Stretch ring coupler for a reloadable hemostatic clamping device

Abstract

A system for treating tissue includes a clamp assembly including a pair of clamp arms. The proximal ends of the clamp arms are slidably received in a channel of a tube chamber to move between a tissue receiving configuration and a tissue clamping configuration. The system also includes a catheter assembly including a control member extending therethrough. The control member includes a distal end connected to the clamp arms to move the clamp assembly between the receiving and clamping configurations. The system also includes a coupler that is releasably coupled to the proximal end of the tube chamber and is configured to couple to the distal end of the catheter assembly. When a proximal force applied to the coupler via the control member exceeds a first predetermined threshold, the coupler breaks to disengage the tube chamber and deploy the clamp assembly.

Description

[0001] Priority declaration

[0002] This application claims priority to U.S. Provisional Patent Application Serial No. 62 / 767,816, filed on November 15, 2018; the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention relates generally to medical clips, and more particularly to hemostatic clips that are delivered to a target site through an endoscope. Background Art

[0004] Lesions 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 are often used to control such internal bleeding. These clips grasp the tissue surrounding the wound and temporarily hold the wound edges together to allow the natural healing process to permanently close the wound. A dedicated endoscopic clamping device is often used to deliver the clip to the desired location in the body, after which the clip delivery device is withdrawn, thereby leaving the clip in the body.

[0005] Hemostatic clips typically include a coupling that connects the clip to a delivery device. By design, the coupling breaks when the clip is deployed to release the clip from the delivery device. One challenge with using a coupling that breaks off is that the broken pieces may be small enough that they may be drawn into the working channel of the endoscope and may become lodged there. As a result, even after a standard clean procedure has been performed, the pieces may remain in the endoscope, increasing the risk of contaminating the endoscope and infecting the patient. Summary of the invention

[0006] The present invention relates to a system for treating tissue, which includes a clamp assembly, the 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 the clamp arms being slidably received in a channel of a tube chamber 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 and in which the distal ends of the clamp arms move toward each other; a catheter assembly, the catheter assembly including a sleeve and a control member extending therethrough, the control member including a distal end configured to be connected to the clamp arms to move the clamp assembly between the tissue receiving configuration and the tissue clamping configuration; and a connector, the connector being releasably connected to the proximal end of the tube chamber and configured to be connected to the distal end of the catheter assembly, the connector being configured to break when a proximal force applied to the connector via the control member exceeds a first predetermined threshold value to disengage the tube chamber and deploy the clamp assembly.

[0007] In one embodiment, the proximal ends of the clamp arms may be connected to each other via a yoke that may be releasably coupled with the enlarged distal end of the control member.

[0008] In one embodiment, the proximal portion of the coupler includes a plurality of fingers mountable over the distal portion of the hub to couple the coupler to the catheter assembly.

[0009] In one embodiment, the connector includes two groups of V-shaped notches diametrically opposed around the circumference of a distal portion of the connector, each group of V-shaped notches including a proximal V-shaped notch extending from a proximal end of a wall of the connector, and a distal V-shaped notch extending from a distal end of the wall of the connector, the V-shaped notches of the group being configured to break when a proximal force applied thereto exceeds a threshold value.

[0010] In one embodiment, the connector includes a ramp portion configured to interact with a ridge extending circumferentially around the outer surface of the sleeve such that when a proximal force is applied to the connector, the ramp portion moves proximally over the ridge, thereby expanding the wall of the connector and causing the V-shaped notch to break.

[0011] In one embodiment, each set of V-shaped notches includes a third V-shaped notch extending from the outer surface of the coupler into the wall of the coupler.

[0012] In one embodiment, the coupler includes an annular portion extending from a first side of each set of V-shaped notches to a second side of each set of V-shaped notches, the annular portion preventing the coupler from being disengaged from the distal end of the bushing when the coupler is broken.

[0013] The present invention also relates to a system for treating tissue, which includes a clamp assembly and a tube chamber, the clamp assembly including a pair of clamp arms, each of the clamp arms extending from a proximal end to a distal end, the proximal end of the clamp arms being slidably received in a channel of the tube chamber to move between a tissue receiving form and a tissue clamping form, in which the distal ends of the clamp arms are separated from each other and in the tissue clamping form, the distal ends of the clamp arms move toward each other; a catheter assembly, the catheter assembly including a control member extending therethrough, the control member including a distal end configured to be connected to the clamp arms to move the clamp assembly between the tissue receiving form and the tissue clamping form; and a connector, the connector being releasably connected to the proximal end of the clamp assembly and configured to be connected to the distal end of the catheter assembly, the connector being configured to break so as to disengage the tube chamber and deploy the clamp assembly.

