Multiple hemostatic clip system
Patent Information
- Application Number
- CN202580023277.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2024-04-02
- Filing Date
- 2025-02-27
- Publication Date
- 2026-10-30
Smart Images
Figure CN123022371A_ABST
Abstract
Description
Priority requirements
[0001] This invention claims priority to U.S. Provisional Patent Application Serial No. 63 / 573,201, filed April 2, 2024, the disclosure of which is incorporated herein by reference. Technical Field
[0002] This invention relates to endoscopic devices and, more particularly, to endoscopic clamping devices for treating tissues along the gastrointestinal tract. Background Technology
[0003] Physicians have become more willing to perform invasive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of GI tract wall perforation or may require closure of the GI tract wall as part of the procedure. Such procedures may include, for example, removal of large lesions, tunneling under the mucosal layer of the GI tract to treat submucosal tissue, full-thickness tissue removal, treatment of tissue in other organs by passing through the outside of the GI tract, and endoscopic treatment / repair of postoperative tissue (e.g., postoperative leakage, suture rupture, and anastomotic leakage).
[0004] Tissue can be treated via endoscopic closure devices, such as, for example, hemostatic clips inserted through the endoscope. However, in some cases, multiple clips are required to stop bleeding and / or close tissue defects. Typically, in these cases, each of the clips is inserted individually through the endoscope to treat the target area. Additionally, each individual clip is inserted into the target area via a single-use catheter, which must be disposed of after each clip deployment. Summary of the Invention
[0005] This invention relates to a clamping system for treating tissue, comprising a first clamp and a second clamp. The first clamp includes a first capsule and a first pair of clamping arms. The first capsule extends longitudinally from a proximal end to a distal end and includes a first channel extending therethrough. The proximal ends of the first pair of clamping arms are slidably received within the first channel to allow the first clamping arms to move between an open configuration and a closed configuration. In the open configuration, the distal ends of the first clamping arms are separated from each other to receive tissue therebetween, and in the closed configuration, the distal ends of the first clamping arms are pulled towards each other to clamp tissue therebetween. The proximal end of the first capsule includes a pivoting feature extending across its first channel.
[0006] The second clip includes a second capsule and a second pair of clip arms. The second capsule extends longitudinally from a proximal end to a distal end and includes a second channel extending therethrough. The proximal ends of the second pair of clip arms are slidably received within the second channel to allow the second clip arms to move between an open configuration and a closed configuration. In the open configuration, the distal ends of the second clip arms are separated from each other to receive tissue therebetween, and in the closed configuration, the distal ends of the second clip arms are pulled toward each other to clamp tissue therebetween. The distal ends of the second clip arms are configured to engage a pivot feature of the first clip, such that the first clip and the second clip are releasably and pivotally connected to each other in an insertion configuration.
[0007] In one embodiment, the system further includes a first core member received between and connected to the proximal ends of the first pair of clamping arms to engage the proximal ends of the first pair of clamping arms with each other. The first core member includes a locking feature movable between an unlocked mode and a locked mode. In the unlocked mode, the first core member is slidable within a first channel, and in the locked mode, the locking feature of the first core member engages a corresponding portion of the first capsule to lock the first pair of clamping arms in a closed mode. Additionally, the system includes a second core member received between and connected to the proximal ends of the second pair of clamping arms to engage the proximal ends of the second pair of clamping arms with each other. The second core member includes a locking feature movable between an unlocked mode and a locked mode. In the unlocked mode, the second core member is slidable within a second channel, and in the locked mode, the locking feature of the second core member engages a corresponding portion of the second capsule to lock the second pair of clamping arms in a closed mode.
[0008] In one embodiment, the system further includes a control member comprising an enlarged distal end and a remaining length extending therefrom proximally, wherein in an insertion configuration, the enlarged distal end is releasably received within a proximal portion of the first core member such that the remaining length passes through an opening extending through a pivot feature of the first clip, between the second clip arms, and through the second core member to a proximal end configured to be accessible by a user, the control member being longitudinally movable relative to the first capsule to move the first clip between an open configuration and a closed configuration.
[0009] In one embodiment, each of the first core member and the second core member includes an opening extending therethrough, the opening communicating with its cavity, the opening being configured to deform when subjected to a force exceeding a predetermined threshold to allow an enlarged distal end to pass through the opening.
[0010] In one embodiment, each of the first core member and the second core member is connected to a corresponding one of the first pair of clamping arms and the second pair of clamping arms via a connector received in a hole and through an elongated opening, the hole extending through the proximal end of each of the first and second clamping arms, and the elongated opening extending through each of the first core member and the second core member.
[0011] In one embodiment, the connector is slidable from the proximal end of the elongated opening to the distal end of the elongated opening to move a locking feature of a corresponding one of the first and second core members from an unlocked state to a locked state. The connector is configured to mate with a portion of the locking feature of a corresponding one of the first and second core members as the connector moves distally through its elongated opening.
[0012] In one embodiment, each of the first core member and the second core member is formed of a stamped metal sheet, the stamped metal sheet being sized and shaped to be bent into a form including a proximal portion and a distal portion, the proximal portion defining a cavity therein for receiving an enlarged distal end of a control member therein, and the distal portion including a locking feature.
[0013] In one embodiment, the pivoting feature includes a curved distal surface configured to pivotally engage a corresponding curved portion of the distal end of the second pair of clamping arms.
[0014] In one embodiment, the pivoting feature may be one of the following: a material machined into the first capsule, stamped from a portion of the wall of the first capsule, and formed from a separate element connected to the proximal end of the first capsule.
[0015] In one embodiment, the pivoting feature includes a pair of lugs extending from the proximal end of the first sac toward its centerline of opposite diameters, the spacing between the pair of lugs being configured to allow the remaining length of the control member to slide between them while preventing the enlarged distal end from passing through it.
[0016] In one embodiment, the pair of lugs are configured to break off from the first capsule when subjected to a force exceeding a predetermined threshold.
[0017] In one embodiment, the first capsule includes a stop located distal to the pivot feature, the stop being configured to prevent the second pair of clamping arms from moving proximally relative to the pivot feature of the first clamp when the distal ends of the second pair of clamping arms engage with the pivot feature of the first clamp in an insertion configuration.
[0018] In one embodiment, the stop is stamped from the material of the wall of the first bladder and bent radially inward.
