Deployment mechanism with shortened length of hemostatic clip

Abstract

To provide a plurality of clips according to the size of a deficit.SOLUTION: A clipping device includes a clip including a capsule having a channel and a pair of clip arms. The clipping device includes a bush. The bush releasably couples the clip to a base end portion of the clipping device. The clipping device includes a control member. The clipping device includes a yoke which is attached to a tip part of the control member. The yoke includes a principal portion. The yoke includes a pair of protrusions extending from an opposite surface of the principal portion so as to be received in an opening extending through base end parts of the clip arms so as to maintain alignment between the clip arms and a pair of reliefs. When the predetermined force is applied to the yoke, a portion of the yoke defined via the relief is separated from a remaining portion of the yoke so as to release the clip arms from the control member during deployment of the clip.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to an endoscope device, and more particularly to an endoscopic clip device for treating tissues along the gastrointestinal tract.

Background Art

[0002] During endoscopic gastrointestinal (GI) procedures, the patient may be at risk of perforation of the GI wall or may need to occlude the GI wall as part of the procedure. Hemostatic clips can be used to occlude a lumen perforation and, for example, for hemostasis of mucosal / submucosal defects, bleeding ulcers, arteries, polyps, and diverticula. Depending on the size of the defect, multiple clips may be required.

Summary of the Invention

[0003] The present invention relates to a clip device, the clip device comprising a clip, the clip including a capsule extending longitudinally from a proximal end portion to a distal end portion and having a channel extending therethrough, and a pair of clip arms, the proximal ends thereof being slidably received within the channel to move the clip arms between an open configuration and a closed configuration. A bushing releasably couples the clip to the proximal end portion of the device. A tension member includes a distal end portion and a proximal end portion. Each of the distal end portion and the proximal end portion is sized and shaped to be received between the proximal ends of the clip arms. The tension member includes a pair of protrusions extending from an opposing surface of the proximal end portion and received within an opening extending through the proximal ends of the clip arms to maintain alignment between the clip arms. The proximal end portion includes a relief that extends longitudinally therealong so as to define a pair of fingers, the fingers being separated from each other at their proximal ends. A yoke includes a main portion sized and shaped to be received between the proximal ends of the clip arms, the main portion including a recess formed at its distal end, the recess being sized and shaped to releasably receive the pair of fingers of the tension member, the pair of fingers being configured to bend toward each other when a predetermined force is applied thereto to release the pair of fingers from the recess and disengage the tension member from the yoke during deployment of the clip. A control member extends through the proximal end portion of the device from the proximal end to a distal end attached to the yoke to move the clip arms between the open configuration and the closed configuration.

[0004] In one embodiment, the outer surfaces of the pair of fingers may be rounded, and the recess formed in the main portion may correspondingly be rounded such that the pair of fingers are held within the recess until a predetermined force is applied thereto.

[0005] In one embodiment, the proximal end portion of the capsule may include tabs that are biased radially inwardly to engage corresponding structures of the bushing, and the main portion of the yoke is sized and shaped such that when the distal end of the control member is moved past the proximal end portion of the capsule in the proximal direction and the clip is deployed from the proximal portion, the tabs are moved radially outwardly.

[0006] In one embodiment, the yoke may include a pair of overhangs extending in the distal direction from the proximal end of the main portion, whereby the proximal end of the clip arm is constrained between the main portion and the overhangs toward an unlocked configuration.

[0007] In one embodiment, the proximal end of the clip arm may be biased radially outwardly so that in the unlocked configuration, the locking structure at the proximal end of the clip arm is prevented from engaging the corresponding locking mechanism of the capsule.

[0008] In one embodiment, the locking structure includes a locking tab extending from the proximal end of the clip arm, and the locking mechanism of the capsule may include a window extending laterally through its wall, whereby when the proximal end of the clip is released from the distal end of the control member, the locking tab is received within the locking window to lock the clip in a closed configuration.

[0009] In one embodiment, the clip arm may include an engagement mechanism configured to engage a portion of the capsule, whereby when the engagement mechanism engages the capsule, the clip arm is prevented from moving further in the proximal direction relative to the capsule and a predetermined force is applied to the distal end of the control member.

[0010] The present invention also relates to a clip device, the clip device comprising a clip, the clip including a capsule extending longitudinally from a base end portion to a tip end portion and including a channel extending therethrough, and a pair of clip arms, the base end portions of which are slidably received within the channel to move the clip arms between an open configuration and a closed configuration. A bushing releasably couples the clip to the proximal portion of the device. A control member extends through the proximal portion of the device from the base end portion to a tip end portion releasably coupled to the clip arms to move the clip between an open configuration and a closed configuration, and a yoke is attached to the tip end portion of the control member to releasably couple the control member to the clip arms. The yoke includes a main portion sized and shaped to be received between the base end portions of the clip arms, a pair of protrusions extending from opposing faces of the main portion and received within openings extending through the base end portions of the clip arms to maintain alignment therebetween, and a pair of reliefs formed therein such that when a predetermined force is applied to the yoke, a portion of the yoke defined by the reliefs is separated from the remainder of the yoke to release the clip arms from the control member during deployment of the clip.