[0014] In one embodiment, the catheter assembly includes a hub at a distal end thereof, the hub configured to couple to a proximal end of the coupler.

[0015] In one embodiment, the connector includes two groups of V-shaped notches diametrically opposed around the circumference of a distal portion of the connector, each group of V-shaped notches including a proximal V-shaped notch extending from a proximal end of a wall of the connector, and a distal V-shaped notch extending from a distal end of the wall of the connector, the V-shaped notches of the group being configured to break when a proximal force applied thereto exceeds a threshold value.

[0016] In one embodiment, the connector includes a ramp portion configured to interact with a ridge extending circumferentially around the outer surface of the sleeve such that when a proximal force is applied to the connector, the ramp portion moves proximally over the ridge, thereby expanding the wall of the connector and causing a portion of the V-shaped notch to break.

[0017] In one embodiment, each set of V-shaped notches includes a third V-shaped notch extending from the outer surface of the coupler into the wall of the coupler.

[0018] In one embodiment, the coupler includes an annular portion extending from a first side of each set of V-shaped notches to a second side of each set of V-shaped notches, the annular portion preventing the coupler from being disengaged from the distal end of the bushing when the coupler is broken.

[0019] In one embodiment, the proximal ends of the clamp arms may be connected to each other via a yoke that may be releasably coupled with the enlarged distal end of the control member.

[0020] In one embodiment, the proximal portion of the coupler includes a plurality of fingers mountable over the distal portion of the hub to couple the coupler to the catheter assembly.

[0021] The present invention also relates to a method for treating tissue, which includes loading a clip assembly on a catheter assembly by connecting a proximal end of a connector to a distal end of a catheter assembly and connecting the distal end of the connector to a proximal end of a clamp assembly, wherein a control member of the catheter assembly is releasably connected to the proximal end of a clamp arm of the clip assembly; inserting the loaded clip assembly into a target site in vivo via a working channel of an insertion device; moving the clip assembly between a tissue receiving form and a tissue clamping form, wherein the distal ends of the clamp arms are separated from each other, and in the tissue clamping form, the distal ends of the clamp arms are moved toward each other until the target site is clamped therebetween by longitudinally moving the control member relative to the clip assembly as needed; and releasing the clip assembly from the catheter by pulling the control member proximally relative to the clamp arm beyond a predetermined threshold, so that the connector yields to disengage the clip assembly and at least a portion of the connector remains connected to the catheter assembly.

[0022] In one embodiment, the method further includes pulling the control member proximally further beyond a predetermined threshold until the enlarged distal end of the control member is disengaged from a yoke of the clip assembly.

[0023] In one embodiment, the proximal ends of the clamp arms may be connected to each other via a yoke that may be releasably coupled with the enlarged distal end of the control member.

[0024] In one embodiment, the connector includes two groups of V-shaped notches diametrically opposed around the circumference of a distal portion of the connector, each group of V-shaped notches including a proximal V-shaped notch extending from a proximal end of a wall of the connector, and a distal V-shaped notch extending from a distal end of the wall of the connector, the V-shaped notches of the group being configured to break when a proximal force applied thereto exceeds a threshold value.

[0025] In one embodiment, the coupler includes an annular portion extending from a first side of each set of V-shaped notches to a second side of each set of V-shaped notches, the annular portion preventing the coupler from being disengaged from the distal end of the bushing when the coupler is broken. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 shows a perspective cross-sectional view of a clamping device according to an exemplary embodiment of the present invention;

[0027] Figure 2 An exemplary embodiment of the present invention is shown. Figure 1 A perspective view of a ring connector of a clamping device;

[0028] Figure 3 Shows Figure 1 Another perspective view of the ring connector;

[0029] Figure 4 shows a perspective view of a ring coupling of a clamping device according to a second exemplary embodiment of the present invention;

[0030] Figure 5 shows a perspective view of a ring coupling of a clamping device according to a third exemplary embodiment of the present invention;

[0031] Figure 6 A perspective view showing a ring coupling of a clamping device according to a fourth exemplary embodiment of the present invention; and

[0032] Figure 7 A perspective view of a ring coupling of a clamping device according to a fifth exemplary embodiment of the present invention is shown. DETAILED DESCRIPTION

