Hemostatic clip deployment

Abstract

To provide a clipping device.SOLUTION: A device includes a clip including a capsule and a pair of clip arms, proximal ends of which are slidably received within a channel of the capsule to move the clip arms between an open configuration and a closed configuration. The clip arms are aligned relative to one another via a pin received within openings extending through proximal ends of the clip arms. A proximal portion includes a flexible shaft extending from a proximal end to a distal end including a bushing releasably coupled to the capsule. A control member extends longitudinally through the flexible shaft from a proximal end to a distal end releasably coupled to the proximal ends of the clip aims. The distal end of the control member includes a pair of holding jaws, each of which includes a pair of fingers extending about the pin along opposing sides thereof to grip the pin therebetween.SELECTED DRAWING: Figure 5

Description

[Technical Field]

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

[0002] During endoscopic gastrointestinal (GI) surgery, patients are at risk for GI wall perforation and may require GI wall closure as part of the procedure. Hemostatic clips can be used, for example, for endoscopic hemostasis of mucosal / submucosal defects, bleeding ulcers, arteries, polyps, and diverticula, as well as for closure of luminal perforations. Depending on the size of the defect, multiple clips may be required. Summary of the Invention

[0003] The present invention relates to a clipping device comprising a capsule extending longitudinally from a proximal end to a distal end, the capsule having a channel extending therethrough, and a clip comprising a pair of clip arms, the proximal ends of which are slidably received within the channel for moving the clip arms between an open configuration in which the distal ends of the clip arms are spaced apart and a closed configuration in which they are drawn together. The clip arms are aligned with one another via a pin received within an opening extending through the proximal ends of the clip arms. The proximal portion is configured to pass through a working channel of an endoscope for inserting the clip, and includes a flexible shaft extending from the proximal end to a distal end including a bushing removably coupled to the capsule. A control member extends longitudinally through the flexible shaft from a proximal end to a distal end that is removably connected to the proximal end of the clip arm and moves the clip arm between an open configuration and a closed configuration, the distal end of the control member including a pair of retaining jaws that extend around the pin along opposite sides of the pin to grip the pin therebetween.

[0004] In one embodiment, the proximal end of the capsule includes radially inwardly biased tabs that engage corresponding structure on the bushing. In one embodiment, the distal end of the control member includes a pair of spacing jaws configured to extend along opposite sides of the pin and between the proximal ends of the clip arms, the pair of spacing jaws being sized and shaped to displace the tabs radially outward when the distal end of the control member is moved further proximally from the proximal end of the capsule to deploy the clip from the proximal portion of the device.

[0005] In one embodiment, the proximal ends of the clip arms are biased radially outward. In one embodiment, a pair of retaining jaws extend outwardly along the proximal end of a corresponding one of the clip arms to restrain the clip arm in the unlocked configuration and prevent the locking structure on the proximal end of the clip arm from engaging a corresponding locking element on the capsule.

[0006] In one embodiment, the locking structure includes a locking tab extending from the proximal end of the clip arm, and the locking element of the capsule includes a window extending laterally through the wall of the capsule so that when the proximal end of the clip is disengaged from the distal end of the control member, the locking tab is received within the locking window to lock the clip in the closed configuration.

[0007] In one embodiment, the clip arms are biased to the open configuration so that they are constrained in the closed configuration by the inner surface of the capsule and return to the biased open configuration when the clip arms are moved distally outward relative to the capsule.

[0008] In one embodiment, the clip arm includes an engagement element configured to engage a portion of the capsule, and when the engagement element engages the capsule, it prevents the clip arm from moving further proximally relative to the capsule and a predetermined force is applied to the distal end of the control member.

[0009] The present invention relates to a clipping device comprising a clip including a capsule extending longitudinally from a proximal end to a distal end, the capsule having a channel extending therethrough, and a pair of clip arms, the proximal ends of which are slidably received within the channels to move the clip between an open configuration in which the distal ends of the clip arms are spaced apart and a closed configuration in which they are drawn together. The proximal portion is configured to pass through a working channel of an endoscope to insert the clip and includes a flexible shaft extending from the proximal end to a distal end including a bushing removably coupled to the capsule. A control member passes through the flexible shaft and extends from the proximal end to a distal end removably coupled to the proximal ends of the clip arms to move the clip arms between the open and closed configurations, the distal end including a central portion received between the proximal ends of the clip arms. The first portion of the pin and the second portion of the pin extend away from opposing surfaces of the central portion and are received in openings extending through both proximal ends of the clip arms to maintain the relative alignment of the both clip arms, and when a predetermined force is applied to the clip arms via the distal ends, the first and second portions are pulled proximally out of the openings of the clip arms and pass through the proximal ends of the clip arms.