[0011] In one embodiment, the pair of reliefs may extend from the tip end portion of the main portion of the yoke along opposing side faces of the protrusions to define a stress concentration neck portion along which the yoke is configured to separate during deployment of the clip.

[0012] In one embodiment, the pair of reliefs may extend through the protrusions proximate to the opposing faces of the main portion such that when a predetermined force is applied thereto, the protrusions are cut off to release the clip arms from the control member.

[0013] In one embodiment, the proximal end portion of the capsule may include tabs that are biased radially inwardly to engage corresponding structures of the bushing, and the main portion of the yoke is sized and shaped such that when the distal end of the control member is moved beyond the proximal end portion of the capsule in the proximal direction, the tabs are moved radially outwardly when the clip is deployed from the proximal portion.

[0014] In one embodiment, the yoke may include a pair of overhangs extending from the proximal end portion of the main portion in the distal direction, whereby the proximal end portion of the clip arm is constrained between the main portion and the overhangs toward an unlocked configuration.

[0015] In one embodiment, the proximal end portion of the clip arm may be biased radially outwardly, whereby in the unlocked configuration, the locking structure at the proximal end portion of the clip arm is prevented from engaging a corresponding locking mechanism of the capsule.

[0016] In one embodiment, the locking structure may include a locking tab extending from the proximal end portion of the clip arm, and the locking mechanism of the capsule may include a window extending laterally through its wall, whereby when the proximal end portion of the clip is released from the distal end of the control member, the locking tab is received within the locking window to lock the clip in a closed configuration.

[0017] In one embodiment, the clip arm may include an engagement mechanism configured to engage a portion of the capsule, whereby when the engagement mechanism engages the capsule, the clip arm is prevented from moving further in the proximal direction relative to the capsule, and a predetermined force is applied to the distal end of the control member.

[0018] The present invention also relates to a method for treating a target tissue. The clip device is inserted through the working channel of an endoscope to a target site in the body until the clip of the clip device extends beyond the distal end of the working channel in the distal direction. The clip device includes a capsule and a pair of clip arms slidably received therein. The pair of clip arms are aligned with each other by a tension member including a distal portion and a proximal portion sized and shaped to be received between the proximal ends of the clip arms, and a pair of protrusions extending from the opposing surfaces of the proximal portion are received within openings extending through the proximal ends of the clip arms to maintain alignment between the clip arms. The clip device is moved between an open configuration and a closed configuration by a control wire coupled to the clip arms until a selected target tissue is received between the distal ends. The distal end of the control wire is coupled to the proximal end of the clip arm by a yoke, the yoke includes a main portion sized to be received between the proximal ends of the clip arms, and a pair of fingers of the proximal portion of the tension member are releasably received within recesses of the main portion. The clip arms are retracted into the capsule in the proximal direction to move the clip towards the closed configuration and grip the target tissue between the clip arms. The clip is deployed from the proximal portion of the clip device by pulling the control member in the proximal direction relative to the capsule until a predetermined force is applied by the yoke to the pair of fingers to bend the pair of fingers towards each other and release the tension member from the yoke.

Brief Description of the Drawings

[0019]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Mode for Carrying Out the Invention

[0020] The present invention can be further understood by referring to the following description and the accompanying drawings, and the same reference numerals are assigned to the same elements. The present invention relates to an endoscopic clip device for treating perforations, defects, and / or bleeding of internal tissues. In some embodiments, when arranging a plurality of clips, in order to make the target site more visible and enable better operability, the deployed clips may preferably be shorter. In an exemplary embodiment of the present invention, there is provided a clip device in which the deployment mechanism is shortened so that the length of the deployed clips is shortened compared to some current clips, and the clip device is configured not to drop a plurality of parts of the clips into the body. The yoke portion of the deployment mechanism may be configured to break and / or separate from the rest of the deployment mechanism by one or more reliefs formed along the yoke. The separable yoke portion connected to the tip of the control member is completely separated during deployment, removed from the deployed clip, and then removed from the body, as will be described in detail below. Those skilled in the art will understand in this specification that the terms proximal end and distal end are intended to refer to the direction towards the user of the device and the direction away from the user of the device, respectively.

