Refillable applicator for hemostatic clips

Abstract

The present invention relates to a system for processing tissue, the system comprising a clamp assembly and an applicator; the clamp assembly comprises a pair of clamp arms, the proximal ends of the clamp arms can be slidably received in a channel of a packaging body to move between a tissue receiving configuration and a tissue clamping configuration; and the applicator is releasably connected to the clamp assembly to enable the clamp assembly to move between the tissue receiving configuration and the tissue clamping configuration, the applicator comprising a control member, the control member having a plurality of nodes extending along it, each node having a cross-sectional area greater than the cross-sectional area of ​​the rest of the control member and configured to be connected to the proximal ends of the clamp arms, the most distal one of the nodes and the next adjacent proximal one of the nodes being separable to release the clamp assembly from the applicator when the force applied thereto exceeds a predetermined threshold.

Description

[0001] Priority claim

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 397,124, filed on September 20, 2016; the disclosure of which is incorporated herein by reference. Background Art

[0003] Pathologies of the gastrointestinal (GI) system, biliary tree, vascular system, and other body cavities and hollow organs are often treated by endoscopic surgery, many of which require hemostasis to control internal bleeding. Hemostatic clips clamp tissue surrounding a wound and temporarily hold the edges of the wound together to allow the natural healing process to permanently close the wound. Specialized endoscopic clamping devices are used to deliver the clip to the desired location in the body, leaving the clip in place in the body after the clip delivery device is withdrawn. Summary of the invention

[0004] The present invention relates to a system for processing tissue, the system comprising a clamp assembly and an applicator; the clamp assembly comprises a pair of clamp arms, each of the clamp arms extending from a proximal end to a distal end, the proximal ends of the clamp arms being received in a channel of a packaging body to move between a tissue receiving configuration and a tissue clamping configuration, in which the distal ends of the clamp arms are separated from each other in the tissue receiving configuration, and in which the distal ends of the clamp arms move toward each other in the tissue clamping configuration; the applicator is configured to be connected to the clamp assembly to move the clamp assembly between the tissue receiving configuration and the tissue clamping configuration, the applicator comprising a control member having a plurality of nodes, each node having a cross-sectional area greater than the cross-sectional area of ​​the rest of the control member and being configured to be connected to the proximal ends of the clamp arms, the most distal one of the nodes and the next adjacent proximal one of the nodes being separable to release the clamp assembly from the applicator when the force applied thereto exceeds a predetermined threshold.

[0005] In one embodiment, the proximal end of the clamp arm may be connected via a yoke including a longitudinal slot sized and shaped to receive each of the nodes. In one embodiment, the yoke may be configured to deform when a force applied thereto by a distal-most one of the nodes exceeds a predetermined threshold. In one embodiment, each node may be sized and shaped to allow coupling with the proximal end of the clamp arm while preventing disengagement therefrom. In one embodiment, the distal surface of each of the nodes may be rounded, while the proximal surface of each of the nodes is generally flat.

[0006] In one embodiment, adjacent nodes of the plurality of nodes may be connected to each other via connecting portions of the control member, each connecting portion being configured to separate from a proximal one of the nodes connected thereto when a force applied thereto exceeds a predetermined threshold.

[0007] In one embodiment, each of the connecting portions may taper from a distal end to a proximal end, with the tapered thickness of each connecting portion of the control member increasing incrementally from a distal one of the connecting portions to a proximal one of the connecting portions.

[0008] In one embodiment, each of the connecting portions may include at least one notch extending thereabout, the at least one notch decreasing in number, size, depth, and length from the distal one of the connecting portions to the proximal one of the connecting portions.

[0009] In one embodiment, each of the connecting portions may be welded to a proximal one of the nodes connected thereto, the strength of the weld of each of the connecting portions increasing from the distal one of the connecting portions to the proximal one of the connecting portions.

[0010] In one embodiment, the applicator may further include a conduit at a distal end thereof that is releasably coupled to the enclosure of the clamp assembly.

[0011] In one embodiment, the conduit may be coupled to the enclosure via one of a friction fit and a snap fit.

[0012] In one embodiment, when the clamp assembly moves from the tissue receiving configuration to the upper tissue clamping configuration, the proximal end of the package body can abut the distal end of the applicator so that separation of the distal-most node from the next immediately adjacent lateral node also separates the package body from the distal end of the applicator.

