Tensile ring coupling for reloadable hemostatic clamping device

Abstract

A system for treating tissue includes a clip assembly including a pair of clip arms. The proximal end of the clip arm is slidably received within the channel of the lumen for movement 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 clip arms to move the clip assembly between the receiving and clamping configurations. The system also includes a coupler releasably coupled to a proximal end of the lumen and configured to be coupled to the distal end of the catheter assembly. When a proximal force exerted on the coupler via the control member exceeds a first predetermined threshold, the coupler breaks to disengage the pod and deploy the clip assembly.

Description

This application is a divisional application of patent application 201980075459.9 for invention patent. Priority Claim

[0001] This invention 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

[0002] The present invention generally relates to medical clips, and more particularly to hemostatic clips that are delivered to a target site via an endoscope. Background Art

[0003] Lesions in the gastrointestinal (GI) system, biliary tree, vascular system, and other body cavities and hollow organs are typically treated via endoscopic surgery, many of which require hemostasis to control internal bleeding. Hemostatic clips are commonly used to control such internal bleeding. These clips grasp the tissue around 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is typically used to deliver the clip to the desired location within the body, after which the clip delivery device is withdrawn, leaving the clip in the body.

[0004] Hemostatic clips typically include a coupler that attaches the clip to the delivery device. By design, the coupler breaks when the clip is deployed to release the clip from the delivery device. One challenge with using a breakable coupler is that the broken fragments may be small enough such that they may be aspirated into the working channel of the endoscope and may become lodged there. As a result, even after performing standard cleaning procedures, the fragments may remain in the endoscope, increasing the risk of contaminating the endoscope and infecting the patient. Summary of the Invention

[0005] The present invention relates to a system for treating tissue, comprising a clip assembly including a pair of clip arms, each of the clip arms extending from a proximal end to a distal end, the proximal ends of the clip arms being slidably received within a channel of a cannula to move between a tissue receiving configuration and a tissue clamping configuration, in the tissue receiving configuration, the distal ends of the clip arms are separated from each other, and in the tissue clamping configuration, the distal ends of the clip arms move towards each other; a catheter assembly including a bushing and a control member extending therethrough, the control member including a distal end configured to be connected to the clip arms to move the clip assembly between the tissue receiving configuration and the tissue clamping configuration; and a coupler releasably coupled to the proximal end of the cannula and configured to be coupled to the distal end of the catheter assembly, the coupler being configured to break when a proximal force applied to the coupler via the control member exceeds a first predetermined threshold, so as to disengage the cannula and deploy the clip assembly.

[0006] In one embodiment, the proximal ends of the clamping arms can be connected to each other via a yoke that is releasably couplable to the enlarged distal end of the control member.

[0007] In one embodiment, the proximal portion of the coupler includes a plurality of fingers that are mountable over the distal portion of the bushing to couple the coupler to the catheter assembly.

[0008] In one embodiment, the coupler includes two sets of V-shaped notches that are diametrically opposed about the circumference of the distal portion of the coupler, each set of V-shaped notches including a proximal V-shaped notch extending from the proximal end of the wall of the coupler and a distal V-shaped notch extending from the distal end of the wall of the coupler, the set of V-shaped notches being configured to break when a proximal force applied thereto exceeds a threshold.

[0009] In one embodiment, the coupler includes a ramp portion that is configured to interact with a ridge extending circumferentially about the outer surface of the bushing such that when a proximal force is applied to the coupler, the ramp portion moves proximally over the ridge, thereby expanding the wall of the coupler and causing the V-shaped notches to break.

[0010] In one embodiment, each set of V-shaped notches includes a third V-shaped notch that extends from the outer surface of the coupler into the wall of the coupler.

[0011] In one embodiment, the coupler includes an annular portion that extends 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 disengaging from the distal end of the bushing when the coupler breaks.