[0033] The present invention may be further understood with reference to the following description and accompanying drawings, wherein like elements are indicated by like reference numerals. 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 clip assembly that can be loaded onto the distal end of a catheter assembly prior to an endoscopic procedure. Once the clip is deployed at a desired target area in the body, the catheter assembly can be reloaded with a new clip. In particular, the catheter assembly includes a coupler for releasably coupling a sleeve of the catheter assembly to the clip assembly so that multiple clips can be fired using a single catheter assembly. The coupler is preassembled with the proximal end of a tube cabin and is configured to be coupled to the distal end of the sleeve. When it is desired to deploy the clip assembly in the body, a control member is pulled proximally relative to the clip assembly until the coupler is disengaged or broken from the tube cabin to release the tube cabin from the catheter assembly. In an exemplary embodiment, the coupler includes a ring that is designed to hold a broken coupler on the top of the catheter assembly when the coupler breaks. It should be noted that the terms "proximal" and "distal" as used herein refer to directions towards (proximal) and away from (distal) a user of the device.

[0034] like Figure 1As shown in , a system 100 according to an exemplary embodiment of the present invention includes a clip assembly 102, a catheter assembly 104, and a coupler 106 that facilitates a releasable connection between the catheter assembly 104 and the clip assembly 102. Before the system 100 is inserted into a living body to clamp a target tissue, the clip assembly 102 can be loaded onto a hub 110 of the catheter assembly 104. The catheter assembly 104 is configured so that after the clip assembly 102 is deployed in the living body, a new clip assembly 102 can be loaded onto the catheter assembly 104, so that the same catheter assembly 104 can be used to deliver multiple clip assemblies 102 to other portions of the target tissue in the living body. In this embodiment, the tube cabin 108 of the clip assembly 102 is preassembled with the coupler 106 and is configured to be releasably connected to the catheter assembly 104. Once the capsule 108 of the clamp assembly 102 has been coupled to the hub 110 of the catheter assembly 104, the control member 112 of the catheter assembly 104, which is releasably connected to the clamp arms 114 of the clamp assembly 102, can be moved longitudinally relative to the catheter 104 and the capsule 108 to move the clamp assembly 102 between an open tissue receiving configuration in which the distal ends 116 of the clamp arms 114 are separated from each other to receive the target tissue therebetween, and a closed tissue clamping configuration in which the distal ends 116 are pulled toward each other to clamp the target tissue therebetween. When clamping the target tissue as desired, a compressive force can be applied to the coupler 106, thereby causing a portion of the coupler 106 of this embodiment to yield and / or break to release the capsule 108 from the catheter assembly 104. It is noted that while this exemplary embodiment is shown and described as the connector 106 preassembled with the tube compartment 108 of the clamp assembly 102, in another embodiment, the connector 106 may be similarly preassembled with the sleeve 110 of the catheter assembly 104 for releasable connection to the tube compartment 108.

[0035] The clamp assembly 102 includes a pair of clamp arms 114 whose proximal ends 118 are connected to a yoke 120 that is slidably received within the tube capsule 108, so that when the yoke 120 is coupled to the control member 112 of the catheter assembly 104 and the tube capsule 108 is coupled to the hub of the catheter assembly 104 via the coupler 106, the longitudinal movement of the control member 112 relative to the hub 110 causes the clamp assembly 102 to move between the tissue receiving and tissue clamping configurations. The clamp arms 114 of this embodiment are biased toward the open tissue receiving configuration, so that when not constrained by the tube capsule 108, the clamp arms 114 move to the tissue receiving configuration under their natural bias, wherein the distal ends 116 of the clamp arms 114 are spread apart from each other. When the clamp arms 114 are pulled into the tube capsule 108, the tube capsule 108 constrains the clamp arms 114, thereby holding the distal ends 116 together in the tissue clamping configuration.

[0036] As described above, each of the clamp arms 114 extends from a proximal end 118 to a distal end 116. As will be appreciated by those skilled in the art, the clamp arms 114 of this embodiment may include optional clamping features configured to enhance the clamping of tissue therebetween. For example, the distal end 116 of one or both of the clamp arms 114 may include a tip extending laterally inward toward the other clamp arm 114, wherein the tip includes, for example, teeth, protrusions, spikes, or other structures configured to clamp tissue between the distal ends 116. One or both of the clamp arms 114 may also include a locking feature configured to lock the clamp arms 114 in a tissue clamping configuration after the target tissue has been clamped by the clamp arms 114 as desired. In one embodiment, the proximal portion of one or both of the clamp arms 114 includes a locking lug extending laterally outward therefrom, which is configured to engage a portion of the tube compartment 108 when the clamp arms 114 have been pulled into the tube compartment 108 by a predetermined distance. For example, the locking lugs may be received within correspondingly sized, shaped, and positioned locking windows extending transversely to or through a wall of the capsule 108 to lock the clamp arms 114 relative to the capsule 108 in the tissue clamping configuration.

