Locking mechanism for hemostatic clips

Abstract

This relates to an endoscopic clipping device for treating tissue along the gastrointestinal tract. [Solution] The clipping system includes a clip, a core member, and a control member. The clip includes a capsule containing a channel that extends longitudinally from a proximal end to a distal end and through it, and a clip arm. The proximal end of the arm is slidably received within the channel to move the arm between an open configuration and a closed configuration. The core member is received between the proximal ends of the arms and connected to the proximal ends of the arms to connect the arms to each other. The core member includes a locking mechanism that can move between an unlocked configuration and a locked configuration. The control member extends through the proximal portion of the system from its proximal end to an enlarged distal end housed within the proximal portion of the core member, such that the longitudinal movement of the control member relative to the capsule moves the clip between an open configuration and a closed configuration.

Description

Technical Field

[0001] The present disclosure relates to an endoscopic device, and more particularly to an endoscopic clipping device for treating tissue along the gastrointestinal tract.

Background Art

[0002] Physicians have become more advanced in performing aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of perforating the wall of the GI tract or may require closure of the GI tract wall as part of the procedure. Such procedures may include, for example, removal of large lesions, tunneling under the mucosal layer of the GI tract to treat submucosal lesions, removal of the entire layer of tissue, treatment of lesions on other organs by passing through the outside of the GI tract, and endoscopic treatment / repair of postoperative lesions (e.g., postoperative leakage, damage to the surgical staple line, and anastomotic leakage). Currently, tissue openings may be closed via an endoscopic closure device, such as a hemostatic clip inserted through an endoscope. However, in some cases, current endoscopic closure devices can be difficult to use, time-consuming to place, or may be inadequate for certain perforations, conditions, and anatomical structures.

Summary of the Invention

[0003] This disclosure relates to embodiments of a clipping system for treating tissue. The system comprises a clip including a capsule having a channel extending longitudinally from a proximal end to a distal end and through the same, the proximal ends of the pair of clip arms being slidably received within the channel so as to move the clip arms between an open configuration, where they are separated from each other so as to receive tissue between them, and a closed configuration, where they are drawn toward each other so as to grasp tissue between them; a core member received between the proximal ends of the clip arms and connected to the proximal ends so as to connect the clip arms together, the core member including a locking mechanism, the locking mechanism being movable between an unlocked configuration, where the core member is slidable within the channel of the capsule, and a locked configuration, where the locking mechanism engages with a corresponding portion of the capsule to lock the clip arms in the closed configuration; and a control member, the control member extending through the proximal portion of the clipping system from its proximal end to an enlarged distal end housed within the proximal portion of the core member, such that the longitudinal movement of the control member relative to the capsule moves the clip between the open and closed configurations.

[0004] In one embodiment, the core member is received in a hole extending through the proximal end of the clip arm and is connected to the clip arm via a connector that passes through an elongated opening extending through the core member.

[0005] In one embodiment, the connector is slidable from the proximal end to the distal end of the elongated opening to move the locking mechanism from an unlocked configuration to a locked configuration, and the connector is configured to interface with a portion of the locking mechanism when the connector is moved distally through the elongated opening.

[0006] In one embodiment, the core member is formed from a stamped sheet of metal having a size and shape that is bent into a configuration including a proximal portion that defines a cavity therein for housing an enlarged distal end of a control member, and a distal portion that includes a locking mechanism.

[0007] In one embodiment, the locking mechanism is configured as part of a die-cut sheet of metal bent to overlap a portion of an elongated opening in the core member, forming a first wing and a second wing, each of which, when engaging with the connector as the connector moves distally along the elongated opening, is moved radially outward to engage with the corresponding locking mechanism of the capsule.

[0008] In one embodiment, the capsule locking mechanism includes a pair of windows extending through its wall, each window having a size and shape for receiving a corresponding one of a first wing and a second wing therein, and configured to receive a corresponding one of a first wing and a second wing therein.

[0009] In one embodiment, the distal end of the clip arm is biased toward an open configuration such that when the clip arm is retracted into the capsule, the clip arm is constrained toward a closed configuration via the inner surface of the capsule, and when the clip arm is moved distally from the capsule, the clip arm can return to its biased open configuration.

[0010] In one embodiment, the distal end of the control member is configured to separate from the rest of the control member when the control member is subjected to a force exceeding a predetermined threshold, thereby releasing the clip from the proximal portion of the clipping system in a clipped configuration.

[0011] In one embodiment, the core member includes a proximal opening extending through the core member in communication with the cavity, the length of the control member extends proximal from a distal end enlarged through the proximal opening, and the proximal opening is configured to deform when the control member is subjected to a force exceeding a predetermined threshold, thereby allowing the distal end to pass through it in the proximal direction.

[0012] In addition, the present disclosure relates to a clipping system for treating tissue, the clipping system comprising an insertion device including a channel extending longitudinally from a proximal end to a distal end and through the same, and a clip comprising a capsule and a pair of clip arms releasably coupled to the insertion device, wherein the capsule includes a channel extending longitudinally from a proximal end to a distal end and through the same, and the proximal ends of the clip arms are slidably received within the channel so as to move the clip arms between an open configuration in which they are separated from each other so as to allow the distal ends of the clip arms to receive tissue between them, and a closed configuration in which the distal ends of the clip arms are drawn toward each other so as to grasp the tissue between them A core member is provided, which is received between a clip and the proximal end of a clip arm and connected to the proximal end to connect the clip arms to each other, the core member including a locking mechanism, the locking mechanism being able to move between an unlocked configuration in which the core member is slidable within a channel of a capsule and a locked configuration in which the locking mechanism engages with a corresponding portion of the capsule to lock the clip arms in a closed configuration, and a control member, the control member extending through the insertion device from a proximal end accessible to the user of the clipping system to an enlarged distal end received in the proximal portion of the core member, such that the longitudinal movement of the control member relative to the capsule moves the clip between an open configuration and a closed configuration.

[0013] In one embodiment, the core member is received in a hole extending through the proximal end of the clip arm and is connected to the clip arm via a connector that passes through an elongated opening extending through the core member.

[0014] In one embodiment, the connector is slidable from the proximal end to the distal end of the elongated opening to move the locking mechanism from an unlocked configuration to a locked configuration, and the connector is configured to contact a portion of the locking mechanism when the pins are moved distally along the elongated opening.