[0013] In one embodiment, the system may further include a torsion member coupled to the distal end of the applicator, the torsion member including an inclined surface along a portion of its interior such that when the proximal end of the package slides along the inclined surface, the clamp assembly rotates relative to the applicator.

[0014] In one embodiment, the system may also include a cutting member that is movably received within a distal portion of the applicator, the cutting member being movable between a non-cutting configuration and a cutting configuration, the cutting member being positioned between the distal-most one of the nodes and the next immediately adjacent proximal one of the nodes.

[0015] The present invention also relates to a reloadable clamping device, which includes a clamp assembly and an applicator. The clamp assembly includes a pair of clamp arms, each of which extends from a proximal end to a distal end, and the proximal ends of each of the clamp arms are connected to each other via a yoke received in a channel of a package body to enable the clamp arms to move between a tissue receiving configuration and a tissue clamping configuration, in which the distal ends of the clamp arms are separated from each other in the tissue receiving configuration and the distal ends of the clamp arms are moved toward each other in the tissue clamping configuration; the applicator has a distal portion that can be inserted through an opening of a box to connect to the clamp assembly, the box containing the clamp assembly, and the applicator includes a catheter and a control A member, the catheter extends from a proximal end to a distal end and includes a lumen extending therethrough, the distal end of the catheter being configured to be coupled to the proximal end of the package body, the control member extending through the lumen of the catheter and including a plurality of nodes extending along a distal portion thereof, each node having a cross-sectional area greater than a cross-sectional area of ​​a remainder of the control member and being configured to be coupled to the proximal end of the clamp arm, the most distal of these nodes being separable from the proximal of the next immediately adjacent one of these nodes to release the clamp assembly from the applicator when a force applied thereto exceeds a predetermined threshold.

[0016] The present invention also relates to a method for processing tissue, the method comprising the following steps: loading a first clamp assembly onto an applicator by connecting a distal-most node of a control member to the proximal ends of clamp arms of the first clamp assembly, inserting the loaded clamp assembly into a target site in vivo through a working channel of an endoscope, moving the first clamp assembly from a tissue receiving configuration (in which the distal ends of the clamp arms are separated from each other) to a tissue clamping configuration (in which the distal ends of the clamp arms are moved toward each other) by moving the control member proximally relative to the applicator until the target tissue is clamped therebetween as needed, and releasing the first clamp assembly from the applicator by further pulling the control member proximally to separate the distal-most node from the next adjacent proximal node. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 shows a longitudinal cross-sectional view of a system according to an exemplary embodiment of the present invention;

[0018] Figure 2 Shown according to Figure 1 A longitudinal cross-sectional view of an applicator of the system;

[0019] Figure 3 Shows the deployment configuration according to Figure 1 A longitudinal cross-sectional view of the system;

[0020] Figure 4 Shows Figure 1 A longitudinal cross-sectional view of a coupling between an applicator and a clamp assembly of a system;

[0021] Figure 5 A longitudinal cross-sectional view showing a coupling between an applicator and a clamp assembly according to an alternative embodiment of the present invention;

[0022] Figure 6 Shown according to Figure 1 a side view of a distal portion of a control member of an applicator of the system;

[0023] Figure 7 shows a side view of a distal portion of a control member according to another exemplary embodiment of the present invention;

[0024] Figure 8 shows a side view of a distal portion of a control member according to yet another exemplary embodiment of the present invention;

[0025] Fig. 9 shows a longitudinal cross-sectional view of a system according to another exemplary embodiment of the present invention;

[0026] Fig.10 Shows Fig. 9 A longitudinal cross-sectional view of a torsional member of the system; and

[0027] Fig.11 A longitudinal cross-sectional view of a system according to another exemplary embodiment of the present invention is shown. DETAILED DESCRIPTION

[0028] The present invention can be further understood with reference to the following description and accompanying drawings, in which similar elements are referred to by the same figure numbers. The present invention relates to a clamping system, and in particular to a reloadable endoscopic clamping system. An exemplary embodiment of the present invention describes a clamp assembly that can be loaded onto the distal end of an applicator assembly prior to endoscopic surgery. Once the clamp has been deployed in the desired target area in the body, the applicator assembly can reload a new clamp. In particular, the applicator assembly includes a control member having a plurality of nodes, each of which is configured to be connected to the proximal end of the clamp. The farthest node can be connected to a first clamp. As needed, the first clamp can be used to clamp tissue and then deployed in the body. The deployment of the first clamp breaks a portion of the control member between the farthest node and the next node immediately proximal to it, so that the next node can then be connected to the second clamp, and the clamping process can be repeated. The applicator can reload as many clamps as nodes. It should be noted that the terms "proximal" and "distal" (as used herein) are intended to refer to directions towards (proximal) and away from (distal) a user of the device.

