Overscope Clip with Compliant Mechanism

Abstract

The clipping system includes an adapter and a clip. The adapter is mounted on a distal end of the insertion device and has a first annular groove formed in a distal face of the adapter. The clip has a body, a central body having a coupling portion and a ring, and a jaw, the jaw having an outer arm coupled to the body at an outer arm proximal end and an inner arm disposed radially inward of the outer arm and coupled to the ring at an inner arm proximal end. The body includes an annular protrusion extending proximally from a proximal face of the body. The protrusion is inserted into the first annular groove of the adapter to couple the clip to the adapter. Movement of the central body along an axis of the clip causes movement of the jaw between an inserted configuration and a deployed configuration.

Description

Technical Field

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

Background Art

[0002] Physicians are now performing more advanced and therapeutic endoscopic gastrointestinal (GI) procedures, which can 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 can include, for example, removal of large lesions, tunneling beneath the mucosal layer of the GI tract to treat submucosal problems, removal of the entire layer of tissue, treatment of problems on other organs by passing through the outside of the GI tract, and endoscopic treatment / repair of postoperative problems (e.g., postoperative leakage, breakdown of surgical staple lines, and anastomotic leakage).

[0003] Currently, tissue can be treated via an endoscopic closure device, including a through-the-scope clip or an over-the-scope clip. Over-the-scope clips can be particularly useful for achieving closure of larger tissue defects. These endoscopic closure devices can save hospital costs 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 configured to be attachable to a distal end of an insertion device to a distal end. The adapter has a first annular groove formed in a distal surface of the adapter. The system further includes a clip having (i) a body, (ii) a central body having a coupling portion and a ring, (iii) outer arms coupled to the body at proximal ends of the outer arms, and first and second jaws having inner arms disposed radially inward of the outer arms and coupled to the ring at proximal ends of the inner arms. 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 an 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 from each other to receive tissue therebetween and an arrangement configuration in which the first and second jaws are drawn toward each other to grip tissue therebetween.

[0005] In one embodiment, the clip has a monolithic structure formed of 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 is configured to cause corresponding proximal movement of the inner arms to bend the outer arms inwardly toward the arrangement 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 arrangement configuration. In one embodiment, a first diameter of a most distal 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 most distal portion of the second annular groove.

[0008] Further, the present disclosure relates to a clipping system for treating tissue, the clipping system including an endoscope having 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 endoscope including the wire having an enlarged portion at a distal end of the wire; an adapter including a proximal portion attached 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, (iii) an outer arm coupled to the body at a proximal end of the outer arm, and first and second jaws having an inner arm disposed radially inward of the outer arm and coupled to the ring at a proximal end of the inner arm. The body includes an annular protrusion extending proximally from a proximal surface of the body, the annular protrusion being 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 coupling portion, and the enlarged portion of the wire is positioned distally of the opening. A diameter of the opening is smaller than a diameter of the enlarged portion of the wire. Movement of the wire proximally and distally causes corresponding movement of the central body along an 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 from each other to receive tissue therebetween and an arrangement configuration in which the first and second jaws are drawn towards each other to grip tissue therebetween.

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

[0010] In one embodiment, the first and second jaw portions are biased toward the insertion configuration. Proximal movement of the wire causes abutment of the enlarged portion of the wire against the coupling portion, proximal movement of the coupling portion, and movement of the first and second jaw portions toward the deployment configuration. Release of the wire enables return of the first and second jaw portions to the insertion configuration.

[0011] In one embodiment, proximal movement of the central body causes corresponding proximal movement of the inner arm to bend the outer arm inwardly toward the deployment 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 deployment configuration. In one embodiment, a first diameter of a most distal portion of the second annular groove is smaller than a second diameter of the ring, and the ring is configured to be fitted within the second annular groove after being pushed proximally beyond the most distal portion of the second annular groove.