[0037] In one embodiment, the proximal ends 118 of the clamp arms 114 are connected to each other to form a unitary piece connected to the yoke 120. In another embodiment, the proximal ends 118 can be formed as separate elements connected to each other via the yoke 120. The yoke 120 is connected to the proximal end 118 of each of the clamp arms 114 and is configured to be releasably connected to the enlarged distal end 122 of the control member 112 of the catheter assembly 104. For example, the yoke 120 can include a longitudinal slot 124 extending along the longitudinal axis of the yoke 120 from a proximal opening 126 located at the proximal end 128 of the yoke 120 to a distal portion 130, which is sized and shaped to receive the enlarged distal end 122 of the control member 112 of the catheter assembly 104. In an exemplary embodiment, the enlarged distal end 122 is configured as a ball that is received in a correspondingly sized and shaped socket of the distal portion 130. A proximal portion 132 of the slot 124 extending between the proximal opening 126 and the distal portion 130 has a cross-sectional area (e.g., diameter) that is less than the cross-sectional area of ​​the distal portion 130. The slot 124 can be defined via opposing portions 134 that can expand to receive the enlarged distal end 122 and are biased toward each other such that once the enlarged distal end 122 passes distally into the distal portion 130, the opposing portions 134 rebound to lock the enlarged distal end 122 within the distal portion 130, thereby coupling the control member 112 to the yoke 120. Thus, longitudinal movement of the control member 112 relative to the tube capsule 108 controls movement of the clamp arm 114 between the tissue receiving and tissue clamping configurations. And, during deployment, as increasing tension is imparted to control member 112 , the tension is applied by enlarged end 122 against proximal portion 132 of slot 124 until opposing portions 134 move away from each other to allow control member 112 to separate from yoke 120 as clip assembly 102 is deployed.

[0038] According to this embodiment, the enlarged distal end 122 of the control member 112 is inserted into the distal portion 130 via the proximal opening 126 of the yoke 120. When the control member 112 is pushed distally into the yoke 120 beyond a predetermined threshold, the proximal opening 126 of the slot 124 is deformed via separation of the opposing portions 134 to allow the enlarged distal end 122 to enter into the distal portion 130 through the proximal portion 132. Once the enlarged end 122 is received within the distal portion 130, the proximal portion 132 of the slot 124 returns to its original size, thereby retaining the enlarged end 122 of the control member 112 in the distal portion 130.

[0039] The tube capsule 108 extends from the proximal end 136 to the distal end 138 and includes a channel 140 extending longitudinally therethrough. The channel 140 is sized and shaped to slidably receive the yoke 120 and at least the proximal portion of the clamp arm 114 therein. As described above, the tube capsule 108 may also include a locking feature (e.g., a locking window) for engaging a corresponding locking feature (e.g., a locking lug) of the clamp arm 114. In this embodiment, the proximal end 136 may be preassembled with the coupler 106. The tube capsule 108 may include a window (not shown) extending transversely through its proximal end 136 for receiving a correspondingly sized and shaped engagement feature of the coupler 106. In one embodiment, the tube capsule 108 includes a pair of diametrically opposed windows for engaging the coupler 106. However, it will be understood by those skilled in the art that the tube capsule 108 may include any number of windows for receiving any number of corresponding engagement features of the coupler 106. Those skilled in the art will also appreciate that the coupler 106 may be pre-assembled with the tube capsule 108 via any of a variety of couplings.

[0040] The coupler 106 extends from a proximal end 144 to a distal end 146 and includes a passage 148 extending therethrough. In one embodiment, as described above, the distal end 146 of the coupler 106 can be preassembled with the proximal end 136 of the tube capsule 108 so that the passage 148 of the coupler 106 communicates with the passage 140 of the tube capsule 108. Thus, the control member 112 of the catheter assembly 104 can pass through the passages 148, 140 of the coupler 106 and the tube capsule 108, respectively, to be coupled to the yoke 120 during loading of the clip assembly 102. The proximal portion of the tube capsule 108 can be sized and shaped to be received within the passage 148 of the coupler 106 so that the inwardly engaging features at the distal portion of the coupler 106 can be received within a window (not shown) of the tube capsule 108 to couple the coupler 106 thereto. In one embodiment, the coupler 106 includes a pair of opposing lugs (not shown) that are received within diametrically opposed windows of the tube capsule 108. However, the coupler 106 may include any number of lugs for coupling the coupler 106 to the nacelle 108 .