[0012] The present invention also relates to a system for treating tissue, which includes a clip assembly and a cannula. The clip assembly includes a pair of clamping arms, each of the clamping arms extending from a proximal end to a distal end. The proximal ends of the clamping arms are slidably received within a channel of the cannula to move between a tissue receiving configuration and a tissue clamping configuration. In the tissue receiving configuration, the distal ends of the clamping arms are separated from each other, and in the tissue clamping configuration, the distal ends of the clamping arms move towards each other. A catheter assembly includes a control member extending therethrough, the control member including a distal end configured to be connected to the clamping arms to move the clip assembly between the tissue receiving configuration and the tissue clamping configuration. And a coupler is releasably coupled to the proximal end of the clip assembly and is configured to be coupled to the distal end of the catheter assembly. The coupler is configured to break to disengage the cannula and deploy the clip assembly.

[0013] In one embodiment, the catheter assembly includes a bushing at its distal end, the bushing being configured to be coupled to the proximal end of the coupler.

[0014] In one embodiment, the connector includes two sets of V-shaped notches that are diametrically opposed around the circumference of the distal portion of the connector. Each set of V-shaped notches includes a proximal V-shaped notch that extends from the proximal end of the wall of the connector, and a distal V-shaped notch that extends from the distal end of the wall of the connector. The set of V-shaped notches is configured to break when the proximal force applied thereto exceeds a threshold value.

[0015] In one embodiment, the connector includes a ramp portion that is configured to interact with a ridge that extends circumferentially around the outer surface of the bushing 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.

[0016] In one embodiment, each set of V-shaped notches includes a third V-shaped notch that extends from the outer surface of the connector into the wall of the connector.

[0017] In one embodiment, the connector includes an annular portion that extends 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 prevents the connector from detaching from the distal end of the bushing when the connector breaks.

[0018] In one embodiment, the proximal ends of the clamping arms can be connected to each other via a yoke that can be releasably coupled to the enlarged distal end of the control member.

[0019] In one embodiment, the proximal portion of the connector includes a plurality of fingers that can be mounted over the distal portion of the bushing to couple the connector to the catheter assembly.

[0020] The present invention also relates to a method for treating tissue, which includes loading a clip assembly onto a catheter assembly by coupling the proximal end of the connector to the distal end of the catheter assembly and coupling the distal end of the connector to the proximal end of the clip assembly. The control member of the catheter assembly is releasably connected to the proximal ends of the clamping arms of the clip assembly; inserting the loaded clip assembly into a target site in a living body via the working channel of an insertion device; moving the clip assembly between a tissue receiving configuration and a tissue clamping configuration. In the tissue receiving configuration, the distal ends of the clamping arms are separated from each other, and in the tissue clamping configuration, the distal ends of the clamping arms are moved toward each other as needed by longitudinally moving the control member relative to the clip assembly until the target site is clamped therebetween; and releasing the clip assembly from the catheter by pulling the control member proximally relative to the clamping arms beyond a predetermined threshold such that the connector yields to disengage the clip assembly and at least a portion of the connector remains connected to the catheter assembly.

[0021] 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 disengages from the yoke of the clip assembly.

[0022] In one embodiment, the proximal ends of the clamping arms can be connected to each other via a yoke that is releasably couplable to the enlarged distal end of the control member.

[0023] In one embodiment, the coupler includes two sets of V-shaped notches that are diametrically opposed around the circumference of the distal portion of the coupler. Each set of V-shaped notches includes a proximal V-shaped notch extending from the proximal end of the wall of the coupler and a distal V-shaped notch extending from the distal end of the wall of the coupler. The set of V-shaped notches is configured to break when the proximal force applied thereto exceeds a threshold.

[0024] In one embodiment, the coupler includes an annular portion that extends 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 prevents the coupler from detaching from the distal end of the bushing when the coupler breaks. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 A perspective cross-sectional view of a clamping device according to an exemplary embodiment of the present invention is shown;

[0026] Figure 2 A perspective view of the ring coupler of the clamping device according to an exemplary embodiment of the present invention is shown; Figure 1 of the clamping device;

[0027] Figure 3 A perspective view of Figure 1 the ring coupler is shown;

[0028] Figure 4 A perspective view of the ring coupler of the clamping device according to a second exemplary embodiment of the present invention is shown;

[0029] Figure 5 A perspective view of the ring coupler of the clamping device according to a third exemplary embodiment of the present invention is shown;

[0030] Figure 6 A perspective view of the ring coupler of the clamping device according to a fourth exemplary embodiment of the present invention is shown; and

