Repositionable over-the-scope clip with compliant mechanism

Abstract

The system includes a clip, a first control member, and an adapter having a channel extending from a proximal end to a distal end. The clip includes a base portion mounted on the periphery of the adapter and a plurality of arms extending distally therefrom. The arms are reciprocally movable between an insertion configuration and an initial placement configuration. The first member is releasably coupled to the base portion and movably connected to the adapter such that longitudinal movement of the first member relative to the adapter moves the clip between the insertion configuration, the initial placement configuration, and the review configuration. The first member is operable to retract the clip proximally on the adapter toward the insertion configuration such that as the clip is retracted on the adapter, the arms are simultaneously forced open, releasing the clip from the tissue that was previously clipped.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to endoscopic devices, and more particularly, to endoscopic clipping devices for treating tissue along the gastrointestinal tract. [Background technology]

[0002] Physicians are becoming more aggressive in performing aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of perforating the wall of the GI tract and may require closure of the GI tract wall as part of the procedure. Such procedures may include, for example, removal of large lesions, submucosal tunneling of the GI tract to treat submucosal problems, full thickness removal of tissue, treatment of problems in other organs by tunneling outside the GI tract, and endoscopic treatment / repair of post-operative problems (e.g., post-operative leaks, broken surgical staple lines, and anastomotic leaks).

[0003] Currently, tissue can 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 relatively large tissue defects. These endoscopic closure devices may provide cost savings to hospitals and benefits to patients. However, in some cases, current endoscopic closure devices may be difficult to use, time consuming to position, or may not be sufficient for certain perforations, conditions, and anatomical structures. For example, current over-the-scope clips generally require the clip to be released from a position where the clip itself is not visible to the operator. That is, prior to clipping, the operator may observe the target tissue to be clipped or determine based on this visualization of the target tissue that the distal end of the device and the clip are in a desired position relative to the target tissue. The operator then places the clip without being able to see the clip itself until the clip is placed based on the observation of the target tissue. Once placed, such current over-the-scope clips generally cannot be repositioned. Summary of the Invention

[0004] The present disclosure relates to a clipping system for treating tissue, comprising an adapter configured to be mounted on a distal end of an insertion device, the adapter comprising a channel extending through the adapter from a proximal end to a distal end, and a clip having a base portion configured to be mounted on an outer periphery of the adapter and a plurality of arms extending distally from the base portion, the arms being movable relative to one another between an insertion configuration and an initial deployment configuration, in which the arms extend along an outer surface of the adapter such that distal ends of the arms are separated from one another in an open configuration to receive tissue therebetween, and in which the clip is moved distally away from the adapter such that distal ends of the arms are moved toward a biased closed configuration in which the distal ends of the arms are drawn toward one another to grasp tissue therebetween. The system further includes a first control member releasably coupled to the base portion of the clip and movably connected to the adapter, whereby longitudinal movement of the first control member relative to the adapter moves the clip between the insertion configuration, the initial placement configuration, and a review configuration, where the first control member allows the adapter to be withdrawn proximally away from the clip while remaining coupled to the clip to enhance visual observation of the clip, and the first control member is operable to pull the clip proximally on the adapter toward the insertion configuration, whereby as the clip is pulled back on the adapter, the arms are pushed open, releasing the clip from the tissue against which it was clipped.

[0005] In one embodiment, the first control member includes an enlarged distal portion that engages a distal surface of the base portion such that a remaining length of the first control member extends proximally through an opening in the base portion to a proximal end accessible to a user, and the enlarged distal end of the first control member is connected to the remaining length of the first control member via a connection configured to release when subjected to a force above a predetermined threshold.

[0006] In one embodiment, the system further comprises a first extending member configured to slidably receive the first control member therein such that the enlarged distal end of the first control member extends distally from the distal end of the first extending member to be coupled to the base portion of the clip, and proximal movement of the first control member relative to the first extending member draws the clip against the distal end of the first extending member to release the connection and move the clip toward a final configuration.

[0007] In one embodiment, each of the multiple arms has a proximal portion and a distal portion movably connected to one another via a hinge that biases each of the multiple arms toward the closed configuration, wherein the proximal portion and the distal portion of each of the multiple arms bend relative to one another in the closed configuration such that multiple distal ends extend toward the longitudinal axis of the adapter.

[0008] In one embodiment, the distal portion of each of the plurality of arms includes an engagement feature extending laterally therefrom that engages a distal end of the adapter to prevent further proximal movement of the clip relative to the adapter when the clip is pulled proximally onto the adapter.

[0009] In one embodiment, when a plurality of engagement features engage the distal end of the adaptor, the distal portion of each of the plurality of arms engages the adaptor to maintain the plurality of arms toward the open configuration.

[0010] In one embodiment, the distal end of the adapter has a lip projecting radially outwardly therefrom. In one embodiment, the distal ends of each of the plurality of arms extend laterally inwardly relative to one another and include tissue gripping features.

[0011] In one embodiment, the base portion is ring-shaped. In one embodiment, the system further comprises a second control member releasably coupled to the base portion of the clip and movably connected to the adapter, such that longitudinal movement of the second control member relative to the adapter moves the clip between the insertion configuration, the initial placement configuration, and the review configuration; and a second extension member extending longitudinally from a proximal end accessible to a user of the system to a distal end, the second control member extending distally from the distal end of the second control member such that the second control member is slidably received within the second extension member, thereby coupling the distal end of the second control member to the clip.

