Hemostatic clip reduced length deployment mechanism

Abstract

A clamping device (100) includes a clip (102) including a bladder (106) and a pair of clip arms (104) movable between an open configuration and a closed configuration. The tensile member (116) includes a distal portion and a proximal portion, a pair of protrusions (150) extending from opposing surfaces of the proximal portion being received within openings extending through the proximal ends of the clip arms (140), the proximal portion including an embossment to define a pair of fingers separated from each other at the proximal ends thereof. The yoke (114) includes a central portion including a recess formed at a distal end thereof, the recess sized and shaped to releasably receive a pair of fingers of the tensile member (116), the pair of fingers configured to flex toward each other when a predetermined force is applied thereon, to release the pair of fingers from the recess and disengage the tensile member from the yoke during deployment of the clip.

Description

[0001] This application is a divisional application of application number 202080041323.9, application date 2020.6.10, and application title “Deployment mechanism for reducing the length of hemostatic clip”.

[0002] Priority declaration

[0003] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 863,320, filed on June 19, 2019; the disclosure of which is incorporated herein by reference. Technical Field

[0004] The present invention relates to endoscopic devices, and in particular to endoscopic gripping devices for manipulating tissue along the gastrointestinal tract. Background Art

[0005] During endoscopic gastrointestinal (GI) surgery, the patient may be at risk for GI tract wall perforation or may require closure of the GI tract wall as part of the procedure. Hemostatic clips can be used, for example, to stop bleeding from mucosal / submucosal defects, bleeding ulcers, arteries, polyps, diverticula, and closure of luminal perforations. Depending on the size of the defect, multiple clips may be required. Summary of the invention

[0006] The present invention relates to a clamping device, comprising a clamp including a capsule extending longitudinally from a proximal end to a distal end and having a channel extending therethrough, and a pair of clamp arms, the proximal ends of the pair of clamp arms being slidably received in the channel to enable the clamp arms to move between an open configuration and a closed configuration. A bushing releasably couples the clamp to a proximal portion of the device. A tensile member includes a distal portion and a proximal portion, each of the distal portion and the proximal portion being sized and shaped to be received between the proximal ends of the clamp arms, and a pair of protrusions extending from opposing surfaces of the proximal portion to be received in an opening extending through the proximal ends of the clamp arms to maintain alignment between the clamp arms, the proximal portion including a relief extending longitudinally thereof to define a pair of fingers separated from each other at a proximal end thereof. The yoke includes a central portion sized and shaped to be received between the proximal ends of the clamp arms, the central portion including a recess formed at a distal end thereof, the recess sized and shaped to releasably receive the pair of fingers of the tensile member, the pair of fingers configured to flex toward each other when a predetermined force is applied thereto to release the pair of fingers from the recess and disengage the tensile member from the yoke during clip deployment. A control member extends from the proximal end through the proximal portion of the device to the distal end attached to the yoke to move the clamp arms between the open and closed configurations.

[0007] In one embodiment, the outer surfaces of the pair of fingers may be rounded, and the recess formed in the central portion may be correspondingly rounded, such that the pair of fingers are retained in the recess until a predetermined force is applied thereto.

[0008] In one embodiment, the proximal end of the capsule may include a lug biased radially inward to engage a corresponding structure of the bushing, and the size and shape of the central portion of the yoke are configured to cause the lug to move radially outward when the distal end of the control member moves proximally beyond the proximal end of the capsule to deploy the clip from the proximal portion.

[0009] In one embodiment, the yoke may include a pair of overhangs extending distally from a proximal end of the central portion such that the proximal ends of the clamp arms are constrained between the central portion and the overhangs toward the unlocked configuration.

[0010] In one embodiment, the proximal ends of the clamp arms may be biased radially outwardly such that, in the unlocked configuration, locking structures at the proximal ends of the clamp arms are prevented from engaging corresponding locking features of the capsule.

[0011] In one embodiment, the locking structure may include a locking lug extending from the proximal end of the clamp arm, and the locking feature of the capsule may include a window extending laterally through its wall, so that when the proximal end of the clamp is released from the distal end of the control member, the locking lug is received within the locking window to lock the clamp in a closed configuration.

[0012] In one embodiment, the clamp arm may include an engagement feature configured to engage a portion of the balloon such that when the engagement feature engages the balloon, the clamp arm is prevented from further proximal movement relative to the balloon and exerts a predetermined force on the distal end of the control member.

[0013] The present invention also relates to a clamping device, including a clip, the clip including a capsule extending longitudinally from a proximal end to a distal end and having a channel extending therethrough, and a pair of clamp arms, the proximal ends of the pair of clamp arms being slidably received in the channel to move the clamp arms between an open configuration and a closed configuration. A bushing releasably couples the clip to a proximal portion of the device. A control member extends from the proximal end through the proximal portion of the device to a distal end releasably coupled to the clamp arms to move the clip between an open configuration and a closed configuration, and a yoke is attached to the distal end of the control member to releasably couple the control member to the clamp arms. The yoke includes a central portion sized and shaped to be received between the proximal ends of the clamp arms, a pair of protrusions extending from opposing surfaces of the central portion to be received in an opening extending through the proximal ends of the clamp arms to maintain alignment therebetween, and a pair of reliefs formed therein so 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 clamp arms from the control member during deployment of the clip.