[0010] In one embodiment, the first and second portions each include an overhang extending therefrom and extending over a portion of the outer surface along the proximal end of a corresponding one of the clip arms to restrain the outwardly biased proximal end of the clip arm in an unlocked configuration, with the proximal end restrained toward a central portion received between the proximal ends, thereby preventing the locking structure along the proximal end of the clip arm from engaging a corresponding locking element of the capsule.

[0011] In one embodiment, each clip arm includes a slot extending proximally from the opening to its proximal end and defining two fingers that bend away from each other to disengage the pin from the fingers when a predetermined force is applied to the fingers.

[0012] In one embodiment, each clip arm includes a relief along a longitudinal edge of the clip arm just distal to the opening to facilitate bending of the two fingers away from each other.

[0013] In one embodiment, each clip arm includes a notch extending along the surface of the clip arm from the opening to the proximal end of the clip arm so that when a predetermined force is applied to the notch via the pin, the clip separates along the notch, disengaging the pin from the opening.

[0014] In one embodiment, the first and second portions of the pin may be tapered toward their proximal ends to separate the clip arms along the notches. In one embodiment, the proximal end of the capsule includes radially inwardly biased tabs that engage corresponding structure on the bushing, and the central portion is sized and shaped to move the tabs radially outward when the distal end of the control member is moved proximally beyond the proximal end of the capsule to deploy the clip from the proximal portion of the device.

[0015] The present invention also relates to a method for treating target tissue, the method including inserting a clipping device through a working channel of an endoscope to a target site within the body until the clip of the clipping device extends distally beyond the distal end of the working channel. The clipping device includes a capsule and a pair of clip arms slidably received within the capsule, the pair of clip arms aligned with one another via pins extending through openings extending through the proximal ends of the clip arms. The clipping device is moved between an open configuration, in which the distal ends of the clip arms are spaced apart, and a closed configuration, in which the distal ends of the clip arms are drawn together, via a control wire coupled to the clip arms until the target tissue is grasped between the distal ends. The distal ends of the control wire are coupled to the proximal ends of the clip arms via first and second retaining jaws, each retaining jaw including a pair of fingers extending around the pin along opposite sides of the pin to grasp the pin therebetween. The clip arms are retracted proximally within the capsule to move the clip to the closed configuration and grasp the target tissue between the clip arms. The clip is deployed from the proximal portion of the clip device by pulling the control member proximally relative to the capsule until a predetermined force is applied to the distal end of the control wire, expanding the fingers apart and disengaging the pin from between the fingers. [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a partial perspective view showing a portion of a clipping device according to a first exemplary embodiment of the present invention in a pre-deployment configuration; [Figure 2] 2 is a partially transparent perspective view showing the clipping device of FIG. 1 in a deployed configuration. [Figure 3] FIG. 2 is a longitudinal side view showing the deployed portion of the clipping device of FIG. 1; [Figure 4] FIG. 10 is a perspective view of a portion of a clipping device according to a second exemplary embodiment of the present invention. [Figure 5] 4 is a perspective view of the clip arm and control member of the clip device of FIG. 3. [Figure 6]FIG. 10 is a perspective view of a clip arm and control member according to a third exemplary embodiment of the present invention. [Figure 7] FIG. 6 is an enlarged perspective view of the clip arm and control member of FIG. 5. DETAILED DESCRIPTION OF THE INVENTION

[0017] The present invention can 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 invention relates to an endoscopic clipping device for treating tissue perforations, defects, and / or bleeding. The clipping device includes a clip having clip arms, the proximal ends of which are slidably received within a capsule to move the clip between an open configuration and a closed configuration for clipping target tissue. The clip arms can be moved via a control member, such as a control wire, connected between the proximal ends of the clip and a handle of the device located outside the body and accessible to the user during use. In some cases, a shorter deployed clip is desirable for improved visualization of the target site and for easier maneuverability when deploying multiple clips.

