Hemostatic clip release mechanism
Patent Information
- Application Number
- JP2024560483
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2022-04-11
- Filing Date
- 2023-02-21
- Publication Date
- 2026-09-09
- Estimated Expiration
- 2043-02-21
Smart Images

Figure 0007918282000001 
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Abstract
Description
Technical Field
[0001] The present disclosure relates to an endoscopic device, and in particular to an endoscopic clipping device for treating tissue along the gastrointestinal tract.
Background Art
[0002] Physicians are increasingly 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 wall as part of the procedure. Such procedures may include, for example, removal of large lesions, tunneling under the mucosal layer of the GI tract to treat sub-mucosal problems, full-thickness removal of tissue, treatment of problems on other organs by passing through the outside of the GI tract, as well as endoscopic treatment / repair of post-operative problems such as post-operative leaks, broken surgical staple lines, and suture failure.
[0003] Currently, tissue may be treated via endoscopic closure devices including through-the-scope clips or over-the-scope clips. Over-the-scope clips may be particularly useful for achieving closure of larger tissue defects. These endoscopic closure devices can save hospital costs and may benefit patients. However, in some cases, current endoscopic closure devices can be difficult to use, time-consuming to position, or inadequate for certain perforations, conditions, and anatomical structures. For example, current over-the-scope clips generally require the clip to be fired from a position where the clip itself is not visible to the operator. That is, prior to clipping, the operator may visually recognize the target tissue to be clipped, and based on this visualization of the target tissue, may determine that the distal end of the device and the clip are in a desired position relative to the target tissue. Then, based on the observation of the target tissue, the operator deploys the clip without being able to see the clip itself until the clip is deployed. Once deployed, such current over-the-scope clips are generally not capable of being repositioned. [Overview of the project]
[0004] This disclosure relates to a clipping system for treating tissue. The system includes an adapter, a clip, and a first extension member. The adapter includes a proximal portion configured to be mounted on the distal end of an insertion device, and a distal portion extending distally from the proximal portion. The clip is configured to be mounted over the distal portion of the adapter. The clip includes first and second jaws connected to each other, the first and second jaws being movable between an insertion configuration in which the first and second jaws extend around opposing portions of the distal portion of the adapter and separate from each other to receive tissue between them, and an initial deployment configuration in which the clip is moved distally from the adapter and the first and second jaws are drawn to each other to clip tissue between them. The first and second jaws are biased toward the initial deployment configuration.
[0005] A first extension member is releasably connected to a clip and movably connected to an adapter. The first extension member includes a connector at its distal end, configured to releasably engage with an opening extending through a first jaw, such that longitudinal movement of the first extension member relative to the adapter moves the clip between an insertion configuration, an initial deployment configuration, and a review configuration. In the review configuration, the adapter can be withdrawn proximal to the clip while the first extension member remains connected to the clip to improve visual observation of the clip. The first extension member is operable to retract the clip proximal to the adapter so that the clip is forced open when retracted along the adapter, releasing the clip from the tissue clipped to the clip. The connector includes a deformable portion configured to deform to release the first extension member from the first jaw toward the final deployment configuration when a distal force applied to the first extension member relative to the clip exceeds a predetermined threshold. The first extension member can be withdrawn proximal to the clip when the connector is deformed.
[0006] In one embodiment, the connector includes a pair of wings extending radially away from the distal end of a first extension member, the pair of wings being configured to be sheared away from the distal end of the first extension member when the pair of wings are deformed toward the final unfolded configuration.
[0007] In one embodiment, the system further includes an insert configured to be received and secured within an opening of a first jaw, the insert including a hole extending longitudinally through it and a recess extending radially outward from the hole, the recess being dimensioned, molded, and configured to receive a pair of wings therein.
[0008] In one embodiment, the radially innermost portion of each wing, where it is connected to the distal end of the first extension member, has a smaller thickness than the rest of the wing. In one embodiment, the distal surfaces of a pair of wings include tapered portions inclined at an angle not perpendicular to the longitudinal axis of the first extension member, the tapered portions being configured to engage with a sharp cutting edge along the surface of the recess when pressed distally against the surface of the recess.
[0009] In one embodiment, the opening of the first jaw extends through the clip from a first surface facing the adapter to a second surface facing away from the adapter, and the opening includes a first portion configured to engage with the connector and a second portion configured as a slot extending from the first portion to the outside of the clip.
[0010] In one embodiment, the connector of the first extension member includes a head portion and a shaft extending proximal therefrom, the shaft being sized, molded, and configured to engage with a first portion of an opening, and the width of the slot being smaller than the shaft to prevent the connector from passing through the slot.
[0011] In one embodiment, the distal end of the first extension member is biased laterally away from the longitudinal axis of the adapter, and when the connector is received within the first portion of the opening, the distal end of the first extension member is constrained laterally inward, and when the connector is pushed distally out of the first portion of the opening, the distal end returns laterally outward, so that the remaining long portion of the first extension member extending proximal to the connector passes through the slot of the second portion of the opening and reaches the outside of the clip.
[0012] In one embodiment, the connector includes a deformable arm extending laterally from the shaft to engage with a first surface of the clip when the shaft is received within a first portion of the opening, so as to move the clip between an insertion configuration, an initial deployment configuration, and a review configuration, and the deformable arm is configured to deform to release the connector from the first portion of the opening when a distal force applied to the first extension member relative to the clip exceeds a predetermined threshold.
[0013] In one embodiment, the system further includes a second extension member releasably coupled to the clip and movably connected to the adapter, the second extension member including a further connector at its distal end configured to releasably engage with an opening extending through a second jaw such that longitudinal movement of the second extension member relative to the adapter moves the clip between an insertion configuration, an initial deployment configuration and a review configuration, the further connector of the second extension member including a deformable portion configured to deform to release the second extension member from the second jaw toward a final deployment configuration when a distal force applied to the second extension member relative to the clip exceeds a predetermined threshold.
[0014] In addition, this disclosure relates to a clipping system for treating tissue. The system includes an adapter, a clip, and a first extension member. The adapter includes a proximal portion configured to be mounted on the distal end of an insertion device, and a distal portion extending distally from the proximal portion. The clip is configured to be mounted over the distal portion of the adapter. The clip includes first and second jaws connected to each other, the first and second jaws being movable between an insertion configuration in which the first and second jaws extend around opposing portions of the distal portion of the adapter and separate from each other to receive tissue between them, and an initial deployment configuration in which the clip is moved distally from the adapter and the first and second jaws are drawn to each other to clip tissue between them. The first and second jaws are biased toward the initial deployment configuration.