[0015] In one embodiment, the core member is formed from a die-cut sheet of metal having a size and shape that is bent into a configuration including a proximal portion that defines a cavity therein for housing an enlarged distal end of a control member therein, and a distal portion that includes a locking mechanism.

[0016] In one embodiment, the locking mechanism is configured as part of a die-cut sheet of metal bent to overlap a portion of an elongated opening in the core member, forming a pair of wings which, when the connector engages with the connector as it moves distally along the elongated opening, are moved radially outward to engage with the corresponding portion of the capsule.

[0017] In one embodiment, the proximal end of the capsule includes a pair of tabs which are crimped radially inward to engage with corresponding portions of a bushing at the distal end of the insertion device, and the clip is releasably coupled to the insertion device, and the core member includes a pair of flaps along its proximal portion which, when the core member is in a locked configuration with respect to the capsule, engage with the tabs of the capsule, deform the tabs radially outward, and disengage from the bushing.

[0018] Furthermore, the present disclosure relates to a method for treating target tissue, comprising inserting a clip into a target site in the body via a catheter through a working channel of an endoscope, the clip comprising a capsule and a pair of clip arms, the proximal ends of the clip arms being coupled to each other via a core member slidably received within the capsule, the method comprising inserting the clip, and optionally moving the clip between an open configuration and a closed configuration until the target tissue is received between the distal ends of the clip arms, the clip being moved between the open configuration and the closed configuration via a control member coupled to the clip arms via the core member, the enlarged distal end of the core member being the proximal portion of the core member The procedure includes moving the clip, which is received within a defined cavity, between an open configuration and a closed configuration; moving the clip toward the closed configuration by pulling the control member proximal to the catheter to grasp the target tissue between the distal ends of the clip arms; locking the clip in the closed configuration by moving the locking mechanism of the core member from an unlocked configuration toward a locked configuration in which the locking mechanism engages with a corresponding portion of the capsule; and deploying the clip from the catheter by pulling the control member proximal until the force applied to the control member exceeds a predetermined threshold, thereby separating the expanded distal end of the control member from its remaining length and releasing the clip from the insertion device.

[0019] In one embodiment, the core member is received in a hole extending through the proximal end of the clip arm and is connected to the clip arm via a connector that passes through an elongated opening extending through the core member.

[0020] In one embodiment, locking the clip into a closed configuration involves pulling the clip arm proximal until a portion of the clip arm engages with a portion of the capsule, preventing any further proximal movement of the clip arm relative to the capsule, thereby causing any further proximal movement of the control member relative to the insertion device to slide the connector from the proximal end of the elongated opening to the distal end of the elongated opening, thereby moving the locking mechanism from an unlocked configuration to a locked configuration, and the connector is configured to contact a portion of the locking mechanism when the pins are moved distally along the elongated opening.

[0021] In one embodiment, the locking mechanism includes a pair of wings that overlap a portion of an elongated opening in the core member, and when the connector engages with the connector as it moves distally along the elongated opening, the wings are moved radially outward to engage with the corresponding portion of the capsule.

[0022] In one embodiment, when the locking mechanism is locked to the capsule, a pair of flaps along the proximal portion of the core member engage with a tab at the proximal end of the capsule, moving the tab to disengage from the corresponding portion of the bushing at the distal end of the catheter, thereby releasing the capsule from the insertion device. [Brief explanation of the drawing]

[0023] [Figure 1] Figure 1 is a partially transparent longitudinal side view of the distal portion of a clipping system according to an exemplary embodiment of the present disclosure. [Figure 2] Figure 2 is an exploded longitudinal side view of the distal portion of the exemplary system shown in Figure 1. [Figure 3] Figure 3 is another exploded longitudinal side view of the distal portion of the exemplary system shown in Figure 2, rotated approximately 90 degrees around the longitudinal axis of the system. [Figure 4] Figure 4 is a perspective view of the core member in the example system shown in Figure 1, in the unlocked configuration. [Figure 5] Figure 5 is a plan view of the proximal end of the core member shown in Figure 4. [Figure 6] Figure 6 is a side view of the core member of FIG. 4. [Figure 7] Figure 7 is a cross-sectional view of the core member of FIG. 4 taken along line A-A. [Figure 8] Figure 8 is a perspective view of the core member by the exemplary system of FIG. 1 in a locked configuration. [Figure 9] Figure 9 is a side view of the core member of FIG. 8. <[ [Figure 10] A side view of a core member according to another embodiment of the system of FIG. 1. [Figure 11] Figure 11 is a side view of a core member according to another alternative embodiment of the system of FIG. 1. [Figure 12] Figure 12 is a partially transparent longitudinal side view of the distal portion of the system of FIG. 1 in an open configuration. [Figure 13] Figure 13 is a partially transparent longitudinal side view of the distal portion of the system of FIG. 1 in a closed configuration. [Figure 14] Figure 14 is an enlarged view of the bushing, core member, and clip arm of the system of FIG. 1, and the core member is in an unlocked configuration. [Figure 15] Figure 15 is an enlarged view of the bushing, core member, and clip arm of the system of FIG. 1, and the core member is in a locked configuration. [Figure 16] Figure 16 is an enlarged view of the junction between the capsule and the bushing by the exemplary system of FIG. 1. [Figure 17] Figure 17 is an enlarged view of the separation between the capsule and the bushing when the clip is deployed according to the exemplary system of FIG. 1. [Figure 18] Figure 18 is a perspective view of a core member according to another exemplary embodiment of the present disclosure. [Figure 19] Figure 19 is a perspective view of an integrally formed core member and clip arm according to yet another exemplary embodiment of the present disclosure. [Figure 20] Figure 20 is a partially transparent longitudinal side view of the distal portion of a system according to another exemplary embodiment of the present disclosure. [Figure 21] Figure 21 is an enlarged longitudinal side view of the control member separated from the clip during the deployment process, according to the system in Figure 20. [Figure 22a] Figures 22a to 22d show a schematic sequence of images illustrating the deformation of the proximal opening of the core member by the system in Figure 20. [Figure 22b] Figures 22a to 22d show a schematic sequence of images illustrating the deformation of the proximal opening of the core member by the system in Figure 20. [Figure 22c] Figures 22a to 22d show a schematic sequence of images illustrating the deformation of the proximal opening of the core member by the system in Figure 20. [Figure 22d] Figures 22a to 22d show a schematic sequence of images illustrating the deformation of the proximal opening of the core member by the system in Figure 20. [Modes for carrying out the invention]

