Backside anastomosis closure clip

Abstract

The system includes a clip, an elongate member, and a control member. The clip includes a barrel member defining a cavity therein and a plurality of clip arms. Distal ends of the clip arms are coupled to one another and slidably received within the cavity to be moved between an open configuration and a closed configuration. The elongate member has a lumen extending longitudinally therethrough. The distal end of the elongate member contacts the distal ends of the pair of clip arms to distally hold the pair of clip arms against the barrel member. The control member is slidably received within the lumen such that the distal end of the control member extends distally beyond the distal end of the elongate member and the distal ends of the pair of clip arms and is coupled to the distal end of the barrel member. Longitudinal movement of the control member relative to the elongate member moves the pair of clip arms between the open configuration and the closed configuration.

Description

[Technical Field]

[0001] The present disclosure relates to minimally invasive procedures, such as endoscopic ultrasound (EUS) procedures, and additionally, the present disclosure relates to a back-side anastomosis clipping system. [Background technology]

[0002] Endoscopic ultrasound (EUS) is a minimally invasive procedure performed with specialized endoscopes that use high-frequency ultrasound to visualize the digestive (gastrointestinal) tract and other structures. Therefore, it is desirable to combine the diagnostic specificity possible with EUS with therapeutic techniques to provide noninvasive treatment for gastrointestinal problems. Depending on the specific application, a lumen-apposing metal stent (LAM), such as the AXIOS® stent, can be used to create an anastomotic passage between two body lumens (e.g., the wall of the gastrointestinal tract and an adjacent fluid-retaining cavity) for transluminal drainage of pancreatic fluid collections under EUS guidance, for example.

[0003] While LAM is commonly used to provide access between closely spaced structures (e.g., stomach / duodenum and pancreatic pseudocysts), as described above, physicians are hesitant to use it on loosely spaced structures because of the time required to create a permanent fistula between the two structures prior to LAM removal. In these cases, there is a risk of leakage if the LAM is removed or displaced prematurely. Currently, there are no endoscopic techniques capable of closing openings or punctures in distant structures (e.g., structures that are desired to be connected to the gastrointestinal wall using LAM), so surgical intervention is required if leakage occurs. Summary of the Invention

[0004] The present disclosure relates to a backside anastomosis clipping system. The system includes a barrel member extending from an open proximal end to a closed distal end and defining a cavity therein, and a pair of clip arms. The distal ends of the pair of clip arms are coupled to one another and slidably received within the cavity of the barrel member between an open configuration in which the proximal ends of the pair of clip arms are spaced apart to receive target tissue therebetween and a closed configuration in which the proximal ends of the pair of clip arms are moved toward one another to grasp the target tissue. The system also includes an elongate member extending from the proximal end to the distal end and extending between the pair of clip arms. The elongate member includes a lumen extending longitudinally therethrough. The distal end of the elongate member contacts the distal ends of the pair of clip arms and distally holds the pair of clip arms relative to the barrel member. Additionally, the system includes a control member slidably received within the lumen of the elongate member. A distal end of the control member extends distally beyond the distal end of the elongate member and the distal ends of the pair of clip arms and is coupled to the distal end of the barrel member, and longitudinal movement of the control member relative to the elongate member moves the pair of clip arms between the open configuration and the closed configuration.

[0005] In one embodiment, the control member is releasably coupled to the barrel member. In one embodiment, the distal end of the control member is coupled to the remainder of the control member via a joint configured to separate the expanding distal end from the remainder of the control member upon exposure to a force above a preset threshold.

[0006] In one embodiment, the proximal end of each of the pair of clip arms includes a pair of fingers that extend along opposite sides of the elongate member when the clip is in the closed configuration, and each of the pair of fingers of a first clip arm of the pair of clip arms extends toward a corresponding finger of a second clip arm of the pair of clip arms.

[0007] In one embodiment, the fingers of each of the pair of clip arms are pointed, and when the pair of clip arms are in the closed configuration, the fingers of the first clip arm of the pair overlap the fingers of the second clip arm of the pair of clip arms.

[0008] In one embodiment, each of the pair of fingers of the first clip arm of the pair of clip arms is sized and shaped to correspond to a corresponding finger of the second clip arm of the pair of clip arms, such that when the pair of clip arms is in the closed configuration, the fingers of the first and second clip arms interlock with each other.

[0009] In one embodiment, the pair of clip arms are formed from a single member that is bent to define the pair of clip arms, with a bend extending in the single member between the distal ends of the pair of clip arms.

[0010] In one embodiment, the bent portion of the unitary member includes an opening therethrough, the opening being sized, shaped, and configured to receive the control member therein.

[0011] In one embodiment, each of the pair of clip arms includes a locking tab extending laterally outward therefrom and configured to engage a corresponding engagement feature on the barrel member in a locked configuration.

[0012] In one embodiment, the corresponding engagement feature includes a window through a wall of the barrel member, the window configured to receive the locking tab therein. In one embodiment, the pair of clip arms are biased to the open configuration such that when the barrel member is moved proximally over the pair of clip arms, the pair of clip arms are constrained to the closed configuration, and when the barrel member is slid distally along the pair of clip arms, the pair of clip arms can return to the biased open configuration of the pair of clip arms.