[0014] In one embodiment, the pair of reliefs may extend from a distal end of the central portion of the yoke along opposing sides of the protrusion to define a stress concentrating neck, the yoke being configured to separate along the stress concentrating neck during clip deployment.

[0015] In one embodiment, the pair of reliefs may extend through protrusions proximate opposing surfaces of the central portion such that when a predetermined force is applied thereto, the protrusions break to release the clamp arm from the control member.

[0016] In one embodiment, the proximal end of the capsule may include a lug biased radially inward to engage a corresponding structure of the bushing, and the central portion of the yoke is sized and shaped to cause the lug to move radially outward when the distal end of the control member moves proximally beyond the proximal end of the capsule to deploy the clip from the proximal portion.

[0017] In one embodiment, the yoke may include a pair of overhangs extending distally from a proximal end of the central portion such that the proximal ends of the clamp arms are constrained between the central portion and the overhangs toward the unlocked configuration.

[0018] In one embodiment, the proximal ends of the clamp arms may be biased radially outwardly such that, in the unlocked configuration, locking structures at the proximal ends of the clamp arms are prevented from engaging corresponding locking features of the capsule.

[0019] In one embodiment, the locking structure may include a locking lug extending from the proximal end of the clamp arm, and the locking feature of the capsule may include a window extending laterally through its wall, so that when the proximal end of the clamp is released from the distal end of the control member, the locking lug is received within the locking window to lock the clamp in a closed configuration.

[0020] In one embodiment, the clamp arm may include an engagement feature configured to engage a portion of the balloon such that when the engagement feature engages the balloon, the clamp arm is prevented from further proximal movement relative to the balloon and a predetermined force is applied to the distal end of the control member.

[0021] The present invention also relates to a method for treating a target tissue. A clip device is inserted through a working channel of an endoscope to a target site in a body until the clip of the clip device extends distally beyond the distal end of the working channel. The clip device includes a capsule and a pair of clip arms slidably received therein, the pair of clip arms being aligned with each other via a tensile member, the tensile 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 opposing surfaces of the proximal portion to be received in an opening 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 via a control line coupled to the clip arms until the selected target tissue is received between the distal ends. The distal ends of the control lines are coupled to the proximal ends of the clip arms via a yoke, the yoke including a central portion received between the proximal ends of the clip arms, and a pair of fingers of the proximal portion of the tensile member being releasably received in a recess of the central portion. The clip arms are pulled proximally into the capsule to move the clip toward the closed configuration to clamp the tissue between the clip arms. The clip is deployed from a proximal portion of the clip device by pulling the control member proximally relative to the balloon until a predetermined force is applied on the pair of fingers via the yoke, causing the pair of fingers to flex toward each other to release the tensile member from the yoke. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 shows a longitudinal side view of a clamping device according to an exemplary embodiment of the present invention;

[0023] Figure 2 Show Figure 1 a partially transparent longitudinal side view of a portion of the middle clamping device;

[0024] Figure 3 Show Figure 1 a partially transparent longitudinal side view of a deployment mechanism of the middle clamping device;

[0025] Figure 4 Show according to Figure 1 a longitudinal side view of a deployed portion of the middle clamping device;

[0026] Figure 5 shows a partially transparent longitudinal side view of a clamping device according to another exemplary embodiment of the present invention;

[0027] Figure 6 Show Figure 5 a partially transparent longitudinal side view of a deployment mechanism of the middle clamping device;

[0028] Figure 7 A partially transparent longitudinal side view showing a clamping device according to another exemplary embodiment of the present invention; and

[0029] Figure 8 Show Figure 7Longitudinal side view of the deployment mechanism of the middle clamping device. DETAILED DESCRIPTION

[0030] The present invention may be further understood with reference to the following description and accompanying drawings, in which like elements are indicated by like reference numerals. The present invention relates to an endoscopic clamping device for treating internal tissue perforations, defects and / or bleeding. In some embodiments, a shorter deployment clip may be preferred to improve visualization of the target site and allow better maneuverability when placing multiple clips. An exemplary embodiment of the present invention describes a clamping device having a shortened deployment mechanism so that the length of the deployment clip is shortened compared to some current clips, and the clamping device is configured to prevent the detached portion of the clip from entering the body. The yoke portion of the deployment mechanism may be configured to break and / or separate from the rest of the deployment mechanism via one or more reliefs formed along it. The separated yoke portion connected to the distal end of the control member is completely separated and removed from the deployed clip during deployment and subsequently removed from the body, as described in more detail below. It should be understood by those skilled in the art that the terms proximal and distal as used herein refer to the direction toward and away from the user of the device, respectively.

[0031] like Figures 1 to 4 As shown, a clamping device 100 for treating tissue defects includes a clamp 102, which includes a pair of clamp arms 104, the proximal ends 108 of the pair of clamp arms 104 being slidably received in a capsule 106, so that the clamp 102 can be moved between an open configuration and a closed configuration, in which the distal ends 110 of the clamp arms 104 are separated from each other, and in which the distal ends 110 are pulled toward each other. The clamp arms 104 are moved proximally and distally via a control member 112 to move between the open and closed configurations, and the control member 112 is coupled to the clamp arms 104 via a yoke 114 and a tension member 116.

