Collet deployable hemostasis clip

Abstract

To provide a clipping system easy to use.SOLUTION: A clipping system comprises a catheter 104, a clip 102, a collet 106, and a control member 116. The clip 102 includes a capsule 112 and a pair of clip arms 108. The clip arms 108 are slidably received within the channel 130 of the capsule 112 between an open configuration and a closed configuration. The collet 106 is slidably mounted over the catheter 104 between an insertion configuration and a deployed configuration. In the insertion configuration, the collet 106 is positioned over the distal portion of the catheter 104 to press the distal portion against the capsule 112. In the deployed configuration, the collet 106 is proximal the distal portion so that the clip 102 is releasable from the catheter 104. The control member 116 is connected to the clip arms 108 and the collet 106. The movement of the clip arms 108 and the movement of the collet 106 are controlled by the longitudinal movement of the control member 116.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] This disclosure relates to an endoscopic device, and more particularly to an endoscopic clipping device for treating tissue along the gastrointestinal tract. This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 261,046, filed September 9, 2021, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Physicians are now more willing to perform aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of perforating the wall of the GI tract or may require closure of the GI tract as part of the procedure. Such procedures may include, for example, removal of large lesions, tunneling beneath the mucosal layer of the GI tract to treat submucosal problems, full-thickness removal of tissue, treatment of problems on other organs by passing outside the GI tract, and endoscopic treatment / repair of post-surgical problems (e.g., post-surgical leaks, surgical staple line breakdown, and anastomotic leaks). Currently, tissue can be treated with endoscopic closure devices, such as hemostatic clips, inserted through an endoscope. Depending on the size of the defect, multiple clips may be required. However, in some cases, current endoscopic closure devices may be difficult to use, time-consuming to position, or inadequate for certain perforations, conditions, and anatomical structures. Summary of the Invention

[0003] The present disclosure relates to a clipping system for treating tissue. The system includes an insertion device extending longitudinally from a proximal end to a distal end. The insertion device includes a channel extending therethrough and a plurality of longitudinal slots extending through a wall of the insertion device and along a distal portion of the insertion device, opening to the channel and the distal end. The system further includes a clip releasably received within the distal portion of the insertion device. The clip includes a capsule extending longitudinally from the proximal end to the distal end, the capsule including a channel extending therethrough. The clip includes a pair of clip arms, the proximal ends of which are slidably received within the channel of the capsule to move the pair of clip arms between an open configuration in which the distal ends of the pair of clip arms are spaced apart to receive tissue therebetween and a closed configuration in which the distal ends of the pair of clip arms are drawn together to grasp tissue therebetween.

[0004] The system further includes a collet slidably mounted to the insertion device, the collet movable between an insertion configuration in which the collet is disposed on the distal portion of the insertion device and presses the distal portion against the capsule to retain the capsule therein, and a deployed configuration in which the collet is positioned proximal to the distal portion to enable release of the clip from the distal portion of the insertion device. The system further includes a control member extending within the channel of the insertion device, the control member coupled to the proximal ends of the pair of clip arms and a portion of the collet such that movement of the clip between the open and closed configurations and movement of the collet between the insertion and deployed configurations are controlled by longitudinal movement of the control member relative to the insertion device.

[0005] In one embodiment, the system further includes a yoke coupling the control member to the pair of clip arms and the collet, the yoke including a distal portion connected to the pair of clip arms and a proximal portion connected to a portion of the collet, the distal and proximal portions of the yoke being connected to one another by a separable connection configured to separate upon application of a predetermined force exceeding a predetermined threshold.

[0006] In one embodiment, the distal portion is received between the proximal ends of the pair of clip arms, and the distal portion includes protrusions extending from opposite sides of the distal portion, the protrusions being received within openings through the proximal portions of the pair of clip arms.

[0007] In one embodiment, the proximal portion houses the distal end of the control member, the proximal portion including a longitudinal groove extending along the proximal portion, and an engagement tab of the collet extending into the channel of the insertion device is slidably received in the longitudinal groove. In one embodiment, the length of the longitudinal groove corresponds to the distance the control member moves relative to the insertion device during movement of the clip between the open and closed configurations.

[0008] In one embodiment, the proximal ends of the pair of clip arms are biased radially outward and include locking structures extending laterally therefrom that engage a proximal edge of the capsule when the proximal ends of the pair of clip arms are moved proximal to the proximal end of the capsule to lock the clip in the closed configuration.

[0009] In one embodiment, the pair of clip arms include an engagement mechanism configured to engage a portion of the capsule, and when the engagement mechanism engages the capsule, the pair of clip arms are prevented from moving further proximally relative to the capsule and a predetermined force is applied to the distal end of the control member.

[0010] In one embodiment, the distal ends of the pair of clip arms are biased toward the open configuration, and when the pair of clip arms are retracted into the capsule, the pair of clip arms are constrained toward the closed configuration by the inner surface of the capsule, and when the pair of clip arms move distally out of the capsule, the pair of clip arms can return to the biased open configuration.