[0018] Additionally, while deployed components naturally pass under normal circumstances, some physicians are concerned that with some current clip designs, particularly in larger defects, deployed components may become trapped in the closed defect during and / or after deployment. Exemplary embodiments of the present invention include a control member having a distal end that is directly and removably coupled to the proximal end of the clip arm, such that after deployment of the clip within the body, the control member is separated from the clip without deploying any portion of the deployment mechanism that extends outward from the capsule, thereby shortening the potential length of the deployed clip and / or the portion of the clip that remains within the body. Those skilled in the art will appreciate that the terms proximal and distal, as used herein, are intended to refer to directions toward (proximal) and away from (distal) the user of the device.

[0019] 1-3 , a clipping device 100 for treating a tissue defect comprises a clip 102 including a pair of clip arms 104 having proximal ends 108 slidably received within a capsule 106, the clip 102 being movable between an open configuration in which distal ends 110 of the clip arms 104 are spaced apart from one another, and a closed configuration in which the clip arms are drawn together. The clip arms 104 are movable between the open and closed configurations via a control member 112, the control member 112 including a distal end 114 configured to be directly coupled to the proximal ends 108 of the clip arms 104.

[0020] In one embodiment, pin 116 extends through proximal end 108 of each clip arm 104 in a direction perpendicular to each clip arm 104 through an opening 118 extending through each clip arm 104. Distal end 114 of control member 112 releasably engages pin 116 and proximal end 108 of clip arm 104 such that, while attached to pin 116, proximal or distal movement of control member 112 moves clip arms 104 proximally or distally relative to capsule 106. When coupled to pin 116, the distal end of control member constrains proximal end 108 of clip arm 104 to prevent clip arms 104 from locking within capsule 106 until it is desired to lock clip 102 in place on target tissue. Clip 102 is releasably coupled to proximal portion 120 of device 100 to facilitate insertion of clipping device 100 into a target site.

[0021] The proximal portion 120 includes an elongate member that houses the control member 112 and couples the clip 102 to a handle and / or actuator located outside the body that is accessible to a user during use to control movement of the device 100 between open and closed configurations to deploy the clip 102 onto target tissue. The proximal portion 120 includes a flexible shaft 121 that extends from a proximal end connected to a user-operable handle member (not shown) outside the patient, e.g., including controls for moving and deploying the device 100, to a distal end 122 that is removably coupled to the proximal end 124 of the capsule 106, e.g., via a bushing 126. The control member 112 passes within the flexible shaft 121 and extends from a proximal end coupled to a portion of the handle member to a distal end 114 that is coupled to the clip arm 104.

[0022] The capsule 106 extends from the proximal end 124 to the distal end 128 and includes a channel 130 extending therethrough. In one embodiment, the proximal end 124 is removably coupled to the bushing 126 via a radially inwardly crimped tab 132 that engages a corresponding portion of the bushing 126 at the distal end 122 of the flexible shaft 121. Although not shown, the distal end 128 includes an inwardly curved tab that extends across the opening of the channel 120 to prevent the proximal ends 108 of the clip arms 104 from advancing distally beyond the tab when the clip 102 is moved to the open configuration. The capsule 106 also includes a locking window 134 extending laterally through the capsule wall that engages a locking element formed in the capsule wall, e.g., a locking tab 136 on the clip arm 104.

[0023] Each clip arm 104 extends from a proximal end 108 to a distal end 110. As described above, a proximal portion of the clip arm 104 is slidably received within a channel 130 of the capsule 106. Specifically, the proximal end 108 of each clip arm 104 is slidably received within the channel 130, allowing the clip 102 to be moved between an open configuration and a closed configuration via manipulation of the control member 112. In one embodiment, the clip arms 104 are biased to the open configuration such that when retracted proximally into the capsule 106, the clip arms 104 are constrained in a closed position by the capsule wall and the distal ends 110 are adjacent to each other. As the clip arms 104 are moved distally to extend further out of the capsule 106, they are released from the constraint of the capsule 106 and return to the open configuration in response to a natural bias. One skilled in the art can use any number of alternative mechanisms for opening and closing the clip arms.