[0024] This disclosure can be further understood by referring to the following description and accompanying drawings, where similar elements are referred to by the same reference numbers. This disclosure relates to an endoscopic clipping system for treating perforations, defects, and / or bleeding of internal tissue. An exemplary embodiment of this disclosure describes a clipping system comprising a clip releasably coupled to the proximal portion of the system, the clip comprising a pair of clip arms, the proximal ends of which are slidable within a capsule to move the clip arms between an open configuration in which the clip arms are separated from each other so as to receive target tissue between them, and a closed configuration in which the clip arms are retracted into a capsule so as to move toward each other so as to grasp target tissue between them.

[0025] An exemplary clipping system further comprises a core member, which connects the proximal ends of the clip arms to each other and to the distal ends of a control member, which is moved by an operator of the clipping system (e.g., a surgeon), to move the clip between an open configuration and a closed configuration, and to move the clip toward deployment once the clip is clipped over target tissue as desired. The exemplary core member includes a locking mechanism or structure that locks the clip arms against the capsule in the closed configuration once deployment is initiated. The exemplary locking mechanism allows the use of a shorter capsule compared to current hemostatic clips in which the clip is locked via a locking structure on the clip arms themselves, thereby reducing the overall length of the deployed clip.

[0026] As those skilled in the art will understand, shorter deployed clips can improve the visibility of the target site and allow for better maneuverability, for example, when deploying multiple clips. Some current clip designs produce a detachable portion during the deployment process that separates the clip from the catheter, which can remain in the body and pass through the GI tube naturally. As the treatment of larger defect cases, such as peroral endoscopic myotomy (POEM) and endoscopic submucosal dissection (ESD), becomes more common, physicians may prefer clips that do not produce detachable portions to eliminate the possibility of causing harm, for example, by the detachable portion becoming embedded in the defect.

[0027] The core member in the exemplary embodiment is molded or configured to eliminate detachment by, for example, encapsulating the distal end of the control wire that separates from the rest of the control wire during the deployment of the clip. The severed distal end of the control member remains trapped within the core member, and the core member remains housed within the capsule of the deployed clip, preventing detachment of these portions. It will be understood by those skilled in the art that, as used herein, the terms proximal and distal are intended to refer to the direction toward and away from the user of the system, respectively.

[0028] Figures 1 to 17 show a clipping system 100 for treating tissue defects, comprising a clip 102 releasably coupled to an insertion device, such as a catheter 104. The clip 102 includes a pair of clip arms 106, whose proximal ends 108 are coupled to each other via a core member 110, which is slidably housed within a capsule 112 to move the clip 102 between an open configuration in which the distal ends 114 of the clip arms 106 are separated from each other to receive tissue between them, and a closed configuration in which the distal ends 114 of the clip arms 106 are drawn toward each other to grasp tissue between them.

[0029] The clip arm 106 is moved between an open and closed configuration via a control member 116, with its distal end 118 receiving into the cavity 120 of the core member 110, while a reduced-dimension portion 122 of the control member 116 extends proximal therefrom and exits the core member 110. The remainder of the control member 116 extends through the catheter 104 to a proximal end accessible to the user of the system 100 for operation via an actuator (not shown). In this embodiment, the distal end 118 of the control member is enlarged (i.e., its diameter is increased) with respect to at least a portion of the control member 116 passing through the opening of the core member 110, so that when the control member 116 is pulled proximal, the distal end 118 pulls the core member 110 and the clip arm proximal to the capsule. Thus, the user can move the control member 116 longitudinally relative to the catheter 104 to move the clip 102 between an open and closed configuration. Specifically, the control member 116 can be moved distal to the capsule 112, allowing the clip arm 106 to move distally out of the capsule 112 toward the open configuration, and also to retract the clip arm 106 proximally into the capsule 112, allowing the clip 102 to move toward the closed configuration.

[0030] According to an exemplary embodiment, the core member 110 includes a locking mechanism 124 such that when the clip 102 is clipped onto target tissue as desired, the deployment of the clip 102 can be initiated by pulling the control member 116 further proximal to the capsule 112. As will be described in more detail below, further proximal movement of the control member 116 moves the locking mechanism 124 radially outward so that the locking mechanism 124 engages with the corresponding locking structure 126 of the capsule 112. Locking the clip 102 facilitates the deployment of the clip 102. In one embodiment, the control member 116 may be pulled further proximal until a force is applied thereto until one or both of the broad portions of the clip arm 106 contact the distal end of the capsule 112, preventing the clip arm 106 from moving further proximal. If a proximal force continues to be applied to the control member 116 after this point, the tension on the control member 116 increases. When this tension exceeds a predetermined threshold force, the distal end 118 of the control member 116 separates from the reduced-size portion 122 of the control member 116, releasing the clip 102 from the catheter 104. The distal end 118 then separates from the rest of the control member 116. The distal end 118 remains trapped within the core member 110 and remains housed within the capsule 112 of the deployed clip 102. Therefore, the deployment of the clip 102 does not result in any detachment.

[0031] As described above, according to an exemplary embodiment, the clipping system 100 includes a catheter 104 for inserting a clip 102 into a target area in the body. The system 100 of this embodiment includes a bushing 128 fixed to the distal end of the catheter 104, the bushing 128 being releasably coupled to a capsule 112. A control member 116 extends through the catheter 104 and the bushing 128, thereby its distal end 118 extending distally therefrom to connect to the clip 102. It will be understood by those skilled in the art that the distal end 118 has a width in at least one dimension greater than the width of the opening in the core member 110 through which the control member 116 extends proximal from the core member 110. This prevents the distal end 118 of this embodiment from proximal to the opening in the core member 110. In addition, as will be understood by those skilled in the art, the separation of the distal end 118 from the rest of the control member 116 and the release of the bushing 128 from the capsule 112 separates the clip 102 from the rest of the system 100, and thus the clip 102 can remain in the body clipped over target tissue after the rest of the system, including the catheter 104, the bushing 128, and the proximal portion of the control member 116, has been withdrawn from the body.

