Over the scope clip with compliant mechanism

Abstract

To provide a clipping system for treating tissue.SOLUTION: A system includes an adapter configured to be mountable on a distal end of an insertion device, and a clip (116). The clip includes: an outer body (305); a central body disposed radially inward of the outer body and movable relative to the outer body in the longitudinal direction; and first and second jaws (120a, 120b). Each of the first and second jaws has an inner arm (125b) and an outer arm (125a) coupled to each other at a distal end. The outer arm is coupled to the outer body, and the inner arm is coupled to the central body. Movement of the central body to the outer body causes the inner arm of the first jaw and the inner arm of the second jaw to be pulled proximally, which causes a distal end of the first jaw and a distal end of the second jaw to be drawn to each other, and the clip is in an arrangement form.SELECTED DRAWING: Figure 3B

Description

[Technical Field]

[0001] The present disclosure relates to an endoscopic device, and more particularly to an endoscopic clipping device for treating tissue. This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 260,325, filed August 17, 2021, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Physicians are now becoming more willing to perform aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of perforating the wall of the GI tract or may require closure of the GI tract as part of the procedure. Such procedures may include, for example, removal of large lesions, tunneling under the mucosal layer of the GI tract to treat submucosal problems, full-thickness removal of tissue, treatment of problems on other organs by passing outside the GI tract, and endoscopic treatment / repair of post-surgical problems (e.g., post-surgical leaks, surgical staple line breakdown, and anastomotic leaks).

[0003] Currently, tissue can be treated via endoscopic closure devices, including through-the-scope clips or over-the-scope clips. Over-the-scope clips can be particularly useful for achieving closure of larger tissue defects. These endoscopic closure devices can save hospitals money and provide benefits to 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. Summary of the Invention

[0004] The present disclosure relates to a clipping system for treating tissue, the clipping system including an adapter extending longitudinally from a proximal end to a distal end configured to be mountable onto a distal end of an insertion device. The adapter has a first annular groove formed in a distal surface of the adapter. The system further includes a clip including: (i) a body; (ii) a central body having a coupling portion and a ring; and (iii) first and second jaws having outer arms coupled to the body at their proximal ends, and inner arms disposed radially inward of the outer arms and coupled to the ring at their proximal ends. The body includes an annular protrusion extending proximally from a proximal surface of the body. The annular protrusion is configured to be insertable into the first annular groove of the adapter to couple the clip to the adapter. Movement of the central body along the axis of the clip causes movement of the first and second jaws between an insertion configuration in which the first and second jaws are spaced apart to receive tissue therebetween and a deployment configuration in which the first and second jaws are drawn together to grasp tissue therebetween.

[0005] In one embodiment, the clip comprises a monolithic structure formed from a compliant material. In one embodiment, the compliant material is nitinol.

[0006] In one embodiment, the first and second jaws are biased toward the insertion configuration. In one embodiment, proximal movement of the central body causes corresponding proximal movement of the inner arms to bend the outer arms inward toward the deployed configuration.

[0007] In one embodiment, the body of the clip includes a second annular groove configured to receive the ring when the clip is in the deployed configuration. In one embodiment, a first diameter of a distal-most portion of the second annular groove is smaller than a second diameter of the ring, and the ring is configured to be fitted into the second annular groove after being pushed proximally beyond the distal-most portion of the second annular groove.

