Endoscope tip-mounted clip application device

Abstract

The system includes an adapter, a clip, a member, a wire, and a mechanism. The adapter includes a proximal portion mounted on the distal end of the insertion device and a distal portion extending distally from the proximal portion. The clip includes a jaw that moves between an insertion configuration in which the jaw extends around the adapter and is separated to receive tissue, and an initial configuration in which the clip moves distally away from the adapter so that the jaw grasps tissue. The member is releasably coupled to the clip and movablely coupled to the adapter. The member extends from a proximal portion that remains outside the body in the operating configuration to a distal portion that is coupled to the distal end. The wire extends to a distal end that is received within the member and, when a predetermined force is applied, is releasably coupled to the clip via a link. The mechanism selectively locks the distal portion of the member so that it does not move proximal to the adapter while the link is released.

Description

Technical Field

[0001] The present disclosure relates to an endoscopic device, and more particularly to an endoscopic clipping device for treating tissue along the gastrointestinal tract.

Background Art

[0002] Physicians are being proactive in performing aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which can increase the risk of perforation of the digestive wall or may require closure of the digestive wall as part of the procedure. Such procedures include, for example, removal of large lesions, tunneling in the submucosal layer of the gastrointestinal tract to treat submucosal lesions, removal of the entire tissue layer, treatment of lesions of other organs by passing through the outside of the gastrointestinal tract, and endoscopic treatment / repair of postoperative problems (e.g., postoperative leakage, collapse of the surgical staple line, and anastomotic leakage).

[0003] Currently, tissue may 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 reduce 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, situations, and anatomical structures.

Summary of the Invention

[0004] This disclosure relates to a system for clipping tissue. The system includes an adapter comprising a proximal portion configured to be attached to the distal end of an insertion device and a distal portion extending distally from the proximal portion. Furthermore, the system includes a clip configured to be attached to the distal portion of the adapter. The clip comprises first and second jaws, the first and second jaws being configured to move between an insertion configuration in which the first and second jaws extend around the adapter and are separated from each other to receive tissue between the first and second jaws, and an initial deployment configuration in which the clip is moved distally away from the adapter so that the first and second jaws are drawn toward each other to grasp the tissue received between the first and second jaws.

[0005] The system also includes a first extension member that is releasably coupled to the clip and movably connected to the adapter. The first extension member extends from a proximal portion configured to remain outside the patient's body in its operating configuration to a distal portion configured to be coupled to the distal end of the insertion device. Furthermore, the system includes a first control wire that is slidably received within the first extension member and extends to the distal end, the distal end of which is releasably coupled to the clip via a first releaseable link configured to release the first control wire when subjected to a force exceeding a predetermined threshold. Furthermore, the system includes a first locking mechanism configured to selectively lock the distal portion of the first extension member so that it does not move proximal to the adapter while the first releaseable link is released.

[0006] In one embodiment, the first extension member includes a recess, and the first locking mechanism includes a locking member configured to enter the recess of the first extension member when the first extension member is moved distally to a locked position.

[0007] In one embodiment, the first locking mechanism includes a first biasing member that abuts against a first locking member, the first biasing member biases the locking member against a first extension member, and as a result, when the first extension member is moved to the locked position, the first biasing member pushes the first locking member into a recess in the first extension member.

[0008] In one embodiment, the first biasing member includes an elastic member that at least partially surrounds the adapter, the adapter includes a first opening, and the first extension member extends slidably through the first opening.

[0009] In one embodiment, the first biasing member includes a first leaf spring. In one embodiment, the system further includes a first flexible member that remains outside the patient's body during use and extends from a proximal end accessible to the user to a distal end adjacent to an adapter. A first leaf spring extends from a proximal end coupled to the first flexible member to a distal end forming a locking member.

[0010] In one embodiment, the distal end of the first leaf spring is configured to lock the first flexible member in place so that it does not move proximal to the adapter via frictional engagement with the outer surface of the first extension member.

[0011] In one embodiment, the system further includes a first tension member that remains outside the patient's body during use and extends from a proximal end accessible to the user to a distal end coupled to a first biasing member, thereby causing tension applied to the first tension member to pull the first biasing member, disengaging it from the first extension member and releasing the first extension member to move proximal to the adapter.

[0012] In one embodiment, the first locking mechanism includes a first locking member fixed to the adapter and a second locking member slidably mounted on the adapter, wherein the first locking member defines a first lumen into which a first extension member is slidably received, and the second locking member defines a second lumen into which the first extension member is slidably received, and the first and second lumens are configured such that when the second locking member is moved to the locked position, a portion of the first locking member received in the second lumen presses and compresses a portion of the second lumen against the first extension member.

[0013] In one embodiment, the first locking member is fixed to the adapter and includes a collet clevis having a substantially conical outer surface that widens radially outward from the distal end of the reduced diameter, and the second lumen tapers radially inward from the proximal end of the increased diameter, thereby the system further includes a tensioning member coupled to the collet clevis, thereby allowing the collet clevis to be pulled proximal over the collet and pressing the radial inner surface of the collet clevis radially inward against the first extension member.

[0014] In one embodiment, the adapter includes a first tapered opening into which a first extension member is received, the first tapered opening having a diameter that gradually decreases from a first diameter at the proximal end of the first tapered opening to a reduced second diameter distal to the proximal end, and the first locking mechanism includes a first compressible member fixed to the first extension member, the first compressible member extending from a distal end fixed to the outer surface of the first extension member to a radially expanding proximal end having a diameter larger than the reduced second diameter of the first tapered opening. The first compressible member is compressible to a reduced diameter configuration in which it is substantially pressed against the outer surface of the first extendable member, up to an expanded configuration that extends radially outward, and is configured to compress as it passes through the first tapered opening, and to expand under its bias as the proximal end of the first compressible member moves distally out of the first tapered opening, thereby preventing the first compressible member from moving proximal to the first tapered opening by contact between the radially expanded proximal end of the first compressible member and the adapter.

[0015] In one embodiment, the adapter includes a second tapered opening into which a first extension member is received, the second tapered opening having a diameter that gradually decreases from a first diameter distal to the second tapered opening to a reduced second diameter proximal to the distal, and the first locking mechanism includes a first gripping member slidably received within the second tapered opening, the first gripping member including a radial inner surface configured to grip the first extension member, and the first gripping member is compressible into a reduced diameter configuration that substantially presses against the outer surface of the first extendable member to lock the position of the first extendable member relative to the adapter, and is expandable into an expanded configuration that expands radially outward to allow the first extendable member to slide through the first gripping member.