[0041] The proximal portion of the coupler 106 of this embodiment includes a plurality of fingers 152 that are configured to engage the hub 110 of the catheter assembly 104. The fingers 152 are mounted over the distal end 160 of the hub 110 such that the hub 110 and the coupler 106 snap together. The fingers 152 are biased toward an engagement configuration, but can be expanded to allow the distal end 160 of the hub 110 to be received therein. In particular, each of the fingers 152 includes a groove 153 extending along an inner surface thereof, the groove 153 being sized and shaped to receive a corresponding engagement feature 162 or ridge of the distal end 160 of the hub 110. The ridge 162 extends around the circumference of the outer surface of the hub 110, as shown in FIG. Figure 3 As shown. When the ridge 162 at the distal end 160 is inserted therebetween, the fingers 152 are deflected away from each other. However, once the ridge 162 is received within the groove 153, the fingers 152 snap inwardly under their natural bias, causing the groove 153 and the ridge 162 to engage each other, thereby coupling the bushing 110 to the coupler 106. Figures 2 to 3 As shown, each of the fingers 152 includes a ramp portion 150 at a distal portion of its inner surface. The ramp portion 150 has an increasing thickness from its proximal end 154 to its distal end 156 and is configured to interface with a ridge 162 on the outer surface of the bushing 110, as will be described in further detail below.

[0042] The distal portion of the wall 164 of the coupler 106 includes two sets of diametrically opposed V-shaped notches 158 that are configured to open (e.g., separate, break, or rupture) to release the tube capsule 108 from the coupler 106. Specifically, each set of V-shaped notches 158 includes a proximal V-shaped notch 166 and a distal V-shaped notch 168. The proximal V-shaped notch 166 tapers from the proximal end to the distal end, and the distal V-shaped notch 168 tapers from the distal end to the proximal end, so that the tips of the V-shaped notches 166, 168 are closest to each other. Each of the two sets of V-shaped notches 158 is configured to open (e.g., separate, break, or rupture) when a proximal force is applied thereto via the proximal movement of the tube capsule 108. Therefore, the coupler 106 is configured to open along two diametrically opposed longitudinal axes parallel to the central longitudinal axis of the coupler 106. The opening of the two V-shaped notch sets 158 allows the distal end 146 of the coupler 106 to expand, thereby allowing the engagement features of the coupler 106 to be released from the window of the tube compartment 108. In order to prevent the coupler 106 from being released from the hub 110 of the catheter assembly 104, a pair of annular portions 170 positioned on the distal side of the wall 164 extend from a first side of each of the V-shaped notch sets 158 to a second side of each of the V-shaped notch sets 158, as shown in FIG. Figures 2 to 3 Thus, when the V-shaped notches 166 , 168 are open, the coupling 106 is held together by the annular portion 170 around the bushing 110 .

[0043] like Figures 4 to 6 As shown, the shape of each of the annular portions 170 can be varied based on the amount of deflection required for the coupler 106 to release the tube chamber 108. For example, in some cases, a greater deflection or outward expansion of the distal end 146 of the coupler 106 may be preferred. In other cases, less deflection may be preferred. In order to provide more deflection toward the distal end of the coupler 106, the annular portions 170 can be formed of a flexible material such as, for example, an injection molded polymer, acrylic, polycarbonate, etc. Conversely, the annular portions 170 formed of a more rigid material will result in less expansion. In another embodiment, as shown in FIG. Figures 4 to 5As shown, it can be seen that the shorter annular portion 170 (with Figure 6 ), which results in less expansion of the coupling 106. Conversely, Figure 6 The length of the annular portion 170 is longer, thereby providing a greater degree of expansion for the coupling 106. In addition, the size of the V-shaped notches 166, 168 can be varied to increase or decrease the amount of deflection of the distal end 146 of the coupling 106. For example, Figure 5 The larger distal V-shaped notch 168 is shown as Figure 4 and Figure 6 The smaller distal V-shaped notch 168 shown allows more deflection of the distal end 146 without breaking.

[0044] The catheter assembly 104 includes a hub 110, a flexible member 172 extending proximally therefrom, and a control member 112 extending longitudinally through the flexible member 172 and the hub 110. The proximal end (not shown) of the flexible member 172 can be connected to a handle portion. The proximal end (not shown) of the control member 112 in this embodiment can be connected to an actuator of the handle portion so that the longitudinal movement of the control member 112 relative to the flexible member 172 and the hub 110 can be controlled by a user at the handle portion.

