Suture passer device and method

Abstract

Suture passer devices and methods of using the same have one or more protective interlocks that prevent or limit operation of the suture passer when deployment of the needle could damage the device or injure the patient. For example, described herein are suture passer devices that include an interlock that prevents deployment of a tissue penetrator (needle) when the jaws are not clamped to the tissue. Also described herein are interlocks that prevent axial retraction of the jaws until the needle is retracted.

Description

[0001] Inventors:

[0002] Michael Murillo

[0003] Stephen J. Peter Suture Passer Device and Method

[0004] CROSS-REFERENCE TO RELATED APPLICATIONS

[0005] This application is a non-provisional application of U.S. Provisional Application No. 62 / 663,471, filed on April 27, 2018, entitled “Suture Passer Devices and Methods,” the entire disclosure of which is incorporated herein by reference.

[0006] Incorporated by Reference

[0007] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0008] The present application relates to methods, devices and systems for suturing tissue, particularly in difficult to access areas. Background Art

[0009] Tissue suturing during surgical procedures is time consuming and can be particularly challenging in difficult to access areas of the body and areas with limited clearance, such as areas partially surrounded or covered by bone. For many surgical procedures, it is necessary to create a large opening in the human body to expose the area requiring surgical repair. However, in many cases, accessing tissue in this manner is undesirable, increases recovery time, and exposes the patient to a greater risk of infection.

[0010] Suturing instruments ("suture passers" or "suture devices") have been developed to aid in accessing and treating internal body areas and generally aid physicians in repairing tissue. Although many such devices are available for endoscopic and / or percutaneous use, these devices suffer from various problems, including limited ability to navigate and operate within the confines of the body, risk of injury to adjacent structures, problems controlling the position and / or condition of tissue before, during, and after passing a suture, and problems with reliable function of the suture passer.

[0011] For example, some surgical instruments used in endoscopic procedures are limited by the way they approach the area of ​​the human body that needs repair. Specifically, the instruments may not be able to access tissue or organs that are located deep in the body or are obstructed in some way. In addition, many instruments are limited by the way they grasp tissue, apply sutures, or recapture needles and sutures. In addition, many instruments are complicated and expensive to use due to the numerous parts and / or subassemblies required to make them work properly. Suturing remains a delicate and time-consuming aspect of most surgical procedures, including those performed under endoscopy.

[0012] There is a need for new methods and devices for suturing tissue, particularly tissue in difficult-to-access areas of the body, including joints (shoulders, knees, etc.). The methods and devices described herein address this need. Summary of the invention

[0013] The present invention relates to suture passer devices and methods of using the devices.

[0014] On the one hand, the present disclosure describes a suture passer device in which the passage of a suture is prevented without clamping a first jaw member and a second jaw member. This has the advantage of avoiding needle failure due to the lack of a suture trap for the suture. The device includes: an elongated body having a proximal region and a distal region; a first jaw member extending from the distal region of the elongated body and configured to move angularly relative to the elongated body; a second jaw member configured to form an opening with the first jaw member when the second jaw member extends axially; a clamping trigger configured to actuate the clamping of the first jaw member and the second jaw member; a tissue penetrator trigger configured to extend a tissue penetrator between the first jaw member and the second jaw member when actuated; and a lock between the clamping trigger and the tissue penetrator trigger, which is configured to interact with the clamping trigger and the tissue penetrator trigger to prevent the tissue penetrator from extending until the first jaw member is closed relative to the second jaw member by a predetermined amount.

[0015] In another aspect, the present disclosure discloses a method for passing a suture. The method includes at least partially closing a first jaw member of a suture passer, wherein the first jaw member extends from a distal region of an elongated body and is configured to angularly move relative to the elongated body; wherein a second jaw is configured to form an opening with the first jaw member; and when the first jaw member and the second jaw member are at least partially clamped, passing a tissue penetrator between the first jaw member and the second jaw member, thereby preventing the tissue penetrator from extending when the jaws are not clamped.

[0016] In another aspect, the present disclosure includes a suture passer device, wherein the device uses a thumb trigger to extend the second jaw member. The device includes: an elongated body having a proximal region and a distal region; a first jaw member extending from the distal region of the elongated body and configured to angularly move relative to the elongated body; a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially; a clamping trigger configured to actuate the clamping of the first jaw member and the second jaw member; a tissue penetrator trigger configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated; and a thumb trigger configured to extend or retract the second jaw member, wherein the thumb trigger has a first surface and a second surface. The suture passer device also includes a handle, a housing, a sleeve member, a slide member and a pawl member; and wherein a first surface of the thumb trigger is connected to an outer surface of the sleeve member, wherein an inner surface of the sleeve member is connected to the slide member, and wherein both the sleeve member and the slide member interact with the pawl member to maintain the position of the extended second jaw member.

[0017] On the other hand, the present disclosure provides a method for controlling a suture passer, the suture passer having a first jaw member extending from a distal region of a slender body and configured to move angularly relative to the slender body; a second jaw member configured to form an opening with the first jaw member when the second jaw member extends axially; and a thumb trigger that is actuated to retract or extend the second jaw member, the method comprising: extending the second jaw by pushing the thumb trigger in a first direction; and retracting the second jaw by pushing the thumb trigger in the same direction.

[0018] On the other hand, the present disclosure includes a suture passer device, wherein the device is designed to prevent retraction of the second jaw member when the tissue penetrator is extending or has been extended. The device includes: a slender body having a proximal region and a distal region; a first jaw member extending from the distal region of the slender body; a second jaw member configured to extend axially relative to the slender body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially. The device also includes a tissue penetrator trigger configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated; and a thumb trigger configured to retract or extend the second jaw member when actuated, wherein the second jaw member is prevented from retracting when the tissue penetrator is extended.

[0019] In another aspect, the present disclosure describes a method for preventing damage to tissue when using a suture passer device. The suture passer device has a first jaw member extending from a distal region of an elongated body, a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially. The suture passer device also includes a tissue penetrator trigger configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated; and a thumb trigger configured to retract or extend the second jaw member when actuated, the method comprising: preventing actuation of the thumb trigger that retracts the second jaw member when the tissue penetrator extends.

[0020] On the other hand, the present disclosure discloses a suture threader device, which includes an elongated body having a proximal end and a distal end, the proximal end being coupled to a device handle. A first jaw member is coupled to the distal end and is angularly movable relative to the longitudinal axis of the elongated body. A second jaw member is also coupled to the distal end and can be retracted into and out of the elongated body and forms an opening with the first jaw member. The handle may include a clamping trigger, which is operably coupled to the first jaw member so that actuation of the clamping trigger can move the first jaw member relative to the second jaw member between an open configuration and a clamped configuration. The first jaw member and the second jaw member are relatively closer to each other in the clamped configuration than in the open configuration. The handle may also include a tissue penetrator trigger, which is operably connected to a tissue penetrator disposed at the distal end so that the tissue penetrator selectively extends between the first jaw member and the second jaw member. The handle also includes a lock member disposed between the clamping trigger and the tissue penetrator trigger. The lock member can interact with the clamping trigger and the tissue penetrator trigger to prevent the tissue penetrator from extending until the first jaw member is in the clamped configuration. The second jaw member may extend and retract axially relative to the elongated body. The lock member may have a first surface configured to interact with the clamping trigger and a second surface configured to interact with the tissue penetrator trigger. The first surface and the second surface may be at opposite ends of each other in the lock member. The lock member may interact with the clamping trigger and the tissue penetrator trigger such that when the first jaw member is in an open configuration, the second surface engages with the tissue penetrator trigger to prevent the tissue penetrator from extending. The clamping trigger may include a surface that engages with the first surface of the lock while moving the first jaw member toward the clamping configuration so as to rotate the lock member and disengage the second surface from the tissue penetrator trigger. When in the clamping configuration, the first jaw member and the second jaw member define a predetermined opening, which may be an angular opening between 5 degrees and 85 degrees. The first jaw member includes Fig. 6AThe invention also provides a tissue penetrator receiving area best seen in the jaw member for receiving a tissue penetrator and capturing a suture, and wherein the predetermined opening defines a maximum opening so that a tissue penetrator can reliably extend from the second jaw member and through the tissue penetrator receiving area. If the predetermined opening or angled opening as any wider tissue penetrator can extend away from the receiving area, the transfer of suture from the second jaw member to the first jaw member may fail.