[0031] Figure 7 A perspective view of the ring coupler of the clamping device according to a fifth exemplary embodiment of the present invention is shown. DETAILED DESCRIPTION

[0032] The present invention can be further understood with reference to the following description and the accompanying drawings, in which like elements are designated by like reference numerals. The present invention relates to a clamping system and, in particular, to a reloadable endoscopic clamping system. Exemplary embodiments of the present invention describe a clip assembly that can be loaded onto the distal end of a catheter assembly prior to an endoscopic procedure. Once the clip has been deployed at a desired target area within the body, the catheter assembly can be reloaded with a new clip. In particular, the catheter assembly includes a coupler that releasably couples a bushing of the catheter assembly to the clip assembly such that multiple clips can be fired using a single catheter assembly. The coupler is pre-assembled to the proximal end of the cannula and is configured to couple to the distal end of the bushing. When it is desired to deploy the clip assembly within the body, the control member is pulled proximally relative to the clip assembly until the coupler disengages or breaks away from the cannula to release the cannula from the catheter assembly. In an exemplary embodiment, the coupler includes a ring that is designed to hold the broken coupler at the tip of the catheter assembly when the coupler breaks. It should be noted that as used herein, the terms "proximal" and "distal" refer to directions toward (proximal) and away from (distal) the user of the device.

[0033] As Figure 1As shown, 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 facilitating a releasable connection between the catheter assembly 104 and the clip assembly 102. Before inserting the system 100 into a living body to clamp target tissue, the clip assembly 102 can be loaded onto a bushing 110 of the catheter assembly 104. The catheter assembly 104 is configured such that after deploying the clip assembly 102 within the living body, a new clip assembly 102 can be loaded onto the catheter assembly 104, such that the same catheter assembly 104 can be used to deliver multiple clip assemblies 102 to additional portions of the target tissue within the living body. In this embodiment, the cannula 108 of the clip assembly 102 is pre-assembled with the coupler 106 and is configured to releasably connect to the catheter assembly 104. Once the cannula 108 of the clip assembly 102 has been coupled to the bushing 110 of the catheter assembly 104, a control member 112 of the catheter assembly 104, which is releasably connected to the clip arms 114 of the clip assembly 102, can move longitudinally relative to the catheter 104 and the cannula 108 to move the clip assembly 102 between an open tissue-receiving configuration and a closed tissue-clamping configuration. In the open tissue-receiving configuration, the distal ends 116 of the clip arms 114 are separated from each other to receive the target tissue therebetween, and in the closed tissue-clamping configuration, the distal ends 116 are pulled towards each other to clamp the target tissue therebetween. When it is desired to clamp the target tissue, a compressive force can be applied to the coupler 106, such that a portion of the coupler 106 of this embodiment yields and / or fractures to release the cannula 108 from the catheter assembly 104. It should be noted that although this exemplary embodiment is shown and described with the coupler 106 pre-assembled with the cannula 108 of the clip assembly 102, in another embodiment, the coupler 106 can be similarly pre-assembled with the bushing 110 of the catheter assembly 104 to releasably connect to the cannula 108.

[0034] The clip assembly 102 includes a pair of clip arms 114, the proximal ends 118 of which are connected to a yoke 120 slidably received within the cannula 108, such that when the yoke 120 is coupled to the control member 112 of the catheter assembly 104 and the cannula 108 is coupled to the bushing 110 of the catheter assembly 104 via the coupler 106, longitudinal movement of the control member 112 relative to the bushing 110 moves the clip assembly 102 between the tissue-receiving and tissue-clamping configurations. The clip arms 114 of this embodiment are biased towards the open tissue-receiving configuration, such that when not constrained by the cannula 108, the clip arms 114 move to the tissue-receiving configuration under their natural biasing, wherein the distal ends 116 of the clip arms 114 are spread apart. When the clip arms 114 are pulled into the cannula 108, the cannula 108 constrains the clip arms 114, thereby holding the distal ends 116 together in the tissue-clamping configuration.