[0032] The tension member 116 is configured to maintain the desired alignment of the clamp arms 104 relative to each other when the yoke 114, which is releasably coupled to the tension member 116, constrains the proximal ends 108 of the clamp arms 104 toward an unlocked configuration, thereby preventing the clamp arms 104 from being locked in the capsule 106 until the clip 102 is deployed and locked in place over the target tissue. The clip 102 is releasably coupled to the proximal portion 118 of the device 100, thereby facilitating insertion of the clamping device 100 into the target site.

[0033] The proximal portion 118 includes a flexible, elongated member 170 that houses the control member 112 and connects the clip 102 to a handle and / or actuator 172 that remains external to the user's body to allow the user to control the operation and movement of the device 100 between the open and closed configurations and to deploy the clip 102 on the target tissue during use. The flexible, elongated member 170 may be releasably coupled to the clip 102 via, for example, a sleeve 122. The control member 112 extends through the elongated member from a proximal end connected to a portion of the handle member 172 to a distal end 126 connected to the yoke 114.

[0034] The balloon 106 extends from a proximal end 124 to a distal end 128 and includes a passage 130 extending therethrough. In one embodiment, the proximal end 124 is configured to be releasably coupled to the sleeve 122 via, for example, a lug 132 that curls radially inward to engage a corresponding portion of the sleeve 122. The balloon 106 also includes a locking feature formed in the balloon wall, such as, for example, a locking window 134 that extends transversely through the balloon wall to engage, for example, a locking lug 136 of the clamp arm 104, as will be described in further detail below.

[0035] Each of the clamp arms 104 extends from a proximal end 108 to a distal end 110 thereof. As described above, the proximal portion of the clamp arms 104 is slidably received within the channel 130 of the capsule 106. Specifically, the proximal end 108 of each of the clamp arms 104 is slidably received within the channel 130, thereby allowing the clip 102 to move between the open and closed configurations via manipulation of the control member 112. In one embodiment, the clamp arms 104 are biased toward the open configuration so that when pushed distally out of the capsule 106, the clamp arms 104 move apart from each other to the open configuration under their natural bias. When the arms 104 are pulled proximally into the capsule 106, the clamp arms 104 are constrained by the walls of the capsule 106 and are thus pulled together into a closed position with the distal ends 110 adjacent to each other. It will be appreciated by those skilled in the art that any number of other mechanisms for opening and closing the clamp arms 104 may be employed.

[0036] The clamp arm 104 of this embodiment also includes an engagement feature 138 extending therefrom that is configured to engage a portion of the capsule 106 such that when the engagement feature 138 engages the capsule 106, the clamp arm 104 is prevented from further proximal movement into the capsule 106. In one embodiment, the engagement feature 138 extends laterally outwardly and has a greater width than a more proximal portion of the clamp arm 104 that is sized to allow it to be pulled proximally into the capsule 106. Thus, when the clamp arm 104 is pulled proximally into the capsule 106, the engagement feature 138 abuts a portion of the distal surface 154 of the capsule 106. The engagement feature 138 is positioned along the clamp arm 104 such that at the point where the engagement feature 138 engages the capsule 106, the clamp arm 104 is sufficiently pulled proximally into the capsule 106 to pull the clamp arm 104 together into a closed configuration. In one example, the engagement features 138 are configured as wings that extend laterally from the longitudinal edges of the clip arms 104 .

[0037] The proximal end 108 of the clamp arm 104 includes a locking feature, such as, for example, a locking lug 136 extending therefrom. In this embodiment, the proximal end 108 of the clamp arm 104 is biased radially outward away from the centerline of the capsule 106, but the proximal end 108 is constrained by the yoke 114 before the clip 102 is deployed, thereby preventing it from engaging the wall of the capsule 106. When the clip 102 is deployed, the control member 112 is released from the clip 102 via the yoke 114 and releases the locking lug 136 to spring radially outward and engage with the locking window 134, thereby locking the clamp arm 104 in a closed configuration above the target tissue. The proximal end 108 of the clamp arm 104 in this embodiment also includes an opening 140 extending therethrough to receive a portion of the tensile member 116 therein to maintain the clamp arms 104 in a desired alignment relative to each other.

[0038] The tensile member 116 is configured to be received between the proximal ends 108 of the clip arms 104 and includes a proximal portion 142 extending proximally from a distal portion 144. The proximal portion 142 is sized and shaped to be received within a correspondingly sized and shaped portion of the yoke 114. The proximal portion 142 includes a relief 146 extending distally therein to define a pair of fingers 148 that can be flexed and / or deformed toward each other to release the tensile member 116 from the yoke 114 during deployment of the clip 102.

[0039] Each of the fingers 148 has an outwardly curved shape such that the pair of fingers 148 together form a substantially circular proximal portion 142 of the clip 102 to retain the proximal portion 142 within the yoke 114 until separation (i.e., deployment) is desired. The fingers 148 include projections 150 extending from opposing surfaces thereof such that each projection 150 is received within a corresponding one of the openings 140 of the clamp arms 104 to maintain alignment between the clamp arms 104. Each projection 150 is sized and shaped to correspond to the shape of the openings 140 and, in one embodiment, has a substantially C-shaped cross-section such that each projection 150 extends along two fingers 148, thereby allowing the fingers 148 to be released from the yoke 114. In this embodiment, the width of the distal portion 144 substantially corresponds to the width (e.g., diameter) of the balloon 106 such that the tensile member 116 can slide within the channel 130 thereof.