[0008] The present disclosure also relates to a clipping system for treating tissue, the clipping system including: an endoscope including a shaft extending longitudinally from a proximal end to a distal end and a wire extending from the proximal end to the distal end, the wire including an enlarged portion at the distal end of the wire; an adapter including a proximal portion mounted on the distal end of the shaft of the endoscope and a distal portion extending distally from the proximal portion; and a clip including: (i) a body; (ii) a central body having a coupling portion and a ring; and (iii) first and second jaws having outer arms coupled to the body at their proximal ends, and inner arms disposed radially inward of the outer arms and coupled to the ring at their proximal ends. The body includes an annular protrusion extending proximally from a proximal surface of the body, the annular protrusion configured to be insertable into a first annular groove of the adapter to couple the clip to the adapter. The wire passes through an opening formed in the bond, with the enlarged portion of the wire located distal to the opening. The diameter of the opening is smaller than the diameter of the enlarged portion of the wire. Proximal and distal movement of the wire causes corresponding movement of the central body along the axis of the clip. Movement of the central body along the axis of the clip causes movement of the first and second jaws between an insertion configuration in which the first and second jaws are spaced apart to receive tissue therebetween and a deployment configuration in which the first and second jaws are drawn together to grasp tissue therebetween.

[0009] In one embodiment, the clip comprises a monolithic structure formed from a compliant material. In one embodiment, the compliant material is nitinol.

[0010] In one embodiment, the first and second jaws are biased toward the insertion configuration. Proximal movement of the wire causes the enlarged portion of the wire to abut the bond, moves the bond proximally, and moves the first and second jaws toward the deployed configuration. Releasing the wire allows the first and second jaws to return to the insertion configuration.

[0011] In one embodiment, proximal movement of the central body causes corresponding proximal movement of the inner arms to bend the outer arms inward toward the deployed configuration.

[0012] In one embodiment, the body of the clip includes a second annular groove configured to receive the ring when the clip is in the deployed configuration. In one embodiment, a first diameter of a distal-most portion of the second annular groove is smaller than a second diameter of the ring, and the ring is configured to be fitted into the second annular groove after being pushed proximally beyond the distal-most portion of the second annular groove.

[0013] The present disclosure further relates to a method for treating tissue, the method including inserting a clip into a target area within a body lumen via an endoscope, the clip being mounted on a distal end of an endoscope shaft via an adapter in an open insertion configuration with jaws of the clip spaced apart, and a body of the clip connecting the clip to the adapter, and inserting a tissue grasper through a working channel of the endoscope and the clip such that the tissue is drawn into a space between the jaws of the clip. The method includes proximally retracting a wire passing through the working channel and the clip, the wire having an enlarged portion at a distal end thereof that engages a coupling portion of the clip to cause corresponding proximal movement of the coupling portion, wherein proximal movement of the coupling portion causes corresponding proximal movement of a ring of the clip connected to the coupling portion, the ring being coupled to a proximal end of an inner arm of the plurality of jaws, wherein proximal movement of the ring causes corresponding proximal movement of the inner arm, the plurality of jaws including outer arms disposed radially outward of the inner arms, the outer arms coupled to the body of the clip at their proximal ends and coupled to the inner arms at their distal ends, wherein proximal movement of the inner arms draws the distal ends of the outer arms together from an insertion configuration in which the plurality of jaws are spaced apart toward a configuration in which the plurality of jaws are positioned closer to each other to grasp the tissue therebetween. The method includes further retracting the wire proximally to force the ring into a corresponding annular groove formed in a body of the clip, the annular groove configured to retain the ring therein and maintain the clip in the deployed configuration, and further retracting the wire to break an enlarged portion of the wire and separate the clip from the adapter.

[0014] In one embodiment, the clip comprises a monolithic structure formed from a compliant material. In one embodiment, the jaws are biased toward the insertion configuration. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 illustrates a perspective view of a system according to an exemplary embodiment of the present disclosure. [Figure 2A] FIG. 2A shows a longitudinal side view of the distal portion of the system of FIG. 1 in the insertion configuration. [Figure 2B] FIG. 2B shows another longitudinal side view of the distal portion of the system of FIG. 1 in the deployed configuration. [Figure 3A] FIG. 3A shows a longitudinal side view of a clip according to an exemplary embodiment of the present disclosure in an insertion configuration. [Figure 3B] FIG. 3B shows another longitudinal side view of the clip of FIG. 3A in a deployed configuration. [Figure 3C] FIG. 3C shows a cross-sectional view of the clip of FIG. 3A in a deployed configuration. DETAILED DESCRIPTION OF THE INVENTION

[0016] The present disclosure may be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to by the same reference numerals. The present disclosure relates to a clipping system, and more particularly, to an over-the-scope endoscopic clipping system that allows the initial placement of a clip to be visualized and adjusted prior to its final placement. An exemplary embodiment of the present disclosure includes a clip that is mountable via an adapter onto the distal end of an endoscope. The clip has multiple jaws that are movable between an insertion configuration and a deployed configuration.