[0035] As described above, each of the clamping arms 114 extends from a proximal end 118 to a distal end 116. As will be understood by those skilled in the art, the clamping arms 114 of this embodiment may include optional clamping features that are configured to enhance the clamping of tissue therebetween. For example, the distal ends 116 of one or both of the clamping arms 114 may include tips that extend transversely inwardly toward the other clamping arm 114, where the tips include, for example, teeth, protrusions, spikes, or other structures that are configured to clamp tissue between the distal ends 116. One or both of the clamping arms 114 may also include locking features that are configured to lock the clamping arms 114 in a tissue clamping configuration after the target tissue has been clamped by the clamping arms 114 as desired. In one embodiment, the proximal portions of one or both of the clamping arms 114 include locking lugs that extend transversely outwardly therefrom and that are configured to engage a portion of the cannula 108 when the clamping arms 114 have been pulled into the cannula 108 by a predetermined distance. For example, the locking lugs may be received within locking windows that extend laterally to or through the cannula 108 wall and that are correspondingly sized, shaped, and positioned to lock the clamping arms 114 relative to the cannula 108 in the tissue clamping configuration.

[0036] In one embodiment, the proximal ends 118 of the clamping arms 114 are connected to each other to form a unitary piece connected to the yoke 120. In another embodiment, the proximal ends 118 may be formed as separate elements connected to each other via the yoke 120. The yoke 120 is connected to the proximal ends 118 of each of the clamping arms 114 and is configured to releasably connect to the enlarged distal end 122 of the control member 112 of the catheter assembly 104. For example, the yoke 120 may 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, the size and shape of which are set to receive the enlarged distal end 122 of the control member 112 of the catheter assembly 104. In one exemplary embodiment, the enlarged distal end 122 is configured as a ball that is received within a correspondingly sized and shaped socket in the distal portion 130. The 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 smaller than the cross-sectional area of the distal portion 130. The slot 124 may be defined by opposing portions 134 that are expandable to receive the enlarged distal end 122 and biased towards each other such that once the enlarged distal end 122 passes distally into the distal portion 130, the opposing portions 134 snap back 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 cannula 108 controls the movement of the clamping arms 114 between the tissue receiving and tissue clamping configurations. Also, during deployment, as increased tension is imparted to the control member 112, the tension is applied by the enlarged end 122 against the proximal portion 132 of the slot 124 until the opposing portions 134 move away from each other to allow the control member 112 to separate from the yoke 120 when deploying the clip assembly 102.

[0037] 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 deforms via separation of the opposing portions 134 to allow the enlarged distal end 122 to pass through the proximal portion 132 into the distal portion 130. 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 holding the enlarged distal end 122 of the control member 112 within the distal portion 130.

[0038] The cannula 108 extends from a proximal end 136 to a distal end 138 and includes a passageway 140 extending longitudinally therethrough. The passageway 140 is sized and shaped to slidably receive at least a proximal portion of the yoke 120 and the clamping arm 114 therein. As described above, the cannula 108 may also include locking features (e.g., locking windows) for engaging corresponding locking features (e.g., locking lugs) of the clamping arm 114. In this embodiment, the proximal end 136 may be pre-assembled with the connector 106. The cannula 108 may include a window (not shown) that extends transversely through its proximal end 136 for receiving correspondingly sized and shaped engagement features of the connector 106. In one embodiment, the cannula 108 includes a pair of diametrically opposed windows for engaging the connector 106. However, those skilled in the art will understand that the cannula 108 may include any number of windows for receiving any number of corresponding engagement features of the connector 106. Those skilled in the art will also understand that the connector 106 may be pre-assembled with the cannula 108 via any one of a variety of couplings.

[0039] The connector 106 extends from a proximal end 144 to a distal end 146 and includes a passageway 148 extending therethrough. In one embodiment, as described above, the distal end 146 of the connector 106 may be pre-assembled with the proximal end 136 of the cannula 108 such that the passageway 148 of the connector 106 is in communication with the passageway 140 of the cannula 108. Thus, the control member 112 of the catheter assembly 104 may pass through the passageways 148, 140 of the connector 106 and the cannula 108, respectively, to be coupled to the yoke 120 during loading of the clip assembly 102. The proximal portion of the cannula 108 may be sized and shaped to be received within the passageway 148 of the connector 106 such that inwardly engaging features of the distal portion of the connector 106 may be received within a window (not shown) of the cannula 108 to couple the connector 106 thereto. In one embodiment, the connector 106 includes a pair of opposing lugs (not shown) that are received within diametrically opposed windows of the cannula 108. However, the connector 106 may include any number of lugs for coupling the connector 106 to the cannula 108.

