REPOSITABLE CLIP HAVING SYMMETRIC OPENING FORCE - Patent application

Abstract

The clipping system includes an adapter and a clip. The proximal portion of the adapter extends along a first longitudinal axis. The distal portion of the adapter includes a cylindrical portion extending along a second longitudinal axis generally perpendicular to the first longitudinal axis. The clip includes first and second pairs of arms and first and second jaws. The proximal ends of the first pair of arms are connected by a first hinge. The proximal ends of the second pair of arms are connected by a second hinge. The first jaw extends between a distal end of a first arm of the first pair of arms and a distal end of a first arm of the second pair of arms. The second jaw extends between a distal end of a second arm of the first pair of arms and a distal end of a second arm of the second pair of arms such that the first and second jaws are mutually movable between an open configuration and a closed configuration.

Description

[Technical Field]

[0001] The present disclosure relates to an endoscopic device, and more particularly to an endoscopic clipping device for treating tissue, for example, along the gastrointestinal tract. This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 508,372, filed June 15, 2023, the disclosure of which is incorporated herein by reference. [Background technology]

[0002] Physicians are increasingly performing aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures that may increase the risk of perforating the wall of the GI tract or may require closure of openings in the GI tract wall as part of the procedure. Such procedures may include, for example, removal of large lesions, tunneling under the mucosal layer of the GI tract to treat submucosal problems, full-thickness removal of tissue, treatment of organs outside the GI tract using instruments inserted into and withdrawn out of the GI tract through openings made in the GI tract wall, and endoscopic treatment / repair of post-operative problems (e.g., post-operative leaks, broken surgical staple lines, and anastomotic leaks).

[0003] Currently, tissue can be treated with endoscopic closure devices, including through-the-scope clips or over-the-scope clips. Over-the-scope clips can be particularly useful for achieving closure of larger tissue defects. However, in some cases, current endoscopic closure devices can be difficult to use, time-consuming to deploy, or inadequate for certain perforations, conditions, and anatomy. For example, current over-the-scope clips are generally deployed from a position where the clip itself is not visible to the operator. That is, the operator visualizes the target tissue to be clipped prior to clipping and, based on this visualization of the target tissue, can determine that the distal end of the device and the clip are in the desired position relative to the target tissue. The operator then deploys the clip based on this observation of the target tissue, but cannot see the clip itself until it is deployed. And, once deployed, such current over-the-scope clips generally cannot be repositioned. Summary of the Invention

[0004] The present disclosure relates to a clipping system for treating tissue. The system includes an adapter and a clip. The adapter includes a proximal portion and a distal portion. The proximal portion extends along a first longitudinal axis and is configured to be attachable to a distal end of an insertion device such that the first longitudinal axis coincides with a longitudinal axis of the insertion device. The distal portion includes a longitudinally chamfered cylindrical portion extending along a second longitudinal axis extending generally perpendicular to the first longitudinal axis.

[0005] The clip includes a first pair of arms, the proximal ends of which are connected to one another by a first hinge. The clip also includes a second pair of arms, the proximal ends of which are connected to one another by a second hinge. The clip also includes first and second jaws. The first jaw extends between a distal end of a first arm of the first pair of arms and a distal end of a first arm of the second pair of arms. The second jaw extends between a distal end of a second arm of the first pair of arms and a distal end of a second arm of the second pair of arms. The first and second jaws are thereby movable relative to one another between an open configuration in which they are attached to the distal portion of the adapter and moved away from one another, and a closed configuration in which they are moved toward one another and away from the adapter.

[0006] In one embodiment, each of the first and second pairs of arms is formed from a single piece of material bent to form an open ring shape with the first and second hinges at the proximal ends of the first and second pairs of arms, the first and second hinges biasing the clip toward a closed configuration.

[0007] In one embodiment, each of the first and second hinges is connected to a proximal end of a corresponding one of the first and second pairs of arms via a waisted portion formed by an inwardly bent portion of the single piece of material.

[0008] In one embodiment, each of the first and second hinges includes a yoke received therein, the yoke configured to releasably engage a pull wire for actuating the clip between the open and closed configurations.

[0009] In one embodiment, each yoke includes a proximal portion including a cavity configured to releasably receive an enlarged end of the pull wire, the proximal opening of the cavity configured to deform when subjected to a force exceeding a predetermined threshold force, thereby enabling the enlarged end of the pull wire to be released from the proximal opening.

[0010] In one embodiment, the proximal opening includes at least one slit extending therearound, the at least one slit configured to deform the proximal opening when subjected to a force exceeding the predetermined threshold force, thereby increasing the size of the proximal opening and enabling the enlarged end of the pull wire to be released from the proximal opening.

[0011] In one embodiment, each yoke includes a flared distal portion configured and sized to couple with a proximal end of a corresponding one of the first and second pairs of arms to assist in movement of the clip from the closed configuration to the open configuration to reduce stress on the first and second hinges.

[0012] In one embodiment, a proximal end of the proximal portion of the adapter includes a flange having a pair of openings therethrough that align with flat ends of the chamfered cylindrical portion of the distal portion and are configured to slidably receive pull wires within the pair of openings such that the first and second pairs of arms slide along the flat ends to move the clip relative to the adapter between the open and closed configurations.

[0013] The present disclosure also relates to a clipping system for treating tissue, the system including an endoscope, an adapter, a clip, and first and second pull wires. The endoscope includes a shaft extending longitudinally from a proximal end to a distal end. The adapter includes a proximal portion extending along a first longitudinal axis and attached to the distal end of the shaft so that the first longitudinal axis is coaxial with the longitudinal axis of the shaft, a distal portion including a longitudinally chamfered cylindrical portion extending along a second longitudinal axis generally perpendicular to the first longitudinal axis, and a channel extending through the proximal and distal portions along the first longitudinal axis.

[0014] The clip includes a first pair of arms, the proximal ends of which are connected to one another by a first hinge. The clip also includes a second pair of arms, the proximal ends of which are connected to one another by a second hinge. The clip also includes first and second jaws. The first jaw extends between a distal end of a first arm of the first pair of arms and a distal end of a first arm of the second pair of arms. The second jaw extends between a distal end of a second arm of the first pair of arms and a distal end of a second arm of the second pair of arms. The first and second jaws are thereby movable relative to one another between an open configuration in which they are attached to the distal portion of the adapter and moved away from one another, and a closed configuration in which they are moved toward one another and away from the adapter.