[0013] Additionally, the present disclosure relates to a backside anastomosis clipping system. The system includes a lumen-apposing metal stent configured to provide a temporary passageway between a first structure in the gastrointestinal tract and a second structure distal to the first structure through a first tissue perforation and a second tissue perforation. The system includes a clip configured to be inserted into the second structure through the second tissue perforation upon removal of the lumen-apposing metal stent to close the second tissue perforation from the interior of the second structure. The clip includes a pair of clip arms. Distal ends of the pair of clip arms are coupled to each other, and the distal ends of the pair of clip arms are received within a cavity of the barrel member so as to move relative to the barrel member between an open configuration in which the proximal ends of the pair of clip arms are spaced apart from each other, and a closed configuration in which the proximal ends of the pair of clip arms are moved toward each other. Additionally, the system includes an elongate member extending from the proximal end to the distal end. The elongate member includes a lumen extending therethrough and is positioned between the pair of clip arms such that the distal end of the elongate member is pressed distally against the distal ends of the pair of clip arms and distally holds the pair of clip arms against the barrel member.

[0014] The system further includes a control member slidably received within the lumen of the elongate member, the control member extending from a proximal end to a distal end, the distal end extending distally beyond the distal end of the elongate member and the distal ends of the pair of clip arms, and the control member releasably coupled to the distal end of the barrel member, such that longitudinal movement of the control member relative to the elongate member moves the pair of clip arms between the open configuration and the closed configuration.

[0015] In one embodiment, the distal end of the control member is an enlarged ball received in a correspondingly shaped socket on the proximal face of the distal end of the barrel member, the enlarged ball being coupled to the remainder of the control member via a joint configured to separate the enlarged distal end from the remainder of the control member upon exposure to a force exceeding a preset threshold.

[0016] In one embodiment, the proximal end of each of the pair of clip arms includes a pair of fingers that extend along opposite sides of the elongate member when the clip is in the closed configuration, and each of the pair of fingers of a first clip arm of the pair of clip arms extends toward a corresponding finger of a second clip arm of the pair of clip arms.

[0017] In one embodiment, each of the pair of clip arms includes a locking tab extending laterally outwardly therefrom, the locking tab configured to engage a corresponding window through a wall of the barrel member to lock the barrel member over the pair of clip arms in the closed configuration.

[0018] Additionally, the present disclosure relates to a method for treating a tissue defect from a distal side (opposite side) of the tissue defect, the method comprising: inserting a clip into a gastrointestinal structure through a tissue perforation through a wall of the gastrointestinal structure in a closed configuration, the clip including a pair of clip arms having distal ends coupled to one another and slidably received within a cavity of a barrel member; moving the barrel member distally along the pair of clip arms to allow the pair of clip arms to return to a biased configuration, thereby moving the clip from the closed configuration in which proximal ends of the pair of clip arms are drawn toward one another to an open configuration in which the proximal ends of the pair of clip arms are moved away from one another; positioning the pair of clip arms about the tissue perforation such that the periphery of the tissue perforation is drawn between and grasped therebetween, and transitioning the clip to the closed configuration.

[0019] In one embodiment, the clip is moved between the open and closed configurations by longitudinally moving a control member coupled to a barrel member relative to an elongate member in which the control member is received, the elongate member being disposed between the pair of clip arms such that the distal end of the elongate member is distally pressed against the distal ends of the pair of clip arms and distally holds the pair of clip arms against the barrel member, whereby the control member is slidably received within the elongate member and the distal end of the control member extends distally beyond the distal end of the elongate member and the distal ends of the clip arms and is coupled to the distal end of the barrel member.

[0020] In one embodiment, the tissue surrounding the tissue perforation is grasped around the elongate member between a pair of clip arms using a pair of fingers at the proximal end of each of the pair of clip arms, each of the pair of fingers extending along opposite sides of the elongate member when the clip is in the closed configuration, and each of the pair of fingers of a first clip arm of the pair of clip arms extending toward a corresponding finger of a second clip arm of the pair of clip arms.

[0021] In one embodiment, the method further comprises locking the clip in the closed configuration by further pulling the barrel member proximally over the pair of clip arms until locking tabs extending laterally outward from the pair of clip arms engage corresponding locking windows extending through the wall of the barrel member.

[0022] In one embodiment, the method further comprises deploying the clip by pulling the control member further proximally relative to the elongate member until the force applied to the control member meets a predetermined threshold required to separate the control member from the barrel member. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 shows a longitudinal cross-sectional view of a distal portion of a system according to an exemplary embodiment of the present disclosure in an open configuration. [Figure 2] FIG. 2 shows a longitudinal cross-sectional view of the distal portion of the system of FIG. 1 in a closed configuration. [Figure 3] FIG. 3 shows a longitudinal cross-sectional view of the distal portion of the system of FIG. 1 in a locked configuration. [Figure 4] FIG. 4 shows a longitudinal cross-sectional view of the distal portion of the system of FIG. 1 in a deployed configuration. [Figure 5] FIG. 5 shows a cross-sectional view of the distal part of the system according to FIG. 1 along line AA in FIG. [Figure 6] FIG. 6 shows a cross-sectional view of a distal portion of a system according to an alternative embodiment of the system of FIG. 1 taken along line AA. [Figure 7] FIG. 7 shows a schematic diagram of a lumen-apposing metal stent (LAM) used as a temporary passageway between adjacent structures in the gastrointestinal tract. [Figure 8] Figure 8 shows a schematic diagram of the gastrointestinal tract with the LAM removed. [Figure 9] FIG. 9 shows a schematic illustration of a perforation in a structure of the gastrointestinal tract being treated using a clipping system according to an exemplary embodiment of the present disclosure. [Figure 10] FIG. 10 is a longitudinal side perspective view of a system according to another exemplary embodiment of the present disclosure. [Figure 11] FIG. 11 shows a schematic diagram of the closure system of FIG. 10 inserted into a target area within the body. [Figure 12] FIG. 12 shows a schematic diagram of the closure device of the closure system of FIG. 11 positioned within a body. DETAILED DESCRIPTION OF THE INVENTION