[0040] The proximal portion of the connector 106 of this embodiment includes a plurality of fingers 152 configured to engage the bushing 110 of the catheter assembly 104. The fingers 152 are mounted over the distal end 160 of the bushing 110 such that the bushing 110 and the connector 106 snap together. The fingers 152 are biased towards an engaged configuration but may be splayed to allow the distal end 160 of the bushing 110 to be received therein. In particular, each of the fingers 152 includes a groove 153 extending along its inner surface, the groove 153 being sized and shaped to receive a corresponding engagement feature 162 or ridge of the distal end 160 of the bushing 110. The ridges 162 extend circumferentially around the outer surface of the bushing 110, asFigure 3 As shown. When the ridge 162 located at the distal end 160 is inserted therebetween, the fingers 152 deflect away from each other. However, once the ridge 162 is received within the groove 153, the fingers 152 snap inwardly under their natural biasing force, such that the groove 153 and the ridge 162 engage with each other, thereby coupling the bushing 110 to the connector 106. As Figures 2 to 3 shown, each of the fingers 152 includes a ramp portion 150 at the distal portion of its inner surface. The ramp portion 150 has a thickness that increases from its proximal end 154 to its distal end 156 and is configured to mate with the ridge 162 on the outer surface of the bushing 110, as will be described in further detail below.

[0041] The distal portion of the wall 164 of the connector 106 includes two diametrically opposed sets of V-shaped notches 158 that are configured to open (e.g., separate, break, or fracture) to release the cannula 108 from the connector 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 is tapered from the proximal end to the distal end, and the distal V-shaped notch 168 is tapered from the distal end to the proximal end such 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, be frangible) when a proximal force is applied thereto via a proximal movement of the cannula 108. Thus, the connector 106 is configured to open along two diametrically opposed longitudinal axes that are parallel to the central longitudinal axis of the connector 106. The opening of the two sets of V-shaped notches 158 allows for the expansion of the distal end 146 of the connector 106, thereby allowing the engagement features of the connector 106 to be released from the window of the cannula 108. To prevent the connector 106 from being released from the bushing 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 sets of V-shaped notches 158 to a second side of each of the sets of V-shaped notches 158, as Figures 2 to 3 shown. Thus, when the V-shaped notches 166, 168 open, the connector 106 is held together around the bushing 110 by the annular portions 170.

[0042] As Figures 4 to 6 shown, the shape of each of the annular portions 170 can be varied based on the amount of deflection required for the connector 106 to release the cannula 108. For example, in some cases, a greater deflection or outward expansion of the distal end 146 of the connector 106 may be preferred. In other cases, a smaller deflection may be preferred. To provide more deflection to the distal end of the connector 106, the annular portions 170 can be formed from a flexible material such as, for example, an injection molded polymer, acrylic, polycarbonate, etc. Conversely, annular portions 170 formed from a more rigid material will result in less expansion. In another embodiment, as Figures 4 to 5As shown, a shorter annular portion 170 (compared to the annular portion 170 of Figure 6 ) can be seen, which results in less expansion of the coupler 106. Conversely, Figure 6 the annular portion 170 has a longer length, thus providing a greater degree of expansion for the coupler 106. In addition, the sizes 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 coupler 106. For example, as Figure 5 shown, the larger distal V-shaped notch 168 allows more deflection of the distal end 146 without breakage compared to the smaller distal V-shaped notch 168 shown in Figure 4 and Figure 6 .

[0043] The catheter assembly 104 includes a bushing 110, a flexible member 172 extending proximally therefrom, and a control member 112 extending longitudinally through the flexible member 172 and the bushing 110. The proximal end (not shown) of the flexible member 172 can be connected to the 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 such that the longitudinal movement of the control member 112 relative to the flexible member 172 and the bushing 110 can be controlled by the user at the handle portion.