[0015] The first and second pull wires are connected to the first and second hinges, respectively, via yokes housed within the first and second hinges, and the first and second pull wires are releasably coupled to the yokes and are longitudinally slidable relative to the endoscope to move the clip between the open configuration, an initial deployed configuration in which the clip is positioned in the closed configuration just distal to the adapter, and a review configuration in which the clip is moved distally away from the distal end of the endoscope while remaining tethered to the endoscope by the first and second pull wires.

[0016] In one embodiment, each of the first and second pairs of arms is formed from a single piece of material bent to form an open ring shape with the first and second hinges at the proximal ends of the first and second pairs of arms, the first and second hinges biasing the clip toward a closed configuration.

[0017] In one embodiment, each of the first and second hinges is connected to a proximal end of a corresponding one of the first and second pairs of arms via a waisted portion formed by an inwardly bent portion of the single piece of material.

[0018] In one embodiment, each of the yokes includes a proximal portion sized and shaped to be received within a corresponding one of the first and second hinges, and a distal portion sized and shaped to couple with a proximal end of a corresponding one of the first and second pairs of arms.

[0019] In one embodiment, a distal portion of the yoke has a flared shape such that when the yoke is moved proximally relative to the clip, the flared distal portion slides proximally along the proximal ends of the first and second pairs of arms, facilitating movement of the clip from the closed configuration to the open configuration.

[0020] In one embodiment, each of the first and second pull wires includes an enlarged distal end that is releasably received within a cavity of a corresponding size and shape within the proximal portion of the corresponding yoke, the proximal opening of the cavity being configured to deform when subjected to a force exceeding a predetermined threshold force to allow proximal passage of the enlarged distal end through the proximal opening.

[0021] In one embodiment, the system further includes first and second tubular deployment members configured to slidably receive the first and second pull wires therein, each of the first and second tubular deployment members being longitudinally movable relative to the endoscope such that distal ends of the first and second tubular deployment members are positionable relative to the first and second hinges, respectively, during final deployment of the clip, and the clip is held in position when the first and second pull wires are pulled proximally relative to the clip to exert the predetermined threshold force on a yoke.

[0022] The present disclosure also relates to a method for treating tissue, including inserting a clip into a target area in a body lumen via an endoscope. The clip is attached to the distal end of an endoscope shaft via an adapter in an open insertion configuration. In the open insertion configuration, first and second jaws of the clip extend away from each other over a curved surface of the distal portion of the adapter. The adapter includes a proximal portion attached to the distal end of the shaft. The proximal portion extends along a first longitudinal axis and is attached to the distal end of the shaft so that the first longitudinal axis is coaxial with the longitudinal axis of the shaft. The distal portion includes a longitudinally chamfered cylindrical portion extending along a second longitudinal axis generally perpendicular to the first longitudinal axis. The method includes applying suction through a working channel of the endoscope such that tissue is drawn into a channel of the adapter extending along the first longitudinal axis and between the first and second jaws of the clip. The method also includes actuating the clip from the open insertion configuration to an initial deployed configuration by releasing tension along a pullwire releasably coupled to the clip. The clip includes a first pair of arms and a second pair of arms, the proximal ends of the first pair of arms being connected to one another by a first hinge and the proximal ends of the second pair of arms being connected to one another by a second hinge. The first jaw extends between a distal end of a first arm of the first pair of arms and a distal end of a first arm of the second pair of arms, and the second jaw extends between a distal end of a second arm of the first pair of arms and a distal end of a second arm of the second pair of arms, such that the first and second jaws are movable relative to one another between the open insertion configuration and the initial deployed configuration. In the initial deployed configuration, the clip is moved distally from the distal portion of the adapter, causing the first and second jaws to return to a biased closed configuration to grasp tissue therebetween.

[0023] In one embodiment, the method further includes operating the clip toward a review configuration in which the endoscope is retracted proximally away from the clip to increase the view of the clip through the endoscope's vision system, while the clip remains tethered to the endoscope by the pull wire.

[0024] In one embodiment, the pull wire is connected to the first and second hinges via a yoke received within the first and second hinges, respectively, and the pull wire is releasably coupled to the yoke and longitudinally slidable relative to the endoscope to move the clip between the open insertion configuration, the initial deployment configuration, and the review configuration.

[0025] In one embodiment, if it is determined that repositioning of the clip is necessary, moving the endoscope distally relative to the clip and pulling the pull wire proximally relative to the endoscope causes the flared distal portion of the yoke to couple with the proximal ends of the first and second pairs of arms, reducing stress on the first and second hinges by assisting in moving the clip from the biased closed configuration to the open insertion configuration as the clip is pulled proximally on the distal portion of the adapter.

[0026] In one embodiment, the method further includes finally deploying the closed clip by sliding the tubular deployment member distally over the pull wire until a distal end of the tubular deployment member is positioned against the first and second hinges to hold the clip in place when the pull wire is pulled proximally relative to the first and second hinges, applying a predetermined threshold force to the yoke, thereby disengaging the pull wire from the yoke and the clip. [Brief explanation of the drawings]

[0027] [Figure 1]FIG. 1 illustrates a perspective view of a distal portion of a clipping system according to an exemplary embodiment of the present disclosure, with the clip in an open insertion configuration. [Figure 2] FIG. 2 shows a perspective view of the distal portion of the clipping system of FIG. 1 when the clip is in the review position. [Figure 3] FIG. 3 illustrates a perspective view of an adapter according to the exemplary clipping system of FIG. [Figure 4] FIG. 4 illustrates a perspective view of a clip in a biased closed configuration according to the exemplary clipping system of FIG. [Figure 5] FIG. 5 illustrates a side view of the yoke and pull wires according to the exemplary clipping system of FIG. [Figure 6] FIG. 6 illustrates a side view of the yoke and pull wire from the exemplary clipping system of FIG. 1 as the pull wire is released from the yoke. [Figure 7] FIG. 7 shows a plan view of a proximal opening of a yoke according to a further exemplary embodiment of the present disclosure. [Figure 8] FIG. 8 shows a perspective view of a portion of the exemplary clipping system of FIG. 1 during clip deployment. [Figure 9] FIG. 9 shows a perspective view of the distal portion of the exemplary clipping system of FIG. 1 with the clip in a final deployed state. [Figure 10] FIG. 10 illustrates a side view of a user interface according to the exemplary clipping system of FIG. DETAILED DESCRIPTION OF THE INVENTION