[0021] On the other hand, the present disclosure includes a method for threading a suture, comprising moving a first jaw member of a suture passer from a first open orientation toward a second jaw member, and thereby moving toward a second clamping orientation, wherein the first jaw member and the second jaw member extend from a distal region of an elongated body of the suture passer. A tissue penetrator is then threaded between the first jaw member and the second jaw member when the first jaw member is in a second clamping configuration, thereby preventing the tissue penetrator from extending when the first jaw member is in a first open orientation. The step of moving the first jaw member may include actuating a clamping trigger coupled to the proximal end of the elongated body. The step of threading the tissue penetrator may include actuating a tissue penetrator trigger coupled to the proximal end of the elongated body. The suture passer may also include a lock member disposed between the clamping trigger and the tissue penetrator trigger, and wherein the lock includes a lock arm, which engages with the tissue penetrator trigger when the first jaw is in a first open orientation and thereby inhibits actuation of the tissue penetrator trigger. Moving the first jaw to the second clamping configuration may include engaging a clamping trigger with a first portion of a lock member to move a lock arm and allow actuation of a tissue penetrator trigger. The lock may be pivotally coupled to the suture passer, and the lock arm may extend in a first direction from a center of rotation of the lock member, and the second arm may extend in a different direction toward the first portion of the lock, and wherein the lock may be rotated to disengage the lock arm from the tissue penetrator trigger. Prior to the step of moving the first jaw member, the second jaw may extend axially from within the elongated body of the suture passer.

[0022] On the other hand, the present disclosure includes a suture threader device with an elongated body, the elongated body having a proximal region and a distal region. The first jaw member can be connected to the distal region of the elongated body and is configured to move relative to the elongated body angle. The second jaw member can extend axially relative to the elongated body and form an opening with the first jaw member when the second jaw member extends axially. The suture threader device can also include a thumb trigger, which is operably connected to the second jaw member so that the second jaw member is extended or retracted, wherein the thumb trigger has a first surface and a second surface. The suture threader device can also include a housing having a sleeve member and a carriage member therein. The first surface of the thumb trigger can be communicatively connected to the sleeve member and the carriage member so that activating the thumb trigger can cause the sleeve member, the carriage member and thus the second jaw member to move axially. The housing can also include a pawl member, and the pawl member engages with the opening of the carriage member to keep the second clamp in an extended configuration. The pawl member can be selectively coupled to the carriage member to disengage from the carriage member opening during retraction of the second jaw member. The pawl member can also include a proximal tip or end tip at the end of an arm of the pawl member that interacts with a curved rib and ramp disposed on a top surface of the sleeve, such that actuation of a thumb trigger that extends the second jaw member slides the sleeve to cause the proximal tip to move axially from a first side of the curved rib and ramp to a second side of the curved rib and ramp, and wherein releasing the thumb trigger to the intermediate position maintains the extended position of the second jaw member while the proximal tip remains on the second side of the curved rib and ramp.

[0023] On the other hand, the present disclosure includes a method for controlling a suture passer. The suture passer may have a first jaw member extending from a distal region of an elongated body, and the first jaw may be coupled to the body so as to be angularly movable relative to the elongated body. A second jaw member may be coupled to the elongated body and may form an opening with the first jaw member when the second jaw member extends axially. A thumb trigger of the suture passer may be actuated to retract or extend the second jaw member. The method may include extending the second jaw by pushing the thumb trigger in a first direction along an arc path, and retracting the second jaw by pushing the thumb trigger in a first direction, and then releasing the thumb trigger. Extending the second jaw may include pushing the thumb trigger to slide the sleeve member and the carriage member axially in the distal direction to extend the second jaw member. Retraction may include pushing the thumb trigger to slide the sleeve member axially in the distal direction, and the step of releasing the thumb trigger may release the sleeve member and the carriage member so that they retract in the proximal direction. The sleeve member may be connected to a biasing member disposed along the proximal side, the biasing member being configured to pull the sleeve proximally during the release step. When the second jaw member is extended, the carriage member may engage with the pawl member. During the retracting step, the carriage member may be disengaged from the pawl member.

[0024] On the other hand, the present disclosure includes a method for preventing damage to tissue when using a suture passer device. The suture passer device includes a first jaw member extending from a distal region of an elongated body, configured to extend axially relative to the elongated body. The second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially. The suture passer device also includes a tissue penetrator trigger, which is configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated, and a thumb trigger, which is configured to retract or extend the second jaw member when actuated. The method may include preventing the actuation of the thumb trigger that retracts the second jaw member when the tissue penetrator extends. Preventing may include pushing the thumb trigger to extend the second jaw and pressing the tissue penetrator trigger to extend the tissue penetrator, thereby preventing the thumb trigger from retracting the second jaw member. Preventing may include limiting the actuation of the thumb trigger by engaging the tissue penetrator trigger with a protruding member extending above the first surface of the thumb trigger, thereby preventing the actuation of the thumb trigger that retracts the second jaw member. The tissue penetrator trigger may include an outer surface adjacent the first surface of the thumb trigger that interacts with the protrusion member to inhibit actuation of the thumb trigger to retract the second jaw member.

[0025] On the other hand, the present disclosure includes a suture threader device with an elongated body, the elongated body having a proximal region and a distal region. The first jaw member extends from the distal region, and the second jaw member can extend axially relative to the elongated body. The second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially. The suture threader device can also include a tissue penetrator trigger, which is configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated, and a thumb trigger, which is configured to retract or extend the second jaw member when actuated. When the tissue penetrator extends, the second jaw member is prevented from retracting. The thumb trigger can include a protruding member extending above the first surface of the thumb trigger, and when engaged with the actuated tissue penetrator trigger, the protruding member can be limited to move, and the actuation of the thumb trigger that retracts the second jaw member can be suppressed thereby. The suture threader device can also include a clamping trigger that actuates the clamping of the first jaw member and the second jaw member. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The novel features of the present invention are particularly set forth in the claims that follow. The features and advantages of the present invention may be better understood by referring to the following detailed description and accompanying drawings which illustrate exemplary embodiments in which the principles of the present invention are utilized, wherein:

[0027] Figure 1Ais a cross-sectional view of a suture passer according to an embodiment of the present invention, wherein the first jaw member and the second jaw member are not clamped on tissue.

[0028] Figure 1B is a perspective view of a first jaw member and a second jaw member of a suture passer, wherein the first jaw member and the second jaw member are not clamped on tissue.

[0029] Figure 2 is a perspective view of a clamp trigger of a suture passer according to an embodiment of the present invention.

