Reloadable clip with flared bladder deformation

Abstract

A clamp system includes a clamp having a pair of clamp arms, proximal ends of which are slidably received within a channel of a balloon for movement between an open configuration and a closed configuration. The proximal end of the balloon includes a connection tab extending proximally therefrom. The applicator includes an elongate flexible member and a control member extending therethrough. The control member includes a distal end configured to be connected to the clip arm to move the clip assembly between an open configuration and a closed configuration. The distal end of the elongate flexible member includes a bushing including: a first sloped surface along which the connection tab slides to engage a corresponding engagement feature of the bushing; and a second sloped surface proximal to the first sloped surface, the connection tab being slidable along the second sloped surface to plastically deform toward the deployed configuration.

Description

This application is a divisional of a Chinese application filed on June 18, 2020, with application number 202080047599.8 and titled “RELOADABLE CLIP WITH EXPANSION BALL DEFORMATION”. Priority claim

[0001] This disclosure claims priority to U.S. Provisional Patent Application Serial No. 62 / 874,679, filed on July 16, 2019; the disclosure of which is incorporated herein by reference. Technical Field

[0002] The present disclosure relates to endoscopic devices, and more particularly to endoscopic clamping devices for treating tissue along the gastrointestinal tract. Background Art

[0003] During endoscopic gastrointestinal (GI) surgery, the patient may be at risk for perforation of the GI wall, or may require closure of the GI wall as part of the procedure. Hemostatic clips can be used, for example, to stop bleeding from mucosal / submucosal defects, bleeding ulcers, arteries, polyps, diverticula, and for closure of luminal perforations. Depending on the size of the defect, multiple clips may be used. Summary of the invention

[0004] The present disclosure relates to a reloadable clamp system for treating tissue, comprising a clamp including a pair of clamp arms, each clamp arm extending from a proximal end to a distal end, the proximal ends of the clamp arms being slidably received within a channel of a capsule to move between an open configuration and a closed configuration. The proximal end of the capsule includes a plurality of connection tabs extending proximally therefrom. An applicator includes an elongated flexible member and a control member extending therethrough, the control member including a distal end configured to connect to the clamp arms to move the clamp assembly between an open configuration and a closed configuration. The distal end of the elongated flexible member includes a bushing including: a first inclined surface along which the connection tab slides until an engagement feature of the connection tab engages a corresponding engagement feature of the bushing; and a second inclined surface proximal to the first inclined surface along which the connection tab can slide to plastically deform toward a deployed configuration in which the connection tab moves away from a longitudinal axis of the capsule to release the bushing therefrom.

[0005] In one embodiment, the corresponding engagement feature of the bushing may be a notch extending around the periphery of the bushing between the first and second inclined surfaces such that the notch defines a proximal end of the first inclined surface and a distal end of the second inclined surface.

[0006] In one embodiment, the diameter of the bushing at the proximal end of the first inclined surface may be greater than the diameter of the bushing at the distal end of the second inclined surface.

[0007] In one embodiment, the connection tabs may elastically deform as they slide along the first inclined surface such that when the engagement features are positioned about the recesses, the connection tabs return to their initial configuration and the engagement features are received within the recesses to couple the bladder to the bushing.

[0008] In one embodiment, each of the first inclined surface and the second inclined surface may define a tapered portion of the bushing that tapers toward a distal end of the bushing.

[0009] In one embodiment, the engagement features of the connection tabs may include an engagement element extending radially inwardly from the proximal end of each connection tab.

[0010] In one embodiment, the engagement element of each connection tab may extend substantially perpendicularly relative to the longitudinal axis of the bladder.

[0011] In one embodiment, the engagement feature of the connection tab may include a stamped boss extending inwardly toward the longitudinal axis of the capsule.

[0012] In one embodiment, the proximal ends of the clamp arms may be connected to each other via a yoke, which may be coupled to the enlarged distal end of the control member.

[0013] In one embodiment, the yoke includes a proximal portion and a distal portion connected to each other at a point configured to separate when a predetermined force is applied thereto.