[0013] Furthermore, the present disclosure relates to a method for treating tissue, the method comprising inserting a clip into a target region within a body lumen via an endoscope, wherein the clip is attached onto the distal end of an endoscope shaft via an adapter in an open insertion configuration in which a plurality of jaws of the clip are spaced apart from each other, and the clip is coupled to the adapter by a body of the clip. The method includes inserting a tissue grasper through the working channel of the endoscope and through the clip such that the tissue is drawn into a space between the plurality of jaws of the clip. The method includes retracting proximally a wire passing through the working channel and the clip, the wire having, at a distal end thereof, an enlarged portion that engages a coupling portion of the clip to cause a corresponding proximal displacement of the coupling portion, the proximal displacement of the coupling portion causing a corresponding proximal displacement of a ring of the clip that is coupled to the coupling portion, the ring being coupled to proximal ends of inner arms of the plurality of jaws, the proximal displacement of the ring causing a corresponding proximal displacement of the inner arms, the plurality of jaws including outer arms disposed radially outside of the inner arms, the outer arms being coupled to the body of the clip at proximal ends of the outer arms and to the inner arms at distal ends of the outer arms, the proximal displacement of the inner arms causing the distal ends of the outer arms to be drawn together toward an arrangement for gripping the tissue therebetween from an insertion configuration in which the plurality of jaws are spaced apart from each other. The method includes pushing the ring into a corresponding annular groove formed in the body of the clip by further retracting the wire, the annular groove being configured to hold the ring therein and maintain the clip in the arrangement. The method includes separating the clip from the adapter by further retracting the wire to break an enlarged portion of the wire.

[0014] In one embodiment, the clip has a monolithic structure formed of a compliant material. In one embodiment, the plurality of jaws are biased toward the insertion configuration.

Brief Description of the Drawings

[0015]

Figure 1

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 3C

Best Mode for Carrying Out the Invention

[0016] The present disclosure may be further understood with reference to the following description and the accompanying drawings. In the present disclosure, like elements are referred to with like reference numerals. The present disclosure relates to a clipping system, and more particularly, to an over-scope endoscope clipping system that makes the initial placement of a clip visible and adjustable prior to its final placement. Exemplary embodiments of the present disclosure include a clip that is attachable via an adapter on the distal end of an endoscope. The clip has a plurality of jaws that are movable between an insertion configuration and a deployed configuration.

[0017] The clip according to an embodiment of the present disclosure is attached to the distal end of an endoscope or other insertion device via an adapter. The adapter slides on 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 and has two tissue-clipping jaws that extend distally beyond the distal end of the endoscope. The jaws of the clip according to an embodiment of the present disclosure are biased toward an insertion configuration in which the jaws of the clip are spaced apart from each other to receive the tissue to be clipped.

[0018] The proximal portion radially inside each jaw is coupled to a ring of a central body. The central body engages a wire, and the wire moves the jaws between an insertion configuration and an arrangement configuration in which the jaws are drawn together to clip the tissue by moving the ring proximally and distally. When the wire moves proximally and the central body is drawn proximally, the proximal portion radially inside each jaw is drawn proximally and the jaws close. Also, by releasing the wire, the jaws can expand into the insertion configuration under their inherent bias. Thereby, as the proximal portion radially inside the jaws is pulled distally, the ring and the wire are pulled distally. Thereby, the user can position the clip with respect to the target tissue to be clipped in the insertion configuration of the clip.

[0019] Next, while observing the jaws and the tissue grasped by the jaws using the vision system of the endoscope, the user draws a part of the tissue between the jaws while drawing the jaws toward the arrangement configuration. If appropriate tissue is not grasped or the tissue is not grasped as desired, the user can release the control wire to open the clip again. Thereby, the grasped tissue is released and the device can be repositioned until the desired portion of the tissue is positioned between the jaws. When it is observed that the tissue is positioned between the jaws as desired, the control wire can be pulled proximally to bring the clip closer to the complete arrangement configuration. In this complete arrangement configuration, the jaws are fixed in a closed state on the clipped tissue, as will be described in more detail below.