[0011] In one embodiment, the capsule is secured to the insertion device such that rotation of the insertion device causes a corresponding rotation of the clip. In one embodiment, the insertion device is secured to the collet such that rotation of the insertion device causes corresponding rotation of the collet and clip.

[0012] In one embodiment, the insertion device further includes a crimp tab positioned distally against the proximal end of the collet in the inserted configuration and extending into the channel of the insertion device, the crimp tab being deformable to allow the collet to move proximally past the crimp tab upon application of a predetermined force through the collet that exceeds a predetermined threshold.

[0013] The present disclosure also relates to a clipping system including a catheter extending longitudinally from a proximal end to a distal end, the catheter including a channel extending therethrough and a plurality of longitudinal slots extending through the wall of the catheter from the distal end along a distal portion of the catheter. The clipping system also includes a clip including a capsule extending longitudinally from the proximal end to the distal end, the capsule including a channel extending therethrough, and the clip including a pair of clip arms, the proximal ends of the pair of clip arms being slidably received within the channel of the capsule for moving the pair of clip arms between an open configuration and a closed configuration, the capsule of the clip being configured to be releasably received within the distal portion of the catheter. The clipping system also includes a collet slidably mounted on the catheter. The collet is movable between an insertion configuration in which the collet is disposed over the distal portion of the catheter and presses the distal portion against the capsule to retain the capsule therein, and a configuration in which the collet is positioned proximal to the distal portion to enable release of the clip from the distal portion of the catheter. The clipping system also includes a control member connected to the pair of clip arms and the collet by a yoke. The yoke has a distal portion connected to the pair of clip arms and a proximal portion connected to a portion of the collet, the distal and proximal portions of the yoke being connected to one another by a separable connection configured to separate upon application of a predetermined force exceeding a predetermined threshold.

[0014] In one embodiment, the proximal portion houses the enlarged distal end of the control member and includes a longitudinal groove extending along the proximal portion, and an engagement tab of the collet extending into the channel of the catheter is slidably received within the longitudinal groove.

[0015] In one embodiment, the proximal ends of the pair of clip arms are biased radially outward and include locking structures extending laterally therefrom that engage a proximal edge of the capsule when the proximal ends of the pair of clip arms are moved proximal to the proximal end of the capsule to lock the clip in the closed configuration.

[0016] In one embodiment, the pair of clip arms include an engagement mechanism configured to engage a portion of the capsule, and when the engagement mechanism engages the capsule, the pair of clip arms are prevented from moving further proximally relative to the capsule and a predetermined force is applied to the distal end of the control member.

[0017] The present disclosure also relates to a method for treating target tissue. The method includes inserting a clip into a target site within a body via a catheter through a working channel of an endoscope. The clip is inserted via the endoscope in an insertion configuration. In the insertion configuration, the clip is received within a distal portion of the catheter and retained within the catheter by a collet mounted on the clip. The clip includes a capsule and a pair of clip arms slidably received within the capsule. The method includes moving the clip between an open configuration and a closed configuration with a control member coupled to the pair of clip arms until the selected target tissue is received between the distal ends of the pair of clip arms. The pair of clip arms are coupled to the control member by a yoke. The method further includes retracting the pair of clip arms further distally within the capsule until engagement tabs on the proximal ends of the pair of clip arms engage a portion of the capsule to lock the pair of clip arms in the closed configuration, and deploying the clip from the catheter by retracting the collet further proximally relative to the catheter with the control member until the collet is positioned proximally from the distal portion and the clip can be opened, a portion of the collet being slidably coupled to the yoke.

[0018] In one embodiment, deploying the clip includes pulling the control member proximally relative to the catheter until the yoke connecting the control member to the clip experiences a predetermined force exceeding a predetermined threshold, such that a proximal portion of the yoke connected to the distal end of the control member is separated from a distal portion of the yoke connected to the pair of clip arms.

[0019] In one embodiment, moving the clip between the open and closed configurations causes an engagement portion of the collet to slide within a longitudinal groove extending along the proximal portion of the yoke.

[0020] In one embodiment, when the engagement mechanisms of the pair of clip arms engage a portion of the capsule, the proximal and distal portions of the yoke separate from each other to prevent the pair of clip arms from moving further proximally relative to the capsule, while the control member is moved further proximally relative to the catheter.