[0014] The present disclosure also relates to a clip device, comprising: a pair of clip arms, each extending from a proximal end to a distal end; and a capsule, which extends longitudinally from the proximal end to the distal end and includes a channel extending therethrough, so that the proximal ends of the clip arms can be slidably received in the channel to move between an open configuration and a closed configuration. A plurality of connecting tabs extend proximally from the proximal end of the capsule, each connecting tab including an engagement feature extending therefrom toward the longitudinal axis of the capsule to engage a notch extending around the periphery of a sleeve of an applicator. The connecting tabs are movable from an initial configuration to a deployed configuration, wherein the connecting tabs are plastically deformed in a direction away from the longitudinal axis of the capsule to release the sleeve therefrom.

[0015] In one embodiment, the engagement features of the connection tabs may include an engagement element extending radially inwardly from a proximal end of each connection tab substantially perpendicular to the longitudinal axis of the balloon.

[0016] In one embodiment, the engagement feature of the connection tab may include a stamped boss.

[0017] In one embodiment, each connection tab may include a window extending therethrough.

[0018] In one embodiment, the proximal ends of the clamp arms may be connected to each other by a yoke, which may be coupled to the enlarged distal end of the control member.

[0019] The present disclosure also relates to a method for treating tissue using a reloadable clamp system. The clamp is loaded onto the applicator by connecting a control member of the applicator to a clamp arm of the clamp and inserting a sleeve distally into the proximal end of a capsule, so that a connection tab at the proximal end of the capsule slides along the sleeve along a first inclined surface until an engagement feature of the connection tab engages with a corresponding engagement feature of the sleeve. The loaded clamp assembly is inserted into a target site in vivo via a working channel of an endoscope. The clamp is moved between an open configuration (where the distal ends of the clamp arms are separated from each other) and a closed configuration (where the distal ends of the clamp arms are moved toward each other) by longitudinally moving the control member relative to the catheter until the target tissue is clamped therebetween. The clamp arms are locked relative to the capsule in the closed configuration. The clamp assembly is deployed from the applicator by pulling the control member proximally relative to the clamp arms until a connector tab slides proximally along a second inclined surface of the sleeve, causing the connector tab to plastically deform from an initial configuration to a deployed configuration, in which the connector tab moves in a direction away from the longitudinal axis of the capsule to release the sleeve therefrom.

[0020] In one embodiment, the corresponding engagement feature of the bushing is a notch extending around a periphery of the bushing between the first and second inclined surfaces such that the notch defines a proximal end of the first inclined surface and a distal end of the second inclined surface.

[0021] In one embodiment, the engagement feature of the connection tab includes an engagement element extending radially inward from a proximal end of the connection tab such that the engagement element is received within the recess.

[0022] In one embodiment, during deployment, the distal end of the second inclined surface exerts a distal force on the engagement elements, causing each of the engagement elements to flex against a corresponding one of the connection tabs to slide along the second inclined surface.

[0023] In one embodiment, the engagement features of the connection tabs include a stamped boss extending along each connection tab to be received within a correspondingly sized and shaped recess extending around the periphery of the bushing. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 shows a longitudinal cross-sectional view of a portion of a clamp system according to an exemplary embodiment of the present disclosure; Figure 2 Shown according to Figure 1 another longitudinal cross-sectional view of a distal portion of a clip of the system; Figure 3 Shows the Figure 1 A perspective view of an applicator of the system; Figure 4 Shown according to Figure 1 An enlarged longitudinal cross-sectional view of the bladder and sleeve of the system prior to engagement; Figure 5 Shown according to Figure 1 An enlarged longitudinal cross-sectional view of the bladder and sleeve of the system engaged; Figure 6 Shown according to Figure 1 An enlarged longitudinal cross-sectional view of the balloon and sleeve of the system during an initial deployment phase; Figure 7 Shown according to Figure 1 An enlarged longitudinal cross-sectional view of the bladder and the liner of the system when the liner is released from the bladder; Figure 8 Shown is the Figure 1 A perspective view of an alternative embodiment of a capsule of the system; Fig. 9 Shown according to Figure 1 A perspective view of a portion of a cartridge of the system; and Fig.10 An enlarged longitudinal cross-sectional view of a bladder and a sleeve according to another exemplary embodiment of the present disclosure is shown. Specific embodiments