[0024] The present disclosure can be further understood by reference to the following description and the accompanying drawings, in which like elements are designated with the same reference numerals. The present disclosure relates to an endoscopic treatment system, and in particular to an endoscopic tissue clipping system. Exemplary embodiments of the present disclosure include a reverse anastomosis clipping system that includes a clip capable of clipping targeted tissue from the far side (opposite side) of a tissue defect, i.e., from the surface of the tissue facing away from (opposite side) a user (e.g., physician) or operator of the system, to close a tissue defect, such as a perforation, puncture, or other tissue opening. In an exemplary embodiment, the backside anastomosis clipping system can be used in conjunction with a lumen-apposing metal stent (LAM) that can be positioned to create a temporary passageway between two nonadherent structures, i.e., a first structure (e.g., stomach) and a second structure (e.g., jejunum), so that an endoscope can be passed from within the first structure (e.g., stomach) proximally into the second structure (e.g., jejunum) distally to provide treatment deeper within the GI tract.

[0025] Once treatment is provided, the LAM is removed, leaving a first perforation in the wall of the first structure and a second perforation in the wall of the second structure where the LAM was located. An exemplary clipping system can be inserted from the first structure into the second structure through the second perforation so that the second perforation can be clipped from the inside. This leaves the clip in a clipped state within the second structure, allowing the clip to pass naturally through the body once the second perforation has healed.

[0026] The first perforation can be closed using a conventional hemostatic clip. While exemplary embodiments show and describe the clip as being used in conjunction with a LAM positioned to provide a temporary passageway between loose structures, it will be understood by those skilled in the art that the clipping system of the present disclosure can be utilized in any of a variety of situations in which it is desirable to clip a tissue defect from the far (e.g., distal) side of the defect, including, for example, recovery of a procedure in which a complication (e.g., LAM migration, perforation, bleeding) occurs during the procedure (e.g., pancreatic fluid retention). It will also be understood by those skilled in the art that the terms "proximal" and "distal" as used herein refer to the direction toward the user (e.g., physician) of the device as proximal and the direction away from the user as distal.

[0027] 1-6, the backside anastomosis clipping system 100 includes a clip 102 configured to be inserted into a patient and clip target tissue from a far side of the target tissue, e.g., at the tissue surface facing away from a user of the system 100. The clip 102 includes a pair of clip arms 104 whose distal ends 106 are coupled to one another and slidably received within a barrel member 108 such that the pair of clip arms 104 are movable between an open configuration (shown in FIG. 1) in which proximal ends 110 of the pair of clip arms 104 are spaced apart to receive target tissue therebetween, and a closed configuration (shown in FIG. 2) in which the proximal ends 110 are drawn together to clip tissue received therebetween.

[0028] The system 100 further includes an elongate member 112 disposed between the pair of clip arms 104 such that a distal end 114 of the elongate member 112 contacts the distal ends 106 of the pair of clip arms 104 to distally hold the pair of clip arms 104 against the barrel member 108. The elongate member 112 in this embodiment is an incompressible, flexible tube (e.g., similar to a Bowden cable) having a cap / termination at the distal end 114. A control member 116 extends through the elongate member 112 and the distal ends 106 of the clip arms 104 and is releasably coupled to the distal end 118 of the barrel member 108. Thus, longitudinal movement of the control member 116 relative to the elongate member 112 correspondingly moves the barrel member 108 relative to the clip arms 104, operating the clip 102 between an open configuration and a closed configuration. In particular, pulling the control member 116 proximally relative to the elongate member 112 causes the barrel member 108 to move proximally over the pair of clip arms 104, thereby transitioning the clip 102 to a closed configuration, and advancing the control member 116 distally relative to the elongate member 112 allows the pair of clip arms 104 to proximally escape the barrel member 108 and assume an open configuration.

[0029] If desired, once the target tissue has been clipped, the control member 116 can be pulled further proximally relative to the elongate member 112, as shown in Figure 3, to lock the barrel member 108 over the clip arms 104 in the closed configuration. Once the clip 102 is locked in the closed configuration, the control member 116 is moved further proximally until it is separated or otherwise released from the barrel member 108 to deploy the clip 102 within the body, as shown in Figure 4, as will be described in more detail below.

[0030] As described above, the pair of clip arms 104 extend from coupled distal ends 106 to proximal ends 110 that can move toward and away from each other between a closed configuration and an open configuration. The proximal ends 110 of each of the pair of clip arms 104 include a pair of inwardly curved fingers 120 that are sized, shaped, and configured to extend around and along opposing sides of the elongate member 112 when the pair of clip arms 104 are in the closed configuration, as shown in FIG. Thus, when the clip 102 is transitioned to the closed configuration, each of the pair of fingers 120 of a first of the pair of clip arms 104 extends toward the corresponding finger 120 of the second of the pair of clip arms 104, thereby grasping target tissue between the fingers 120. In an exemplary embodiment, a proximal end 122 of each of the fingers 120 includes a gripping feature to facilitate grasping tissue between the pair of clip arms 104.

