Hemostatic clamp unfolding device

Abstract

An apparatus includes a clamp including a sheath and a pair of clamp arms whose proximal ends are slidably received within a channel of the sheath to move the clamp arms between an open configuration and a closed configuration. The clamp arms are aligned relative to each other via a pin received within an opening extending through proximal ends of the clamp arms. The proximal portion includes a flexible shaft extending from a proximal end to a distal end, the flexible shaft including a bushing releasably coupled to the sheath. A control member extends longitudinally through the flexible shaft from a proximal end to a distal end, the distal end being releasably coupled to the proximal end of the clamp arm, the distal end of the control member including a pair of retention jaws, each retention jaw including a pair of fingers extending around the pin along opposite sides of the pin to grasp the pin therebetween.

Description

This application is a divisional application of invention patent 202080029608.0. Priority declaration

[0001] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 62 / 853,334, filed on May 28, 2019; the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to endoscopic devices and, in particular, to endoscopic gripping devices for treating tissue along the gastrointestinal tract. Background Art

[0003] During endoscopic gastrointestinal (GI) surgery, the patient may be at risk for perforation of the wall of the GI tract, or may require closure of the GI tract wall as part of the surgery. Hemostatic clamps can be used, for example, for endoscopic hemostasis of mucosal / submucosal defects, bleeding ulcers, arteries, polyps, diverticula, and closure of luminal perforations. Depending on the size of the defect, multiple clamps may be required. Summary of the invention

[0004] The present disclosure relates to a clamping device, comprising a clamp including a sheath extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, and a pair of clamping arms, the proximal ends of the pair of clamping arms being slidably received in the channel to move the clamping arms between an open configuration in which their distal ends are separated from each other and a closed configuration in which the distal ends of the clamping arms are pulled toward each other. The clamping arms are aligned relative to each other via pins received in an opening extending through the proximal ends of the clamping arms. The proximal portion is configured for insertion of the clamp through a working channel of an endoscope, the proximal portion including a flexible shaft extending from the proximal end to the distal end, the flexible shaft including a bushing releasably coupled to the sheath. The control member extends longitudinally from the proximal end through the flexible shaft to a distal end that is releasably connected to the proximal end of the clamp arm to move the clamp arm between open and closed configurations, the distal end of the control member including a pair of retaining claws, each retaining claw including a pair of fingers extending around the pin along opposite sides of the pin to grasp the pin therebetween.

[0005] In one embodiment, the proximal end of the sheath may include radially inwardly biased tabs to engage corresponding structure of the hub.

[0006] In one embodiment, the distal end of the control member may include a pair of spaced jaws configured to extend between the proximal ends of the clamp arms along opposite sides of the pin. The pair of spaced jaws are sized and shaped to move the tabs radially outward to deploy the clamp from the proximal portion of the device when the distal end of the control member moves proximally past the proximal end of the sheath.

[0007] In one embodiment, the proximal ends of the clamp arms may be biased radially outward.

[0008] In one embodiment, the pair of retaining claws may extend above the outer surface along the proximal end of a respective one of the clamp arms to constrain the clamp arm to an unlocked configuration in which the locking structure at the proximal end of the clamp arm is prevented from engaging a corresponding locking feature of the sheath.

[0009] In one embodiment, the locking structure may include a locking tab extending from the proximal end of the clamp arm, and the locking feature of the sleeve 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 tab is received within the locking window to lock the clamp in a closed structure.

[0010] In one embodiment, the clamp arm may be biased toward an open configuration such that the clamp arm is constrained toward the closed configuration via an inner surface of the sheath and returns to the biased open configuration when the clamp arm moves distally relative to the sheath.

[0011] In one embodiment, the clamp arm may include an engagement feature configured to engage a portion of the sheath such that when the engagement feature engages the sheath, the clamp arm is prevented from further proximal movement relative to the sheath and a predetermined force is exerted on the distal end of the control member.

[0012] The present disclosure relates to a clamping device, which includes a clamp and a pair of clamping arms, the clamp including a sheath extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, the proximal ends of the pair of clamping arms being slidably received in the channel to move the clamping arms between an open configuration in which the distal ends thereof are separated from each other and a closed configuration in which the distal ends of the clamping arms are pulled toward each other. The proximal portion is configured for inserting the clamp through a working channel of an endoscope, the proximal portion including a flexible shaft extending from the proximal end to the distal end, the flexible shaft including a bushing releasably coupled to the sheath. A control member extends from the proximal end through the flexible shaft to a distal end releasably coupled to the proximal ends of the clamping arms to move the clamping arms between the open and closed configurations, the distal end including an intermediate portion received between the proximal ends of the clamping arms. The first portion of the pin and the second portion of the pin extend away from opposing surfaces of the intermediate portion to be received in an opening extending through the proximal end of the clamp arm to maintain alignment of the clamp arms relative to each other, and when a predetermined force is applied to the clamp arm via the distal end, the first and second portions are pulled proximally out of the opening of the clamp arm and past the proximal edge thereof.