[0045] The flexible member 172 may be formed as a coil through which the control member 112 extends from the enlarged distal end 122 to the proximal end (not shown). As will be appreciated by those skilled in the art, the coil is preferably flexible enough to pass through even tortuous paths of a living body, and in this embodiment (e.g., it will be flexible so that it can pass through a flexible endoscope along any path that can be traversed by an endoscope) is sized and shaped to pass through a working channel of an endoscope or other insertion device. However, the flexible member 172 may be shown and described as a coil, but it will be appreciated by those skilled in the art that any other suitable flexible structure may be employed, so long as the flexible member 172 is capable of providing a compressive force sufficient to offset the tension to be placed on the control member 112 from the clip assembly 102. As will be appreciated by those skilled in the art, the catheter assembly 104 may include any of a variety of actuation mechanisms for moving the control member 112 to control the movement of the clamp arm 114.

[0046] The bushing 110 extends longitudinally from a proximal end connected to the flexible member 172 to a distal end 160 configured to be releasably coupled to the coupler 106. The control member 112 extends through a cavity 174 of the bushing 110. The distal portion 176 of the bushing 110 can be sized and shaped to be inserted between the fingers 152 of the coupler 106 such that the ridges 162 at the distal end 160 of the bushing 110 are received and engaged with the grooves 153 of the fingers 152 of the coupler 106.

[0047] When it is desired to disengage the hub 110 from the coupler 106 to deploy the clip assembly 102 in vivo, the coupler 106 can be moved proximally by pulling the control member 112 proximally relative thereto. Specifically, once the clip assembly 102 is locked in the tissue clamping configuration, the proximal movement of the control member 112 pulls the tube capsule 108 proximally via the yoke 120, causing the coupler 106 to be pulled proximally against the hub 110. As the proximal force continues to be applied, the coupler 106 is pulled over the ridge 162 of the hub 110 via the ramp portion 150. When the ramp portion 150 is pulled further proximally, the fingers 152 are deflected radially outward from the longitudinal axis of the coupler 106 by the outward force of the ridge 162 against the ramp portion 150, thereby causing the V-shaped notches 166, 168 to break. The breaking of the V-shaped notches 166, 168 allows the distal end 146 of the coupler 106 to expand, thereby releasing the tube compartment 108. After the V-shaped notches 166, 168 are broken, the annular portion 170 prevents the coupler 106 from breaking apart from the clip assembly 102 and retains the coupler 106 on the hub 110 so that the coupler 106 can be pulled out of the body with the catheter assembly 104.

[0048] An exemplary method for loading the clip assembly 102 onto the catheter assembly 104 includes coupling the control member 112 to the yoke 120 and coupling the hub 110 to the tube chamber 108 via the coupler 106. The enlarged distal end 122 of the control member 112 can be coupled to the clamp arm 114 via the yoke 120 by pushing the enlarged distal end 122 distally against the proximal opening 126 of the yoke 120 until the distal force exerted thereon exceeds a predetermined threshold, thereby causing the opposing portions 134 thereof to deflect away from each other to allow the enlarged distal end 122 to move distally therethrough into the distal portion 130 of the longitudinal slot 124. Once the enlarged distal end 122 is received within the distal portion 130, the opposing portions 134 return to their original position, thereby retaining the enlarged distal end 122 within the yoke 120. The bushing 110 can be coupled to the tube capsule 108 via the coupler 106 by inserting a portion of the bushing 110 between the fingers 152 of the coupler 106 so that the coupler 106 and the bushing 110 engage each other via a snap fit. The proximal end 136 of the tube capsule 108 can be inserted into the distal end 146 of the coupler 106. Once the bushing 110 has been releasably connected to the tube capsule 108 and the enlarged distal end 122 is coupled to the yoke 120, the control member 112 can then be moved proximally to pull the clamp assembly 102 toward the closed clamping configuration.

[0049] In use, after the clip assembly 102 is loaded onto the catheter assembly 104, the clip 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 cavity) to a location adjacent to the target portion of the tissue to be clamped. The clip assembly 102 is inserted into the target tissue in a tissue clamping configuration to reduce trauma and facilitate its passage through the working channel. Upon reaching the location of the target tissue, the clip assembly 102 is pushed out of the distal end of the working channel and the control member 112 is moved distally relative to the sleeve 110 so that the clamp arms 114 extend distally from the tube compartment 108 into the tissue receiving configuration. Once the clip assembly 102 has been positioned so that the target tissue is received between the clamp arms 114, the clip assembly 102 can then be moved toward the tissue clamping configuration (performed by pulling the control member 112 proximally) so that the target tissue is clamped between its distal ends 118. The clamp arms 114 are moved toward the tissue-gripping configuration by pulling the control member 112 proximally relative to the hub 110 and the capsule 108. Once the clamp assembly 102 is in the tissue-gripping configuration, the control member 112 is further pulled proximally relative to the capsule 108 to lock the clamp arms 114.