[0031] 5, the proximal ends 122 of the fingers 120 taper to pointed tips so that when the pair of clip arms 104 are transitioned to the closed configuration, the pointed tips of a corresponding pair of the fingers 120 of the fingers 120 overlap each other to grasp tissue therebetween. In another example, as shown in FIG. 6, the proximal end 222 of each finger 220 of a first clip arm 204 of the pair of clip arms 204 is sized and shaped to correspond to the proximal end 222 of the corresponding finger 220 of a second clip arm 204 of the pair of clip arms 204 such that when the pair of clip arms 204 are drawn together, the finger 220 of a first clip arm 204 of the pair of clip arms 204 interlocks with the finger 220 of a second clip arm 204 of the pair of clip arms 204. However, it will be understood by those skilled in the art that the proximal ends 122, 222 of the fingers 120, 220 of a pair of clip arms 104, 204 may have any of a variety of configurations so long as the fingers 120, 220 are configured to grasp tissue therebetween. It will also be understood by those skilled in the art that tissue gripping features may be located around or on the sides of the elongate member 112 where the fingers 220 of a pair of clip arms contact one another. This may provide some increased tissue pressure against the shaft, but because the locking mechanism is on the side where the jaws contact, withdrawing the shaft does not disrupt the jaws' hold on the tissue.

[0032] In the exemplary embodiment, the pair of clip arms 104 are biased to the open configuration so that as the barrel member 108 moves distally relative to the pair of clip arms 104, the pair of clip arms 104 gradually become unconstrained as they move proximally from the barrel member 108, causing the proximal ends 110 of the pair of clip arms 104 to follow their natural bias and move away from each other to the open configuration. When the barrel member 108 is pulled proximally over the pair of clip arms 104, the pair of clip arms 104 are constrained by the walls of the barrel member 108 to the closed configuration, causing the fingers 120 of each of the pair of clip arms 104 to be drawn radially inward and extend around the elongate member 112 along opposite sides of the elongate member 112.

[0033] Additionally, each of the pair of clip arms 104 may include a locking feature configured to engage a portion of the barrel member 108 to lock the barrel member 108 over the pair of clip arms 104 in the closed configuration. In an exemplary embodiment, the locking feature includes a locking tab 124 (e.g., a particular locking tab on each of the pair of clip arms 104) extending laterally outward. Each locking tab 124 extends from an outer surface 126 of a corresponding one of the pair of clip arms 104 and faces away from the elongate member 112.

[0034] As described in further detail below, the locking tabs 124 are sized, shaped, and configured to engage a portion of the barrel member 108 when the locking tabs 124 engage the barrel member 108 so that the pair of clip arms 104 are locked relative to the barrel member 108 in the closed configuration. In the exemplary embodiment, each locking tab 124 is biased to a locked configuration in which the locking tabs 124 extend laterally outward from the longitudinal axis of the clip 102. A distal end 128 of each of the pair of locking tabs 124 is coupled to an outer surface 126 of the clip arm 104, and each of the pair of locking tabs 124 extends to a proximal end 130 that is freely movable relative to the proximal end 110 of the clip arm 104.

[0035] Each locking tab 124 is configured to deflect toward the longitudinal axis of the clip 102 and the outer surface 126 of the clip arm 104 (i.e., the proximal end of each locking tab 124 is forced radially inward toward the longitudinal axis upon contact with the barrel member 108) when the barrel member 108 is slid proximally over the clip arm 104. When the proximal end 130 of each of the pair of locking tabs 124 then reaches a corresponding locking window 142, it follows its natural bias to spring laterally away from the longitudinal axis of the clip 102 and assumes the locked configuration. The angle of the laterally extending locking tabs 124 is selected such that when one or both of the pair of locking tabs 124 are received within the corresponding locking window 142 in the locked configuration, the barrel member 108 is prevented from being moved distally from the clip arm 104.

[0036] According to the exemplary embodiment, the pair of clip arms 104 are formed from a single element 132 that includes a bend 134 to define the pair of clip arms 104. The bend 134 in this embodiment extends between the distal ends 106 of the pair of clip arms 104, and the bend 134 includes an opening 136 therethrough. The opening 136 is sized and configured to receive the control member 116 therethrough. However, it will be understood by those skilled in the art that the pair of clip arms 104 may be formed from two or more elements and may have any of a variety of configurations so long as the pair of distal ends 106 are coupled to one another and are capable of accommodating the control member 116 such that the pair of clip arms 104 can be moved between open and closed configurations, as described herein.

[0037] The barrel member 108 extends from a closed distal end 118 to an open proximal end 138 such that a cavity 140 is defined within the barrel member 108. The distal ends 106 of the pair of clip arms 104 are slidably received within the cavity 140 and are configured to move longitudinally relative to the cavity 140 to move the pair of clip arms 104 between an open configuration and a closed configuration. The barrel member 108 includes a plurality of engagement features configured to engage with the locking features of the pair of clip arms 104. In the exemplary embodiment, the length of the barrel member 108 is selected such that when the barrel member 108 is locked over the pair of clip arms 104, the distal end 118 of the barrel member 108 contacts and / or engages the distal ends 106 (or bends 134) of the pair of clip arms 104, preventing further proximal movement of the barrel member 108 relative to the pair of clip arms 104.