[0012] A clipping system for treating tissue includes an endoscope extending longitudinally from a proximal end to a distal end, an adapter mountable on a distal end of the endoscope whereby a channel of the adapter is aligned along a longitudinal axis of the endoscope, a clip having a ring-shaped base portion configured to be mounted on the adapter, and a plurality of arms extending distally from the base portion, the arms being movable relative to one another between an insertion configuration and an initial configuration, in which the arms extend along an outer surface of the adapter such that the distal ends of the arms are separated from one another in an open configuration to receive tissue therebetween, and in which the clip is moved distally away from the adapter such that the distal ends of the arms are moved toward one another in a biased closed configuration in which the distal ends of the arms are drawn toward one another to grasp tissue therebetween. and first and second control members releasably coupled to the base portion of the clip and movably connected to the adapter, whereby longitudinal movement of the first and second control members relative to the adapter moves the clip between the insertion configuration, the initial placement configuration, and a review configuration, where the first and second control members remain coupled to the clip and allow the endoscope to be withdrawn proximally away from the clip to improve visual observation of the clip through the endoscope, and the first and second control members are operable to pull the clip proximally back on the adapter toward the insertion configuration, such that as the clip is pulled back on the adapter, the multiple arms are forced open, releasing the clip from the tissue against which it was clipped.

[0013] In one embodiment, the first control member and the second control member each include an enlarged distal portion that engages a distal surface of the base portion, a remaining length of the first control member extending proximally through an opening in the base portion to a proximal end of the first control member that is accessible to a user, and the enlarged distal end of the first control member is connected to the remaining length of the first control member via a connection configured to release when subjected to a force exceeding a predetermined threshold.

[0014] In one embodiment, the system further comprises first and second elongated members extending longitudinally from a proximal end accessible to a user of the system to a distal end, each of the first and second elongated members configured to slidably receive a corresponding one of the first and second control members therein, such that pulling the clip proximally toward the distal ends of the first and second elongated members via the first and second control members releases the clip from the proximal portions of the first and second control members.

[0015] In one embodiment, each of the multiple arms has a proximal portion and a distal portion movably connected to one another via a hinge that biases each of the multiple arms toward the closed configuration, wherein the proximal portion and the distal portion of a first arm of the multiple arms bend relative to the distal portion of a second arm of the multiple arms such that distal ends of the first arm and the second arm extend toward a longitudinal axis of the adapter.

[0016] In one embodiment, the adapter has a lip protruding radially outward from the distal end of the adapter such that when the distal portions of the arms engage the lip, the distal portions of the arms are lifted onto the adapter.

[0017] The present disclosure also relates to a method for treating tissue, the method including inserting a clip via an endoscope to a target area within a body lumen, the clip being mounted on a distal end of the endoscope via an adapter in an open insertion configuration, where a base portion of the clip is mounted on the adapter such that a plurality of arms extending distally from the base portion extend along an outer surface of the adapter and distal ends of the plurality of arms of the clip are spaced apart from one another; drawing tissue into a channel of the adapter between the arms of the clip; and releasably coupling the clip to the base portion of the clip. moving the clip from the open insertion configuration toward an initial deployment configuration by moving distal ends of a plurality of control members distally relative to the endoscope, whereby the control members push the clip distally away from the adapter and release the arms to move the clip back toward a biased closed configuration in which the distal ends of the arms extend toward each other to grasp tissue therebetween; and pulling the endoscope proximally away from the clip while the clip remains coupled to the distal ends of the plurality of control members toward a review configuration in which visualization of the clip through the endoscope is improved.

[0018] In one embodiment, when it is determined that the clip needs to be repositioned, the control member may be pulled proximally relative to the endoscope until the clip is pulled proximally on the adapter toward the open insertion configuration and the clip may be repositioned on the target tissue.

[0019] In one embodiment, the method further comprises moving the clip from the review configuration towards a final configuration by drawing the control members proximally relative to the endoscope such that the clip is drawn proximally against distal ends of extension members that slidably receive the control members therethrough until a force exerted on the control members exceeds a predetermined threshold force, thereby separating the enlarged distal end of each of the control members from a remaining length thereof, thereby releasing the clip from the endoscope.

[0020] In one embodiment, to move the clip between the open insertion configuration, the initial placement configuration, and the review configuration, the enlarged distal end of each of the plurality of control members is positioned against a distal surface of the base portion of the clip such that a remaining length of each of the plurality of control members extends proximally through an opening in the base portion, and distal ends of the plurality of extending members are positioned just proximal to the base portion of the clip such that the plurality of control members and the plurality of extending members move simultaneously relative to the endoscope.

[0021] In one embodiment, moving the clip toward the final configuration may comprise moving the extension member distally relative to the endoscope until the distal ends are positioned against a proximal face of the base portion of the clip, such that the clip is drawn proximally therewith. [Brief description of the drawings]

[0022] [Figure 1] 1 is a perspective view of a distal portion of a clipping system according to an exemplary embodiment of the present disclosure; [Diagram 2] 2 is a perspective view of a clip according to the exemplary system of FIG. 1; [Diagram 3] 2 is a longitudinal side view of a distal portion of the clipping system of FIG. 1 in an open insertion configuration. [Figure 4]2 is a perspective view of a distal portion of the clipping system of FIG. 1 in a closed configuration. [Diagram 5] 2 is an enlarged perspective view of a control member and an extension member connected to a clip according to the exemplary system of FIG. 1. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] The present disclosure may be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals. The present disclosure relates to a clipping system, and in particular to an over-the-scope endoscopic clipping system, in which the initial placement of the clip may be observed and adjusted prior to its final placement. An exemplary embodiment of the present disclosure includes a clip mountable onto a distal end of an endoscope via an adapter. The clip is releasably coupled to a distal end of a control member, which is slidably received within an extension member. The clip may be moved between an insertion configuration, an initial placement configuration, and a review configuration via movement of the control member and / or the extension member relative to the endoscope. In this embodiment, the clip comprises a base portion sized and shaped to be mounted onto the adapter and a plurality of arms extending distally from the base portion. The arms are movable from an open configuration to a closed configuration in which the distal ends of the arms are moved away from one another to receive tissue therebetween and in which the distal ends of the arms are moved toward one another to grasp tissue.