[0021] As shown in FIGS. 1-4, a clip device 100 for treating tissue defects includes a clip 102 that includes a pair of clip arms 104. The proximal ends 108 of the clip arms are slidably received within a capsule 106 such that the clip 102 can move between an open configuration in which the distal ends 110 of the clip arms 104 are separated from each other and a closed configuration in which the distal ends 110 are drawn toward each other. The clip arms 104 are moved between the open and closed configurations by movement of a control member 112, coupled to the clip arms 104 via a yoke 114 and a tension member 116, in the proximal and distal directions.

[0022] The tension member 116 is configured to maintain a desired alignment of the clip arms 104 relative to each other while a yoke 114, releasably coupled to the tension member 116, holds the proximal ends 108 of the clip arms 104 in a release configuration that prevents locking of the clip arms 104 within the capsule 106 until the clip 102 is deployed over the target tissue and locked in place. The clip 102 is releasably coupled to a proximal portion 118 of the device 100 to facilitate insertion of the clip device 100 into the target site.

[0023] The proximal portion 118 includes a flexible elongate member 170 that houses the control member 112 and connects the clip 102 to a handle and / or actuator 172. The handle and / or actuator remains outside the body during use and is accessible to the user such that the user can control the operation and movement of the device 100 between the open and closed configurations and deploy the clip 102 over the target tissue. The flexible elongate member 170 can be releasably coupled to the clip 102, for example, by a bushing 122. The control member 112 extends through the elongate member from a proximal end connected to a portion of the handle member 172 to a distal end connected to the yoke 114.

[0024] The capsule 106 includes a channel 130 that extends from the base end portion 124 to the tip end portion 128 and that extends through the base end portion to the tip end. In one embodiment, the base end portion 124 is configured to be releasably coupled to the bushing 122, for example, by a tab 132, which is crimped radially inwardly to engage a corresponding portion of the bushing 122. The capsule 106 also includes a locking mechanism formed in the capsule wall, such as a locking window 134 that extends laterally through the capsule wall and that engages, for example, a locking tab 136 of the clip arm 104, as will be described in detail below.

[0025] Each of the clip arms 104 extends from the base end portion 108 to its tip end portion 110. As described above, the base end portions of these clip arms 104 are slidably received within the channel 130 of the capsule 106. Specifically, the base end portion 108 of each of the clip arms 104 is slidably received within the channel 130 such that the clip 102 can be moved between an open configuration and a closed configuration by operating the control member 112. In one embodiment, the clip arms 104 are biased toward the open configuration such that when they are extended out of the capsule 106 and advanced in the tip end direction, the clip arms 104 move away from each other and into the open configuration under their natural bias. When the arms 104 are drawn into the capsule 106 in the base end direction, the clip arms 104 are constrained by the wall of the capsule 106 and the tip end portions 110 are drawn together into the closed position adjacent to each other. Those skilled in the art will understand that any number of other mechanisms may be used to open and close the clip arms 104.

[0026] The clip arm 104 of this embodiment also includes an engagement mechanism 138 extending from the clip arm 104, and the engagement mechanism is configured to engage a portion of the capsule 106. Thereby, when the engagement mechanism 138 engages with the capsule 106, the clip arm 104 is prevented from further moving in the proximal direction into the capsule 106. In one embodiment, the engagement mechanism 138 has a width that is wider than the width of the more proximal portion of these clip arms 104 and extends laterally outwardly in a size that can be drawn into the capsule 106 in the proximal direction. Therefore, when the clip arm 104 is drawn into the capsule 106 in the proximal direction, the engagement mechanism 138 abuts against a portion of the distal end face 154 of the capsule 106. The engagement mechanism 138 is positioned along the clip arm 104, whereby at the location where the engagement mechanism 138 engages with the capsule 106, the clip arm 104 is sufficiently drawn into the capsule 106 in the proximal direction to pull the clip arms 104 together into a closed configuration. In one example, the engagement mechanism 138 is configured as a wing extending laterally from the longitudinal edge of the clip arm 104.

[0027] The proximal end portion 108 of the clip arm 104 includes a locking mechanism such as a locking tab 136 extending therefrom. In this embodiment, the proximal end portion 108 of the clip arm 104 is biased radially outwardly away from the center line of the capsule 106, but is held down by the yoke 114 and prevented from engaging the wall of the capsule 106 before the clip 102 is deployed. When the clip 102 is deployed, the control member 112 is released from the clip 102 by the yoke 114, and the locking tab 136 is freed and springs radially outwardly to engage the locking window 134 and cover the target tissue of the clip 102 to lock the clip arm 104 in a closed configuration. The proximal end portion 108 of the clip arm 104 of this embodiment is also provided with an opening 140 extending therethrough to receive a portion of the tension member 116 and hold the clip arms 104 in the desired alignment with respect to each other.