[0021] In one embodiment, deploying the clip includes pulling the control member proximally relative to the catheter until the collet is pressed proximally against the crimp tabs of the catheter, allowing the collet to move proximally past the crimp tabs. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 shows a longitudinal side view of a clipping system according to an exemplary embodiment of the present disclosure in an insertion configuration. [Figure 2] FIG. 2 shows a partially perspective longitudinal side view of the system of FIG. 1 in an insertion configuration. [Figure 3] FIG. 3 shows a side view in longitudinal section of the system of FIG. 1 in the insertion configuration. [Figure 4] FIG. 4 shows a longitudinal side view of the system of FIG. 1 moving towards the deployed configuration. [Figure 5] FIG. 5 shows a partially perspective longitudinal side view of the system of FIG. 1 in a deployed configuration. [Figure 6] FIG. 6 shows a longitudinal side view of a clip in the open configuration according to the system of FIG. [Figure 7] FIG. 7 shows a perspective view of a clip in a closed configuration according to the system of FIG. [Figure 8] FIG. 8 shows a perspective longitudinal side view of the clip of FIG. [Figure 9] FIG. 9 shows another perspective view of the clip of FIG. [Figure 10] FIG. 10 illustrates a cross-sectional view of a clipping system in accordance with an exemplary embodiment. [Figure 11]FIG. 11 illustrates a cross-sectional view of a clipping system according to yet another exemplary embodiment. [Figure 12] FIG. 12 shows a partially transparent longitudinal side view of a system according to a further embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0023] The present disclosure may be further understood with reference to the following description and the accompanying drawings. In this disclosure, like elements are referred to by the same reference numerals. The present disclosure is directed to an endoscopic clipping system for treating, for example, internal tissue perforations, defects, and / or bleeding. An exemplary embodiment of the present disclosure describes a clipping system that includes a clip releasably coupled to a catheter via a collet that is slidable relative to the catheter to deploy the clip. The collet coupling allows for a shortened deployment clip compared to most current clips that include a joint at the proximal end of the clip that couples the clip to the catheter, while minimizing the possibility of the clip inadvertently re-engaging the catheter during or after deployment. A shorter deployment clip may improve visualization of the target site and allow for better maneuverability when deploying multiple clips.

[0024] The yoke of the deployment mechanism according to an exemplary embodiment includes a proximal portion configured to break and / or separate from the distal portion of the yoke, such that the proximal portion, connected to both the distal end of the control member and the proximal end of the collet, is completely separated and removed from the deployment clip during deployment and then removed from the body, eliminating any loose parts. Some current clip designs produce loose parts during the process of separating the clip from the catheter, which are left in the body after the procedure is completed. As larger defect cases, such as peroral endoscopic myotomy (POEM) and endoscopic submucosal dissection (ESD), become more common, physicians may prefer clips that can be embedded into tissue defects and do not produce loose parts. It will be understood by those skilled in the art that the terms proximal and distal, as used herein, are intended to refer to directions toward and away from the user of the system, respectively.

[0025] 1-9 illustrate a clipping system 100 for treating a tissue defect. The clipping system 100 includes a clip 102 releasably coupled to a catheter 104 via a collet 106 slidably mounted on the catheter 104 to move the clipping system 100 between an insertion configuration, as shown in FIGS. 1-3, and a deployment configuration, as shown in FIGS. 4-5. The clip 102 includes a pair of clip arms 108. Proximal ends 110 of the pair of clip arms 108 are slidably received within a capsule 112 such that the clip 102 is movable between an open configuration in which distal ends 114 of the pair of clip arms 108 are separated from one another, and a closed configuration in which the distal ends 114 are drawn together. In the insertion configuration, the capsule 112 is received within a distal section 160 of the catheter 104, and the collet 106 is positioned on the distal section 160 to retain the capsule 112 within the distal section 160.

[0026] Upon insertion of clip 102 into a target site within the body, clip 102 can be moved between an open configuration and a closed configuration by a control member 116 that extends from a distal end 118 coupled to clip arms 108 to a proximal end accessible to a user (e.g., a surgeon) of system 100, proximal to the proximal end of catheter 104. Control member 116 is connected to clip arms 108 via a yoke 120 that includes a distal portion 122 connected to clip arms 108 and a proximal portion 124 fixedly connected to distal end 118 of control member 116 and slidably connected to collet 106. Distal portion 122 and proximal portion 124 of yoke 120 are configured to split or separate from one another.

[0027] Thus, once the tissue has been grasped as desired by the clip arms 108, the clip 102 is deployed by pulling the control member 116 proximally relative to the catheter 104 until the clip arms 108 are locked relative to the capsule 112, the proximal portion 124 of the yoke 120 is separated from the distal portion 122 of the yoke 120, the collet 106 is pulled proximally relative to the catheter 104 to release the capsule 112 and clip 102 from the proximal portion of the device, and the device can then be withdrawn from the body leaving the clip 102 in position within the body clipped to the target tissue.

[0028] 6-9, clip 102 includes clip arms 108 and a capsule 112. Capsule 112 extends longitudinally from a proximal end 126 to a distal end 128 and includes a channel 130 extending therethrough. Distal end 128 of capsule 112 in this embodiment includes a pair of capsule tabs 132 extending therefrom and bent radially inward into channel 130. In one embodiment, capsule tabs 132 are radially opposed to one another such that capsule tabs 132 aid in aligning and positioning the pair of clip arms 108, as described in further detail below.