[0024] In the insertion configuration, the clip is mounted on the adapter with the base portion extending near the periphery of the adapter and the proximal portions of the arms extending distally from the base portion along the exterior of the adapter to maintain the arms in an open configuration. The clip is maintained in an insertion configuration that facilitates insertion of an endoscope into a target site adjacent the tissue to be clipped such that the position of the clip minimizes obstruction of the view of an endoscope visual system. The arms are biased toward a closed configuration such that as the clip moves distally from the adapter and the arms extend distally beyond the distal end of the adapter, the arms are released to spring radially inward under their natural bias toward the closed configuration (e.g., clipping on tissue in an initial deployment configuration).

[0025] The system allows the endoscope to be withdrawn proximally away from the clip and the tissue it clips, while the clip remains coupled to the endoscope via the control member. As the endoscope is withdrawn proximally while the clip remains in place on the target tissue, the field of view of the endoscope vision system is expanded to reveal the clip and the tissue clipped thereby, so that the operator can determine whether the position of the clip is desired or requires adjustment. If the operator determines that the clip is positioned as desired, the clip is moved toward a final placement configuration by releasing the clip from the control member such that the clip remains in place clipped onto the target tissue, while the remainder of the device, including the adapter and endoscope, is withdrawn from the body. If the operator determines that the position of the clip needs to be adjusted, the endoscope and its coupled adapter are moved distally to a position adjacent the clip. The clip is then drawn proximally on the adapter (via proximal retraction of the control member) to re-release the clip, and as the clip is drawn proximally on the adapter, the arms of the clip are forced open to return the clip to the insertion configuration.

[0026] After the clip has been removed from the tissue and returned to the insertion configuration, the operator can reposition the endoscope and device as desired and draw a new portion of tissue into the adapter (e.g., under suction or with a grasper applied, such as through the working channel of the endoscope). The user can then reposition the clip from the adapter in this new location so that the clip closes over the new portion of tissue (i.e., back to the initial placement position). The endoscope is then again withdrawn proximally while the clip remains connected to the device, moving the device back to the review configuration. The position of the clip and the clipped tissue can again be observed, and the process can be repeated until the operator determines that the clip is desirably positioned. When the operator determines that the tissue that the clip will close over is the desired portion of tissue, the clip may be released from the control member in the final placement configuration. 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 device user, respectively.

[0027] As shown in FIGS. 1-5, an exemplary embodiment of a clipping system 100 for treating tissue defects and / or perforations includes a clip 102 configured to be inserted, for example, through a body lumen to a target area to clip target tissue therein. The clip 102 can be inserted into the target area via an insertion device 104, for example, comprising an endoscope 106. As shown in FIG. 1, the clip 102 is coupled to a distal end 108 of an endoscope 106 via an adapter 110 mounted on the distal end 108 of the endoscope 106. According to an exemplary embodiment, the clip 102 includes a base portion 112 configured to be slidably mounted on the adapter 110 and a plurality of arms 114 extending distally from the base portion 112, the plurality of arms 114 being movable between an open configuration in which a plurality of distal ends 124 thereof are spaced apart from one another and a closed configuration in which the plurality of distal ends 124 are drawn together from one another. The clip 102 is releasably coupled to a control member 116 via which the clip 102 is moved between an insertion configuration, an initial placement configuration, and a review configuration, in which the clip 102 is mounted on the adapter 110 in an open configuration, in which the clip 102 is pushed distally from the adapter 110 toward a closed configuration, and in which the clip 102 is moved away from the distal end 108 of the endoscope 106 to increase the field of view of the endoscope 106 in the review configuration.

[0028] In the exemplary embodiment, each of the plurality of control members 116 has a distal end 120 that couples to the clip 102, and the distal end 120 is connected to the remaining length of the control member 116 via a releasable connection 160 such that the clip 102 can be released from the control member 116 via release and / or separation of the connection 160 when it is desired to move the clip 102 towards its final configuration. Each of the plurality of control members 116 extends through a corresponding extension member 118 such that the distal end 120 of the control member 116 extends distally beyond the distal end 122 of the extension member 118 to couple to the clip 102. Release of the connection 160 may be facilitated by drawing the control member 116 against the extension member 118, as described in more detail below.

[0029] In the insertion configuration, the clip 102 is mounted on the adapter 110 such that a portion of the arms 114 extend along the exterior of the adapter 110, thereby holding the arms 114 in an open configuration in which the distal ends 124 of the arms 114 are separated from one another to receive tissue therebetween. To move the clip 102 from the insertion configuration toward the initial placement configuration, the extension member 118 (and control member 116) is moved distally relative to the adapter 110 to push the clip 102 out and away from the adapter 110, thereby moving the arms 114 toward a closed configuration in which the distal ends 124 move toward one another to grasp tissue therebetween. Upon clipping of tissue in the initial placement configuration, the clip 102 may be moved toward the review configuration by drawing the endoscope 106 proximally away from the clip 102 (or by moving the clip 102 distally away from the distal end 108) while still tethered to the insertion device 104 via the control member 116 and extension member 118. This provides an increased view of the endoscopic vision system relative to the clip 102 and the target tissue. If the user determines that the position of the clip 102 is incorrect or suboptimal, as described below, the user may move the endoscope 106 distally to a position adjacent the clip 102.