[0032] In an exemplary embodiment, the distal end 118 is connected to the remaining length of the control member 116 (the proximal portion of the control member 116) via a thinned portion, joint, or connection configured to release, break, or otherwise separate the distal end 118 from the reduced-dimension portion 122 when subjected to a force exceeding a predetermined threshold during the deployment process. In one example, the connection between the distal end 118 and the remaining length includes a reduced-dimension portion configured to fail when subjected to a force exceeding a predetermined threshold force (i.e., failing at a force lower than the force required to break any other portion of the control member 116 or to pull the distal end 118 from the core member 110).

[0033] However, it will be understood by those skilled in the art that the connection between the distal end 118 of the control member 116 and the reduced-size portion 122 may have any of a variety of configurations. In addition, although the exemplary embodiment describes the insertion device as a catheter 104, it will be understood by those skilled in the art that the insertion device may include any flexible, extendable member that can be inserted, for example, through a tortuous path in a body lumen to reach a target site.

[0034] The capsule 112 of the clip 102 includes a channel 134 that extends from and through the proximal end 130 to the distal end 132. In one embodiment, the proximal end 130 is releasably coupled to a bushing 128, for example, via one or more tabs 136, each of which is crimped radially inward to engage with a corresponding engaging portion 142 of the bushing 128. The corresponding engaging portion 142 of the bushing 128 may include, for example, a groove or recess formed within the bushing 128, which is sized, shaped, or configured to engage with a radially crimped tab 136. In one embodiment, the capsule 112 includes a pair of tabs 136 that are diametrically opposed to each other. The capsule 112 also includes a locking structure 126 configured to engage with a locking mechanism 124 of the core member 110. The locking structure 126 may be formed in the capsule wall and, in one embodiment, includes a window that extends laterally through the capsule wall.

[0035] Each of the clip arms 106 extends from a proximal end 108 to a distal end 114. As described above, the proximal end 108 is slidably received within the channel 134, thereby allowing the clip arms 106 to be moved relative to the capsule 112 between an open configuration and a closed configuration via the operation of a control member 116. In one embodiment, when the clip arms 106 are biased toward the open configuration and thereby advanced distally from the capsule 112, the clip arms 106 transition to the open configuration, moving away from each other under their natural bias. When the clip arms 106 are retracted proximal into the capsule 112, they are constrained by the walls of the capsule 112 and retracted together toward the closed configuration, with their distal ends 114 adjacent to each other. Those skilled in the art will understand that many other mechanisms may be used to open and close the clip arms 106.

[0036] Each of the clip arms 106 in this embodiment includes an engaging mechanism 138 extending therefrom, configured to engage with a portion of the capsule 112, thereby preventing the clip arm 106 from moving further proximal to the capsule 112 when the engaging mechanism 138 engages with the capsule 112. In one embodiment, the engaging mechanism 138 extends laterally outward from the distal portion of the clip arm 106, resulting in the distal portion of the clip arm 106 being larger than the proximal portion of the clip arm 106 and having a width greater than the diameter of the distal opening of the capsule 112. Therefore, the proximal portion of the clip arm 106 is sized to allow it to be retracted proximal to the capsule 112, while the portion of the clip arm 106 extending distally from the engaging mechanism 138 is too wide to be retracted into the capsule 112. Therefore, as the clip arm 106 is retracted proximally into the capsule 112, the engagement mechanism 138 contacts a portion of the distal surface 140 of the capsule 112, preventing further proximal movement of the clip arm 106 relative to the capsule 112. The engagement mechanism 138 is positioned along the clip arm 106, so that at the point where the engagement mechanism 138 engages with the capsule 112, the clip arm 106 is retracted sufficiently proximally into the capsule 112, pulling the clip arm 106 together to form a closed configuration. In one example, the engagement mechanism 138 may be configured as a wing portion extending laterally from the longitudinal edge of the clip arm 106.

[0037] Each of the proximal ends 108 of the clip arm 106 includes a hole 152 extending through it, which is configured to facilitate coupling between the proximal end 108 of the clip arm 106 and the core member 110. According to an exemplary embodiment, when the clip arms 106 are diametrically opposed to each other, the holes 152 of the clip arms 106 are aligned with each other, so that a connector, such as a rivet 154, can pass through the hole 152 in the proximal end 108 of the clip arm 106 and through the corresponding opening 156 in the core member 110 to couple the clip arm 106 to the core member 110.

[0038] As described above, the core member 110 is sized to be longitudinally slidable within the channel 134 of the capsule 112 and is configured to be longitudinally slidable within the channel 134 of the capsule 112. In an exemplary embodiment, the core member 110 is an integrated mechanism configured to connect the control member 116 to the clip arm 106, and according to the exemplary embodiment, as will be described in more detail below, when bent, the material 117 is formed from a punched sheet of material 117 (e.g., metal) having a size and shape that includes a proximal portion 158 defining a cavity 120 configured to receive the distal end 118 of the control member 116, and a distal portion 160 defining a locking mechanism 124 configured to lock the clip arm 106 to the capsule 112 in a closed configuration.

[0039] In a bent configuration, the core member 110 extends from the proximal end 162 to the distal end 164. According to an exemplary embodiment, the material 117 is bent over the proximal end 162 to include a first surface 166 and a second surface 168. Parts of the first surface 166 and the second surface 168 extending along the proximal portion 158 define a cavity 120 between them. Parts of the first surface 166 and the second surface 168 extending along the distal portion 160 of the core member 110 may be substantially planar and may extend parallel to each other and parallel to the longitudinal axis of the capsule 112 that is received therein in a configuration in which the core member 110 is operable.

[0040] Along the distal portion 160, each of the first surface 166 and the second surface 168 includes an elongated opening 170 that extends through it along the central axis. Each elongated opening 170 is elongated along the longitudinal axis of the core member 110 and is aligned with respect to one another along the central axis that extends substantially perpendicularly to the first surface 166 and the second surface 168. As will be described in more detail below, each elongated opening 170 of the first surface 166 and the second surface 168 is configured to receive a rivet 154 or other connector for connecting the clip arm 106 to the core member 110.