[0030] Figure 3A and Figure 3B A perspective view of a lock of a suture passer is shown.

[0031] Figure 4 is a perspective view of a tissue penetrator trigger of a suture passer.

[0032] Figure 5A is a perspective view of a first jaw member and a second jaw member of a suture passer with the first jaw member and the second jaw member clamped onto tissue.

[0033] Figure 5B is a cross-sectional view of a suture passer handle according to an embodiment of the present invention, with the first jaw member and the second jaw member clamped onto tissue.

[0034] Fig. 6A is a perspective view of partially closed first and second jaw members of a suture passer with the first and second jaw members clamped on tissue and a suture passed through.

[0035] Figure 6B is a cross-sectional view of a suture passer according to an embodiment of the present invention, with the first jaw member and the second jaw member clamped on tissue and a suture passed through.

[0036] Figure 7 is a perspective view of a suture passer with a thumb trigger in accordance with an embodiment of the present invention.

[0037] Figure 8A-8B The operation of the thumb trigger is shown.

[0038] Fig. 9 is a cross-sectional view of internal functional components when the thumb trigger is used according to at least some embodiments.

[0039] Fig.10 is a perspective view of the pawl member.

[0040] Fig.11A and 11B is a perspective view of the sleeve member.

[0041] Fig.12 Here is a perspective view of the thumb trigger.

[0042] Fig.13 is a perspective view of the carriage member.

[0043] Figure 14A-Figure 14C Shown is how the internal features operate to extend the second jaw when the thumb trigger is pushed forward.

[0044] Figure 15A-15B It shows how the internal features operate to retract the second jaw when the thumb trigger is pushed forward again.

[0045] Fig.16 Cross-sectional views (A, B, C, and D) of the suture passer and operation of preventing the second jaw member from retracting when the tissue penetrator is extended are shown. DETAILED DESCRIPTION

[0046] Suture passer devices and methods of using the device are described herein. The device disclosed herein has improved reliability, for example, by preventing the suture from passing without clamping the jaw member. The novel design also includes the device being equipped with a thumb trigger to extend and retract the second jaw member or the lower jaw member, which has improved control of the suture passer. The device disclosed herein also has the advantage of preventing tissue damage by avoiding retraction of the lower jaw or the second jaw member when the tissue penetrator is extending.

[0047] In one aspect, the present disclosure includes a suture passer device. The device includes: an elongated body having a proximal region and a distal region; a first jaw member extending from the distal region of the elongated body and configured to angularly move relative to the elongated body; a second jaw member configured to form an opening with the first jaw member when the second jaw member extends axially; a clamping trigger configured to actuate clamping of the first jaw member and the second jaw member; a tissue penetrator trigger configured to extend a tissue penetrator between the first jaw member and the second jaw member when actuated; and a lock between the clamping trigger and the tissue penetrator trigger and configured to interact with the clamping trigger and the tissue penetrator trigger to prevent the tissue penetrator from extending until the first jaw member is closed relative to the second jaw member by a predetermined amount.

[0048] In some embodiments of the suture devices described herein, the second jaw member of the suture device is configured to extend axially relative to the elongated body.

[0049] In some embodiments of the suture devices described herein, the lock of the suture device has a first surface configured to interact with the clamp trigger and a second surface configured to interact with the tissue penetrator trigger.

[0050] In some embodiments of the suture devices described herein, when the first and second jaw members are unclamped, the first surface of the lock disengages from the clamp trigger and the second surface engages the tissue penetrator trigger to prevent the tissue penetrator from extending from the second jaw.

[0051] In some embodiments of the suture device described herein, when the clamping of the first jaw member and the second jaw member is actuated, the first surface of the lock engages with the clamping trigger and the second surface of the lock disengages from the tissue penetrator trigger, thereby allowing actuation of the tissue penetrator trigger and extending the tissue penetrator between the first jaw member and the second jaw member.

[0052] In some embodiments of the suturing devices described herein, engagement of the first surface of the lock with the clamp trigger actuates rotation of the lock to disengage the second surface of the lock from the tissue penetrator trigger.

[0053] In some embodiments of the suture device described herein, the first jaw member and the second jaw member are clamped to form an opening with a predetermined amount. The predetermined amount is about 5% or greater. In some cases, the predetermined amount is about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% or 95%. In some cases, the predetermined amount is defined by the angle formed between the opposing surfaces of the first jaw member and the second jaw member. The predetermined amount can be 5 degrees or greater or between 5 degrees and 85 degrees.

[0054] Figure 1A-1B A portion of a suture passer 100 according to an embodiment of the present invention is shown. Suture passer 100 includes a first jaw member 113 and a second jaw member 115 extending from the distal end of an elongated body region to form a distally facing port into which the tissue to be sutured is adapted. For example, the device has a first (upper) jaw member 113 coupled to the distal end of a more proximal elongated body 121 and extending distally therefrom. The second jaw member 115 is shown coupled to the distal end of the body and extending distally below the first jaw member 113.

[0055] The first jaw member 113 is angled relative to the long axis of the proximal elongated body. The first jaw member 113 in this example is shown as having a hinge region 119 about which the first jaw member 113 can be angled relative to the elongated body 121. In some variations, this hinge region 119 is a pinned hinge; a non-pinned (e.g., living hinge) region may be used. Any suitable articulation region that allows the first jaw member 113 to be angularly moved relative to the proximal portion of the device (e.g., an elongated member) may be used. In some variations, this first jaw member 113 is referred to as an upper jaw member, but alternative variations in which the first jaw member is a lower jaw member are also possible.

[0056] The first jaw member 113 pivots about a hinge point 118 and is controlled by a pulling member 117 that pushes and / or pulls proximally and / or distally to control the angle of the first jaw member 113 relative to the second jaw member 115. The pulling member 117 may include a shaft, wire, tenon, tube, cannula, etc., and may extend to the proximal end of the device where it may be controlled.

[0057] Second jaw member 115 is configured to slide proximally toward and into proximal elongated body 121 of the device. Second jaw member 115 generally moves axially in the direction of the proximal-distal axis of suture passer 100. In other words, second jaw member 115 moves axially toward and away from handle housing 120. Figure 1B as well as Fig. 8A The second jaw member 115 shown in FIG. 1 can be fully retracted into the elongated body 121 and extend therefrom.

[0058] Figure 1A An embodiment of a handle for deploying a suture passer is shown. The clamp trigger 101 is a squeeze handle that controls the angle of the first jaw member 113 relative to the elongated body 121. When pulled or released, the clamp trigger 101 can move about the pivot point 109. The tissue penetrator trigger 107 controls the tissue penetrator ( Fig. 6A In this embodiment, the lock 103 is located between the clamp trigger 101 and the tissue penetrator trigger 107. Figure 1A In the embodiment, the lock controller 103 is connected to the spring 104 and can be rotated around the pivot point 105 by the clamping trigger 101. The spring 104 can always be in a compressed state and is configured to Figure 1A The orientation shown biases the lock 103 and inhibits actuation of the trigger 107. The lock control 103 is arranged to allow or prevent actuation of the tissue penetrator trigger 107. Figure 1A and Figure 1B A first configuration of the device is shown in which the clamp trigger 101 is not engaged and the first and second jaw members are not clamped to tissue 114, as shown in FIG. Figure 1B As shown. This first configuration, in which the jaws are not clamped or in an open configuration, is defined as a distance or angular orientation / separation between the first and second jaws such that the first jaw 113 may not reliably capture a tissue penetrator extending from the second jaw 115 toward the first jaw 113. This may include a capture position / area associated with the first jaw 113 that is not fully captured by the first jaw 113 or may be missed. Thus, activation of the tissue penetrator is inhibited until the first jaw is positioned sufficiently close to the second jaw so that the suture and tissue penetrator capture position of the first jaw can be reliably aimed when the tissue penetrator extends from the second jaw 115. In this embodiment, the lock 103 blocks or abuts a portion of the tissue penetrator trigger 107, thereby preventing the tissue penetrator from extending and the suture from passing through. In an alternative embodiment, the lock 103 may be in electronic communication with the clamping trigger and the tissue penetrator trigger to allow or prevent actuation of the tissue penetrator trigger.