[0029] like Figures 1 to 4 As shown, the system 100 according to an exemplary embodiment of the present invention includes a clamp assembly 102 and an applicator 104. Figure 1As shown, the clamp assembly 102 can be reinstalled on the distal portion of the applicator 104 before the system 100 is inserted into a living body for clamping of target tissue. Figure 2 As shown, the applicator 104 is configured such that, after the deployment of the clamp assembly 102 in vivo, a new clamp assembly 102 can be loaded onto the applicator 104 so that the same applicator 104 can be used to deliver the new clamp assembly 102 to a second portion of the target tissue in vivo. In particular, the applicator 104 includes a control member 106 having a plurality of nodes 108, each of the nodes 108 being configured to couple to a portion of the clamp assembly 102. In use, the distal-most node 108a can be coupled to the clamp assembly 102. Once the clamp assembly 102 has been used to clamp the target tissue, the control member 106 can be pulled proximally relative to the applicator 104 until a predetermined threshold is exceeded, thereby causing the control member 106 to break at a point between the distal-most node 108a and the next immediately proximal node 108b (e.g., Figure 3 104 can be reloaded with a clamp assembly 102. The next proximal node 108b can then be coupled to a new clamp assembly 102 so that the new clamp assembly 102 can be applied to a second target tissue. The number of nodes 108 of the control member 106 corresponds to the number of times the applicator 104 can be reloaded with a clamp assembly 102.

[0030] The clamp assembly 102 includes a pair of clamp arms 110, the proximal ends of which are slidably received in an enclosure 116 to move the clamp assembly 102 between a tissue receiving configuration and a tissue clamping configuration. The proximal ends 112 of the clamp arms 110 can be connected to each other via a yoke 114, which is slidably received in a channel 142 of the enclosure 116. The clamp arms 110 of this embodiment are biased so that when not pulled into the enclosure 116, the distal ends 118 of the clamp arms 110 are spaced apart from each other and moved to the tissue receiving configuration. When pulled into the enclosure 116, the enclosure 116 constrains the clamp arms 110, thereby holding their distal ends 118 together in the tissue clamping configuration. The yoke 114 is longitudinally slidable within the enclosure 116 to move the clamp arms 110 between the tissue receiving configuration and the tissue clamping configuration.

[0031] The clamp arms 110 may include clamping features that are configured to facilitate clamping of tissue therebetween. For example, the distal ends 118 of the clamp arms 110 may include tips that extend laterally inward toward each other and / or teeth, protrusions, spikes, or other structures that are configured to clamp tissue between the distal ends 118 of the clamp arms 110. The clamp arms 110 may also include locking features that are configured to lock the clamp arms 110 in a tissue clamping configuration once the desired target tissue has been clamped by the clamp arms 110. In one embodiment, the clamp arms 110 may include locking tabs that extend laterally outward therefrom. The locking tabs may be configured to engage a portion of the enclosure 116 when the clamp arms 110 have been pulled a predetermined distance into the enclosure 116. For example, the locking tab may be received within a correspondingly sized, shaped, and positioned locking window that extends transversely through the wall of the enclosure 116 to lock the clamp arm 110 relative to the enclosure 116 in the tissue clamping configuration.

[0032] As described above, the yoke 114 connects the proximal end 112 of the clamp arm 110 and is slidably received within the enclosure 116. The yoke 114 includes a longitudinal slot 120 extending longitudinally from a proximal opening 122 at a proximal end 124 of the yoke 114 to a distal portion 126 sized and shaped to receive the nodes 108 of the control member 106 of the applicator 104. Each of the nodes 108 is enlarged relative to the rest of the control member 106. A proximal portion 128 of the slot 120 extending between the proximal opening 122 and the distal portion 126 has a cross-sectional area (e.g., diameter) that is smaller than the cross-sectional area of ​​the distal portion 126, wherein opposing portions 136 of the proximal portion 128 can expand to receive the node 108 and are biased toward each other such that once the node 108 travels distally into the distal portion 126, the opposing portions 136 of the proximal portion 128 rebound to lock the node 108 in the distal portion 126, thereby coupling the control member 106 to the yoke 114. Thus, longitudinal movement of the control member 106 relative to the enclosure 116 can control movement of the clamp arm 110 between the tissue receiving configuration and the tissue clamping configuration.