[0041] In addition to the first surface 166 and the second surface 168, the core member 110 also includes a first flap 172 and a second flap 174 that extend from the proximal end 162 and are bent toward the distal end 164 with respect to the longitudinal axis of the core member 110 to further define the cavity 120. Specifically, each of the first flap 172 and the second flap 174 extends along the proximal portion 158 of the core member 110 such that the cavity 120 is defined between the first surface 166 and the second surface 168 and the first flap 172 and the second flap 174. The proximal end 162 includes an opening 180 that extends through it along a central axis substantially aligned with the longitudinal axis of the core member 110. The proximal opening 180 is sized and shaped such that, once the distal end 118 is received within the cavity 120, the reduced-size portion 122 of the control member 116 passes through the proximal opening 180 and extends proximally from the enlarged distal end 118.

[0042] It will be understood by those skilled in the art that the defined cavity 120 has a size and shape to accommodate the enlarged distal end 118 of the control member 116, and is configured to accommodate the enlarged distal end 118 of the control member 116, while the proximal opening 180 has a size and shape to prevent the enlarged distal end 118 from passing through it. The space extending between the adjacent first flaps 172 and the second flaps 174 and the first surface 166 and the second surface 168 is not sufficient to allow the enlarged distal end 118 to pass through it, and as a result, when the clip 102 is deployed, the enlarged distal end 118 is housed and held within the cavity 120, eliminating the possibility of the severed enlarged distal end 118 falling off the core member 110, thereby eliminating the risk of a detached part.

[0043] The first flap 172 and the second flap 174 are angled with respect to the longitudinal axis of the core member 110 such that the width of the core member 110 at the distal ends 176 of the first flap 172 and the second flap 174 (e.g., the distance between the distal ends 176) is greater than the width of the core member 110 at the proximal end 162 (e.g., the distance between the proximal ends of the first flap 172 and the second flap 174). The first flap 172 and the second flap 174 are angled so that when the core member 110 is pulled proximal to the capsule 112 during the deployment of the clip 102, the first flap 172 and the second flap 174 contact and engage with the tab 136, which is pressed radially inward relative to the longitudinal capsule 112 in order to engage the capsule 112 with the bushing 128. As the angled surfaces of the first flap 172 and the second flap 174 slide proximal to the tab 136, the engagement between the first flap 172 and the second flap 174 and the radially inwardly pressed tab 136 causes the tab 136 to move radially outward with respect to the longitudinal axis of the capsule 112, disengaging the tab 136 from the corresponding engaging portion of the bushing 128.

[0044] A portion of the material 117 extending from the outer longitudinal edge 182 of one of the first surface 166 and the second surface 168 is also bent inward and extends between the first surface 166 and the second surface 168, defining a locking mechanism 124. In an exemplary embodiment, the locking mechanism 124 is configured as a pair of wing portions 144 that extend between the first surface 166 and the second surface 168 and can move between an unlocked configuration and a locked configuration. In the unlocked configuration, the outer longitudinal edge 146 of the wing portion 144 is substantially aligned with the longitudinal edge 182 of the first surface 166 (and the longitudinal edge of the second surface 168), so that the core member 110 slides freely longitudinally within the channel 134 of the capsule 112, moving the clip arm 106 between an open configuration and a closed configuration. In the locked configuration, a portion of each of the pair of wings 144 is moved radially outward to engage with the locking structure 126 of the capsule 112.

[0045] According to an exemplary embodiment, each of the wing portions 144 is connected to either the first surface 166 or the second surface 168 via a bent portion 184 of material 117 that extends along the proximal length of the outer longitudinal edges 182,146 of the wing portion 144. This bent portion 184 is deformed so that the distal portion of each wing portion 144 is moved radially outward as the core member 110 is moved from an unlocked configuration to a locked configuration. The inner longitudinal edge 148 includes a proximal portion 186 and a distal portion 188, which are angled with respect to each other and with respect to the longitudinal axis of the core member 110.

[0046] Each of the proximal and distal portions 186 and 188 of the inner longitudinal edge 148 of the wing portion 144 is angled such that the width of each wing portion 144 (for example, the distance between the outer longitudinal edge 146 and the inner longitudinal edge 148) increases toward the distal end 162 of the core member 110. The inner longitudinal edge 148 is angled such that each portion of the wing portion 144 overlaps with the elongated opening 156. Specifically, each portion of the wing portion 144 overlaps with the elongated opening 156 so as not to interfere with the rivet 154 that is received in the proximal portion of the elongated opening 156 in the unlocked configuration. In one embodiment, the proximal portion 186 of the inner longitudinal edge 148 defines a portion of the space within the elongated opening 156 through which the rivet 154 is received in the unlocked configuration.

[0047] As the core member 110 is moved toward the locking configuration, the rivet 154 is moved toward the distal portion of the elongated opening 156 and is pressed distally against a point 150 along the inner longitudinal edge 148 where the proximal portion 186 and distal portion 188 of the inner longitudinal edge 148 intersect. As the rivet 154 moves beyond point 150, the rivet 154 is slid distally along and between the angled distal portions 188 of the inner longitudinal edge 148, moving the wing portions 144 away from each other and radially outward away from the longitudinal axis of the core member 110 toward the locking configuration.

[0048] The force required to facilitate the deployment of the clip 102 can be adjusted as desired by adjusting the magnitude of the angle at which the proximal portion 186 and distal portion 188 of the inner longitudinal edge 148 of the wing section 144 intersect. In one example, as shown in Figure 10, the point 150a where the proximal portion 186a and distal portion 188a of the inner longitudinal edge 148a of each wing section 144a are located includes a smooth curved edge that reduces the force required to deploy the clip 102. In another example, as shown in Figure 11, the angle 150b at which the proximal portion 186b and distal portion 188b of the inner longitudinal edge 148b of each wing section 144b intersect is sharpened to increase the force required to deploy the clip 102. Those skilled in the art will understand that the force required to deploy the clip 102 can also be adjusted by adjusting the length of the bent portion 184 that extends along and between the wing portions 144, and the length of one of the first surface 166 and the second surface 168 from which the wing portion 144 extends.

