almost contact with the first end of the trigger slot 114. Similarly, when the trigger 32 is in the actuated position ( Fig. 7E ), the closing ear shaft 116 can be in contact with the second end (opposite to the first end) of the trigger slot 114 or be positioned to be in almost contact with the second end of the trigger slot 114. When the trigger 32 is in an intermediate position between the initial position and the actuated position, the closing ear shaft 116 can be positioned between the first end and the second end of the trigger slot 114. The lateral pin of the ejection ear shaft 164 is received in the trigger sub-operating rod 122 (see also Figure 10A-10C ) so that the movement of the trigger 32 also causes the trigger sub-operating rod 122 to perform corresponding movement due to the movement of the ejection ear shaft 164 in the trigger slot 114 (see Figure 10A-10C ).

[0127] Continue to refer to Figure 5, the second end of the trigger sub-operating lever 122 has a pin 125 pivotally connected to the trigger 32. In this way, the first end of the trigger sub-operating lever 122 can slide relative to the trigger slot 166 and the ejection trunnion 164, while the second end of the trigger sub-operating lever 122 can pivotally move relative to the trigger sub-stop feature 172 on the handle 34 (see Figure 10A-10C ). When the second end of the trigger sub-lever 122 strikes the trigger sub-stop feature 172 on the handle 34 and the trigger 32 continues to move proximally toward the actuated position, the relative movement of the first end of the trigger sub-lever 122 is amplified by pivoting about the pin 125. The amplification factor is Fig. 10B The ratio of the two distances L1 and L2 in is determined. L1 is the distance between the trigger sub-stop feature 172 and the trigger sub-operating lever pin 125, while L2 is the distance between the trigger sub-operating lever pin 125 and the ejection trunnion 164. The trigger sub-operating lever 122 affects the ejection trunnion 164 through the trigger sub-operating lever slot 170. In this way, since the ejection trunnion 164 is linked to the ejection tube 77, a first (small) movement of the trigger 32 can have a second (larger) movement on the ejection trunnion 164. In this way, the comb 66 can be retracted by the rib 82 to release the fastener 22 (such as Figure 2 shown).

[0128] Reference Fig. 6A , the fastener applicator 10 has a locking mechanism 140a, which can move between a locked position and an unlocked position relative to the trigger 32. According to one example of the present invention, there is shown Fig. 6A The locking mechanism 140a is operatively arranged to lock the trigger 32 in the intermediate position ( Figure 7B The locking mechanism 140a is also operatively arranged to move from the locked position to the unlocked position ( Figure 7C ) allows the trigger 32 to move from the intermediate position to the initial position or the actuated position. The locking mechanism 140a is also operatively arranged to lock the trigger 32 in the initial position when the trigger release button 96 moves from the first position to the second position before the trigger 32 moves from the initial position.

[0129] Continue to refer to Fig. 6A, the locking mechanism 140a includes a trigger release button 96, a trigger stop 40, and a ratchet mechanism 46. As described herein, movement of the trigger 32 from the initial position to the post-actuation position engages the trigger 32 with the trigger stop 40 and moves the trigger stop 40 to automatically lock the trigger 32 in the intermediate position. In order to release the trigger 32 from the intermediate position, movement of the trigger release button 96 about the trigger release button pivot pin 100 from the first position to the second position when the trigger 32 is in the intermediate position allows the trigger stop 40 to disengage from the trigger 32. In this way, the trigger 32 can be retracted to the initial position due to the restoring force of the trigger spring 38, or moved to the post-actuation position to close the fastener 22 (such as Figure 2 shown).

[0130] The trigger release button 96 extends through an opening 98 ( Figure 5 ). In various examples, the trigger release button 96 is positioned relative to the first end 92 and the second end 94 of the trigger 32 so that the trigger release button 96 can be operated with a user's index finger in contact with a pressing surface 97 of the trigger release button 96. The trigger release button 96 is movable between a first position in which the trigger release button 96 protrudes from the opening 98 and a second position in which at least a portion of the trigger release button 96 moves into the opening 98 on the trigger. In some examples, the trigger release button 96 can protrude from the opening 98 in the first position and the second position.