[0059] Figure 2 A perspective view of the clamp trigger 101 is shown. The clamp trigger 101 has a surface 201 that can interact with the lock 103. Pivot joints 203 and 205 are connected to the housing 120, and more specifically, are configured to be rotationally coupled to the pivot 109, such as Figure 1A , to allow the clamp trigger 101 to pivot when squeezed or pulled. Surface 201 defines a smooth elongated surface so that when the clamp trigger 101 pivots, the surface 201 can engage and slide along the locking surface while beginning to move or rotate the lock 103 around the pivot 105. The rotation of the lock 103 can also further compress the spring 104 and begin to release the trigger 107.

[0060] Figure 3A-3BA perspective view of the lock 103 is shown. The lock 103 has a first surface or first end region 301 that can interact with the clamp trigger 101 and more specifically with the surface 201. The first end region 301 defines a curved surface that is configured to abut the surface 201 and assist in continuous contact between the two surfaces when the two surfaces (201 and 301) slide and rotate relative to each other when the clamp trigger 101 pivots around the pivot 109 and when the lock 103 rotates. The second surface or second end region 303 is configured to interact with the tissue penetrator trigger 107 and defines a substantially flat surface for selective engagement with the rib 108. The pivot member 307 allows the lock 103 to rotate when the first end region 301 engages with the clamp trigger 101. The protruding member 305 can be used to prevent pivotal movement of the lock 103 when the surface or end 301 does not interact with the clamp trigger. The protruding member 305 can rest on the reference surface 110 used as a reference mark to ensure that the lock 103 is properly assembled within the housing 120 and the position of the lock 103 is controlled within the handle. Having a method of controlling this dimension allows the ability to determine a specific angle (or position) of the trigger 101 at which the travel restriction on the trigger 107 is released. In other words, the measurability of a controllable offset distance between the distal-most surface of the member 305 and the distal-most surface of the first end region 301 after the housing 120 is assembled and closed will ensure that the lock 103 is properly installed within the housing 120.

[0061] Figure 3B Another perspective view of the lock 103 is shown. The lock 103 may be generally L-shaped, with the first arm terminating in a first end region 301 and the second arm terminating in a second end region 303.

[0062] Figure 4A perspective view of the tissue penetrator trigger 107 is shown. The tissue penetrator trigger 107 has an elongated arm 401 that may include a distal snap 402 for selectively engaging a portion of the housing 120. The elongated arm 401 extends substantially parallel to the top surface 404 to define an opening 410. The elongated arm 401 terminates in a snap feature that interacts with a rib or surface on the handle to provide a tactile feedback to the user that the penetrator trigger 107 has reached the end of travel. The top surface 404 is configured to interact with a thumb trigger discussed in the following figures. The tissue penetrator trigger 107 includes a hollow space 403 that allows the lock second region 303 to pass therethrough, and thereby allows the interaction of the tissue penetrator trigger 107 with the lock 103. The pivot point 405 allows the tissue penetrator trigger 107 to rotate when squeezed. The hollow space 403 includes at least one rib or protrusion 108 configured to abut the second surface 303 when the jaws (113 and 115) are in the first, un-clamped configuration. Activation or movement of the tissue penetrator trigger 107 is thereby inhibited. Figure 1A , at least one rib or protrusion 108 is positioned so that movement of the clamping trigger 101 to a second (squeezing) position moves the locking surface 303 away from at least one rib 108 so that the tissue penetrator trigger 107 can move; the second position is defined as placing the jaws (113, 115) in a second or clamping configuration sufficient for suture capture.

[0063] Figure 5A-Figure 5B A perspective view of a partially closed first and second jaw members and corresponding operation of a suture passer 500 disposed on a distal end 521 of a body on tissue 514 when the first and second jaw members are fully clamped on the tissue is shown in accordance with an embodiment of the present invention. This can be defined as a second or clamping configuration. The first jaw member 513 pivots about a hinge point 519 and is controlled by a pulling member 517 that pushes and / or pulls proximally and / or distally to control the angle of the first jaw member 513 relative to the second jaw member 515.

[0064] Figure 5B The housing 520 is shown coupled to the proximal end of the elongated body 511 when the first and second jaw members are partially closed on tissue by pulling the clamp trigger 501, which is shown pivoted about the pivot 509 and engaged with the first surface or first end region of the lock (e.g., 301, Figure 3A506. As shown, the clamping trigger 501 further overcomes the spring bias from the spring 104 and moves the lock 505 so that the second region 305 is disengaged from the tissue penetrator trigger 507 by rotating the lock about the pivot 503 and away from the path of the tissue penetrator trigger 507. For example, the second surface or end of the lock is rotated away so that the tissue penetrator trigger 507 is no longer inhibited by the lock when squeezed. The second surface moves to a position that no longer interferes with the internal features of the trigger 507 and thus no longer inhibits activation of the trigger 507.

[0065] Figure 6A-6B Also illustrated is the operation of the suture passer 600 according to an embodiment of the present invention. In this perspective view of the device, the first jaw member and the second jaw member are disposed on the distal end 621 of the body and clamped on the tissue 614. The first jaw member 613 pivots about the hinge point 619 and is controlled by the pulling member 617, which pushes and / or pulls proximally and / or distally to control the angle of the first jaw member 613 relative to the second jaw member 615. More specifically, the first jaw member and the second jaw member are disposed such that the spacing therebetween is limited to a maximum predetermined distance so that a successful transfer of the suture from the second jaw member to the first jaw member is achieved. The first jaw member 613 may include a suture capture area for receiving a tissue penetrator 623. If the opening exceeds the maximum predetermined amount, the tissue penetrator 623 may fail to interact with the first jaw member, or may interact with an area of ​​the first jaw member outside of the suture capture area and, thus, fail to capture the suture. In Fig. 6A 603 and 615. The exemplary suture capture area can be seen as a boundary line on the first jaw member 613 directly adjacent to where the tissue penetrator 623 intersects the first jaw member 613. The housing 620 is coupled to the body proximal end 611. The clamp trigger 601 engages with the first surface or first end of the lock 605 so that the lock 605 has moved or rotated to the second position and disengaged from the internal features (such as ribs 108) associated with the tissue penetrator trigger 607. The lock 605 pivots about point 603 and the clamp trigger 601 pivots about pivot 609. The tissue penetrator trigger 607 is shown as being actuated so that the tissue penetrator 623 can extend from the first jaw 613 to the second jaw 615 and the suture is passed through. The lock second region 303 is shaped so as to easily pass through the hollow space 403 and the ribs 108 below when the trigger 607 is activated.