[0025] The present disclosure may be further understood with reference to the following description and accompanying drawings, in which like elements are represented by like reference numerals. The present disclosure relates to a clamp system, and more particularly to a reloadable endoscopic clamp system, in which a clip may be loaded onto a distal end of an applicator prior to endoscopic surgery. Once the clip has been deployed at a desired target area in the body, the applicator assembly may be reloaded with a new clip. Although a dislodged portion (e.g., a portion that remains in the body when the clip is deployed) would normally be naturally expelled from the body, the dislodged portion may become trapped in a larger defect after closure.

[0026] Exemplary embodiments of the present disclosure include a clip including a clamp arm that can slide within a capsule to move between an open configuration and a closed configuration as needed to clamp tissue. The proximal end of the capsule includes a connection tab that facilitates direct releasable connection of the clip to an applicator, which minimizes or eliminates the possibility of a dislodged portion being within the body when the clip is deployed. It will be understood by those skilled in the art that the terms proximal and distal as used herein are intended to refer to directions toward and away from a user of the device, respectively.

[0027] like Figure 1-9As shown, the reloadable clamp system 100 includes a clamp 102 configured to be loaded onto an applicator 104 to clamp target tissue therein before the system 100 is inserted into the body. The clamp 102 includes a pair of clamp arms 106, whose proximal ends 110 are slidably received in a capsule 108, so that the clamp arms 106 can be moved between an open configuration (in which the distal ends 112 of the clamp arms 104 are separated from each other) and a closed configuration (in which the distal ends 112 are pulled toward each other to clamp tissue). The proximal end 114 of the capsule 108 includes a plurality of connecting tabs 116, which extend proximally from the proximal end 114 of the capsule 108 and are configured so that, for example, when a sleeve 118 of the applicator 104 is inserted into the proximal end 114 of the capsule 108, the connecting tabs 116 engage corresponding portions of the sleeve 118 to connect the clamp 102 to the applicator 104. When sleeve 118 is connected to balloon 108, enlarged distal end 122 of control member 120 of applicator 104 is connected to clip arm 106 such that longitudinal movement of control member 120 relative to balloon 108 moves clip 102 between open and closed configurations.

[0028] As will be described in further detail below, once the target tissue has been clamped as desired, the user of the system 100 (e.g., a physician) begins the deployment process, which causes the connection tab 116 to plastically deform away from the centerline of the capsule 108, causing the sleeve 118 to be released therefrom. Since the connection tab 116 plastically deforms without breaking to release the sleeve 118, the deployment of the clip 102 does not result in a dislodged portion being left in the body. The applicator 104 is configured such that after the clip 102 is deployed in the body, a new clip 102 can be loaded onto the applicator 104, so that the new clip 102 can be delivered to a second portion of the target tissue in the body using the same applicator 104. Each clip 102 according to this embodiment is stored in a cartridge 124, which facilitates loading the clip assembly 102 onto the applicator 104.

[0029] like Figure 1-2 As shown, the clip 102 includes a pair of clip arms 106, in this embodiment, the proximal ends 110 of which are connected to each other by a yoke 126 that is slidably received in the capsule 108. In this embodiment, the clip arms 106 are biased toward an open configuration, so that when not constrained by the capsule 108, the clip arms 106 move to the open configuration under their natural bias, wherein the distal ends 112 of the clip arms 106 are separated from each other to receive tissue therebetween. In some embodiments, the clip arms 106 can be biased in a closed configuration. When the clip arms 106 are pulled into the capsule 108, the capsule 108 constrains the clip arms 106, holding the distal ends 112 together so that tissue can be clamped therebetween. The yoke 126 can slide longitudinally within the capsule 108 to move the clip arms 106 proximally and distally relative to the capsule 108 between the open and closed configurations.