[0020] The clip includes a groove configured to receive the ring of the central body. When the wire moves proximally beyond a predetermined distance, even if the ring is fitted into the groove and the control wire is released, the ring is prevented from moving distally. Thereby, the jaw is fixed in a clipped configuration on the tissue. The control wire passes through the opening of the cross member coupled to the ring, and when the enlarged portion at the distal end of the control wire engages the surface of the cross member surrounding the opening, when the control wire is pulled proximally, the cross member and the ring are pulled proximally and the jaw closes.

[0021] When the ring is fitted into the groove, even if tension is applied to the control wire, the control wire does not move further proximally. When this tension exceeds a predetermined level, the end of the enlarged portion tears away from the rest of the control wire. At this point, the clip is connected to the endoscope only by the interface between the clip and the adapter. Thereby, the clip can be completely separated from the endoscope and the adapter by simply pulling the endoscope proximally so that the clip separates from the adapter due to the connection between the clip and the clipped tissue. Thereby, as will be described in more detail below, the endoscope and the adapter can be removed from the body leaving the clip at the clipping position on the target tissue.

[0022] Specifically, as shown in FIGS. 1 to 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 to which the clip 116 is coupled is configured to be attachable on the distal end of the endoscope 102. Those skilled in the art can understand that the clip 116 and the adapter 118 can be made in different sizes and shapes to correspond to different models of endoscopes. Also, the clip 116 and the adapter 118 can be sized and shaped to fit any other type of insertion device having flexibility or rigidity. The adapter 118 slides on the distal end 112 of the endoscope shaft 108 of the endoscope 102 and is maintained on the shaft 108, for example, by a friction fit. The clip 116 is attached on the distal end of the adapter 118 such that the jaws 120a, 120b 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 120a, 120b of the clip 116 are spaced apart to receive tissue therebetween and an initial placement configuration (FIGS. 2B and 3C) in which the jaws 120a, 120b of the clip 116 are closed to grip the tissue drawn into the clip 116. In the initial placement configuration, the jaws 120a, 120b are closed or partially closed and can be reopened if it is desired to reposition the clip 116. Each of the jaws 120a, 120b optionally includes a gripping mechanism 132, such as teeth or a rough surface, for gripping the target tissue therebetween, as can be understood by those skilled in the art.

[0023] Clip 116 includes a body 305 having an annular protrusion 302 (Figs. 3B and 3C) that extends proximally from a proximal face 304 of the body 305. The annular protrusion 302 is configured to be insertable into a corresponding annular groove 306 formed in a distal face 308 of the adapter 118 to releasably couple the clip 116 to the adapter 118. In one embodiment, the adapter 118 and the clip 116 are fitted together such that the clip 116 is freely rotatable relative to the adapter 118. Thereby, even if the endoscope 102 is rotated during removal of the endoscope 102, the placed clip is prevented from being inadvertently rotated. Thus, the rotational force applied to the endoscope 102 is not transmitted to the clip 116 and the clipped tissue.

[0024] The clip 116 in this embodiment has a monolithic structure formed of a compliant material and is biased toward an insertion configuration with the jaws 120a, 120b separated to receive tissue. Examples of such compliant materials include, for example, plastic, nitinol, compliant metal, and the like. Those skilled in the art will recognize that the clip 116 may be formed as a single unit or may be composed 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 of 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 terminated by a gripping mechanism 132. Each of the inner arms 125b of the jaws 120a, 120b extends from a proximal end coupled to a ring 122 of the central body 121 to a distal end similarly terminated by the gripping mechanism portion 132.

[0025] The outer arm 125a and the inner arm 125b are coupled at their distal ends by a gripping mechanism 132. Each of the jaws 120a, 120b includes a support element 126 that extends between the outer arm 125a and the inner arm 125b. Each of the outer arm 125a and the inner arm 125b includes a distal portion 127 (FIG. 2B) having a wide width adjacent to the gripping mechanism 132 to increase the gripping area of the gripping mechanism 132.