[0016] In one embodiment, the first gripping member is coupled to a control member, which is operable to move the first gripping member proximal to a second tapered opening, and when the first gripping member is moved proximal to the second tapered opening, the radial inner surface of the first gripping member is pressed against the first extendable member.

[0017] Furthermore, the present disclosure relates to a method for treating tissue, comprising inserting the insertion device to a target region within a body lumen, wherein the insertion device includes a clip mounted on an adapter coupled to the distal end of the insertion device in an insertion configuration where the jaws of the clip are separated from each other to receive tissue between them; drawing a portion of the tissue to be clipped into the channel of the adapter and between the jaws of the clip; moving the clip distally from the adapter to enable the clip to be moved from the insertion configuration to an initial deployment configuration where the jaws close over a portion of the tissue by advancing a first extendable member distally, which slidably receives a first control wire releasedly coupled to the clip via a first releaseable link; locking the distal portion of the first extendable member so as not to move proximal to the adapter; and pulling the first control wire distally to the first extendable member until force is applied to the first releaseable link until the coupling between the first control wire and the clip is released.

[0018] In one embodiment, the distal portion of the first extendable member is locked adjacent to the adapter. In one embodiment, a first extendable member is slidably received within a first flexible member, the first flexible member extending to a distal end coupled to an adapter, and the distal portion of the first flexible member is locked distally to the distal end of the first flexible member.

[0019] In one embodiment, the first extendable member is locked by a locking member inserted into a recess on the outer surface of the first extendable member so as not to move proximal to the adapter. In one embodiment, the locking member is coupled to a leaf spring that biases the locking member toward a gripping configuration in which the radially inner surface of the locking member presses against the outer surface of the first extensible member.

[0020] In one embodiment, the method further includes unlocking the first extensible member to move proximally relative to the adapter by pulling the tension member proximally after the first extensible member is locked so as not to move proximally relative to the adapter, and the tension member is coupled to the leaf spring.

Brief Description of the Drawings

[0021] [Figure 1] A perspective view of a clipping system according to an exemplary embodiment of the present disclosure is shown. [Figure 2] A perspective view of the distal portion of the clipping system of FIG. 1 in an inspection configuration is shown. [Figure 3A] A cross-sectional perspective view of the distal portion of the clipping system of FIG. 1 with the clip in an inspection configuration is shown. [Figure 3B] A partial cross-sectional view of the distal portion of the clipping system of FIG. 1 including details of the connection between the control wire and the clip is shown. [Figure 3C] A partial cross-sectional view of the distal portion of the clipping system of FIG. 1 including details of the connection between the control wire and the clip is shown. [Figure 4] A perspective view of the distal portion of the clipping system of FIG. 1 showing the pull wire and flexible tube of the mechanism for deploying and locking the clip is shown. [Figure 5] A cross-sectional view of the distal portion of the adapter of the system of FIG. 1 is shown. [Figure 6] A perspective view of an adapter according to a second embodiment is shown. [Figure 7A] A prospective view of the adapter of FIG. 6 is shown. [Figure 7B] A cross-sectional view of the adapter of FIG. 6 is shown. [Figure 8] A partially transparent view of an adapter according to a third embodiment is shown. [Figure 9] A cross-sectional view of the adapter of FIG. 8 is shown. [Figure 10] Shows a cross-sectional view of the distal end of a clipping system in a further embodiment in the first configuration. [Figure 11] Shows a cross-sectional view of the distal end of the clipping system of FIG. 10 in the second position. [Figure 12] Shows a cross-sectional view of the distal end of a clipping system in yet another embodiment in the first configuration. [Figure 13] Shows a cross-sectional view of the distal end of the clipping system of FIG. 12 in the second position. [Figure 14] Shows a schematic view of the locking mechanism of FIG. 10 in the fourth position. [Figure 15] Shows a perspective view of the distal portion of a system according to one embodiment, including a leaf spring of a mechanism for deploying and locking a clip. [Figure 16] Shows a perspective view of the handle of the system of FIG. 14.

Mode for Carrying Out the Invention

[0022] The present disclosure can be further understood by reference to the following description and the accompanying drawings, in which like elements are referred to by like reference numerals. The present disclosure relates to a clipping system, and more particularly to an endoscope tip-mounted endoscope clipping system in which a clip is attached to an adapter coupled to the distal end of an insertion device such as a flexible endoscope. The system includes a control wire that extends from a handle to the clip and is slidably received within a first elongate member, the first elongate member being movable proximally and distally relative to the adapter to move the clip proximally and distally relative to the adapter, to separate the clip from the adapter, and to clip tissue drawn into the adapter.

[0023] The system according to the disclosed embodiment includes various mechanisms for locking the position of the first elongated member at a distal position (e.g., an adapter) such that, if it is desired to fully deploy the clip, a proximal tension applied to the control wire pulls the clip against the first elongated member locked distally, applying a counter-distant distal force sufficient to sever the connection between the control wire and the clip. This is in contrast to conventional endoscope tip-mounted clip systems in which this counter-force is applied by one or more elongated members locked at a handle (i.e., the proximal end of the system far from the clip). Locking the elongated member near the clip improves the functionality of the disclosed embodiment, allows the use of elongated members with reduced column strength compared to conventional systems, and reduces material costs.

[0024] According to an exemplary embodiment, the distal end of a control wire within each extension member is connected to a clip by a severable link such that the control wire separates from the clip when a predetermined level of tension is applied to the control wire. For example, the control wire extends through a first elongated member and through a first opening in a clip, which is sized to prevent the enlarged end of the first control wire from passing proximal to the first opening. Each control wire includes a fragile link between its distal end and the rest of its length, which is configured to break, break, or otherwise separate when subjected to a force exceeding a predetermined threshold force, so that the fragile link breaks or separates during the final deployment of the clip, freeing the clip from the control wire and the extension member.

[0025] After the user has positioned the clip as desired (for example, after visually confirming that the target portion of the tissue has been clipped as desired), the user can finally unfold the clip by separating it from the rest of the system. To do this, the user positions the distal end of the first elongated member relative to the proximal surface of the clip, locking the distal end of the first elongated member relative to the adapter and the clip to prevent the clip from moving proximal. The user then applies a proximal force to the control wire until it reaches a predetermined level through which the control wire is separated from the clip (for example, by separating the expanded distal end from the rest of the control wire, or by deforming or breaking a portion of the clip that forms an opening through which the control wire passes), thereby separating the control wire from the clip.