[0033] According to this embodiment, the node 108 of the control member 106 is insertable into the distal portion 126 via the proximal opening 112 of the yoke 114. When the control member 106 is pushed distally into the yoke 114 beyond a predetermined threshold, the proximal opening 122 of the slot 120 is deformed to allow the node 108 to pass through the proximal portion 128 into the distal portion 126. In particular, the opposing portions 136 of the yoke 114 defining the slot 120 can be separated from each other to allow the node 108 to pass through the proximal portion 128 into the distal portion 126. Once the node 108 is received within the distal portion 126, the proximal portion 128 of the slot 120 returns to its original size, thereby retaining the node 108 of the control member 106 in the distal portion 126.

[0034] The nodes 108 and the distal portion 126 may have any of a variety of corresponding shapes. In one exemplary embodiment, each of the nodes 108 may be configured as a ball that is received within a correspondingly sized and shaped socket of the distal portion 126. In another exemplary embodiment, each of the nodes 108 may be shaped to facilitate distal insertion of the node 108 into the slot 120 of the yoke 114, but prevent disengagement therefrom (once the node 108 has been received within the distal portion 126). For example, the distal surface 130 of the node 108 may be rounded to facilitate insertion into the slot 120, while the proximal surface 132 of the node 108 may be generally flat such that once the node 108 has been received within the distal portion 126, the proximal surface 132 engages a corresponding proximal surface 134 of the distal portion 126. In other words, the engagement between the planar proximal surfaces 132 , 134 of the node 108 and the distal portion 126 , respectively, does not cause the opposing portions 136 to separate from one another, thereby preventing the node 108 from proximally passing through the proximal portion 128 of the slot 120 .

[0035] The enclosure 116 extends longitudinally from a proximal end 138 to a distal end 140 and includes a channel 142 extending longitudinally therethrough. The channel 142 is sized and shaped to receive the yoke 114 and at least a proximal portion of the clamp arm 110 therein. The proximal end 138 of the enclosure 116 may be configured to releasably engage the applicator 104. According to this exemplary embodiment, the enclosure 116 engages the applicator 104 in a manner that allows the clamp arm 110 to move distally relative to the enclosure 116 from an initial insertion configuration that is generally similar to a tissue clamping configuration (wherein the clamp arms 110 are constrained via an interior surface of the enclosure 116 such that their distal ends 118 are adjacent to and / or in contact with each other) toward a tissue receiving configuration. However, distal movement of the clamp arm 110 relative to the enclosure 116 toward the tissue receiving configuration may cause the enclosure 116 to disengage from the applicator 104. Thus, when the clamp arms 110 are pulled proximally after receiving the target tissue therebetween, the enclosure 116 will also move proximally until the enclosure 116 contacts the distal end of the applicator 104. Once the enclosure 116 abuts the distal end of the applicator 104, the clamp arms 110 can be further pulled proximally relative to the enclosure 116 toward the tissue clamping configuration.

[0036] In one embodiment, the enclosure 116 may engage the catheter 144 at the distal end of the applicator 104 via a friction fit. In another embodiment, the enclosure 116 may engage the catheter 144 via a loose snap fit. Figure 4 As shown, the proximal end 138 of the package body 116 may include a flexible tab 146 including a protrusion extending radially inwardly toward its longitudinal axis. The conduit 144 includes a correspondingly shaped groove 148 extending around it along its outer surface 150 so that the proximal end 138 of the package body 116 can be loosely mounted on the distal end 152 of the conduit 144. When the clamp arm 110 moves from the insertion configuration toward the open configuration, the package body 116 also pushes the conduit 144 away. When the clamp arm 110 moves proximally toward the tissue clamping configuration, the package body 116 abuts the distal end 152 of the conduit 144 so that the clamp arm 110 can move proximally relative to the package body 116. Because the enclosure 116 abuts only the catheter 144 , disengagement of the distal-most node 108a from the remainder of the control member 106 will also release the enclosure 116 from the applicator 104 when it is desired to deploy the clip assembly 102 in the body.