[0015] A first extension member is releasably connected to the clip and movably connected to the adapter. The first extension member includes a distal end biased toward a coiled configuration, the distal end being configured to releasably engage with a portion of an opening extending through a first jaw so that longitudinal movement of the first extension member toward the adapter moves the clip toward an insertion configuration, an initial deployment configuration, and a review configuration, in which the adapter can be pulled away proximal to the clip while the first extension member remains connected to the clip to improve visual observation of the clip, and the first extension member is operable to retract the clip proximal to the adapter so that the clip is forced open when retracted toward the adapter while releasing the clip from the tissue clipped by the clip, and the coiled configuration of the first extension member is configured to unwind when subjected to a force exceeding a predetermined threshold so that the first extension member is disengaged from the first jaw toward the final deployment configuration.
[0016] In one embodiment, the system further includes an insert configured to be received and secured within an opening of a first jaw, the insert including a curved opening extending therein, the curved opening configured to receive and engage the distal end of a first extension member.
[0017] In one embodiment, the distal end of the first extension member is reinforced with a compressible rod. In one embodiment, the curved opening includes an inclined edge extending along it. In one embodiment, the system further includes a second extension member that is releasably coupled to the clip and movably connected to the adapter, the second extension member including a distal end biased toward a coiled configuration, the distal end being configured to releasably engage with a portion of an opening extending through the second jaw, the longitudinal movement of the second extension member relative to the adapter moving the clip between an insertion configuration, an initial deployment configuration and a review configuration, the coiled configuration of the first extension member being configured to unwind when subjected to a force exceeding a predetermined threshold, and the second extension member being disengaged from the second jaw toward the final deployment configuration.
[0018] In addition, the present disclosure includes a method for treating tissue, the method comprising inserting a clip into a target region in a body lumen via an endoscope, the clip being mounted on the distal end of the endoscope via an adapter in an open insertion configuration in which the jaws of the clip are separated from each other; pulling tissue into the channels of the adapter and between the jaws of the clip; moving the clip from an open insertion configuration to an initial deployment configuration by releasing tension along an extension member so that the clip moves distally from the adapter and the jaws return to a biased closed configuration in which the jaws extend toward each other to clip the tissue received between them; pulling the endoscope proximal away from the clip, toward a review configuration in which visualization of the clip via the endoscope is improved, while the clip remains connected to the extension member; and moving the extension member distal to the clip until the force applied to the extension member exceeds a predetermined threshold so that the connector at the distal end of the extension member deforms to release the extension member from the clip toward a final deployment configuration.
[0019] In one embodiment, when it is determined that the clip requires repositioning, the extension member is pulled proximal to the endoscope until the clip is pulled proximal along the adapter toward the open insertion configuration, thereby repositioning the clip along the target tissue.
[0020] In one embodiment, each connector includes a pair of wings extending radially away from the distal end of an extension member, the pair of wings being sheared from the distal end of the extension member as the pair of wings are deformed toward the final unfolded configuration.
[0021] In one embodiment, as the extension member is moved toward the final unfolded configuration, the extension member is moved distally to an insert fixed within an opening extending through the jaws of the clip, the insert including a hole extending longitudinally through it and a recess extending radially outward from the hole, and a pair of wings are received within the recess.
[0022] In one embodiment, when the elongate member is moved distally relative to the insert toward the final deployed configuration, the distal surfaces of a pair of wings comprising a tapered portion angled at a non-perpendicular angle relative to the longitudinal axis of one of the elongate members engage a sharp cutting edge along the surface of the recess when pressed distally against the surface of the recess, and the sharp cutting edge shears the pair of wings from the distal end of the elongate member. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] [Figure 1] A longitudinal side view of a tissue clipping system in an insertion configuration, according to an exemplary embodiment of the present disclosure. [Figure 2] A cross-sectional view of a connector received within an opening of an insert of the system of Figure 1. [Figure 3] A perspective view of a clip of the system of Figure 1. [Figure 4] An exploded perspective view of an insert of the system of Figure 1. [Figure 5] A longitudinal side view of the system of Figure 1 in a review configuration. [Figure 6] A cross-sectional view of the elongate member moved distally relative to the insert during initiation of a final deployed configuration by the system of Figure 1. [Figure 7] A cross-sectional view of a wing of a connector being sheared from the distal end of the elongate member during final deployment of a clip by the system of Figure 1. [Figure 8] A view showing withdrawal of the distal end of the elongate member from the insert during final deployment of the clip by the system of Figure 1. [Figure 9] A longitudinal side view of the system according to the system of Figure 1, in a final deployed configuration. [Figure 10] A side cross-sectional view of an insert and an elongate member engaged with each other, according to another exemplary embodiment of the present disclosure. [Figure 11] A side cross-sectional view of the insert and the elongate member disengaged from each other, according to the embodiment of Figure 10. [Figure 12]A longitudinal side view of the distal portion of a clipping system according to another exemplary embodiment of the present disclosure in an insert configuration. [Figure 13] A longitudinal side view of the distal portion of the system in the review configuration, as shown in Figure 12. [Figure 14] A longitudinal side view of the distal portion of the system during the final deployment process, as shown in Figure 12. [Figure 15] An enlarged perspective view of a portion of the clip in the system, including an opening extending through the clip, as shown in Figure 12. [Figure 16] A longitudinal side view of the distal end of the extension member in the system shown in Figure 12. [Figure 17] A cross-sectional view of a portion of a clip and an extension member engaged with the clip, according to another exemplary embodiment of the present disclosure. [Figure 18] A cross-sectional view of a portion of a clip, deformed to allow the extension member to be released from the clip, according to the embodiment shown in Figure 17. [Figure 19] A cross-sectional view of the extension member released from the clip, according to the embodiment shown in Figure 17. [Figure 20] A cross-sectional view of a portion of a clip, deformed to allow the release of an extension member from the clip, according to another exemplary embodiment of the present disclosure. [Figure 21] Cross-sectional view of the extension member released from the clip according to the embodiment shown in Figure 20. [Modes for carrying out the invention]
[0024] This disclosure can be further understood by reference to the following description and accompanying drawings, where similar elements are referenced by the same reference numerals. This disclosure relates to clipping systems, and more particularly to over-the-scope endoscopic clipping systems in which the initial position of the clip can be viewed and adjusted before its final deployment. Exemplary embodiments of this disclosure include a clip that is attachable to the distal end of an endoscope via an adapter and is releasably coupled to an extension member so that the clip can move relative to the adapter between an insertion configuration, an initial deployment configuration and a review configuration, and the clip can be viewed via an endoscopic viewing system before it is finally deployed.