[0013] In one embodiment, each of the first and second portions may include a protrusion extending therefrom to extend over a portion of the outer surface along the proximal end of a corresponding one of the clamp arms to constrain the outwardly biased proximal end of the clamp arm toward an unlocked configuration in which the proximal end is constrained toward an intermediate portion received therebetween such that a locking structure along the proximal end of the clamp arm is prevented from engaging a corresponding locking feature of the sheath.

[0014] In one embodiment, each clamp arm may include a slot extending proximally from the opening to a proximal edge thereof to define two fingers that flex away from one another to release the pin therefrom when a predetermined force is exerted thereon.

[0015] In one embodiment, each clamp arm may include a protrusion along a longitudinal edge of the clamp arm immediately distal to the opening to facilitate bending of the two fingers away from each other.

[0016] In one embodiment, each clamp arm may include a notch extending along a surface thereof from the opening to a proximal edge thereof, such that when a predetermined force is applied thereon via the pin, the clamp separates along the notch to release the pin from the opening.

[0017] In one embodiment, the first and second portions of the pin may taper toward proximal ends thereof to separate each clamp arm along the notch.

[0018] In one embodiment, the proximal end of the sheath can include a radially inwardly biased tab to engage a corresponding structure of the sleeve, and the intermediate portion is sized and shaped to cause the tab to move radially outward to deploy the clamp from the proximal portion of the device when the distal end of the control member moves proximally past the proximal end of the sheath.

[0019] The present disclosure also relates to a method for treating a target tissue, the method comprising inserting a clamping device into a target site in a body through a working channel of an endoscope until a clamp of the clamping device extends distally past a distal end of the working channel. The clamping device comprises a sheath and a pair of clamping arms slidably received therein, the pair of clamping arms being aligned relative to each other via a pin extending through an opening, the opening extending through the proximal ends of the clamping arms. The clamping device moves between an open configuration, in which the distal ends of the clamping arms are separated from each other, and a closed configuration, in which the distal ends of the clamping arms are pulled toward each other via a control wire coupled to the clamping arms. The distal ends of the control wires are coupled to the proximal ends of the clamping arms via first and second retaining claws, each retaining claw comprising a pair of fingers extending around the pin along opposite sides of the pin to grip the pin therebetween. The clamping arms are pulled proximally into the sheath to move the clamp toward the closed configuration, thereby gripping the target tissue between the clamping arms. The clamp is deployed from the proximal portion of the clamping device by pulling the control member proximally relative to the sheath until a predetermined force is exerted on the distal end of the control wire to separate the fingers from each other and release the pin therebetween. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 showing a partially transparent perspective view of a portion of a clamping device in a pre-deployed configuration according to a first exemplary embodiment of the present disclosure; Figure 2 Shown in expanded configuration Figure 1 A partially transparent perspective view of a clamping device; Figure 3 Shows the Figure 1 A longitudinal side view of an expanded portion of the clamping device; Figure 4 shows a perspective view of a portion of a clamping device according to a second exemplary embodiment of the present disclosure; Figure 5 Shows Figure 3 A perspective view of a clamping arm and a control member of a clamping device; Figure 6 a perspective view showing a clamping arm and a control member according to a third exemplary embodiment of the present disclosure; and Figure 7 Shows Figure 5 An enlarged perspective view of the clamping arm and control member. DETAILED DESCRIPTION

[0021] The present disclosure may be further understood with reference to the following description and accompanying drawings, in which similar elements are referred to by the same reference numerals. The present disclosure relates to an endoscopic clamping device for treating tissue perforation, defect and / or bleeding. The clamping device may include a clamp including a clamping arm, the proximal end of which is slidably received in a sheath to move the clamp between an open configuration and a closed configuration as needed to clamp the target tissue. The clamping arm may be moved via a control member, such as a control line connected between the proximal end of the clamp and a handle of the device, the handle of the device being maintained outside the body accessible to the user during use. In some cases, a shorter deployment clamp may be preferred to improve visualization of the target site and allow better operability when multiple clamps are placed.

[0022] In addition, although the dislodged parts will normally pass naturally, some physicians are concerned that, particularly for larger defects, the dislodged portions produced during and / or after deployment of some current clamp designs may be captured in the defect after closure. An exemplary embodiment of the present disclosure describes a control member having a distal end that is configured to be directly and releasably coupled to a proximal end of a clamp arm so that when the clamp is deployed within the body, as will be described in further detail below, the control member separates from the clamp without leaving a portion of the deployment mechanism extending outside of the sheath, thereby reducing the potential length of the deployed clamp and / or the dislodged portions of the clamp entering the body. It should be understood by those skilled in the art that, as used herein, the terms proximal and distal are intended to refer to directions toward (proximal) and away from (distal) a user of the device.

[0023] like Figure 1-3 , a clamping device 100 for treating a tissue defect includes a clamp 102 including a pair of clamp arms 104 having a proximal end 108 slidably received within a sheath 106 such that the clamp 102 can be moved between an open configuration in which distal ends 110 of the clamp arms 104 are separated from each other and a closed configuration in which distal ends 110 are pulled toward each other. The clamp arms 104 are movable between the open configuration and the closed configuration via a control member 112 including a distal end 114 configured to be directly coupled to the proximal end 108 of the clamp arms 104.