[0026] The inner arm 125b is coupled to the central body 121 such that movement of the central body 121 proximally or distally moves the inner arm 125b proximally or distally to move the jaws 120a, 120b closer to or away from each other, thereby transitioning the clip between an inserted configuration and an arranged configuration. Since the main body 305 does not move, there is no proximal or distal movement of the proximal end of the outer arm 125a. On the other hand, when the inner arm 125b moves proximally as the ring 122 moves, the distal ends of the outer arms 125a are bent inwardly so that the distal ends of the outer arms 125a are both in the arranged configuration as shown in FIGS. 3B and 3C. When the central body 121 moves distally, the inner arm 125b is pushed distally and the outer arms 125a are allowed to return to their initial shape, so that the distal ends of the jaws 120a, 120b are separated from each other in the inserted configuration. The support element 126 is configured to maintain the distance between the outer arm 125a and the inner arm 125b when the outer arm 125a is bent and to bias the jaws 120a, 120b toward the inserted configuration.

[0027] To control the movement of the central body 121, the control wire 114 extends distally from the handle portion 104 to the clip assembly 110 and engages the coupling portion 123 of the central body 121. The control wire 114 passes through the 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 diameter larger than that of the opening 312 and is disposed distally of the opening 312 so that the enlarged portion cannot move proximally 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. By moving the control wire 114 proximally, the enlarged portion 310 is pressed against the coupling portion 123, whereby the central body 121 is pulled proximally relative to the adapter 118 and the jaws 120a, 120b are closed as described above.

[0028] Since the jaws 120a, 120b of the clip 116 are biased toward the open position (insertion configuration), by releasing the wire 114, the jaws 120a, 120b can return to the biased open position. As described above, the operator can position the clip 116 adjacent to the target tissue to be clipped by operating the endoscope 102. The operator can then draw the 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 visually identifying 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 open the clip 116 again and release the tissue.

[0029] Next, the endoscope 102 can be repositioned. This process can 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 additional tension to the control wire 114 (e.g., using an actuator on the handle portion 104) until the dilator reaches a predetermined tension at which it separates from the remainder of the control wire 114. As a result, the clip 116 is released from the control wire 114 and is fixed in a closed state on the tissue being clipped. Next, the operator can 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 the adapter 118 can be removed from the body while leaving the clip 116 at the clipped position relative to the target tissue.

[0030] As described above, in one embodiment, the clip 116 is attached to the endoscope 102 via the adapter 118. The adapter 118 is sized and shaped in this embodiment to be attachable on 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 can be sized and shaped to be attachable on the distal end of any (flexible or rigid) insertion device 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 attachable on the distal end of the endoscope. The adapter 118 includes a channel that passes through the adapter 118. This channel is substantially aligned with the longitudinal axis of the endoscope when the adapter 118 is attached to the endoscope and extends away from the distal end of the endoscope so that occlusion of the field of view of the optical system of the endoscope is minimized when the adapter 118 is attached to the distal end of the endoscope. In one embodiment, the adapter 118 has a substantially circular cross-section so as to conform to the similar shape of the endoscope.

[0031] However, as would be understood by one of ordinary skill in the art, when the endoscope is non-circular (e.g., elliptical), the adapter can be appropriately sized and shaped, for example, to provide a friction fit with 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 passage of tools such as, for example, tissue graspers. 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 to the target tissue to be clipped. As would be understood by one of ordinary skill in the art, the endoscope shaft 108 in this embodiment has sufficient flexibility to be inserted through the tortuous path of the body lumen, and thus all of the components of this system that extend through or along the endoscope to the clip 116 also have sufficient flexibility to allow this insertion to the target site.

[0033] The body 305 of the clip 116 in this embodiment includes an annular groove 318 configured to fixedly receive the ring 122 when the clip 116 is in the deployed configuration. As the control wire 114 moves proximally beyond a certain point, the ring 122 is pushed into the annular groove 318. The annular groove 318 includes, at its most distal end, a reduced diameter portion 320 having a diameter smaller than the diameter of the ring 122. Since the clip 116 is formed of a compliant material, the ring 122 is fitted into and fixed within the annular groove 318 by being pushed through the reduced diameter portion 320. When the ring 122 is fixed within the annular groove 318, the jaws 120a, 120b are held in the deployed configuration. To prevent the ring 122 from moving further proximally than the annular groove 318 upon further proximal movement of the control wire 114, one or more stops 322 (three are shown in FIG. 3C) are provided adjacent to the annular groove 318, and these stops 322 extend radially inwardly from the inner surface of the clip 116 proximal to the annular groove 318.