[0026] The system according to the exemplary embodiment includes a first control wire and a second control wire, the distal end of each control wire being connected to the corresponding end of a clip. If the fragile link breaks or separates, the distal ends of the control wires remain attached to the clip or the proximal portion of each control wire, preventing detachment during final deployment, while the remaining length of the control wires is connected to the clip so that it can be removed from the body.

[0027] While the control wire remains attached to the clip, for example, because the force applied to the vulnerable link does not exceed a predetermined threshold, and the vulnerable link remains intact, the control wire may be moved longitudinally relative to the insertion device and elongated members to move the clip between an insertion configuration in which the clip is stretched and opened over the adapter, an initial deployment configuration in which the clip is moved distally away from the adapter to clip tissue, and a scrutiny configuration in which the adapter and insertion device are moved proximal away from the clip to expand the field of view of the insertion device, while the clip remains attached to the proximal components of the system.

[0028] In the insertion configuration, the clip is mounted proximal to the adapter and retained in the insertion configuration, ready to receive tissue between its jaws, while the clip's position minimizes its obstruction of the endoscopic visual system's field of view. The insertion configuration is configured to facilitate the insertion of the endoscope into the target site adjacent to the tissue to be clipped, and the system allows the clip to be deployed in the initial deployment configuration and clipped onto the tissue.

[0029] As the endoscope and adapter are withdrawn proximally while the clip remains in place on the target tissue, the field of view of the endoscope's visual system widens, allowing the operator to see the clip and the tissue it clips, enabling them to determine if the clip is in the desired position or if adjustment is needed. If the operator determines that the clip is positioned as desired, the clip is deployed by releasing it from the control wire / extension member and remains in place, clipped on the target tissue. If the operator determines that the clip's position needs adjustment, the endoscope and adapter are moved distal to the position adjacent to the clip. The clip is then pulled proximally over the adapter to reopen it, having been pulled proximally away from the previously clipped tissue so that it moves over the adapter. As the clip slides proximally over the adapter, it opens against its natural bias and returns to the insertion configuration.

[0030] After the clip is removed from the tissue and returned to the insertion configuration, the operator can reposition the endoscope as desired, draw a new portion of the target tissue into the adapter (e.g., under the application of suction or a grasping device via the endoscope's working channel), and redeploy the clip from the adapter onto the target tissue in its initial deployment position. The endoscope is then withdrawn proximal again, with the clip still attached to the device, and the device is moved back to the examination configuration.

[0031] The position of the clip and the clipped tissue is observed again, and this process may be repeated until the operator determines that the clip is positioned as desired. Once the operator confirms that the tissue on which the clip is closed is the desired portion of tissue, the fragile link of the control wire may be broken, releasing the clip therefrom, thereby moving the clip to a final deployed configuration where the clip is completely separated from the rest of the system and the insertion device. As used herein, it will be understood by those skilled in the art that the terms proximal and distal are intended to refer to the direction toward the user of the device (proximal) and the direction toward the user of the device (distal), respectively.

[0032] As shown in Figures 1 to 5, a clipping system 100 for treating tissue defects and / or perforations according to an exemplary embodiment includes, for example, a clip 102 configured to be inserted through a body lumen to a target region and to clip the target tissue. The clip 102 is insertable into the target region via an insertion device 104, for example, an endoscope 106. As shown in Figures 1 to 5, the clip 102 is coupled to the distal end 108 of the endoscope 106 via an adapter 110 mounted on the distal end 108 of the endoscope 106.

[0033] The adapter 110 in this exemplary embodiment is sized and shaped to precisely match the profile of the endoscope 106, is hollow, and defines a central channel within it that leads to, for example, the working channel and the visual system V of the endoscope 106 (terminating at the distal surface 111 of the endoscope 106, as will be understood by those skilled in the art). The clip 102 is configured to move relative to the adapter 110 and the endoscope 106 via a flexible member 112, each of which houses a tube 114, and a control wire 116 is slidably received in each tube 114.

[0034] Each control wire 116 includes a first crimped portion 117 located proximal to the proximal section 121 within the lumen of the corresponding tube 114, and a second crimped portion 123 located distal to the distal section 125, such that when the control wire 116 is moved distally within the tube 114, the first crimped portion 117 is pushed distally relative to the proximal section 121, causing the tube 114 to move distally together with the control wire 116.

[0035] If the position of tube 114 is not locked to prevent it from moving proximal to the adapter 110 (as described in more detail below), when the control wire 116 moves proximal to the tube 114, the second crimp 123 is pulled proximal to the distal section 125, and the tube 114 is pulled proximal to the control wire 116. If the position of tube 114 is locked to prevent it from moving proximal to the adapter 110, when the control wire 116 moves proximal to the tube 114, the clip 102 is pulled proximal to the distal end of the tube 114, so that the column strength of the tube 114 resists the force applied to the control wire 116, and the control wire 116 is subjected to tension. The clip 102 is releasably coupled to the control wire 116.

[0036] The clip 102 is movable from an insertion configuration to an initial deployment configuration and from an initial deployment configuration to a detailed configuration by moving the tube 114 within the flexible member 112, as will be described in more detail below. In the various embodiments herein, the tube 114 and control wire 116 are configured to allow the endoscope 106 to be withdrawn from the clip 102 within a range of 25.4 mm (1 inch) to 76.2 mm (3 inches) when in the detailed configuration. As will be understood by those skilled in the art, the user may decide to withdraw the endoscope 106 by any distance smaller than the maximum range depending on, for example, anatomical constraints and / or the quality of the visual system V of the endoscope 106, with respect to the distance necessary to provide the required field of view of the clip 102 and the surrounding area, which is sufficient for the user to determine whether the clip 102 has been deployed as desired.

[0037] If the user so desires, clip 102 may be moved again from the examination configuration to the insertion configuration, and then moved again to the initial deployment configuration in the new position. Once the user is satisfied that clip 102 is positioned as desired, clip 102 may be moved from the initial deployment configuration to the final deployment configuration in which clip 102 is separated from the control wire 116 and the rest of system 100, the rest of system 100 is removed from the body, but clip 102 may be left in place clipped onto the desired tissue.