[0066] In another aspect, the present disclosure provides a method for passing a suture. The method includes at least partially closing a first jaw member of a suture passer, wherein the first jaw member extends from a distal region of an elongated body and is configured to angularly move relative to the elongated body; and a second jaw member, wherein the second jaw is configured to form an opening with the first jaw member; and when the first jaw member and the second jaw member are at least partially clamped, passing a tissue penetrator between the first jaw member and the second jaw member, thereby preventing the tissue penetrator from extending when the jaws are not clamped.

[0067] In some embodiments of the methods provided herein, the suture passer includes: a clamping trigger configured to move the first jaw member relative to the elongated body with an angular movement; a tissue penetrator trigger configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated; and a lock between the clamping trigger and the tissue penetrator trigger and configured to interact with the clamping trigger and the tissue penetrator trigger to prevent the tissue penetrator from extending until the first jaw member is closed relative to the second jaw member by a predetermined amount. The predetermined amount may be at least about 5% or more. In some cases, the predetermined amount is about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90% or 95%.

[0068] In some embodiments of the methods provided herein, the clamp trigger is configured to actuate clamping of the first jaw member and the second jaw member.

[0069] In some embodiments of the methods provided herein, the lock has a first surface configured to interact with the clamp trigger and a second surface configured to interact with the tissue penetrator trigger.

[0070] In some embodiments of the methods provided herein, when the first and second jaw members are unclamped, the first surface of the lock disengages from the clamp trigger and the second surface engages the tissue penetrator trigger to prevent the tissue penetrator from extending from the second jaw.

[0071] In some embodiments of the methods provided herein, a first surface of the lock engages with a clamping trigger to actuate clamping of the first jaw member and the second jaw member, and a second surface of the lock disengages from a tissue penetrator trigger to actuate the tissue penetrator trigger and extend the tissue penetrator between the first jaw member and the second jaw member.

[0072] In some embodiments of the methods provided herein, engagement or interaction of the first surface of the lock with the clamp trigger actuates rotation of the lock to disengage the second surface of the lock from the tissue penetrator trigger. In this embodiment, the lock is no longer in the path of the tissue penetrator trigger to prevent actuation of the tissue penetrator trigger.

[0073] In some embodiments of the methods provided herein, the second jaw member is configured to extend axially relative to the elongated body.

[0074] In some embodiments of the methods provided herein, the suture is threaded by a tissue penetrator that is expandably retained with the distal tip fully retracted within the first jaw member or the second jaw member.

[0075] In some embodiments of the methods provided herein, the tissue penetrator is deflected as it extends from within the first jaw member or the second jaw member to extend between the first jaw member and the second jaw member.

[0076] On the other hand, the present disclosure provides a suture passer device. The device includes: an elongated body having a proximal region and a distal region; a first jaw member extending from the distal region of the elongated body and configured to move angularly relative to the elongated body; a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially; a clamping trigger configured to actuate the clamping of the first jaw member and the second jaw member; a tissue penetrator trigger configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated; and a thumb trigger configured to extend or retract the second jaw member, wherein the thumb trigger has a first surface and a second surface; a housing including a sleeve member, a carriage member, and a pawl member; and wherein the first surface of the thumb trigger engages with the sleeve member, wherein the inner surface of the sleeve member is connected to the carriage member, wherein the carriage member engages with the pawl member to actuate the second jaw member to extend or retract.

[0077] In some embodiments of the devices provided herein, the thumb trigger, when pushed, moves the sleeve member, which moves the carriage member to actuate extension or retraction of the second jaw member.

[0078] In some embodiments of the devices provided herein, the carriage member engages the pawl member to extend the second jaw member.

[0079] In some embodiments of the devices provided herein, the carriage member disengages from the pawl member to retract the second jaw member.

[0080] In some embodiments, the devices provided herein further include a lock configured to interact with the clamp trigger and the tissue penetrator trigger to prevent the tissue penetrator from extending until the first jaw member is closed a predetermined amount relative to the second jaw member.

[0081] Figure 7 A perspective view of an embodiment of a suture passer equipped with a thumb trigger 709 is shown. The thumb triggers 709 each have a push button 713. The thumb trigger 709 can extend or retract the second jaw member 703 when pushed. From this angle, it is not visible that the second thumb trigger 709 can be disposed on the rear side of the suture passer. The suture passer includes a grip trigger 707, a tissue penetrator trigger 711, an elongated body 705 coupled to the distal end of the handle housing, and a first jaw and a second jaw (respectively 701 and 703) coupled to the distal end of the elongated body 705.

[0082] Figure 8A-8B The operation of thumb trigger 809 to extend or retract second jaw member 803 is shown. The first jaw member 801 is also shown. Fig. 8A , with the second jaw (lower jaw) member retracted, thumb trigger 809 begins in its fully rearward position (position 1). Thumb trigger 809 moves forward or is depressed along a curved path to extend second jaw member 803 (position 2). When released, thumb trigger 809 returns to the neutral position (position 3) and second jaw 803 remains extended. Figure 8B 803, the thumb trigger 809 is again advanced (position 2) and released to retract the second jaw member 803, thereby returning the thumb trigger 809 to position 1. In other embodiments, the thumb trigger 809 may remain in the forward position (position 2) after extending the second jaw member 803, or may be fully returned (position 1) after extending the second jaw member. The orientation and path of the thumb trigger button 713 as the button is advanced and retracted may be at a non-zero angle relative to the long axis of the body and may travel along a curved path that is configured so that a person's thumb can easily reach the button 713 with the same hand that grasps the tissue penetrator trigger 707. Thus, the path orientation and curvature are such that the range of distances between the trigger curved surface portion 106 and the path orientation is considered so as to be kept within the range of one to two inches.

[0083] Fig. 9A cross-sectional view of functional internal components when the thumb trigger is used is shown. The housing 920 can include two thumb triggers 909 (only one is shown), one on each lateral side of the housing 920. Generally, advancing the thumb trigger 909 along a defined path causes a sleeve member 915 disposed within the housing 920 to move axially, the sleeve member 915 being coupled to a carriage 917, which is coupled to a second jaw member. Axial movement of the carriage 917 causes the second jaw to slide axially so as to advance the second jaw into and retract it from the elongated body. A flexible arm associated with the pawl member 911 is bent around a series of channels and protrusions on the sleeve member 915 so as to selectively advance and retract the second jaw as shown in FIG. Fig. 8A and 8B The second clamping member described in. Fig. 9 As shown, the thumb trigger 909 is connected to the slot on the sleeve member 915 by the protrusion member 913. The protrusion member 913 and the slot are configured so that the forward movement of the thumb trigger 909 slides the sleeve member axially, and the sleeve member thereby slides the carriage 917 axially to actuate the jaw member. The position of the carriage 917 controls whether the second jaw member is extended or retracted. The pawl member 911 (including the proximal tip or tooth 907) interacts with the rib 902 and the ramp 904 on the sleeve member 915 to control the position of the carriage 917 and thereby the axial position of the second jaw.

[0084] Fig.10 1 is a perspective view of the pawl member 911. A first pawl tip or tooth 1001 is provided at the end of the arm 1002, the first tooth 1001 being designed to interact with the sleeve member 915 to selectively maintain the axial position of the carriage 917 and thereby the position of the second jaw 115 (according to Fig. 8A , position 3). The first pawl tooth 1001 may extend substantially orthogonal to the arm 1002 so as to extend toward the top surface of the sleeve member 915, and more specifically toward the rib 902 and the ramp 904. The pawl member 911 also includes a second pawl tooth or tip 1003, which is configured to engage with the slide member 917 to control the movement of the second jaw member (more details of which are in later figures). The second tooth 1003 may have a forward inclined surface and a rear orthogonal surface relative to the top surface of the slide 917. The pawl member 911 also includes a nesting portion 1004, which is used to accommodate a biasing member and a portion of the tubular opening 1005 for rotationally coupling the pawl member 911 to the housing 920 via a pin or protrusion (not shown). In operation, the pawl member 911 may have some limited rotation to compress the biasing member, the biasing member (in Fig. 9 914 ) is configured to maintain engagement of the first and second pawl teeth 1001, 1003 with features of the sleeve member 915 and the carriage 917, respectively.