[0029] Each clip arm 108 extends from a proximal end 110 to a distal end 114. As described above, a proximal portion of each clip arm 108 is slidably received within channel 130. Specifically, the proximal end 110 of each clip arm 108 is slidably received within channel 130, allowing the clip 102 to be moved between an open configuration and a closed configuration by manipulation of control member 116. In one embodiment, the clip arms 108 are diametrically opposed to one another within channel 130 and extend along opposite sides of capsule tab 132.

[0030] In one embodiment, the clip arms 108 are biased toward the open configuration, such that as the clip arms 108 advance distally out of the capsule 112, they move away from each other under their inherent bias toward the open configuration. As the clip arms 108 are retracted proximally into the capsule 112, they are constrained by the walls of the capsule 112 and are retracted together toward a closed configuration in which their distal ends 114 are adjacent to each other. Those skilled in the art will appreciate that any number of other mechanisms for opening and closing the clip arms 108 may be employed.

[0031] The clip arms 108 of this embodiment further include an engagement feature 134 extending from the clip arms 108. The engagement feature is configured to engage a portion of the capsule 112, thereby preventing the clip arms 108 from moving further proximally relative to the capsule when the engagement feature 134 engages the capsule 112. In one embodiment, the engagement feature 134 extends laterally outward from a distal portion 136 of each clip arm 108, the distal portion 136 having a width greater than the width of a proximal portion 138 of the clip arm 108, which is sized and shaped to allow it to be retracted proximally into the capsule 112.

[0032] Thus, as the clip arms 108 are retracted proximally into the capsule 112, the engagement features 134 abut the capsule tabs 132 and / or the distal faces 140 of the capsule 112, preventing the distal portions 136 of the clip arms 108 from being retracted proximally into the capsule 112. The engagement features 134 are disposed along the clip arms 108 such that, once the engagement features 134 engage the capsule 112, the clip arms 108 have been retracted proximally enough into the capsule 112 to retract the clip arms 108 into a closed configuration. In one example, the engagement features 134 are configured as wings extending laterally from the longitudinal edges of the clip arms.

[0033] At least one of the proximal ends 110 of the clip arms 108 (in this embodiment, both proximal ends 110 of the clip arms 108 include a locking mechanism), such as, for example, a locking tab 142 extending from the proximal end 110, which is positioned and configured to engage a corresponding locking portion of the capsule 112 when the clip 102 is retracted proximally into the capsule 112 to a locked position. The proximal ends 110 of the clip arms 108, in this embodiment, are biased radially outward, away from the centerline of the capsule 112. Before the clip 102 is locked, the proximal ends 110 are constrained by the inner surface 144 of the capsule 112 such that the proximal ends 110 are slidable along the inner surface 144 of the channel 130 as the clip 102 moves between the open and closed configurations.

[0034] When target tissue is grasped by the clip arms 108 and it is desired to lock the clip arms 108 in the closed configuration, the clip arms 108 are pulled further proximally relative to the capsule 112 until the proximal ends 110 move proximally beyond the proximal end 126 of the capsule 112, whereupon the proximal ends 110 are no longer constrained by the capsule 112 and are free to move radially apart under their inherent bias. The locking tabs 142 extend radially outward to engage the proximal edges 146 of the capsule 112 to prevent the clip arms 108 from moving distally relative to the capsule 112 and retain the clip arms 108 in the closed configuration. In this embodiment, the distance between the engagement feature 134 and the locking tabs 142 of the clip arms 108 substantially corresponds to the length of the capsule 112.

[0035] In the locking configuration, the engagement feature 134 engages the distal end of the capsule 112 while the locking tab 142 extends proximally of the capsule 112, thereby locking the clip arms 108 in a closed configuration relative to the capsule 112. In the exemplary embodiment, the proximal portion 138 of each clip arm 108 further includes an opening 148 extending therethrough. As described in further detail below, the opening 148 receives a portion of the yoke 120 so that the pair of clip arms 108 can be held in a desired alignment with one another and so that the clip arms 108 can be connected to the control member 116.

[0036] According to one example, the clip 102 has a rigid length of approximately 0.25 inches (0.635 cm). As will be appreciated by those skilled in the art, the clip 102 may have a shorter length relative to other standard hemostatic clips. In particular, because the clip 102 does not require a separate coupling joint to connect the capsule 112 to the catheter 104, and because the clip arms 108 engage the proximal edge 146 of the capsule 112 rather than a locking structure along the length of the capsule 112, the capsule 112 may be reduced in length compared to typical hemostatic clipping devices. In one example, the capsule 112 may be reduced in length by approximately 0.10 inches (0.254 cm). However, it will be appreciated by those skilled in the art that the clip 102 and capsule 112 may have any of a variety of lengths, so long as the clip arms 108 are coupled to the control member 116 and the capsule 112 is configured to be received within the distal portion 160 of the catheter 104, as described in further detail below.