[0038] As shown in Figures 2 and 3A-3C, each control wire 116 is passed through the opening 119 of a corresponding mount 120 of the jaw portion 122 of the clip 102 in its initial configuration (before the final deployment of the clip 102), which includes an enlarged distal end 118 located distal to the opening 119. The opening 119 has a diameter selected to allow the proximal portion of the control wire 116 to pass through it, but a smaller diameter than the diameter of the enlarged distal end 118 so that each control wire 116 is secured to the corresponding jaw portion 122. The flexible members 112 extend proximal from the adapter 110 to the joint 113, where they join to form a single flexible member 112a. The tubes 114 extend distally from the handle 124 into which they are slidably received, and the control wires 116 extend through the tubes 114 and connect to a spool 126 slidably mounted on the body 128 of the handle 124. As the spool 126 moves relative to the body 128 of the handle 124, the control wire 116 moves proximal and distal within the tube 114 through the interaction between the first crimp portion 117 and the second crimp portion 123 and the proximal section 121 and distal section 125, respectively, causing the tube 114 to move proximal and distal together with the control wire 116.

[0039] Furthermore, the tubes 114 join together to form a single tube 114a proximal to the joint 113. As will be understood by those skilled in the art, the tube 114a is divided into two tubes 114 at a position proximal to the joint 113 by a distance at least equal to the distance that the clip 102 can move distally from the insertion configuration when the clip 102 is in the insertion configuration. That is, as will be understood by those skilled in the art, the tube 114a must remain proximal to the joint 113 at its most distal position.

[0040] Those skilled in the art will understand that, alternatively, the jaw portion 122 may be formed having an opening 119 configured to yield when a predetermined proximal force is applied via a control wire 116. In this case, the control wire 116 and the expanding distal end 118 do not separate from each other during the final deployment of the clip 102 and are withdrawn from the socket intact.

[0041] As shown in Figures 2, 3A, and 3C, the adapter 110 includes a compression ring 130 contained within a grooved member 132 that extends circumferentially around at least a portion of the adapter 110. The tube 114 passes radially through the adapter 110 within the ring 130. The ring 130 extends around at least a portion of the adapter 110 that surrounds the position where the tube 114 passes through the adapter 110. The grooved member 132 includes radially inward projections 134 of a size and shape that allow them to be releasably received within corresponding recesses 136 formed in the tube 114.

[0042] As will be understood by those skilled in the art, and as will be described in more detail below, if the user wishes to ultimately deploy the clip 102, the user operates the spool 126 to advance the tube 114 distally until the recess 136 reaches a position radially inward of the grooved member 132. Once this position is reached, the grooved member 132 is pushed radially inward by the compressive force from the ring 130, and the grooved member 132 enters the recess 136. In this embodiment, the distal surface 138 of the grooved member 132 extends substantially radially, as does the distal surface 140 of each recess 136, so that when the grooved member 132 enters the recess 136, the tube 114 is locked, preventing them from moving proximal to the grooved member 132.

[0043] For example, the recess 136 is positioned so as to be separated from the distal end of the tube 114 by a distance selected to allow for more effective locking of the distal end of the tube 114 (i.e., by positioning the recess 136 near the distal end of the tube 114 rather than locking the tube 114 at its proximal end (i.e., handle)), thereby reducing bending / kinking that occurs when the smaller portion of the tube 114 extending distally from the recess 136 is subjected to compressive force. In exemplary embodiments, the distance between each recess 136 and the corresponding distal end of the tube 114 may be 12 to 75 mm.

[0044] The proximal surface 142 of the radially inward portion of the grooved member 132 in this embodiment includes an optional curvature, as it does not need to lock the tube 114 to distal movement relative to the grooved member 132. The system 100 further includes a pair of tension members 144 (e.g., flexible thread or cable) extending from a distal end coupled to a ring 130 (e.g., the tension member 144 may be wrapped around the ring 130). As shown in Figure 2, the tension members 144 in this embodiment are coupled to form a single tension member 144a extending from the distal end coupled to the tension member 144 to the proximal end coupled to the actuator 146 of the handle 124.

[0045] As will be described in more detail below, the tube 114 is locked by the grooved member 132 and the ring 130, and if the user wishes to unlock the tube 114 (for example, if they wish to open and reposition the clip 102), the actuator 146 may be operated to apply tension to a single tension member 144a and tension member 144 so that the ring 130 is pulled proximal and exits the recess 136. The tube 114 may then be moved proximal to the grooved member 132, and the process of positioning the clip 102 and positioning it on different parts of the tissue may be repeated until the clip 102 is positioned as desired.

[0046] Once the user has positioned the clip 102 as desired (for example, after the clip 102 has been initially unfolded, observed in the examination configuration, reopened, repositioned, and clipped to a new portion of tissue), the user can finally unfold the clip 102. Specifically, the jaws 122 of the clip 102 in this embodiment are biased toward a closed tissue-grasping configuration in which the distal ends of the jaws 122 are drawn toward each other to grasp any tissue received between them. Thus, as the user advances the spool 126 distally relative to the body 128, the tube 114 pushes the clip 102 distally until the jaws 122 move distally beyond the distal end of the adapter 110. The jaws 122 then close under their natural bias, grasping any tissue positioned between them.

[0047] As shown in Figure 4 and as will be understood by those skilled in the art, before the clip 102 is moved distally away from the adapter 110 (i.e., the clip 102 is in the insertion configuration), the clip 102 is held on the adapter 110 with its jaws 122 open so that the user can pull a target portion of tissue into the channel 115 of the adapter 110 (for example, by applying a suction or grasping device through the working channel of the endoscope 106). As shown in Figure 2, in the insertion configuration, the clip 102 is mounted on the adapter 110 with its jaws 122 separated from each other to receive tissue between them. To move the clip 102 from the insertion configuration to the initial deployment configuration (Figures 1-3 and 5), the tube 114 is moved distally relative to the endoscope 106 (by manipulating the spool 126 as described above), the jaw portion 122 protrudes distally away from the adapter 110, and the jaw portion 122 closes under its own bias (i.e., moves to the initial deployment configuration), moving the clip 102 distally until it clips the tissue that has been drawn into the channel 115 of the adapter 110.