[0028] The present disclosure may be further understood with reference to the following description and the accompanying drawings, in which like elements are referred to with the same reference numerals. The present disclosure relates to a clipping system, and more particularly to an over-the-scope endoscopic clipping system that allows for viewing and adjusting the initial placement of a clip prior to its final deployment. An exemplary embodiment of the present disclosure includes a clip attachable to the distal end of a scoping device via an adapter and releasably coupled to first and second pull wires, the clip operable between an insertion position, an initial deployment position, and a review position that allows viewing of the clip before final deployment.

[0029] In an exemplary embodiment, the clip includes a first pair of arms and a second pair of arms, the proximal ends of the first pair of arms connected to one another by a first hinge and the proximal ends of the second pair of arms connected to one another by a second hinge, a first jaw extending between a distal end of a first arm of the first pair of arms and a distal end of a first arm of the second pair of arms, and a second jaw extending between a distal end of a second arm of the first pair of arms and a distal end of a second arm of the second pair of arms, such that the first and second jaws are movable relative to one another between an open configuration in which they are spaced apart to receive tissue therebetween and a closed configuration in which they are brought together to grasp tissue. The first pull wire is connected to the first hinge via a first yoke, while the second pull wire is connected to the second hinge via a second yoke, and the first and second yokes are configured to reduce stress acting on the first and second hinges when the clip moves between an open configuration and a closed configuration.

[0030] When positioned for insertion into the body, the clip is mounted on the adapter in an open configuration with the first and second jaws of the clip spaced apart, thereby preparing the clip to receive tissue between the first and second jaws. The insertion position is configured to facilitate insertion of a scoping device (e.g., along a tortuous path through a body lumen) to a target site adjacent the tissue to be clipped. Once the clip is inserted into the target site, tissue can be drawn into the adapter (e.g., under suction or a grasper applied through the working channel of the endoscope) so that it is received between the first and second jaws. The clip can then be moved distally on the adapter so that the first and second jaws move toward each other (to a closed configuration) to grasp the tissue in the initial deployed configuration. The system then allows the scoping device to be withdrawn proximally away from the clip to a review configuration, with the clip remaining coupled to the scoping device via the pull wire.

[0031] When the scoping device is withdrawn proximally while the clip is clipped onto the tissue, the field of view of the scoping device's visual system expands to show the clip and the tissue clipped by the clip, allowing the operator to determine whether the clip's position relative to the target tissue is desired or whether adjustment is needed. Once the operator determines that the clip is positioned as desired, the clip is finally deployed and clipped onto the target tissue, leaving it in place. If the operator determines that the clip's position needs to be adjusted, the scoping device is moved distally to a position adjacent the clip. The clip is then reopened by pulling it proximally on the adapter. This reopening is accomplished by pulling the clip proximally on the distal end of the adapter, causing the clip to open against its own bias as it slides proximally back onto the adapter, removing it from the tissue and returning to the insertion configuration.

[0032] After the clip has been removed from the tissue and returned to the insertion configuration, the operator can, if desired, reposition the distal end of the scoping device, retract a new target portion of tissue into the adapter, and once again move the clip distally from the adapter, causing the clip to return to its initial deployed position and close on the new portion of target tissue. The scoping device is then withdrawn proximally to the review position while the clip remains coupled to the scoping device. The position of the clip and clipped tissue is then again observed, and this process can be repeated until the clip is positioned in the desired location. Once the operator determines that the tissue around which the clip is closed is the desired portion of tissue, the clip can be fully deployed and released from the scoping device, as described below. Those skilled in the art will understand that the terms proximal and distal, as used herein, are intended to refer to directions toward (proximal) and away from (distal), respectively, the user of the device.

[0033] 1-10 , a clipping system 100 for treating tissue defects and / or perforations according to an exemplary embodiment includes a clip 102 configured to be mountable onto the distal end 106 of a scoping device 104 via an adapter 108 removably coupled to the distal end 106 of the scoping device 104. The clip 102 is movable relative to the adapter 108 between an insertion position in which the clip 102 is mounted on the adapter 108 in an open configuration in which the first and second jaws 110, 112 are spaced apart to receive tissue therebetween, and an initial deployed position in which the clip 102 is moved distally relative to the adapter 108 in which the first and second jaws 110, 112 close to grasp tissue therebetween.

[0034] The clip 102 is releasably coupled to a pair of pull wires 114 via a yoke 166 received within the first and second hinges 146, 152 of the clip 102, thereby reducing stress on the first and second hinges 146, 152 during movement of the clip 102 between the open and closed positions. The pull wires 114 also allow the scoping device 104 to be retracted proximally away from the closed clip 102 to a review position, while the clip 102 remains tethered to the scoping device 104. In this review position, the field of view of the scoping vision system is expanded, allowing a user of the system 100 (e.g., a surgeon) to view and confirm whether the clip 102 has clipped onto the target tissue, if desired.

[0035] As explained in further detail below, if the user determines that the position of the clip 102 relative to the target tissue is incorrect or suboptimal, the user may move the scoping device 104 distally relative to the clip 102 and retract the clip 102 proximally on the adapter 108 to reopen the clip 102 (separating the first and second jaws 110, 112) and release the clip 102 from the previously clipped tissue. The user then repositions the clip 102 relative to the target tissue and draws a new portion of tissue into the adapter 108. The user then moves the clip 102 distally off the adapter 108, returning the clip 102 to its initial deployment position clipped onto that new portion of tissue, and then withdraws the scoping device 104 proximally away from the clip 102 to a review position, repeating these steps until the target tissue is clipped as desired. Then, once the user is satisfied that the clip 102 is clipped onto the target tissue as desired, the clip is finally deployed, separating the clip 102 from the rest of the clipping system 100 .