[0037] As described above, the clip arm 108 is connected to the control member 116 via the yoke 120. As shown in FIGS. 2 and 3 , the yoke 120 includes a distal portion 122 and a proximal portion 124 connected to each other by a separable connection 152 configured to break, fail, or separate when subjected to a predetermined force exceeding a threshold force. In one embodiment, the distal portion 122 and the proximal portion 124 are connected to each other by a frangible link including, for example, a reduced diameter portion configured to break when the yoke 120 is subjected to the predetermined force. In another embodiment, the distal portion 122 and the proximal portion 124 are connected to each other by corresponding mating features that deform and separate from each other when subjected to the predetermined force. However, one skilled in the art will appreciate that the distal portion 122 and the proximal portion 124 can be connected to each other by any of a variety of connections, provided that the distal portion 122 and the proximal portion 124 are configured to separate from each other when subjected to the predetermined force.

[0038] The distal portion 122 of the yoke 120 is received between the proximal ends 110 of the pair of clip arms 108. The distal portion 122 of the yoke 120 includes a pair of protrusions 150 extending from opposite sides, with each protrusion 150 received in a corresponding one of the openings 148 of the pair of clip arms 108 to maintain the desired alignment between the pair of clip arms 108. Thus, each protrusion 150 has a size and shape that corresponds to the shape of a corresponding one of the openings 148.

[0039] The proximal portion 124 of the yoke 120 extends longitudinally and receives the distal end 118 of the control member 116 within the proximal portion 124. In one embodiment, the control member 116 includes an enlarged distal end 118 that is received within a correspondingly sized and shaped recess 154 within the proximal portion 124 of the yoke 120. However, one skilled in the art will appreciate that the proximal portion 116 can be connected to the distal end 118 of the control member 124 in any of a variety of ways, provided that longitudinal movement of the control member 116 relative to the catheter 104 and capsule 112 causes a corresponding movement of the clip arm 108 to which the yoke 120 is connected, thereby maintaining the control member 116 connected to the proximal portion 124 when the proximal portion 124 of the yoke 120 is separated from the distal portion 122.

[0040] According to one embodiment, the proximal portion 124 further includes a longitudinal groove 156 extending longitudinally along an outer surface 158 of the proximal portion 124. The longitudinal groove 156 is configured to slidably receive a portion of the collet 106, as described in further detail below. In another embodiment, the proximal portion 124 includes a pair of longitudinal grooves 156 extending along opposite sides of the proximal portion 124. In yet another embodiment, the longitudinal grooves 156 extend laterally through the proximal portion 124 of the yoke 120 to receive a portion of the collet 106 from either side of the yoke 120 within the longitudinal grooves 156.

[0041] As described above, the clip 102 is releasably coupled to a catheter 104 (or any other flexible insertion device) as shown in FIGS. 1-5 , which is sized and configured for insertion into a target site within the body, for example, through the working channel of an endoscope. In one embodiment, the catheter 104 or other insertion device is sufficiently flexible to navigate the tortuous paths of a body lumen, as would be understood by one skilled in the art. The catheter 104 extends longitudinally from a distal end 162 to a proximal end outside the body, with the clip 102 inserted into the target site during use of the clipping system 100. The catheter 104 includes a channel 168 extending longitudinally therethrough.

[0042] The channel 168 is sized and shaped to receive the capsule 112 therein, and the distal portion 160 of the catheter 104 includes a plurality of longitudinal slots 164 extending through a wall 166 of the catheter 104. The longitudinal slots 164 open to the distal face 140 of the capsule 112 and communicate with the channel 168 so that the clip 102 can be received within the distal portion 160. The clip 102 is substantially coaxially received within the channel 168 such that a portion of the yoke 120 is received within the channel 168 and the control member 116 extends from the yoke 120 through the channel 168 to a proximal end accessible to a user of the system 100 (e.g., via any known actuator (not shown)). The distal end 162 of the catheter 104 includes a lip 172 extending therearound. The lip 172 functions as a stop that prevents the collet 106 from moving distally beyond the lip 172, as will be explained in more detail below.

[0043] In one embodiment, the catheter 104 includes two longitudinal slots 164 extending along the distal portion 160. The longitudinal slots 164 in this embodiment extend through the wall 166 along both sides of the catheter 104. In another embodiment, the catheter 104 includes three longitudinal slots 164 extending along the distal portion 160. The longitudinal slots 164 are, in certain embodiments, equally spaced circumferentially around the circumference of the catheter 104. While the exemplary embodiment specifically illustrates a catheter 104 including two or three longitudinal slots 164, one skilled in the art will understand that the catheter 104 may include any number of longitudinal slots 164. Additionally, although the exemplary embodiment illustrates and describes longitudinal slots 164 that are evenly spaced apart, those skilled in the art will appreciate that the catheter 104 may have any number of longitudinal slots 164 in any of a variety of configurations, provided that the longitudinal slots 164 facilitate slidable insertion of the capsule 112 into the distal portion 160.