[0034] One or more stops 322 function 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 fitted into the annular groove 318, further proximal movement of the control wire 114 is prevented, and when the additional tension applied to the control wire 114 finally rises to a level that separates the expansion portion 310 from the remaining portion of the control wire 114, the clip 116 is separated from the adapter 118. The endoscope 102 and the adapter 118 can then be removed while leaving the deployed clip 116 in place. The operator can control the movement of the wire 114 as desired by using the actuating device within the handle portion 104.

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

Claims

1. A clipping system for treating tissue, comprising: An adapter extending longitudinally from a proximal end to a distal end and configured to be attachable to the distal end of an insertion device, the adapter having a first annular groove formed in a distal surface thereof; A clip including (i) a body, (ii) a central body having a coupling portion and a ring, and (iii) outer arms coupled to the body at proximal ends of the outer arms, and first and second jaws disposed radially inward of the outer arms and having inner arms coupled to the ring at proximal ends of the inner arms; Comprising: The body includes an annular protrusion extending proximally from a proximal surface of the body, the annular protrusion being configured to be insertable into the first annular groove of the adapter for coupling the clip to the adapter; The body includes a second annular groove configured to receive the ring when the clip is in a deployed configuration; 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 from each other to receive tissue therebetween and a deployed configuration in which the first and second jaws are drawn together to grip tissue therebetween. A clipping system.

2. The clipping system according to claim 1, wherein the clip has a monolithic structure formed of a compliant material.

3. The clipping system according to claim 2, wherein the compliant material is nitinol.

4. The clipping system according to claim 1, wherein the first and second jaws are biased toward the insertion configuration.

5. The clipping system according to claim 1, wherein proximal movement of the central body causes corresponding proximal movement of the inner arms to bend the outer arms inward toward the deployed configuration.

6. The clipping system according to claim 1, wherein a first diameter of a most distal 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 most distal portion of the second annular groove.

7. A clipping system for treating tissue, comprising: 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, wherein the wire includes an enlarged portion at the distal end of the wire. An adapter including a proximal portion attached to the distal end of the shaft of the endoscope and a distal portion extending distally from the proximal portion. A clip including (i) a body, (ii) a central body having a coupling portion and a ring, (iii) an outer arm coupled to the body at the proximal end of the outer arm, and first and second jaws disposed radially inward of the outer arm and coupled to the ring at the proximal end of the inner arm. Comprising The body includes an annular protrusion extending proximally from the proximal surface of the body, and the annular protrusion is configured to be insertable into a first annular groove of the adapter to couple the clip to the adapter. The body includes a second annular groove configured to receive the ring when the clip is in the deployed configuration. The wire passes through an opening formed in the coupling portion, and the enlarged portion of the wire is located distal to the opening. The diameter of the opening is smaller than the diameter of the enlarged portion of the wire. Movement of the wire proximally and distally 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 inserted configuration in which the first and second jaws are spaced apart from each other to receive tissue therebetween and an arranged configuration in which the first and second jaws are drawn towards each other to grip tissue therebetween. A clipping system.

8. The clipping system according to claim 7, wherein the clip has a monolithic structure formed of a compliant material.

9. The clipping system according to claim 8, wherein the compliant material is nitinol.

10. The first and second jaws are biased towards the inserted configuration. Proximal movement of the wire causes abutment of the enlarged portion of the wire against the coupling portion, proximal movement of the coupling portion, and movement of the first and second jaws towards the arranged configuration. The clipping system according to claim 7, wherein release of the wire enables return of the first and second jaw portions to the inserted configuration.

11. The clipping system according to claim 7, wherein proximal movement of the central body causes corresponding proximal movement of the inner arm to bend the outer arm inwardly toward the deployed configuration.

12. The clipping system according to claim 7, wherein a first diameter of a most distal 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 most distal portion of the second annular groove.

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