[0085] Fig.11A and Fig. 11B 1 is a perspective view of sleeve member 1100. Curved rib 1101 and ramp 1107 are formed so as to be a continuous protrusion that selectively interacts with pawl member 911 when advancing the second jaw member. More specifically, curved rib 1101 and ramp 1107 selectively interact with first pawl tooth 1001. Groove 1105 is configured to engage with a thumb trigger to allow the thumb trigger to control movement of the sleeve and carriage member. Lower surface 1103 may contact or connect with carriage member 917. Fig. 11B A second ramp 1108 and a second rib 1109 are shown, which are configured to interact with the first pawl tooth 1001 when the second jaw member is retracted, as will be described in more detail in later figures. The curved rib 1101 and the second rib 1109 are laterally spaced apart to allow the first pawl 1001 to pass therebetween.

[0086] Fig.12 1 is a perspective view of thumb trigger 1201. Thumb trigger 1209 has a push button, protruding members 1203 and 1205, and a first surface 1204. Protruding member 1205 is configured to interact or selectively engage with a tissue penetrator trigger to prevent retraction of the second jaw member when the tissue penetrator is extended (disclosed in a later figure). Protruding member 1203 is configured to interact with a slot in a sleeve member to drive axial advancement and retraction of the second jaw.

[0087] Fig.13 1 is a perspective view of a carriage member having surfaces 1301 and 1303 for slidingly engaging with a sleeve member. More specifically, surfaces 1301 and 1303 slideably fit within mating features associated with surface 1103. An opening 1305 on the carriage member is sized to engage with second pawl tip 1003 of pawl member 911 while the second jaw member is in the extended position.

[0088] Figure 14A-Figure 14C The mechanical operation of the functional internal components of the suture passer for extending second jaw member 1402 is shown when thumb trigger 1403 is pushed forward. Fig.14A The position (position 1) corresponding to the second jaw 1402 being fully retracted and the thumb trigger being in the most retracted configuration, causes the push button 1405 to be retracted and only the first jaw member 1401 to extend from the body. The pawl first tooth (proximal tip) 1419 is disposed distally and axially relative to the curved rib 1413 and the ramp 1407, and the second tooth 1421 is spaced distally and axially from the carriage member 1417. As the thumb trigger 1403 moves along its path, the thumb trigger protrusion member engages within the slot of the sleeve member 1415, thereby Fig. 14BAs shown, the sleeve 1415 is moved forward (distal), which simultaneously pushes the carriage member 1417 forward and thereby extends the lower jaw 1402. The pawl member 1411 includes a flexible arm as disclosed in the previous figures, which bends laterally around the first ramp side of the curved rib 1413 on the sleeve and upward from the ramp 1407. The engagement with the ramp 1407 is maintained using a biasing member at least partially disposed in the nest 1004. Once the carriage member 1417 is fully moved forward, the second pawl tooth 1421 engages the carriage opening to maintain the extension of the second jaw member 1402. The first tooth 1419 is now located on the other side of the curved rib 1413 and the ramp 1407 and can abut against the rib 1109 (at Fig. 11B The release guide of thumb trigger 1403 is located at Fig. 14C The first tooth 1419 between the curved rib 1413 and the rib 1109 is best seen in FIG. 1 and the thumb trigger is placed in position 2 (eg, Fig. 8A With the second tooth 1421 engaged, release of the thumb trigger 1403 at this stage will not retract the lower jaw 1402 because the carriage 1417 is inhibited from retracting by the first and second teeth (1419 and 1421) and corresponding mating features in the carriage and sleeve.

[0089] Still Fig. 14C 1403 is shown as a spring at the proximal end of the sleeve pulling the sleeve member 1415 back against the proximal end of the carriage member 1417 when the thumb trigger 1403 is released, maintaining the sleeve member 1415 and thumb trigger 1403 in an intermediate position. (The spring is not shown in all figures as being coupled to the sleeve member, but rather as a hook around a slot adjacent to the sleeve member to maintain a proximal bias on the sleeve member). At the proximal end of the carriage member 1417, there may be a lip, protrusion, or stop member to prevent the sleeve member 1415 from sliding off the carriage member 1417. Fig.13 Can see the near end of lip and carriage member in, it is configured to limit the sliding of sleeve member.In this intermediate position, first pawl tip 1419 remains behind curved rib 1413, and is arranged far side and along axial direction with respect to the inclined surface 1108 of sleeve member 1415.

[0090] Figure 15A-15BThe operation of retracting the second jaw is shown when the thumb trigger is pressed forward again to position 3. When the thumb trigger is pressed again, the tip 1519 of the pawl member slides upward on the second ramp 1108 on the sleeve member 1515, which is configured to raise a portion of the pawl member 1511 to facilitate removal and release of the second pawl tooth 1521 from the opening in the carriage member 1517. The carriage member 1517 is then pulled rearward by the spring, causing the second jaw member to retract. When the thumb trigger is released and the sleeve member 1515 returns, the pawl tip 1519 bends laterally around the end of the curved rib 1513 on the sleeve member 1515 and returns to its initial position in front of the rib.

[0091] On the other hand, the present disclosure provides a method for controlling a suture passer, the suture passer having a first jaw member extending from a distal region of an elongated body and configured to move angularly relative to the elongated body; a second jaw member configured to form an opening with the first jaw member when the second jaw member extends axially; and a thumb trigger that is actuated to retract or extend the second jaw member, the method comprising: extending the second jaw by pushing the thumb trigger; and retracting the second jaw by pushing the thumb trigger.

[0092] In some embodiments of the methods provided herein, extending includes pushing a thumb trigger to actuate a sleeve member to move the carriage member forward to actuate extension of the second jaw member.

[0093] In some embodiments of the methods provided herein, retracting includes pushing a thumb trigger to actuate a sleeve member to move the carriage member rearward to actuate retraction of the second jaw member.

[0094] In some embodiments of the methods provided herein, a thumb trigger is coupled to an outer surface of a sleeve member, wherein the inner surface is coupled to a carriage member, wherein the carriage member actuates extension or retraction of the second jaw member.

[0095] In some embodiments of the methods provided herein, the carriage member engages the pawl member to extend the second jaw member.

[0096] In some embodiments of the methods provided herein, the carriage member is disengaged from the pawl member to retract the second jaw member.

[0097] In some embodiments of the methods provided herein, the method further comprises passing a tissue penetrator between the first jaw member and the second jaw member when the first jaw member and the second jaw member are at least partially clamped, thereby preventing the tissue penetrator from passing therethrough without clamping the jaws.

[0098] In some embodiments of the methods provided herein, a suture is threaded by a tissue penetrator that is expandably held with the distal tip fully retracted within the first or second jaw member, thereby preventing passage of the suture without clamping the jaws.