[0037] In another embodiment, Figure 5As shown, the package 116' of the clamp assembly 102' can be loosely coupled to the catheter 144' of the applicator 104' in a manner generally similar to the package 116 and the catheter 144 described above. However, instead of being mounted on the distal end 152' of the catheter 144', the proximal end 138' of the package 116' is received within the catheter 144'. The package 116' can include a flexible tab 146' that is biased in a laterally outward position. In one example, the flexible tab 146' can be formed via a cut through the wall of the package 116' that is biased to be laterally outwardly angled. As will be described in further detail below, the clamp assemblies 102 and 102' can be housed in a box that is used to load the clamp assemblies 102, 102' onto the applicators 104, 104'. When the clamp assembly 102' is contained in the box, the flexible tabs 146' are compressed so that the tabs 146' can be received in the conduit 144'. When the tabs 146' are received in the conduit 144', they are constrained via their internal surfaces. The clamp assembly 102' can be moved toward the insertion configuration to be removed from the box and / or inserted into a living body. Once at the target site in the body, the control member 106' connected to the clamp arm 110' can be moved distally relative to the applicator 104' to move the clamp arm 110' toward the tissue receiving configuration. Moving the control member 106' distally also pushes the package 116' distally relative to the conduit 144', so that the flexible tabs 146' move distally through the distal end 152' of the conduit 144', so that the flexible tabs 146' are no longer constrained by the conduit 144' and are allowed to return to their laterally extended biased position. Thus, when the clamp arm 110' is subsequently moved proximally toward the tissue clamping configuration, the package body 116' will also move proximally until the transversely extending tab 146' contacts the distal end 152' of the conduit 144'. The tab 146' of the package body 116' abuts the conduit 144' so that the clamp arm 110' can be further pulled proximally relative thereto toward the tissue clamping configuration. Thus, when the distal-most node 108a' is disengaged from the rest of the control member 106', the package body 116' is also released from the applicator 104' to deploy the clamp assembly 102' into the body.

[0038] The exemplary embodiments describe and illustrate a package that abuts the catheter when the clamp assembly moves from a tissue receiving configuration to a tissue clamping configuration such that the breaking / disengagement of the distal-most node from the remainder of the control member deploys the entire clamp assembly. However, those skilled in the art will appreciate that the package and the catheter can be releasably coupled to each other in any of a variety of ways. In some embodiments, the package can be coupled to the catheter in a manner that requires a separate release mechanism regarding the breaking of the distal-most node. For example, the breaking / disengagement of the distal-most node from the remainder of the control member can cause a subsequent action that releases the engagement between the package and the catheter.

[0039] Prior to loading on the applicator 104, the clamp assembly 102 (or clamp assembly 102') of the present invention may be housed in a box. The box may be configured as a storage container defining a space therein, the size and shape of the storage container being set to house the clamp assembly 102. The clamp assembly 102 may be housed in the box in a tissue receiving configuration. The box includes a proximal opening through which the distal portion 154 of the control member 106 and the catheter 144 may be inserted to be connected to the clamp arm 110 and the enclosure 116, respectively.

[0040] Applicator 104 may include a catheter 144, a flexible member (not shown) extending proximally therefrom, and a control member 106. The proximal end of the flexible member may be coupled to a handle portion. Control member 106 extends through catheter 144 and the flexible member from a distal portion 154 including node 108 to a proximal end of an actuator connected to the handle portion. The flexible member may be formed, for example, as a coil of wire having sufficient flexibility to pass through even a tortuous path in a living body, and in this embodiment is sized and shaped to pass through a working channel of an endoscope or other insertion device.

[0041] The distal portion 154 includes a plurality of nodes 108. As discussed above, each of the nodes 108 is configured to engage the yoke 114 of the clamp arm 110 of the clamp assembly 102. The most distal one of the nodes 108a engages the yoke 114 so that the control member 106 can be moved longitudinally relative to the applicator 104 to move the clamp assembly 102 between the tissue receiving configuration and the tissue clamping configuration. When it is desired to deploy the clamp assembly 102 in vivo, the control member 106 can be pulled proximally relative to the applicator 104 until the most distal node 108a is disconnected or disengaged from the rest of the control member 106. Once the most distal node 108a is disengaged from the rest of the control member 106, the immediately adjacent proximal node 108b can be coupled to a new clamp assembly 102.