[0028] The tension member 116 is configured to be received between the proximal ends 108 of the clip arms 104 and includes a proximal portion 142 that extends in the proximal direction from the distal portion 144. The proximal portion 142 is sized and shaped to be received within a portion of the yoke 114 that is of a corresponding size and shape. The proximal portion 142 includes a relief 146. The relief 146 extends into its interior in the distal direction and defines a pair of fingers 148. The fingers 148 can bend and / or deform towards each other during the deployment of the clip 102 to release the tension member 116 from the yoke 114.

[0029] Each of the fingers 148 has an outwardly curved shape, whereby the pair of fingers 148 forms a generally rounded proximal portion 142 of the clip 102 and facilitates the retention of the proximal portion 142 within the yoke 114 until separation (i.e., deployment) is desired. The fingers 148 include protrusions 150 that extend from their opposing surfaces, and each protrusion 150 is received within a corresponding opening of the opening 140 of the clip arm 104 to maintain alignment between the clip arms 104. Each protrusion 150 is sized and shaped to correspond to the shape of the opening 140 and, in one embodiment, has a generally C-shaped cross-section such that each protrusion 150 extends along both fingers 148 to enable the release of the fingers 148 from the yoke 114. In this embodiment, the width of the distal portion 144 generally matches the width (e.g., diameter) of the capsule 106, whereby the tension member 116 is slidable within its channel 130.

[0030] The yoke 114 includes a main portion 152 sized and shaped to be received between the proximal ends 108 of the clip arms 104, and an overhang 160 that restrains the proximal ends 108 of the clip arms 104 in an unlocked configuration. In the unlocked configuration, the locking tabs 136 of the clip arms 104 are held out of engagement with the locking windows 134 of the capsule 106. The main portion 152 extends from a proximal end 154 attached to the distal end 126 of the control member 112 to a distal end 156. In one embodiment, the main portion 152 is defined by opposing surfaces 162 and lateral surfaces 164. Each opposing surface 162 contacts a corresponding proximal end of the proximal ends 108 of the clip arms 104, and the lateral surfaces 164 connect the longitudinal edges 166 of the opposing surfaces 162 from the proximal end 154 to the distal end 156.

[0031] The overhang 160 extends distally from the proximal end 154 along the opposing surfaces 162 such that each proximal end 108 is received between the main portion 152 and one of the corresponding ones of the overhangs 160. In this way, the overhang 160 holds the proximal ends 108 of the clip arms 104 out of engagement with the capsule wall and in a position near the centerline of the capsule 106, preventing the locking tabs 136 from engaging the locking windows 134 until the clip 102 is deployed.

[0032] The recess 158 extending in the proximal direction into the tip 156 of the main portion 152 is sized and shaped to receive the proximal portion 142 of the tension member 116. In one embodiment, the recess 158 is generally C-shaped to receive the curved fingers 148 of the proximal portion 142 within the recess 158. The corresponding curved portions of the recess 158 and the fingers 148 ensure that the fingers 148 are securely held within the recess 158 until it is desired for the yoke 114 and the tension member 116 to disengage from each other. As described above, the pair of fingers 148 are designed to deform towards each other and release the tension member 116 from the yoke 114 when a predetermined force is applied. When the clip 102 is closed and the engagement mechanism 138 of the clip arm 104 prevents further proximal movement of the clip arm 104 relative to the capsule 106, the tension applied to the control member 112 is increased by continuously applying a proximal force to the control member 112 until a predetermined force is applied at the location where the yoke 114 separates from the tension member 116.

[0033] The width of the main portion 152 generally matches the width (e.g., diameter) of the capsule 106, thereby allowing the main portion 152 to slide within the channel 130 of the capsule 106 as the clip arm 104 moves between the open and closed configurations. This also facilitates the release of the capsule 106 from the bushing 122 during deployment. When the yoke 114 separates from the tension member 116, the proximal end 108 of the clip arm 104 is released from the overhang 160, and the locking tab 136 of the clip arm 104 becomes free and snaps radially outwardly to engage the locking window 134 of the capsule 106, locking the clip 102 in the closed configuration.

[0034] Next, the user continues to apply a proximal - direction force to the control member 112, moving the yoke 114 in the proximal direction beyond the proximal end portion 124 of the capsule 106, such that the lateral surface 162 that defines the width of the main portion 152 presses the tab 132, whose edge is bent inwardly of the capsule 106, radially outwardly away from the center line of the capsule 106, disengaging the capsule 106 from the bushing 122 and freeing the clip 102 from the proximal portion 118 of the device 100 so that when the proximal portion 118 of the device 100 is withdrawn from the body, the clip 102 can cover the target tissue and be clip - fastened and left in place.