[0044] Proximal to the longitudinal slot 164, the catheter 104 includes an engagement slot 170 extending through the wall 166 along a portion of the length of the catheter 104. The engagement slot 170 receives a portion of the collet 106 from the exterior of the capsule 112 within the channel 168 such that the collet 106 is slidably engaged with the longitudinal groove 156 in the proximal portion 124 of the yoke 120. In one embodiment, the catheter 104 includes one engagement slot 170. In another embodiment, the catheter 104 includes two engagement slots 170 extending through opposite portions of the catheter 104 and corresponding in size and position to the longitudinal groove 156 in the proximal portion 124 of the yoke 120.

[0045] The collet 106 is slidably mounted on the distal portion 160 of the catheter 104 for movement between an insertion configuration and a deployment configuration. As shown in FIGS. 1-3 , in the insertion configuration, the collet 106 is positioned on the distal portion 160 of the catheter 104 such that the distal portion 160 presses against the capsule 112 to retain the clip 102 within the capsule 112. Those skilled in the art will appreciate that the collet 106 may be mounted on the distal portion 160 and held in position on the distal portion 160 by a friction fit. In the insertion configuration, the collet 106 of this embodiment abuts against a lip 172 at the distal end 162 of the catheter 104, thereby preventing distal movement beyond the distal end 162 of the catheter 104 and thereby preventing interference with opening and closing of the clip arms 108. 4 and 5, as collet 106 moves toward the deployed configuration, it moves proximally along catheter 104 until it is positioned proximal to longitudinal slot 164 in catheter 104. In the deployed configuration, distal portion 160 of catheter 104 is no longer pressed against capsule 112, allowing clip 102 to be released from distal portion 160.

[0046] As will be appreciated by those skilled in the art, as collet 106 is moved on distal portion 160 toward the insertion configuration, the width of longitudinal slot 164 (i.e., the distance between the longitudinal sides of longitudinal slot 164) decreases, thereby reducing the inner diameter of distal portion 160 and tightly holding catheter 104 against capsule 112, thereby retaining capsule 112 and clip 102 within catheter 104. As collet 106 is moved toward the deployment configuration, the width of longitudinal slot 164 is allowed to increase, preventing distal portion 160 from being pressed tightly against capsule 112. Thus, clip 102 can be released from catheter 104 by pulling catheter 104 proximally away from clip 102.

[0047] The collet 106 in this embodiment includes a ring portion 174 sized and shaped to extend around the catheter 104 and a pair of fingers 176 extending proximally from the ring portion 174 and extending longitudinally along a portion of the catheter 104. At the proximal end 178 of each finger 176, the collet 106 includes an engagement tab 180 extending radially inward. Each engagement tab 180 extends into a corresponding one of the engagement slots 170 and is configured to be received in a corresponding one of the longitudinal grooves 156 in the proximal portion 124. Each engagement tab 180 is longitudinally slidable within the corresponding longitudinal groove 156 to allow movement of the clip 102 between the open and closed configurations while the clipping system 100 is in the insertion configuration.

[0048] In particular, the yoke 120 slides along the engagement tabs 180 via the longitudinal grooves 156 while the collet 106 remains stationary on the catheter 104 and the control member 116 moves distally and proximally relative to the catheter 104 to move the clip 102 between the open and closed configurations, respectively. Thus, the length of the longitudinal grooves 156 corresponds to the extent to which the control member 116 may move relative to the catheter 104 as the clip 102 moves between the open and closed configurations.

[0049] Once it is determined that the clip 102 is closed on the target tissue as desired, the control member 116 is pulled proximally relative to the catheter 104 until the engagement tabs 180 engage the distal ends 186 of the longitudinal grooves 156. At this time, as the control member 116 is moved further proximally relative to the catheter 104, the collet 106 is also pulled proximally relative to the catheter 104 toward the deployed configuration. As the collet 106 moves proximally along the catheter 104, the engagement tabs 180 of each finger 176 slide proximally within a corresponding one of the engagement slots 170. Although the exemplary embodiment illustrates and describes the collet 106 as including two fingers 176, one skilled in the art will understand that the collet 106 can include any number of fingers 176 (so long as the number of fingers 176 and engagement tabs 180 corresponds to the number of longitudinal grooves 156 along the proximal portion 124 of the yoke 120).