[0024] In an embodiment, the pin 116 extends through the proximal end 108 in a transverse direction of each clamp arm 104 via an opening 118 extending through each clamp arm 104. As will be described in further detail below, the distal end 114 of the control member 112 releasably engages the pin 116 and the proximal end 108 of the clamp arm 104, so that when attached to the pin 116, the proximal and distal movement of the control member 112 causes the clamp arm 104 to move proximally and distally relative to the sheath 106. When coupled to the pin 116, the distal end of the control member also constrains the proximal end 108 of the clamp arm 104 to prevent the clamp arm 104 from locking in the sheath 106 until it is desired to lock the clamp 102 in place on the target tissue. The clamp 102 is releasably coupled to the proximal portion 120 of the device 100 to facilitate insertion of the clamp device 100 into the target site.

[0025] The proximal portion 120 comprises an elongated member housing a control member 112 and connects the clamp 102 to a handle and / or actuator that remains external to the body accessible to a user during use to permit the user to control movement of the device 100 between an open configuration and a closed configuration and to deploy the clamp 102 over target tissue. The proximal portion 120 may comprise, for example, a flexible shaft 121 extending from a proximal end connected to a user-operable handle member (not shown) external to the patient to a distal end 122, wherein the flexible shaft comprises controls for moving and deploying the device 100, the distal end being releasably coupled to a proximal end 124 of the sheath 106 via, for example, a bushing 126. The control member 112 extends through the flexible shaft 121 from a proximal end connected to a portion of the handle member to a distal end 114 connected to the clamp arm 104.

[0026] The sleeve 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 bushing 126 via a tab 132 that, for example, curls radially inwardly to engage a corresponding portion of the bushing 126 at the distal end 122 of the flexible shaft 121. Although not shown, the distal end 128 may include an inwardly bent tab extending through the opening of the passage 120 to prevent the proximal end 108 of the clamp arm 104 from passing distally therethrough when the clamp 102 is moved to the open configuration. The sleeve 106 also includes a locking feature formed in the sleeve wall, such as, for example, a locking window 134 that extends transversely through the sleeve wall to engage a locking tab 136 of the clamp arm 104, which will be described in further detail below.

[0027] Each clamp arm 104 extends from a proximal end 108 to a distal end 110. As described above, the proximal portion of the clamp arm 104 is slidably received within the channel 130 of the sheath 106. Specifically, the proximal end 108 of each clamp arm 104 is slidably received within the channel 130 to allow the clamp 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 the sheath 106 is pulled proximally, the clamp arms 104 are constrained by the walls of the sheath in the closed position, and the distal ends 110 are adjacent to each other. When the clamp arms 104 move distally to further extend out of the sheath 106, the clamp arms 104 are not constrained by the sheath 106 and return to the open configuration under their natural bias. Those skilled in the art will appreciate that any number of other mechanisms for opening and closing the clamp arms may be employed.

[0028] The clamp arm 104 of this embodiment also includes an engagement feature 138 extending therefrom and configured to engage a portion of the sheath 106 such that when the engagement feature 138 engages the sheath 106, the clamp arm 104 is prevented from further proximal movement relative to the sheath 106. In one embodiment, the engagement feature 138 extends laterally outward from a portion of the clamp arm 104 such that when the clamp arm 104 is pulled proximally relative to the sheath 106, the engagement feature 138 abuts a portion of the distal surface 129 of the sheath 106. The engagement feature 138 is positioned along the clamp arm 104 such that at the point at which the engagement feature 138 has engaged the sheath 106, the clamp arm 104 has been pulled proximally into the sheath 106 sufficiently to pull the clamp arm 104 together into the closed configuration. In one example, the engagement feature 138 is configured as a wing extending laterally from a longitudinal edge of the clamp arm 104.

[0029] The proximal end 108 of the clamp arm 104 also includes a locking tab 136 extending therefrom. In an embodiment, the proximal end 108 is biased outwardly, radially away from the centerline of the sheath 106, but is constrained and prevented from engaging the wall of the sheath 106 while the distal end 114 of the control member 112 remains coupled to the clamp 112. When the clamp 102 is deployed, the control member 112 is released from the clamp 102, and the locking tab 136 is released to spring outwardly to engage the locking window 134, thereby locking the clamp arm 104 in a closed configuration on the target tissue. The proximal end 108 of the clamp arm 104 also includes an opening 118 that permits the pin 116 to extend through each clamp arm 104, thereby maintaining the clamp arms 104 in a desired alignment relative to each other. In one embodiment, the length of the pin 116 in this embodiment substantially corresponds to the width (eg, diameter) of the sheath 106 such that the pin 116 slides along the inner surface of the sheath 106 when the clamp arm 104 moves longitudinally relative to the sheath 106 .