[0024] The clip arms 104 in this embodiment include engaging elements 138 extending therefrom and configured to engage a portion of the capsule 106, preventing the clip arms 104 from moving further proximally relative to the capsule 106 when the engaging elements 138 engage the capsule 106. In one embodiment, the engaging elements 138 extend laterally outward from a portion of the clip arms 104 such that when the clip arms 104 are pulled proximally relative to the capsule 106, the engaging elements 138 abut a portion of the distal surface 129 of the capsule 106. The engaging elements 138 are positioned along the clip arms 104 such that, at the location where the engaging elements 138 engage the capsule 106, the clip arms 104 are pulled proximally sufficiently into the capsule 106 to pull the clip arms 104 into a closed configuration. In one example, the engaging elements 138 are configured as wings extending laterally from the longitudinal edges of the clip arms 104.

[0025] The proximal ends 108 of the clip arms 104 also include locking tabs 136 extending therefrom. In one embodiment, the proximal ends 108 are biased outward, radially away from the centerline of the capsule 106, but are prevented from engaging the walls of the capsule 106 while the distal end 114 of the control member 112 is coupled to the clip 102. When the clip 102 is deployed, the control member 112 is disengaged from the clip 102 and the locking tabs 136 recoil outward, engaging the locking windows and locking the clip arms 104 in a closed configuration on the target tissue. The proximal ends 108 of the clip arms 104 also include openings 118 that allow a pin 116 to extend through each clip arm 104 to hold the clip arms 104 in a desired arrangement relative to one another. In one embodiment, the length of the pin 116 in this embodiment corresponds approximately to the width (e.g., diameter) of the capsule 106, so that when the clip arm 104 is moved longitudinally relative to the capsule 106, the pin 116 slides along the inner surface of the capsule 106.

[0026] The distal end 114 of the control member 112 is removably coupled to the proximal end 108 of the clip arm 104 and maintains the proximal end 108 in a radially compressed position away from the inner surface of the capsule 106 to prevent the locking tabs 136 from engaging the locking windows 134 until the control member 112 is disengaged from the clip arm 104. As will be explained in more detail below, the distal end 114 is sized and shaped to disengage the capsule 106 from the bushing 126 during deployment of the clip 102. As shown in FIG. 1 , in the pre-deployed configuration, the distal end 114 is removably engaged with the pin 116 such that proximal or distal longitudinal movement of the control member 112 relative to the capsule 106 causes corresponding movement of the clip arms 104 relative to the capsule 106.

[0027] In one embodiment, the distal end 114 includes first and second jaws 140, 142 that engage the clip arms 104 and pin 116, as well as first and second retaining jaws 144, 146. In particular, the first and second spacing jaws 140, 142 extend between the proximal ends 108 of the clip arms 104 (with the inner surfaces of the clip arms 104 facing the central axis of the capsule 106 engaging the radially outer surfaces of the jaws 140, 142). The first spacing jaw 140 extends along a first side of the pin 116, while the second spacing jaw 142 extends along a second side of the pin 116 generally opposite the first side. First and second spacing jaws 140, 142 extend between the clip arms 104 to hold the proximal ends 108 apart from one another, act as a positive stop on the distal end 128 of the capsule 106 when the clip 102 is in the open configuration, and facilitate disengagement of the capsule 106 from the proximal portion 120 during deployment.

[0028] Each of the first and second retaining jaws 144, 146 extends on an outer surface of the proximal end 108 of a corresponding one of the clip arms 104 to restrain the proximal end 108 of the clip arm 104 and prevent the clip arm 104 from engaging and locking into the capsule 106 until the clip is deployed. In particular, the first retaining jaw 144 extends along a first surface of the clip arm 104 that faces away from the centerline of the capsule 106, and the second retaining jaw 146 extends along a second surface of the clip arm 104 that faces away from the centerline of the capsule 106. The first and second holding jaws 144, 146 each include a pair of fingers 150 that extend around opposite sides of the pin 116, with distal ends 152 of the fingers 150 curved around the distal face of the pin 116 to grasp the pin 116 until the jaws 140, 142, 144, 146 are disengaged from the clip 102 and the clip 102 is deployed.

[0029] In another embodiment, the distal ends 148 of the first and second spacing jaws 140, 142 curve toward each other and wrap around at least a portion of the distal face of the pin 116 to provide additional holding / gripping force on the pin 116 until deployment of the clip 102. Alternatively, according to another embodiment, the distal ends 148 of both the first and second spacing jaws 140, 142 are curved to grip the pin 116, but the fingers 150 of the first and second retaining jaws 144, 146 simply extend along opposite sides of the pin 116 to restrain the proximal ends 108 of the clip arms 104 and prevent them from engaging and locking into the capsule 106 until deployment.