[0131] The trigger release button 96 can be pivotally moved about the first trigger release button pivot pin 100 relative to the trigger 32 between a first position and a second position. In other examples, the trigger release button 96 can be linearly moved relative to the trigger 32, such as by moving in the proximal / distal direction of the fastener applicator 10 or in a lateral direction relative to the trigger 32. A trigger release button slot 104 in the trigger release button 96 receives the second trigger release button pin 106 and can define a range of motion of the trigger release button 96. When the trigger release button 96 is in the first position, the second trigger release button pin 106 can contact or be positioned to be nearly in contact with a first end of the trigger release button slot 104. Similarly, when the trigger release button 96 is in the second position, the second trigger release button pin 106 can contact or be positioned to be nearly in contact with a second end (opposite to the first end) of the trigger release button slot 104.

[0132] The trigger release button 96 is biased to the first position by a release button biasing member such as a trigger release button spring 102. The trigger release button spring 102 may be compressed as the trigger release button 96 moves from the first position to the second position, so that a restoring force is generated in the trigger release button spring 102, which restores the trigger release button 96 to the first position when the pushing force on the trigger release button 96 is removed and the trigger release button 96 is disconnected from the trigger stop 40.

[0133] Continue to refer to Fig. 6A , the trigger release button 96 has a stop member 150 located at the second free end 95 of the trigger release button 96 and configured to engage at least a portion of the trigger stop 40 so as to prevent the trigger 32 from moving from the initial position if the trigger release button 96 is pressed before the trigger 32 moves to the intermediate position. In this way, the trigger 32 can only move from the initial position if the trigger release button 96 is not pressed. In some examples, the stop member 150 can be configured as a rounded top end at the second end of the trigger release button 96.

[0134] Continue to refer to Fig. 6A , the trigger release button 96 has a trigger stopper release member 152 located between the first trigger release button pivot pin 100 and the stop member 150. The trigger stopper release member 152 is configured to engage at least a portion of the trigger stopper 40 when the trigger 32 is in an intermediate position between the initial position and the actuated position. Pressing the trigger release button 96 when the trigger 32 is in the intermediate position engages the trigger stopper release member 152 with the trigger stopper 40 to unlock the trigger stopper 40 and allow the trigger 32 to move from the intermediate position to the actuated position or the initial position. In some examples, the trigger stopper release member 152 can be formed as a circular protrusion at the proximal portion of the trigger release button 96 between the first trigger release button pivot pin 100 and the stop member 150.

[0135] A non-limiting example embodiment of the trigger release button 96a is Fig.11 . An embodiment of the trigger release button 96a includes a pressing surface 97a, a trigger release button slot 104a, and a stop member 150a. Fig.11 In the illustrated embodiment of the trigger release button 96a, the pressing surface 97a includes a raised cross pattern 197, which provides a unique surface for the user to locate the trigger release button and provide the user with a greater grip, thereby making the fastener applicator easier to use. This non-limiting example embodiment of the trigger release button 96a can be used in embodiments of the fastener applicators of the present invention, including Fig. 6A, Figure 6B and Figure 7A-7E An embodiment of a fastener applicator is shown.

[0136] Continue to refer to Fig. 6A The trigger stop 40 is connected to the handle 34 and can be in a first position ( Fig. 7A ) and the second position ( Fig. 7E ) between the trigger stopper 40 and the trigger stopper 40. The trigger stopper 40 is biased by a trigger stopper biasing member (such as a damping spring 50 ( Figure 3 )) is biased to the first position. In some examples, the trigger stop 40 can be pivotally moved about the trigger stop pin 142 relative to the handle 34 between the first position and the second position. The trigger stop 40 has a first end 144 that can pivot about the trigger stop pin 142 and a second free end 146 opposite the first end 144.

[0137] When the trigger stop 40 is in the first position, at least a portion of the trigger stop 40 can be recessed within the housing 36 of the handle 34. For example, the first end 144 and the second end 146 of the trigger stop 40 can be recessed within the housing 36 of the handle 40 when the trigger stop 40 is in the first position. In some examples, when the trigger stop 40 pivots from the first position to the second position, at least a portion of the trigger stop 40 can extend from the housing 36 of the handle 34. For example, when the trigger stop 40 pivots from the first position to the second position, the first end 144 of the trigger stop 40 can be recessed into the interior of the housing 36 of the handle 34 while at least a portion of the second end 146 of the trigger stop 40 protrudes from the interior of the housing 36.