[0050] As shown in FIG. 10 , according to another exemplary embodiment, system 1100 is substantially similar to system 100, including all of the features of the above-described system, except for the differences described below. The capsule 1112, catheter 1104, and collet 1106 of system 1100 are substantially similar to those of system 100 described above in this embodiment. However, capsule 1112 and catheter 1104 may have corresponding sizes and shapes such that when a portion of capsule 1112 is received within longitudinal slot 1164, torque is transferred from catheter 1104 to clip 1102, and rotation of catheter 1104 rotates clip 1102. In one example, capsule 1112, catheter 1104, and collet 1106 have a substantially oval cross-sectional shape. In another example, capsule 1112 includes a feature 1182 that is secured in longitudinal slot 1164 to prevent capsule 1112 from rotating relative to catheter 1104. Thus, torsional forces applied to the catheter 1104 (eg, through rotation of the catheter 1104 ) are transmitted to the clip 1102 .

[0051] 11 , in another exemplary embodiment, the ring portion 1274 of the collet 1206 of the system 1200 includes a locking feature 1282 that is received within the longitudinal slot 1264 of the catheter 1204 such that rotation of the catheter 1204 correspondingly rotates the collet 1206 and capsule 1212. In one embodiment, the locking feature 1282 is configured as a protrusion that extends radially inward from the inner surface of the ring portion 1274 along the length of the ring portion 1274. However, the embodiments shown in FIGS. 10 and 11 are exemplary only, and one skilled in the art will appreciate that there are any number of ways to secure the catheter 104 to the clip 102 and / or collet 106 such that rotation of the catheter 104 results in torque transfer to the clip 102.

[0052] According to an exemplary method of utilizing system 100, clip 102 is inserted into a target site within the body, for example, through a working channel of an endoscope. In the insertion configuration, clip 102 remains coupled to catheter 104 by collet 106. Clip 102 is inserted into the body by catheter 104 in a closed configuration, such that the proximal end of catheter 104 remains outside the body. Once clip 102 reaches the target site, a user distally advances control member 116 to advance clip arms 108 distally out of capsule 112, releasing clip arms 108 and moving them under their inherent bias toward the open configuration so that target tissue can be received between clip arms 108.

[0053] The user may then manipulate the control member 116 to move the clip 102 between the open and closed configurations as desired until the target portion of tissue is positioned between the clip arms 108 as desired. The user then retracts the control member 116 proximally (or advances the catheter 104 distally over the control member 116), thereby drawing the clip arms 108 toward each other and grasping the target tissue between the distal ends 114 of the clip arms 108 as they are retracted into the capsule 112. As described above, the engagement tabs 180 of the collet 106 slide within the longitudinal grooves 156 along the proximal portion 124 of the yoke 120 while the clip 102 is moving between the open and closed configurations.

[0054] Once the user is satisfied that the clip 102 has grasped the target tissue in the desired position, the user pulls the control member 116 proximally relative to the catheter 104 until the locking tabs 142 on the proximal ends 110 of the clip arms 108 move proximal to the proximal end 126 of the capsule 112. When the proximal ends 110 are no longer constrained by the inner surface 144 of the capsule 112, the proximal ends 110 pop outwardly away from the centerline of the capsule 112, causing the locking tabs 142 to engage the proximal edges 146 of the capsule 112 and lock the clip arms 108 closed on the target tissue. The user continues to pull the control member 116 proximally until the engagement features 134 engage the capsule tabs 132 and / or the distal faces 140 of the capsule 112 and a predetermined force is exerted on the separable connection portions 152 of the yoke 120. When this predetermined force is met or exceeded, separable connection 152 breaks or separates such that proximal portion 124 of yoke 120 is separated from distal portion 122 of yoke 120. This leaves distal portion 122 within capsule 112 and locks clip 102 in a closed configuration, while proximal portion 124 is pulled proximally away from clip 102.

[0055] The user then operates the actuator to move the control member 116 proximally relative to the catheter 104, thereby moving the proximal portion 124 of the yoke 120 proximally relative to the catheter 104 until the distal end 186 of the longitudinal groove 156 engages the engagement tab 180 of the collet 106. At this time, continued proximal movement of the control member 116 pulls the collet 106 proximally relative to the catheter 104, thereby moving the collet 106 from the insertion configuration toward the deployed configuration. As the collet 106 moves toward the deployed configuration, as shown in FIG. 4 , the engagement tab 180 of the collet 106 moves along the engagement slot 170 of the catheter 104.

[0056] Once the collet 106 reaches the deployed configuration, the distal portion 160 of the catheter 104 expands and the capsule 112 is no longer frictionally held within the distal portion 160 of the catheter 104. Thus, pulling the catheter 104 proximally relative to the clip 102 moves the catheter 104 proximally away from the clip 102, as shown in FIG. 5 . Thus, the clip 102 can remain in a position clipped to the target tissue as the catheter 104 is withdrawn from the body. In further embodiments, once the clip 102 is released from the catheter 104 and the catheter 104 is removed from the body, the catheter 104 can be reloaded with a new clip 102 and the additional clip 102 can be placed within the body to treat the target site.