[0049] The clip 102 is assembled such that the core member 110 is received between the proximal ends 108 of the clip arm 106, and the elongated opening 156 of the core member is aligned with a hole 152 that extends through the proximal end 108 of the clip arm 106. The rivet 154 extends through the hole 152 of the clip arm 106 and through the proximal portion of the elongated opening 156. The core member 110 assembled with the clip arm 106 is slidably received within the channel 134 of the capsule 112. As described above, the enlarged distal end 118 of the control member 116 is housed in a cavity 120 within the proximal portion 158 of the core member 110, and the reduced-dimension portion 122 extends proximal therefrom through an opening 180 at the proximal end 162 of the core member 110 and through the bushing 128 and catheter 104 to a proximal end accessible by the user or operator of the system 100.

[0050] According to an exemplary method utilizing the clipping system 100, as shown in Figures 12 to 17, the clip 102 is inserted into a target site in the body, for example, through the working channel of an endoscope. The clip 102 is inserted into the target site in a closed configuration via an insertion device such as a catheter 104 to which the clip 102 is releasably coupled via a bushing 128. Once the clip 102 reaches the target site, the user advances the control member 116 distally relative to the catheter 104 and moves the clip arm 106 distally relative to the capsule 112 toward an open configuration.

[0051] As the clip arms 106 are extended distally from the capsule 112, the clip arms 106 move toward the open configuration, as shown in Figure 12, under their natural bias (as they are released from the constraint of the capsule 112), so that tissue can be received between their distal ends 114. The user can then pull the control member 116 proximal (or advance the catheter 104 distally on the control member 116) so that, as the clip arms 106 are retracted into the capsule 112, the clip arms 106 are drawn toward each other and grasp the tissue received between the distal ends 114 of the clip arms 106. The clip 102 may be moved between the open and closed configurations until the target portion of the tissue is positioned between the clip arms 106 as desired.

[0052] Once the user is satisfied that the clip 102 is in the desired position to grasp the target tissue, the user can unfold the clip 102 to lock it into a closed configuration and release the clip 102 from the catheter 104. According to an exemplary embodiment, the user pulls the control member 116 proximal, causing the engagement mechanism 138 of the clip arm 106 to engage with the distal surface 140 of the capsule 112, preventing further proximal movement of the clip arm 106 relative to the capsule 112. After this point, continued proximal movement of the control member 116 pulls the core member 110 proximal to the clip arm 106, the rivet 154 received in the opening 156 of the clip arm 106, and the capsule 112. This causes the core member 110 to slide proximal over the rivet 154, which moves from its position in the proximal portion of the elongated opening 156 of the core member 110 toward the distal portion of the elongated opening 156.

[0053] As the rivet 154 slides toward the distal portion of the elongated opening 156, it engages with the portion of the wing 144 that overlaps the elongated opening 156. The rivet 154 slides distally along the angled inner longitudinal edge 148 of the wing 144, pushing the wing 144 radially outward from the unlocked configuration toward the locked configuration. In the locked configuration, the wing 144 is moved radially outward with respect to the longitudinal axis of the core member 110 to engage with a locking structure 126 that extends along the capsule wall (for example, the wing 144 extends into and / or through the window).

[0054] The core member 110 is configured such that when the wing portion 144 of the locking mechanism 124 of the core member 110 is in the locked position, the proximal portion 158 of the core member 110 is received within the proximal end 130 of the capsule 112, and the first flap 172 and the second flap 174 engage with a radially inwardly pressed tab 136 of the capsule 112, pushing the tab 136 radially outward to disengage from the bushing 128. Thus, once the core member 110 is locked against the capsule 112, in order to finally deploy the clip 102, the user can continue to pull the control member 116 proximal until the force applied along it exceeds a predetermined threshold, thereby separating the enlarged distal end 118 from the rest of the control member 116. The catheter 104 and the reduced-size portion 122 of the control member 116 can then be withdrawn from the body, allowing the clip 102 to be deployed within the body and remain grasped on the target tissue.

[0055] As shown in Figure 18, a core member 210 according to another exemplary embodiment of the present disclosure may be substantially similar to the core member 110 described above with respect to the clipping system 100, and comprises a proximal portion 258 defining a cavity 220 into which an enlarged distal end 118 of a control member 116 can be received, and a distal portion 260 including a locking mechanism 224, such as a wing portion 244 that is received between a first surface 266 and a second surface 268 of the core member 110. The distal portion 260 may be substantially similar to the distal portion 160 of the core member 110, and includes a mechanism substantially similar to that of the core member 110, and functions substantially similarly.

[0056] The proximal portion 258 may be substantially similar to the proximal portion 158 of the core member 110, and the cavity 220 is defined via the proximal portions of the first surface 266 and the second surface 268, and via the first flap 272 and the second flap 274. However, in this embodiment, one of the first flap 272 and the second flap 274 includes a slot 290 extending along it such that a proximal opening 280 extending through the proximal end 262 of the core member 210 opens to an edge 292 of one of the first flap 272 and the second flap 274. The slot 290 is sized and shaped to facilitate assembly of the control member 116 and the core member 210, and is configured to facilitate assembly of the control member 116 and the core member 210. Specifically, a portion of the control member 116 immediately proximal to the enlarged distal end 118 can slide along the slot 290 so that the enlarged distal end 118 can pass through the cavity 220, and the reduced-size portion 122 of the control member 116 extends proximal therefrom through the proximal opening 280.

[0057] In one embodiment, during deployment, the enlarged distal end 118 may separate from the reduced-size portion 122 if the force acting on it exceeds a predetermined threshold force, so that the enlarged distal end 118 remains housed within the cavity 220. In another embodiment, during deployment, if the force acting on the proximal end 262 exceeds a predetermined threshold, one of the first flap 272 and the second flap 274, which are configured via the slot 290, deforms to move away from each other, increasing the size of the proximal opening 280 so that the enlarged distal end 118 can pass proximal to it.

[0058] In yet another exemplary embodiment, as shown in Figure 19, the clip arm 306 is integrally formed with the core member 310 such that the clip arm 306 and the core member 310 form a single component 301. The clip arm 306 and core member 310 may be substantially similar to the clip arm 106 and core member 110 described above with respect to the clipping system 100. However, in this embodiment, the proximal end 308 of the clip arm 306 is directly connected to the core member 310 (for example, at the distal end 364 of the core member 310). Since a rivet is not required to connect the proximal end 308 of the clip arm 306 to the core member 310, in this embodiment a pin or rivet may be received together with the distal portion of the elongated opening 356 of the core member 310 in the unlocked configuration and may slide toward the proximal portion of the elongated opening 356 in the locked configuration. The pin or rivet may be attached to the distal end of the control member extending through the proximal opening of the core member 310, substantially as described above with respect to system 100.