[0017] A clip according to an embodiment of the present disclosure is attached to the distal end of an endoscope or other insertion instrument via an adapter. The adapter slides over the end of the endoscope and is maintained on the endoscope via a friction fit. The clip is attached within the adapter and extends around the distal end of the endoscope, with two tissue clipping jaws that extend distally beyond the distal end of the endoscope. The jaws of a clip according to an embodiment of the present disclosure are biased toward an insertion configuration in which the jaws are spaced apart to receive tissue to be clipped.

[0018] A radially inner proximal portion of each jaw is coupled to a ring on the central body. The central body is engaged with a wire that moves the ring proximally and distally to move the jaws between an insertion configuration and a configuration in which the jaws are drawn together to clip tissue. Proximal movement of the wire retracts the central body proximally, thereby retracting the radially inner proximal portion of each jaw proximally and closing the jaws. Releasing the wire also allows the jaws to expand under their inherent bias to the insertion configuration. This pulls the radially inner proximal portions of the jaws distally, thereby pulling the ring and wire distally. A user can then position the clip against target tissue to be clipped in the clip's insertion configuration.

[0019] The user then retracts the jaws toward the deployed configuration while drawing a portion of tissue between the jaws, using the endoscope's visual system to view the jaws and the tissue grasped by them. If adequate tissue is not grasped or the tissue is not grasped as desired, the user can release the control wire to reopen the clip, thereby releasing the grasped tissue and allowing the device to be repositioned until the desired portion of tissue is positioned between the jaws. Once the tissue is observed to be positioned between the jaws as desired, the control wire can be pulled proximally to move the clip toward the fully deployed configuration, in which the jaws are secured closed on the clipped tissue, as described in more detail below.

[0020] The clip includes a groove configured to receive the ring of the central body, and when the wire is moved proximally beyond a predetermined distance, the ring engages within the groove, preventing distal movement of the ring even when the control wire is released, thereby securing the jaws in a clipped configuration on tissue. The control wire passes through an opening in a cross member coupled to the ring, and an enlarged portion at the distal end of the control wire engages a surface of the cross member surrounding the opening, such that when the control wire is pulled proximally, the cross member and ring are pulled proximally and the jaws are closed.

[0021] Once the ring is seated within the groove, applying tension to the control wire will not cause the control wire to move further proximally. If this tension exceeds a predetermined level, the end of the enlarged section will tear away from the remainder of the control wire. At this point, the clip is connected to the endoscope only by the interface between the clip and the adapter. This allows the clip to be completely separated from the endoscope and adapter by simply withdrawing the endoscope proximally so that the connection between the clip and the clipped tissue causes the clip to separate from the adapter. This allows the endoscope and adapter to be removed from the body, leaving the clip in place on the target tissue, as described in more detail below.