[0025] According to one exemplary embodiment, the distal end of each extension member is connected to the corresponding jaw of a clip via a coupling mechanism configured to release in order to disengage the clip when subjected to a force exceeding a predetermined threshold force. In the exemplary embodiment, during the final deployment of the clip, the extension member may be pushed or pulled against the clip until the force applied to the clip exceeds a predetermined threshold force, thereby deforming and / or breaking the coupling mechanism so that the extension member is released from the clip and the clip can be removed from the body while still clipped over target tissue.
[0026] However, while the extension member remains connected to the clip, the extension member can move longitudinally relative to the endoscope to move the clip between the insertion configuration, the initial deployment configuration, and the review configuration. In the insertion configuration, the clip is attached to the adapter at a proximal position that is maintained in the insertion configuration, where the clip is ready to receive tissue between its jaws, while minimizing obstruction of the field of view of the endoscopic visual system. The insertion configuration is configured to facilitate the insertion of the endoscope into a target site adjacent to the tissue to be clipped, while allowing the system to deploy and clip the clip into the tissue in the initial deployment configuration. The device allows the endoscope to be withdrawn away from the clip and the tissue to which the clip is clipped, while the clip remains connected to the device in the review configuration.
[0027] As the endoscope is withdrawn proximally while the clip is positioned over the target tissue, the field of view of the endoscope's visual system expands to show the clip and the tissue it is holding, allowing the operator to determine if the clip is positioned as desired or if adjustment is needed. If the operator determines that the clip is positioned as desired, the clip is unfolded by releasing it from the fasteners of the extension member, leaving it in place and clipping the target tissue. If the operator determines that the clip needs to be adjusted, the endoscope and its connected adapter are moved distally to a position adjacent to the clip. The clip is then pulled proximally along the adapter and reopened. In this process, the clip is pulled from distal to proximal on the adapter and, as it slides proximally along the adapter, is forced back into an insertion configuration against its natural bias. After the clip is removed from the tissue and returned to the insertion configuration, the operator can reposition the endoscope and device as desired, draw the target tissue into the adapter (for example, under suction or grasping applied through the endoscope's working channel), and, in the initial deployment position, deploy the clip again from the adapter to the target tissue.
[0028] Next, with the clip still attached to the device, the endoscope is withdrawn proximal again so that the device moves back into the review configuration. The position of the clip and the clipped tissue is observed again, and this process may be repeated until the clip is positioned as desired. When the operator sees that the tissue to which the clip is closed is the desired portion of tissue, the operator may initiate the final deployment process by applying force to the stretching member against the clip so as to deform the stretching member and disengage the clip. The stretching member can then be removed from the body with the clip still over and clipping the target tissue. It will be understood by those skilled in the art that, when used herein, the terms proximal and distal are intended to refer to the direction toward and away from the user of the device, respectively.
[0029] As shown in Figures 1 to 9, a clipping system 100 for treating tissue defects and / or perforations according to an exemplary embodiment comprises a clip 102 configured to be inserted into a target area, for example, through a body lumen, to clip target tissue (e.g., tissue of the lumen wall). The clip 102 is insertable into the target area via an insertion device 104, such as an endoscope 106. The clip 102 is configured to be connected to the distal end 108 of the endoscope 106 via an adapter 110 that is fitted over the distal end 108 of the endoscope 106. The clip 102 is configured to move relative to the adapter 110 and the endoscope 106 between an insertion configuration, an initial deployment configuration in which the clip 102 is covered and closed over the target tissue, and a review configuration via an extension member 112 to which the clip 102 is releasably connected.
[0030] In one exemplary embodiment, each distal end 114 of the extension member 112 includes a connector 116 configured to engage with a portion of the clip 102 that is sized, molded, and constructed accordingly. The connector 116 includes a pair of wings 118 extending radially outward from the distal end 114. The wings 118 are configured to shear when the extension member 112 is moved distally relative to the clip 102 by a force exceeding a predetermined threshold force, and the distal end 114 is released from the clip 102 and detachable therefrom toward the final unfolded configuration.
[0031] However, while the pair of wings 118 remain connected to the distal end 114, longitudinal movement of the extension member 112 relative to the endoscope 106 moves the clip 102 between the insertion configuration, the initial deployment configuration, and the review configuration. In the insertion configuration, as shown in Figure 1, the clip 102 is mounted on the adapter 110, separated from each other so that the jaws 120 receive tissue between them. To move the clip 102 from the insertion configuration to the initial deployment configuration, the extension member 112 is moved distally relative to the endoscope 106, allowing the clip 102 to move distally from the adapter 110 towards the closed configuration, and the jaws 120 are moved toward each other to clip the tissue drawn into the adapter 110.
[0032] When tissue is clipped via the jaws 120 in the initial deployment configuration, the clip 102 remains anchored to the insertion device 104 via the extension member 112, as shown in Figure 5. It can then be moved toward the review configuration by moving the extension member 112 distally away from the endoscope 106 (or by pulling the endoscope 106 proximal to the extension member 112) so that the clip 102 moves away from the adapter 110. This widens the field of view of the endoscopic visual system for the clip 102 and the target tissue, and allows some movement of the endoscope 106 relative to the clip 102, enabling a broader observation of the placement and / or position of the clip 102 relative to the target tissue. If the user determines that the position of the clip 102 is inaccurate or suboptimal, as described below, the user may move the endoscope 106 distally to a position adjacent to the clip 102, and then retract the clip 102 along the distal end of the adapter 110 toward the open insertion configuration.