[0044] The flexible member 172 can be formed as a coil through which the control member 112 extends from an enlarged distal end 122 to the proximal end (not shown). As will be understood by those skilled in the art, the coil preferably has sufficient flexibility to pass through even a tortuous path of a living body and in this embodiment (e.g., it will have flexibility such that it can pass through the working channel of an endoscope or other insertion device) is sized and shaped to pass through the working channel of an endoscope or other insertion device. However, although the flexible member 172 can be shown and described as a coil, those skilled in the art will understand that any other suitable flexible structure can be employed as long as the flexible member 172 can provide a compressive force sufficient to counteract the tension to be placed on the control member 112 from the clip assembly 102. As will be understood by those skilled in the art, the catheter assembly 104 can include any one of a variety of actuation mechanisms for moving the control member 112 to control the movement of the clip arms 114.

[0045] The bushing 110 extends longitudinally from the 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 the lumen 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 ridge 162 at the distal end 160 of the bushing 110 is received and engages the groove 153 of the fingers 152 of the coupler 106.

[0046] When it is desired to disengage the bushing 110 from the connector 106 to deploy the clip assembly 102 within the body, the connector 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-holding configuration, the proximal movement of the control member 112 pulls the cannula housing 108 proximally via the yoke 120, such that the connector 106 is pulled proximally against the bushing 110. As the proximal force continues to be applied, the connector 106 is pulled over the ridge 162 of the bushing 110 via the ramp portion 150. When the ramp portion 150 is pulled further proximally, the fingers 152 deflect radially outward from the longitudinal axis of the connector 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 breakage of the V-shaped notches 166, 168 allows the distal end 146 of the connector 106 to expand, thereby releasing the cannula housing 108. After the V-shaped notches 166, 168 break, the annular portion 170 prevents the connector 106 from splitting from the clip assembly 102 and holds the connector 106 on the bushing 110 such that the connector 106 can be pulled out of the body with the catheter assembly 104.

[0047] 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 bushing 110 to the cannula housing 108 via the connector 106. The enlarged distal end 122 of the control member 112 can be coupled to the clip 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 applied thereon exceeds a predetermined threshold, such that the opposing portions 134 thereof deflect away from each other to allow the enlarged distal end 122 to move distally therethrough to 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 positions, thereby holding the enlarged distal end 122 within the yoke 120. The bushing 110 can be coupled to the cannula housing 108 via the connector 106 by inserting a portion of the bushing 110 between the fingers 152 of the connector 106 such that the connector 106 and the bushing 110 are engaged with each other via a snap fit. The proximal end 136 of the cannula housing 108 can be inserted into the distal end 146 of the connector 106. Once the bushing 110 has been releasably connected to the cannula housing 108 and the enlarged distal end 122 is coupled to the yoke 120, the control member 112 can be moved proximally to pull the clip assembly 102 toward the closed clamping configuration.

[0048] In use, after loading the clip assembly 102 onto the catheter assembly 104, the clip assembly 102 is inserted through the working channel of an endoscope (or any other insertion device) and 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 in a tissue-holding configuration into the target tissue to reduce trauma and facilitate its passage through the working channel. Upon reaching the location of the target tissue, the clip assembly 102 is advanced distally out of the distal end of the working channel and the control member 112 is moved distally relative to the bushing 110 to cause the clip arms 114 to extend distally out of the cannula 108 into a tissue-receiving configuration. Once the clip assembly 102 has been positioned such that the target tissue is received between the clip arms 114, the clip assembly 102 can be moved toward a tissue-clamping configuration (by pulling the control member 112 proximally) such that the target tissue is clamped between its distal ends 118. The clip arms 114 are moved toward the tissue-clamping configuration by pulling the control member 112 proximally relative to the bushing 110 and the cannula 108. Once the clip assembly 102 is in the tissue-clamping configuration, the control member 112 is pulled further proximally relative to the cannula 108 to lock the clip arms 114.

[0049] To deploy the clip assembly 102, the control member 112 can be pulled proximally into the cannula until the coupler 106 attached to the cannula 108 is pulled proximally against the bushing 110. Further proximal movement of the coupler 106 causes the ridge 162 of the bushing 110 to slide distally against the ramp portion 150 of the coupling finger 152, thereby deflecting the finger 152 radially outward. The coupler 106 is then moved further proximally, thereby causing the ridge 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. The opening of the V-notch set 158 allows the distal end of the coupler 106 to expand sufficiently to release the cannula 108 therefrom, while the annular portion 170 holds the broken coupler 106 together and prevents the proximal end of the coupler 106 from expanding sufficiently to release from the distal end of the bushing 110.