[0022] Specifically, as shown in FIGS. 1-3C , a clipping system 100 for treating tissue defects and / or perforations according to an exemplary embodiment includes a clip assembly 110 having a clip 116 coupled to an adapter 118. The adapter 118 with the coupled clip 116 is configured to be mountable onto the distal end of an endoscope 102. Those skilled in the art will appreciate that the clip 116 and adapter 118 can be manufactured in different sizes and shapes to accommodate different models of endoscopes. The clip 116 and adapter 118 can also be sized and shaped to fit any other type of flexible or rigid insertion device. The adapter 118 slides over the distal end 112 of the endoscope shaft 108 of the endoscope 102 and is maintained on the shaft 108 by, for example, a friction fit. The clip 116 is mounted onto the distal end of the adapter 118 such that the jaws 120 a, 120 b extend distally beyond the distal end of the shaft 108, as shown in FIG. 1 . The clip 116 is movable between an insertion configuration ( FIGS. 2A and 3A ) in which the jaws 120 a, 120 b of the clip 116 are spaced apart to receive tissue therebetween, and an initial deployment configuration ( FIGS. 2B and 3C ) in which the jaws 120 a, 120 b of the clip 116 are closed to grasp tissue drawn into the clip 116. In the initial deployment configuration, the jaws 120 a, 120 b are closed or partially closed but can be reopened if it is desired to reposition the clip 116. Each of the jaws 120 a, 120 b optionally includes a grasping mechanism 132, such as teeth or rough surfaces, for grasping target tissue therebetween, as would be understood by one skilled in the art.

[0023] Clip 116 includes a body 305 having an annular projection 302 ( FIGS. 3B and 3C ) extending proximally from a proximal surface 304 of body 305. Annular projection 302 is configured for insertion into a corresponding annular groove 306 formed in a distal surface 308 of adapter 118 to releasably couple clip 116 to adapter 118. In one embodiment, adapter 118 and clip 116 are mated to one another such that clip 116 is freely rotatable relative to adapter 118. This prevents inadvertent rotation of the deployed clip when endoscope 102 is rotated during removal of endoscope 102. Therefore, rotational forces applied to endoscope 102 are not transmitted to clip 116 and the clipped tissue.

[0024] In this embodiment, the clip 116 has a monolithic structure formed from a compliant material, biasing the jaws 120a, 120b toward a spaced-apart insertion configuration to receive tissue. Such compliant materials may include, for example, plastic, nitinol, or a compliant metal. Those skilled in the art will recognize that the clip 116 may be formed as a single piece or may be comprised of separate elements joined together, for example, by welding. Each of the jaws 120a, 120b of the clip 116 includes an outer arm 125a and an inner arm 125b disposed radially inward relative to the outer arm 125a. Each of the outer arms 125a of the jaws 120a, 120b extends from a proximal end coupled to the body 305 to a distal end terminating in a grasping mechanism 132. Each of the inner arms 125b of the jaws 120a, 120b extends from a proximal end that is connected to the ring 122 of the central body 121 to a distal end that also terminates in a gripping mechanism 132.

[0025] Outer arm 125a and inner arm 125b are joined at their distal ends by a gripping mechanism 132. Each of jaws 120a, 120b includes a support element 126 extending between outer arm 125a and inner arm 125b. Each of outer arm 125a and inner arm 125b includes a distal portion 127 (FIG. 2B) having an increased width proximate gripping mechanism 132 to increase the gripping area of ​​gripping mechanism 132.

[0026] The inner arms 125b are coupled to the central body 121 such that proximal or distal movement of the central body 121 moves the inner arms 125b proximally or distally, thereby moving the jaws 120a, 120b toward or away from one another, thereby transitioning the clip between the insertion configuration and the deployed configuration. Because the body 305 does not move, there is no proximal or distal movement of the proximal ends of the outer arms 125a. However, proximal movement of the inner arms 125b with movement of the ring 122 causes the distal ends of the outer arms 125a to bend inward, thereby causing them to both assume the deployed configuration, as shown in FIGS. 3B and 3C. As central body 121 moves distally, inner arm 125b is pushed distally, allowing outer arm 125a to return to its initial shape so that the distal ends of jaws 120a, 120b are spaced apart in the insertion configuration. Support element 126 is configured to maintain the distance between outer arm 125a and inner arm 125b when outer arm 125a is bent, and to bias jaws 120a, 120b toward the insertion configuration.