[0030] The distal end 114 of the control member 112 is releasably coupled to the proximal end 108 of the clamp arm 104, thereby maintaining the proximal end 108 in a radially depressed position separated from the inner surface of the sheath 106 to prevent the locking tab 136 from engaging the locking window 134 until the control member 112 is separated from the clamp arm 104. As will be described in more detail below, the distal end 114 is sized and shaped to disengage the sheath 106 from the bushing 126 during deployment of the clamp 102. In the pre-deployment configuration, as shown in FIG. Figure 1 , the distal end 114 releasably engages the pin 116 such that proximal and distal longitudinal movement of the control member 112 relative to the sheath 106 results in corresponding movement of the clamp arm 104 relative to the sheath 106 .

[0031] In one embodiment, the distal end 114 includes first and second jaws 140, 142 and first and second retaining jaws 144, 146 for engaging the clamp arm 104 and the pin 116. In particular, the first and second spaced jaws 140, 142 extend between the proximal ends 108 of the clamp arm 104 (such that the inner surface of the clamp arm 104 facing the central axis of the sheath 106 radially engages the outer surface of the jaws 140, 142). The first spaced jaw 140 extends along a first side of the pin 116, while the second spaced jaw 142 extends along a second side of the pin 116 that is substantially opposite the first side. The first and second spaced jaws 140, 142 extend between the clamp arms 104 to hold the proximal ends 108 away from each other so as to act as a positive stop on the distal end 128 of the sheath 106 when the clamp 102 is in the open configuration, and as will be described in further detail below, to facilitate the release of the sheath 106 from the proximal portion 120 during deployment.

[0032] Each of the first and second retaining claws 144, 146 extends on an outer surface of the proximal end 108 of a corresponding one of the clamp arms 104 to constrain the proximal end 108 of the clamp arms 104 and prevent the clamp arms 104 from lockingly engaging the sheath 106 until the clamp is deployed. In particular, the first retaining claw 144 extends along a surface of the first of the clamp arms 104 facing away from the centerline of the sheath 106, and the second retaining claw 146 extends along a surface of the second of the clamp arms 104 facing away from the centerline of the sheath 106. Each of the first and second retaining claws 144, 146 includes a pair of fingers 150 extending around opposite sides of the pin 116, with distal ends 152 of the fingers 150 bent around the distal surface of the pin 116 to grasp the pin 116 until the claws 140, 142, 144 and 146 are separated from the clamp 102 and the clamp 102 is deployed.

[0033] Those skilled in the art will appreciate that in another embodiment, the distal ends 148 of the first and second spaced jaws 140, 142 may also be bent toward each other to wrap around at least a portion of the distal surface of the pin 116, thereby providing additional retention / gripping force on the pin 116 until it is desired to deploy the clamp 102. Alternatively, according to another embodiment, the distal ends 148 of the first and second spaced jaws 140, 142 may be bent to grip the pin 116, while the fingers 150 of the first and second retaining jaws 144, 146 extend only along opposite sides of the pin 116 to constrain the proximal ends 108 of the clamp arms 104, thereby preventing the clamp arms 104 from lockingly engaging the sheath 106 until deployment.

[0034] As described above, the distal end 114 of the control member 112 is coupled to the pin 116 and the proximal end 108 of the clamp arm 104 so that the clamp 102 can be moved between the open configuration and the closed configuration via movement of the control member 112. When the clamp arm 104 is pulled proximally into the sheath 106 until the engagement feature 138 engages the sheath 106 to prevent the clamp arm 104 from further proximally moving relative to the sheath 106, the proximally directed force applied to the control member 112 increases, and the tension applied to the control member 112 increases until the fingers 150 of the first and second retaining jaws 144, 146 separate from each other to release the pin 116 from the control member 112, thereby freeing the proximal end 108 of the clamp arm 104 to spring outward until the locking tab 136 engages the locking window of the sheath 106, thereby locking the clamp 102 in the closed configuration.

[0035] After the control member 112 is disengaged from the pin 116 and the proximal end 108 of the clamp arm 102, the user continues to pull the control member 112 proximally until the distal end 114 is received in the proximal end 124 of the sheath 106. The distal portion 114 is sized and shaped so that as it moves between the inwardly curled tabs 132, the tabs 132 are pushed radially outward, disengaging the sheath 106 from the bushing 126 and separating the clamp 102 from the proximal portion 120 of the device 100 so that the device 100 can be withdrawn from the body while the clamp 102 remains in place clamped on the target tissue.

[0036] In one embodiment, the outer surfaces 154 of the first and second spaced apart prongs 140, 142 extend radially a selected distance away from the centerline of the sheath 106 such that the prongs 140 and 142 abut the curled tabs 132 and push the tabs 132 radially outward as the distal end 114 of the control member 112 moves proximally therethrough. In this embodiment, the distance between the outer surfaces 154 of the first and second portions 140, 142 substantially corresponds to the width (e.g., diameter) of the channel 130 of the sheath 106 away from the inwardly curled tabs 132. Figure 2 1, the internal passageway of the bushing 126 is sized and shaped to receive the distal end 114 of the control member 112 therein after the clamp 102 has been deployed. In this embodiment, no portion of the control member 112 affects the length of the deployed clamp 102, as shown in FIG. Figure 3 , and all portions of the control member 112 are removed from the body along with the proximal portion 120 of the clamping device 100 without any portions becoming dislodged within the body.