[0035] In one embodiment, the yoke 114 is drawn proximally into the bushing 122 and the yoke 114 is removed from the body together with the proximal portion 118 of the device 100, but at that time, no part of the device 100 falls off inside the body, and the only thing remaining inside the body after withdrawing the proximal portion 118 from the body is the deployed clip 102. In another embodiment, the yoke 114 is drawn into the flared distal end portion of the flexible elongate member 170 through the bushing 122 and the yoke 114 can be removed from the body while similarly withdrawing the proximal portion 118.

[0036] According to an exemplary method of using the clip device 100, the clip 102 is inserted, for example, through the working channel of an endoscope to a target site in the body, while the handle member remains outside the body. The clip 102 is inserted through the working channel in a closed configuration. When the clip 102 reaches the target site, the user advances the control member 112 in the distal direction, advances the clip arms 104 in the distal direction out of the capsule 106, releases the clip arms 104 so that they can move towards the open configuration under their natural biasing, and allows the target tissue to be received between the clip arms 104. Thereafter, the user can operate the control member 112 to move the clip 102 between the open and closed configurations as needed until the target portion of the tissue is positioned between the clip arms 104 as needed. Thereafter, the user pulls the control member 112 in the proximal direction (or advances the proximal portion 118 in the distal direction across the control member 112) so that when the clip arms 104 are drawn into the capsule 106, the clip arms 104 are drawn towards each other to grasp the target tissue between the distal ends 110 of the clip arms 104.

[0037] When the user is satisfied that the clip 102 is in the desired position to grasp the target tissue, the user continues to increase the force applied to the control member 112 in the proximal direction as described above until the fingers 148 of the tension member 116 bend / deform towards each other and are released from the recess 158 of the yoke 114 after the engagement mechanism 138 engages the capsule 106. When the yoke 114 is separated from the tension member 116, the proximal end portion 108 of the clip arm 104 is released from the overhang 160 and becomes free to spring outwardly away from the centerline of the capsule 106 until the locking tab 136 engages the locking window 134 of the capsule 106 to lock the clip 102 in the closed configuration.

[0038] Thereafter, the user further pulls the control member 112 in the proximal direction relative to the capsule 106 until the distal end portion 114 engages the tab 132 and presses them outwardly to disengage the capsule 106 from the bushing 122 and to free the clip 102 from the proximal end portion 118 of the device 100 while leaving the clip 102 attached to the target tissue. Thereafter, the control member 112 can be pulled in the proximal direction until the yoke 114 is received within the bushing 122 and the proximal end portion 118 is pulled out of the body together with the entire control member 112 received therein.

[0039] The combined length of the tension member 116 and the yoke 114 in this embodiment can be about 2 mm, and compared with some conventional clip designs, in the conventional clip designs, the combined length of the deployment mechanism is about 6 - 7 mm. The relatively short deployment mechanism correspondingly shortens the length of the capsule 106 to about 7 - 8 mm, about 7.5 mm in a particular embodiment. The capsule 106 of this embodiment can be generally shorter than some conventional clips whose length can reach 12.5 - 13.5 mm. Those skilled in the art will understand that separation of the yoke 114 from the tension member 116 during deployment and removal of the yoke 114 during deployment prevent multiple parts from falling off in the body. Those skilled in the art will also understand that the clip devices 200 - 300 have similarly short deployment mechanisms and capsule lengths, thereby shortening the deployed clip length compared with some conventional clips, as will be described in detail below.

[0040] As shown in FIGS. 5-6, a clip device 200 according to another exemplary embodiment is generally similar to the above-described clip device 100. The clip device 200 includes a clip 202, which includes a pair of clip arms 204. The proximal ends 208 of the clip arms are slidably received within a capsule 206, whereby the clip 202 can move between an open configuration in which the distal ends of the clip arms 204 are separated from each other and a closed configuration in which the distal ends are drawn towards each other. The clip arms 204 are moved between the open and closed configurations by a control member 212 as described above, and the distal end 226 of the control member is coupled to a yoke 214.

[0041] The capsule 206, the clip arms 204, and the proximal portion 218 of the clip device 200 to which the capsule 206 is releasably coupled are generally similar to the corresponding elements of the above-described device 100. However, rather than separate yokes and tension members that are releasably coupled to each other, the clip device 200 includes a single element, namely a yoke 214. The yoke 214 releasably couples the control member 212 to the clip arms 204 and maintains the desired alignment between the clip arms 204.

[0042] Similar to the yoke 114, the yoke 214 includes a main body 252 sized and shaped to be received between the proximal ends 208 of the clip arms 204. The main body 252 extends from a proximal end 254 connected to the distal end 226 of the control member 212 to a distal end 256. The main body 252 is defined by opposing surfaces 262, each of which faces and / or contacts a corresponding clip arm of the clip arms 204. Lateral surfaces 264 connect the longitudinal edges 266 of the opposing surfaces 262 from the proximal end 254 to the distal end 256. The yoke 214 also includes overhangs 260 that extend distally from the proximal ends 255 along each of the opposing surfaces 262, whereby the proximal ends 208 of each clip arm 204 are received between the main body 252 and the corresponding overhang of the overhangs 260. The overhangs 260 restrain the proximal ends 208 and hold them away from the walls of the capsule 206 to prevent the locking tabs 236 at the proximal ends 208 of the clip arms 204 from engaging the locking windows 234 of the capsule 206 and locking the clip 202 in the closed configuration until the clip 202 is deployed.