[0036] As shown in FIGS. 1 and 2 , the clip 102 can be attached to the distal end of any standard scoping device 104, such as an endoscope, via an adapter 108. The adapter 108 is sized and shaped to fit onto the distal end 106 of a shaft 118 (e.g., an endoscope shaft) of the scoping device 104. As will be appreciated by those skilled in the art, the shaft 118 of the scoping device 104 is configured to be insertable through a body lumen to a target site within that lumen and should be sufficiently flexible to be able to navigate even the tortuous paths of the body lumen. However, as will be appreciated by those skilled in the art, the adapter 108 can be sized and shaped to fit onto the distal end of any insertion device (flexible or rigid) suitable for accessing the target site within the body where the tissue to be clipped is located. The proximal end 186 of the shaft 118 in this embodiment is connected to a handle member 190 of a user interface 188 that can be used by a physician or other user to guide a flexible endoscope, for example, through a body lumen (e.g., the gastrointestinal tract) to a target site adjacent the target tissue to be clipped, as described in further detail below. The user interface 188 also facilitates movement of the clip 102 between the insertion position, the initial deployment position, the review position, and the final deployment position.

[0037] 1-3 , the adapter 108 includes a proximal portion 120 configured to be mountable onto the distal end 106 of the shaft 118 and a distal portion 122 configured to receive the clip 102 in an open insertion configuration. The proximal portion 120 may be generally tubular extending from a proximal end 124 to a distal end 126. The proximal portion 120 may be configured to be mountable onto the distal end 106 of the scoping device 104, for example, by a friction fit. The longitudinal axis 1L of the proximal portion 120 is configured to coincide with the longitudinal axis of the shaft 118 when the adapter 108 is mounted on the shaft 118. The proximal end 124 of the proximal portion 120 includes a flange 128 having a pair of openings 130 extending therethrough. As described in more detail below, each of the pair of openings 130 is configured to connect to a corresponding one of a pair of outer sheaths 132 or outer coils through which the pull wire 114 and tubular deployment member 116 can be received. In the exemplary embodiment, the openings 130 extend through diametrically opposed portions of the flange 128.

[0038] In the illustrative embodiment, the distal portion 122 of the adapter 108 is configured as a right cylinder 134 (e.g., having an end face 135 extending generally perpendicular to its longitudinal axis 2L) and has a longitudinal truncation 136 (i.e., a chamfer extending along the length of the cylinder 134 generally parallel to its longitudinal axis 2L). The longitudinal axis 2L of the cylinder 134 extends generally perpendicular to the longitudinal axis 1L of the proximal portion 120 such that the longitudinal truncation is located at a distal end 138 of the distal portion 122. A channel 140 extends through both the proximal and distal portions 120, 122 of the adapter 108, allowing tissue to be drawn into the adapter 108 via, for example, a tissue grasper and / or suction force applied through or passing through a working channel of the shaft 118. In the exemplary embodiment, the longitudinal chamfer 136 penetrates the cylinder 134 at a distal point beyond the diameter of the cylinder 134 such that the width of the longitudinal chamfer 136 (e.g., the distance between the longitudinal ends 137 of the longitudinal chamfer 136) is less than the diameter of the cylinder 134.

[0039] In the exemplary embodiment, opening 130 through flange 128 is aligned with end face 135 of distal portion 122 of adapter 108, thereby allowing first and second pairs of arms 142, 148 to extend along end face 135, as described in further detail below. In the exemplary embodiment, adapter 108 is formed from a transparent material to enhance visibility with an endoscopic vision system.

[0040] 4 , clip 102 includes a first pair of arms 142 and a second pair of arms 148, with proximal ends 144 of first pair of arms 142 connected to one another by a first hinge 146 and proximal ends 150 of second pair of arms 148 connected to one another by a second hinge 152. First jaw 110 extends between a distal end 154 of a first arm of first pair of arms 142 and a distal end 156 of a first arm of second pair of arms 148, and second jaw 112 extends between a distal end 154 of a second arm of first pair of arms 142 and a distal end 156 of a second arm of second pair of arms 148. Thus, the first and second jaws 110, 112 are movable between an open configuration in which the first and second jaws 110, 112 are moved away from each other and a closed configuration in which the first and second jaws 110, 112 are moved toward each other by the function of the first and second hinges 146, 152.

[0041] In the exemplary embodiment, each of the first and second hinges 146, 152 is spring-biased such that the first and second jaws 110, 112 are biased toward the closed configuration. However, when the clip 102 is loaded onto the adapter 108 in the insertion configuration, the first and second jaws 110, 112 are stretched over opposing portions of the distal portion 122 of the adapter 108, such that the outer surfaces of the first and second jaws 110, 112 maintain the clip 102 open with the first and second jaws 110, 112 spaced apart from one another so that target tissue can be received therebetween. As the clip 102 moves distally away from the adapter 108, the clip 102 closes under the bias of the first and second hinges 146, 152 themselves. It will be understood by those skilled in the art that portions of the clip 102, particularly the first and second hinges 146, 152, are sufficiently biased toward the closed configuration to maintain the clip 102 in a clipped position on the target tissue after the clip is finally deployed. In one embodiment, portions of the clip 102 (e.g., the first and second hinges 146, 152) are formed from a shape memory alloy, such as, for example, Nitinol, to provide and / or add to the bias toward the closed configuration.

[0042] Each of the first pair of arms 142 extends from a proximal end 144 to a distal end 154. The proximal ends 144 of the first pair of arms 142 are connected to one another by a first hinge 146 such that the distal ends 154 of the first pair of arms 142 are movable between an open configuration in which they are spaced apart and a closed configuration in which they are moved together. The first hinge 146 is configured to bias the first pair of arms 142 toward the closed configuration. In the exemplary embodiment, the first pair of arms 142 are formed from a single piece of material 143 configured in an open ring shape. In other words, each of the first and second arms 142 a, 142 b of the first pair of arms 142 is curved in a semicircular shape, with an opening extending between the distal ends 154 of the first pair of arms 142.