[0048] After the jaw portion 122 is closed over this portion of the tissue by moving the clip 102 to the initial deployment configuration, the clip 102 may be moved to the examination configuration to expand the field of view of the visual system V as described above by extending the tube 114 distally to the adapter 110 and moving the endoscope 106 and adapter 110 proximal away from the clip 102, with the distal end of the endoscope 106 and adapter 110 separated from the clip 102, while the clip 102 remains clipped to the tissue. In this configuration, the clip 102 remains connected to the insertion device 104 via the control wire 116, but the field of view of the endoscopic visual system to the clip 102 and the target tissue is expanded, and the endoscope 106 can also be moved relative to the clip 102 to allow for a wider observation of the placement and / or position of the clip 102 relative to the target tissue.

[0049] If the user determines that the position of clip 102 is incorrect or suboptimal, as described below, the user may move the endoscope 106 and adapter 110 distal to the position adjacent to clip 102 by sliding the endoscope 106 and tube 114 on the control wire 116 until clip 102 contacts the distal end of adapter 110. The endoscope 106 and adapter 110 can be held in place immediately proximal to clip 102 once clip 102 is retracted proximal to the distal end of adapter 110 by retracting the tube 114 and control wire 116 proximal to clip 102. This force causes the jaw 122 of clip 102 to forcibly release the already clipped tissue (for example, by simultaneously releasing any gripping device or suction) and return clip 102 to the insertion configuration.

[0050] Subsequently, the user may reposition the endoscope 106 and clip 102 before the final deployment of clip 102, as described below, and repeat these steps to adjust the placement and / or position of clip 102 relative to the target tissue as desired. That is, if the operator determines that clip 102 is not positioned as desired in the examination configuration, clip 102 may be opened again and removed from the tissue as many times as necessary, and the device may be repositioned until clip 102 is closed as desired on the target portion of the tissue.

[0051] Once the user determines that the clip 102 has clipped onto the target portion of the tissue and is positioned as desired, the user advances the tube 114 distally until the recess 136 aligns with the ring 130 and the radially inward projection 134 of the grooved member 132. As described above, the compression applied by the ring 130 pushes the radially inward projection 134 into the recess 136, locking the position of the tube 114 and preventing them from moving proximal to the adapter 110. The user then applies a proximal force to the control wire 116 via the spool 126 until a predetermined tension is reached that releases the connection between the control wire 116 and the jaw portion 122.

[0052] For example, as described above, when a predetermined tension is applied to the magnified distal end 118, it can damage a portion of the control wire 116, separating the proximal portion of the control wire 116 from its magnified distal end. This allows the clip 102 to be completely separated from the rest of the system 100, enabling the endoscope 106 to be withdrawn proximal to the patient's body along with the adapter 110, the proximal portion of the control wire 116, and the tube 114, leaving the clip 102 clipped to the target tissue and in place.

[0053] If, for any reason, the user wishes to reposition the clip 102 after the tube 114 has been locked in place by the grooved member 132, the system 100 further includes a mechanism for unlocking the connection between the tube 114 and the grooved member 132. For example, as described above, the user may operate the tension member 144 to pull the ring 130 proximal, thereby releasing the compressive force applied to the grooved member 132. This releases the tube 114 and allows it to move as desired proximal and distal to the adapter 110 until the user wishes to relock the tube 114 in place to finally deploy the clip 102. Furthermore, the user may apply tension to the tension member 144 after the clip 102 has finally deployed so that the proximal portions of the tube 114 and control wire 116 can be withdrawn proximal to the flexible member 112 to prevent trauma to surrounding tissue when the endoscope 106 is withdrawn proximal to the patient's body.

[0054] The system 200 shown in Figures 6, 7A, and 7B is substantially similar in structure and operation to system 100, except as described below. Specifically, system 200 includes an adapter 210 configured to be attached to an insertion device such as a flexible endoscope, as described above with respect to system 100, and has similar handles and actuators configured to operate various components in a similar manner. However, the adapter 210 includes a recess 236 formed in each tube 214 and a clip ring 230 configured to interact in a similar manner to the interaction between the recess 136 and the grooved member 132 described above. Specifically, when the recess 236 is longitudinally aligned with the clip ring 230, the clip ring 230 is compressed radially inward into the recess 236, locking the position of the tube 214 relative to the clip ring 230.

[0055] As seen in Figures 7A and 7B, the adapter 110 includes an opening 228 through which the radial inner surface of the clip ring 230 can directly engage with the tube 214. When the tube 214 is moved distally so that the recess 236 aligns with the clip ring 230, the clip ring 230 is pressed into the recess 236, as described above with respect to the tube 114 and ring 130, locking the position of the tube 214 so that it does not move proximal (relative to the adapter 210). That is, if the user of the system 200 wishes to finally deploy the clip 202 including the pair of jaws 222, the user advances the tube 214 distally until the recess 236 aligns with the clip ring 230.

[0056] At this point, the clip ring 230 moves radially inward into the recess 236, locking the tube 214 in place. The user then applies tension to the control wire 216 until a predetermined tension is reached that separates the connection between the control wire 216 and the clip 202. Thus, the clip 202 is deployed in substantially the same manner as described above with respect to the clip 102 (including the movement of the clip 202 between the insertion configuration, initial deployment configuration, refinement configuration and final deployment configuration described above).

[0057] Subsequently, the user can unlock the tube 214 from the clip ring 230 by applying tension to one or more tension members 244 to pull the clip ring 230 proximal and disengage it from the recess 236. In this embodiment, the tension members 244 are coupled to the clip ring 230 through the opening 246 of the clip ring 230. As will be understood by those skilled in the art, the system 200 includes only a single tension member 244, but any number of tension members may be used to ensure that the unlocking of the tube 214 from the clip ring 230 is achieved as desired. Similarly, the system 100 may include only a single tension member 144a or at least three tension members 144, as needed.

[0058] System 300, shown in Figures 8 and 9, is substantially similar in structure and operation to systems 100 and 200, except as described below. Specifically, system 300 includes an adapter 310 configured to be attached to an insertion device such as a flexible endoscope, as described above with respect to systems 100 and 200, and has similar handles and actuators configured to operate various components in a similar manner. System 300 includes a different mechanism for locking the tube 314 to the adapter 310, as described below. As seen in Figures 8 and 9, the adapter 310 includes a collet clevis 330 attached to one or more tension members 331 that are slidably mounted on the adapter 310 and remain outside the body during use, extending back to the proximal end of system 300 accessible to the user. Thus, if the user wishes to pull the collet clevis 330 proximal, the user simply pulls the tension member 331 proximal, pulling the collet clevis proximal as desired. Each tube 314 slides through the corresponding opening 336 of the collet clevis 330.