[0040] The yoke 114 includes a central portion 152 that is sized and shaped to be received between the proximal end 108 of the clamp arm 104 and an overhang 160 that constrains the proximal end 108 of the clamp arm 104 in an unlocked configuration in which the locking lug 136 of the clamp arm 104 is held out of engagement with the locking window 134 of the capsule 106. The central 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 central portion 152 is defined via opposing surfaces 162, wherein each opposing surface 162 contacts a respective one of the proximal ends 108 of the clamp arm 104, and side surfaces 164 connect longitudinal edges 166 of the opposing surfaces 162 from the proximal end 154 to the distal end 156.

[0041] Overhangs 160 extend distally from proximal ends 154 along opposing surfaces 162 such that each proximal end 108 is received between central portion 152 and a corresponding one of overhangs 160. Thus, overhangs 160 hold proximal ends 108 of clip arms 104 in a position proximate the centerline of capsule 106, out of engagement with the walls of the capsule to prevent locking lugs 136 from engaging locking windows 134 until the clip 102 is deployed.

[0042] The recess 158 extending proximally into the distal end 156 of the central portion 152 is sized and shaped to receive the proximal portion 142 of the tensile member 116. In one embodiment, the recess 158 is substantially C-shaped to receive the curved fingers 148 of the proximal portion 142 therein. The corresponding curvatures of the recess 158 and the fingers 148 ensure that the fingers 148 are retained within the recess 158 until it is desired that the yoke 114 and the tensile member 116 be disengaged from each other. As described above, the pair of fingers 148 are designed to deform toward each other when subjected to a predetermined force to release the tensile member 116 from the yoke 114. When the clip 102 is closed and the engagement features 138 of the clamp arms 104 prevent further proximal movement of the clamp arms 104 relative to the capsule 106, the proximal force continued to be applied to the control member 112 increases the tension on the control member 112 until the predetermined force is applied at the point where the yoke 114 is separated from the tensile member 116.

[0043] The width of the central portion 152 substantially corresponds to the width (e.g., diameter) of the balloon 106, so that the central portion 152 can slide within the channel 130 of the balloon 106 during movement of the clip arms 104 between the open and closed configurations. This also facilitates release of the balloon 106 from the bushing 122 during deployment. When the yoke 114 is separated from the tensile member 116, the proximal end 108 of the clip arm 104 is released from the overhang 160, thereby releasing the locking lugs 136 of the clip arm 104 to spring radially outward to engage with the locking windows 134 of the balloon 106, thereby locking the clip 102 in the closed configuration.

[0044] The user can then continue to apply a proximal force on the control member 112 to move the yoke 114 proximally beyond the proximal end 124 of the capsule 106, such that the side surfaces 162 defining the width of the central portion 152 push the inwardly curled lugs 132 of the capsule 106 radially outward, away from the centerline of the capsule 106, thereby separating the capsule 106 from the sleeve 122 and releasing the clip 102 from the proximal portion 118 of the device 100, so that when the proximal portion 118 of the device 100 is removed from the body, the clip 102 can remain in the appropriate position above the target tissue.

[0045] In one embodiment, the yoke 114 is pulled proximally into the bushing 122 so that the yoke 114 is removed from the body along with the proximal portion 118 of the device 100, so no part of the device 100 falls into the body, and after the proximal portion 118 is removed from the body, the only thing left in the body is the deployed clip 102. In another embodiment, the yoke 114 can be pulled through the bushing 122 into the flared distal end of the flexible elongated member 170 to similarly remove the yoke 114 from the body during the removal of the proximal portion 118.

[0046] According to an exemplary method of using the clamping device 100, the clip 102 is inserted through a working channel, such as an endoscope, to a target site in the body, while the handle member is held 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 user pushes the control member 112 distally to advance the clamp arms 104 distally out of the capsule 106, thereby releasing the clamp arms 104 to move toward the open configuration under natural bias, so that the target tissue can be received between the clamp arms 104. The user can then operate the control member 112 as needed to move the clip 102 between the open and closed configurations until the target portion of the tissue is positioned between the clamp arms 104 as desired. The user then pulls the control member 112 proximally (or advances the proximal portion 118 distally on the control member 112) so that when the clamp arms 104 are pulled into the capsule 106, the clamp arms 104 are pulled toward each other to clamp the target tissue between the distal ends 110 of the clamp arms 104.

[0047] When the user is satisfied that the clip 102 is in the desired position to clamp the target tissue, the user applies an increasing proximally directed force to the control member 112 after the engagement feature 138 engages the capsule 106, as described above, until the fingers 148 of the tensile member 116 flex / deform toward each other and release from the recesses 158 of the yoke 114. As the yoke 114 is separated from the tensile member 116, the proximal ends 108 of the clip arms 104 are released from the overhangs 160, thereby freeing the proximal ends 108 to spring outwardly away from the centerline of the capsule 106 until the locking lugs 136 engage the locking windows 134 of the capsule 106, thereby locking the clip 102 in the closed configuration.

[0048] The user then pulls the control member 112 further proximally relative to the balloon 106 until the distal end 114 engages the lugs 132, thereby pushing them outward to disengage the balloon 106 from the sleeve 122 and release the clip 102 from the proximal portion 118 of the device 100, thereby leaving the clip 102 attached to the target tissue. The control member 112 can then be removed proximally until the yoke 114 is received within the sleeve 122 and the proximal portion 118, in which the entire control member 112 is received, is removed from the body.