[0033] The user can then repeat these steps to reposition the endoscope 106 and the clip 102 so that the placement and / or position of the clip 102 relative to the target tissue can be adjusted as desired before the final deployment of the clip 102. That is, if the operator determines in the review configuration that the clip 102 is not positioned as desired, the clip 102 can be opened again and removed from the tissue so that the device can be repositioned until the clip 102 closes along the desired portion of the tissue. Once it is determined that the clip 102 has clipped the desired tissue, the extension members 112 are moved distally relative to the clip 102 so that the wings 118 of the distal end 114 are pressed distally against the portion of the clip 102 into which they are received. The extension member 112 is moved distally until the force applied to the wing 118 exceeds a predetermined threshold force, causing the wing 118 to be sheared from its distal end 114, thereby releasing its distal end from the clip 102, and allowing the extension member 112 to be removed from the clip 102 so that the clip 102 remains clipped to the target tissue in the final deployment configuration.
[0034] As described above and shown in Figure 1, the insertion device 104 may include any standard endoscope 106. The clip 102 may be attached to the endoscope 106 via an adapter 110, which is sized, molded, and configured to be attached to the distal end 108 of the endoscope 106. As will be understood by those skilled in the art, the endoscope 106 is configured to be inserted through a body lumen into a target region within the lumen and therefore must be sufficiently flexible to navigate even through the torrent paths of the body lumen. The adapter 110 includes a channel 126 extending from a proximal end 122 to a distal end 124, configured to be attached to the distal end 108 of the endoscope 106, and extending through therein. The adapter 110 may be attached to the endoscope 106, for example by friction fitting, such that the channel 126 is substantially longitudinally aligned with the channel of the endoscope 106. Thus, tissue is visible through the channel 126 via the optical system of the endoscope 106. In another embodiment, the adapter 110 may also be formed of a transparent material to improve the visibility of the tissue.
[0035] In one embodiment, the adapter 110 includes a pair of holes 128 extending longitudinally through its walls. The holes 128 are configured to slidably receive an extension member 112 passing through them. The outer diameter of the distal portion 130 of the adapter 110 is dimensioned, molded, and configured to receive a clip 102 on it in the insertion configuration. In one exemplary embodiment, the distal portion 130 of the adapter 110 tapers from the maximum diameter of the proximal end 122 to the minimum diameter of the distal end 124, and as the clip 102 moves distally along the adapter 110, the diameter of the adapter 110 decreases, causing the jaws 120 to gradually close, thereby biasing the clip 102 toward the initial deployment configuration (pulling the jaws 120 toward each other), thus biasing the clip 102 distally along the adapter.
[0036] However, while sufficient proximal tension is applied to the extension member 112 (i.e., while the extension member 112 holds the clip 102 in place), the jaws 120 remain separated from each other and the clip 102 remains attached to the adapter 110 in the open insertion configuration (i.e., in the proximal position on the adapter 110). As the clip 102 moves across the adapter 110, this tension is released from the extension member 112, and as the extension member 112 is stretched distally, the natural bias of the clip 102 pulls the jaws 120 toward each other and pushes the clip 102 distally along the tapered surface of the adapter 110 until the clip 102 slides distally away from the adapter 110.
[0037] In one embodiment, the insertion device 104 includes a pair of extension members 112. Each extension member 112 extends longitudinally along or within the endoscope 106 and passes radially through a hole 128 in the adapter 110, such that the distal portion of the extension member 112 is longitudinally movable along the outer surface of the adapter 110. Each extension member 112 extends from a proximal end accessible to the user, for example via an actuator, to a distal end 114. The extension members 112 can be moved longitudinally relative to the endoscope 106, and can move a clip 102 connected to the endoscope 106 toward and toward the distal end 108 of the endoscope 106 between the insertion configuration, the initial deployment configuration, and the review configuration.
[0038] According to one exemplary embodiment, as shown in Figure 2, each connector 116 of the extension member 112 includes a pair of wings 118 extending radially outward from the distal end 114 along a plane substantially perpendicular to the longitudinal axis of the extension member 112. The pair of wings 118 are molded on the corresponding distal end 114, and when the pair of wings 118 are pressed distally against a portion of the clip 102, the proximal force applied to the wings 118 by the clip 102 shears the wings 118 away from the distal end 114. In one exemplary embodiment, the thickness of each wing 118 at its radially innermost location 132, where each wing 118 contacts the distal end 114 (the dimension of the wing 118 perpendicular to the longitudinal axis (proximal to distal) of the adapter 110), is smaller than the thickness of the same wing 118 at its radially outermost location 134, facilitating shearing of the wing 118 at its radially innermost location 132. That is, the distance between the distal surface 136 and the proximal surface 138 of each wing 118 at its radially innermost location 132 is smaller than the distance between the distal surface 136 and the proximal surface 138 at its radially outermost location 134.
[0039] In this embodiment, each distal surface 136 of the wing 118 includes an inclined surface 140 that tapers toward the distal end 114. In other words, the inclined surface 140 extends at an angle not perpendicular to the longitudinal axis of the extension member 112. The proximal surface 138 includes a groove 142 that extends within it (i.e. toward the distal surface 136) at its innermost radial location 132. However, the groove 142 includes a flat portion 144 that extends substantially perpendicular to the longitudinal axis of the extension member 112.
[0040] The exemplary embodiment shows and describes a connector 116 including a pair of wings 118, but it will be understood by those skilled in the art that the connector 116 may include any of a variety of radially extending features for engaging with corresponding portions of the clip 102. In an alternative embodiment, instead of wings 118, the connector 116 may include a circumferential engaging element including a circumferentially extending slit, configured to shear when a proximal force exceeding a predetermined threshold force is applied by the clip 102 in response to a distal force applied to the corresponding extension member 112. Similar to the wings 118, the circumferential engaging element may extend from the distal end 114 along a plane substantially perpendicular to the longitudinal axis of the extension member 112.
[0041] As shown in Figure 3, the clip 102 includes a pair of jaws 120, each containing a gripping mechanism 148, such as teeth, to clip target tissue between them. In one embodiment, the jaws 120 are connected to each other via a hinge 150. In one embodiment, each jaw 120 extends along a curve from a first end 152 to a second end 154, such that a first hinge of the hinge 150 connects the first ends 152 of the jaws 120 to each other, and a second hinge of the hinge 150 connects the second ends 154 of the jaws 120 to each other. In one embodiment, the hinge 150 is spring-biased to bias the jaws 120 toward an initial deployment configuration, in which the jaws 120 are closed such that the gripping mechanism 148 of the first jaw of the jaws 120 contacts the gripping mechanism 148 of the second jaw of the jaws 120. In particular, in the initial deployment configuration, the jaws 120 extend toward each other so that any tissue pulled between the jaws 120 is clipped between the jaws 120, for example, via the gripping mechanism 148.