[0099] In another aspect, the present disclosure provides a suture passer device, wherein the device is designed to prevent retraction of a second jaw member when a tissue penetrator is extended. The device includes: an elongated body having a proximal region and a distal region; a first jaw member extending from the distal region of the elongated body; a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially; a tissue penetrator trigger configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated; and a thumb trigger configured to retract or extend the second jaw member when actuated, wherein the second jaw member is prevented from retracting when the tissue penetrator is extended.

[0100] In some embodiments of the devices provided herein, the thumb trigger includes a protruding member extending above a first surface of the thumb trigger that extends when engaged with an actuated tissue penetrator trigger, the protruding member limiting actuation of the thumb trigger to retract the second jaw.

[0101] In some embodiments of the devices provided herein, the tissue penetrator trigger includes an interference member adjacent to the first surface of the thumb trigger that interacts with the protrusion member to prevent actuation of the thumb trigger to retract the second jaw member.

[0102] In some embodiments of the devices provided herein, the first jaw member is configured for angular movement relative to the elongated body.

[0103] In some embodiments, the device further includes a clamp trigger configured to actuate clamping of the first jaw member and the second jaw member.

[0104] On the other hand, the present disclosure provides a method for preventing damage to tissue when using a suture passer device, the suture passer device having a first jaw member extending from a distal region of a slender body; a second jaw member configured to extend axially relative to the slender body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially; a tissue penetrator trigger configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated; and a thumb trigger configured to retract or extend the second jaw member when actuated, the method comprising: preventing the thumb trigger from being actuated to retract the second jaw member when the tissue penetrator is extended.

[0105] In some embodiments of the methods provided herein, preventing includes: pushing the thumb trigger to extend the second jaw; and depressing the tissue penetrator trigger to extend the tissue penetrator, thereby preventing the thumb trigger from retracting the second jaw member.

[0106] In some embodiments of the methods provided herein, preventing includes limiting actuation of the thumb trigger by engaging the tissue penetrator trigger with a protruding member extending above the first surface of the thumb trigger, thereby preventing actuation of the thumb trigger to retract the second jaw member.

[0107] In some embodiments of the methods provided herein, the tissue penetrator trigger includes an interference member adjacent to the first surface of the thumb trigger, the interference member interacting with the protrusion member to prevent actuation of the thumb trigger to retract the second jaw member.

[0108] Fig.16 Operation of a suture passer that prevents retraction of the second jaw member when the tissue penetrator is extended is shown. The suture passer includes a clamping trigger 1601 and a tissue penetration trigger 1607. Retraction of the second jaw member in the suture passer is performed by pressing the thumb trigger forward. The design includes a protrusion member 1605 on each thumb trigger that sweeps across the path of the tissue penetrator trigger 1607. When the tissue penetrator trigger 1607 is fully retracted and the tissue penetrator is therefore not extended, the protrusion member 1605 is not blocked and the thumb trigger can be actuated to retract the second jaw member. When the tissue penetrator trigger 1607 is fully retracted and the tissue penetrator is therefore not extended, the protrusion member 1605 is not blocked and the thumb trigger can be actuated to retract the second jaw member. Fig.16 When the tissue penetrator is moved forward to extend the tissue penetrator as shown in step C, the tissue penetrator trigger blocks the protruding member 1605. More specifically, such as Figure 4 4. The surface of the interference surface 404 in FIG. 4 is moved across the trajectory of the protrusion member 1605 to inhibit the thumb trigger from retracting. It is worth noting that in order to retract the lower jaw, the thumb trigger is first pushed to position 2 before releasing, and therefore the protrusion 1605 must first move beyond the surface 404 to retract the lower jaw. The surface 404 limits the actuation of the thumb trigger and thus prevents retraction of the second jaw member. In step D, the protrusion 1605 is shown as abutting the surface 404 so as to be inhibited from moving forward (and thereby releasing the first and second teeth of the pawl member).

[0109] On the other hand, the present disclosure provides a method for preventing damage to tissue when using a suture passer device, the suture passer device having a first jaw member extending from a distal region of a slender body; a second jaw member configured to extend axially relative to the slender body, wherein the second jaw is configured to form an opening with the first jaw member when the second jaw member extends axially; a tissue penetrator trigger configured to extend the tissue penetrator between the first jaw member and the second jaw member when actuated; and a thumb trigger configured to retract or extend the second jaw member when actuated, the method comprising: actuating the thumb trigger to prevent retraction of the second jaw member when the tissue penetrator is extended.

[0110] In some embodiments of the methods provided herein, preventing includes: pushing the thumb trigger to extend the second jaw; and depressing the tissue penetrator trigger to extend the tissue penetrator, thereby preventing the thumb trigger from retracting the second jaw member.

[0111] In some embodiments of the methods provided herein, preventing includes limiting actuation of the thumb trigger by engaging the tissue penetrator trigger with a protruding member extending above the first surface of the thumb trigger, thereby preventing actuation of the thumb trigger to retract the second jaw member.

[0112] In some embodiments of the methods provided herein, the tissue penetrator trigger includes an interference surface adjacent to the first surface of the thumb trigger that interacts with the protruding member to prevent actuation of the thumb trigger to retract the second jaw member.

[0113] Any method described herein (including user interface) may be implemented as software, hardware, or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions executable by a processor (e.g., a computer, tablet, smartphone, etc.), which when executed by the processor causes the processor to perform any of the following steps, including but not limited to: displaying, communicating with a user, analyzing, modifying parameters (including time, frequency, intensity, etc.), determining, issuing an alarm, etc.

[0114] When a feature or element is referred to as "on" another feature or element in this article, it can be directly on another feature or element, or there may be intermediate features and / or elements. In contrast, when a feature or element is referred to as "directly on" another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is referred to as "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element or there may be intermediate features or elements. In contrast, when a feature or element is referred to as "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although described or shown relative to an embodiment, the features and elements described or shown in this way may be applicable to other embodiments. Those skilled in the art will also recognize that the reference to the structure or feature set to "adjacent" another feature may have a part overlapping or covering adjacent features with adjacent features.

[0115] The terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the present invention. For example, as used herein, the singular forms "a", "an", and "the" are also intended to include the plural forms, unless the context clearly indicates otherwise. It will also be understood that when used in this specification, the terms "comprises" and / or "comprising" specify the presence of the features, steps, operations, elements, and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0116] For ease of description, spatial relative terms such as "below", "below", "lower", "above", "on", etc. may be used herein to describe the relationship between an element or feature and another element or feature as shown in the accompanying drawings. It should be understood that, in addition to the orientation depicted in the figures, spatial relative terms are intended to cover different orientations of the device in use or operation. For example, if the device in the accompanying drawings is inverted, the element described as being "below" or "below" other elements or features will be oriented as being "above" other elements or features. Therefore, the exemplary term "below" may cover both the orientation above and below. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein are interpreted accordingly. Similarly, unless otherwise specifically noted, the terms "upward", "downward", "vertical", "horizontal", etc. are used herein only for the purpose of explanation.

[0117] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another feature / element. Thus, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element without departing from the teachings of the present invention.

[0118] In this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" mean that various components (e.g., compositions and apparatus including devices and methods) can be used together in methods and articles. For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps, but not the exclusion of any other elements or steps.

[0119] In general, any apparatus and method described herein should be understood to be inclusive, but all or a subset of components and / or steps may alternatively be exclusive and may be expressed as "consisting of" or alternatively "consisting essentially of" various components, steps, sub-components or sub-steps.