[0019] In one embodiment, the distal end of the second pair of clamping arms includes an opening extending between its distal tips, the size, shape, and form of which are configured to allow the enlarged distal end of the control member to pass through it.
[0020] In one embodiment, the proximal portion of the second pair of clamping arms includes a longitudinal slot extending through and along it, the size, shape, and morphology of which are configured to allow the extended distal end of the control member to pass between the second pair of clamping arms.
[0021] Additionally, the present invention relates to a method for treating target tissue. The method includes inserting a plurality of clips into a target site within the body via a working channel of an endoscope. The plurality of clips includes a first distal clip and a second adjacent clip. The first clip includes a first capsule and a first pair of clip arms, the proximal ends of the first pair of clip arms being slidably received within the first capsule to allow the first clip to move between an open and closed configuration. The proximal end of the first capsule includes a pivot feature extending across a first channel of the first capsule. A second clip includes a second capsule and a second pair of clip arms, the proximal ends of the second pair of clip arms being slidably received within the second capsule. The second pair of clip arms are clamped above the pivot feature of the first clip so that the first and second clips are releasably and pivotally connected to each other in the insertion configuration. The first clip is moved between the open and closed configurations as needed until the target tissue is clamped therein. In the open configuration, the first pair of clip arms... The distal ends of the first pair of clamping arms are separated from each other to receive tissue therebetween. In the closed configuration, the distal ends of the first pair of clamping arms are pulled toward each other to clamp tissue therebetween. The first clamp is locked in the closed configuration by moving the locking feature of the first core member. The control member is connected to the first pair of arms via the first core member to move the first pair of clamping arms relative to the first capsule from the unlocked configuration toward the locked configuration. In the locked configuration, the locking feature engages the corresponding portion of the first capsule. The deployment of the first clamp is initiated by pulling the control member proximally until the force applied to the control member exceeds a predetermined threshold, such that the enlarged distal end of the control member received within a portion of the first core member causes deformation of the first core member, such that the control member is released from the first core member and pulled proximally between the second pair of clamping arms to engage the second core member connecting the proximal ends of the second pair of clamping arms.
[0022] In one embodiment, the method further includes moving the control member distally relative to the second capsule, such that the second pair of clamping arms move from a closed configuration toward an open configuration to release the pivoting feature of the first clamp, thereby separating the first clamp from the second clamp.
[0023] In one embodiment, during the deployment of the first clip, the lug against the pivot feature pulls the extended distal end of the control member proximally until the force applied thereon exceeds a predetermined threshold, thereby causing the lug to break off from the first capsule and separate the first clip from the second clip.
[0024] In one embodiment, the method further includes moving the second clamp between an open and a closed configuration as needed until the target tissue is clamped therebetween, in the open configuration the distal ends of the second pair of clamping arms are separated from each other to receive tissue therebetween, and in the closed configuration the distal ends of the second pair of clamping arms are pulled toward each other to clamp tissue therebetween; locking the second clamp in the closed configuration by moving a locking feature of the second core member, the control member being coupled to the second pair of arms via the second core member to move the second pair of clamping arms relative to the second capsule from an unlocked configuration toward a locked configuration, in the locked configuration the locking feature engages a corresponding portion of the second capsule; and initiating the deployment of the second clamp by pulling the control member proximally until the force applied to the control member exceeds a predetermined threshold, such that the enlarged distal end of the control member received within a portion of the first core member causes deformation of the first core member, thereby releasing the control member from the second core member.
[0025] In one embodiment, the distal ends of the second pair of clamping arms abut against a stop located distal to a pivot feature of the first bladder, such that the second clamp is prevented from moving distally relative to the first clamp when the plurality of clamps are inserted into the target area. Attached Figure Description
[0026] Figure 1 A cross-sectional side view of a clamping system according to an exemplary embodiment of the present invention is shown;
[0027] Figure 2 It shows the pivoting state Figure 1 A partially transparent side view of the clamping system;
[0028] Figure 3 It shows that according to Figure 1 Enlarged perspective view of the first and second clamps of the clamping system;
[0029] Figure 4 It shows that according to Figure 1 Enlarged cross-sectional side view of the first and second clamps of the clamping system;
[0030] Figure 5 An example of another exemplary embodiment is shown. Figure 1 A three-dimensional view of the pivoting characteristics of the clamping system;
[0031] Figure 6 It shows that according to Figure 1 A side view of the distal end of the clamp arm of the clamping system;
[0032] Figure 7 It shows that according to Figure 1 A three-dimensional view of the clamping arms of the clamping system;
[0033] Figure 8 It shows that according to Figure 1 A perspective view of an exemplary control component of a clamping system;
[0034] Figure 9 It shows the extension through according to Figure 1 A partial cross-sectional side view of the control component of the clamping system's core component;
[0035] Figure 10 The receipt is shown in accordance with Figure 1 A cross-sectional side view of the enlarged distal portion of the control component within the cavity of the core component of the clamping system.
[0036] Figure 11 A cross-sectional side view of a portion of a clamping system according to another exemplary embodiment of the present invention is shown, wherein a control member is received within a first clamp and a second clamp of the clamping system;
[0037] Figure 12 It shows Figure 11 A cross-sectional side view of a portion of the clamping system, wherein during the deployment of the first clamp, a control member engages the pivoting feature of the first clamp;
[0038] Figure 13 It shows Figure 11 A cross-sectional side view of a portion of a clamping system, wherein a pivot feature breaks to separate the first clamp from the second clamp and deploy the first clamp;
[0039] Figure 14 A side view of a clamping system according to another exemplary embodiment of the present invention is shown;
[0040] Figure 15 It shows that according to Figure 14 A three-dimensional view of the clamping system, with each of the multiple clamps clamping around the periphery of the target tissue defect; and
[0041] Figure 16 It shows that according to Figure 15 Another perspective view of the clamping system, where each suture connected to multiple clamps is tightened to close the target tissue defect. Detailed Implementation
[0042] The invention can be further understood with reference to the following description and accompanying drawings, wherein like elements are designated by like reference numerals. The present invention relates to an endoscopic clamping system for treating internal tissue perforations, defects, and / or bleeding. Exemplary embodiments of the invention describe a clamping system comprising a plurality of clamps that can be loaded within a single insertion device, such that multiple clamps can be deployed during a single pass through an endoscope or other insertion device.