[0043] The first hinge 146 connecting the proximal ends 144 of the first and second arms 142 a, 142 b may be formed by bending the single piece of material 143 such that the first hinge 146 is formed by a rounded portion of the single piece of material 143. The first hinge 146 includes an opening 162 therethrough that is configured to have a size and shape to receive a portion of a corresponding one of the pull wires 114 therein. In an exemplary embodiment, such rounded first hinge 146 is connected to the first and second arms 142 a, 142 b of the first pair of arms 142 via a waisted portion 158 along which the spacing between opposing portions of the single piece of material 143 is smaller than the diameter of the first hinge 146. In one example, waisted portion 158 is defined by an inwardly curved portion of single piece of material 143. In another example, waisted portion 158 is formed by an inwardly sloping portion of single piece of material 143. Thus, proximal ends 144 of first and second arms 142 a, 142 b, waisted portion 158, and hourglass portion 145 of single piece of material 143 extending along first hinge 146 have a substantially hourglass shape.

[0044] Similarly, each of the second pair of arms 148 extends from a proximal end 150 to a distal end 156. The proximal ends 150 of the second pair of arms 148 are connected to one another by a second hinge 152 such that the distal ends 156 of the second pair of arms 148 are movable between an open configuration in which they are spaced apart and a closed configuration in which they are moved together. The second hinge 152 is configured to bias the second pair of arms 148 toward the closed configuration. In the exemplary embodiment, the second pair of arms 148 are formed from a single piece of material 149 configured in an open ring shape. In other words, each of the first and second arms 148 a, 148 b of the second pair of arms 148 is curved in a semicircular shape, with an opening extending between the distal ends 156 of the second pair of arms 148.

[0045] In the exemplary embodiment, second hinge 152 connecting proximal ends 150 of first and second arms 148 a, 148 b is formed by bending a single piece of material 149 such that second hinge 152 is formed by a rounded portion of the single piece of material 149. Second hinge 152 includes an opening 164 extending therethrough. This opening 164 is configured to have a size and shape to receive a portion of a corresponding one of pull wires 114 therein. In the exemplary embodiment, this rounded second hinge 152 is connected to first and second arms 148 a, 148 b via a waisted portion 160, along which the distance between opposing portions of single piece of material 149 is less than the diameter of rounded second hinge 152. In one example, waisted portion 160 is defined by an inwardly curved portion of single piece of material 149. In another example, waisted portion 160 is defined by an inwardly bent (i.e., slanted) portion of single piece of material 149. Thus, proximal ends 150 of first and second arms 148a, 148b of second pair of arms 148, waisted portion 160, and hourglass portion 151 of single piece of material 149 extending along second hinge 152 have a substantially hourglass shape.

[0046] As described above, the first jaw 110 extends between the distal end 154 of the first arm 142 a of the first pair of arms 142 and the distal end 156 of the first arm 148 a of the second pair of arms 148, and the second jaw 112 extends between the distal end 154 of the second arm 142 b of the first pair of arms 142 and the distal end 156 of the second arm 148 b of the second pair of arms 148. Each of the first jaw 110 and the second jaw 112 in this embodiment is curved so that when the clip 102 is mounted on the distal portion 122 of the adapter 108 in the open configuration, the first jaw 110 and the second jaw 112 have a shape that corresponds to the appearance of the distal portion 122. In the exemplary embodiment, each of the first and second jaws 110, 112 includes gripping structures, such as teeth 168, for grasping tissue therebetween. For example, the teeth 168 of the first jaw 110 extend toward the second jaw 112, and the teeth 168 of the second jaw 112 extend toward the first jaw 110.

[0047] Each of the hourglass portions 145, 151 of the first and second pairs of arms 142, 148 is configured to receive a correspondingly sized and shaped yoke 166 therein. In the exemplary embodiment, as shown in FIG. 4 , each yoke 166 has a rounded proximal portion 170 and a distal portion 172 that flares out toward a distal end 174 of the yoke 166, with the proximal and distal portions 170, 172 connected to one another via a waisted portion. The yoke 166 in this embodiment has a size and shape corresponding to the hourglass portions 145, 151 such that the proximal portion 170 is received within a corresponding one of the first and second hinges 146, 152 (as shown in FIGS. 1, 2, and 8 ) and retained via the hourglass portions 145, 151.

[0048] However, as one skilled in the art will appreciate, while the proximal portion 170 of the yoke 166 is retained within the first and second hinges 146, 152, longitudinal movement of the yoke 166 relative to the first and second pairs of arms 142, 148 assists in operating the clip 102 between the open and closed configurations and reduces stress on the first and second hinges 146, 152. In particular, as the yoke 166 moves distally relative to the first and second pairs of arms 142, 148, the rounded proximal portion 170 of the yoke 166 engages and / or slides along the proximal portions of the inwardly angled / curved portions 158, 160 such that the distal ends 154, 156 of the first and second pairs of arms 142, 148 move toward each other toward the closed configuration. As the yoke 166 moves proximally relative to the first and second pairs of arms 142, 148, the flared distal portion 172 engages and / or slides along the distal portions of the inwardly curved / sloped waist portions 158, 160 such that the first and second pairs of arms 142, 148 move toward the open configuration.

[0049] The rounded proximal portion 170 of each yoke 166 in this embodiment includes a cavity 176 formed therein. The cavity 176 is configured to have a size and shape to receive an enlarged distal end 178 (e.g., ball-shaped) of a corresponding one of the pull wires 114 therein. In particular, the enlarged end 178 of the pull wire 114 is received within the cavity 176 such that the remaining length of the pull wire 114 extends through a proximal opening 177 of the cavity 176 and a corresponding one of the openings 162, 164 of the first and second hinges 146, 152 to a user-accessible proximal end at the proximal end of the system 100.