[0038] As mentioned above, in the exemplary embodiment, the plurality of engagement features include a plurality of locking windows 142 extending through a wall 144 of the barrel member 108, each of the plurality of locking windows 142 being sized, shaped, and configured to receive a corresponding one of the locking tabs 124 therein. The plurality of locking windows 142 extend through a portion of the wall 144 positioned such that when the locking tabs 124 are received within the locking windows 142, the clip 102 is locked in the closed configuration. To lock the barrel member 108 over the pair of clip arms 104, the barrel member 108 is pulled proximally relative to the pair of clip arms 104 until each of the pair of locking tabs 124 flips outward through a corresponding one of the plurality of locking windows 142.

[0039] While the exemplary embodiment has been shown and described as including a pair of clip arms 104 that include a plurality of locking tabs 124 and a barrel member 108 that includes a plurality of locking windows 142, it will be understood by those skilled in the art that the pair of clip arms 104 and the barrel member 108 may include any of a variety of corresponding features or structures configured to engage with one another and lock the barrel member 108 over the pair of clip arms 104 in a closed configuration.

[0040] The elongate member 112 extends from a proximal end (not shown), which may include an actuator outside the body for user access, and a distal end 114 that is inserted into the body to reach a site adjacent the target tissue to be clipped. The elongate member 112 includes a lumen 146 extending therethrough. As described above, the elongate member 112 is positioned between the pair of clip arms 104 such that the distal end 114 contacts the distal ends 106 of the pair of clip arms 104, thereby distally holding the pair of clip arms 104 against the barrel member 108. In one embodiment, the distal end 114 of the elongate member 112 is pushed or held distally against a bend 134 extending between the distal ends 106 of the pair of clip arms 104. In one embodiment, the elongate member 112 may include a Bowden cable shaft. However, it will be understood by those skilled in the art that the elongate member 112 may include any catheter or other non-compressible elongate element configured to facilitate insertion of the clip 102 into a target area within a patient's body, for example, through an endoscope.

[0041] The control member 116 is releasably coupled to the barrel member 108 and extends from a user-accessible proximal end (not shown) to a distal end 148. In the exemplary embodiment, the control member 116 extends through a lumen 146 of the elongate member 112 and through an opening 136 through the bent portion 134 of the pair of clip arms 104, such that the distal end 148 extends distally beyond the distal ends 106 of the pair of clip arms 104 and can be coupled to the distal end 118 of the barrel member 108. Thus, the control member 116 can be moved longitudinally relative to the elongate member 112, which distally holds the pair of clip arms 104 relative to the barrel member 108, to move the barrel member 108 longitudinally relative to the pair of clip arms 104 to operate the clip 102 between an open configuration and a closed configuration.

[0042] In particular, moving the control member 116 proximally relative to the elongate member 112 draws the barrel member 108 proximally over the pair of clip arms 104 such that the proximal ends 110 of the pair of clip arms 104 are moved radially inward toward each other and toward the elongate member 112 extending therebetween. Thus, when the proximal ends 110 of the pair of clip arms 104 are positioned near tissue and transitioned to the closed configuration, the tissue is grasped between the fingers 120 of the pair of clip arms 104 and pressed against the elongate member 112 with a force that is less than the grasping force applied to the tissue by the fingers 120 against the elongate member 112. Moving the control member 116 distally relative to the elongate member 112 allows the pair of clip arms 104 to move proximally out of the barrel member 108, thereby allowing the pair of clip arms 104 to return to the open configuration. The clip 102 may be moved between the open and closed configurations, as described, until the target tissue is grasped as desired.

[0043] It will be understood by those skilled in the art that, as the pair of clip arms 104 are biased toward the open configuration, moving the control member 116 distally relative to the elongate member 112 releases tension along the elongate member 112, thereby allowing the barrel member 108 to slide distally away from the pair of clip arms 104 as the pair of clip arms 104 follow their natural bias and move toward the open configuration. Thus, the pair of clip arms 104 maintain contact with the distal end 114 of the elongate member 112, thereby holding / pressing the pair of clip arms 104 against the barrel member 108 until final deployment of the clip 102, as described in more detail below.

[0044] In the illustrative embodiment, the distal end 148 of the control member 116 includes a ball or other enlarged shape configured to be received within a correspondingly shaped socket 154 or recess in a proximal face 156 of the distal end 118 of the barrel member 108. The distal end 148 may be coupled to the remaining length 150 of the control member 116 via a joint 152 configured to break, release, or otherwise separate upon receiving a preset threshold force. In one embodiment, the joint 152 is configured as a reduced diameter portion of the control member 116. In another embodiment, the joint 152 is configured as an adhesive subject to breaking upon application of at least a preset amount of force. In yet another embodiment, the joint 152 is configured as a releasable coupling. However, it will be understood by those skilled in the art that the joint 152 may have any of a variety of configurations, so long as the joint 152 is configured to separate the distal end 148 from the remaining length 150 upon receiving a preset threshold force. In another exemplary embodiment, rather than having a joint 152 that is releasable, the distal end 148 may be coupled to the distal end 118 of the barrel member via a releasable connection that breaks, releases, or otherwise separates when subjected to a preset threshold force.