[0043] Each of the first and second clips includes a pair of clamping arms, the proximal ends of which are slidable within the capsule to move between an open and a closed configuration. In the open configuration, the distal ends of the clamping arms are separated from each other to receive target tissue therebetween, and in the closed configuration, the distal ends of the clamping arms are pulled into the capsule such that the distal ends of the clamping arms move toward each other to clamp target tissue therebetween. The proximal end of each capsule includes a pivoting feature configured to connect adjacent clips to each other, while also allowing connected clips to be received between the jaws of an adjacent proximal clip in a pivoting manner relative to each other, such that multiple clips can be inserted along a tortuous path into a target site within the body (e.g., via a flexible insertion device inserted through a natural body orifice and through a natural body cavity). In another embodiment, the proximal end of the nearest clamp may be configured to be coupled via a connector to a control member extending through the insertion device.
[0044] During the deployment of the first clip (the farthest clip), for example, a second clip immediately adjacent to the first clip releases the pivoting feature of the first clip from between the jaws, thereby separating the first clip from the second clip. Those skilled in the art will understand that, as used herein, the terms proximal and distal are intended to refer to the direction toward (proximal) and away from (distal) the system, respectively.
[0045] Figures 1 to 10 A clamping system 100 for treating tissue defects is shown according to an exemplary embodiment, comprising a plurality of clamps 102, the clamps 102 being interconnected and configured to be inserted through a working channel of a flexible endoscope or other suitable insertion device to reach a target site in the body adjacent to the tissue to be treated by the first clamp 102. Figure 1 As shown, each of the clips 102 includes a pair of clamping arms 104, the proximal ends 106 of which are connected to each other via a core member 108 slidably received within a capsule 110, such that each of the clips 102 can move between an open and a closed configuration. In the open configuration, the distal ends 112 of the clamping arms 104 are separated from each other to receive tissue therebetween, and in the closed configuration, the distal ends 112 of the clamping arms 104 are pulled toward each other to clamp tissue. The proximal end 114 of the capsule 110 of each of the clips 102 includes a pivoting feature 116 configured to be received between the clamping arms 104 of adjacent proximal clips 102, such that adjacent clips 102 are connected to each other in a clip chain, while also allowing them to pivot relative to each other, as... Figure 2 As shown.
[0046] In one exemplary embodiment, the pivoting feature 116 of the first clip 102A in the clip 102 is received between the clip arms 104 of the second clip 102B adjacent to the first clip 102A, such that the first clip 102A and the second clip 102B are pivotally connected to each other, as shown below. Figure 2 As shown. Therefore, the chain of clips 102 can navigate through body cavities, even along the most tortuous paths, to a target site within the body. Although the exemplary embodiment shows and describes two clips 102—first clip 102A and second clip 102B—those skilled in the art will understand that the chain of clips 102 of the clamping system 100 can include any number of clips 102 while maintaining sufficient flexibility to navigate through tortuous paths through body cavities. For example, in another embodiment, the clamping system 100 can include ten clips 102. As will be described in further detail below, each of the clips 102 is movable between an open and closed configuration and is subsequently deployed via a control member 118, which includes an enlarged distal end 119 configured to releasably engage the core member 108 of the most distal clip of the clips 102.
[0047] As described above, each of the clips 102 includes a capsule 110 and a clamping arm 104 movable relative to the capsule 110, such that the clamping arm 104 moves between an open and closed configuration when it is retracted within the capsule 110 and extended distally out of the capsule 110. According to an exemplary embodiment, the capsule 110 extends from a proximal end 114 to a distal end 120 and includes a channel 122 extending therethrough. As described above, the proximal end 114 includes a pivoting feature 116 extending across the channel 122 of the capsule 110, the pivoting feature 116 having an opening extending through the pivoting feature 116 and configured such that a control member 118 can slidably pass through it.
[0048] like Figures 3 to 5 As shown, the pivot feature 116 includes a curved distal surface 126 configured to engage the clamp arm 104 of an adjacent clamp to form a hinge joint therebetween. An opening 124 extends coaxially through the pivot feature 116 relative to the axis of the channel 122 of the capsule 110, such that a length of the control member 118 can pass through the channel 122 of the capsule 110 and the pivot feature 116 in each of the clamps 102.
[0049] In one exemplary embodiment, such as Figures 3 to 4 As shown, the pivoting feature 116 is machined from a portion of the capsule 110; however, those skilled in the art will understand that the pivoting feature 116 can be formed in any of a variety of suitable manners. In another exemplary embodiment, as... Figure 5As shown, pivot feature 116A is stamped from a portion of the wall 130 of the bladder 110 and radially inwardly curved to include all features of pivot feature 116 (e.g., the curved distal surface 126 and opening 124), as described above. In yet another embodiment, as Figure 2 As shown, pivot feature 116B is formed as a separate piece connected to the bladder 110 via, for example, a crimp or weld. However, those skilled in the art will understand that pivot feature 116 can be formed in any of a variety of forms, as long as the pivot feature 116 of each of the clips 102 is configured to be pivotally coupled to the clamp arm 104 of the adjacent clip 102, as described above.
[0050] Each of the clips 102, including its plenum 110, further includes a stop 128 positioned at a proximal end 114 adjacent to the plenum 110, distal to the pivot feature 116, such that it prevents the clamping arm 104 of the adjacent proximal clip 102 holding the pivot feature 116 from moving distally relative to the plenum 110 of the clip 102, to which the adjacent proximal clip 102 is connected. However, the stop 128 also includes an opening 134 through which a portion of a length of the control member 118 can be slidably received.
[0051] In one exemplary embodiment, the stop 128 is formed via a portion 132 of the wall 130 of a stamped and radially inwardly curved bladder 110. In another exemplary embodiment, the stop 128 may be formed via two stamped portions with opposite diameters. An opening 134 is formed via a space extending between the radially innermost edges 136 of the inwardly curved stamped portions 132, the size, shape, and morphology of which are configured to receive a portion of the control member 118 therebetween. However, those skilled in the art will understand that the stop 128 may be formed in any of a variety of suitable manners without departing from the scope of the disclosed embodiments.