[0043] The yoke 214 also includes projections 250 that extend from its opposing surfaces 262, each projection 250 being received in a corresponding opening 240 that extends through the proximal end 208 of a corresponding clip arm of the clip arms 204 to maintain alignment therebetween. Thus, in the pre-deployment configuration, the main body 252 is received between the proximal ends 208, each overhang extends over and covers a corresponding clip arm of the clip arms 204, and each projection 250 extends through one corresponding opening 240 of the clip arms 204.

[0044] The main body 252 also includes a pair of reliefs 246 that extend longitudinally along the main body 252 from the tip 256 along the opposing surface of the projection 250. The reliefs 246 are sized, shaped, and configured to provide a stress concentration neck portion 248 on the proximal side of the projection 250, and the stress concentration neck portion breaks or otherwise disengages or separates during deployment. In particular, as described above with respect to the clip device 100, when the engagement mechanism of the clip arm 204 engages the tip of the capsule 206 and a predetermined force is applied to the yoke 214, the yoke 214 breaks or separates at the stress concentration neck portion 248, leaving the first portion 244 of the yoke 214 including the projection 250 connected to the clip arm 204, while the remaining proximal portion (the second portion 242) separates therefrom and remains coupled to the control member 212.

[0045] Similar to the yoke 114, the width of the main portion 252 of the yoke 214 generally matches the width (e.g., diameter) of the capsule 206, whereby the main portion 152 is slidable within the channel 230 of the capsule 206 while the clip arm 204 moves between the open and closed configurations and facilitates the release of the capsule 206 from the bushing 222 of the proximal portion 218 during deployment. In particular, at the stress concentration neck portion 248, when the first portion 244 separates from the second portion 242, the proximal end 208 of the clip arm 204 is released from the overhang 260 such that the locking tab 236 of the clip arm 204 snaps outwardly and engages the locking window 234 of the capsule 206 to lock the clip 202 in the closed configuration.

[0046] When the user continuously applies a proximal - direction force to the control member 212, the second portion 242 is moved in the proximal direction beyond the proximal end portion 224 of the capsule 206. Thereby, the lateral surface 264 that defines the width of the main portion 252 presses the tab 232, whose edge is bent inwardly of the capsule 206, radially outward away from the center line of the capsule 206, disengaging the capsule 206 from the bushing 222 and freeing the clip 202 from the proximal portion of the device 200. When the proximal portion of the device 200 is removed from the body, the clip can be clipped onto the upper side of the target tissue and remain in the body. Those skilled in the art will understand that since the clip device 200 can be used in generally the same manner as the clip device 100, only the clip 202 remains in the body and no part of the device 200 will fall off inside the body.

[0047] As shown in FIGS. 7 - 8, the clip device 300 is generally similar to the clip device 200 described above and includes a clip 302 that is movable between an open configuration and a closed configuration. The clip 302 is releasably coupled to the proximal portion 318 of the device 300 by a separable connection between a bushing 322 at the distal end of the proximal portion 318 and a capsule 306 of the clip 302. The clip device 300 includes a yoke 314. The yoke 314 couples a control member 312 to a pair of clip arms 304 of the clip 302 and moves the clip arms 304 relative to the capsule 306 to move the clip arms 304 between the open configuration and the closed configuration as described above.

[0048] The yoke 314 also maintains the desired alignment between the clip arms 304. Similar to the yoke 214, the yoke 314 has a main portion 352 sized and shaped to be received between the proximal ends 308 of the clip arms 304, an overhang 360 that restrains the clip arms 304 in an unlocked configuration with the locking tab 336 at the proximal end 308 disengaged from engagement with the locking window 334 of the capsule 306, and a protrusion 350 that extends from an opposing surface 362 of the main portion 352, is received within an opening that extends through the proximal ends 308 of the clip arms 304, and maintains the desired alignment between them.

[0049] The main portion 352 is sized, shaped, and configured generally similar to the main portion 252 of the clip device 200. Instead of a pair of reliefs that define a stress concentration neck located at the location where the first and second portions of the main portion separate during deployment, in this embodiment, the yoke 314 includes slots 346 that extend through the protrusions 350. These slots reduce the cross-section of the protrusions 350 to create a vulnerable location where, as described in detail below, the protrusions 350 are cut off and the clip 302 is no longer deployed.