[0049] The combined tensile member 116 and yoke 114 in this embodiment may be approximately 2 mm in length, compared to some conventional clip designs having a combined deployment mechanism of approximately 6 to 7 mm in length. The relatively shortened deployment mechanism results in a correspondingly reduced capsule 106 of approximately 7 to 8 mm in length, and in one particular embodiment, approximately 7.5 mm. The capsule 106 in this embodiment may be significantly shorter than some conventional clips, which have lengths ranging between 12.5 and 13.5 mm. It will be appreciated by those skilled in the art that the separation of the yoke 114 from the tensile member 116 during deployment and the removal of the yoke 114 upon deployment prevents a portion from falling out of the body. It will also be appreciated by those skilled in the art that, as described in detail below, the clamping devices 200-300 have similar shortened deployment mechanisms and capsule lengths, which result in a shortened deployed clip length compared to some conventional clips.

[0050] like Figures 5 to 6 As shown, a clamping device 200 according to another exemplary embodiment is substantially similar to the clamping device 100 described above and includes a clamp 202, which includes a pair of clamp arms 204, the proximal ends 208 of which are slidably received in a capsule 206, so that the clamp 202 can be moved between an open configuration and a closed configuration, in which the distal ends of the clamp arms 204 are separated from each other, and in which the distal ends are pulled toward each other. The clamp arms 204 are moved between the open and closed configurations via a control member 212 as described above, and the distal end 226 of the control member is coupled to the yoke 214.

[0051] The balloon 206, the clamp arms 204, and the proximal portion 218 of the clamping device 200 to which the balloon 206 is releasably coupled are substantially similar to corresponding elements of the above-described device 100. However, rather than separate yokes and tension members that are releasably coupled to one another, the clamping device 200 includes a single element - the yoke 214 - that releasably couples the control member 212 to the clamp arms 204 and maintains the desired alignment between the clamp arms 204.

[0052] Similar to the yoke 114, the yoke 214 includes a central body 252 that is sized and shaped to be received between the proximal ends 208 of the clamp arms 204. The central 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 central body 252 is defined via opposing surfaces 262, each of which faces and / or contacts a corresponding one of the clamp arms 204. The side surfaces 264 connect longitudinal edges 266 of the opposing surfaces 262 from the proximal end 254 to the distal end 256. The yoke 214 also includes an overhang 260 extending distally from the proximal end 255 along each of the opposing surfaces 262, such that the proximal end 208 of each of the clamp arms 204 is received between the central body 252 and a corresponding one of the overhangs 260. The overhang 260 constrains the proximal end 208 away from the wall of the balloon 206 to prevent the locking lugs 236 at the proximal end 208 of the clip arms 204 from engaging the locking windows 234 of the balloon 206 and locking the clip 202 in the closed configuration until the clip 202 is deployed.

[0053] The yoke 214 also includes projections 250 extending from opposing surfaces 262 thereof, wherein each projection 250 is received within a corresponding opening 240 extending through the proximal ends 208 of a corresponding one of the clamp arms 204 to maintain alignment therebetween. Thus, in the pre-deployed configuration, the central body 252 is received between the proximal ends 208, wherein each overhang extends above a corresponding one of the clamp arms 204 and each projection 250 extends through a corresponding opening 240 of a corresponding one of the clamp arms 204.

[0054] The central body 252 also includes a pair of reliefs 246 extending longitudinally along the central body 252 from the distal end 256 along opposite sides of the protrusion 250. The reliefs 246 are sized, shaped, and configured to create a stress concentrating neck 248 proximal to the protrusion 250 that will break or otherwise disengage or separate during deployment. In particular, when the engagement features of the clamp arm 204 engage the distal end of the capsule 206, as described above with respect to the clamping device 100, and a predetermined force is applied to the yoke 214, the yoke 214 will break or separate at the stress concentrating neck 248, thereby leaving the first portion 244 of the yoke 214 (which includes the protrusion 250 connected to the clamp arm 204), while the remaining proximal portion (the second portion 242) is separated therefrom and remains coupled to the control member 212.

[0055] Similar to the yoke 114, the width of the central portion 252 of the yoke 214 substantially corresponds to the width (e.g., diameter) of the capsule 206, so that the central portion 152 can slide within the channel 230 of the capsule 206 during movement of the clip arm 204 between the open and closed configurations and facilitate release of the capsule 206 from the bushing 222 of the proximal portion 218 during deployment. In particular, when the first portion 244 is separated from the second portion 242 at the stress concentration neck 248, the proximal end 208 of the clip arm 204 is released from the overhang 260, allowing the locking lugs 236 of the clip arm 204 to spring outward to engage the locking windows 234 of the capsule 206, thereby locking the clip 202 in the closed configuration.

[0056] As the user continues to apply a proximal force to the control member 212, the second portion 242 moves proximally beyond the proximal end 224 of the balloon 206, causing the side surfaces 264 defining the width of the central portion 252 to push the inwardly curled lugs 232 of the balloon 206 radially outward, away from the centerline of the balloon 206, to disengage the balloon 206 from the sleeve 222, releasing the clip 202 from the proximal portion of the device 200, so that it can remain in the body clamped over the target tissue when the proximal portion of the device 200 is removed from the body. It should be understood by those skilled in the art that the clamping device 200 can be used in a substantially similar manner to the clamping device 100, so that only the clip 202 remains in the body and no part of the device 200 falls out of the body.