[0052] In one exemplary embodiment, when the pivot feature 116 of the first clip 102A is received and clamped between the distal ends 112 of the clamping arms 104 of the second clip 102B, the distal ends 112 of the clamping arms 104 of the second clip 102B pivotally engage the pivot feature 116 of the first clip 102A, such that the second clip 102B can pivot relative to the first clip 102A about the pivot feature 116, as... Figure 2 As shown. Furthermore, as... Figures 3 to 5 As shown, the distal end 112 of the clamping arm 104 of the second clamp 102B abuts against the stop 128 of the first clamp 102A to prevent the second clamp 102B from moving further distally relative to the pouch 110 of the first clamp 102A. Figures 3 to 5As shown, the distal end 112 of the clamping arm 104 of the second clamp 102B is received between the stop 128 and the pivot feature 116 of the first clamp 102A.
[0053] Each of the clips 102 has a sac 110 that further includes one or more locking structures 138, each configured to engage a corresponding locking feature 140 of the core member 108, which will be described in further detail below. According to one exemplary embodiment, the locking structure 138 is formed in the wall 130 of the sac 110 and, in a particular embodiment, is configured to extend laterally through a window in the wall 130. Alternatively, the locking structure may be formed as a recess or other wall within the sac 110, configured to engage the corresponding locking feature in a manner similar to the engagement between the edges of the locking feature 140 and the locking structure 138.
[0054] Each of the clamping arms 104 extends from its proximal end 106 to its distal end 112. As described above, the proximal end 106 of the clamping arm 104 is slidably received within the channel 122, such that the clamping arm 104 can be moved relative to the capsule 110 between an open and closed configuration via manipulation of the control member 118, as will be described in further detail below. According to an exemplary embodiment, the clamping arms 104 are biased toward the open configuration such that when the clamping arms 104 are pushed distally out of the capsule 110, the distal ends 112 of the clamping arms 104 move apart toward each other in their natural bias toward the open configuration. When the clamping arms 104 are pulled proximally into the capsule 110, the clamping arms 104 are constrained by the walls of the capsule 110 and converge toward the closed configuration, wherein the distal ends 112 are adjacent to each other. Those skilled in the art will understand that a variety of other mechanisms for opening and closing the clamping arms 104 can be employed.
[0055] In one exemplary embodiment, the distal end 112 of each of the clamping arms 104 is curved inward toward the centerline of the clamp 102, such that the size, shape, and morphology of the distal end 112 are configured to extend about the curved distal surface 126 of the pivoting feature 116 of the adjacent clamp 102 to facilitate pivoting of the adjacent clamps in the clamp 102 relative to each other. The shape of the distal end 112 is also configured such that when the clamping arms 104 are pulled together in a closed configuration, an opening 142 is formed between the distal tips 144 of the distal ends 112, as... Figure 6 As shown below, the size, shape, and form of the opening 142 are configured to allow a portion of the control member 118 to pass through it.
[0056] According to an exemplary embodiment, such as Figure 7As shown, each of the clamping arms 104 may further include an engagement feature 146 along its distal portion 148. In this embodiment, the engagement feature 146 is configured to engage the distal end 120 of the bladder 110 to prevent the clamping arm 104 from moving proximally beyond a desired maximum proximal point. In one exemplary embodiment, the engagement feature 146 extends laterally outward along the distal portion 148 of the clamping arm 104 such that the width of the distal portion 148 is greater than the width of the proximal portion 150 of the clamping arm 104, the proximal portion 150 of the clamping arm 104 being sized to allow it to be pulled proximally into the bladder 110. In one example, the engagement feature 146 is configured as a wing extending laterally from the longitudinal edge of the distal portion 148 of the clamping arm 104.
[0057] The proximal portion 150 of the clamping arm 104 may include a longitudinal slot 151 extending through it and along a portion of its length. The size, shape, and morphology of the longitudinal slot 151 are configured to provide sufficient spacing between the proximal portions 150 of the clamping arm 104 (which may bend toward each other in a closed configuration) through which a portion of the control member 118 may be pulled proximal during deployment of the most distal clamp in the clamp 102 (e.g., the first clamp 102A). For example, after the enlarged distal end 119 of the control member 118 has separated from the core member 108 of the first clamp 102A, the control member 118 is pulled proximal relative to the clamp 102 chain until the enlarged distal end 119 is pulled between the clamping arms 104 of the second clamp 102B to engage the core member 108 of the second clamp 102B, as will be described in further detail below.
[0058] As described above, each of the proximal ends 106 of the clamping arms 104 can be connected to the core member 108. In one exemplary embodiment, each of the proximal ends 106 of the clamping arms 104 may include a hole 152 extending therethrough, such that when the clamping arms 104 are diametrically opposed to each other, the holes 152 of the clamping arms 104 are aligned with each other, such that a connector, such as, for example, a rivet 154, can pass through the holes 152 at the proximal ends 106 of the clamping arms 104 and through the corresponding openings 156 of the core member 108 to engage the clamping arms 104 to the core member 108. The holes 152 of the clamping arms 104 are positioned proximal to the longitudinal slot 151 along the clamping arms 104.
[0059] like Figures 8 to 10As shown, each core member 108 is sized and shaped to slide longitudinally within the channel 122 of the corresponding capsule 110. According to an exemplary embodiment, each core member 108 extends longitudinally from a proximal end 164 to a distal end 166 and includes a proximal portion 158 and a distal portion 162. The proximal portion 158 includes a cavity 160 configured to releasably receive the enlarged distal end 119 of the core member 108, and the distal portion 162 is configured to connect to the proximal end 106 of the clamping arm 104. The proximal end 164 defining the proximal surface of the cavity 160 includes an opening 168 extending therethrough along a central axis aligned with the longitudinal axis of the core member 108. The opening 168 is open and communicates with the cavity 160 such that when the enlarged distal end 119 is received within the cavity 160, the remaining length 121 of the control member 118 extending proximally from the enlarged distal end 119 extends proximally through it.
[0060] In one exemplary embodiment, the opening 168 is sized and shaped such that when the control member 118 extends distally and is pulled proximally to open and close the clip 102, the enlarged distal end 119 is prevented from passing proximally through it. However, a portion of the core member 108 surrounding the opening 168 is formed of a material configured to deform and / or fail when subjected to a force exceeding a predetermined threshold. Therefore, as described further below, when the clip 102 is locked and a continuous proximal force is applied to the control member 118, the enlarged distal end 119 exerts an increased proximal force on the opening 168 because further proximal movement of the control member 118 is prevented. When the force applied to the opening 168 exceeds a predetermined threshold, the opening 168 deforms to allow the enlarged distal end 119 to pass proximally through it, thereby deploying the clip 102 and allowing the enlarged distal end 119 to pass proximally through the stop 128 and through the opening 124 in the pivot feature 116 of the bladder 110 of the farthest clip 102A to enter the bladder 110 of the adjacent proximal second clip 102B.