[0050] In one embodiment, each of the slots 346 is formed in a portion of the protrusion 350 proximate to the opposing surface 362 such that when a predetermined force is applied thereto, the protrusion 350 is cut off at this location, releasing the proximal end 308 of the clip arm 304 from the yoke 314. In particular, when the target tissue is grasped between the clip arms 304 as needed, the control member 312 is moved distally relative to the capsule 306 until the engagement mechanism of the clip arms 304 engages the capsule 306 and prevents further proximal movement of the clip arms 304 relative to the capsule 306. When the user applies a further distally directed force to the control member 312, the capsule 306 applies a force to the protrusions 350 until a predetermined force is reached at which the protrusions 350 are cut off and the proximal end 308 is released therefrom, and the proximal ends 308 of the clip arms 304 become free and snap radially outwardly, engaging the locking mechanism of the clip arms 304 with the corresponding locking mechanism of the capsule 306.

[0051] For example, since the proximal end portion 308 forcefully disengages outwardly away from the centerline of the capsule 306, the locking tab 336 extending from the proximal end portion 308 engages the locking window 334 of the capsule 306. At this point, the yoke 314 is separated from the clip arm 304, and the user further pulls the control member 312 in the proximal direction until the lateral surface 364 of the main portion 352 that defines the width of the main portion 352 engages a tab 332 whose edge is bent inwardly at the proximal end portion 324 of the capsule 306 and moves the tab 332 radially outwardly away from engagement with the bushing 322. One of ordinary skill in the art will understand that the clip device 300 can be used in a manner generally similar to the clip devices 100, 200. One of ordinary skill in the art will also understand that any dropped parts in this embodiment (e.g., cutting off the protrusion 350) will remain trapped in the clip 302, preventing the dropped parts from interfering with the closed target tissue.

[0052] It will be apparent to those of ordinary skill in the art that various modifications can be made to the present invention without departing from the scope of the invention. Some embodiments may be described using the terms "coupled" and "connected" along with their derivatives. These terms are not intended to be synonyms of each other. For example, some embodiments may be described using the terms "connected" and / or "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" can also mean that two or more elements are not in direct contact with each other but still cooperate or interact with each other.

[0053] As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. As used herein, the terms "comprises," "comprising," "includes," and / or "including" specify the presence of the stated features, regions, steps, elements, and / or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof.

[0054] Furthermore, in some embodiments, the terms "substantially" or "generally" and the terms "approximately" or "about" may be used interchangeably and may be described using any relative method recognized by those skilled in the art. For example, these terms may serve a function as a comparison to a reference parameter to indicate a deviation that still results in the intended function. Without limitation, the deviation from the reference parameter may be, for example, an amount less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, less than 20%, etc.

[0055] It should be recognized that while specific embodiments have been shown and described herein, any arrangement configured to achieve the same purpose may be substituted for the specific embodiments shown. The present invention is intended to cover any adaptations or variations of various embodiments. It is understood that the foregoing description is for purposes of illustration and not limitation. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon review of the foregoing description. Accordingly, the scope of various embodiments includes any other applications in which the above-described components, structures, and methods are used.

[0056] (Appendix) As a preferred embodiment, the technical idea that can be grasped from the above embodiments is described below. [Item 1] A clip device, A clip device comprising a capsule having a clip that extends longitudinally from a proximal end portion to a distal end portion and includes a channel extending therethrough, and a pair of clip arms whose proximal end portions are slidably received within the channel for moving the clip arms between an open configuration and a closed configuration. A bushing that releasably couples the clip to a proximal end portion of the clip device. A tension member including a distal end portion and a proximal end portion, each of the distal end portion and the proximal end portion being sized and shaped to be received between proximal end portions of the clip arms, and the tension member including a pair of protrusions that extend from opposing surfaces of the proximal end portion of the tension member and are received within openings extending through the proximal end portions of the clip arms to maintain alignment between the clip arms, the proximal end portion of the tension member including a relief that extends longitudinally therealong to define a pair of fingers that are separated from each other at proximal end portions of the pair of fingers. A yoke including a main portion sized and shaped to be received between the proximal end portions of the clip arms, the main portion including a recess formed at its distal end portion, the recess being sized and shaped to releasably receive the pair of fingers of the tension member, the pair of fingers being configured to bend towards each other when a predetermined force is applied thereto to release the pair of fingers from the recess and disengage the tension member from the yoke during deployment of the clip. A control member that extends from a proximal end portion of the control member through a proximal end portion of the clip device to a distal end portion of the control member attached to the yoke for moving the clip arms between the open configuration and the closed configuration. The clip device. [Item 2] The outer surfaces of the pair of fingers are rounded, and the recess formed in the main portion is rounded to correspond such that the pair of fingers are held within the recess until the predetermined force is applied thereto. The clip device according to item 1. [Item 3] The base end portion of the capsule includes a tab biased radially inwardly to engage a corresponding structure of the bush, and the main portion of the yoke is sized and shaped such that when the tip end portion of the control member is moved beyond the base end portion of the capsule in the base end direction and the clip is deployed from the base end portion of the present clip device, the tab is moved radially outwardly. The clip device according to item 1 or 2. [Item 4] The yoke includes a pair of overhangs extending from the base end portion of the main portion in the tip end direction, whereby the base end portion of the clip arm is constrained between the main portion and the overhangs. The clip device according to any one of items 1 to 3. [Item 5] The base end portion of the clip arm is biased radially outwardly in the unlocking configuration to prevent a locking tab at the base end portion of the clip arm from engaging a corresponding locking window of the capsule. The clip device according to item 4. [Item 6] The locking tab extends from the base end portion of the clip arm, and the locking window extends laterally through the wall of the capsule, whereby when the base end portion of the clip arm is released from the yoke, the locking tab is received within the locking window to lock the clip in the closed configuration. The clip device according to item 5. [Item 7] The clip arm includes an engagement mechanism configured to engage a portion of the capsule, such that when the engagement mechanism engages the capsule, the clip arm is prevented from moving further in the proximal direction relative to the capsule, and the predetermined force is applied to the tip of the control member. The clip device according to any one of items 1 to 6. It should be understood that although the subject matter has been described in language specific to structural features and / or methodological acts, the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as illustrative forms for carrying out the claims.