[0030] Each clamp arm 106 extends from a proximal end 110 connected to the yoke 126 to a distal end 112. The distal end 112 of one or both of the clamp arms 106 may include a tip extending laterally inward toward the other clamp arm 106, the tip including, for example, teeth, protrusions, spikes, or other structures, configured to clamp tissue between the distal ends 112. One or both of the clamp arms 106 may also include a locking feature configured to lock the clamp arms 106 in a tissue clamping configuration after the target tissue has been clamped by the clamp arms 106 as desired. In one embodiment, one or both of the clamp arms 106 include a locking tab extending laterally outward therefrom, the locking tab being configured to engage a portion of the capsule 108 when the clamp arms 106 have been pulled into the capsule 108 by a predetermined distance. For example, the locking tab may be received within a correspondingly sized, shaped, and positioned locking window that extends laterally into or through the wall of the capsule 108 to lock the clamp arms 106 relative to the capsule 108 in the tissue clamping configuration.

[0031] The yoke 126 is connected to the proximal end 110 of the clamp arm 106 and is configured to be connected to the enlarged distal end 122 of the control member 120. In this embodiment, the yoke 126 includes a proximal portion 128 and a distal portion 130 that are connected to each other at a point 132, and the point 132 is configured to break or separate when subjected to a force exceeding a predetermined threshold. For example, the point 132 may include a weld, a portion of reduced diameter, or an adhesive that breaks or otherwise separates when sufficient force is applied thereto. The distal portion 130 is configured to engage the proximal portion of the clamp arm 106 by, for example, a pair of protrusions extending from the distal portion 130 and received in a correspondingly sized and shaped opening extending through the proximal portion of the clamp arm 106, so that the clamp arms 106 are positioned relative to each other.

[0032] The proximal portion 128 is configured to engage the enlarged distal end 122 of the control member 120. In one embodiment, the proximal portion 128 includes a cavity 134 sized and shaped to receive the enlarged distal end 122 and a longitudinal slot 136 extending proximally from the cavity 134 to a proximal end 138 of the yoke 126. The longitudinal slot 136 is sized and shaped to receive a portion of the control member 120 extending proximally from the enlarged distal end 122. In one embodiment, the opening of the longitudinal slot 136 at the proximal end 138 includes an inclined surface 140 that tapers toward its distal end to facilitate distal passage of the enlarged distal end 122 through the longitudinal slot 136 and insertion into the cavity 134 during loading of the clip 102 onto the applier 104. The cavity 134 and the longitudinal slot 136 are configured such that once the enlarged distal end 122 is received within the cavity 134, the enlarged distal end 122 is prevented from being withdrawn proximally therefrom. Thus, longitudinal movement of the control member 120 relative to the capsule 108 moves the clamp arms 106 between the open and closed configurations.

[0033] The capsule 108 extends longitudinally from the proximal end 114 to the distal end 142 and includes a passage 144 extending longitudinally therethrough. The passage 144 is sized and shaped to slidably receive the yoke 126 and the clamp arm 106 therein. As described above, the capsule 108 of this embodiment also includes a locking structure (e.g., a locking window) for engaging a corresponding locking feature (e.g., a locking tab) of the clamp arm 106. The capsule 108 includes connecting tabs 116 that extend proximally from the proximal end 114 around the periphery of the proximal end 114 in an initial configuration, flaring radially outward therefrom. In particular, each connecting tab 116 extends at an angle relative to the longitudinal axis of the capsule 108 such that the proximal end 146 of each connecting tab 116 extends away from the longitudinal axis to form a substantially flared end.