[0027] To control movement of the central body 121, a control wire 114 extends distally from the handle portion 104 to the clip assembly 110 and engages a coupling portion 123 of the central body 121. The control wire 114 passes through an opening 312 formed in the coupling portion 123 and includes an enlarged portion 310 ( FIG. 3C ) at the distal end of the control wire 114. The enlarged portion 310 has a larger diameter than the opening 312 and is positioned distal to the opening 312 to prevent proximal movement of the enlarged portion through the opening 312. The coupling portion 123 is coupled to the ring 122 via one or more ribs 314 that extend radially outward from the coupling portion 123 to the ring 122. Proximal movement of the control wire 114 presses the enlarged portion 310 against the coupling portion 123, thereby drawing the central body 121 proximally relative to the adapter 118 and closing the jaws 120 a, 120 b as described above.

[0028] Because the jaws 120a, 120b of the clip 116 are biased toward an open position (insertion configuration), releasing the wire 114 allows the jaws 120a, 120b to return to the biased open position. As described above, the operator can manipulate the endoscope 102 to position the clip 116 adjacent to the target tissue to be clipped. The operator can then draw tissue into the space between the jaws 120a, 120b (e.g., by applying suction or a grasping tool through the working channel of the endoscope 102) and partially close the jaws 120a, 120b while visualizing the clip and the clipped tissue using the vision system of the endoscope 102. If the operator determines that the clip 116 is not properly positioned, the operator can release the control wire 114 to reopen the clip 116 and release the tissue.

[0029] The endoscope 102 may then be repositioned. This process may be repeated until the operator observes that the desired tissue is properly grasped between the partially closed jaws 120a, 120b. At this point, the operator applies further tension to the control wire 114 (e.g., utilizing an actuator on the handle portion 104) until a predetermined tension is reached that causes the extensions to separate from the remainder of the control wire 114. This releases the clip 116 from the control wire 114 and secures the clip 116 in a closed position on the clipped tissue. The operator may then retract the endoscope 102 proximally to separate the clip 116 from the adapter 118 and the endoscope 102. As a result, the endoscope 102 and adapter 118 may be removed from the body while the clip 116 remains in its clipped position against the target tissue.

[0030] As described above, in one embodiment, the clip 116 is attached to the endoscope 102 via an adapter 118. In this embodiment, the adapter 118 is sized and shaped to be mountable onto the distal end 112 of the endoscope shaft 108 of a standard endoscope 102; however, as will be appreciated by those skilled in the art, the adapter 118 may be sized and shaped to be mountable onto the distal end of any insertion device (flexible or rigid) suitable for accessing the target site within the body where the tissue to be clipped is located. The adapter 118 in this embodiment is a substantially tubular structure sized and shaped to be mountable onto the distal end of the endoscope. The adapter 118 includes a channel extending therethrough. The channel is substantially aligned with the longitudinal axis of the endoscope when the adapter 118 is mounted on the endoscope and extends away from the distal end of the endoscope so as to minimize obstruction of the field of view of the endoscope's optical system when the adapter 118 is mounted on the distal end of the endoscope. In one embodiment, the adapter 118 is substantially circular in cross section to match the similar shape of the endoscope.

[0031] However, as one skilled in the art would understand, if the endoscope is non-circular (e.g., oval), the adapter may be sized and shaped appropriately to provide a friction fit with, for example, the distal end of the endoscope. The central body 121 in this embodiment includes one or more spaces 316 disposed between the coupling portion 123 and the ring 122 to allow for the passage of a tool, such as a tissue grasper. The one or more spaces 316 are configured to minimize obstruction of the field of view of the endoscope's optical system.

[0032] The proximal end 111 of the endoscope shaft 108 in this embodiment includes a handle portion 104. This handle portion 104 can be used by a physician or other user to guide a flexible endoscope, for example, through a body lumen (e.g., the gastrointestinal tract), to a target site adjacent the target tissue to be clipped. As one skilled in the art will appreciate, the endoscope shaft 108 in this embodiment is sufficiently flexible to be inserted through the tortuous path of a body lumen, and therefore, all of the components of the system that extend through or along the endoscope to the clip 116 are also sufficiently flexible to enable this insertion to the target site.