[0030] The clip 102 may then be pulled back on the adapter 110 toward the open insertion configuration by drawing the control member 116 (and extension member 118) proximally relative to the adapter 110. The user may then reposition the endoscope 106 and clip 102 so that the placement and / or position of the clip 102 relative to the target tissue can be adjusted as desired prior to final placement of the clip 102, and these steps may be repeated. That is, if the operator determines in the review configuration that the clip 102 is not positioned as desired, the clip 102 can again be opened and removed from the tissue, and the device can be repositioned until the clip 102 is closed over the desired portion of tissue. Once it is determined that the clip 102 has been clipped onto the target tissue as desired, the clip 102 can be moved toward the final placement configuration by releasing the clip 102 from the control member 116.

[0031] As described above, clip 102 includes a base portion 112 and a number of arms 114 extending distally therefrom. Base portion 112 is sized and shaped to be mounted on adapter 110 such that base portion 112 extends about the periphery of adapter 110. In one embodiment, base portion 112 may be substantially ring-shaped. However, one of ordinary skill in the art will appreciate that base portion 112 may have any type of shape and size, so long as base portion 112 is sized, shaped and configured to be slidably mounted on adapter 110.

[0032] According to an exemplary embodiment, the base portion 112 includes a pair of openings 166 extending longitudinally therethrough from the proximal surface 162 to the distal surface 156 of the base portion 112. Each opening 166 is configured to receive a portion of a corresponding one of the control members 116 therethrough. In some embodiments, the openings 166 may extend through diametrically opposed regions of the base portion 112. Although the exemplary embodiment shows and describes two openings 166, it will be understood by one of ordinary skill in the art that the base portion 112 may have any number of openings 166 so long as the number of openings 166 corresponds to the number of control members 116 of the insertion device 104.

[0033] As shown in FIGS. 2-4 , the arms 114 extend distally from the base portion 112 to a distal end 124, with each of the arms 114 having a proximal portion 126 and a distal portion 128 that are movable relative to one another between an open configuration and a closed configuration. According to an exemplary embodiment, the arms 114 are biased toward a closed configuration in which the distal ends 124 are drawn toward one another. In this embodiment, the proximal portion 126 and the distal portion 128 of each of the arms 114 are angled and / or curved relative to one another such that, in the biased closed configuration, according to one embodiment, the proximal portion 126 extends substantially parallel to the longitudinal axis of the adapter 110 while the distal portion 128 extends at an angle relative to the longitudinal axis of the adapter 110. In this embodiment, the distal portion 128 is angled relative to the proximal portion 126 such that the distal end 124 tapers toward the longitudinal axis of the adapter 110.

[0034] The proximal and distal portions 126, 128 of each of the plurality of arms 114 may be connected to one another via a hinge 130, which allows movement of the clip 102 between a closed configuration and an open configuration. In an exemplary embodiment, the hinge 130 is spring loaded to bias the arms 114 toward the closed configuration. In particular, when the clip 102 is mounted on the adapter 110 in the insertion configuration, the arms 114 extend along a portion of the adapter 110 such that an outer surface 164 of the adapter 110 maintains the clip 102 toward the open configuration with the distal ends 124 of the plurality of arms 114 spaced apart from one another.

[0035] In some instances, the proximal and distal portions 126, 128 of the arms 114 may be substantially straight relative to one another in the open configuration such that the tissue receiving space between the distal ends 124 is larger than in conventional clips. However, as the clip 102 is moved distally away from the adapter 110 toward the initial deployment configuration, the arms 114 may return toward the biased closed configuration, with the distal portions 128 bending relative to the proximal portions 126 via the hinges 130 such that tissue may be grasped between the distal ends 124. In some embodiments, the hinges 130 may be configured as curved portions of the arms 114 connecting the proximal and distal portions 126, 128. Those skilled in the art will appreciate that the hinges 130 and / or each of the arms 114 may be formed of any of a variety of materials, so long as the hinges 130 bias each of the arms 114 toward the closed configuration as described above, and such that the bias is strong enough to maintain the clip 102 in a clipping position on the target tissue after the clip is finally deployed. In one example, a portion of the clip 102 (eg, the hinge 130) is formed from a shape memory alloy, such as, for example, Nitinol, to provide and / or add a bias toward the closed configuration.

[0036] Distal portion 128 of arm 114 includes an engagement feature 132 extending therefrom and configured to engage a portion of adapter 110 to prevent arm 114 from moving further proximally relative to adapter 110 when engagement feature 132 engages adapter 110. According to an exemplary embodiment, engagement feature 132 extends laterally therefrom along distal portion 128, for example to engage a distal end 138 of adapter 110.

[0037] In one embodiment, the engagement feature 132 may be configured as wings extending laterally from a longitudinal edge of the arm 114 such that the distal portion 128 of the arm 114 has a greater width than the proximal portion 126 of the arm 114. When the arm 114 is moved from the closed configuration toward the open configuration, the arm 114 is drawn proximally on the adapter 110 until the proximal portion 126 and hinge 130 extend along the outer surface 164 of the adapter 110. As the hinge 130 is moved proximally on the adapter 110, the engagement feature 132 along the distal portion 128 will abut a portion of the distal end 138 of the adapter 110. As shown in FIG. 3, the engagement feature 132 is positioned along the arm 114 such that where the engagement feature 132 engages the adapter 110, the arm 114 is pulled proximally enough on the adapter 110, thereby moving the arm 114, and in particular the distal portion 128 of the arm 114, toward the open configuration.