[0030] As described above, the distal end 114 of the control member 112 is coupled to the pin 116 and the proximal end 108 of the clip arm 104 so that the clip 102 can be moved between the open and closed configurations by movement of the control member 112. As the clip arm 104 is pulled proximally into the capsule 106 until the engaging element 138 engages the capsule 106 and prevents further proximal movement of the clip arm 104 relative to the capsule 106, the increased proximally acting force applied to the control member 112, the tension applied to the control member 112, increases until the fingers 150 of the first and second retaining jaws 144, 146 move apart, disengaging the pin 116 from the control member 112 and causing the proximal end 108 of the clip arm 104 to flip outward as the locking tab 136 engages the locking window of the capsule 106, locking the clip 102 in the closed configuration.

[0031] After the control member 112 disengages from the pin 116 and the proximal end 108 of the clip arm 102, the user further pulls the control member 112 proximally until the distal end 114 is received in the proximal end 124 of the capsule 106. The distal portion 114 is sized and shaped to exert a radially outward force against the inwardly crimped tabs 132 as the distal portion 114 moves between them, disengaging the capsule 106 from the bushing 126 and separating the clip 102 from the proximal portion 120 of the device 100 so that the device 100 can be withdrawn from the body, leaving the clip 102 in place on the target tissue.

[0032] In one embodiment, the outer surfaces 154 of the first and second spacing jaws 140, 142 extend radially away from the centerline of the capsule 106 a selected distance so that when the distal end 114 of the control member 112 is moved proximally beyond the outer surfaces 154, the jaws 140, 142 abut against the crimped tabs 132 and force the tabs 132 radially outward. In this embodiment, the distance between the outer surfaces 154 of the first and second portions 140, 142 corresponds approximately to the width (e.g., diameter) of the channel 130 in the capsule 106 distal to the inwardly crimped tabs 132. As shown in FIG. 2 , the internal channel of the bushing 126 is sized and shaped to receive the distal end 114 of the control member 112 therein after the clip 102 is deployed. In this embodiment, as shown in FIG. 3, no portion of the control member 112 contributes to the length of the deployed clip 102, and all portions of the control member 112 are removed from the body along with the proximal portion 120 of the clipping device 100, leaving no portion remaining in the body.

[0033] According to an exemplary method of using the clipping device 100, the clip 102 is inserted into a target site within the body, for example, through a working channel of an endoscope, while the handle member remains outside the body. The clip 102 is inserted through the working channel in a closed configuration. Once the clip 102 reaches the target site, the clip arms 104 are extended distally from the capsule 106, and a natural bias causes the clip arms 104 to move to an open configuration, with the target tissue received between the clip arms 104. A user can manipulate the control member 112 to move the clip 102 between the open and closed configurations until the target portion of tissue is disposed between the clip arms 104. As the user pulls the control member 112 proximally (or advances the proximal portions 120 distally on the control member 112) and more of the clip arms 104 are received within the capsule 106, the clip arms 104 are drawn together to grasp the target tissue between the distal ends 110 of the clip arms 104.

[0034] Once the user is satisfied that the clip 102 is positioned to grasp the target tissue, the user continues to apply a proximally acting force on the control member 112 after the engaging element 138 engages the capsule 106, as described above, until the distal ends 152 of the fingers 150 of the retaining jaws 144, 146 move apart to disengage the pin 116. Once the pin 116 is disengaged, the distal end 114 of the control member 112 also disengages from the proximal end 108 of the clip arm 104, allowing the proximal end 108 to flip outwardly, away from the centerline of the capsule 106, until the locking tabs 136 engage the locking windows 134 of the capsule 106, locking the clip 102 in the closed configuration. The user then pulls the control member 112 further proximally relative to the capsule 106 until the distal end 114 engages the tabs 132 and pushes them outward, disengaging the capsule 106 from the bushing 126 and releasing the clip 102 engaged with the target tissue. The control member 112 is pulled proximally until the distal end 114 is received within the bushing 126, and the proximal portion 120, along with the entire control member 112 received therein, may be removed from the body.