[0042] However, when the clip 102 is mounted over the adapter 110 in an insertion configuration, the jaws 120 extend around opposing portions of the adapter 110, and the outer surface of the adapter 110 keeps the clip 102 open with the jaws 120 separated from each other, so that the target tissue can be drawn into the adapter 110 between the jaws 120. When the clip 102 is moved distally to the adapter 110, the clip 102 covers any tissue drawn into the adapter 110 and closes freely under the natural bias of the hinge 150. It will be understood by those skilled in the art that the hinge 150 and / or jaws 120 of the clip 102 can be formed of any of a variety of materials, as described above, insofar as the hinge 150 biases the jaws 120 toward the initial deployment configuration and the bias is strong enough to hold the clip 102 in the position where the target tissue was clipped after the clip has finally deployed. In one embodiment, a portion of the clip 102 (e.g., a hinge 150) is formed of a shape memory alloy, such as nitinol, to provide and / or add bias toward the closed configuration.
[0043] Each of the jaws 120 in this embodiment also includes an opening 156 that extends through from a first surface 158 of the clip 102 facing the adapter 110 to a second surface 160 of the clip 102 facing away from the adapter 110. Each opening 156 is configured to releasably engage with a corresponding connector 116 of the extension member 112. In one embodiment, each opening 156 is configured to directly engage with a corresponding wing 118 of the connector 116. In this embodiment, each of the openings 156 includes, for example, a radially extending recess into which the wing 118 of the corresponding extension member 112 can be received. To accommodate the radially extending recess, each portion of the jaw 120 surrounding the opening 156 may have a greater thickness than the rest of the clip 102 (for example, the distance between the first surface 158 and the second surface 160).
[0044] In another exemplary embodiment, as shown in the figure, each of the openings 156 may be configured to receive an insert 162 configured to engage with one of the connectors 116, as described above. In particular, as shown in Figure 4, the insert 162 may be sized and molded to fit into the opening 156 and may be welded, molded, mechanically coupled or bonded to the clip 102 within the opening 156. The insert 162 includes a hole 164 extending longitudinally through from a first surface 166 of the insert 162 to a second surface 168 of the insert 162, such that when the insert 162 is received into the opening 156, the first surface 166 faces toward the adapter 110 and the second surface 168 faces toward away from the adapter 110. The insert 162 further includes a recess 170 extending radially outward from the hole 164. The recess 170 in this embodiment is sized and molded to correspond to the wings 118 of the extension member 112 that are received therein. In one embodiment, the insert 162 includes a pair of recesses 170 configured to accommodate one of the corresponding wings 118 of the extension member 112. In another embodiment, the recesses 170 extend circumferentially around the hole 164 to accommodate the wings of two or more connectors 116.
[0045] In one embodiment, the distal surface 171 of the recess 170 includes a sharp cutting edge 172. When the wing 118 is pushed distally to the cutting edge 172 (via a distal force applied to the corresponding extension member 112), it engages with the inclined surface 140 of the distal surface 136 at the innermost portion 132 of the corresponding wing 118, facilitating shearing of the wing 118 at the innermost portion 132. On the other hand, the proximal surface 173 of the recess 170 includes a plane 174 configured to engage with a flat portion 144 at the innermost portion 132 along the proximal surface 138 of the wing 118, so that the wing 118 is not sheared even when it is pulled proximal to it (for example, via a proximal force applied to the corresponding extension member 112). It will be understood by those skilled in the art that the corresponding planes 174, 144 prevent accidental shearing of the wing 118 when the clip 102 is pulled proximal toward the insertion configuration along the adapter 110, for example, while removing the clip 102 from previously clipped tissue for repositioning of the clip 102.
[0046] When the wing 118 is sheared, it separates from the distal end 114 of the extension member 112, and the distal end 114 can be removed from the insert 162 through the hole 164. In particular, when the wing 118 is sheared following the initial distal movement of the extension member 112 relative to the clip 102 which initiates the final deployment of the clip 102, the extension member 112 may be pulled proximal to the clip 102, and as a result, the distal end 114 may exit the hole 164 and pass distally. Thus, the clip 102 is finally deployed and remains on the body clipped over the target tissue. The wing 118 remains trapped in the recess 170 to prevent any detachment within the main body.
[0047] According to an exemplary method for tissue closure utilizing the clipping system 100, the clip 102 can be inserted into a target region within a body lumen, such as a GI tube, through an insertion device 104, which in one embodiment may include an endoscope 106. As described above, in an insertion configuration (as shown in Figure 1), the clip 102 is attached to the distal end 108 of the endoscope 106 via an adapter 110 such that the jaws 120 are separated from each other toward an open configuration. In this insertion configuration, the clip 102 is guided to the target region and positioned over the target tissue via the visualization system of the endoscope 106. Suction force and / or tissue grippers may be applied through the working channel of the endoscope 106 so that the target tissue can be drawn into the channel 126 of the adapter 110. Therefore, when the clip 102 is moved toward the initial deployment configuration by moving the extension member 112 distally relative to the endoscope 106, thereby releasing the tension along it, the clip 102 is allowed to slide distally along the adapter 110 toward the biased closed configuration. When the clip 102 is moved toward the biased closed configuration, the tissue is clipped between the jaws 120 of the clip 102 in the initial deployment configuration.
[0048] It will be understood by those skilled in the art that tissue aspiration and / or clipping in this initial deployment configuration may obstruct the imaging / optical lens of the endoscope 106, so that the user may not be able to visualize and / or confirm whether the desired target tissue has been properly clipped. Therefore, clip 102 can be moved toward the review configuration (as shown in Figure 5) by pulling the endoscope 106 proximal to clip 102, while clip 102 remains engaged with the extension member 112. The distance between the adapter 110 and clip 102 widens the field of view of the endoscope 106, so that clip 102 and the tissue clipped by it can be viewed through the optical / visualization system of the endoscope 106.
[0049] When visualized, if the user determines that the clip 102 requires adjustment and / or repositioning relative to the target tissue, the extension member 112 may be moved proximal to the endoscope 106 until the clip 102 is moved proximal along the adapter 110 toward the open insertion configuration, as described above. In particular, the endoscope 106 may be moved distal to the extension member 112 so that the clip 102 and the adapter 110 are drawn toward each other. Once the clip 102 is moved toward the open configuration, the clipped tissue is released, and the clip 102 can be repositioned on the target tissue as desired. The clip 102 may then be moved again toward the initial deployment configuration, and then again toward the review configuration. This process may be repeated as needed until the user can visually confirm that the clip 102 has clipped the target tissue as desired.