[0038] Each of the distal ends 124 of the plurality of arms 114 may include a gripping feature 134 configured to grip tissue received between the distal ends 124. The gripping feature 134 of each arm 114 may extend laterally inward and may have a radially inward curved portion that may be substantially hook-shaped in some embodiments. The gripping feature 134 may have teeth, for example. It will be understood by those skilled in the art that the gripping feature 134 may have any of a variety of configurations, so long as the gripping feature 134 is configured to facilitate gripping of tissue between the distal ends 124 when the clip 102 is in the closed configuration. For example, in the closed configuration, the plurality of gripping features 134 may contact and / or extend toward one another to grip tissue received between the distal ends 124 of the plurality of arms 114, as shown in FIG. 4.

[0039] Although the exemplary embodiment is shown as having four arms 114, it will be understood by one of ordinary skill in the art that the clip 102 may have any number of arms 114, so long as the clip 102 has at least two arms 114. In some embodiments, the arms 114 may be spaced equidistant from one another about the base portion 112. However, it will be understood by one of ordinary skill in the art that the arms 114 may extend distally from the base portion 112 in any number of configurations, so long as the arms 114 are configured to grasp tissue between their distal ends.

[0040] As mentioned above, the clip 102 may be attached to an insertion device 104, which may comprise any standard endoscope 106. The clip 102 may be attached to the endoscope 106 via an adapter 110 that is sized, shaped and configured to fit onto the distal end 108 of the endoscope 106. As will be appreciated by those skilled in the art, the endoscope 106 is configured to be inserted through a body lumen to a target area within the lumen, and therefore must be sufficiently flexible to navigate even the tortuous paths of a body lumen.

[0041] The adapter 110 extends from the proximal end 136 to the distal end 138 with a channel 140 extending therethrough. In one embodiment, the adapter 110 may be substantially cylindrical. However, one of ordinary skill in the art will appreciate that the adapter 110 may have any of a variety of shapes and configurations, so long as the adapter 110 is configured to be mounted onto the distal end 108 of the endoscope 106. The adapter 110 may be attached to the endoscope 106, for example, via a friction fit, such that the channel 140 of the adapter 110 substantially longitudinally lines up with the channel of the endoscope 106. In this manner, tissue may be viewed through the channel 140 via a viewing system of the endoscope 106. In another embodiment, the adapter 110 may be formed of a transparent material to enhance visibility of the tissue and / or clip 102.

[0042] According to an exemplary embodiment, the adapter 110 may include a proximal portion 142 having a larger outer cross-section (e.g., diameter) than a remaining distal portion 148 of the adapter 110. The proximal portion 142 may have a pair of holes 144 extending longitudinally through a wall 146 of the proximal portion 142. As described in more detail below, each of the pair of holes 144 is configured to slidably receive a corresponding one of the extension members 118 therein. The distal end 122 of the extension member 118 extends distally beyond the distal opening of the hole 144. Each of the plurality of extension members 118 slidably receives a corresponding one of the control members 116 therein such that the distal end 120 of the control member 116 extends distally beyond the distal end 122 of the extension member 118 and is releasably coupled to the clip 102.

[0043] The outer diameter of the distal portion 148 of the adapter 110 is sized, shaped, and configured to allow the base portion 112 to be slidably received over the distal portion 148 in the insertion configuration. In an exemplary embodiment, the distal end 138 of the adapter 110 may include a lip 150 that projects radially outward. The lip 150 projects beyond the outer diameter of the distal portion 148, but the base portion 112 is sized and shaped to be slidable proximally along the distal portion 148 over the lip 150.

[0044] As described in more detail below, the lip 150 is configured such that as the base portion 112 is slid proximally along the distal portion 148, the arm 114 slides along the lip 150, causing the lip 150 to lift the distal portion 128 of the arm 114 away from the longitudinal axis of the adapter 110. In particular, as the arm 114 is drawn proximally over the lip 150, the distal portion 128 of the arm 114 is moved relative to the proximal portion 126 of the arm via the hinge 130, increasing the angle between the distal portion 128 and the proximal portion 126, thereby moving the distal ends 124 of the arms away from the longitudinal axis of the adapter 110 and away from each other. According to an exemplary embodiment, the arm 114 is moved proximally over the distal portion 148 of the adapter 110 until the engagement feature 132 abuts the distal end 138 of the adapter 110, which prevents further proximal movement of the clip 102 relative to the adapter 110. Here, the lip 150 engages the proximal end of the distal portion 128 of each of the plurality of arms 114 thereby lifting the distal portion 128 away from the longitudinal axis.

[0045] The extension member 118 extends along the length of the endoscope 106 from a proximal end accessible to a user, for example, through a user interface at the proximal end of the insertion device 104, to the distal end 122. As described above, each of the plurality of extension members 118 may be slidably received within a corresponding one of a plurality of holes 144 extending through the proximal portion 142 of the adapter 110. Each of the plurality of extension members 118 may be configured, for example, as a nitinol hypotube, a plastic tube, or any of a variety of structures having a coiled and / or substantially tubular configuration. The extension member 118 may have any of a variety of configurations so long as it is configured to slidably receive the control member 116 therein.

[0046] According to one embodiment, each of the plurality of extension members 118 may extend through, for example, an outer shaft 152 that extends from a proximal end connected to a portion of a user interface to a distal end 154 connected to the adapter 110. In particular, the distal end 154 of the outer shaft 152 may be connected to the proximal end 136 of the adapter 110 such that each of the plurality of outer shafts 152 mates with a corresponding one of the plurality of holes 144 of the adapter 110. Thus, in this embodiment, each extension member 118 extends through the plurality of outer shafts 152 and a corresponding one of the plurality of holes 144 such that the extension member 118 can move longitudinally therethrough relative to the endoscope 106.