Claims

**Claim 1** A clip device, comprising a clip arranged to be deployed on a target tissue so as to be placed over the target tissue and locked in place, the clip including a capsule extending longitudinally from a proximal end portion to a distal end portion and including a channel extending therethrough, and a pair of clip arms whose proximal end portions are slidably received within the channel to move the clip arms between an open configuration and a closed configuration; comprising a bushing that releasably couples the clip to a proximal end portion of the clip device; comprising a control member that extends through the proximal end portion of the clip device from a proximal end portion to a distal end portion that is releasably coupled to the clip arms to move the clip between the open configuration and the closed configuration; comprising a yoke attached to the distal end portion of the control member to releasably couple the control member to the clip arms, the yoke having a main portion sized and shaped to be received between the proximal end portions of the clip arms, a pair of protrusions extending from opposing faces of the main portion to be received within an opening extending through the proximal end portions of the clip arms to maintain alignment between the clip arms, and a pair of reliefs formed in the yoke, the reliefs being such that when a predetermined force is applied to the clip and the yoke to deploy the clip on the target tissue, a portion of the yoke defined through the reliefs separates from the remaining portion of the yoke to release the clip arms from the control member during deployment of the clip; a clip device. **Claim 2** The clip device according to claim 1, wherein the pair of reliefs extend from a distal end portion of the main portion of the yoke along an opposite side of the protrusions so as to define a stress concentration neck portion, and the yoke is configured to separate along the stress concentration neck portion during deployment of the clip. **Claim 3** The clip device according to claim 1, wherein the pair of reliefs extend through the protrusions proximate to opposing faces of the main portion such that when the predetermined force is applied to the pair of reliefs, the protrusions are severed to release the clip arms from the main portion. **Claim 4** The base end portion of the capsule includes tabs that are biased radially inwardly to engage corresponding structures of the bushing, and the main portion of the yoke is sized and shaped such that when the tip end portion of the control member is moved beyond the base end portion of the capsule in the base end direction and the clip is deployed from the base end portion, the tabs are moved radially outwardly. The clip device according to claim 1.

5. The yoke includes a pair of overhangs extending from the base end portion of the main portion in the tip end direction, whereby the base end portion of the clip arm is constrained between the main portion and the overhangs toward an unlocked state. The clip device according to claim 1.

6. The base end portion of the clip arm is biased radially outwardly so as to prevent a locking mechanism at the base end portion of the clip arm from engaging a corresponding locking mechanism of the capsule while being constrained in an unlocked configuration between the main portion and the overhangs. The clip device according to claim 5.

7. The locking mechanism includes a locking tab that extends from the base end portion of the clip arm, and the locking mechanism of the capsule includes a locking window that extends laterally through the wall of the capsule, whereby when the base end portion of the clip arm is released from the tip end portion of the control member, the locking tab is received within the locking window to lock the clip in the closed configuration. The clip device according to claim 6.

8. The clip arm includes an engagement mechanism configured to engage a portion of the capsule, whereby when the engagement mechanism engages the capsule, the clip arm is prevented from moving further in the base end direction with respect to the capsule, and the predetermined force is applied to the tip end portion of the control member. The clip device according to claim 1.

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