[0138] Continue to refer to Fig. 6A The trigger stop 40 has a damping cam 148 that is configured to interact with the damping mechanism 48 when the trigger 32 moves from the intermediate position to the actuated position. The damping cam 148 is positioned at the first end 144 of the trigger stop 40 and is configured to change the damping spring 50 (e.g., during the travel of the trigger 32 between the intermediate position and the actuated position) Figure 3 As shown in FIG. 1 and FIG. 2 , the damping plunger 52 is displaced by the damping spring 50. When the damping plunger 52 is compressed against the restoring force of the damping spring 50, the damping plunger 52 engages with the damper 54 (as shown in FIG. 1 ). Fig. 7EIn some examples, the damping cam 148 and damping mechanism 48 on the trigger stop 40 can be configured to require a persistent resistance on the trigger 32 during the movement of the trigger 32 from the intermediate position to the final position, regardless of the position of the trigger 32 during its travel between the intermediate position and the final position. In this way, the user does not need to change the force input on the trigger 32 during actuation of the fastener applicator 10, which may inadvertently change the jaw assembly 16 (such as Figure 1 shown) relative to the organizational structure.

[0139] Continue to refer to Fig. 6A , the second end 146 of the trigger stop 40 has a first stop member engagement surface 154 that is configured to engage the stop member 150 of the trigger release button 96 if the trigger release button 96 is pressed while the trigger 32 is in the initial position. The contact between the first stop member engagement surface 154 of the trigger stop 40 and the stop member 150 of the trigger release button 96 prevents the movement of the trigger 32 from the initial position to the actuated position when the trigger release button 96 is pressed before the trigger 32 moves to the intermediate position. In this way, the trigger 32 is locked in the initial position until the trigger release button 96 is released, thereby disengaging the first stop member engagement surface 154 of the trigger stop 40 from the stop member 150 of the trigger release button 96. In some examples, the first stop member engagement surface 154 of the trigger stop 40 can be configured as a recess at the end portion of the second end 146 of the trigger stop 40.

[0140] Movement of the trigger 32 to the intermediate position locks the trigger 32 relative to the handle 34 as the trigger latch 156 on the trigger stop 40 engages the trigger detent 158 ​​on the trigger 32. In some examples, the trigger latch 156 on the trigger stop 40 is configured as at least one protrusion extending laterally from at least one side of the trigger stop 40. In some examples, the trigger latch 156 is a pair of protrusions extending laterally from opposing sides of the trigger stop 40. The trigger detent 158 ​​on the trigger 32 can be configured as a recess on the proximal side 108 of the trigger 32 that is shaped to receive at least a portion of the trigger latch 156.

[0141] The trigger latch 156 and the trigger catch 158 engage when the trigger 32 moves to the intermediate position and prevents the trigger 32 from moving to the initial position or the actuated position. The trigger latch 156 and the trigger catch 158 are disengaged by pressing the trigger release button 96, so that at least a portion of the trigger release button 96 contacts at least a portion of the trigger stop 40 to move the trigger stop 40 and displace the trigger latch 156 so that it is not in contact with the trigger catch 158 on the trigger 32. In some examples, the stop member 150 of the trigger release button 96 engages with a release surface 160 on the trigger stop 40 to move the trigger stop 40 and displace the trigger latch 156 so that it is not in contact with the trigger catch 158 on the trigger 32. The release surface 160 may be located at the second end 146 of the trigger stop 40 and proximal to the stop member 150.

[0142] Continue to refer to Fig. 6A , the trigger stop 40 has a trigger actuation surface 162 located proximal to the second stop member engagement surface 155 and the release surface 160. When the trigger 32 is moved from the intermediate position to the actuated post position while the trigger release button 96 is pressed, the trigger actuation surface 162 of the trigger stop 40 is configured to engage the trigger stop release member 152 of the trigger release button 96. Pressing the trigger release button 96 when the trigger 32 moves from the intermediate position to the actuated post position causes the trigger stop release member 152 to engage with the trigger actuation surface 162 of the trigger stop 40 to unlock the trigger stop 40 and allow the trigger 32 to move to the actuated post position. In some examples, the trigger actuation surface 162 can be shaped as a ramp that engages with the trigger stop release member 152 of the trigger release button 96. In an example where the trigger actuation surface 162 is shaped as a groove, the trigger actuation surface 162 provides a gap for the trigger stop release member 152 to move along the trigger actuation surface 162.

[0143] exist Fig. 12A and Fig. 12B A non-limiting example embodiment of a trigger stop 40a is shown in FIG. The embodiment of the trigger stop 40a includes a first end 144a, a second end 146a, a damping cam 148a, a first stop member engagement surface 154a, a trigger latch 156a, a release surface 160a, and a trigger actuation surface 162a. This non-limiting example embodiment of the trigger stop 40a can be used in embodiments of the fastener applicator of the present invention, including Fig. 6A , Figure 6B and Figure 7A-7E An embodiment of a fastener applicator is shown in .