[0047] As discussed above, the control member 116 is received within the extension member 118 and extends from a proximal end that is connected to, for example, a user interface at the proximal end of the insertion device 104 to a distal end 120 that extends distally beyond the distal end 122 of the extension member 118. In an exemplary embodiment, as shown in FIG. 5, the distal end 120 of the control member 116 may be enlarged and coupled to the clip 102 via an opening 166 that extends through the base portion. In one embodiment, the enlarged distal end 120 is sized and shaped such that the enlarged distal end 120 cannot pass through the opening 166. In this embodiment, the enlarged distal end 120 of the control member 116 engages the distal surface 156 of the base portion 112 such that the remaining length of the control member 116 extends proximally through the opening 166 and through the extension member 118 to the proximal end of the insertion device 104.

[0048] In one embodiment, the enlarged distal end 120 may be secured and / or otherwise adhered to the distal surface 156 such that the enlarged distal end 120 does not lose any parts within the body upon final placement of the clip 102. As discussed above, the enlarged distal end 120 is sized, shaped and configured to prevent proximal passage of the enlarged distal end 120 through the opening 166 in the base portion 112. Similarly, the opening 166 is sized, shaped and configured to prevent distal passage of the distal end 122 of the extension member 118 therethrough. Thus, the base portion 112 of the clip 102 is held between the enlarged distal end 120 of the control member 116 and the distal end 122 of the extension member 118.

[0049] According to an exemplary embodiment, during the final deployment step, the enlarged distal ends 120 of the control members 116 are configured to release and / or separate from the remaining length 158 of the control member 116. In one embodiment, as described above, each enlarged distal end 120 is connected to the remaining length 158 of the control member 116 via a connection 160 configured to break, fracture, release or otherwise separate upon receiving a predetermined threshold force. In one embodiment, the connection 160 may be configured as a reduced diameter portion of the control member 116.

[0050] In another embodiment, the connection may be configured as an adhesive configured to break or fail when subjected to a predetermined force. In yet another embodiment, the connection may be configured as a releasable link or other mechanical connection configured to release when subjected to a predetermined force. However, it will be understood by those skilled in the art that the connection 160 may have any of a variety of configurations, so long as the connection 160 is configured to separate the enlarged distal end 120 from the remaining length 158 when subjected to a predetermined threshold force. Thus, when it is desired to move the clip 102 toward the final configuration, the control member 116 may be drawn proximally relative to the extension member 118, such that the enlarged distal end 120 and the clip 102 are pulled proximally relative to the distal end 122 of the extension member 118. The clip 102 is pulled proximally relative to the extension member 118 until the force exerted on the connection 160 reaches or exceeds the predetermined threshold force required to break, break, or otherwise separate the connection 160. The distal end 120 is thereby released from the remaining length 158 of the control member 116 and the clip 102 is deployed from the insertion device 104 .

[0051] According to one exemplary embodiment, the control member 116 and the extension member 118 are moved together simultaneously to move the clip 102 between the insertion configuration, the initial placement configuration, and the review configuration. In this embodiment, the distal end 120 of the control member 116 is fixed to and / or contacts the distal surface 1565 of the base portion 112, while the distal end 122 of the extension member 118 is positioned just proximal to the proximal surface 162 of the base portion 112. In this manner, the base portion 112 is held between the distal ends 120, 122 of the control member 116 and the extension member 118, respectively, to correspondingly move the clip 102 by simultaneous movement of the control member 116 and the extension member 118.

[0052] According to an exemplary embodiment, the control member 116 and the extension member 118 may be locked relative to one another via a user interface such that movement of one of them correspondingly moves the other. Only when it is desired to move the clip 102 toward the final configuration may the control member 116 and the extension member 118 be unlocked relative to one another such that the control member 116 can be drawn proximally relative to the extension member 118 by forcing the base portion 112, via the distal end 120 of the control member 116, proximally against the distal end 122 of the extension member 118 until an applied force reaches and / or exceeds a predetermined threshold. When this force reaches the predetermined threshold, the connection 160 breaks, fractures or otherwise separates, thereby releasing the clip 102 from the remaining length 158 of the control member 116.

[0053] In another embodiment, the control member 116 and the extension member 118 may remain movable independently of one another. However, because the distal end 120 of the control member 116 is connected and / or fixed to the base portion 112 of the clip 102, the control member 116 correspondingly moves distally relative to the endoscope 106 when the extension member 118 is moved distally relative to the endoscope 106 to push the clip 102 from the insertion configuration toward the initial deployment configuration and away from the adapter 110. To move the clip 102 from the initial deployment configuration toward the review configuration, the endoscope 106 may simply be withdrawn relative to the clip 102 such that the endoscope 106 moves proximally relative to the control member 116 and / or the extension member 118.

[0054] To move the clip 102 toward its final position, the control member 116 may be drawn proximally relative to the extension member 118 until the connection 160 is released, e.g., to lock the position of the extension member 118 and simultaneously draw the control member 116 proximally relative thereto, thereby finally positioning the clip 102 by separating it from the remaining length 158 of the control member 116, as described above. However, if it is desired to reposition the clip 102, the clip 102 may be moved back toward the insertion configuration by drawing the control member 116 proximally relative to the endoscope 106 until the clip 102 is pulled proximally on the adapter 110 toward the open configuration, which correspondingly draws the extension member 118 proximally. The clip 102 may then be repositioned on the tissue as desired.