[0035] 4 and 5 , a clipping device 200 according to another exemplary embodiment is generally similar to the clipping device 100 described above and includes a clip 202 having a pair of clip arms 204, the proximal ends 208 of which are slidably received within a capsule 206 such that the clip 202 can move between an open configuration in which the distal ends 210 of the clip arms 204 are spaced apart and a closed configuration in which the distal ends 210 are drawn together. The clip arms 204 are moved between the open and closed configurations via a control member 212, as described above, the control member 212 having a distal end 214 directly coupled to the proximal ends 208 of the clip arms 204. The capsule 206, the clip arms 204, and a proximal portion 220 of the clipping device 200, which is removably coupled to the capsule 206, are generally similar to the corresponding elements of the device 100 described above. A pin 216 received within an opening 218 extending through the proximal end 208 of the clip arm 204 is integrally formed with the control member 212 in this embodiment and forms part of the distal end 214 of the control member 212, the pin 216 being withdrawn out of the opening 218 during deployment of the clip 202.

[0036] The control member 212, similar to the control member 112, extends through the proximal portion 220 from a proximal end coupled to a portion of the handle member to a distal end 214 removably coupled to the proximal ends 208 of the clip arms 204. However, the distal end 214 includes a central portion 240 sized and shaped to be received between the proximal ends 208 of the clip arms 204 and to have a width corresponding approximately to the width (e.g., diameter) of the capsule 206. The pin 216 is formed by a first portion 244 extending laterally away from a first surface of the central portion 240 that is received in the opening 218 of a first one of the clip arms 204, and a second portion 246 extending laterally from a second surface of the central portion 240 that faces the first surface of the central portion 240 that is received in the opening 218 of the second one of the clip arms 204. The first and second portions 244, 246 each include a longitudinally extending tab 242 configured to engage the outer surface of the clip arm 204, for example, a surface along the proximal portion 208 of the clip arm 204 that faces away from the centerline of the capsule 206, restraining the proximal end 208 toward the centerline of the capsule 206 and preventing the locking tab 236 extending from the proximal end 208 from engaging the locking window 234 of the capsule 206 until the clip 202 is deployed.

[0037] The clip arms 204 are generally similar to the clip arms 104, extending from the proximal end 208 to the distal end 210 and including an opening 218 extending therethrough for receiving a pin 216. As described above with respect to the device 100, the pin 216 is received in the opening 218 to hold the clip arms 204 in a desired relative position. However, each clip arm 204 includes an elongated slot 258 extending proximally from the opening 218 to the proximal end 259 of the clip arm 204, and extending proximally from the opening 218 to form a pair of fingers 264 separated by the slot 258. Because the slot 258 has a width less than the width of the opening 218 and the pin 216 received therein, simply moving the clip arms 204 between the open and closed configurations via the control member 212 does not disengage the control member 212 from the clip arms 214. Each clip arm 204 includes a relief portion 260 formed along a longitudinal edge 262 of the clip arm 204 just distal to the opening 218, such that when a predetermined proximal force is applied to the distal end 214 of the clip arm 204, the relief 260 allows the pair of fingers 264 to bend away from each other, causing the pin 216 to disengage from the control member 212.

[0038] Clipping device 200 can be used in much the same manner as clipping device 100. In particular, upon insertion into a target site within the body, clip 202 can be moved between an open configuration and a closed configuration until a target portion of tissue is received between distal ends 210 of clip arms 204. Once the target tissue is grasped, control member 212 is pulled proximally relative to capsule 206, preventing further proximal movement of clip arms 204 relative to capsule 206, until engaging elements 238 of clip arms 208 engage capsule 206. When the user is ready to deploy the clip 202, the user applies further force acting proximally on the control member 212 until the force applied by the pin 216 to the fingers 264 bends the fingers 264 away from each other and the pin 216 moves proximally through the enlarged slot 258, disengaging the clip arms 204 from the control member 212 and causing the proximal ends 208 of the clip arms 204 to flip outward until the locking tabs 236 engage the locking windows 234 and lock the clip 202 in the closed configuration.

[0039] The user then pulls control member 212 further proximally until distal end 214 is retracted into proximal end 224 of capsule 206, engaging outer surface 256 of central portion 240 with crimped tabs 232 and causing tabs 232 to move radially outward, e.g., out of engagement with bushing 226 of proximal portion 220, and clip 202 separates from proximal portion 220 of device 200. Distal end 214 is retracted proximally into bushing 226, and proximal portion 220 and control member 212 are removed from the body. As with device 100, control member 212 and proximal portion 220 of device 200 are removed from the body without retaining any internal parts thereof.