[0050] Once the user confirms that the target tissue has been clipped as desired, the clip 102 can be moved from the review configuration to the final deployment configuration by releasing the clip 102 from the extension member 112. As described above, in one embodiment, as shown in Figure 6, the extension member 112 can be moved distally relative to the clip 102 so that the wings 118 at each distal end 114 of the extension member 112 are pressed against the distal surface 171 of the recess 170 of the insert 162 into which they are received. The extension member 112 is moved distally relative to the clip 102 until the proximal force applied to the wings 118 via the distal surface 171 exceeds a predetermined threshold force, causing the cutting edge 172 to shear the wings 118 at the radially innermost location 132, as shown in Figure 7.
[0051] Therefore, the wing 118 is separated from the distal end 114, and the extension member 112 can be pulled distally relative to the clip 102 so that the distal end 114 is pulled distally out of the hole 164 in the insert 162, as shown in Figure 8. As described above, the sheared wing 118 remains trapped in the recess 170 to prevent any detachment during the final deployment process. Thereafter, the extension member 112 and the rest of the insertion device 104 can be removed proximal to the clip 102 and withdrawn from the body, leaving the clip 102 clipped over the target tissue, as shown in Figure 9.
[0052] As shown in Figures 10-11, an extension member 212 in another exemplary embodiment can be releasably engaged with the clip 102, as described above with respect to system 100, to move the clip 102 between an insertion configuration, an initial deployment configuration, and a review configuration. When the extension member 212 is released from the clip 102, the clip 102 can finally be deployed. Similar to the extension member 112, the extension member 212 can be directly connected to the opening 156 of the clip 102. Alternatively, in another embodiment as shown in the figures, the extension member 212 can be connected to the clip 102 via an insert 262 that is received into and fixed therein within the opening 156 of the clip 102. However, rather than a connector including wings that can be sheared, each distal end 214 of the extension member 212 is biased toward a curled configuration, as shown in Figure 10, and is receivable into the opening 264 of the insert 262 in the engagement configuration.
[0053] In one exemplary embodiment, the opening 264 may extend through the insert 262 along a curve having a curvature smaller than the curvature of the curled distal end 214, such that the distal end 214 engages with the opening 264 and allows the clip 102 (and insert 262) to move between the insertion configuration, the initial deployment configuration and the review configuration via the movement of the extension member 212. In other words, the biasing force of the curled distal end 214 causes the distal end 214 to clip the curved surface of the opening 264 until the force applied thereto exceeds a predetermined threshold force.
[0054] If it is desired to move the clip 102 toward the final unfolded configuration, the extension member 212 is pulled proximal to the clip 102 until the force applied to the extension member 212 exceeds a predetermined threshold force, unwinding the curled distal end 214 so that the distal end 214 can be removed from the opening 264, as shown in Figure 11. With respect to system 100, the extension member 112 described above requires distal movement of the extension member 112 relative to the clip 102 to release the distal end 214 from the insert, but it will be understood by those skilled in the art that the extension member 212 is moved proximal to the clip 102 to release the distal end 114 from the opening 264 of the insert 262.
[0055] In one exemplary embodiment, at least a portion of the extension member 212 (e.g., the distal end 214) may be formed of a material biased toward a curled configuration, such as nitinol or spring steel. In one embodiment, to achieve a desired curl of the distal end 214 and to ensure that the distal end 214 does not unravel during the movement of the clip 102 between the insertion configuration, the initial deployment configuration and the review configuration, the distal end 214 may be reinforced with, for example, a compressible rod. It will be understood by those skilled in the art that the force required to release the extension member 212 from the insert 262 can be adjusted in any of several different ways, such as adjusting the degree of curl of the distal end 214, the thickness or material of the distal end 214, or the geometry of the opening 264 of the insert 262. In one embodiment, the opening 264 may include an angled edge to further facilitate clipping of the surface of the opening 264 through the biased curl of the distal end 214.
[0056] According to another exemplary embodiment, instead of being received within the curved opening 264, the curled distal end 214 may be wrapped around a post or other geometric structure within the insert 262. As described above, when the extension member 212 is pulled proximal to the clip 102 by a force exceeding a predetermined threshold force, the curled distal end 214 can unwind and release the post so that the extension member 212 can be removed from the insert 262 and the clip 102 can be deployed. In yet another exemplary embodiment, instead of unwinding by applying a proximal force exceeding a predetermined threshold force to the extension member 212, the oversheath can be placed over the distal end 214 of the extension member 212 and moved distally, straightening the distal end 214 and removing the distal end 214 from the insert, thereby releasing the clip 102.
[0057] Similar to the system 100 described above, the extension member 212 can be moved longitudinally relative to the endoscope 106 to move the clip 102 between the insertion configuration, the initial deployment configuration, and the review configuration. During the repositioning of the clip 102, it will be understood by those skilled in the art that the proximal force applied to the extension member 212 to move the clip 102 proximal along the adapter 110 back from the review configuration to the insertion configuration is less than a predetermined threshold force required for the final deployment of the clip 102.
[0058] In other words, by retracting the clip 102 across the adapter 110, the distal end 214 does not unravel, but rather the clip 102 is clipped over the target tissue as desired, so that the clip 102 can move between the insertion configuration, the initial deployment configuration, and the review configuration as needed. Once it is determined that the clip 102 has clipped the target tissue, the extension member 212 may be pulled proximal to the clip 102 until the force applied thereto exceeds a predetermined threshold force. The extension member 212 unravels the curled distal end 214 and is released from the insert 262, thereby deploying the clip 102. Once released from the insert 262, the extension member 212 (and the rest of the insertion device 104) is withdrawn from the clip 102 and the main body, leaving the clip 102 clipped over the target tissue.