[0144] Continue to refer to Fig. 6A , the locking mechanism 140a also includes a ratchet mechanism 46 that engages when the trigger 32 moves from the intermediate position to the actuated position. The ratchet mechanism 46 is configured to prevent the trigger 32 from moving to the initial position after the trigger 32 has moved from the intermediate position to the actuated position. In some examples, the ratchet mechanism 46 is actuated when the trigger 32 moves a predetermined distance from the intermediate position to the actuated position. In other examples, the ratchet mechanism 46 is actuated when the trigger actuation surface 162 of the trigger stop 40 engages with the trigger stop release member 152 of the trigger release button 96 as the trigger 32 moves from the intermediate position to the actuated position while pressing the trigger release button 96. In other examples, the ratchet mechanism 46 is configured to automatically disengage when the trigger 32 reaches the actuated position to allow the trigger 32 to move backward to the initial position.

[0145] The ratchet mechanism 46 includes a ratchet lever 120 that is selectively engageable with a ratchet handle 128 when the trigger 32 moves from the intermediate position to the actuated position. Fig. 7A ) to the actuated position ( Fig. 7E ) pivots, the ratchet lever 120 can move axially in the distal to proximal direction. The ratchet lever 120 is connected to the coupling 131 (such as Figure 5 The ratchet lever 120 can pivot relative to the trigger 32 about the pin 168 (as shown). Figure 5 The ratchet handle 128 may be in the initial position ( Fig. 7A ) and the joint position ( Figure 7D-Figure 7E ). In some examples, the ratchet handle 128 can pivot about the ratchet pivot pin 132. The ratchet handle 128 can be biased in a direction toward the initial position by a ratchet handle biasing mechanism such as a ratchet handle spring 134. Fig. 7A ) to the actuated position ( Fig. 7E ) movement causes axial movement of the pull rod 78 in a proximal direction of the longitudinal axis 118 of the shaft 14 and axial movement of the ratchet rod 120 in a proximal direction.

[0146] Continue to refer to Fig. 6A The proximal end of the ratchet bar 120 has one or more teeth 130 that interact with the ratchet handle 128. The movement of the ratchet bar 120 in the proximal direction caused by the movement of the trigger 32 from the intermediate position to the actuated position causes the proximal end of the ratchet bar 120 to engage with the ratchet handle 128. The initial contact between the proximal end of the ratchet bar 120 and the ratchet handle 128 causes the ratchet handle 128 to shift from the disengaged position to the engaged position by causing the ratchet handle 128 to pivot against the ratchet handle spring 134.

[0147] When the trigger 32 moves from the intermediate position to the actuated position, one or more teeth 130 of the ratchet bar 120 engage with the locking tip 136 of the ratchet handle 128 to prevent the trigger 32 from moving from the intermediate position to the initial position. The ratchet bar 120 may include any number of teeth so that the ratchet bar 120 may be driven more completely (e.g., from the ratchet handle 128) in the direction for closing the trigger 32. Fig. 7A Configuration to Fig. 7E configuration) to gradually close the trigger 32 (i.e., bring it closer to the handle 32).

[0148] In some examples, the ratchet handle 128 can engage the ratchet bar 120 before the trigger 32 reaches the post-actuated position to prevent the trigger from moving back toward the initial position from the post-actuated position. For example, the proximal end of the ratchet bar 120 can contact the ratchet handle engagement surface 138 at the proximal end of the ratchet handle 128. The ratchet handle engagement surface 138 can be angled so that the proximal movement of the ratchet bar 120 pivots the ratchet handle 128. In some examples, the ratchet handle 128 can be locked due to the engagement of one or more locking tabs 139 on the ratchet handle 128 with at least a portion of the housing 36. In some examples, the one or more locking tabs 139 can be laterally deflected between a first position (wherein the ratchet handle 128 can freely pivot about the ratchet pivot pin 132) and a second position (wherein the ratchet handle 128 is locked relative to the housing 36). The one or more locking tabs 139 may strike the housing 36, thereby causing a loud click to audibly alert the user that the trigger 32 has reached the post-actuation position and the jaws 18, 20 have been closed. This audible confirmation indicates to the user that the fastener 22 has been closed and the trigger 32 may be released. Once the one or more locking tabs 139 of the ratchet handle 128 engage the housing 36, the ratchet handle 128 is locked in a disengaged state relative to the ratchet bar 120.