[0045] Thus, once the barrel member 108 is locked over the pair of clip arms 104, when it is desired to transition the clip 102 to the deployed configuration, a preset threshold force can be applied to the control member 116 and the control member 116 can be pulled proximally relative to the elongate member 112 until the control member 116 separates from the barrel member 108. The system 100 is configured such that, once this separation occurs, the locking tabs 124 are received within the locking windows 142, and the clip 102 is locked closed over the clipped tissue when separated from the elongate member 112. The elongate member 112 and control member 116 can then be removed proximally from between the pair of clip arms 104, leaving only the clip 102 clipped over the target tissue.

[0046] In a further exemplary embodiment, the pair of clip arms 104 includes a plurality of surface features along the outer surface 126 of the pair of clip arms 104 and / or the barrel member 108, configured to enable echo imaging of the clip 102. As will be appreciated by one skilled in the art, these surface features create an angled (slanted) surface that changes the angle of incidence of ultrasound energy at the outer surface 126, resulting in different angles of reflection, including back toward the transducer, for improved visibility in ultrasound imaging.

[0047] According to an exemplary method utilizing the clipping system 100, the clip 102 is used to treat a tissue defect, such as a tissue perforation, puncture, or other opening formed during the creation of a passageway or tract between adjacent structures. In an exemplary embodiment, as shown in FIG. 7 , a lumen-apposing metal stent (LAM) 30 is used to create a temporary passageway between non-apposed structures in a patient's gastrointestinal (GI) tract. As will be appreciated by those skilled in the art, the LAM 30 may be used to create a passageway further along the GI tract from within a first structure / body lumen 10 (e.g., stomach) to the interior of a second structure 20 (e.g., jejunum) to enable the delivery of endoscopic treatment to regions deeper along the GI tract. As shown in FIG. 8 , once the GI tract has been treated and the LAM 30 has been removed, the first and second perforations 15, 25 in the first structure 10 and second structure 20, respectively, remain and must be closed.

[0048] To close such an opening, clip 102 of system 100 may be inserted into a patient's body in a closed configuration, for example, via an endoscope advanced through a physiological body lumen (e.g., esophagus, stomach, etc.). Clip 102 is inserted through first structure 10 and into second structure 20 via first perforation 15 and second perforation 25, respectively. Once clip 102 is inserted into second structure 20, clip 102 may be transitioned to an open configuration by releasing tension along control member 116 and allowing barrel member 108 to slide distally along pair of clip arms 104 as proximal ends 110 of pair of clip arms 104 are moved away from each other according to their natural bias.

[0049] The proximal ends 110 of the pair of clip arms 104 may then be positioned near the second perforation 25 and transitioned to the closed configuration by pulling the control member 116 proximally relative to the elongate member 112 such that the barrel member 108 is moved proximally over the pair of clip arms 104. As the pair of clip arms 104 are drawn toward each other toward the closed configuration, tissue is grasped between the fingers 120 of the pair of clip arms 104 and compressed around the elongate member 112. The clip 102 may be reopened if the user does not feel that the tissue is grasped as desired. The clip 102 may be moved between the open and closed configurations as desired until the tissue at the second perforation 25 is clipped.

[0050] Once the tissue in the second perforation 25 has been clipped as desired, the clip 102 is locked in the closed configuration by further pulling the control member 116 proximally relative to the elongate member 112 until the locking tabs 124 of the pair of clip arms 104 engage the plurality of locking windows 142 in the barrel member 108. Once the clip 102 is locked, the clip 102 may be deployed by further pulling the control member 116 proximally relative to the elongate member 112 until the force applied to the control member 116 meets a predetermined threshold, causing the control member 116 to separate from the barrel member 108. The control member 116 and the elongate member 112 are then withdrawn proximally from between the pair of clip arms 104, leaving the clip 102 clipped against the targeted tissue in the second perforation 25, as shown in FIG. 9 .

[0051] As will be appreciated by those skilled in the art, system 100 enables clipping of the second structure in the lumen of the target tissue such that clip 102 may naturally fall off and pass through the body as the tissue heals. Upon clipping second perforation 25 of second structure 20, first perforation 15 may be treated using one or more conventional hemostatic clips 40 or any other desired method.

[0052] 10-12 , a reverse anastomosis closure system 300 according to another exemplary embodiment of the present disclosure is substantially similar to system 100 described above, except as described below. System 300 includes a closure device 302 configured to close a tissue defect from the far (opposite) side of the tissue defect. System 300 further includes an elongate member 312 configured to enable insertion of closure device 302 into a target region, a control member 316 to enable placement of closure device 302, and an outer sheath 360 through which closure device 302 can be delivered to the target region. Similar to system 100, system 300 may be used in conjunction with a LAM used to create a temporary passageway between a first structure (e.g., the stomach) and a second structure (e.g., the jejunum) further along the gastrointestinal (GI) tract of a patient. During treatment of the GI tract, the LAM is removed, leaving a first perforation in the first structure and a second perforation in the second structure, which can be treated luminally via system 300.