[0050] In an exemplary embodiment, the yoke 166 is formed from a material such that when a force exceeding a predetermined threshold force is applied to the yoke 166 through the enlarged end 178, the proximal opening 177 deforms as shown in FIG. 6 to allow the enlarged end 178 to pass proximally during final deployment of the clip 102, as described in further detail below. In an exemplary embodiment, the yoke 166 is formed from a thermoplastic material, such as ABS, or a metallic material with a memory effect, such as Nitinol. In a further exemplary embodiment, as shown in FIG. 7, the proximal opening 277 in the cavity 276 of the yoke 166 includes one or more slits 267 extending therearound such that when a force exceeding a predetermined threshold force is applied to the slits 267, the one or more slits 267 deform, increasing the size of the proximal opening 277 and allowing the enlarged end of the pull wire to pass proximally therethrough.

[0051] As described above, movement of the clip 102 between the insertion position (i.e., open configuration), the initial deployment position (i.e., closed configuration), and the review position (e.g., with the scoping device and adapter 108 proximally spaced away from the clip 102 with the clip in a closed position) is achieved via pull wires 114. The pull wires 114 extend from an enlarged end 178, which is releasably coupled to the clip 102 via the yoke 166, to a proximal end (not shown) coupled to a user interface 188. Each pull wire 114 extends through a tubular deployment member 116, which extends along the length of the shaft 118 of the scoping device 104 such that the pull wires 114 are longitudinally slidable within the tubular deployment member 116. Each tubular deployment member 116 extends from a distal end 180, located proximal to a corresponding one of the first and second hinges 146, 152, to a proximal end accessible to and connected to the user interface 188. In an exemplary embodiment, tubular deployment member 116 is formed, for example, from a flexible strand, filament, or coil, for example, made of metal or polymer, as will be appreciated by those skilled in the art.

[0052] The pull wires 114 are slidably received within the tubular deployment members 116, which in turn are slidably received within the outer sheaths 132. In the exemplary embodiment, each outer sheath 132 extends from a distal end 182 that is received within and connected to a corresponding one of the openings 130 in the flanges 128 of the adapter 108, to a proximal end 184 that is fixedly attached to the handle member 190. In the exemplary embodiment, the outer sheaths 132 extend along diametrically opposed portions of the shaft 118 to be aligned with an end face 135 of the distal portion 122 of the adapter 108, as shown in FIGS. 1 and 2 , such that the first and second pairs of arms 142, 148 to which the pull wires 114 are releasably connected can extend and move along the end face 135 as the clip 102 moves between the open and closed configurations.

[0053] The outer sheath 132 of the exemplary embodiment is fixed relative to the shaft 118, such that as the pull wire 114 is longitudinally translated relative to the outer sheath 132, the pull wire 114 moves the clip 102 relative to the scoping device 104 between an insertion position, an initial deployed position, and a review position. In particular, when tension along the pull wire 114 is released, the clip 102's own bias moves the clip 102 from the insertion position toward the initial deployed position as the first and second jaws 110, 112 slide distally along the distal portion 122 of the adapter 108 from the open configuration toward the closed configuration. Thus, as the clip 102 moves from the insertion configuration toward the initial deployed configuration, the first and second jaws 110, 112 grasp tissue received within the channel 140 of the adapter 108.

[0054] Once the clip 102 is in this initial deployed configuration, the scoping device 104, while remaining tethered to the clip 102 by the pull wire 114, is withdrawn proximally relative to the clip 102 to a review configuration, increasing the distance between the clip 102 and the distal end 106 of the scoping device 104 and allowing the clip 102 to be more easily viewed through the optical system of the scoping device 104. If it is desired to adjust the position / location of the clip 102 during this review, the pull wire 114 is withdrawn proximally relative to the outer sheath 132, and the scoping device is moved distally until the clip 102 is retracted into contact with the adapter 108. The pull wire 114 is then further withdrawn proximally to pull the clip 102 onto the adapter 108, pulling the first and second jaws 110, 112 away from each other as they move over the curved surface of the distal portion 122 of the adapter 108, returning the clip 102 to the open configuration.

[0055] As described above, during movement of clip 102 from the closed configuration toward the open configuration by pulling clip 102 proximally on adapter 108, flared distal portion 172 of yoke 166 engages waisted portions 158, 160 of first and second pairs of arms 142, 148, thereby assisting movement of clip 102 from the closed configuration to the open configuration and reducing stress on first and second hinges 146, 152. The scoping device 104 and clip 102 can then be repositioned relative to the target tissue such that clip 102 can again be moved to the initial deployed position and then to the review position, as described above, to verify whether clip 102 has been clipped in the desired location on the target tissue.

[0056] According to one embodiment, when it is desired to release the clip 102 from the scoping device 104 (i.e., move the clip 102 to its final deployed configuration), the tubular deployment member 116 is moved distally relative to the scoping device 104 until the distal end 180 of the tubular deployment member 116 is positioned relative to the first and second hinges 146, 152, as shown in FIG. 8 . Holding the tubular deployment member 116 relative to the clip 102 retracts the pull wire 114 proximally relative to the tubular deployment member 116 (and clip 102) until the force exerted on the clip 102 exceeds a predetermined threshold force, which deforms the proximal opening 177 of the yoke 166 and allows the enlarged end 178 of the pull wire 114 to be withdrawn proximally from the yoke 166. Once the extension end 178 is released from the yoke 166, the extension end 178 is pulled proximally through the openings 162, 164 in the first and second hinges 146, 152, respectively, thereby releasing the clip 102 from the pull wire 114 and ultimately deploying the clip 102, as shown in FIG. 9.

[0057] The user interface 188 is configured to allow a user to actuate the clip 102 between an insertion position, an initial deployed position, a review position, and a final deployed position, as would be understood by one skilled in the art. As shown in FIG. 10 , the user interface 188 includes a handle member 190 connected to the proximal end 186 of the shaft 118 of the scoping device 104, a first actuator 192 configured to move the tubular deployment member 116 relative to the outer sheath 132 and shaft 118, and a second actuator 194 configured to move the pull wire 114 relative to the outer sheath 132 and shaft 118 of the scoping device 104. As described above, the proximal end 184 of the outer sheath 132 is fixedly attached to the handle member 190, and operation of each of the first and second actuators 192, 194 relative to the handle member 190 moves the tubular deployment member 116 and the pull wire 114, respectively.