[0061] The distal portion 162 includes an opening 156 through which the core member 108 is configured to be coupled to the clamping arm 104 via a rivet 154. In one exemplary embodiment, the opening 156 is elongated along the length of the distal portion 162 such that the rivet 154 is slidable along its length from a proximal position within the opening 156 toward a distal position within the opening 156, thereby moving its locking feature 140 toward a locked configuration, as will be described in further detail below.
[0062] In one exemplary embodiment, the core member 108 is formed from a sheet of stamped material (e.g., metal) sized and shaped such that when bent, it will include a proximal portion 158 and a distal portion 162, as described above. In one embodiment, the material is bent around a proximal end 164 to further include a first surface 170 and a second surface 172. A portion of the first surface 170 and the second surface 172 extending along the proximal portion 158 (together with the proximal end 164) defines a cavity 160 therebetween. In one embodiment, a portion of the first surface 170 and the second surface 172 extending along the distal portion 162 of the core member 108 may be substantially planar, extending parallel to each other and parallel to the longitudinal axis of the capsule 110, within which the core member 108 is received.
[0063] In one exemplary embodiment, the first surface 170 and the second surface 172 are biased toward a collapsed shape, wherein the first surface 170 and the second surface 172 are biased toward each other. Figure 9 As shown, the core member 108 is in an expanded state, such that the first surface 170 and the second surface 172 along the distal portion 162 are configured to move apart from each other to accommodate a portion of the remaining length 121 of the control member 118 therebetween. However, once the control member 118 has been moved out from between the first surface 170 and the second surface 172 along the distal portion 162, the first surface 170 and the second surface 172 recover their offset collapsed state by moving toward each other, as... Figure 10 As shown.
[0064] As those skilled in the art will understand, the opening 156 of the distal portion 162 extends along a central axis to extend through each of the first surface 170 and the second surface 172, and as described above, the length along the distal portion 162 is elongated. A rivet 154 received within the opening 156 extends along a central axis aligned with and / or parallel to the central axis of the opening 156, while the rivet 154 is movable along the length of the opening 156. The rivet 154 includes a hole (not shown) extending through it along an axis transverse to its central axis to slidably receive a portion of the remaining length 121 of the control member 118. In one exemplary embodiment, the axis along which the hole of the rivet 154 extends is substantially perpendicular to the central axis of the rivet 154.
[0065] In one exemplary embodiment, a portion of the material of the core member 108 extending from the first surface 170 and the second surface 172 is also bent inward to extend between the first surface 170 and the second surface 172 to define a locking feature 140. In one exemplary embodiment, the locking feature 140 is configured as a pair of wings 174 extending between the first surface 170 and the second surface 172 and movable between an unlocked and a locked configuration. In the unlocked configuration, the outer longitudinal edges 176 of the wings 174 are substantially aligned with the longitudinal edges 178 of the first surface 170 and the second surface 172, such that the core member 108 can slide longitudinally within the channel 122 of the capsule 110 to allow the clamping arm 104 to move between an open and a closed configuration. In the locked configuration, a portion of each of the wings 174 moves radially outward beyond the longitudinal edges 178 of the first surface 170 and the second surface 172 to engage the locking structure 138 of the capsule 110.
[0066] Each of the wings 174 may be connected to either the first surface 170 or the second surface 172 via, for example, a curved portion 180 extending along a longitudinal edge 178 of one of the first surface 170 and the second surface 172. The curved portion 180 may deform as the core member 108 moves from an unlocked state to a locked state, wherein the distal portion of the wing 174 moves radially outward.
[0067] In one exemplary embodiment, each of the wings 174 may be further defined by an inner longitudinal edge 182, which is angled such that a portion of each of the wings 174 overlaps with the elongated opening 156. Specifically, when the rivet 154 is received in an unlocked configuration within a proximal portion of the elongated opening 156, a portion of each of the wings 174 overlaps with the elongated opening 156 to avoid interfering with the rivet 154. Those skilled in the art will understand that the inner longitudinal edge 182 overlapping the elongated opening 156 can hold the rivet 154 in a proximal position within the elongated opening 156 as the clamping arm 104 moves between an open and closed configuration.
[0068] However, when it is necessary to lock the clip 102, the rivet 154 engages the angled inner longitudinal edge 182 of the wing 174 as it moves from a proximal position within the elongated opening 156 to a distal position, thereby applying force thereon. When the force applied to the inner longitudinal edge 182 via the rivet 154 exceeds a predetermined threshold, it deforms the core member 108, thereby allowing the wing 174 to move from an unlocked state to a locked state.
[0069] Each of the clips 102 is assembled such that the core member 108 is received between the proximal ends 106 of the clip arms 104. An elongated opening 156 of the core member 108 is aligned with a hole 152 extending through the proximal ends 106 of the clip arms 104. A rivet 154 extends through the hole 152 of the clip arms 104 and through the proximal portion of the elongated opening 156 of the core member 108. The core member 108, assembled with the clip arms 104, is slidably received within a channel 122 of the capsule 110.
[0070] In the initial insertion configuration, each clip 102 in the chain of clips 102 is in a closed configuration. The clips 102 are connected to each other, allowing them to be loaded into the working channel of an endoscope or other insertion device. Specifically, the first clip 102A is positioned distal to the second clip 102B such that the clamping arm 104 of the second clip 102B receives the pivoting feature 116 of the first clip 102A between the clamping arms 104 of the second clip 102B. The distal end 112 of the second clip 102B engages the pivoting feature 116 of the first clip 102A to both connect the first clip 102A and the second clip 102B and allow the first clip 102A and the second clip 102B to pivot relative to each other. Because adjacent clips 102 can pivot relative to each other, the chain of clips 102 can be inserted through body cavities, even along the most tortuous paths, to reach the target area. Those skilled in the art will understand that the nearest one of the clips 102 in the chain can be releasably coupled to, for example, a catheter 103, to facilitate insertion of the chain of clips 102 through an endoscope or other insertion device to a target area within the body.