[0057] 12, system 200 is substantially similar to system 100 described above, except as described below. Catheter 204 further includes a crimp tab 284 that is crimped through the wall of catheter 204 at a location along catheter 204 proximally adjacent proximal end 278 of collet 206 when collet 206 is in the insertion configuration. Crimp tab 284 acts as a stop to prevent inadvertent movement of collet 206 from the insertion configuration toward the deployment configuration.

[0058] However, crimp tabs 284 are deformable and, in this embodiment, are configured to deform when subjected to a proximal force of at least a predetermined amount. Thus, when it is desired to move system 200 toward the deployed configuration, control member 216 is pulled proximally relative to catheter 204 until collet 206 is pressed proximally against crimp tabs 284 with sufficient force to deform crimp tabs 284. Collet 206 deforms crimp tabs 122 as it moves proximally over crimp tabs 284 toward the deployed configuration.

[0059] It will be apparent to those skilled in the art that various modifications can be made in the present disclosure without departing from the scope of the disclosure. While specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to encompass any adaptations or variations of the various embodiments. The foregoing description is illustrative and not limiting. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description. Thus, the scope of the various embodiments includes any other applications in which the above compositions, structures, and methods are used.

Claims

1. It is a clipping system a catheter extending longitudinally from a proximal end to a distal end, the catheter including a channel extending within the catheter and a plurality of longitudinal slots extending through a wall of the catheter from the distal end along a distal portion of the catheter; a clip including a capsule extending longitudinally from a proximal end to a distal end, the capsule including a channel extending therethrough, the clip including a pair of clip arms, the proximal ends of the pair of clip arms being slidably received within the channel of the capsule for moving the pair of clip arms between an open configuration and a closed configuration, the capsule of the clip being configured to be releasably received within the distal portion of the catheter; a collet slidably mounted on the catheter, the collet movable between an insertion configuration in which the collet is disposed on the distal portion of the catheter and presses the distal portion against the capsule to retain the capsule within the distal portion, and a configuration in which the collet is positioned proximal to the distal portion to allow release of the clip from the distal portion of the catheter; a control member connected to the pair of clip arms and the collet, wherein longitudinal movement of the control member relative to the catheter controls movement of the pair of clip arms and the collet; A clipping system comprising:

2. 2. The clipping system of claim 1, further comprising a yoke connecting the control member to the pair of clip arms and the collet, the yoke including a distal portion connected to the pair of clip arms and a proximal portion connected to a portion of the collet, the distal portion and the proximal portion of the yoke being connected to one another by a separable connection configured to separate when subjected to a predetermined force exceeding a predetermined threshold.

3. the proximal portion houses an enlarged distal end of the control member; 3. The clipping system of claim 2, wherein the proximal portion includes a longitudinal groove extending along the proximal portion, and an engagement tab of the collet extending into the channel of the catheter is slidably received within the longitudinal groove.

4. 4. The clipping system of claim 3, wherein the length of the longitudinal groove corresponds to the distance the control member travels relative to the catheter during movement of the clip between the open and closed configurations.

5. The proximal ends of the pair of clip arms are biased radially outward; 2. The clipping system of claim 1, wherein the proximal ends of the pair of clip arms include a locking structure extending laterally therefrom that engages a proximal edge of the capsule when the proximal ends of the pair of clip arms are moved proximal to the proximal end of the capsule to lock the clip in the closed configuration.

6. 2. The clipping system of claim 1, wherein the pair of clip arms include an engagement mechanism configured to engage with a portion of the capsule, and when the engagement mechanism engages with the capsule, the pair of clip arms are prevented from moving further proximally relative to the capsule and a predetermined force is applied to the distal end of the control member.

7. the distal portion of the yoke is received between the proximal ends of the pair of clip arms; 3. The clipping system of claim 2, wherein the distal portion includes protrusions extending from opposite sides of the distal portion, the protrusions being received within openings extending through proximal portions of the pair of clip arms.

8. 2. The clipping system of claim 1, wherein the distal ends of the pair of clip arms are biased toward the open configuration, and when the pair of clip arms are retracted into the capsule, the pair of clip arms are constrained toward the closed configuration by an inner surface of the capsule, and when the pair of clip arms move distally from the capsule, the pair of clip arms can return to the biased open configuration.

9. 10. The clipping system of claim 1, wherein the capsule is secured to the catheter such that rotation of the catheter causes corresponding rotation of the clip.

10. The clipping system of claim 1 , wherein the catheter is secured to the collet such that rotation of the catheter causes corresponding rotation of the collet and the clip.

11. 2. The clipping system of claim 1, wherein the catheter further includes a crimp tab extending into the channel of the catheter distally adjacent the proximal end of the collet when the collet is in the insertion configuration, the crimp tab being deformable to allow the collet to move proximally beyond the crimp tab when a predetermined force exceeding a predetermined threshold is applied through the collet.

Images