[0050] To deploy the clip assembly 102, the control member 112 may be pulled proximally into the tube chamber until the coupler 106 attached to the tube chamber 108 is pulled proximally against the bushing 110. Further proximal movement of the coupler 106 causes the ridges 162 of the bushing 110 to slide distally against the ramped portions 150 of the coupling fingers 152, thereby deflecting the fingers 152 radially outward. The coupler 106 is then moved further proximally, causing the ridges 162 of the bushing 110 to expand the fingers 152 of the coupler 106 until the tension applied to the V-notch set 158 ​​causes the V-notch set 158 ​​to open. Opening of V-notch set 158 ​​allows the distal end of connector 106 to expand sufficiently to release tube capsule 108 therefrom, while annular portion 170 holds the broken connector 106 together and prevents the proximal end of connector 106 from expanding sufficiently to release from the distal end of bushing 110.

[0051] Once the tube cabin 108 has been disengaged from the connector 106, the control member 112 is further pulled proximally until the enlarged distal end 122 is disengaged from the yoke 120. In particular, when the force applied by the enlarged distal end 122 on the yoke 120 exceeds a predetermined threshold, the relative portion 134 is unfolded, thereby releasing the enlarged distal end therefrom. Alternatively, the yoke 120 can be broken to release the clip assembly 102 from the control member 112. Subsequently, the entire catheter assembly 104 including the control member 112 and the sleeve 110 can be withdrawn proximally from the body, leaving the clip assembly 102 (and any portion of the connector 106 still attached thereto) clamped above the target tissue. The connector 106 can be manually removed from the top of the catheter assembly 104, and if necessary, a new clip assembly 102 can be loaded onto the catheter assembly 104 in the same manner as described above. The process can be repeated as needed or desired using the same catheter assembly 104.

[0052] like Figure 7 As shown, a coupler 206 according to another exemplary embodiment of the present invention is substantially similar to the coupler 106, except that each set of V-shaped notches 258 includes a third V-shaped notch 280 extending transversely into the wall 264. Specifically, as with the coupler 106, the wall 264 of the coupler 206 includes two diametrically opposed sets of V-shaped notches 258 that are configured to break or rupture to release the tube capsule 208 from the coupler 206. Specifically, each set of V-shaped notches includes a proximal V-shaped notch 266 and a distal V-shaped notch 268. The proximal V-shaped notch is tapered from the proximal end to the distal end, and the distal V-shaped notch 268 is tapered from the distal end to the proximal end such that the tips of the V-shaped notches 266, 268 are closest to each other. Additionally, as shown Figure 7As can be seen in the figure, the group of V-shaped notches 258 includes a third V-shaped notch 280 cut into the wall 264 laterally. As shown, the third V-shaped notch 280 extends from the proximal end of the wall 264 to the distal end of the wall 264, thereby connecting the proximal and distal V-shaped notches 266, 268. The third V-shaped notch 280 only partially extends through the thickness of the wall 264 (that is, the dimension extending perpendicular to the longitudinal axis of the coupler 206 between the inner surface and the outer surface of the coupler 206). The depth of the third V-shaped notch 280 to the wall 264 can be changed according to the preferred amount of force required to break the coupler 206. That is, the third V-shaped notch 280 allows the user to have more control over the amount of force required to open the coupler 206. The shallower third V-shaped notch 280 will require a larger amount of force than the deeper third V-shaped notch 280. Each of the set of V-shaped notches 258 is configured to open (e.g., separate, break, or snap) when a proximal compressive force is applied thereto via the capsule 208. Thus, the coupler 206 is configured to open along two diametrically opposed longitudinal axes parallel to the central longitudinal axis of the coupler 206. The opening of the two sets of V-shaped notches 258 allows expansion of the distal end 246 of the coupler 206, thereby allowing the capsule 208 to be released from the capsule 206.

[0053] Although the exemplary embodiments show and describe a specific system configured to load a clip assembly onto a catheter assembly via a coupler, it will be understood by those skilled in the art that the present invention includes any of a variety of couplers for coupling a tube capsule of a clip assembly to a catheter assembly, so long as the coupler can be preassembled with the tube capsule and yield, break, and / or otherwise separate from the tube capsule during deployment of the clip assembly. Once the clip assembly has been deployed, the coupler (or the remainder thereof) can be removed from the hub of the catheter assembly so that the catheter assembly can be loaded with a new clip assembly.