[0040] Although the clip arms 204 are shown and described as including slots 258 through which the first and second portions 244, 246 of the pin 216 can pass to disengage the clip arms 204 from the control member 212, those skilled in the art will appreciate that the pin 216, which is integral with other portions of the control member 212, can be disengaged from the clip arms 204 to lock and deploy the clip 202 using a different deployment mechanism. For example, according to an alternative embodiment, as shown in FIGS. 6 and 7 , the clip arms 304 releasably engage the control member 312 via a distal end 314 of the control member that includes a central portion 340 received between the proximal ends 308 of the clip arms 304. The pins 316 extending from opposing surfaces of the central portion 340 are received in openings 318 along the proximal ends 308 of the clip arms 304.

[0041] Similar to device 200 described above, pin 316 couples the clip to the control member, maintains the desired alignment between clip arms 304, and constrains proximal ends 308 radially inward in an unlocked configuration. Central portion 340 is sized and shaped to disengage the capsule from the proximal portion during deployment, for example, by outwardly displacing inwardly crimped tabs on the capsule when distal end 314 is moved proximally thereover. However, proximal end 308 is configured to break apart when a predetermined proximal force is applied via pin 316, rather than a slot extending proximally from opening 318 in clip arm 304 to disengage pin 316 during deployment.

[0042] In one embodiment, each clip arm 304 includes a notch 358 extending along the outer surface of the clip arm 304 from the opening 318 to the proximal end 359 of the clip arm. The notch 358 forms a weakened portion configured to split when a predetermined force is applied to the notch via the pin 316. While the pin 316 and the opening 318 of the clip arm 304 in which it is received can have any of a variety of shapes, in one example, the pin 316 has a generally triangular cross-section that tapers toward the proximal end 317 to form a cutting edge for cutting and / or splitting the notch 358 when the pin 316 is moved proximally relative to the notch 358. Similar to the pin 216, the end of the pin 316 includes a longitudinally extending tab or overhang 342 for holding the proximal end 308 in an unlocked configuration until the pin 316 is pulled out of engagement with the proximal end 308. The longitudinally extending tabs 342 in this embodiment are generally triangular in shape, however, one skilled in the art will appreciate that the longitudinally extending tabs 342 may have any shape so long as the longitudinally extending tabs 342 engage the outer surfaces of the proximal ends 308 of the clip arms 304, e.g., surfaces along the proximal portions 308 of the clip arms 304 that are oriented away from the central portion 340, to hold the proximal ends 308 in the unlocked configuration.

[0043] Those skilled in the art will appreciate that the strength of the deployment mechanism shown and described with respect to Figures 6 and 7 can be optimized for different applications based on the depth of the notch 358, the cutting angle of the pin 316, and the thickness of the material at the proximal end 308 of the clip arm 304. Various configurations can be used to tailor the desired proximal force required for deployment to meet the deployment requirements of multiple applications. Those skilled in the art will appreciate that a clipping device including the deployment mechanism shown and described with respect to Figures 6 and 7 can be used in much the same manner as clipping device 200, as described above.