[0059] During the deployment of the clip according to this embodiment, the control member (and a pin or rivet received in the elongated opening 356) is pulled proximal to the clip arm 306, moving the core member 310 from the unlocked configuration to the locked configuration. It will be understood by those skilled in the art that the locking mechanism 324 of the core member 310 may be simply an inversion of the locking mechanism 124 described above with respect to system 100. For example, the wing portion of the locking mechanism 324 may overlap the proximal portion of the elongated opening 356.

[0060] As shown in Figures 20-22, a system 400 according to another exemplary embodiment of the present disclosure may be substantially similar to system 100 described above and comprises a clip 402 releasably coupled to an insertion device, such as a catheter (not shown), via a bushing 428. Similar to clip 102, clip 402 comprises a pair of clip arms 406, as shown in Figure 20, whose proximal ends 408 are coupled to each other via a core member 410, which is slidably housed within a capsule 412 to move clip 402 between an open configuration, where the distal ends 414 of the clip arms 406 are separated from each other to receive tissue between them, and a closed configuration, where the distal ends 414 of the clip arms 406 are drawn toward each other to grasp tissue between them. Clip 402 is moved between the open and closed configurations via a control member 416, and its enlarged distal end 418 is housed within a cavity 420 of the core member 410. The clip 402, control member 416, and core member 410 may be substantially similar in this embodiment to the clip 102, control member 116, and core member 110 (or core members 210, 310) described above, and may be used in substantially the same manner as in system 100. However, as will be described in more detail below, the enlarged distal end 418 does not separate from the rest of the control member 416 during the deployment process in this embodiment. Rather, during deployment, the enlarged distal end 418 of the control member 416 is pulled proximal to the proximal opening 480 of the core member 410 until the proximal opening 480 deforms to allow the enlarged distal end 418 to pass proximal, thereby separating the control member 416 from the clip 402.

[0061] Similar to clip 102, clip 402 is moved between an open configuration and a closed configuration as desired until target tissue is clipped. Specifically, the control member 416 is moved distal to capsule 412 to move the clip arm 406 toward the open configuration, and moved proximal to capsule 412 to move the clip arm 406 toward the closed configuration. Once target tissue is clipped, clip 402 can be locked in the closed configuration by pulling the control member 416 further proximal to capsule 412 until the locking mechanism 424 (e.g., wings) of core member 410 engages with the corresponding locking structure 426 (e.g., window) of capsule 412. As described above with respect to system 100, this further proximal movement of the control member 416 relative to capsule 412 moves the locking mechanism 424 radially outward so that the locking mechanism 424 engages with the corresponding locking structure 426 (shown in Figures 20-21) of capsule 410. According to one embodiment, when the locking mechanism 424 engages with the corresponding locking structure 426, the first flap 472 and the second flap 474 along the proximal portion 458 of the core member 410 engage with the radially inwardly crimped tab 436 of the capsule 412, forcibly disengaging the tab 436 from the bushing 428 that connects the clip 402 to the insertion device. Thus, once the core member 410 is locked against the capsule 412, in order to finally deploy the clip 402, the user can continue to pull the control member 416 proximal to the capsule 412 until the force exerted along it exceeds a predetermined threshold, thereby separating the control member 416 from the clip 402, as shown in Figure 20. The user can then withdraw the insertion device and the control member 416 from the body, leaving the deployed clip 402, as shown in Figure 21.

[0062] However, in this embodiment, the proximal opening 480 of the core member 410, through which the remaining length 422 of the control member 416 extends when the enlarged distal end 418 is received in the cavity 420, is configured to deform when subjected to a force exceeding a predetermined threshold. Specifically, the proximal opening 480 deforms to allow the enlarged distal end 418 to pass through it in the proximal direction, so that the control member 416 remains intact during deployment. According to an exemplary embodiment, the thickness of a portion of the material 417 surrounding the proximal opening 480 may be selected to facilitate its deformation when the enlarged distal end 418 is pulled proximal to it. As shown in the series of images in Figures 22a to 22d, the control member 416 is pulled proximal to the core member 410 so that the enlarged distal end 418 continues to apply a force exceeding a predetermined threshold force to the proximal opening 480, particularly along a portion of the material 417 surrounding the proximal opening 480, until the proximal opening 480 is sufficiently deformed to allow the entire enlarged distal end 418 to pass through it. Thus, once the enlarged distal end 418 has passed through the deformed proximal opening 480, the insertion device and control member 416 can be separated from the clip 402, removed from the body, leaving the deployed clip 402 clipped onto the target tissue in the body. Since there are no broken and / or separated parts during deployment, no detached parts occur in this embodiment, and thus the risk of such detachment is eliminated, as will be understood by those skilled in the art.

[0063] In exemplary embodiments, the core member 410 is shown and described as including a first flap 472 and a second flap 474 configured to engage with a portion of the capsule 412 and release the bushing 428 therefrom; however, in other embodiments, the first flap 472 and the second flap 474 may be omitted. As described above with respect to system 100, the first flap 472 and the second flap 474 facilitate the accommodation of the enlarged distal end 418 into the cavity 420. However, since the enlarged distal end 418 of system 400 is not separated from the remaining length 422 of the control member 416 during deployment, the flaps 472, 474 are not required to prevent the enlarged distal end 418 from falling out after deployment and may therefore be omitted. In this embodiment, the bent portions 484 of the core member 410, which connect the locking mechanism 424 to the surface of the core member 410, may be configured to engage with the crimped tabs 436 of the capsule 412 during the deployment process. Similar to the core member 110, these bent portions 484 deform as the locking mechanism 424 is moved toward the locked configuration. In this embodiment, the bent portions 484 are configured such that when they deform as the core member 410 moves from the unlocked configuration to the locked configuration, the bent portions 484 engage with the radially inwardly crimped tabs 436 of the capsule 412, pushing the tabs 436 radially outward to disengage from the bushing 428.