[0059] Another exemplary embodiment of the tissue clipping system 300 may be substantially similar to the clipping system 100 described above, as shown in Figures 12 to 16. The tissue clipping system 300 comprises a clip 302 connected to the distal end of an insertion device 304, such as an endoscope, via an adapter 310 fitted over the distal end of an endoscope. Similar to the clip 102, the clip 302 is movable relative to the adapter 310 (and the endoscope to which it is attached) between an insertion configuration (Figure 12), an initial deployment configuration, and a review configuration (Figure 13) via an extension member 312 connected to the clip 302. When it is determined that the clip 302 has clipped target tissue, the extension member 312 may, if desired, be released from the clip 302, moving the clip from the review configuration to the final deployment configuration.
[0060] However, in this embodiment, the distal end 314 of the extension member 312 is releasably connected to the clip 302 via a connector 316 configured to engage with an opening 356 extending through the jaws 320 of the clip 302. However, the distal end 314 is biased radially away from each other and / or laterally away from the longitudinal axis of the adapter 310, and if the extension member 312 is moved distally relative to the clip 302 by a force exceeding a predetermined threshold force, the connector 316 moves distally from the first portion 376 of the opening 356, as shown in Figure 14, and as a result, the distal end 314 can return to a biased configuration in which the distal end 314 is moved away from each other. As the distal ends 314 are moved away from each other, the longer portion of the extension member 312 extending proximally from the connector 316 is moved laterally with respect to the longitudinal axis of the adapter 310 through the second portion 378 of the opening 356, which extends between the first portion 376 of the opening 356 and the outside of the clip 302. The extension member 312 passes through the second portion 378 of the opening 356 and is no longer connected to the clip 302. The extension member 312 may be pulled proximally away from the clip 302, while the clip 302 remains clipped to the target tissue in the final deployment configuration.
[0061] In this embodiment, clip 302 may be substantially similar to clip 102 described above with respect to system 100. As shown in Figure 15, the opening 356 extends through each jaw 320 of clip 302 from a first surface facing the adapter 310 to a second surface 360 facing away from the adapter 310, while the opening 356 may be substantially keyhole-shaped, including a first portion 376 and a second portion 378. As described above, the first portion 376 is sized and molded to correspond to the connector 316 so that the connector 316 can be received and engaged therein. The second portion 378 extends from the first portion 376 to each outer edge 361 of the jaw 320 so that the opening 356 opens to the outside of clip 302 through the second portion 378. The second portion 378 may be configured as a slot having a smaller width than the first portion 376 so that the connector 316 cannot be received therein. However, the width of the second portion 378 is configured to allow the remaining long portion of the extension member 312 (for example, the portion of the extension member 312 extending proximal to the connector 316) to pass through it.
[0062] Each of the extension members 312 extends from a proximal end 313 accessible to the user, for example, via an actuator 380, to a distal end 314 containing a connector 316. As described above, each connector 316 is dimensioned, molded, and configured to engage with a first portion 376 of the opening 356 of the corresponding jaw 320 of the clip 302, for example, via a friction fit or a snap connection. The distal ends 314 of the extension members 312 are radially biased away from each other so that when the connector 316 is received within the first portion 376 of the clip 302, the distal ends 314 are constrained toward each other.
[0063] In one exemplary embodiment, as shown in Figure 16, each of the connectors 316 includes a head portion 386 and a shaft 388 extending proximal therefrom. The head portion 386 is configured to be positioned along the second surface 360 of the clip 302 when the shaft 388 is received in the first portion 376. The connector 316 may also include one or more arms 382 extending laterally from the shaft 388 and one or more arms 382 positioned along the shaft 388. When the connector 316 engages with the first portion 376 of the opening 356, the arms 382 extend along and / or adjacent to the first surface 358 of the clip 302 to prevent the clip 302 from being inadvertently disengaged from the connector 316 when the clip 302 is pressed against tissue. Thus, each connector 316 can be received in a corresponding one of the openings 356 such that the clip 302 is received between the head portion 386 and its arms 382.
[0064] System 300 can be used to position the clip 302 in substantially the same manner as System 100 described above. In particular, as described above, while the clip 302 remains connected to the extension member 312, the clip 302 can be moved between the insertion configuration, the initial deployment configuration, and the review configuration. Similar to the clip 102, in the insertion configuration, the clip 302 is attached to the adapter 310 with the jaws 320 extended across their opposing portions so that tissue can be received between them. To move the clip 302 toward the initial deployment configuration, tension along the extension member 312 can be released so that the clip 302 slides distally from the adapter toward the biased closed configuration and clips the tissue between the jaws 320. The clip 302 can be moved toward the review configuration by pulling the adapter 310 proximal away from the clip 302 to widen the field of view of the endoscope. The user can then observe whether the clip 302 is overlapping and clipping the target tissue as desired.
[0065] As described above with respect to system 100, clip 302 can also be repositioned by pulling clip 302 proximal along adapter 310 and returning it to the insertion configuration. The above process may be repeated, as desired, by moving clip 302 between the insertion configuration, initial deployment configuration and review configuration until it is determined that clip 302 is clipped to the target tissue.
[0066] When clip 302 is in a review configuration and it is determined that clip 302 is clipped to target tissue, the extension member 312 is optionally moved distal to clip 302 until the applied force exceeds a predetermined threshold force, thereby deforming the arm 382 and allowing each connector 316 to move distally from the first portion 376 of the corresponding opening 356. As the connector 316 moves distally from the opening 356, the distal end 314 is able to return to a biased configuration and moves away from each other so that the longer portion of the extension member 312 extending proximal to the connector 316 passes through the second portion 378 of the opening 356 and exits clip 302. Thus, the extension member 312 is released from clip 302 so that the extension member 312 and the rest of the insertion device 304 can be withdrawn from the body, and clip 302 remains clipped to target tissue in the final deployment configuration.
[0067] While exemplary embodiments show and describe the opening 356 of the clip 302 as being directly connected to the connector 316 of the extension member 312, it will be understood by those skilled in the art that, similar to the clip 102, the opening 356 may be configured to accept an insert having the features of a first portion 376 and a second portion 378, so that the connector 316 can be connected to the clip 302 via an insert fixed within the opening 356.