[0054] Those skilled in the art will appreciate that the above-described embodiments may be modified without departing from the concept of the present invention. It should also be understood that structural features and methods associated with one of the embodiments may be incorporated into other embodiments. Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but modifications are also encompassed within the scope of the present invention as defined by the appended claims.

Claims

1. A system for treating tissue, comprising: a clamp assembly including a tube chamber and 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 slidably received within the passage of the tube chamber 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; a catheter assembly including a hub and a control member extending therethrough, the control member including a distal end configured to couple to the clamp arm to move the clamp assembly between the tissue receiving configuration and the tissue clamping configuration; as well as a coupler releasably coupled to the proximal end of the capsule and configured to couple to the distal end of the catheter assembly, the coupler being configured to move proximally by pulling the control member proximally relative thereto and being configured to break to disengage the capsule and deploy the clip assembly when a proximal force applied to the coupler via the control member exceeds a first predetermined threshold, The connector comprises two groups of V-shaped notches diametrically opposed around the circumference of the distal portion of the connector, each group of V-shaped notches comprising a proximal V-shaped notch extending from the proximal end of the wall of the connector, and a distal V-shaped notch extending from the distal end of the wall of the connector, the two groups of V-shaped notches being configured to break when the proximal force applied thereto exceeds a threshold value.

2. The system of claim 1, wherein the proximal ends of the clamp arms are connected to each other via a yoke that releasably couples with an enlarged distal end of the control member.

3. A system according to any one of claims 1 and 2, wherein the proximal portion of the connector includes a plurality of fingers that can be mounted over the distal portion of the hub to connect the connector to the catheter assembly.

4. A system according to claim 1, wherein the connector includes a ramp portion, which is configured to interact with a ridge extending circumferentially around the outer surface of the sleeve so that when a proximal force is applied to the connector, the ramp portion moves proximally over the ridge, thereby expanding the wall of the connector and causing a portion of the V-shaped notch to break.

5. The system of claim 1, wherein each set of V-shaped notches further comprises a third V-shaped notch extending from an outer surface of the coupler into the wall of the coupler.

6. The system of claim 1, wherein the connector includes an annular portion extending from a first side of each set of V-shaped notches to a second side of each set of V-shaped notches, the annular portion preventing the connector from being disengaged from the distal end of the bushing when the connector is broken.

7. A system for treating tissue, comprising: a clamp assembly including a pair of clamp arms and a tube chamber, each of the clamp arms extending from a proximal end to a distal end, the proximal ends of the clamp arms being slidably received within a channel of the tube chamber 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; a catheter assembly including a control member extending therethrough, the control member including a distal end configured to couple to the clamp arm to move the clamp assembly between the tissue receiving configuration and the tissue clamping configuration; as well as a coupler releasably coupled to the proximal end of the clip assembly and configured to couple to the distal end of the catheter assembly, the coupler being configured to move proximally by pulling the control member proximally relative thereto and being configured to break to disengage the capsule and deploy the clip assembly, the coupler comprising two sets of V-shaped notches diametrically opposedly disposed about a circumference of a distal portion of the coupler, each set of V-shaped notches comprising a proximal V-shaped notch extending from a proximal end of a wall of the coupler, and a distal V-shaped notch extending from a distal end of the wall of the coupler, the two sets of V-shaped notches being configured to break when a proximal force applied thereto exceeds a threshold value; as well as A hub at the distal end of the catheter assembly is configured to couple to the proximal end of the coupler.

8. A system according to claim 7, wherein the connector includes a ramp portion, which is configured to interact with a ridge extending circumferentially around the outer surface of the sleeve so that when a proximal force is applied to the connector, the ramp portion moves proximally over the ridge, thereby expanding the wall of the connector and causing a portion of the V-shaped notch to break.

9. The system of claim 7, wherein each set of V-shaped notches further comprises a third V-shaped notch extending from an outer surface of the coupler into the wall of the coupler.

10. The system of claim 7, wherein the connector includes an annular portion extending from a first side of each set of V-shaped notches to a second side of each set of V-shaped notches, the annular portion preventing the connector from being disengaged from the distal end of the bushing when the connector is broken.

11. The system of claim 7, wherein the proximal ends of the clamp arms are connected to each other via a yoke that releasably couples with an enlarged distal end of the control member.

12. The system of any one of claims 7 to 11, wherein the proximal portion of the coupler includes a plurality of fingers mountable over the distal portion of the hub to couple the coupler to the catheter assembly.

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