[0055] According to yet another exemplary embodiment, the clip 102 may be moved between the insertion configuration, the initial placement configuration, and the review configuration via movement of the control member 116 relative to the endoscope 106. In this embodiment, the distal end 120 of the control member 116 is fixed to the base portion 112 such that movement of the control member 116 relative to the endoscope 106 correspondingly moves the clip 102. Only when it is desired to move the clip 102 toward the final placement configuration will the extension member 118 be moved distally toward the clip 102 until the distal end 122 is positioned just proximal to the base portion 112 and / or against the proximal face 162 of the base portion 112.

[0056] Similar to the embodiment described above, the control member 116 may then be drawn proximally relative to the extension member 118 such that the clip 102 is drawn proximally relative to the distal end 122 of the extension member 118, thereby applying a force to the control member 116. If this force reaches / exceeds a predetermined threshold, the connection 160 will break, fracture or otherwise separate, releasing the clip 102 from the remaining length 158 of the control member 116 such that the clip 102 is positioned in the final configuration and clips on the target tissue. It will be appreciated by those skilled in the art that in this embodiment the predetermined threshold force is greater than the force required to move the clip 102 between the insertion configuration, the initial deployment configuration and the review configuration.

[0057] According to an exemplary method of tissue closure utilizing clipping system 100, clip 102 may be inserted through a body lumen, such as the GI tract, to a target area within a body lumen via insertion device 104, which in one embodiment may comprise an endoscope 106. As described above, in an insertion configuration (FIG. 3), clip 102 is attached to a distal end 108 of endoscope 106 via adapter 110 such that distal ends 124 of multiple arms 114 of clip 102 move away from one another toward an open configuration. In this insertion configuration, clip 102 is guided to the target area via a visualization system of endoscope 106 and positioned over the target tissue.

[0058] Suction and / or tissue graspers may be used through the working channel of the endoscope 106 to draw target tissue into the channel 140 of the adapter 110. Thus, as the clip 102 moves toward the initial deployment configuration ( FIG. 4 ) by distal movement of the control member 116 and / or extension member 118 relative to the endoscope 106, the clip 102 is slid distally away from the adapter 110 toward the biased closed configuration. As the clip 102 is moved toward the biased closed configuration, tissue is grasped between the distal ends 124 of the multiple arms 114 of the clip 102 in the initial deployment configuration.

[0059] It will be appreciated by those skilled in the art that aspirating and / or grasping tissue in this initial placement configuration may interfere with the imaging / optical lenses of the endoscope 106, such that the user is unable to visualize and / or confirm whether the desired target tissue has been properly clipped. Thus, the clip 102 may be moved toward the review configuration (FIG. 1) by drawing the endoscope 106 proximally relative to the clip 102 while the clip 102 remains engaged with the control member 116. The distance between the adapter 110 and the clip 102 increases the field of view of the endoscope 106, such that the clip 102 and the tissue grasped thereby may be viewed via the optical / visualization system of the endoscope 106.

[0060] If, upon visualization, the user determines that adjustment and / or repositioning of clip 102 relative to the target tissue is necessary, control member 116 and / or extension member 118 may be moved proximally relative to endoscope 106 until clip 102 moves proximally over adapter 110 into the open insertion configuration, as described above. In particular, endoscope 106 may be moved distally relative to control member 116 such that clip 102 and adapter 110 are drawn toward one another.

[0061] The clip 102 is moved toward the open configuration, thereby releasing the gripped tissue and allowing the clip 102 to be repositioned on the target tissue as desired. The clip 102 can then be moved again toward the initial placement configuration and then again toward the review configuration. This process can be repeated as necessary until the user can visually confirm that the clip 102 has clipped on the target tissue as desired.

[0062] As mentioned above, in one embodiment, the clip 102 is moved between the insertion configuration, the initial placement configuration, and the review configuration by moving both the control member 116 and the extension member 118 together relative to the endoscope 106. In another embodiment, the clip 102 may be moved between the insertion configuration, the initial placement configuration, and the review configuration via movement of only the control member 116 relative to the endoscope 106. Only when it is determined during the review configuration that the clip 102 has been clipped onto the target tissue as desired, may the extension member 118 be moved distally relative to the endoscope 106 such that the distal end 122 is positioned just proximal to the proximal face 162 of the base portion 112 of the clip 102.

[0063] The clip 102 may then be moved toward the final configuration by pulling the clip 102 proximally relative to the distal end 122 via the control member 116 until the force exerted on the connection 160 reaches or exceeds a predetermined threshold, thereby releasing the clip 102 from the remaining length 158 of the control member 116. Once the clip 102 has been moved toward the final configuration, the insertion device 104, including the remaining length 158 of the control member 116 and the extension member 118, is removed from the body, leaving the clip 102 clipped onto the target tissue.

[0064] It will be apparent to those skilled in the art that various changes may be made in the present disclosure without departing from the scope of the present disclosure. Furthermore, those skilled in the art will understand that any of the features of the various embodiments may be combined in any manner not inconsistent with the description and / or functionality of the embodiments.

Claims

1. 1. A clipping system for treating tissue, comprising: an adapter configured to be mounted onto a distal end of an insertion device, the adapter extending from a proximal end to a distal end and comprising a channel extending therethrough; a clip having a base portion configured to be mounted on an outer periphery of the adapter and a plurality of arms extending distally from the base portion, the plurality of arms being movable relative to one another between an insertion configuration and an initial deployment configuration, in which the plurality of arms extend along an outer surface of the adapter such that distal ends of the plurality of arms are separated from one another in an open configuration to receive tissue therebetween, and in which the clip is moved distally away from the adapter such that the distal ends of the plurality of arms return toward a biased closed configuration in which the distal ends of the plurality of arms are drawn toward one another to grasp tissue therebetween; a first control member releasably coupled to the base portion of the clip and movably connected to the adapter, whereby longitudinal movement of the first control member relative to the adapter moves the clip between the insertion configuration, the initial placement configuration and a review configuration, where the first control member allows the adapter to be withdrawn proximally away from the clip while remaining coupled to the clip to enhance visual observation of the clip, and the first control member is operable to pull the clip proximally on the adapter towards the insertion configuration, whereby as the clip is pulled back on the adapter, the multiple arms are pushed open, releasing the clip from the tissue against which it was clipped.