[0068] According to an alternative embodiment, as shown in Figures 17-19, instead of the connector 316 including the arm 382 described above to prevent accidental release of the connector 316 from the clip 302, the insert of the clip 402, i.e., the opening 456, may include a flap 490 extending over a first portion 476 of the opening 456 along the surface 460 of the clip 402 facing away from the adapter, as shown in Figure 17. The flap 490 is configured to deform, as shown in Figure 18, allowing the connector 416 of the corresponding extension member 412 to pass distally when the distal force applied to the extension member 412 exceeds a predetermined threshold force. Similar to system 300, as the connector 416 moves distally from the first portion 476 of the opening 456, the distal end 414 of the extension member 412 returns to its biased configuration, and moves away from each other so that the longer portion of the proximal extension member of the connecting member 412 passes laterally through the second portion of the opening 456 of the clip 402 to the outside of the clip 402, and the extension member 412 is pulled out proximal therefrom, as shown in Figure 19, leaving the clip 402 clipping the target tissue in its final deployed configuration.
[0069] In yet another alternative embodiment, as shown in Figures 20-21, the flap 590 may extend over the opening 556 of the clip 502 along a surface 558 facing the adapter to which the clip 502 can be attached in the initial configuration. In this embodiment, when the extension member 512 is pulled proximal to the clip 502 by a force exceeding a predetermined threshold force, the flap 590 deforms as shown in Figure 20, allowing the connector 516 of the extension member 512 to be released from the opening 556 of the clip 502 so that the clip 502 can be moved toward the final deployed configuration.
[0070] Those skilled in the art will understand that this embodiment does not require the distal ends 514 of the extension members 512 to be biased away from each other, nor does it require an opening 556 in the clip 502, nor does it require a slot to open the opening 556 to the outside of the clip 502. As described above, when the flap 590 is deformed, the connector 516 is released from the opening 556 by pulling the extension members 512 proximal to the clip 502 and out of the body (as shown in Figure 21), leaving the clip 502 clipping the target tissue in its final deployed configuration.
[0071] It will be apparent to those skilled in the art that various modifications can be made to this disclosure without departing from the scope of this disclosure. Furthermore, those skilled in the art will understand that any feature of any of the various embodiments can be combined in any way that does not contradict the description and / or function of the embodiments.
Claims
1. A clipping system for treating tissue, The clipping system comprises an adapter including a proximal portion configured to be mounted on the distal end of an insertion device and a distal portion extending distally from the proximal portion. The clipping system comprises a clip configured to be attached over the distal portion of the adapter, the clip comprising a first jaw and a second jaw connected to each other, the first jaw and the second jaw being movable between an insertion configuration and an initial deployment configuration, the insertion configuration comprising the first jaw and the second jaw extending around opposing portions of the distal portion of the adapter and separating from each other to receive tissue between the first jaw and the second jaw, the initial deployment configuration comprising the clip being moved distally from the adapter so that the first jaw and the second jaw are attracted to each other and clip tissue between the first jaw and the second jaw, the first jaw and the second jaw being biased toward the initial deployment configuration. The clipping system comprises a first extension member releasably connected to the clip and movably connected to the adapter, the first extension member including a connector at its distal end, the connector being configured to releasably engage with an opening extending through the first jaws such that longitudinal movement of the first extension member relative to the adapter moves the clip between the insertion configuration, the initial deployment configuration and the review configuration, the adapter being able to be withdrawn proximal to the clip while the first extension member remains connected to the clip to improve visual observation of the clip. A clipping system wherein the first extension member is operable to retract the clip proximal to the adapter such that the clip is forcibly opened when the first extension member is retracted along the adapter while releasing the clip from the tissue clipped to the clip, the connector includes a deformable portion, the deformable portion is configured to deform in order to release the first extension member from the first jaw toward a final deployment configuration when a force applied to the first extension member acting distally on the clip exceeds a predetermined threshold, and the first extension member is capable of being pulled proximal to the clip when the connector is deformed.
2. The clipping system according to claim 1, wherein the connector includes a pair of wings extending radially away from the distal end of the first extension member, the pair of wings being configured to be sheared from the distal end of the first extension member when the pair of wings are deformed toward the final unfolded configuration.
3. The clipping system according to claim 2, further comprising an insert configured to be received and secured within the opening of the first jaw, the insert including a hole extending longitudinally through the insert and a recess extending radially outward from the hole, the recess being sized, molded and configured to receive the pair of wings within the recess.
4. The clipping system according to claim 2, wherein the radially innermost portion of each wing, where it is connected to the distal end of the first extension member, has a thickness smaller than the rest of the wing.
5. The clipping system according to claim 3, wherein the distal surfaces of the pair of wings include a tapered portion inclined at an angle not perpendicular to the longitudinal axis of the first extension member, and the tapered portion is configured to engage with a sharp cutting edge along the surface of the recess when pressed distally against the surface of the recess.
6. The clipping system according to claim 1, wherein the opening of the first jaw extends through the clip from a first surface facing the adapter to a second surface facing away from the adapter, and the opening includes a first portion configured to engage with the connector and a second portion configured as a slot extending from the first portion to the outside of the clip.
7. The clipping system according to claim 6, wherein the connector of the first extension member includes a head portion and a shaft extending proximal to the head portion, the shaft being sized, molded, and configured to engage with the first portion of the opening, and the width of the slot being smaller than the shaft to prevent the connector from passing through the slot.
8. The clipping system according to claim 6, wherein the deformable portion of the first extension member deforms, thereby biasing the distal end of the first extension member laterally away from the longitudinal axis of the adapter, so that when the connector is received in the first portion of the opening, the distal end of the first extension member is constrained toward a laterally inward position, and when the connector is pushed distally out of the first portion of the opening, the distal end returns toward its biased laterally outward position, so that the remaining long portion of the first extension member extending proximal to the connector passes through the slot of the second portion of the opening to the outside of the clip.
9. The clipping system according to claim 7, wherein the connector includes a deformable arm extending laterally from the shaft to engage with the first surface of the clip when the shaft is received within the first portion of the opening, so as to move the clip between the insertion configuration, the initial deployment configuration and the review configuration, and the deformable arm is configured to deform to release the connector from the first portion of the opening when a force acting distally on the clip applied to the first extension member exceeds a predetermined threshold.
10. A clipping system according to any one of claims 1 to 9, further comprising a second extension member releasably connected to the clip and movably connected to the adapter, wherein the second extension member includes a further connector at its distal end, configured to releasably engage with an opening extending through the second jaw such that longitudinal movement of the second extension member relative to the adapter moves the clip between the insertion configuration, the initial deployment configuration and the review configuration, the further connector of the second extension member including a deformable portion configured to deform to release the second extension member from the second jaw toward the final deployment configuration when a force applied to the second extension member acting distally on the clip exceeds a predetermined threshold.
Citation Information
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