[0037] According to an exemplary method of using the clamping device 100, the clamp 102 is inserted into a target site in the body through a working channel of an endoscope, for example, while the handle member remains outside the body. The clamp 102 is inserted through the working channel in a closed configuration. Once the clamp 102 reaches the target site, the clamp arms 104 extend distally from the sheath 106 so that the clamp arms 104 move to an open configuration under their natural bias so that the target tissue can be received between the clamp arms 104. The user can operate the control member 112 as needed to move the clamp 102 between the open and closed configurations until the target portion of the tissue is positioned between the clamp arms 104. Then, the user pulls the control member 112 proximally (or pushes the proximal portion 120 distally on the control member 112) so that as more of the clamp arms 104 are received in the sheath 106, the clamp arms 104 are pulled toward each other to grasp the target tissue between the distal ends 110 of the clamp arms 104.

[0038] When the user is satisfied that the clamp 102 is in a desired position to grasp the target tissue, as described above, after the engagement feature 138 has engaged the sheath 106, the user applies an increasing proximally directed force to the control member 112 until the distal ends 152 of the fingers 150 of the retaining jaws 144, 146 separate from each other, thereby releasing the pin 116. As the pin 116 is released, the distal end 114 of the control member 112 also disengages from the proximal end 108 of the clamp arm 104, thereby releasing the proximal end 108 to spring outwardly away from the centerline of the sheath 106 until the locking tab 136 engages the locking window 134 of the sheath 106, thereby locking the clamp 102 in the closed configuration. The user then pulls the control member 112 further proximally relative to the sheath 106 until the distal end 114 engages the tabs 132 to push them outward to disengage the sheath 106 from the sleeve 126 and release the clamp 102 coupled to the target tissue. The control member 112 can then be withdrawn proximally until the distal end 114 is received within the sleeve 126 so that the proximal portion 120, along with the entire control member 112 received therein, can be removed from the body.

[0039] According to another exemplary embodiment of a clamping device 200, Figure 4-5 , is shown substantially similar to the clamp device 100 described above, and includes a clamp 202 including a pair of clamp arms 204 having proximal ends 208 slidably received within a sheath 206 such that the clamp 202 can be moved between an open configuration in which distal ends 210 of the clamp arms 204 are separated from one another and a closed configuration in which distal ends 210 are pulled toward one another. As described above, the clamp arms 204 are moved between the open and closed configurations via a control member 212, and the control member 212 includes a distal end 214 configured to be directly coupled to the proximal ends 208 of the clamp arms 204. The sheath 206, the clamp arms 204, and the proximal portion 220 of the clamp device 200 to which the sheath 206 is releasably coupled are substantially similar to the corresponding elements of the device 100 described above. In this embodiment, a pin 216 received within an opening 218 extending through the proximal end 208 of the clamp arm 204 is integrally formed with the control member 212 and defines a portion of the distal end 214 of the control member 212 such that the pin 216 is pulled out of the opening 218 during deployment of the clamp 202, as will be described in further detail below.

[0040] The control member 212 is substantially similar to the control member 112 and extends from a proximal end connected to a portion of the handle member through a proximal portion 220 to a distal end 214 that is releasably coupled to the proximal ends 208 of the clamp arms 204. However, the distal end 214 includes an intermediate portion 240 that is sized and shaped to be received between the proximal ends 208 of the clamp arms 204 and has a width that substantially corresponds to the width (e.g., diameter) of the sleeve 206. The pin 216 is defined via a first portion 244 that extends laterally away from a first surface of the intermediate portion 240 to be received within the opening 218 of the first clamp arm 204 and a second portion 246 that extends laterally away from a second surface of the intermediate portion 240 that is opposite the first surface of the intermediate portion 240 to be received within the opening 218 of the second clamp arm 204. Each of the first and second portions 244, 246 also includes a longitudinally extending tab 242 that is configured to engage an outer surface of the clamp arm 204 (e.g., a surface along the proximal portion 208 of the clamp arm 204 that faces away from the centerline of the sleeve 206) to constrain the proximal end 208 toward the centerline of the sleeve 206 to prevent the locking tab 236 extending from the proximal end 208 from engaging the locking window 234 of the sleeve 206 before the clamp 202 is deployed.

[0041] The clamp arm 204 is substantially similar to the clamp arm 104, extending from a proximal end 208 to a distal end 210, and includes an opening 218 extending through the proximal end 208 to receive a pin 216. As described above with respect to the device 100, the pin 216 is received within the opening 218 and maintains the clamp arms 204 in a desired alignment relative to each other. However, each of the clamp arms 204 includes a longitudinal slot 258 extending proximally from the opening 218 to a proximal edge 259 of the clamp arm 204 to define a pair of fingers 264 extending proximally from the opening 218 and separated by the slot 258. The width of the slot 258 is less than the width of the opening 218 and the pin 216 received therein, so that simply moving the clamp arm 204 between the open and closed configurations via the control member 212 does not disengage the control member 212 from the clamp arm 214. Each clamp arm 204 also includes a protrusion 260 formed along a longitudinal edge 262 of the clamp arm 204 proximal to the distal side of the opening 218, such that when a predetermined proximal force is applied to the distal end 214 relative to the clamp arm 204, the protrusion 260 allows the pair of fingers 264 to bend away from each other, thereby releasing the pin 216 from the control member 212.