[0059] Each opening 336 tapers from its maximum diameter at the proximal end 338 of the collet clevis 330 to a reduced diameter approximately equal to the outer diameter of the tube 314 at point 339 within the opening 336. A pair of collets 340 are fixed to the adapter 310, and each tube 314 passes through one of the corresponding collets 340. Thus, the movement of the collet clevis 330 relative to the adapter 310 causes the collet clevis 330 to move distally and proximal to the collet 340 on the tube 314. The proximal end of each opening 336 is configured to slidably receive the distal end 341 of the collet 340 fixed to the adapter 310 when the collet clevis 330 moves proximal or distal to the adapter 310.

[0060] Each collet 340 includes inclined surfaces 342 that spread apart from each other at the proximal end of the collet 340, and the minimum diameter of each collet 340 is at the distal end 341. When the user wishes to finally deploy the clip 302, the user pulls the collet clevis 330 proximal, pushing each opening 336 proximal onto the corresponding collet 340. As the collet 340 is inserted further distally into the tapered opening 336, the inclined surfaces 342 of the collet 340 are pressed radially outward against the tapered surface of the opening 336, bringing the radial inner surface of the distal portion of the opening 336 (e.g., distal to point 339) into contact with the tube 314 until the tube 314 is frictionally locked in place by the collet clevis 330.

[0061] Subsequently, the user applies tension to the control wire 316 while maintaining the position of the tube 314 until a predetermined tension is reached that separates the connection between the control wire 316 and the clip 302. Thus, the clip 302 is deployed in substantially the same manner as described above with respect to the clip 102 (including the movement of the clip 302 between the insertion configuration, initial deployment configuration, refinement configuration and final deployment configuration described above). The user can then unlock the tube 314 from the collet 340 by pushing the collet clevis distally so that the inclined surface 342 exits the opening 336.

[0062] Those skilled in the art will understand that the various parts of the collet 340 and collet clevis 330 can be rearranged in any number of ways to achieve the same locking effect. For example, the distal end of the collet 340 may be formed as a flared opening of a lumen that tapers radially inward toward the proximal end of the collet 340, while the collet clevis 330 includes an inclined outer surface that widens outward from the constricted proximal end to the expanded distal end. In this case, as the collet clevis 330 is pulled proximal on the collet 340, the decreasing diameter of the opening of the collet 340 closes the proximal end of the lumen of the collet clevis 330 toward the tube 314.

[0063] System 400, shown in Figures 10 and 11, is substantially similar in structure and operation to systems 100, 200, and 300, except as described below. Specifically, system 400 includes an adapter 410 configured to be attached to an insertion device such as a flexible endoscope, as described above with respect to systems 100 and 200, and has similar handles and actuators configured to operate various components in a similar manner. System 400 includes different mechanisms for locking the tube 414 to the adapter 410, as described below.

[0064] As shown in Figures 10 and 11, each tube 414 includes an expandable member 430 fixed thereto. Each expandable member 430 includes a distal end 432 having a diameter substantially equal to the outer diameter of the tube 414 to which it is attached, and expands radially outward from this distal end 432 to the expandable proximal end 434. The expandable member is flexible so as to be compressible radially inward, and when no external force is acting on it, it is biased to expand outward into a substantially conical shape having the maximum diameter of the expandable member at its proximal end 434.

[0065] The proximal end 434 forms a contact surface that withstands the distal force applied to it. The adapter 410 includes a pair of holes 420 extending through it, each hole 420 slidably receiving one of the corresponding tubes 414. The holes 420 taper such that the maximum diameter of each hole 420 is at its proximal end 422, and the diameter of each hole 420 gradually decreases over at least a portion of its length as it moves distally from its proximal end 422.

[0066] When a user of system 400 wishes to finally deploy the clips 402 that have been clipped onto the target tissue as desired, the user advances the tube 414 distally until each expandable member 430 enters the corresponding hole 420. As the user advances the tube 414 further distally, the expanding member 430 is compressed due to the tapering diameter of the hole 420 until the expanding member 430 passes distally through the hole 420 and exits.

[0067] As the proximal end 434 of the expandable member 430 moves distally and exits the hole 420, the expandable member 430 expands outward under its natural bias with the contact surface of the proximal end 434 facing the distal end of the adapter 410. Thus, the tube 414 is locked so as not to move proximal beyond the point where the proximal end 434 contacts the distal end of the adapter 410. The user then applies tension to the control wire 416 until a predetermined tension is reached that separates the connection between the control wire 416 and the clip 402 (for example, by breaking the control wire 416 and leaving its expanded distal end 418 attached to the clip 402).

[0068] Therefore, clip 402 is deployed in substantially the same manner as described above with respect to clips 102, 202, and 302 (including the movement of clip 402 between the insertion configuration, initial deployment configuration, examination configuration, and final deployment configuration described above). The user can then remove system 400 from the patient's body, leaving clip 402 clipped to the target tissue and in place.

[0069] System 500, shown in Figures 12 and 13, is substantially similar in structure and operation to systems 100, 200, 300 and 400, except as described below. Specifically, system 500 includes an adapter 510 configured to be attached to an insertion device such as a flexible endoscope, as described above, and has similar handles and actuators configured to operate various components in a similar manner. System 500 includes different mechanisms for locking tubes 514 to the adapter 510, as described below. As seen in Figures 12 and 13, each tube 514 is slidably received within a hole 520 in the adapter 510.

[0070] Each tube 514 is therefore slidably received within a corresponding one of a pair of flexible members 512. The distal end of each flexible member 512 is fixed to a compressible jaw 526, which is slidably received within a corresponding one of the holes 520. Thus, when the flexible member 512 is moved proximal to the adapter 510, the compressible jaw 526 is pulled proximal through the hole 520. As seen in Figures 12 and 13, each compressible jaw 526 includes a proximal end 528 having a diameter substantially equal to or smaller than the inner diameter of the proximal end of the corresponding hole 520.