[0050] Once the cannula 108 has been disengaged from the coupler 106, the control member 112 is further pulled proximally until the enlarged distal end 122 disengages from the yoke 120. In particular, when the force exerted by the enlarged distal end 122 on the yoke 120 exceeds a predetermined threshold, the opposing portion 134 unfolds, thereby releasing the enlarged distal end from it. Alternatively, the yoke 120 can break to release the clip assembly 102 from the control member 112. Subsequently, the entire catheter assembly 104 including the control member 112 and the bushing 110 can be withdrawn proximally from the body, leaving the clip assembly 102 (and any portion of the coupler 106 still attached thereto) clamped over the target tissue. The coupler 106 can be manually removed from the distal end of the catheter assembly 104, and if desired, 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 using the same catheter assembly 104 as needed or desired.

[0051] As Figure 7 shown, the 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 that extends laterally into the wall 264. Specifically, like 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 fracture to release the cannula 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 tapers from the proximal end to the distal end, and the distal V-shaped notch 268 tapers 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 Figure 7As can be seen, the set of V-shaped notches 258 includes a third V-shaped notch 280 that laterally cuts into wall 264. As shown, the third V-shaped notch 280 extends from the proximal end of wall 264 to the distal end of 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 wall 264 (i.e., the dimension extending perpendicular to the longitudinal axis of the coupler 206 between the inner and outer surfaces of the coupler 206). The depth of the third V-shaped notch 280 into wall 264 can vary 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. A shallower third V-shaped notch 280 will require a greater amount of force than a 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 cannula 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 for the expansion of the distal end 246 of the coupler 206, thereby allowing the release of the cannula 208 from the cannula 206.

[0052] Although the exemplary embodiments show and describe specific systems that are configured to load a clip assembly onto a catheter assembly via a coupler, those skilled in the art will understand that the present invention includes any of a variety of couplers for coupling the cannula of a clip assembly to a catheter assembly, provided that the coupler can be pre-assembled with the cannula and yield, break, and / or otherwise separate from the cannula during deployment of the clip assembly. Once the clip assembly has been deployed, the coupler (or its remaining portion) can be removed from the bushing of the catheter assembly so that the catheter assembly can be loaded with a new clip assembly.

[0053] Those skilled in the art will understand that changes can be made to the above-described embodiments without departing from the concepts of the present invention. It should also be understood that the structural features and methods associated with one of the embodiments can be incorporated into other embodiments. Thus, it should be understood that the present invention is not limited to the specific embodiments disclosed, but that modifications are also covered within the scope of the present invention as defined by the appended claims.

Claims

1. A method of loading a clamping device, comprising: coupling a plurality of fingers extending from a proximal end of a coupler to a distal end of a bushing, wherein the bushing is connected to a distal end of a flexible tube; coupling a distal end of the coupler to a proximal end of a clip assembly, and a control member of the flexible tube is releasably connected to a proximal end of a clip arm of the clip assembly; moving the distal ends of the clip arms closer to each other by longitudinally moving the control member relative to the clip assembly, thereby moving the clip assembly between a receiving configuration and a clamping configuration, in the receiving configuration, the distal ends of the clip arms are separated from each other, and in the clamping configuration, the distal ends of the clip arms move towards each other; releasing the clip assembly from the flexible tube by pulling the control member proximally relative to the clip arm beyond a predetermined threshold, such that the coupler yields, causing the clip assembly to disengage and at least a portion of the coupler to remain connected to the flexible tube, wherein the coupler includes a distal portion, the distal portion of the coupler includes a wall connecting the plurality of fingers to each other and having a pair of V-shaped notches at its opposite ends, the V-shaped notches extending towards each other, wherein the wall is disposed around an outer surface of the clip assembly, and wherein the V-shaped notches are configured to separate when a proximally directed force applied to the coupler through the control member exceeds a threshold, to allow the coupler to break, causing the clip assembly to disengage from the coupler.