[0042] The clamp device 200 can be used in a manner substantially similar to the clamp device 100. In particular, when inserted into a target site within a body, the clamp 202 can be moved between open and closed configurations until a target portion of tissue is received between the distal ends 210 of the clamp arms 204, as desired. Once the target tissue has been grasped as desired, the control member 212 is pulled proximally relative to the sheath 206 until the engagement features 238 of the clamp arms 208 engage the sheath 206, thereby preventing further proximal movement of the clamp arms 204 relative to the sheath 206. When the user is ready to deploy the clamp 202, the user further applies a proximally directed force to the control member 212 until the force applied by the pin 216 against the finger 264 causes the finger 264 to bend away from one finger, thereby allowing the pin 216 to move proximally through the widened slot 258, releasing the clamp arm 204 from the control member 212 and freeing the proximal end 208 of the clamp arm 204 to spring outward until the locking tab 236 engages the locking window 234 to lock the clamp 202 in the closed structure.

[0043] The user then further pulls the control member 212 proximally until the distal end 214 is pulled through the proximal end 224 of the sheath 206, forcing the outer surface 256 of the intermediate portion 240 to engage the curled tabs 232, thereby forcing the tabs 232 radially outward, disengaging from, for example, the bushing 226 of the proximal portion 220, and separating the clamp 202 from the proximal portion 220 of the device 200. The distal end 214 is pulled proximally into the bushing 226, allowing the proximal portion 220 and the control member 212 to be removed from the body. Similar to the device 100, the proximal portion 220 and the control member 212 of the device 200 can be removed from the body without any of the parts falling off.

[0044] Although the clamp arm 204 is shown and described as including a slot 258 through which the first and second portions 244, 246 of the pin 216 can pass to release the clamp arm 204 from the control member 212, those skilled in the art will appreciate that the pin 216 formed integrally with the remainder of the control member 212 can be released from the clamp arm 204 to lock and deploy the clamp 202 using other deployment mechanisms. For example, according to alternative embodiments, as Figure 6-7 , the clamp arm 304 releasably engages the control member 312 via its distal end 314, which includes an intermediate portion 340 received between the proximal ends 308 of the clamp arms 304. Pins 316 extending from opposing surfaces of the intermediate portion 340 are received within openings 318 along the proximal ends 308 of the clamp arms 304.

[0045] Similar to the device 200 described above, the pin 316 couples the clamp to the control member, maintains the desired alignment between the clamp arms 304, and also constrains the proximal end 308 in a radially inward unlocked configuration. The intermediate portion 340 is sized and shaped to allow the sheath to be disengaged from the proximal portion during deployment by, for example, moving the inwardly curled tabs of the sheath outwardly as the distal end 314 moves proximally therethrough. However, when a predetermined proximal force is applied to the proximal end via the pin 316, the proximal end 308 is configured to break and split, rather than extending proximally from the opening 318 of the clamp arm 304 to release the slot of the pin 316 during deployment.

[0046] In one embodiment, each clamp arm 304 includes a notch 358 extending from the opening 318 to its proximal edge 359 along the outer surface of the clamp arm 304. The notch 358 forms a weakened location that is configured to break when a predetermined force is applied thereon via the pin 316. Although the pin 316 and the opening 318 of the clamp arm 304 receiving the pin 316 can have any of a variety of shapes, in one example, the pin 316 has a substantially triangular cross-section that tapers toward its proximal end 317 and defines a cutting edge for cutting and / or breaking the notch when the pin 316 moves proximally against the notch 358. Similar to the pin 216, the end of the pin 316 may include a longitudinally extending tab or protrusion 342 for holding the proximal end 308 in an unlocked configuration until the pin 316 is pulled out of engagement with the proximal end 308. In this embodiment, the longitudinally extending tab 342 is substantially triangular. However, those skilled in the art will appreciate that the longitudinally extending tab 342 can have any of a variety of shapes, so long as the longitudinally extending tab 342 engages an outer surface of the proximal end 308 of the clamp arm 304 (e.g., a surface along the proximal portion 308 of the clamp arm 304 that faces away from the intermediate portion 340) to retain the proximal end 308 in an unlocked configuration.

[0047] Those skilled in the art will understand that Figure 6 and Figure 7 The strength of the deployment mechanism shown and described can be optimized for different applications based on the depth of the notch 358, the cutting edge angle of the pin 316, and the thickness of the material of the proximal end 308 of the clamp arm 304. Different configurations can be used to adjust the predetermined proximal force required for deployment to meet the deployment requirements of a variety of applications. Those skilled in the art will also understand that, including with respect to Figure 6 and Figure 7 The clamping device of the deployment mechanism shown and described may be used in a manner substantially similar to the clamping device 200 described above.