[0042] To ensure that each of the nodes 108 is disconnected from the rest of the control member 106 in an order from the most distal node 108a to the most proximal node 108c, a portion of the control member 106 connected to each of the nodes 108 may be configured to facilitate the disconnection of the nodes 108 in that order. Figure 6 As shown, the connecting portion 156 of the control wire 106 connecting adjacent nodes 108 can be tapered from its distal end 158 to the proximal end 160. The tapered thickness of each connecting portion 156 increases incrementally for each adjacent proximal node 108. In an exemplary embodiment, the first connecting portion 156a (which connects the most distal node 108a to the adjacent proximal node 108b) has a tapered thickness that is less than the tapered thickness of the second connecting portion 156b (which connects the adjacent proximal node 108b to the next immediately adjacent proximal node 108c). Therefore, when a proximal force is applied to the control member 106, the first connecting portion 156a will break before the second connecting portion 156b. Although the exemplary embodiment is shown and described as including three nodes 108, the control member 106 may include any number of nodes, and the number of nodes 108 determines the number of times the applicator 104 can be reloaded with a new clamp assembly. Each connecting portion 156 will have a tapered thickness greater than the adjacent distal connecting portion. The connecting portion 156 having the smallest tapered thickness will break or break away first.

[0043] According to another exemplary embodiment, Figure 7 As shown, the connection portion 256 connecting the node 208 along the distal portion 254 of the control member 206 may include one or more notches 262 extending therearound. The notches 262 weaken the connection portion 256 to facilitate its breaking when a predetermined force is applied thereto. Each connection portion 256 may have fewer, thinner, and / or shallower notches 262 than an adjacent distal connection portion 256. The connection portion 256 having the most, thickest, and / or deepest notches 262 (i.e., the most distal connection portion 256a) will be the weakest, causing the connection portion 256 to break or break away first.

[0044] According to yet another exemplary embodiment, Figure 8As shown, the connecting portion 356 connecting the nodes 308 along the distal portion 354 of the control member 306 can be welded to at least one of the nodes 308 connected thereto. Each connecting portion 356 connects two adjacent nodes 308, with the distal end 358 of the connecting portion 356 connected to the distal one of the adjacent nodes 308a and the proximal end 360 of the connecting portion connected to the proximal one of the adjacent nodes 308b. According to one example, the distal end 358 can be integrally formed with the distal one of the nodes 308a, while the proximal end 360 is connected to the proximal one of the nodes 308b via a weld 362. Each connecting portion 356 can have a stronger, more solid weld 362 that connects the connecting portion of one of the nodes 308 compared to the adjacent distal connecting portion 356. In other words, for each immediately adjacent distal connecting portion 356, the weld 362 of the connecting portion 356 becomes progressively less solid. Therefore, the connection portion 356 attached to the currently most distal one of the nodes 308 will be first to disengage or break from the remainder of the control member 306 .

[0045] Although the exemplary embodiment describes and illustrates connecting portions 156, 256, 356 having specific features, those skilled in the art will understand that nodes along the control member of the present invention may be connected to one another in any of a variety of ways, as long as a proximal force applied to the control member that exceeds a predetermined threshold force causes the current distal-most node to disengage from the immediately adjacent proximal node.

[0046] An exemplary method for loading the clamp assembly 102 to the applicator 104 includes pushing the distal-most node 108a of the control member 106 (or, the distal-most one of the nodes 208, 308) against the yoke 114 of the clamp assembly 102 distally until the distal force against it exceeds a predetermined threshold, thereby causing the opposing portion 136 thereof to separate. The separation of the opposing portion 136 allows the distal-most node 108a to pass through the proximal portion 128 and into the distal portion 126. Once the distal-most node 108a is received within the distal portion 126, the yoke 114 returns to its original shape (e.g., under its natural bias), thereby retaining the distal-most node 108a therein. Prior to coupling the control member 106 to the yoke 114 or after coupling the control member 106 and the yoke 114, the catheter 144 may be moved distally to couple to the package 116.

[0047] As described above, in the case where the clamp assembly 102 is housed within the cartridge, the catheter 144 and the distal portion 154 of the control member 106 can be inserted through the proximal opening of the cartridge to couple to the clamp assembly 102. Once the applicator 104 has been coupled to the clamp assembly 102 (as described above), the clamp assembly 102 can be removed from the cartridge by pulling the control member 106 proximally relative to the catheter 144 to pull the clamp arms 110 toward the insertion / tissue clamping configuration into the enclosure 116. Once the clamp arms 110 are in the insertion / tissue clamping configuration, the entire applicator 104 can be moved proximally relative to the cartridge to pull the clamp assembly 102 out of the cartridge via the proximal opening.