[0071] Each compressible jaw portion 526 extends radially outward from its proximal end 528 to its extended distal end 530. The compressible jaw portions 526 are radially flexible so as to be compressible radially inward, and when no external force is acting on them, they are biased to expand outward into a substantially conical shape having the maximum diameter of each compressible jaw portion 526 at its proximal end 528. Each compressible jaw portion 526 includes a radially inward gripping surface configured to frictionally and / or mechanically engage with the outer surface of the corresponding tube 514. Each hole 520 extends tapered so that the maximum diameter of each hole 520 is at its distal end 521, and the diameter of each hole 520 gradually decreases over at least a portion of its length as it moves proximally from its distal end 521.

[0072] When a user of system 500 wishes to finally deploy the clip 502 that has been clipped onto the target tissue as desired, the user pulls the flexible member 512 proximal (for example, using an actuator coupled to a handle similar to the handle 124) and pulls each compressible jaw 526 proximal to the corresponding hole 520. As the user further pulls the flexible member 512 proximal, the tapering diameter of the hole 520 compresses the compressible jaw 526 until its gripping surface engages with the outer surface of the tube 514, locking the tube 414 in place.

[0073] Subsequently, the user applies tension to the control wire 516 until a predetermined tension is reached that separates the connection between the control wire 516 and the clip 502 (for example, by breaking the control wire 516 and leaving its expanded distal end 518 attached to the clip 502). Thus, the clip 502 is deployed in substantially the same manner as described above with respect to clips 102, 202, 302 and 402 (including the movement of the clip 502 between the insertion configuration, initial deployment configuration, examination configuration and final deployment configuration described above). The user can then push the flexible member 512 distally to disengage the compressible jaw portion 526 from the tube 514. The tube 514 can then be removed proximal to the adapter 510, the flexible member 512 and the system 500 can be removed from the patient's body, leaving the clip 502 clipped to the target tissue and in place.

[0074] As shown in Figures 14 to 16, the clipping system 600 for treating tissue defects and / or perforations according to an exemplary embodiment includes, for example, a clip (not shown) of substantially the same design as in the above-described embodiment, which is inserted through a body lumen to a target area and configured to clip the target tissue. The clip of system 600 is insertable into the target area via an insertion device, for example, an endoscope 606, as described above. The clip is coupled to the distal end 608 of the endoscope 606 via an adapter 610 which is mounted on the distal end 608 of the endoscope 606 (for example, by friction fitting, similar to the adapter in the above-described embodiment).

[0075] The adapter 610 in this embodiment is sized and shaped to precisely match the profile of the endoscope 606, is hollow, and defines a central channel within it that leads to, for example, the working channel and visual system of the endoscope 606 (terminating, for example, on the distal surface of the endoscope as described above). The clip is configured to move relative to the adapter 610 and the endoscope 606 via a flexible member 612, each of which slidably houses a tube 614, and control wires 616 are slidably received within each tube 614, as described above in the previous embodiment.

[0076] The clip of this embodiment is similarly movable from the insertion configuration to the initial deployment configuration and from the initial deployment configuration to the examination configuration by moving the tube 614 within the flexible member 612. If the user desires, the clip of this embodiment may also be moved again from the examination configuration to the insertion configuration, and then moved again to the initial deployment configuration in the new position as described above. Once the user is satisfied that the clip of this embodiment is positioned as desired, the clip may be moved from the initial deployment configuration to the final deployment configuration in which the clip is separated from the control wire 616 and the rest of the system 600, the rest of the system 600 is removed from the body, but the clip may be left in place clipped onto the desired tissue.

[0077] As shown in Figure 15, the flexible member 612 and the tube 614 housed therein extend distally from the handle 624 and are coupled to a spool 626 slidably attached to the body 628 of the handle 624. The control wire 616 in this embodiment interfaces with the proximal and distal sections in the lumen of the tube 114 and may include, for example, the same or similar mechanism, including a first crimp and a second crimp to ensure that the movement of the control wire relative to the adapter 610 results in the corresponding movement of the tube 614, as described above with respect to the system 100.

[0078] As shown in Figure 14, the flexible member 612 is configured to extend distally along the outer surface of the endoscope 606 to the distal end 613 adjacent to the proximal end 611 of the adapter 610 when the system 600 is assembled with the endoscope 606. Each tube 614 extends distally from the distal end 613 of the corresponding flexible member 612 and passes through the adapter 610. The system 600 further includes a locking mechanism for selectively locking the tubes 614 to prevent proximal movement (relative to the adapter 610 and the flexible member 612), the locking mechanism including a pair of leaf springs 630, each coupled to a corresponding distal end 613 of the flexible member 612.

[0079] Each leaf spring 630 in this embodiment extends distally from the radially outer portion of the corresponding flexible member 612 and overlaps the corresponding opening 620 of the adapter 610. Each leaf spring 630 includes a distal end 632 that protrudes through the corresponding opening 620 and engages with the corresponding tube 614. Similar to the tube 114 of the system 100 described above, each tube 614 includes a recess 634 configured to lockingly engage with the distal end 632 of the corresponding leaf spring 630 when the recess 634 is aligned with the corresponding opening 620.

[0080] That is, as the tube 614 advances distally from the flexible member 612 and is retracted proximally into the flexible member 612, the natural biasing of each leaf spring causes its distal end 632 to contact the corresponding tube 614 through the corresponding opening 620. Thus, as the tube 614 is moved proximally and distally through the adapter 610, the distal end 632 moves along the outer surface of the distal section 617 of the tube 614. When the user wishes to finally deploy the clip (for example, when the user determines that the clip has been clipped onto the target tissue as desired), the user advances the tube 614 distally from the flexible member 612 until the recess 634 aligns with the opening 620. At this point, the biasing of the leaf spring 630 pushes its distal end 632 into the recess 634, locking the tube 614 from moving proximally relative to the adapter 610 and the tube 614, as described above with respect to the tube 114.

[0081] Subsequently, the user can separate the clip of this embodiment from the control wire 616, tube 614, and the rest of the system 600 (for example, by pulling the control wire 616 proximally while the locked tube 614 provides a distal force that ultimately increases the level of tension applied to the fragile link, separating the control wire from the clip), and finally deploy the clip as described above. At this point, the clip is completely separated from the rest of the system 600, and the user can remove the tube 614 into the flexible member 612 by unlocking the tube 614 in order to remove the system 600 from the patient's body.