[0053] As shown in FIG. 10 , the closure device 302 includes a plurality of wire struts 304 coupled to an expandable, non-permeable membrane 362, such that the struts 304 can move relative to one another to move the membrane 362 between a folded configuration and an expanded configuration, substantially similar to an umbrella. The membrane 362 in this embodiment is formed from a non-permeable, biocompatible material, such as nylon, a rubberized material, or any other suitable material, such as polyethylene, polypropylene, and Teflon. Each of the plurality of struts 304 extends from a proximal end 310 to a distal end 306. The distal ends 306 of the plurality of struts 304 are coupled to be movable relative to one another such that, in the folded configuration, the proximal ends 310 move toward one another and the membrane 362 folds upon itself. In the expanded configuration, the proximal ends 310 of the plurality of struts 304 move radially outward relative to one another, causing the membrane 362 to have a substantially dome shape.

[0054] The proximal ends 310 of the plurality of struts 304 are tapered and / or pointed so that when the closure device 302 in the expanded configuration is pulled proximally against the interior surface of the second structure, the plurality of proximal ends 310 can grasp and / or abut against tissue surrounding the second perforation, enabling closure of the second perforation. As will be appreciated by those skilled in the art, these ends can also exert a radially inward force, drawing the edges of the plurality of anastomoses closer together to promote healing. In an exemplary embodiment, the plurality of proximal ends 310 grasp the tissue surrounding the second perforation, enabling the membrane 362 to completely cover and close the second perforation in the expanded configuration.

[0055] The outer sheath 360 is configured as a substantially tubular member sized and shaped to be inserted, for example, through a working channel of an endoscope and into a target area (e.g., through the first and second perforations and into the interior of a second structure). The outer sheath 360 includes a channel 364 extending therethrough, the channel 364 sized and shaped to slidably receive the closure device 302 therein. In the exemplary embodiment, the struts 304 are biased toward an expanded configuration in which the proximal ends 310 of the struts 304 are spaced apart from one another and the membrane 362 has an expanded dome shape. When the closure device 302 is received within the outer sheath 360, the closure device 302 is constrained in a collapsed configuration. However, once the closure device 302 is inserted into the target area, the closure device 302 is moved distally from the outer sheath 360, allowing the closure device 302 to return to its naturally biased expanded configuration.

[0056] The elongate member 312 is substantially similar to the elongate member 112, extending longitudinally from a proximal end (not shown) to a distal end 314 and including a channel 346 therethrough. The elongate member 312 is disposed between the struts 304, with the distal end 314 located proximal to and in contact with the joined distal ends 306 of the struts 304. The elongate member 312 can be moved distally relative to the outer sheath 360 to transition the closure device 302 from a collapsed configuration to an expanded configuration. In the collapsed configuration, the closure device 302 is contained within the outer sheath 360. However, moving the elongate member 312 distally relative to the outer sheath 360 pushes the closure device 302 distally out of the outer sheath 360, thereby allowing the closure device 302 to return to its biased expanded configuration.

[0057] The control member 316 is substantially similar to the control member 116 and extends through a channel 346 in the elongate member 312 such that a distal end 348 of the control member 316 extends distally from the distal end 314 of the elongate member 312 and is connected to the distal ends 306 of the plurality of struts 304. Like the control member 116, the control member 316 is configured to release or otherwise separate from the closure device 302 upon receiving a preset threshold force. In particular, when it is desired to deploy the closure device 302, the control member 316 is pulled proximally relative to the elongate member 312, which in turn pulls the closure device 302 proximally relative to the distal end 314 of the elongate member 312 and exerts a proximal force on the control member 316.

[0058] As described above, system 300 can be used in a manner substantially similar to system 100. In an exemplary embodiment, as shown in FIGURE 11 , upon insertion of closure device 302 into a second structure through a second perforation, closure device 302 transitions from a collapsed configuration to an expanded configuration by pushing the closure device distally out of outer sheath 360 via elongate member 312. Once in the expanded configuration, closure device 302 is moved proximally against tissue surrounding the second perforation via control member 316, allowing proximal ends 310 of multiple struts 304 to grasp the tissue and membrane 362 to completely cover the opening of the second perforation.

[0059] The closure device 302 can then be deployed by pulling the control member 316 further proximally relative to the elongate member 312 until the force applied to the control member 316 reaches a threshold at which the control member 316 separates from the closure device 302. The elongate member 312 and control member 316 are then removed from the body, leaving the closure device 302 in the lumen, covering the second perforation, as shown in FIGURE 12. The first perforation may then be clipped and / or closed, for example, using a conventional hemostatic clip or any other desired method, as described above with respect to the system 100.

[0060] Those skilled in the art will appreciate that the above-described embodiments may be modified without departing from the concept of the present invention. Furthermore, it will be appreciated that structural features and methods associated with one embodiment may be incorporated into other embodiments. Therefore, it will be appreciated that the present invention is not limited to the specific embodiments described, and that modifications are within the scope of the present invention as defined by the appended claims.