[0048] In use, after the clamp assembly 102 has been loaded onto the applicator 104, the clamp assembly 102 is inserted through the working channel of the endoscope (or any other insertion device) and inserted into the body (e.g., through a natural body lumen) to a site adjacent to the target portion of the tissue to be clamped. The clamp assembly 102 is inserted into the target tissue in an insertion configuration to facilitate its passage through the working channel. After reaching the site of the target tissue, the clamp assembly 102 is pushed out of the distal end of the working channel, and the clamp arm 110 extends out of the enclosure 116 to move the clamp arm 110 to a tissue receiving configuration. Once the target tissue has been received between the clamp arms 110, the clamp assembly 102 can be moved toward the tissue clamping configuration so that the target tissue is clamped between its distal ends 118. By pulling the control member 106 proximally relative to the catheter 144, the clamp arm 110 moves toward the tissue clamping configuration. Once the clamp assembly 102 is in the tissue clamping configuration, the control member 106 may be further pulled proximally to lock the clamp arm 110 relative to the enclosure 116 .

[0049] To deploy the clip assembly 102, the control member 106 is pulled even further proximally until the force applied thereto exceeds a predetermined threshold, thereby causing the distal-most node 108a housed within the yoke 114 to disconnect or disengage from the remainder of the control member 106, as described above. Once the distal-most node 108a is separated from the remainder of the control member 106, the clip assembly 102 can be deployed in the body.

[0050] After the clamp assembly 102 is deployed in the body, the next immediately proximal node 108b can be used to couple the applicator 104 to the new clamp assembly 102 in the same manner as described above. The new clamp assembly can be used to clamp a second portion of tissue. Using the same applicator 104, this process can be repeated as many times as there are nodes.

[0051] like Fig. 9 and Fig.10As shown, a system 400 according to another exemplary embodiment of the present invention can be generally similar to system 100, including a clamp assembly 402 and an applicator 404. Similar to system 100, a control member 406 of the applicator 404 includes a plurality of nodes 408a, 408b along a distal portion of the control member 406, each of the nodes 408 being configured to couple to a portion of the clamp assembly 402. However, the system 400 also includes a torsion member 464 that can be coupled to a distal end 452 of a catheter 444 of the applicator 404. When it is desired to deploy the clamp assembly 402 in the body, the clamp assembly 402 can be locked in a tissue clamping configuration by pulling the control member 406 proximally relative thereto (generally as described above with respect to system 100). After locking of the clamp assembly 402, further proximal movement of the control member 406 causes the proximal end 438 of the package body 416 to engage the torsion member 464, thereby causing the package body 416, and thus a portion of the control member 406 coupled thereto, to rotate about its longitudinal axis relative to the torsion member 464. As will be described in further detail below, the rotation of the package body 416 causes torsional stresses along a portion of the control member 406 to cause the control member 406 to rupture at a point between the distal-most node 408a and the next immediately proximal node 408b, thereby releasing the clamp assembly 403 from the applicator 404 for deployment of the clamp assembly 402 into the body.

[0052] like Fig.10 As shown, the torsion member 464 extends longitudinally from a proximal end 466 to a distal end 468 and includes a channel 470 extending therethrough. The channel 470 may include a pair of inclined surfaces 472 along its distal portion, each of the inclined surfaces 472 circumscribing approximately halfway around the surface of the channel 470 so that when the corresponding proximal end 438 of the package 416 is docked therewith, the package 416 can rotate about the longitudinal axis relative to the torsion member 464. The proximal end 438 may, for example, include a radially extending tab for docking with the inclined surface 472 so that when the package 416 moves proximally relative to the torsion member 464, the tab of the package 416 slides along the inclined surface 472 to rotate the package 416 about the longitudinal axis. Because the clamp arm 410 is locked relative to the package 416 in the locked tissue clamping configuration, the distal-most node 408a connected to the clamp arm 410 also rotates with the rotation of the package 416. The proximal end 466 of the torsion member 464 is configured to prevent the next immediately proximal node 408b from rotating, so that rotation of the package body 416 and the distal-most node 408a connected to the clamp assembly 402 causes torsional stress along a portion of the control member between the distal-most node 408a and the next immediately proximal node 408b. As the control member 406 continues to move proximally, the control member 406 fractures due to the combined torsional and tensile loads.