[0149] A non-limiting example embodiment of the ratchet handle 128a is Fig.13A and Fig. 13B , and the ratchet handle 128a includes a locking tip 136a and two locking tabs 139a. This non-limiting example embodiment of the ratchet handle 128a can be used in embodiments of the fastener applicator of the present invention, including Fig. 6A , Figure 6B and Figure 7A-7E An embodiment of a fastener applicator is shown.

[0150] Reference Figure 6B , shows a fastener applicator 10 having a locking mechanism 140b according to another example of the present invention. Figure 6B The components of the locking mechanism 140b shown are similar to those of the present invention. Fig. 6A The components of the locking mechanism 140a are substantially similar. Fig. 6A The discussion of the locking mechanism 140a generally shown in FIG. 1 may be applied to Figure 6B The latching mechanism 140b is shown in FIG. 1 , and therefore only the relative differences between the two latching mechanisms are discussed below.

[0151] Continue to refer to Figure 6B The trigger release button 96 has a stop member 150 positioned at the second free end 95 of the trigger release button 96 and configured to engage at least a portion of the trigger stop 40 only when the trigger 32 moves to the intermediate position. Fig. 6A The trigger release button 96 and the trigger stop 40 shown in FIG. Figure 6B The trigger release button 96 and the trigger stop 40 are configured to allow the trigger 32 to move from the initial position even if the trigger release button 96 is pressed before the trigger 32 moves from the initial position. In other words, if the trigger release button 96 is pressed and held, the trigger 32 can pass through the intermediate position without stopping and eventually reach the actuated position.

[0152] Continue to refer to Figure 6B , the trigger stop release member 152 of the trigger release button 96 is configured to engage at least a portion of the trigger stop 40 when the trigger 32 is positioned in an intermediate position between the initial position and the actuated position. Pressing the trigger release button 96 when the trigger 32 is in the intermediate position causes the trigger stop release member 152 to engage with the trigger stop 40 to unlock the trigger stop 40 and allow the trigger 32 to move from the intermediate position to the actuated position. In some examples, pressing the trigger release button 96 when the trigger 32 is in the initial position causes the trigger stop release member 152 to engage with the trigger stop 40 to unlock the trigger stop 40 and allow the trigger 32 to move from the initial position to the actuated position, thereby bypassing the locking of the trigger 32 in the intermediate position.

[0153] Continue to refer to Figure 6B , the first stop member engagement surface 154 of the trigger stop 40 is configured as a substantially flat portion at the distal end portion of the second end 146 of the trigger stop 40. Similarly, the second stop member engagement surface 155 can be substantially flat, with Fig. 6A The recessed configuration shown is relative. Pressing the trigger release button 96 before moving the trigger 32 from the intermediate position to the actuated position causes the trigger stop release member 152 to engage with the second stop member engagement surface 155 and the trigger actuation surface 162 of the trigger stop 40 to unlock the trigger stop 40 and allow the trigger 32 to move to the actuated position.

[0154] Having described the structure of fastener applicator 10, reference will now be made to Figures 7A-8D and Figure 10A-10C A method of using fastener applicator 10 to close fastener 22 on a tissue structure is described below. Fig. 7A , fastener applicator 10 is shown in an initial or factory configuration, with trigger 32 in an initial position and jaws 18, 20 (eg, Fig. 8A 22 is in an open configuration to receive the fastener 22 therebetween. After the fastener 22 is advanced over a tissue structure such as the LAA, the trigger 32 is manually actuated to engage the LAA. Figure 7B The trigger 32 can be moved from the initial position ( ) to the handle 34 in the direction of arrow A to close the jaws 18, 20. By directing a proximal force in the direction of arrow A on the distal side 110 of the trigger 32, the trigger 32 can be moved from the initial position ( Fig. 7A ) moves toward the handle 34.

[0155] The trigger 32 is closed relative to the handle 34, i.e., pivoted about the trigger pivot pin 44 from the initial position of the trigger 32 (e.g., Fig. 10A or Fig. 7A ), the pull rod 78 is pulled proximally toward the proximal end of the shaft 14 relative to the clamp tube 76, which in turn closes the jaws 18, 20 ( Figure 8B As long as the trigger 32 is not advanced past the intermediate position, the trigger 32 can be moved in a proximal direction to close the jaws 18, 20 during positioning of the fastener 22 relative to the tissue structure, or moved distally to open the jaws 18, 20. This allows the user to carefully position the fastener 22 relative to the tissue structure without closing the fastener 22.