[0048] It will be apparent to those skilled in the art that various modifications can be made in the present disclosure without departing from the scope of the disclosure.

Claims

1. A clamping device, comprising: a flexible shaft extending from a proximal end configured to remain outside the body to a distal end configured to be inserted inside the body to a location proximal to a target tissue to be clamped; a clamp releasably coupled to the flexible shaft, the clamp comprising a sheath including a channel extending therethrough, and a pair of clamp arms having proximal ends slidably received within the channel to move the clamp arms between an open configuration and a closed configuration, the clamp comprising a pin within the sheath passing through an opening extending through the proximal ends of the clamp arms; as well as A control member extends longitudinally through the flexible shaft from a proximal end to a distal end, the distal end being releasably coupled to the clamp arm to move the clamp arm between the open configuration and the closed configuration, the distal end of the control member including a pair of fingers extending around opposite sides of the pin and grasping the pin.

2. The device of claim 1, wherein the flexible shaft comprises a sleeve at a distal end thereof that is releasably coupled to the clamp.

3. A device according to claim 1, wherein the distal end of the control member includes a pair of retaining claws, the first retaining claw includes a first pair of fingers, and the second retaining claw includes a second pair of fingers, the second pair of fingers extend around opposite sides of the pin and grasp the pin, and the first retaining claw and the second retaining claw are located on opposite sides of the longitudinal axis of the sleeve.

4. The device of claim 3 wherein the distal end of the control member includes a pair of spaced apart jaws configured to extend between the proximal ends of the clamp arms along opposite sides of the pin, the pair of spaced apart jaws being sized and shaped such that when the distal end of the control member moves proximally past the proximal end of the sheath to deploy the clamp from the proximal portion of the device, the pair of spaced apart jaws cause the tabs of the proximal end of the sheath to move radially outward.

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

6. The device according to claim 5, wherein: Each of the first and second retaining claws extends above the outer surface along the proximal end of a corresponding one of the clamp arms to constrain the clamp arm to an unlocked configuration in which a locking structure at the proximal end of the clamp arm is maintained in a radially inward position and is prevented from engaging a corresponding locking feature of the sleeve.

7. A device according to claim 6, wherein the locking structure includes a locking tab extending from the proximal end of the clamping arm, and the locking feature of the sleeve includes 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 tab is received in the locking window to lock the clamp in a closed structure.

8. The device according to claim 1, wherein: The clamp arm is biased toward the open configuration such that the clamp arm is restrained to the closed configuration via an inner surface of the sheath and returns to the biased open configuration when the clamp arm moves distally such that a distal portion of the clamp arm protrudes distally from the sheath.

9. The device according to claim 1, wherein: The clamp arm includes an engagement feature configured to engage a corresponding portion of the sheath such that when the engagement feature engages the corresponding portion of the sheath, the clamp arm is prevented from further proximal movement relative to the sheath.

10. A clamping device comprising: a clamp including a sheath having a passage extending therethrough, a pair of clamp arms having proximal ends slidably received within the passage to move the clamp arms between an open configuration and a closed configuration, and an alignment mechanism configured to align the clamp arms with one another; as well as a flexible shaft extending from a proximal end to a distal end, the distal end of the flexible shaft being releasably coupled to the clamp arm; A control member extends longitudinally through the flexible shaft, the distal end of the control member being releasably coupled to the proximal end of the clamp arm via a deployment mechanism including a first retaining claw having a pair of fingers configured to grasp a first portion of the alignment mechanism.

11. The device according to claim 10, wherein: The deployment mechanism includes a second retaining jaw having a pair of fingers configured to grasp a second portion of the alignment mechanism, the first retaining jaw and the second retaining jaw being located on opposite sides of a longitudinal axis of the sheath from each other.

12. The device of claim 11, wherein the alignment mechanism comprises a pin that passes through an opening in the clamp arm.

13. A device according to claim 11, wherein each of the first retaining claw and the second retaining claw extends above the outer surface of the proximal end of a corresponding clamping arm to restrict the clamping arm to an unlocked configuration, in which the locking structure at the proximal end of the clamping arm is maintained in a radially inward position and is prevented from engaging a corresponding locking feature of the sleeve.

14. A device according to claim 13, wherein the locking structure includes a locking tab extending from the proximal end of the clamping arm, and the locking feature of the sleeve includes a window extending laterally through its wall, the window being configured so that when the proximal end of the clamp is released from the control member, the locking tab is received within the locking window to lock the clamp in a closed structure.

15. The device according to claim 11, wherein The deployment mechanism includes a pair of spaced jaws configured to extend between the proximal ends of the clamp arms and to grasp the third portion of the alignment mechanism, the pair of spaced jaws configured to move tabs at the proximal end of the sheath radially outward when the deployment mechanism is moved proximally past the proximal end of the sheath to deploy the clamp from the flexible shaft.