[0057] like Figures 7 to 8 As shown, the clamping device 300 is substantially similar to the clamping device 200 described above, and includes a clamp 302 movable between an open configuration and a closed configuration, the clamp 302 being releasably coupled to a proximal portion 318 of the device 300 via a detachable connection between a sleeve 322 at a distal end of the proximal portion 318 and a capsule 306 of the clamp 302. The clamping device 300 includes a yoke 314 coupling a control member 312 to a pair of clamp arms 304 of the clamp 302, which is used to move the clamp arms 304 relative to the capsule 306 to move the clamp arms 304 between the open and closed configurations, as described above.

[0058] The yoke 314 also maintains the desired alignment between the clamp arms 304. Similar to the yoke 214, the yoke 314 includes a central portion 352 sized and shaped to be received between the proximal ends 308 of the clamp arms 304, a cantilever 360 that constrains the clamp arms 304 in the unlocked configuration (where the locking lugs 336 at the proximal ends 308 remain out of engagement with the locking windows 334 of the capsule 306), and a protrusion 350 extending from an opposing surface 362 of the central portion 352 that is received within an opening extending through the proximal ends 308 of the clamp arms 304 to maintain the desired alignment between the clamp arms.

[0059] The center portion 352 is sized, shaped, and configured to be substantially similar to the center portion 252 of the clamping device 200. Rather than a pair of bosses defining a stress concentrating neck positioned at the separation point between the first and second portions of the center portion during deployment, in this embodiment, the yoke 314 includes a slot 346 extending through the tab 350 that reduces the cross-sectional area of ​​the tab 350, thereby creating a weakened location at which the tab 350 will break and the clip 302 cannot be deployed, as will be described in more detail below.

[0060] In one embodiment, each of the slots 346 is formed in a portion of the protrusion 350 proximate to the opposing surface 362, so that when a predetermined force is applied thereto, the protrusion 350 breaks at that location, thereby releasing the proximal end 308 of the clamp arm 304 from the yoke 314. In particular, when the target tissue has been clamped between the clamp arms 304 as desired, the control member 312 is moved proximally relative to the capsule 306 until the engagement features of the clamp arms 304 engage the capsule 306, thereby preventing the clamp arms 304 from further proximal movement relative to the capsule 306. When the user further applies a proximally directed force to the control member 312, the capsule 306 applies a force on the protrusion 350 until a predetermined force is reached, at which the protrusion 350 breaks and releases the proximal end 308 therefrom, thereby releasing the proximal end 308 of the clamp arm 304 to spring radially outward under its natural bias, so that the locking features of the clamp arms 304 engage the corresponding locking features of the capsule 306.

[0061] For example, the proximal end 308 springs outwardly away from the centerline of the capsule 306, causing the locking lugs 336 extending from the proximal end 308 to engage the locking windows 334 of the capsule 306. At this point, the yoke 314 is separated from the clamp arm 304 and the user further pulls the control member 312 proximally until the side surfaces 364 of the central portion 352 defining its width engage the inwardly curled lugs 332 at the proximal end 324 of the capsule 306 to move the lugs 332 radially outwardly out of engagement with the bushing 322. It will be appreciated by those skilled in the art that the clamping device 300 can be used in a manner substantially similar to the clamping devices 100, 200. It will also be appreciated by those skilled in the art that in this embodiment any dislodged portions (e.g., broken protrusions 350) will remain captured in the clip 302, thereby preventing the dislodged portions from interfering with the closed target tissue.

[0062] It will be apparent to those skilled in the art that various modifications can be made to the present invention without departing from the scope of the invention.

[0063] The expressions "coupled" and "connected" and their derivatives may be used to describe some embodiments. These terms are not intended to be synonymous with 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" may also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0064] As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the terms "include" or "comprises" when used herein indicate the presence of the features, regions, steps, elements and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and / or groups thereof.

[0065] In addition, the terms "substantially" or "substantially" and the terms "approximately" or "approximately" are used interchangeably in some embodiments and can be described using any relevant measurement values ​​acceptable to a skilled person. For example, these terms can be used as a comparison to a reference parameter to indicate a deviation that still provides the intended function. Although non-limiting, the deviation from the reference parameter can be, for example, less than 1%, less than 3%, less than 5%, less than 10%, less than 15%, less than 20%, etc. in quantity.

[0066] Although specific embodiments have been shown and described herein, it should be understood that any arrangement calculated to achieve the same purpose may replace the specific embodiments shown. The present invention is intended to cover any and all adaptations or modifications of the various embodiments. It should be understood that the above description is in an illustrative manner, rather than a restrictive manner. After reviewing the above description, the combination of the above-described embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art. Therefore, the scope of the various embodiments includes any other application in which the above-described compositions, structures, and methods are used.

[0067] Although the subject matter has been described in language specific to structural features and / or methodological acts, it is to be understood that 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 example forms of implementing the claims.