[0156] Reference Figure 7B , the trigger 32 is shown in an intermediate position, wherein the trigger 32 is temporarily locked relative to the handle 34 due to the engagement of the trigger latch 156 on the trigger stop 40 with the trigger catch 158 on the trigger 32. When the trigger 32 is moved to the intermediate position and locked therein, further movement of the trigger 32 to the initial position or the post-actuation position is prevented without further input from the user via the trigger release button 96. With the trigger 32 locked in the intermediate position, the jaws 18, 20 are closed in a "rehearsal" position, wherein the legs 26 of the fastener 22 are directed toward each other to engage the tissue penetrating fastener 30 ( Fig. 8A ) to capture the tissue structure therebetween. This allows the user to preview the positioning of the fastener 22 relative to the tissue structure without closing the fastener 22.

[0157] If it is necessary to reposition the fastener 22 relative to the tissue structure, the trigger release button 96 can be pressed to disengage the trigger latch 156 from the trigger lock 158 ( Figure 7C ), thereby unlocking the trigger 32. By pressing the trigger release button 96, at least a portion of the trigger release button 96 (such as the stop member 150 of the trigger release button 96) contacts at least a portion of the trigger stop 40 (such as the release surface 160 on the trigger stop 40) to move the trigger stop 40 and displace the trigger latch 156 so that it does not contact the trigger latch 158 on the trigger 32. Then, due to the restoring force of the trigger spring 42 (such as Figure 3 34 ), the trigger 32 may be moved distally relative to the handle 34. Movement of the trigger 32 toward the initial position and away from the handle 34 opens the jaws 18, 20 to allow the fastener 22 to be repositioned.

[0158] Now refer to Fig.7D , if the fastener applicator 10 is oriented so that the fastener 22 is disposed at the desired position relative to the tissue structure, the trigger 32 is unlocked from the intermediate position by pressing the trigger release button 96 to disengage the trigger latch 156 from the trigger catch 158. The trigger 32 can then be advanced proximally toward the handle 34 by moving the trigger 32 in the direction of arrow A. The trigger 32 is closed relative to the handle 34 so that the trigger stop 40 moves from the first position ( Figure 7C ) moves to the second position ( Fig. 7E ) to allow the trigger 32 to move further proximally toward the actuated position.

[0159] Closing the trigger 32 relative to the handle 34 also retracts the ratchet rod 120 linked to the trigger 32 proximally. Fig. 10C , with the trigger 32 in the actuated position, the trunnion 116 moves to the proximal end of the trigger slot 114 so that the center of the trunnion 116, and therefore the opening 123, is spaced proximally from the center of the trigger pivot pin 44 by a second predetermined distance X2 greater than Fig. 10A The trigger sub-operating rod 122 is oriented so that its tip contacts the ratchet rod 120 and advances the ratchet rod 120 in the proximal direction. The proximal movement of the ratchet rod 120 caused by the movement of the trigger 32 through the intermediate position causes the teeth 130 of the ratchet rod 120 to engage with the locking tip 136 of the locking handle 128, thereby activating the ratchet mechanism 46. Once the ratchet mechanism 46 is engaged, the trigger 32 is prevented from moving toward the initial position ( Fig. 7A ) direction. In this way, the user is committed to closing the fastener 22 on the tissue structure by fully engaging the trigger 32 to the actuated position.

[0160] Closing of the trigger 32 from the neutral position to the actuated position further pulls the pull rod 78 proximally relative to the clamp tube 76 toward the proximal end of the shaft 14. The ejection tube 77 pulls on at least one rib 82 to retract the comb stud 66. When the jaws 18, 20 are closed, the stud comb 66 engages the tissue-penetrating fastener 30 so that they engage and lock with each other, thereby closing the two legs 26 of the fastener 22, as shown in FIG. Figure 8C shown.