16. A clamping device comprising: a clamp including a sheath having a passage extending therethrough and a pair of clamp arms, the sheath having proximal ends of the clamp arms slidably received within the passage to move the clamp arms between an open configuration in which the distal ends of the clamp arms are separated from one another and a closed configuration in which the distal ends of the clamp arms are brought closer together; an applicator configured to insert the clamp through a working channel of an endoscope, the applicator comprising a flexible shaft extending from a proximal end to a distal end, the distal end of the flexible shaft being releasably coupled to the clamp via a bushing and insertable into a living body adjacent to a target tissue; a control member extending longitudinally through the flexible shaft from the proximal end to the distal end; as well as a deployment mechanism configured to releasably couple the distal end of the control member to the proximal end of the clamp arm and maintain alignment of the clamp arms relative to each other, the deployment mechanism comprising: an intermediate portion received between the proximal ends of the clamp arms; a first protrusion extending from the first surface of the intermediate portion so as to be received through an opening in a first of the clamping arms; and a second protrusion extending from a second surface of the intermediate portion so as to be received through an opening in a second one of the clamping arms, the second surface being opposite the first surface, Wherein, when a predetermined force is applied to the deployment mechanism by the control member, the protrusion is configured to be pulled proximally out of the opening of the proximal end of the clamp arm and pass through the proximal edge thereof.

17. A device according to claim 16, wherein each of the protrusions includes a projection extending therefrom onto a portion of an outer surface of the proximal end of a corresponding one of the clamp arms to radially restrain the outwardly biased proximal end of the clamp arm radially inward in an unlocked configuration, wherein a locking structure along the proximal end of the clamp arm is prevented from engaging a corresponding locking feature of the sleeve.

18. The device of claim 17, wherein each of the clamp arms includes a slot extending proximally from the opening to the proximal edge to define two fingers that flex away from each other to release a corresponding one of the protrusions when a predetermined force is applied thereto.

19. The device according to claim 18, wherein: Each clamping arm includes a protrusion along a longitudinal edge immediately distal to the opening to facilitate bending the two fingers away from each other when a predetermined force is applied thereto.

20. The device of claim 16, wherein each clamp arm includes a notch extending along a surface thereof from the opening to the proximal edge, such that when a predetermined force is applied thereon via a corresponding one of the protrusions, the clamp arms separate along the notch to release the protrusion from the opening.

21. A clamping system comprising: The flexible shaft extends from a proximal end to a sleeve at a distal end, wherein in an operating state, the proximal end remains outside the living body, and the sleeve at the distal end is inserted into the living body to reach a position close to a target tissue to be clamped; a clamp releasably coupled to the bushing, the clamp comprising a sleeve having a passage extending therethrough, and a pair of clamp arms having proximal ends slidably received within the passage to move the clamp arms between an open configuration and a closed configuration, the clamp arms being aligned relative to each other by pins received within openings extending through the proximal ends of the clamp arms; as well as A control member extends longitudinally from a proximal end through the flexible shaft to a distal end, the distal end being releasably coupled to the proximal end of the clamp arm to move the clamp arm between the open configuration and the closed configuration, the distal end of the control member including a first retaining claw including a pair of fingers extending around opposite sides of the pin and grasping the pin.

22. The system of claim 21, wherein the control member includes a second retaining jaw including a pair of fingers extending around opposite sides of the pin and grasping the pin, the first and second retaining jaws being located on opposite sides of the longitudinal axis of the sheath from each other.

23. The system of claim 21, wherein the proximal end of the sheath includes a radially inwardly biased tab to engage a corresponding structure of the hub.

24. A system according to claim 23, wherein the distal end of the control member includes a pair of spacer claws configured to extend between the proximal ends of the clamping arms along opposite sides of the pin, and the pair of spacer claws are sized and shaped so that when the distal end of the control member moves proximally past the proximal end of the sheath to deploy the clamp from the flexible shaft, the pair of spacer claws cause the protrusions to move radially outward.

25. The system of claim 22, wherein: The proximal ends of the clamp arms are biased radially outward.

26. A system according to claim 25, wherein each of the first retaining claw and the second retaining claw extends along the outer surface of the proximal end of a corresponding one of the clamping arms to constrain the clamping arm to an unlocked configuration, in which the locking structure at the proximal end of the clamping arm is maintained in a radially inward position and is prevented from engaging a corresponding locking feature of the sleeve.

27. A system according to claim 26, wherein the locking structure includes a locking tab extending from the proximal end of the clamping arm, and the locking feature of the sleeve includes 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 tab is received in the locking window to lock the clamp in a closed structure.

28. The system of claim 21 , wherein the clamp arm is biased toward the open configuration such that the clamp arm is constrained toward the closed configuration via an inner surface of the sheath, and returns to the biased open configuration when the clamp arm moves distally such that a distal portion of the clamp arm protrudes distally from the sheath.

29. The system of claim 21, wherein each of the clamp arms includes an engagement feature configured to engage a corresponding portion of the sheath such that when the engagement feature engages the corresponding portion of the sheath, the clamp arm is prevented from further proximal movement relative to the sheath.

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