[0071] In its initial configuration, the enlarged distal end 119 of the control member 118 is received within the cavity 160 of the core member 108 of the first clip 102A. The remaining length 121 of the control member 118 extends proximally through the opening 156 of the core member 108 of the first clip 102A, between the clip arms 104, and through the core member 108 of the second clip 102B (and similarly through all the clips 102 in the chain of clips 102 proximal to the second clip 102B) to reach the proximal end of the system, making it accessible to the user via, for example, a control mechanism or actuator at the proximal end of the insertion device.
[0072] Those skilled in the art will understand that although all clips 102 are shown and described as having the same features, in some embodiments, one or more of the clips 102 may have different features depending on, for example, the position of the clips along the chain of clips 102. For example, while each of the clips 102 is described as including a longitudinal slot 151 along the clamp arm 104 and an opening 142 formed via the distal tip 144 of the clamp arm 104, the most distal one of the clips 102 (e.g., the first clip 102A) does not need to include these features because the enlarged distal end 119 does not pass between the distal portions of the clamp arm 104 of the first clip 102A, since in the initial insertion configuration, the enlarged distal end 119 of the control member 118 is positioned at the proximal end 106 of the clamp arm 104 immediately adjacent to the first clip 102A. In another example, the nearest one of the clips 102 does not need to include the pivot feature 116 or the stop 128, because the nearest clip 102 is not coupled to the more proximal clip 102 and can be coupled to the catheter 103 in any desired manner.
[0073] According to an exemplary method utilizing the clamping system 100, a chain of clips 102 is inserted through, for example, the working channel of an endoscope to reach a target site within the body. The chain of clips 102 is inserted into the target site in an initial insertion configuration, wherein the clips 102 in the chain are connected to each other via hinge joints formed by the interaction of a pivot feature 116 and a clamp arm 104, allowing the chain of clips 102 to navigate through body cavities, even along the most tortuous paths, to reach the target site. As described above, the most proximal clip 102 can be releasably coupled to a catheter 103 to facilitate insertion of the chain of clips 102 through an endoscope or other insertion device.
[0074] Once the chain of clip 102 has reached the target location, the user can push the control member 118 distally relative to the pouch 110 of clip 102. As described above, in the initial insertion configuration, the enlarged distal end 119 of the control member is received within the core member 108 of the farthest clip 102 (i.e., the first clip 102A), such that the distal movement of the control member 118 relative to the pouch 110 causes the clamp arm 104 of the first clip 102A to be moved distally out of the pouch 110 of the first clip 102A toward the open configuration under its natural bias, for reception between its distal ends 112.
[0075] Upon reaching the target site, the user positions the first clamp 102A such that the distal ends of the open clamp arms 104 contact the desired tissue portion (e.g., tissue portions on opposite sides of an opening in the tissue to be closed). The user then pulls the control member 118 proximally (or advances the catheter 103 distally over the control member 118) such that as the clamp arms 104 of the first clamp 102A are pulled into its capsule 110, the clamp arms 104 are pulled towards each other to pull and clamp the tissue contacted by the distal ends 112 of the clamp arms 104. The first clamp 102A can be moved between open and closed positions as needed until the target portion of the tissue has been clamped between the clamp arms 104 as needed (e.g., when opposite sides of an opening in the tissue are pulled to close the opening).
[0076] When the user is satisfied that the first clip 102A is in the desired position holding the target tissue, the user can finally deploy the first clip 102A by locking the clip arm 104 in a closed configuration within the capsule 110 and releasing the first clip 102A from the adjacent proximal second clip 102B. Specifically, according to an exemplary embodiment, when the first clip 102A is holding the target tissue as needed, the user pulls the control member 118 proximally until the engagement feature 146 along the distal portion 148 of the clip arm 104 engages the distal end 120 of the capsule 110, thereby preventing further proximal movement of the clip arm 104 of the first clip 102A relative to its capsule 110. Thereafter, the continued proximal movement of the control member 118 applies increased tension to the control member 118 and the core member 108 of the first clip 102A. This will pull the core member 108 proximally past the rivet 154, which connects the clamp arm 104 to the core member 108, so that the rivet 154 moves from its proximity within the elongated opening 156 of the core member 108 to its distality within the elongated opening 156.
[0077] As rivet 154 slides toward the distal portion of elongated opening 156, rivet 154 engages the portion of wing 174 that overlaps with elongated opening 156. Rivet 154 slides distally along the angled inner longitudinal edge 182 of wing 174, thereby pushing wing 174 radially outward from an unlocked state toward a locked state. In the locked state, wing 174 moves radially outward relative to the longitudinal axis of core member 108 to engage locking structure 138. In an exemplary embodiment, wing 174 moves radially outward to extend into and / or through locking structure 138, which in this embodiment is configured to extend through a window of wall 130 of capsule 110.
[0078] Once the first clip 102A is locked in the clamped / closed configuration—its core member 108 locked relative to the capsule 110—the user continues to pull the control member 118 proximally until the force applied via the enlarged distal end 119 to the opening 168 of the core member 108 of the first clip 102A exceeds a predetermined threshold, thereby deforming the opening 168 to allow the enlarged distal end 119 to pass proximally through it. The control member 118 continues to move proximally until the enlarged distal end 119 is received within the cavity 160 of the core member 108 of the adjacent proximal clip 102—that is, the second clip 102B. The second clip 102B can now be controlled using the control member 118 in the same manner as described above with respect to the first clip 102A, moving between the open and closed configurations.
[0079] In other words, the core member 108 of the second clip 102B remains in an expanded state, wherein the first surface 170 and the second surface 172 are separated from each other by the control member 118 until the expanded distal end 119 passes between the first surface 170 and the second surface 172 to be received within the cavity 160 of the core member 108, thereby restoring the core member 108 to a biased collapsed state. When the core member 108 returns to the biased collapsed state, the distal force applied to the control member 118 exerts a distal force on the core member 108, thereby moving the second clip 102B between an open state and a closed state.
[0080] To finally deploy the first clip 102A, the control member 118 moves distally to move the clamping arm 104 of the second clip 102B toward an open configuration until the pivoting feature 116 of the first clip 102A is released therebetween. The second clip 102B can then be clamped over the target tissue as needed in a manner substantially similar to that described above with respect to the first clip 102A. While the exemplary embodiment shows and describes two clips 102, those skilled in the art will understand that the clamping system 100 may include any number of clips 102, allowing the user to continue placing additional clips 102 as needed without removing or reloading the insertion device.