[0161] When the trigger 32 advances from the intermediate position to the actuated position, the trigger stop 40 is actuated by the trigger 32 from the first position ( Fig. 7A ) to the second position ( Fig. 7E ) deflects. When the trigger stopper 40 moves from the first position to the second position, the damping cam 148 of the trigger stopper 40 contacts the damping plunger 52 of the damping mechanism 48, thereby compressing the damping spring 50 (eg, Figure 3 When the damping plunger 52 is compressed against the restoring force of the damping spring 50, the damping plunger 52 engages the damper 54 (as shown in FIG. Fig. 7E ), which provides resistance to the compressive force directed toward the trigger 32 in the direction of arrow A. As described herein, the damping cam 148 and the damping mechanism 48 on the trigger stop 40 are configured so that during the movement of the trigger 32 from the intermediate position to the final position, the user feels a substantially constant reaction force from the trigger 32, regardless of the position of the trigger 32 during its travel between the intermediate position and the post-actuation position. For example, while moving the trigger 32 toward the handle 34 in the direction of arrow A, the user may feel a substantially constant reaction force from the trigger 32, thereby requiring a substantially constant compressive force during the movement of the trigger 32 from the intermediate position to the post-actuation position.

[0162] Now refer to Fig. 7E , the trigger 32 is moved to the post-actuation position to release the trigger 32 from the ratchet mechanism 46 and allow the trigger 32 to retract toward the initial position. As described herein, the proximal end of the ratchet bar 120 contacts the ratchet handle disengagement surface 138 at the proximal end of the ratchet handle 128, which lifts the ratchet handle 128 from the ratchet bar 120 and prevents reengagement with the ratchet bar 120 due to the interaction of one or more locking tabs 139 on the ratchet handle 128 with at least a portion of the housing 36. The jaws 18, 20 can be opened by releasing manual pressure on the trigger 32, thereby allowing the trigger spring 38 and the main spring 42 (which are compressed during the closing of the trigger 32) to push the ratchet bar 120 distally and forward, opening the jaws 18, 20 and leaving the fastener 22 in place ( Fig.8D ).

[0163] Now refer to Fig. 9, showing a specific example of use. In this example, the fastener applicator 10 is used to deliver a fastener 22 to the base of the left atrial appendage LAA during an open-chest beating heart procedure. The sternum S is opened and the ribs R are spread apart to provide a working space above the heart H. After the pericardium is opened, the heart H can be lifted and rotated, for example using a piece of gauze or other material placed behind the heart, to expose the left atrial appendage LAA within the opening, such as Fig. 9 As shown. After the left atrial appendage LAA is exposed, the jaws 18, 20 of the fastener applicator 10a are placed around the base of the left atrial appendage LAA by manipulating the shaft 12. Once the jaws 18, 20 correctly position the fastener 22 around the base of the left atrial appendage LAA, the jaws 18, 20 are actuated and the fastener 22 is deployed as described above.

[0164] Although the present invention has been described in detail based on what are currently considered to be the most practical and preferred examples for the purpose of illustration, it should be understood that such details are only for this purpose and that the present invention is not limited to the disclosed examples, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present invention contemplates that one or more features of any example may be combined with one or more features of any other example to the extent possible.

Claims

1. A surgical applicator for a fastener, the surgical applicator comprising: handle; a trigger movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; as well as A locking mechanism movable between a locked position and an unlocked position relative to the trigger, the locking mechanism being operatively arranged to: locking the trigger at the intermediate position when the trigger moves from the initial position to the actuated position; as well as When the locking mechanism moves from the locked position to the unlocked position, the trigger is allowed to move from the intermediate position to the initial position or the actuated position, wherein the locking mechanism comprises a release button connected to the trigger, the release button being movable between a first position and a second position relative to the trigger, and wherein the first end and the second free end of the release button relative to the trigger are positioned such that the release button can be operated using a user's index finger in contact with a pressing surface of the release button, and When the lockout mechanism is operatively arranged to lock the trigger in the intermediate position, the trigger is prevented from moving in a forward direction and a rearward direction when pressure is applied to the trigger.

2. The surgical applicator of claim 1, wherein: The lockout mechanism is further operatively arranged to allow the trigger to move from the initial position to the post-actuated position when the lockout mechanism moves from the locked position to the unlocked position before the trigger moves from the initial position.

3. The surgical applicator of claim 1, wherein: The trigger is movable relative to the handle from the initial position by exerting a compressive force on the trigger in a direction toward the handle.

4. The surgical applicator of claim 1, wherein: The trigger has a distal side opposite a proximal side facing the handle, and wherein at least a portion of the lockout mechanism is located on the distal side of the trigger.

5. The surgical applicator of claim 1, wherein: The locking mechanism also includes: A trigger stop is pivotally connected to the handle, the trigger stop being movable relative to the handle between a first position and a second position.

6. The surgical applicator of claim 1, wherein: The release button is pivotally movable relative to the trigger.

7. The surgical applicator of claim 1, wherein: The release button is linearly movable in a direction transverse to the trigger.