Claims

1. A clamping system comprising: an applicator including a flexible member extending from a proximal end that remains outside the body in an operative configuration to a hub at a distal end thereof that is inserted into the body in the operative configuration to a site adjacent to a target tissue to be clamped, the applicator including a control member extending therethrough; and a clip releasably attached to the sleeve, the clip comprising a capsule having a passage extending therethrough, and a pair of clip arms having proximal ends slidably received within the passage to move the clip arms between an open configuration and a closed configuration, the clip comprising: a tensile member including a distal portion and a proximal portion, each of the distal portion and the proximal portion being sized and shaped to be received between the proximal ends of the clamp arms; and a pair of protrusions extending from opposing surfaces of the proximal portion to be received within openings extending through the proximal ends of the clamp arms to maintain a desired alignment of the clamp arms relative to each other, the proximal portion including a relief defining a pair of fingers, the proximal ends of the fingers being spaced apart from each other; and a yoke attached to the distal end of the control member such that movement of the control member within the flexible member moves the yoke relative to the capsule to move the clamp arms between the open and closed configurations, the yoke including a central portion sized and shaped to be received between the proximal ends of the clamp arms, the central portion including a recess at a distal end thereof sized and shaped to releasably receive the fingers of the stretch member, the fingers being configured to flex toward each other when subjected to a predetermined force such that the fingers are released from the recesses to disengage the stretch member from the yoke.

2. The system of claim 1 , wherein the outer surface of each of the fingers is circular and the recess formed in the central portion is correspondingly circular such that the fingers are retained within the recess until the predetermined force is applied thereto.

3. A system according to claim 1, wherein the proximal end of the capsule includes a lug that is radially biased inward to engage a corresponding structure of the sleeve, and the size and shape of the central portion of the yoke are configured to cause the lug to move radially outward when the distal end of the control member moves proximally beyond the proximal end of the capsule to separate the clip from the proximal portion of the stretch member.

4. The system of claim 1 , wherein the yoke includes a pair of overhangs extending distally from a proximal end of the central portion such that the proximal ends of the clamp arms are constrained between the central portion and the overhangs toward an unlocked configuration.

5. The system of claim 4, wherein the proximal ends of the clamp arms are biased radially outwardly such that in the unlocked configuration, a locking structure at the proximal ends of the clamp arms is prevented from engaging a corresponding locking feature of the capsule.

6. A system according to claim 5, wherein the locking structure includes locking lugs extending from the proximal end of the clamp arm, and the locking feature of the capsule includes windows extending laterally through its wall, so that when the proximal end of the clamp is released from the distal end of the control member, each of the locking lugs is received in one of the locking windows to lock the clamp in the closed form.

7. The system of claim 1, wherein the clamp arm includes an engagement feature configured to engage a portion of the balloon such that when the engagement feature engages the balloon, the clamp arm is prevented from further proximal movement relative to the balloon.

8. A clamping system comprising: an applicator including a flexible member extending from a proximal end that remains outside the body in an operative configuration to a distal end that is inserted into the body in the operative configuration to a site adjacent to a target tissue to be clamped, the applicator including a control member extending therethrough; and a clip releasably coupled to the applicator via a sleeve at the distal end of the flexible member, the clip comprising: a balloon extending from a proximal end to a distal end and having a passage extending therethrough; a pair of clamp arms, the proximal ends of the pair of clamp arms being slidably received within the channel to enable the clamp arms to move between an open configuration and a closed configuration; and a yoke attached to the control member such that movement of the control member within the flexible member moves the yoke within the capsule to move the clamp arms between the open configuration and the closed configuration, the yoke including a central portion sized and shaped to be received between the proximal ends of the clamp arms, projections extending from opposing surfaces of the central portion to be received within openings extending through the proximal ends of the clamp arms to maintain a desired alignment of the clamp arms relative to each other, and a slot extending along the central portion such that when a predetermined force is applied to the yoke, the yoke separates from the remainder of the yoke via a portion defined by the slot to release the clamp arms from the control member, The yoke includes an overhang extending distally from a proximal end of the central portion such that the proximal end of the clamp arm is constrained between the central portion and the overhang toward an unlocked configuration.

9. The system of claim 8, wherein the slot extends from a distal end of the central portion of the yoke along opposite sides of the protrusion to define a stress concentrating neck, the yoke being configured to separate along the stress concentrating neck during deployment of the clip.

10. The system of claim 8, wherein the slot extends through the protrusion proximate to the opposing surface of the central portion such that when the predetermined force is applied thereto, the protrusion breaks to release the clamp arm from the control member.

11. A system according to claim 8, wherein the proximal end of the capsule includes a lug that is radially biased inward to engage a corresponding structure of the sleeve, and the size and shape of the central portion of the yoke are configured to cause the lug to move radially outward when the distal end of the control member moves proximally beyond the proximal end of the capsule to separate the clip from the applicator.

12. The system of claim 8, wherein the slot extends through the protrusion proximate to an opposing surface of the central portion to reduce a cross-sectional area of ​​the protrusion.

13. The system of claim 8, wherein the proximal ends of the clamp arms are biased radially outwardly such that in the unlocked configuration, a locking structure at the proximal ends of the clamp arms is prevented from engaging a corresponding locking feature of the balloon.

14. A system according to claim 13, wherein the locking structure includes locking lugs extending from the proximal end of the clamp arm, and the locking feature of the capsule includes windows extending laterally through its wall, so that when the proximal end of the clamp is released from the distal end of the control member, each of the locking lugs is received in one of the locking windows to lock the clamp in the closed form.