[0120] As used herein in the specification and claims, including those used in the examples, and unless otherwise expressly provided, all numbers can be read as if beginning with the word "about" or "approximately", even if the term does not appear explicitly. When describing a value and / or position, the phrase "about" or "approximately" can be used to indicate that the value and / or position described is within the reasonable expected range of the value and / or position. For example, the value of a numerical value can be + / -0.1% of a specified value (or range of values), + / -1% of a specified value (or range of values), + / -2% of a specified value (or range of values), + / -5% of a specified value (or range of values), + / -10% of a specified value (or range of values), etc. Unless otherwise indicated by the context, any numerical value given herein should also be understood to include approximately or approximately the value. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any value range described herein is intended to include all sub-ranges listed below. It should also be understood that when a value is disclosed as "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It should also be understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points and ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed, and between 10 and 15. It should also be understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0121] Although various exemplary embodiments are described above, any of a variety of changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various method steps described are performed may often be changed, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0122] The examples and illustrations included herein show the specific embodiments in which this theme can be practiced in an illustrative and non-limiting manner. As described above, other embodiments can be used and derived so that structural and logical replacements and changes can be made without departing from the scope of the present disclosure. For convenience only, the term "invention" can be used herein to refer to such embodiments of the inventive theme individually or collectively, and it is not intended that the scope of the present application be limited to any single invention or inventive concept (if in fact more than one is disclosed). Therefore, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose can replace the specific embodiments shown. The present disclosure is intended to cover any and all modifications or changes of various embodiments. By reading the above description, the combination of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. A suture passer device, comprising: an elongated body having a proximal end and a distal end, the proximal end coupled to the handle; a first jaw member coupled to a distal end of the elongated body and configured for angular movement relative to the elongated body; a second jaw member configured to form an opening with the first jaw member; a clamp trigger defining a portion of the handle, the clamp trigger configured to move the first jaw member between an open configuration and a clamped configuration, wherein the first jaw member and the second jaw member are angularly closer to each other in the clamped configuration than in the open configuration; a tissue penetrator trigger defining a portion of the handle, the tissue penetrator trigger configured to selectively extend a tissue penetrator between the first jaw member and the second jaw member; as well as a lock disposed between the clamp trigger and the tissue penetrator trigger and configured to interact with the clamp trigger and the tissue penetrator trigger to prevent extension of the tissue penetrator until the first jaw member is in the clamped configuration; wherein the lock has a first surface configured to interact with the clamp trigger and a second surface configured to interact with the tissue penetrator trigger; Wherein when the first jaw member is in the open configuration, the second surface of the lock engages the tissue penetrator trigger to prevent the tissue penetrator from extending.

2. The suture passer device of claim 1, wherein the second jaw member is configured to extend and retract axially relative to the elongated body.

3. The suture passer device of claim 1 , wherein the clamping trigger comprises a surface configured to engage a first surface of the lock when the first jaw member is moved toward the clamping configuration so as to rotate the lock and disengage the second surface from the tissue penetrator trigger. 4 . The suture passer device of claim 1 , wherein the clamping configuration defines a predetermined angular opening between the first jaw member and the second jaw member.

5. The suture passer device of claim 4, wherein the predetermined angle opening is between 5 degrees and 85 degrees.

6. A suture passer device according to claim 5, wherein the first clamp member includes a tissue penetrator receiving area for receiving and capturing the tissue penetrator, and wherein the predetermined angle opening defines a maximum opening so that the tissue penetrator extends from the second clamp member and passes through the tissue penetrator receiving area.

7. A suture passer device comprising: an elongated body having a proximal region and a distal region, the proximal region being coupled to the handle; a first jaw member coupled to a distal region of the elongated body and configured for angular movement relative to the elongated body; a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw member is configured to form an opening with the first jaw member when the second jaw member extends axially; a thumb trigger configured to extend or retract the second jaw member, wherein the thumb trigger has a first surface and a second surface; a housing including a sleeve member and a carriage member operatively coupled to each other and also operatively coupled to the second jaw member, wherein a first surface of the thumb trigger is communicatively coupled to the sleeve member such that actuation of the thumb trigger axially moves the sleeve member and the carriage member and thereby the second jaw member; a clamp trigger defining a portion of the handle, the clamp trigger configured to move the first jaw member between an open configuration and a clamped configuration, wherein the first jaw member and the second jaw member are angularly closer to each other in the clamped configuration than in the open configuration; a tissue penetrator trigger defining a portion of the handle, the tissue penetrator trigger configured to selectively extend a tissue penetrator between the first jaw member and the second jaw member; as well as a lock disposed between the clamp trigger and the tissue penetrator trigger and configured to interact with the clamp trigger and the tissue penetrator trigger to prevent extension of the tissue penetrator until the first jaw member is in the clamped configuration; wherein the lock has a first surface configured to interact with the clamp trigger and a second surface configured to interact with the tissue penetrator trigger; Wherein when the first jaw member is in the open configuration, the second surface of the lock engages the tissue penetrator trigger to prevent the tissue penetrator from extending.

8. The device of claim 7, wherein the housing further comprises a detent member configured to engage with the opening of the carriage member to retain the second jaw member in the extended configuration.

9. The device of claim 8, wherein the pawl member is configured to disengage from the carriage member opening during retraction of the second jaw member.

10. The device of claim 8, wherein the pawl member further comprises a tip configured to interact with a curved rib and a ramp disposed on a top surface of the sleeve member such that actuation of the thumb trigger to extend the second jaw member slides the sleeve member to cause the tip to move axially from a first side of the curved rib and ramp to a second side of the curved rib and ramp, and wherein releasing the thumb trigger to an intermediate position maintains the extended position of the second jaw member while the distal tip remains on the second side of the curved rib and ramp.

11. A suture passer device comprising: an elongated body having a proximal region and a distal region, the proximal region being coupled to the handle; a first jaw member extending from a distal region of the elongated body; a second jaw member configured to extend axially relative to the elongated body, wherein the second jaw member is configured to form an opening with the first jaw member when the second jaw member extends axially; a clamp trigger defining a portion of the handle, the clamp trigger configured to move the first jaw member between an open configuration and a clamped configuration, wherein the first jaw member and the second jaw member are angularly closer to each other in the clamped configuration than in the open configuration; a tissue penetrator trigger defining a portion of the handle, the tissue penetrator trigger being configured to extend a tissue penetrator between the first jaw member and the second jaw member when actuated; a thumb trigger configured to retract or extend the second jaw member when actuated, wherein the second jaw member is prevented from retracting when the tissue penetrator is extended; as well as a lock disposed between the clamp trigger and the tissue penetrator trigger and configured to interact with the clamp trigger and the tissue penetrator trigger to prevent extension of the tissue penetrator until the first jaw member is in the clamped configuration; wherein the lock has a first surface configured to interact with the clamp trigger and a second surface configured to interact with the tissue penetrator trigger; Wherein when the first jaw member is in the open configuration, the second surface of the lock engages the tissue penetrator trigger to prevent the tissue penetrator from extending.

12. The device of claim 11, wherein the thumb trigger includes a protrusion member extending above a first surface of the thumb trigger, the protrusion member configured to limit actuation of the thumb trigger to retract the second jaw member.

13. The device of claim 12, wherein the tissue penetrator trigger includes an interference surface adjacent to the first surface of the thumb trigger, the interference surface interacting with the protruding member to prevent actuation of the thumb trigger from retracting the second jaw member.

14. The device of claim 11, further comprising a clamp trigger configured to actuate clamping of the first jaw member and the second jaw member.

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