[0058] In the exemplary embodiment, the first actuator 192 is configured as a spool rotatable relative to the handle member 190 to move the tubular deployment member 116 relative to the outer sheath 132. In particular, the proximal end of the tubular deployment member 116 is connected to the spool of the first actuator 192 such that, when the spool is rotated relative to the handle member 190, the tubular deployment member 116 is moved relative to the outer sheath 132. Rotating the first actuator 192 in a first direction moves the tubular deployment member 116 distally relative to the outer sheath 132 and scoping device 104, and rotating the first actuator 192 in a second direction moves the tubular deployment member 116 proximally relative to the outer sheath 132.

[0059] First actuator 192 further includes a locking mechanism, configured in the exemplary embodiment as a locking lever 196. When locking lever 196 is moved to the locked configuration, tubular deployment member 116 is locked in a desired position relative to outer sheath 132. For example, during final deployment of clip 102, tubular deployment member 116 may be locked in a position where its distal end 180 is positioned relative to first and second hinges 146, 152. Thus, tubular deployment member 116 holds clip 102 when pull wire 114 is retracted proximally relative to clip 102, releasing pull wire 114 from yoke 166 and clip 102.

[0060] In the exemplary embodiment, the second actuator 194 is similarly configured as a spool rotatable relative to the handle member 190. The proximal end of the pull wire 114 is connected to the spool, such that rotation of the spool of the second actuator 194 moves the pull wire 114 longitudinally relative to the outer sheath 132. In particular, rotation of the second actuator 194 in a first direction relative to the handle member 190 moves the pull wire distally relative to the outer sheath 132 and scoping device 104, and rotation of the second actuator 194 in a second direction relative to the handle member 190 moves the pull wire proximally relative to the outer sheath 132 and scoping device 104.

[0061] According to an exemplary method for tissue closure utilizing system 100, clip 102 may be inserted into a target site through a body lumen, such as the GI tract, with scoping device 104. As described above, clip 102 is mounted in an insertion position onto adapter 108 disposed on the distal end 106 of scoping device 104. In this insertion position, first and second jaws 110, 112 extend over a portion of adapter 108 so as to be spaced apart from one another in an open configuration. In this insertion position, clip 102 is guided to the target site with scoping device 104 and placed over a selected portion of the target tissue.

[0062] Upon reaching the target site, a user-selected portion of tissue is drawn into the channel 140 of the adapter 108 via a tissue grasper inserted through the working channel of the scoping device 104 and / or via suction applied through the working channel. The clip 102 is then actuated toward the initial deployed position by releasing tension along the pull wire 114 via the second actuator 194, thereby allowing the first and second pairs of arms 142, 148 to return to the biased closed configuration, closing the first and second jaws 110, 112 on the selected portion of tissue in the initial deployed position by moving toward each other as the first and second jaws 110, 112 move distally from the adapter 108. Thus, tissue received within the channel of the adapter 108 is grasped between the first and second jaws 110, 112.

[0063] After the user clips tissue between the first and second jaws 110, 112 in the initial deployed configuration, the scoping device 104 is pulled proximally relative to the clip 102 to move the clip 102 to the review configuration, increasing the distance between the clip 102 and the distal end 106 of the scoping device 104. This increases the user's field of view and allows them to more easily observe the placement of the clip 102 relative to the target tissue. As described above, in the review position, the clip 102 remains tethered to the scoping device 104 via the pull wire 114, so that if it is determined that adjustment and / or repositioning of the clip 102 is necessary, the scoping device 104 can be moved distally toward the clip 102, and the clip 102 can be pulled proximally on the adapter 108 via the pull wire 114 to move it back toward the open configuration.

[0064] The yoke 166 assists in the opening of the clip 110, reducing stress on the first and second hinges 146, 152 as the clip 102 is pulled back to the insertion configuration. The system 100 and clip 102 are then repositioned adjacent a new portion of target tissue, and the clip 102 is again moved to the initial deployed position to clip the newly captured tissue portion. The user then moves the system 100 to the review position to observe the placement of the clip 102 relative to the desired clipping location. This process can be repeated, if necessary, until the user visually confirms that the clip 102 has clipped onto the target tissue.

[0065] Once the user confirms that the target tissue has been clipped as desired, the clip 102 transitions from the review configuration to a final deployed configuration in which the clip 102 is released from the extension member, the pull wire 114, as shown in FIG. 9 . As described above, to release the clip 102, the tubular deployment member 116 is moved distally relative to the scoping device 104 (e.g., via a first actuator 192) until its distal end 180 abuts the first and second hinges 146, 152 of the clip 102. Once the tubular deployment member 116 is in position relative to the clip 102, the locking lever 196 can be used to lock the tubular deployment member 116 relative to the scoping device 104. This allows the pull wire 110 to be retracted proximally relative to the tubular deployment member 116 and clip 102 until the force applied to the clip 102 exceeds a predetermined threshold force, releasing the extended end 178 of the pull wire 114 from the yoke 166.

[0066] In the exemplary embodiment, during final deployment, the proximal opening 177 of the yoke 166 deforms to release the expanding end 178, thereby allowing the expanding end 178 to pass proximally through the openings 162, 164 of the first and second hinges 146, 152, respectively, disengaging the clip 102 from the remainder of the system 100 and the scoping device 104, leaving the finally deployed clip 102 clipped in position on the target tissue when the scoping device 104 and the remainder of the system 100 are removed from the body. As will be appreciated by those skilled in the art, the openings 162, 164 are sized and shaped to allow the passage of the expanding end 178 of the pull wire 114 while preventing passage distally of the distal end 180 of the tubular deployment member 116. Thus, upon release of the clip 102, the scoping device 104 and pull wire 114 can be removed from the body such that only the clip 102 remains clipped on the target tissue.

[0067] It will be apparent to those skilled in the art that various modifications can be made in the present disclosure without departing from the scope of the present disclosure. Furthermore, those skilled in the art will understand that features of various embodiments can be combined in any manner not inconsistent with the description and / or functionality of the embodiments.