2. The method according to claim 1, wherein the proximal ends of the clip arms are connected to each other via a yoke releasably coupled to an enlarged distal end of the control member.

3. The method according to claim 2, further comprising: pulling the control member further proximally beyond another predetermined threshold until the enlarged distal end of the control member disengages from the yoke.

4. The method according to any one of claims 1 to 3, wherein the pair of V-shaped notches includes a proximal V-shaped notch extending from a proximal end of the wall and a distal V-shaped notch extending from a distal end of the wall.

5. The method according to claim 1, wherein 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, which prevents the coupler from disengaging from the distal end of the bushing when the coupler breaks.

6. The method according to claim 1, wherein the coupler includes a ramp portion configured to interact with a ridge extending circumferentially around an outer surface of the bushing, such that when a proximal force is applied to the coupler, the ramp portion moves proximally over the ridge, thereby expanding the wall of the coupler and causing a portion of the V-shaped notches to break.

7. The method according to claim 1, wherein each set of V-shaped notches includes a third V-shaped notch extending from an outer surface of the coupler into the wall of the coupler.

8. The method according to claim 1, further comprising: After the clip assembly is released from the flexible tube, another clip assembly is loaded onto the flexible tube by connecting a plurality of fingers protruding from the proximal end of another connector to the distal end of the bushing; The distal end of the connector is connected to the proximal end of the another clip assembly, and the control member of the catheter assembly is releasably connected to the proximal end of another clip arm of the another clip assembly.

9. A method of loading a clamping device, comprising: Loading a first clip assembly onto a reusable flexible tube by connecting a plurality of fingers protruding from the proximal end of a first connector to the distal end of a bushing connected to the distal end of the flexible tube; Connecting the distal end of the first connector to the proximal end of the first clip assembly, and the control member of the flexible tube is releasably connected to the proximal end of the clip arm of the first clip assembly; By longitudinally moving the control member relative to the first clip assembly, the distal ends of the clip arms are brought closer to each other, so that the first clip assembly moves between a receiving configuration and a clamping configuration, in the receiving configuration, the distal ends of the clip arms are separated from each other, and in the clamping configuration, the distal ends of the clip arms move towards each other; By pulling the control member proximally relative to the clip arm beyond a predetermined threshold, the first clip assembly is released from the flexible tube, causing the first connector to yield, so that the first clip assembly is disengaged from the flexible tube and at least a portion of the first connector remains connected to the flexible tube, Wherein the first connector includes a distal portion, the distal portion of the first connector includes a wall connecting the plurality of fingers to each other, and has a pair of V-shaped notches at its opposite ends, the V-shaped notches extending towards each other, wherein the wall is disposed around the outer surface of the first clip assembly, and wherein the V-shaped notches are configured to rupture when the proximally directed force applied to the first connector by the control member exceeds a threshold, to allow the first connector to break to disengage the first clip assembly from the connector.

10. The method according to claim 9, wherein the proximal ends of the clip arms are connected to each other via a yoke releasably coupled to the enlarged distal end of the control member.

11. The method according to claim 10, wherein the control member is coupled to the first clip assembly such that further pulling the control member proximally until the force applied to the control member exceeds another predetermined threshold, the enlarged distal end of the control member disengages from the yoke.

12. The method according to any one of claims 9 to 11, wherein the pair of V-shaped notches includes a proximal V-shaped notch extending from the proximal end of the wall and a distal V-shaped notch extending from the distal end of the wall.

13. The method according to claim 9, wherein the connector includes an annular portion that extends from a first side of each set of V-shaped notches to a second side of each set of V-shaped notches, and when the connector breaks, the annular portion prevents the first connector from disengaging from the distal end of the bushing.

14. The method according to claim 9, wherein the first connector includes a ramp portion configured to interact with a ridge extending circumferentially around an outer surface of the bushing such that when a proximal force is applied to the first connector, the ramp portion moves proximally over the ridge, thereby expanding the wall of the first connector and causing a portion of the V-notch to break.

15. The method according to claim 9, wherein each set of V-notches includes a third V-notch extending from an outer surface of the connector into the wall of the connector.

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