[0082] To do this, the user rotates a knob 642 on the handle 624 to pull a pair of tension members 640 proximal. In this embodiment, each tension member 640 extends distally from the handle 624 to form a loop around a corresponding one of the leaf springs 630. Thus, pulling the tension member 640 proximal pulls the leaf spring 630, pulling the distal end 632 so as to disengage from the tube 614, which can then be pulled proximal into the flexible member 612.

[0083] As shown in detail in Figure 16, the tube 614 of this embodiment includes a proximal section 615 and a distal section 617 formed as a coil of a flexible material (e.g., a stainless steel coil). The proximal section 615 of this embodiment is joined to the distal section 617 via a reduced-diameter section 619 formed by a cylinder having an outer diameter smaller than the outer diameters of the respective proximal section 615 and distal section 617. Thus, the reduced-diameter section 619 forms a recess 634 for each tube 614. Those skilled in the art will understand that a similar structure may be used for the tube of any of the embodiments described above, wherein the tube includes a recess configured to engage with a locking mechanism and lock the position of the tube relative to the adapter and / or flexible member.

[0084] It will be apparent to those skilled in the art that various modifications to this disclosure can be made without departing from the scope of this disclosure. Furthermore, those skilled in the art will understand that features of any of the various embodiments can be combined in any way that does not contradict the description and / or function of the embodiments.

Claims

1. It is a system for clipping organizations, An adapter comprising a proximal portion configured to be attached to the distal end of an insertion device, and a distal portion extending distally from the proximal portion, A clip configured to be attached to the distal portion of the adapter, comprising first and second jaws, the first and second jaws being configured to move between an insertion configuration extending around the adapter and separated from each other to receive tissue between the first and second jaws, and an initial deployment configuration which moves distally away from the adapter so that the first and second jaws are drawn toward each other to grasp the tissue received between the first and second jaws, A first extension member, which is releasably coupled to the clip and movably connected to the adapter, the first extension member extending from a proximal portion configured to remain outside the patient's body in the operating configuration to a distal portion configured to be coupled to the distal end of the insertion device, A first control wire slidably received within the first extension member and extending to a distal end, wherein the distal end is releasably coupled to the clip via a first releasable link configured to release when the first control wire is subjected to a force exceeding a predetermined threshold, A first locking mechanism is configured to selectively lock the distal portion of the first extension member so that it does not move proximal to the adapter while the first releaseable link is being released. A system that includes this.

2. The system according to claim 1, wherein the first extension member includes a recess, and the first locking mechanism includes a locking member configured to enter the recess of the first extension member when the first extension member is moved distally to a locked position.

3. The system according to claim 1 or 2, wherein the first locking mechanism includes a first biasing member that abuts against the first locking member, the first biasing member biases the locking member to press against the first extension member, and thereby, when the first extension member is moved to the locked position, the first biasing member pushes the first locking member into the recess of the first extension member.

4. The system according to claim 3, wherein the first biasing member includes an elastic member that at least partially surrounds the adapter, the adapter includes a first opening, and the first extension member extends slidably through the first opening.

5. The system according to claim 3, wherein the first biasing member includes a first leaf spring.

6. The device further includes a first flexible member that remains outside the patient's body during use and extends from a proximal end accessible to the user to a distal end adjacent to the adapter, The system according to claim 5, wherein the first leaf spring extends from a proximal end coupled to the first flexible member to a distal end forming the locking member.

7. The system according to claim 6, wherein the distal end of the first leaf spring is configured to lock the first flexible member so that it does not move proximal to the adapter via frictional engagement with the outer surface of the first extension member.

8. The system according to claim 3, further comprising a first tensioning member that remains outside the patient's body during use and extends from a proximal end accessible to the user to a distal end coupled to the first biasing member, wherein tension applied to the first tensioning member pulls the first biasing member, disengaging it from the first extension member and releasing the first extension member so that it moves proximal to the adapter.

9. The system according to any one of claims 1 to 8, wherein the first locking mechanism includes a first locking member fixed to the adapter and a second locking member slidably mounted on the adapter, the first locking member defining a first lumen into which the first extension member is slidably received, and the second locking member defining a second lumen into which the first extension member is slidably received, and the first and second lumens are configured such that when the second locking member is moved to the locked position, a portion of the first locking member received in the second lumen presses and compresses a portion of the second lumen against the first extension member.

10. The system according to claim 9, wherein the first locking member is fixed to the adapter and includes a collet clevis having a substantially conical outer surface that extends radially outward from the distal end of the reduced diameter, and the second lumen tapers radially inward from the proximal end of the enlarged diameter, thereby the system further includes a tensioning member coupled to the collet clevis, thereby allowing the collet clevis to be pulled proximal over the collet and pressing the radial inner surface of the collet clevis radially inward against the first extension member.

11. The adapter includes a first tapered opening into which the first extension member is received, the first tapered opening having a diameter that gradually decreases from a first diameter at the proximal end of the first tapered opening to a reduced second diameter distal to the proximal end, the first locking mechanism includes a first compressible member fixed to the first extension member, the first compressible member having an expanded configuration that extends radially outward from a distal end fixed to the outer surface of the first extension member to a radially expanded proximal end having a diameter larger than the reduced second diameter of the first tapered opening, The system according to any one of claims 1 to 10, wherein a first compressible member is compressible into a reduced diameter configuration such that it is substantially pressed against the outer surface of the first extendable member, the first compressible member is configured to compress as it passes through the first tapered opening, and to expand under bias as the proximal end of the first compressible member moves distally out of the first tapered opening, thereby preventing the first compressible member from moving proximal to the first tapered opening.

12. The system according to any one of claims 1 to 11, wherein the adapter includes a second tapered opening into which the first extension member is received, the second tapered opening having a diameter that gradually decreases from a first diameter distal to the second tapered opening to a reduced second diameter proximal to the distal, the first locking mechanism includes a first gripping member slidably received within the second tapered opening, the first gripping member including a radial inner surface configured to grip the first extension member, and the first gripping member is compressible into a reduced diameter configuration that substantially presses against the outer surface of the first extendable member to lock the position of the first extendable member relative to the adapter, and the first gripping member is expandable into an expanded configuration that expands radially outward to allow the first extendable member to slide through the first gripping member.

13. The system according to claim 12, wherein the first gripping member is coupled to a control member, the control member is operable to move the first gripping member proximal to the second tapered opening, and when the first gripping member is moved proximal to the second tapered opening, the radial inner surface of the first gripping member is pressed against the first extendable member.

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