[0081] In addition to the following, such as Figures 11 to 13Another embodiment of the clamping system 200 shown is substantially similar to the clamping system 100 described above, wherein the clamp chains 202—e.g., first clamp 202A and second clamp 202B—are releasably connected to each other via a pivoting feature 216 of at least the first clamp 202A, allowing multiple clamps to be deployed to treat tissue defects during a single pass through the working channel of an endoscope or other insertion device. Each of the clamps 202 is substantially similar to the clamp 102 described above with respect to the clamping system 100, except that the pivoting feature 216 at the proximal end 214 of the capsule 210 of each clamp 202 is formed via a pair of lugs 284 extending from the proximal end 214 of the capsule 210 toward its centerline. Each pair of lugs 284 is diametrically opposed to each other, such that they are received between the distal ends 212 of the closed clamping arms 204 of adjacent clamps in the clamp 202.
[0082] In one exemplary embodiment, lugs 284 of the first clip 202A are received between the arms 204 of the second clip 202B, such that the pair of lugs 284 together form an axis about which the second clip 202B can pivot relative to the first clip 202A. The space 224 between the lugs 284 is sized to allow a portion of a length 221 of the control member 218 extending proximally from the extended distal end 219 of the control member 218 to be slidably received therebetween, while preventing the extended distal end 219 from passing through it. In one exemplary embodiment, this portion of the length 221 of the control member 218 is received between the lugs 284 of the first clip 202A and between the arms 204 of the second clip 202B via, for example, an opening 242 coaxially formed between the distal ends 212 of the arms 204 relative to the longitudinal axis of each of the clips 202.
[0083] Similar to clamping system 100, control member 218 can move longitudinally relative to the capsule 210 of clip 202 to move the clamping arm 204 of first clip 202A between an open and closed configuration until target tissue is clamped therebetween as needed. Although not shown, the clamping arm 204 of first clip 202A (and any subsequently deployed clips 202) moves between the open and closed configurations via a core member that connects the proximal end of the clamping arm 204 to the enlarged distal end 219 of control member 218. Once the target tissue has been clamped between the distal ends 212 of first clip 202A as needed, control member 218 can be pulled proximally relative to capsule 210 until the locking feature of the core member locks first clip 202A in a closed configuration in a manner substantially similar to that described above for clip 102.
[0084] After locking the first clip 202A, deployment is initiated by pulling the control member 218 proximally relative to the first clip 202A, such as... Figure 11 As shown, until the enlarged distal end 219 is released from the core member of the first clamp 202A, this is essentially the same as described above regarding the clamping system 100. The user continues to move the control member 218 proximally until the enlarged distal end 219 is pulled through the opening 242 between the distal ends 212 of the second clamp 202B and against the lug 284 of the first clamp, as... Figure 12 As shown. When the force applied to the lug 284 via the enlarged distal end 219 exceeds a predetermined threshold, the lug 284 bends and shifts or breaks from the capsule 210, thereby releasing the first clip 202A from the second clip 202B and allowing the enlarged distal end 219 to move proximally relative to the second clip 202B, as... Figure 13 As shown, the core member of the second clip 202B is engaged until the enlarged distal end 219 engages, so as to facilitate subsequent clamping of the second clip 202B.
[0085] In addition to the following, such as Figures 14 to 16 Another embodiment of the clamping system 300 shown is substantially similar to the clamping systems 100, 200 described above, and includes a chain of clamps 302 (e.g., first clamp 302A, second clamp 302B, and third clamp 302C) connected to each other via, for example, a pivot feature (not shown) of each of the clamps 302. The clamps 302 and pivot features can be substantially similar to any of the clamps 102, 202 and pivot features 116, 216 described above with respect to clamping systems 100, 200. However, the clamping system 300 also includes a suture 390 extending through a portion of each of the clamps 302, such that after each of the clamps 302 has been placed and deployed (e.g., around the periphery of a tissue defect), the suture 390 can be tensioned to pull the clamps 302 toward each other to close the tissue defect.
[0086] Similar to clips 102 and 202, each of clips 302 includes a pair of clamping arms 304, the proximal ends of which are slidably received within a capsule 310 to allow the clamping arms 304 to move between an open and a closed configuration. In the open configuration, the distal ends 312 of the clamping arms 304 are separated from each other to receive tissue between the clamping arms 304, and in the closed configuration, the distal ends 312 of the clamping arms 304 are pulled towards each other to clamp tissue therebetween. However, in this embodiment, each of the capsules 310 includes a hole 392 extending through its wall. In one embodiment, each of these holes is configured to receive a portion of a suture 390 therein.
[0087] In one exemplary embodiment, a suture 390 extends from a distal end 394 to a proximal end (not shown). The distal end 394 is received within and connected to the hole 392 of the most distal clip 302 (e.g., the first clip 302A) via, for example, a knot, tightening device, or other attachment mechanism, to securely attach the distal end 394 to the most distal clip 302. The remaining length of the suture 390 slidably passes through the holes 392 of the remaining clips 302 (e.g., the second clip 302B and the third clip 302C) and through the working channel 398 of the endoscope 396 or other insertion instrument to a proximal end (not shown), which can be reached by a user via, for example, a control handle or actuator at the proximal end of the endoscope / insertion device. Those skilled in the art will understand that although the clamping system 300 is shown and described as comprising three clips 302, the clamping system 300 may also comprise any number of a plurality of clips 302.
[0088] According to an exemplary method of using the clamping system 300, the clamp chain 302 is inserted into a target region within the body via an endoscope 396 or other insertion device, for example, a catheter 303 releasably coupled to one of the clamps 302 (e.g., 302C). The clamp 302 can then be clamped over a portion of the target tissue in a manner substantially similar to that described above with respect to clamps 102, 202. In this embodiment, the clamp 302 can, for example, clamp tissue at a location surrounding the periphery of the target tissue defect to be treated, such as… Figure 15 As shown. Once all clips 302 are in place as needed, tension can be applied to the suture 390 to pull all clips 302 and the tissue portions they clamp toward each other to close and seal the tissue defect.
[0089] In one exemplary embodiment, since the distal end 394 of the suture is fixedly attached to the first clip 302A, tension is applied along the suture 390 to pull the suture through the holes 392 of the remaining clips (e.g., the second clip 302B, the third clip 302C), thereby pulling the clips 302 toward each other. When the clips 302 are pulled toward each other, as... Figure 16 As shown, the edges of the tissue defect are also pulled towards each other to close the tissue defect. Once the tissue defect is closed as needed, the clamping device or other similar device can slide along the suture 390 until it abuts against the capsule 310 of the last deployed clip 302 (e.g., the third clip 302C) to maintain tension along a portion of the suture 390 extending between the clips 302 to keep the tissue defect closed. Excess suture portions extending proximally from the clamping device or other device can then be removed, as those skilled in the art will understand, so that the remainder of the clamping system 300 can be removed from the target area.