8. The surgical applicator of claim 1, wherein: The release button is biased to the first position by a release button biasing member.

9. The surgical applicator of claim 4, wherein: The trigger stop is biased to the first position by a trigger stop biasing member.

10. The surgical applicator of claim 4, wherein: Movement of the trigger from the initial position to the actuated position engages the trigger with the trigger stop to automatically lock the trigger in the intermediate position.

11. The surgical applicator of claim 4, wherein: Movement of the release button from the first position to the second position when the trigger is in the intermediate position allows the trigger to disengage from the trigger stop.

12. The surgical applicator of claim 1 further comprising a ratchet mechanism that engages the trigger when the trigger moves from the intermediate position to the actuated position to prevent the trigger from moving to the initial position.

13. The surgical applicator of claim 12, wherein: The ratchet mechanism disengages from the trigger when the trigger moves to the actuated position.

14. The surgical applicator of claim 12, wherein: The ratchet mechanism includes a ratchet lever and a ratchet wheel that engages with the ratchet lever when the trigger moves from the intermediate position to the actuated position.

15. The surgical applicator of claim 12, wherein: The ratchet mechanism is actuated when the trigger moves a predetermined distance from the intermediate position to the actuated position.

16. The surgical applicator of claim 1, further comprising a jaw assembly selectively movable between an open position and a closed position by movement of the trigger from the initial position to the actuated position.

17. The surgical applicator of claim 16, wherein: The jaw assembly includes a pair of jaws movably attached to each other, each jaw having a pair of sides with a plurality of side slots extending through each side.

18. The surgical applicator of claim 17, wherein: An outer surface of at least one of the sides of each jaw has a recess.

19. The surgical applicator of claim 18, wherein: The recess receives a cover element that surrounds at least a portion of the plurality of side grooves.

20. The surgical applicator of claim 19, wherein: The cover element is adhesively fastened in the recess.

21. The surgical applicator of claim 17, wherein: The jaws are pivotally attached to each other by a pin.

22. The surgical applicator of claim 1, further comprising a damping mechanism operatively disposed with the trigger to dampen changes in compressive force applied to the trigger during movement between the initial position and the actuated position.

23. The surgical applicator of claim 22, wherein: The damping mechanism includes a spring and a damper.

24. A surgical applicator for a fastener, the surgical applicator comprising: handle; a trigger movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; as well as a lockout mechanism comprising a release button connected to the trigger and a trigger stop connected to the handle, wherein the release button is movable between a first position and a second position relative to the trigger, and wherein the release button is positioned relative to a first end and a second free end of the trigger so that the release button can be operated with a user's index finger in contact with a pressing surface of the release button, and wherein movement of the trigger from the initial position to the actuated position causes the trigger stop to engage the trigger to lock the trigger at the intermediate position such that the trigger is prevented from moving in a forward direction and a rearward direction when pressure is applied to the trigger; and Wherein movement of the release button relative to the trigger when the trigger is in the intermediate position disengages the trigger from the trigger stopper to allow the trigger to move from the intermediate position to the initial position or the actuated position.

25. The surgical applicator of claim 24, further comprising a ratchet mechanism that engages the trigger when the trigger moves from the intermediate position to the actuated position to prevent the trigger from moving to the initial position.

26. The surgical applicator of claim 25, wherein: The ratchet mechanism disengages from the trigger when the trigger moves to the actuated position.

27. A surgical applicator for a fastener, the surgical applicator comprising: handle; a trigger movable relative to the handle between an initial position, an actuated position, and an intermediate position between the initial position and the actuated position; an elongated body extending distally from the handle, the elongated body having a distal portion; a jaw assembly at the distal portion of the elongated body, the jaw assembly selectively movable between an open position, a closed position, and an intermediate position between the open position and the closed position by movement of the trigger; as well as A locking mechanism operatively arranged to: locking the trigger and the jaw assembly in the intermediate position when the trigger moves from the initial position to the actuated position so that the trigger is prevented from moving in a forward direction and a rearward direction when pressure is applied to the trigger; as well as allowing the trigger to move from the intermediate position to the initial position or the actuated position to move the jaw assembly from the intermediate position to the open position or the closed position, respectively; wherein the locking mechanism comprises a release button connected to the trigger, the release button being movable between a first position and a second position relative to the trigger, and wherein the release button is positioned relative to the first end and the second free end of the trigger so that the release button can be operated by a user's index finger in contact with a pressing surface of the release button.

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