[0044] It will be apparent to those skilled in the art that various modifications can be made in the present invention without departing from the scope of the invention. The technical ideas included in the present disclosure are described below. (Appendix 1) a clip including a capsule extending longitudinally from a proximal end to a distal end and having a channel extending therethrough, and a pair of clip arms, the proximal ends of the clip arms being slidably received within the channels to move the clip arms between an open configuration in which the distal ends of the clip arms are spaced apart and a closed configuration in which the distal ends of the clip arms are close together, the clip arms being aligned with one another via pins received within openings extending through the proximal ends of the clip arms; a proximal portion configured to pass through a working channel of an endoscope to receive a clip, the proximal portion including a flexible shaft extending from a proximal end to a distal end including a bushing removably coupled to the capsule; a control member passing through the flexible shaft and extending longitudinally from a proximal end to a distal end removably coupled to the proximal end of the clip arm for moving the clip arm between the open and closed configurations; the distal end of the control member including a pair of retaining jaws, each of the pair of retaining jaws including a pair of fingers extending around the pin along opposite sides thereof for grasping the pin therebetween; A clipping device comprising: the proximal end of the capsule includes radially inwardly biased tabs for engaging corresponding structure on the bushing; A clipping device, wherein the distal end of the control member includes a pair of spacing jaws extending along opposite sides of the pin between the proximal ends of the clip arms, the pair of spacing jaws being sized and shaped to move the tabs radially outward when the distal end of the control member is pulled proximally beyond the proximal end of the capsule to deploy the clip from the proximal portion of the clipping device. (Appendix 2) 10. The device of claim 1, wherein the proximal ends of the clip arms are biased radially outward. (Appendix 3) 3. The device of claim 2, wherein the pair of retaining jaws extend outwardly along the proximal end of a corresponding one of the clip arms to restrain the clip arm in an unlocked configuration and prevent a locking structure on the proximal end of the clip arm from engaging a corresponding locking element on the capsule. (Appendix 4) 4. The device of claim 3, wherein the locking structure includes a locking tab extending from the proximal end of the clip arm, and the locking element of the capsule includes a window extending laterally through the wall of the capsule, and when the proximal end of the clip is disengaged from the distal end of the control member, the locking tab is received within the window to lock the clip in a closed configuration. (Appendix 5) 5. The device of any one of claims 1 to 4, wherein the clip arms are biased to the open configuration such that the clip arms are constrained to the closed configuration via an inner surface of the capsule and return to the biased open configuration when the clip arms are moved distally outward relative to the capsule. (Appendix 6) 6. The device of any one of claims 1 to 5, wherein the clip arm includes an engaging element configured to engage a portion of the capsule, and when the engaging element engages the capsule, further proximal movement of the clip arm relative to the capsule is prevented and a predetermined force is applied to the distal end of the control member.

Claims

1. a flexible shaft extending from a proximal end configured to be left outside the body to a distal end that, in an operational configuration, is inserted into the body at a site adjacent to the target tissue to be grasped; a clip removably coupled to the flexible shaft, the clip including a capsule having a channel extending therethrough and a pair of clip arms, proximal ends of the pair of clip arms slidably received within the channel to move the pair of clip arms between an open configuration and a closed configuration, the clip including a pin within the capsule, the pin passing through an opening extending through the proximal ends of the pair of clip arms; a control member extending longitudinally through the flexible shaft from a proximal end to a distal end removably connected to the pair of clip arms to move the pair of clip arms between the open and closed configurations, the distal end of the control member including a first pair of fingers extending along opposite sides of the pin to grip the pin.

2. The device of claim 1 , wherein the flexible shaft includes a bushing at its distal end that is removably coupled to the clip.

3. 2. The device of claim 1, wherein the distal end of the control member includes a pair of retaining jaws, a first retaining jaw of the pair including the first pair of fingers, and a second retaining jaw of the pair including a second pair of fingers extending along opposite sides of the pin to grip the pin, the first retaining jaw and the second retaining jaw being located on opposite sides of a longitudinal axis of the capsule.

4. 4. The device of claim 3, wherein the distal end of the control member includes a pair of spacing jaws configured to extend along either side of the pin between the proximal ends of the pair of clip arms, the pair of spacing jaws being sized and shaped to move tabs radially outward at the proximal end of the capsule when the distal end of the control member is moved proximally beyond the proximal end of the capsule to deploy the clip from the flexible shaft.

5. The device of claim 3 , wherein the proximal ends of the pair of clip arms are biased radially outward.

6. 6. The device of claim 5, wherein the first and second retention jaws each extend outwardly along a corresponding one of the proximal ends of the pair of clip arms to restrain the pair of clip arms in an unlocked configuration, wherein locking structures at the proximal ends of the pair of clip arms are held in a radially inward position and prevented from engaging corresponding locking elements of the capsule.

7. 7. The device of claim 6, wherein the locking structure includes locking tabs extending from the proximal ends of the pair of clip arms, and the locking element of the capsule includes locking windows extending laterally through the capsule wall such that when the proximal ends of the pair of clip arms are disengaged from the distal end of the control member, the locking tabs are received within the locking windows to lock the clip in the closed configuration.

8. 2. The device of claim 1, wherein the pair of clip arms are biased toward the open configuration so that the pair of clip arms are constrained in the closed configuration by an inner surface of the capsule, and when the pair of clip arms are moved distally, the pair of clip arms return to the biased open configuration so that both distal portions of the pair of clip arms protrude distally from the capsule.

9. 2. The device of claim 1, wherein each of the pair of clip arms includes an engaging element configured to engage a corresponding portion of the capsule, and when the engaging element engages the corresponding portion of the capsule, further proximal movement of the pair of clip arms relative to the capsule is prevented.

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