[0090] It will be apparent to those skilled in the art that various modifications can be made to this invention without departing from its scope. Although specific embodiments have been shown and described herein, it should be understood that the specific embodiments shown can be replaced with any arrangement contemplated to achieve the same purpose. This invention is intended to cover any and all adaptive changes or variations of the various embodiments. It should be understood that the above description is illustrative and not restrictive. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art upon review of the foregoing description. Therefore, the scope of the various embodiments includes any other application using the above compositions, structures, and methods.
Claims
1. A clamping system for treating tissue, comprising: A first clip includes a first capsule and a first pair of clamping arms. The first capsule extends longitudinally from a proximal end to a distal end and includes a first channel extending therethrough. The proximal ends of the first pair of clamping arms are slidably received within the first channel to allow the first clamping arms to move between an open configuration and a closed configuration. In the open configuration, the distal ends of the first clamping arms are separated from each other to receive tissue therebetween. In the closed configuration, the distal ends of the first clamping arms are pulled toward each other to clamp tissue therebetween. The proximal end of the first capsule includes a pivoting feature extending across its first channel. as well as The second clip includes a second capsule and a pair of clamping arms. The second capsule extends longitudinally from a proximal end to a distal end and includes a second channel extending therethrough. The proximal ends of the second pair of clamping arms are slidably received within the second channel to allow the second clamping arms to move between an open configuration and a closed configuration. In the open configuration, the distal ends of the second clamping arms are separated from each other to receive the tissue therebetween. In the closed configuration, the distal ends of the second clamping arms are pulled toward each other to clamp the tissue therebetween. The distal ends of the second clamping arms are configured to engage the pivoting feature of the first clip such that the first clip and the second clip are releasably and pivotally connected to each other in an insertion configuration.
2. The clamping system according to claim 1, further comprising: A first core member is received between and connected to the proximal ends of the first pair of clamping arms to engage the proximal ends of the first pair of clamping arms with each other. The first core member includes a locking feature movable between an unlocked mode and a locked mode. In the unlocked mode, the first core member is slidable within the first channel, and in the locked mode, the locking feature of the first core member engages a corresponding portion of the first capsule to lock the first pair of clamping arms in the closed mode. as well as A second core member is received between and connected to the proximal ends of the second pair of clamping arms to engage the proximal ends of the second pair of clamping arms with each other. The second core member includes a locking feature movable between an unlocked mode and a locked mode. In the unlocked mode, the second core member can slide within the second channel, and in the locked mode, the locking feature of the second core member engages a corresponding portion of the second capsule to lock the second pair of clamping arms in the closed mode.
3. The clamping system according to claim 2, further comprising: A control member comprising an enlarged distal end and a remaining length extending therefrom proximally, wherein, in the insertion configuration, the enlarged distal end is releasably received within a proximal portion of the first core member such that the remaining length passes through an opening extending through the pivoting feature of the first clip, between the second clip arms, and through the second core member to reach a proximal end configured to be accessible by a user, the control member being longitudinally movable relative to the first capsule to move the first clip between the open configuration and the closed configuration.
4. The clamping system of claim 3, wherein each of the first core member and the second core member includes an opening extending therethrough, the opening communicating with its cavity, the opening being configured to deform upon being subjected to a force exceeding a predetermined threshold to allow the enlarged distal end to pass through the opening.
5. The clamping system of claim 2, wherein each of the first core member and the second core member is connected to a corresponding one of the first pair of clamping arms and the second pair of clamping arms via a connector received in a hole and through an elongated opening, the hole extending through the proximal end of each of the first clamping arm and the second clamping arm, and the elongated opening extending through each of the first core member and the second core member.
6. The clamping system of claim 5, wherein the connector is slidable from the proximal end of the elongated opening to the distal end of the elongated opening to move the locking feature of a corresponding one of the first core member and the second core member from the unlocked state to the locked state, the connector being configured to mate with a portion of the locking feature of the corresponding one of the first core member and the second core member as the connector moves distally through its elongated opening.
7. The clamping system of claim 3, wherein each of the first core member and the second core member is formed of a stamped metal sheet, the stamped metal sheet being sized and shaped to be bent into a form including a proximal portion and a distal portion, the proximal portion defining a cavity therein for receiving the enlarged distal end of the control member therein, and the distal portion including the locking feature.
8. The system according to any one of claims 1 to 7, wherein the pivoting feature includes a curved distal surface configured to pivotally engage a corresponding curved portion of the distal end of the second pair of clamping arms.
9. The system according to any one of claims 1 to 8, wherein the pivoting feature may be one of the following: a material machined into the first capsule, stamped from a portion of the wall of the first capsule, and formed from a separate element connected to the proximal end of the first capsule.
10. The clamping system of claim 3, wherein the pivoting feature includes a pair of lugs extending from the diameter-opposing portions of the proximal end of the first bladder toward its centerline, the spacing between the pair of lugs being configured to allow the remaining length of the control member to slide between them while preventing the enlarged distal end from passing through it.
11. The clamping system according to claim 10, wherein, The pair of lugs are configured to break off from the first capsule when subjected to a force exceeding a predetermined threshold.
12. The clamping system of claim 9, wherein the first bladder includes a stop positioned distal to the pivot feature, the stop being configured to prevent the second pair of clamp arms from moving proximally relative to the pivot feature of the first clamp when the distal ends of the second pair of clamp arms engage with the pivot feature of the first clamp in the insertion configuration.
13. The clamping system of claim 12, wherein the stop is stamped from the material of the wall of the first bladder and is radially inwardly bent.
14. The clamping system of claim 3, wherein the distal ends of the second pair of clamping arms include an opening extending between their distal tips, the size, shape, and morphology of the opening being configured to allow the enlarged distal ends of the control member to pass through it.
15. The clamping system of claim 3, wherein the proximal portion of the second pair of clamping arms includes a longitudinal slot extending through and along it, the longitudinal slot being sized, shaped, and shaped to allow the enlarged distal end of the control member to pass between the second pair of clamping arms.