15. The system of claim 8, wherein the clamp arm includes an engagement feature configured to engage a portion of the balloon such that when the engagement feature engages the balloon, the clamp arm is prevented from further proximal movement relative to the balloon.

16. A clamping device comprising: a clamp including a capsule and a pair of clamp arms, each proximal end of the clamp arms being slidably received within the capsule and including an opening extending therethrough; a flexible member extending from a proximal end that remains outside the body to a distal end, the distal end including a sleeve; a tensile member including a pair of fingers and a pair of protrusions extending from opposing surfaces thereof and configured to be received within openings at proximal ends of the clamp arms to maintain a desired alignment between the clamp arms; and A yoke is attached to the distal end of the control member such that movement of the control member within the flexible member causes the yoke to move relative to the capsule to move the clamp arm between an open configuration and a closed configuration, the yoke releasably receiving the pair of fingers therein such that when a predetermined force is applied to the control member, the pair of fingers flex together, thereby disengaging the tensile member from the yoke and deploying the clamp.

17. A device according to claim 16, wherein the outer surface of each of the fingers is circular, and each of the fingers is received in a corresponding circular recess at the distal end of the yoke so that each of the fingers remains in the corresponding circular recess until the clip is deployed.

18. A device according to claim 16, wherein the proximal end of the capsule includes a lug biased radially inward to engage a corresponding structure of the sleeve, and the yoke is configured to move the lug radially outward when the distal end of the control member moves proximally beyond the proximal end of the capsule to separate the clip from the tensile member.

19. The device of claim 16, wherein the yoke includes a pair of overhangs extending distally from a proximal end thereof such that a locking structure at the proximal end of the clamp arm is constrained between a central portion of the yoke and the overhangs.

20. The device of claim 19, wherein the proximal ends of the clamp arms are biased radially outwardly such that the locking structure at the proximal ends of the clamp arms is prevented from engaging a corresponding locking feature of the capsule when retained between the central portion of the yoke and the overhang.

21. A device according to claim 20, wherein the locking structure includes locking lugs extending from the proximal end of the clamp arm, and the locking feature of the capsule includes a seat formed in the wall of the capsule, so that when the proximal end of the clamp arm is no longer constrained by the overhang, each of the locking lugs springs outward and locks in one of a plurality of locking windows, thereby locking the clip in the closed configuration.

22. The device of claim 16, wherein each of the clamp arms includes an engagement feature configured to engage a corresponding portion of the balloon such that when the engagement feature engages the balloon, the clamp arm is prevented from further proximal movement relative to the balloon.

23. A clamping device comprising: a clamp including a capsule and a pair of clamp arms, each proximal end of the clamp arms being slidably received within the capsule and including an opening extending therethrough; a flexible member extending from a proximal end that remains outside the body to a distal end, the distal end including a sleeve; and A yoke is attached to the distal end of the control member such that movement of the control member within the flexible member causes the yoke to move proximally and distally relative to the capsule to move the clamp arms between an open configuration in which the distal ends of the clamp arms extend distally from the capsule and separate from each other, and a closed configuration in which the clamp arms are drawn proximally into the capsule so that the capsule forces the distal ends of the clamp arms toward each other, the yoke including a pair of protrusions extending from opposing surfaces thereof, each of the protrusions being configured to be received in a corresponding one of the openings in the proximal ends of the clamp arms to maintain a desired alignment between the clamp arms, wherein the yoke is configured to separate when a predetermined force is applied thereto to deploy the clamp.

24. The device of claim 23, wherein the yoke includes a slot extending from a distal end of the yoke along opposite sides of the protrusion to define a stress concentrating neck, the yoke being configured to separate along the stress concentrating neck during deployment of the clip.

25. The device of claim 23, wherein the yoke includes a slot extending through the protrusion proximate an opposing surface of the yoke such that when the predetermined force is applied thereto, the protrusion breaks to release the clamp arm from the control member.

26. A device according to claim 23, wherein the proximal end of the capsule includes a lug biased radially inward to engage a corresponding structure of the bushing, and the yoke is configured to move the lug radially outward when the distal end of the control member moves proximally beyond the proximal end of the capsule to separate the clip from the bushing.

27. The device of claim 23, wherein the yoke includes an overhang extending distally from a proximal end thereof such that a proximal end of each of the clamp arms is constrained in an unlocked configuration between a central portion of the yoke and the overhang.

28. The device of claim 27, wherein the proximal ends of the clamp arms are biased radially outward, and wherein the clamp arms are retained in the unlocked configuration by the overhang so that a locking structure at the proximal ends of the clamp arms is prevented from engaging a corresponding locking feature of the capsule.

29. A device according to claim 28, wherein the locking structure includes a locking lug extending from the proximal end of the clamp arm, and the locking feature of the capsule includes a seat formed in the wall of the capsule, so that when the proximal end of the clamp is released from the distal end of the control member, each of the locking lugs is received in a corresponding one of a plurality of locking windows, thereby locking the clamp in the closed form.

30. The device of claim 23, wherein the clamp arm includes an engagement feature configured to engage a portion of the balloon such that when the engagement feature engages the balloon, the clamp arm is prevented from further proximal movement relative to the balloon.

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