[0033] In this embodiment, the body 305 of the clip 116 includes an annular groove 318 configured to securely receive the ring 122 when the clip 116 is in the deployed configuration. When the control wire 114 is moved proximally beyond a certain point, the ring 122 is forced into the annular groove 318. The annular groove 318 includes a reduced diameter portion 320 at its distal-most end, the reduced diameter portion having a diameter smaller than the diameter of the ring 122. Because the clip 116 is formed from a compliant material, the ring 122 is forced through the reduced diameter portion 320 and is secured within the annular groove 318. Securing the ring 122 within the annular groove 318 holds the jaws 120a, 120b in the deployed configuration. To prevent further proximal movement of the control wire 114 from moving the ring 122 further proximally than the annular groove 318, one or more stops 322 (three are shown in FIG. 3C ) are provided adjacent the annular groove 318 and extend radially inward from the inner surface of the clip 116 proximal to the annular groove 318.

[0034] The one or more stops 322 act as a hard stop to prevent the ring 122 from moving further proximally than the annular groove 318. As a result, after the ring 122 is seated within the annular groove 318, further proximal movement of the control wire 114 is prevented, and the clip 116 will separate from the adapter 118 when additional tension on the control wire 114 builds up to a level that eventually separates the enlarged portion 310 from the remainder of the control wire 114. The endoscope 102 and adapter 118 can then be removed, leaving the clip 116 in place. The operator can control the movement of the wire 114 as desired using an actuator in the handle portion 104.

[0035] It will be apparent to those skilled in the art that various modifications can be made in the present disclosure without departing from the scope of the present disclosure. Furthermore, those skilled in the art will understand that the features of any of the various embodiments can be combined in any manner not inconsistent with the description and / or functionality of the embodiments.

Claims

1. 1. A system for treating tissue, comprising: an adapter configured to be mountable onto a distal end of the insertion device; a clip comprising: (i) an outer body; (ii) a central body disposed radially inward of the outer body and longitudinally movable relative to the outer body; and (iii) first and second jaws, the first and second jaws having inner and outer arms, respectively, joined to one another at distal ends of the first and second jaws; the outer arm is coupled to the outer body and the inner arm is coupled to the central body; proximal movement of the central body relative to the outer body pulls the inner arms of the first jaw and the inner arms of the second jaw proximally, drawing the distal ends of the first jaw and the distal ends of the second jaw radially inward toward each other to place the clip in a deployed configuration.

2. 2. The system of claim 1, wherein the first and second jaws are biased toward an insertion configuration in which the distal ends of the first and second jaws are spaced apart from one another to receive tissue therebetween.

3. The system of claim 1 , wherein the clip has a monolithic structure formed from a compliant material.

4. The system of claim 3 , wherein the compliant material is nitinol.

5. 2. The system of claim 1, wherein the central body has a connecting portion and a ring, and a proximal end of an inner arm of the first jaw and a proximal end of an inner arm of the second jaw are connected to the ring.

6. 6. The system of claim 5, wherein the adapter has a first annular groove formed in a distal surface of the adapter, and the outer body includes an annular protrusion extending proximally from a proximal surface of the outer body, the annular protrusion configured to be insertable into the first annular groove of the adapter to couple the clip to the adapter.

7. The system of claim 6 , wherein the outer body of the clip includes a second annular groove configured to receive the ring of the central body when the clip is in the deployed configuration.

8. 8. The system of claim 7, wherein the diameter of the distal-most portion of the second annular groove is smaller than the diameter of the ring, and the ring is configured to be pushed proximally beyond the distal-most portion of the second annular groove before being fitted into the second annular groove.

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