Claims

1. 1. A backside anastomosis clipping system comprising: a clip including a barrel member extending from an open proximal end to a closed distal end and defining a cavity therein; and a pair of clip arms, the distal ends of the pair of clip arms coupled to one another and slidably received within the cavity of the barrel member between an open configuration in which the proximal ends of the pair of clip arms are spaced apart to receive target tissue therebetween, and a closed configuration in which the proximal ends of the pair of clip arms are moved toward one another to grasp the target tissue; an elongate member extending from a proximal end to a distal end and extending between the pair of clip arms, the elongate member including a lumen extending longitudinally therethrough, the distal end of the elongate member contacting the distal ends of the pair of clip arms and distally retaining the pair of clip arms against the barrel member; a control member slidably received within the lumen of the elongate member, the control member having a distal end extending distally beyond the distal end of the elongate member and the distal ends of the pair of clip arms and coupled to the distal end of the barrel member, wherein longitudinal movement of the control member relative to the elongate member moves the pair of clip arms between the open configuration and the closed configuration.

2. The back-side anastomotic clipping system of claim 1 , wherein the control member is releasably coupled to the barrel member.

3. 3. The back-side anastomosis clipping system of claim 2, wherein the distal end of the control member is coupled to a remaining length of the control member via a joint configured to separate the expanding distal end from the remaining length of the control member upon exposure to a force exceeding a preset threshold.

4. 4. The back-side anastomosis clipping system according to claim 1, wherein the proximal end of each of the pair of clip arms includes a pair of fingers that extend along opposite sides of the elongate member when the clip is in the closed configuration, and wherein each of the pair of fingers of a first clip arm of the pair of clip arms extends toward a corresponding finger of a second clip arm of the pair of clip arms.

5. 5. The back-side anastomosis clipping system of claim 4, wherein the fingers of each of the pair of clip arms are pointed, and when the pair of clip arms are in the closed configuration, the fingers of the first clip arm of the pair overlap the fingers of the second clip arm of the pair of clip arms.

6. 5. The back-side anastomosis clipping system of claim 4, wherein each of the pair of fingers of the first clip arm of the pair of clip arms is sized and shaped to correspond to a corresponding finger of the second clip arm of the pair of clip arms, and wherein the fingers of the first and second clip arms interlock with each other when the pair of clip arms is in the closed configuration.

7. 7. The back-side anastomosis clipping system according to claim 1, wherein the pair of clip arms are formed from a single member that is bent to define the pair of clip arms, and a bend extends in the single member between the distal ends of the pair of clip arms.

8. 8. The back-side anastomosis clipping system of claim 7, wherein the bent portion of the single member includes an opening therethrough, the opening being sized and shaped to receive the control member therein and configured to receive the control member therein.

9. Each of the pair of clip arms The back-side anastomosis clipping system of any one of claims 1 to 8, including a locking tab extending laterally outward from the clip arm and configured to engage a corresponding engagement feature of the barrel member in a locked configuration.

10. The back-side anastomotic clipping system of claim 9 , wherein the corresponding engagement feature includes a window through a wall of the barrel member, the window configured to receive the locking tab therein.

11. 11. The back-side anastomosis clipping system according to claim 1, wherein the pair of clip arms are biased to the open configuration, and when the barrel member is moved proximally while covering the pair of clip arms, the pair of clip arms are constrained to the closed configuration, and when the barrel member is slid distally along the pair of clip arms, the pair of clip arms can return to the biased open configuration of the pair of clip arms.

12. 1. A backside anastomosis clipping system comprising: a lumen-apposing metallic stent configured to provide a temporary passageway between a first structure in the gastrointestinal tract and a second structure distal to the first structure in the gastrointestinal tract via a first tissue perforation extending through a wall of the first structure and a second tissue perforation extending through a wall of the second structure; a clip configured to be inserted into the second structure through the second tissue perforation during removal of the lumen-apposing metallic stent to close the second tissue perforation from within the second structure, the clip including a pair of clip arms having distal ends coupled to one another and received within a cavity of the barrel member for movement relative to the barrel member between an open configuration in which proximal ends of the pair of clip arms are moved away from one another and a closed configuration in which the proximal ends of the pair of clip arms are moved toward one another; an elongate member extending from a proximal end to a distal end, the elongate member including a lumen extending therethrough, the elongate member positioned between the pair of clip arms such that the distal end of the elongate member is pressed distally against the distal ends of the pair of clip arms and distally holds the pair of clip arms against the barrel member; a control member slidably received within the lumen of the elongate member, the control member extending from a proximal end to a distal end, the distal end extending distally beyond the distal end of the elongate member and the distal ends of the pair of clip arms, the control member being releasably coupled to the distal end of the barrel member, wherein longitudinal movement of the control member relative to the elongate member moves the pair of clip arms between the open configuration and the closed configuration.

13. 13. The back-side anastomosis clipping system of claim 12, wherein the distal end of the control member is an enlarged ball received in a correspondingly shaped socket on a proximal face of the distal end of the barrel member, the enlarged ball being coupled to the remaining length of the control member via a joint configured to separate the enlarged distal end from the remaining length of the control member upon exposure to a force exceeding a preset threshold.

14. 14. The back-side anastomosis clipping system of claim 12 or 13, wherein the proximal end of each of the pair of clip arms includes a pair of fingers that extend along opposite sides of the elongate member when the clip is in the closed configuration, and wherein each of the pair of fingers of a first clip arm of the pair extends toward a corresponding finger of a second clip arm of the pair of clip arms.

15. Each of the pair of clip arms a locking tab extending laterally outward from said clip arm; The locking tab 15. The back-side anastomosis clipping system according to claim 12, wherein the clip arms are configured to engage corresponding windows through a wall of the barrel member to lock the barrel member over the pair of clip arms in the closed configuration.

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