2. 2. The system of claim 1, wherein the first control member includes an enlarged distal portion that engages a distal surface of the base portion such that a remaining length of the first control member extends proximally through an opening in the base portion to a proximal end accessible to a user, and the enlarged distal end of the first control member is connected to the remaining length of the first control member via a connection configured to release when subjected to a force exceeding a predetermined threshold.

3. 3. The system of claim 2, further comprising a first extending member configured to slidably receive the first control member therein, such that the enlarged distal end of the first control member extends distally from the distal end of the first extending member to be coupled to the base portion of the clip, and such that proximal movement of the first control member relative to the first extending member draws the clip against the distal end of the first extending member to release the connection and move the clip toward a final configuration.

4. 4. The system of claim 1, wherein each of the plurality of arms has a proximal portion and a distal portion movably connected to one another via a hinge that biases each of the plurality of arms toward the closed configuration, and wherein in the closed configuration the proximal portion and the distal portion of each of the plurality of arms bend relative to one another such that multiple distal ends extend toward a longitudinal axis of the adapter.

5. 5. The system of claim 4, wherein the distal portion of each of the plurality of arms includes an engagement feature extending laterally therefrom that engages a distal end of the adapter to prevent further proximal movement of the clip relative to the adapter when the clip is pulled proximally onto the adapter.

6. 6. The system of claim 5, wherein when a plurality of engagement features engage the distal end of the adaptor, the distal portion of each of the plurality of arms engages the adaptor to maintain the plurality of arms toward the open configuration.

7. The system of any one of claims 1 to 6, wherein the distal end of the adapter has a lip projecting radially outwardly therefrom.

8. The system of any one of claims 1 to 7, wherein the distal ends of each of the plurality of arms extend laterally inwardly relative to one another and comprise tissue gripping features.

9. The system according to any one of claims 1 to 8, wherein the base portion is ring-shaped.

10. a second control member releasably coupled to the base portion of the clip and movably connected to the adapter, such that longitudinal movement of the second control member relative to the adapter moves the clip between the insertion configuration, the initial placement configuration, and the review configuration; and 10. The system of claim 1, further comprising: a second extension member extending longitudinally from a proximal end accessible to a user of the system to a distal end, the second control member extending distally from the distal end of the second control member such that the second control member is slidably received within the second extension member, thereby coupling the distal end of the second control member to the clip.

11. 1. A clipping system for treating tissue, comprising: an endoscope extending longitudinally from a proximal end to a distal end; an adaptor mountable onto a distal end of the endoscope, whereby a channel of the adaptor is aligned with a longitudinal axis of the endoscope; and a clip having a ring-shaped base portion configured to be mounted on the adapter and a plurality of arms extending distally from the base portion, the arms being movable relative to one another between an insertion configuration and an initial deployment configuration, in which the arms extend along an outer surface of the adapter such that the distal ends of the arms are separated from one another in an open configuration to receive tissue therebetween, and in which the clip is moved distally away from the adapter such that the distal ends of the arms return toward a biased closed configuration in which the distal ends of the arms are drawn toward one another to grasp tissue therebetween; a first control member and a second control member releasably coupled to the base portion of the clip and movably connected to the adapter, whereby longitudinal movement of the first control member and the second control member relative to the adapter moves the clip between the insertion configuration, the initial placement configuration and a review configuration, where the first control member and the second control member remain coupled to the clip and allow the endoscope to be withdrawn proximally away from the clip to improve visual observation of the clip through the endoscope, and the first control member and the second control member are operable to pull the clip proximally back on the adapter toward the insertion configuration, whereby as the clip is pulled back on the adapter, the multiple arms are pushed open, releasing the clip from the tissue against which it was clipped.

12. 12. The system of claim 11, wherein each of the first and second control members comprises an enlarged distal portion that engages a distal surface of the base portion and wherein a remaining length of the first control member extends proximally through an opening in the base portion to a proximal end of the first control member accessible to a user, the enlarged distal end of the first control member being connected to the remaining length of the first control member via a connection configured to release when subjected to a force exceeding a predetermined threshold.

13. 13. The system of claim 12, further comprising first and second extending members extending longitudinally from a proximal end accessible to a user of the system to a distal end, each of the first and second extending members configured to slidably receive a corresponding one of the first and second control members therein, such that pulling the clip proximally via the first and second control members relative to the distal ends of the first and second extending members releases the clip from a proximal portion of the first and second control members.

14. 14. The system of claim 11, wherein each of the plurality of arms has a proximal portion and a distal portion movably connected to one another via a hinge that biases each of the plurality of arms toward the closed configuration, and wherein in the closed configuration the proximal portion and the distal portion of a first arm of the plurality of arms bend relative to the distal portion of a second arm of the plurality of arms such that distal ends of the first arm and the second arm extend toward a longitudinal axis of the adapter.

15. 15. The system of claim 14, wherein the adapter has a lip protruding radially outward from the distal end of the adapter such that when the distal portions of the arms engage the lip, the distal portions of the arms are lifted onto the adapter.

Images