[0053] like Fig.11 As shown, a system 500 according to another exemplary embodiment can be generally similar to the systems described above, including an applicator 504 on which a clamp assembly 502 can be loaded. The applicator 504 and the clamp assembly 502 can be generally similar to the applicator 104 and the clamp assembly 102 described above with respect to the system 100. However, the system 500 can also include a stressing mechanism that includes a cutting member 580 that is movably received within a distal end 552 of a channel 545 of a catheter 544 of the applicator 504. The cutting member 580 can pivot between a non-cutting configuration; in the non-cutting configuration, the cutting member 580 is generally aligned with an interior surface 582 of the catheter 544 (e.g., generally parallel to the longitudinal axis of the catheter 544); and in the cutting configuration, the cutting end 584 of the cutting member 580 extends toward the longitudinal axis of the catheter 544. In the cutting configuration, the cutting end 584 of the cutting member 580 contacts a portion of the control member 506 proximate the distal-most node 508a to sever the distal-most node 508a from the remainder of the control member 506. As described above with respect to the system 100, separation of the distal-most node 508a from the remainder of the control member 506 enables the clamp assembly 502 to be deployed in the body.

[0054] Then, the clamp assembly 502 moves from the tissue receiving configuration to the tissue clamping configuration, and the proximal movement of the control member 506 relative to the catheter 544 causes the cutting member 580 to pivot toward the cutting configuration. For example, the cutting member 580 can be movable between the cutting configuration and the non-cutting configuration via the pull wire 586 connected thereto. When the control member 506 moves toward the proximal side, the next adjacent proximal node 508b can engage the end 588 of the pull wire 586, thereby causing the proximal movement of the pull wire 586 toward the cutting configuration and the pivoting of the cutting member 580. The cutting end 584 of the cutting member 580 contacts a portion of the control member 506 between the most distal node 508a and the next adjacent proximal node 508b. The contact between the cutting end 584 and the portion of the control member 506 causes shear stress thereto, thereby cutting the control member 506 along it. Therefore, the most distal node 508a is separated from the rest of the control member 506, thereby deploying the clamp assembly 502.

[0055] It will be apparent to those skilled in the art that various modifications can be made to the present invention without departing from the scope of the invention.

Claims

1. A reloadable clamping device, comprising: a clamp assembly including a pair of clamp arms, each of the clamp arms extending from a proximal end to a distal end, the proximal ends of each of the clamp arms being connected to each other via a yoke received in a channel of an enclosure to enable the clamp arms to move between a tissue receiving configuration in which the distal ends of the clamp arms are separated from each other and a tissue clamping configuration in which the distal ends of the clamp arms are moved toward each other; and An applicator having an opening insertable through the box to couple to the distal portion of the clamp assembly, the applicator comprising a catheter and a control member, the catheter extending from a proximal end to a distal end and including a lumen extending therethrough, the distal end of the catheter being configured to couple to the proximal end of the package body, the control member extending through the lumen of the catheter and including a plurality of nodes extending along its distal portion, each node having a cross-sectional area greater than the cross-sectional area of ​​the remainder of the control member and being configured to couple to the proximal end of the clamp arm, the distal-most one of the nodes being separable from the next immediately proximal one of the nodes to release the clamp assembly from the applicator when a force applied thereto exceeds a predetermined threshold.

2. The reloadable clamping device of claim 1, wherein the proximal end of the enclosure is configured to be received within the catheter.

3. A reloadable clamping device according to claim 1 or 2, wherein the clamp assembly is configured to be housed in a box.

4. The reloadable clamping device of claim 3, wherein the enclosure includes a flexible tab biased in a laterally outward position.

5. The reloadable clamping device of claim 4, wherein the flexible tab is formed via a cut through a wall of the enclosure, wherein the cut is biased to be angled laterally outward.

6. The reloadable clamping device of claim 4, wherein when the clamp assembly is received within the cartridge, the flexible tab is compressed such that the flexible tab is received within the conduit.

7. The reloadable clamping device of claim 4, wherein when the flexible tab is received within the conduit, the flexible tab is constrained via an interior surface of the conduit.

8. A reloadable clamping device according to claim 4, wherein the control member is constructed so that it can move distally so that it pushes the package body distally relative to the catheter, so that the flexible tab moves distally through the distal end of the catheter, allowing the flexible tab to return to its laterally extended biased position.

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