Claims

1. 1. A clipping system for treating tissue, comprising: an adapter including a proximal portion and a distal portion, the proximal portion extending along a first longitudinal axis and configured to be attachable to a distal end of the insertion device such that the first longitudinal axis coincides with a longitudinal axis of the insertion device, the distal portion including a longitudinally chamfered cylindrical portion extending along a second longitudinal axis extending generally perpendicular to the first longitudinal axis; a clip including a first pair of arms and a second pair of arms, wherein proximal ends of the first pair of arms are connected to one another by a first hinge and proximal ends of the second pair of arms are connected to one another by a second hinge, a first jaw extends between a distal end of a first arm of the first pair of arms and a distal end of a first arm of the second pair of arms, and a second jaw extends between a distal end of a second arm of the first pair of arms and a distal end of a second arm of the second pair of arms, such that the first and second jaws are movable relative to one another between an open configuration in which they are attached to a distal portion of the adapter and moved away from the adapter and toward one another; A clipping system comprising:

2. 2. The clipping system of claim 1, wherein each of the first and second pairs of arms is formed from a single piece of material bent to form an open ring shape with the first and second hinges at proximal ends of the first and second pairs of arms, the first and second hinges biasing the clip toward the closed configuration.

3. 3. The clipping system of claim 2, wherein each of the first and second hinges is connected to a proximal end of a corresponding one of the first and second pairs of arms via a waisted portion formed by an inwardly bent portion of the single piece of material.

4. 4. The clipping system of claim 1, wherein each of the first and second hinges includes a yoke received therein, the yoke configured to releasably engage a pull wire for actuating the clip between the open and closed configurations.

5. 5. The clipping system of claim 4, wherein each yoke includes a proximal portion including a cavity configured to releasably receive an enlarged end of the pull wire, the proximal opening of the cavity configured to deform when subjected to a force exceeding a predetermined threshold force, thereby enabling the enlarged end of the pull wire to be released from the proximal opening.

6. 6. The clipping system of claim 5, wherein the proximal opening includes at least one slit extending therearound, the at least one slit configured to deform the proximal opening when subjected to a force exceeding the predetermined threshold force, thereby increasing the size of the proximal opening and enabling the enlarged end of the pull wire to be released from the proximal opening.

7. 5. The clipping system of claim 4, wherein each of the yokes includes a flared distal portion configured with a size and shape to couple with a proximal end of a corresponding one of the first and second pairs of arms to assist movement of the clip from the closed configuration to the open configuration to reduce stress on the first and second hinges.

8. 8. The clipping system of claim 1, wherein a proximal end of the proximal portion of the adapter includes a flange having a pair of openings extending therethrough, the pair of openings being aligned with flat ends of the chamfered cylindrical portion of the distal portion and configured to slidably receive pull wires within the pair of openings such that the first and second pairs of arms slide along the flat ends to move the clip between the open and closed configurations relative to the adapter.

9. 1. A clipping system for treating tissue, comprising: an endoscope including a shaft extending longitudinally from a proximal end to a distal end; an adapter including a proximal portion, a distal portion, and a channel, the adapter including: the proximal portion extending along a first longitudinal axis and attached to a distal end of the shaft such that the first longitudinal axis is coaxial with a longitudinal axis of the shaft; the distal portion including a longitudinally chamfered cylindrical portion extending along a second longitudinal axis generally perpendicular to the first longitudinal axis; and the channel extending through the proximal portion and the distal portion along the first longitudinal axis; a clip including a first pair of arms and a second pair of arms, wherein proximal ends of the first pair of arms are connected to one another by a first hinge and proximal ends of the second pair of arms are connected to one another by a second hinge, a first jaw extends between a distal end of a first arm of the first pair of arms and a distal end of a first arm of the second pair of arms, and a second jaw extends between a distal end of a second arm of the first pair of arms and a distal end of a second arm of the second pair of arms, such that the first and second jaws are movable relative to one another between an open configuration in which they are attached to a distal portion of the adapter and moved away from the adapter and toward one another; first and second pull wires connected to the first and second hinges, respectively, via yokes received within the first and second hinges, the first and second pull wires releasably coupled to the yokes and longitudinally slidable relative to the endoscope to operate the clip between the open configuration, an initial deployed configuration in which the clip is positioned in the closed configuration just distal to the adapter, and a review configuration in which the clip is moved distally away from the distal end of the endoscope while remaining tethered to the endoscope by the first and second pull wires; A clipping system comprising:

10. 10. The clipping system of claim 9, wherein each of the first and second pairs of arms is formed from a single piece of material bent to form an open ring shape with the first and second hinges at proximal ends of the first and second pairs of arms, the first and second hinges biasing the clip toward the closed configuration.

11. 11. The clipping system of claim 10, wherein each of the first and second hinges is connected to a proximal end of a corresponding one of the first and second pairs of arms via a waisted portion formed by an inwardly bent portion of the single piece of material.

12. 12. The clipping system of claim 9, wherein each of the yokes includes a proximal portion sized and shaped to be received within a corresponding one of the first and second hinges, and a distal portion sized and shaped to couple with a proximal end of a corresponding one of the first and second pairs of arms.

13. 13. The clipping system of claim 12, wherein a distal portion of the yoke has a flared shape such that when the yoke is moved proximally relative to the clip, the flared distal portion slides proximally along the proximal ends of the first and second pairs of arms, facilitating movement of the clip from the closed configuration to the open configuration.

14. 13. The clipping system of claim 12, wherein each of the first and second pull wires includes an enlarged distal end portion releasably received within a cavity formed in a corresponding size and shape within a proximal portion of the corresponding yoke, the proximal opening of the cavity being configured to deform when subjected to a force exceeding a predetermined threshold force to allow proximal passage of the enlarged distal end portion through the proximal opening.

15. first and second tubular deployment members configured to slidably receive the first and second pull wires therein; 15. The clipping system of claim 14, wherein each of the first and second tubular deployment members is longitudinally movable relative to the endoscope such that a distal end of the first and second tubular deployment members is positionable relative to the first and second hinges, respectively, during final deployment of the clip, and wherein the position of the clip is maintained when the first and second pull wires are pulled proximally relative to the clip to exert the predetermined threshold force on the yoke.

Images