[0064] It will be apparent to those skilled in the art that various modifications can be made to this disclosure without departing from the scope of this disclosure. While specific embodiments have been illustrated and described herein, it should be understood that any configuration calculated to achieve the same objective may be used instead of the specific embodiments shown. This disclosure is intended to encompass any and all adaptations or variations of various embodiments. It should be understood that the above descriptions are illustrative and not limiting. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those skilled in the art by considering the above descriptions. Thus, the scope of various embodiments includes any other uses in which the above compositions, structures, and methods are used.

Claims

1. A clipping system for treating tissue, A clip comprising a capsule containing a channel extending longitudinally from a proximal end to a distal end and through the same, and a pair of clip arms, wherein the proximal ends of the pair of clip arms are slidably received within the channel, such that the clip arms move between an open configuration in which they are separated from each other so that the distal ends of the clip arms receive tissue between them, and a closed configuration in which they are drawn toward each other so that they grasp tissue between them. A core member that is received between the proximal ends of the clip arms and connected to the proximal ends of the clip arms to connect the clip arms to each other, wherein the core member includes a locking mechanism, the locking mechanism being movable between an unlocking configuration in which the core member is slidable within the channel of the capsule and a locking configuration in which the locking mechanism engages with a corresponding portion of the capsule to lock the clip arms into the closed configuration, Control member and A system comprising, wherein the control member extends through the proximal portion of the clipping system from its proximal end to an enlarged distal end housed within the proximal portion of the core member, such that the longitudinal movement of the control member relative to the capsule moves the clip between the open and closed configurations.

2. The system according to claim 1, wherein the core member is received in a hole extending through the proximal end of the clip arm and is connected to the clip arm via a connector passing through an elongated opening extending through the core member.

3. The system according to claim 2, wherein the connector is slidable from the proximal end to the distal end of the elongated opening so as to move the locking mechanism from the unlocked configuration to the locked configuration, and the connector is configured to contact a part of the locking mechanism when the connector is moved distally through the elongated opening.

4. The system according to claim 2, wherein the core member is formed from a die-cut sheet of metal having a size and shape that is bent to a configuration including a proximal portion that defines a cavity therein for housing the enlarged distal end of the control member therein, and a distal portion that includes the locking mechanism.

5. The system according to claim 4, wherein the locking mechanism is configured as part of the die-cut sheet of metal bent to overlap a portion of the elongated opening of the core member, forming a first wing and a second wing, and when the connector engages with the connector as it moves distally along the elongated opening, each of the first wing and the second wing is moved radially outward to engage with the corresponding locking mechanism of the capsule.

6. The system according to claim 5, wherein the locking mechanism of the capsule includes a pair of windows extending through its wall, the windows having a size and shape to receive therein a corresponding one of the first wing portion and the second wing portion, and configured to receive therein a corresponding one of the first wing portion and the second wing portion.

7. The system according to any one of claims 1 to 6, wherein the distal end of the clip arm is biased toward the open configuration such that when the clip arm is retracted into the capsule, the clip arm is constrained toward the closed configuration via the inner surface of the capsule, and when the clip arm is moved distally from the capsule, the clip arm can return to its biased open configuration.

8. The system according to any one of claims 1 to 7, wherein the enlarged distal end of the control member is configured to separate from the rest of the control member when the control member is subjected to a force exceeding a predetermined threshold, thereby releasing the clip from the proximal portion of the clipping system in a clipped configuration.

9. The system according to claim 4, wherein the core member includes a proximal opening extending through the core member and communicating with the cavity, the length of the control member extends proximal to the enlarged distal end through the proximal opening, and the proximal opening is configured to deform when the control member is subjected to a force exceeding a predetermined threshold, thereby allowing the distal end to pass through it in the proximal direction.

10. A clipping system for treating tissue, An insertion device including a channel that extends longitudinally from the proximal end to the distal end and through it, A clip comprising a capsule releasably coupled to the insertion device and a pair of clip arms, wherein the capsule includes a channel extending longitudinally from a proximal end to a distal end and through it, and the proximal ends of the clip arms are slidably received within the channel to move the clip arms between an open configuration in which they are separated from each other so that the distal ends of the clip arms receive tissue between them, and a closed configuration in which they are drawn toward each other so that they grasp tissue between them, A core member that is received between the proximal ends of the clip arms and connected to the proximal ends of the clip arms to connect the clip arms to each other, wherein the core member includes a locking mechanism, the locking mechanism being movable between an unlocking configuration in which the core member is slidable within the channel of the capsule and a locking configuration in which the locking mechanism engages with a corresponding portion of the capsule to lock the clip arms into the closed configuration, Control member and A system comprising, wherein the control member extends through the insertion device from a user-accessible proximal end of the clipping system to an enlarged distal end received in the proximal portion of the core member, such that the longitudinal movement of the control member relative to the capsule moves the clip between the open and closed configurations.

11. The system according to claim 10, wherein the core member is received in a hole extending through the proximal end of the clip arm and is connected to the clip arm via a connector passing through an elongated opening extending through the core member.

12. The system according to claim 11, wherein the connector is slidable from the proximal end to the distal end of the elongated opening to move the locking mechanism from the unlocked configuration to the locked configuration, and the connector is configured to contact a portion of the locking mechanism when the pins are moved distally along the elongated opening.

13. The system according to claim 11, wherein the core member is formed from a die-cut sheet of metal having a size and shape that is bent to include a proximal portion that defines a cavity therein for housing the enlarged distal end of the control member therein, and a distal portion that includes the locking mechanism.

14. The system according to claim 13, wherein the locking mechanism is configured as part of the die-cut sheet of metal bent so as to overlap a portion of the elongated opening of the core member, forming a pair of wings, and when the connector engages with the connector as it moves distally along the elongated opening, the pair of wings are moved radially outward to engage with the corresponding portion of the capsule.

15. The system according to any one of claims 10 to 14, wherein the proximal end of the capsule includes a pair of tabs, the pair of tabs being crimped radially inward to engage with corresponding portions of a bushing at the distal end of the insertion device, thereby releasably coupling the clip to the insertion device, and the core member includes a pair of flaps along its proximal portion, the pair of flaps engaging with the tabs of the capsule when the core member is in the locked configuration with respect to the capsule, deforming the tabs radially outward, thereby disengaging from the bushing.

Images