[0034] The proximal end 146 of each connection tab 116 also includes an engagement element 148 that extends transversely therefrom toward the longitudinal axis of the capsule 108. In one embodiment, the engagement element 148 extends substantially perpendicular to the longitudinal axis. As will be described in further detail below, the engagement element 148 is configured to engage a corresponding notch or recess 150 of the sleeve 118 of the applicator 104. In one embodiment, the capsule 108 includes four connection tabs 116. Those skilled in the art will appreciate that the capsule 108 may include any number of connection tabs 116, so long as the connection tabs 116 are configured to engage the sleeve 118, as described below.

[0035] like Figure 3 As shown, applicator 104 includes a flexible member 152, such as a catheter extending from a proximal end connected to a handle portion 154, which remains outside the body during the clamping of the target tissue, to a distal end, which includes, for example, a hub 118 for connecting applicator 104 to clip 102. A control member 120 extends through flexible member 152, and the proximal end of control member 120 is connected to handle portion 154, which includes an actuator for controlling the movement of clip 102 after clip 102 is loaded into applicator 104.

[0036] In this embodiment, the bushing 118 is connected to the distal end of the flexible member 152 and is configured to be connected to the clip 102 through the connection tab 116 of the bladder 108. The bushing 118 extends from a proximal end 155 to a distal end 156 and includes a channel 158 extending therethrough. The proximal end 155 is connected to the distal end of the flexible member 152, and the distal end 156 is configured to engage the connection tab 116. When the bushing 118 is coupled to the bladder 108, the channel 158 of the bushing 108 is substantially aligned with the channel 144 of the bladder 108.

[0037] An outer surface 160 along a distal portion of the bushing 118 includes a first inclined surface 162 that facilitates engagement of the distal portion of the bushing 118 with the flared end of the capsule 108 formed by the connection tab 116 at its proximal end 114, and a second inclined surface 164 that facilitates separation of the capsule 108 from the bushing 118 during deployment of the clip 102. The first and second inclined surfaces 162, 164 extend around the periphery of the bushing 118 to define, in one embodiment, a generally conical portion of the bushing 118. A notch 150 extends around the periphery of the bushing 118 between the first and second inclined surfaces 162, 164 such that the notch 150 defines a proximal end 166 of the first inclined surface 162 and a distal end 168 of the second inclined surface 164. The size and shape of the notch 150 corresponds to the size and shape of the engagement element 148 of the connection tab 116.

[0038] The first inclined surface 162 tapers toward the distal end 156 to facilitate insertion of the sleeve 118 into the flared end formed by the connecting tab 116 at the proximal end of the balloon 108. In particular, when the balloon 108 is pulled proximally over the sleeve 118, as shown in FIG. Figure 4 As shown, when the engagement element 148 of each connecting tab 116 slides along the first inclined surface 162, the connecting tab 116 elastically deforms (e.g., expands radially outward). When the engagement elements 148 are positioned around the recesses 150, the connecting tabs 116 return to their initial configuration (e.g., the recesses 150 allow the elements 148 to bend radially inward due to their natural bias) so that the engagement elements 148 are received within the recesses 150, as shown in FIG. Figure 5 150, and the balloon 108 snaps onto the sleeve 118 via the connection tabs 116. Once the engagement element 148 is received within and engaged with the notch 150, the clip 102 remains coupled to the sleeve 104 until deployed.

[0039] The second inclined surface 164 tapers toward its distal end 168. In one embodiment, the diameter of the bushing 118 at the distal end 168 of the second inclined surface 164 is smaller than the diameter of the bushing 118 at the proximal end 166 of the first inclined surface 162. As will be described in further detail below, when the clip 102 has been clamped onto the target tissue as desired, the control member 120 can be pulled proximally relative to the balloon 108 until the clamp arm 106 is locked in a closed configuration relative to the balloon 108 (e.g., by a locking tab of the clamp arm 106 being received within a locking window of the balloon 108).

[0040] After this point, further proximal movement of control member 120 draws capsule 108 proximally against sleeve 118, as shown in FIG. Figure 6As shown, when sufficient proximal force is applied, the engagement element 148 bends against the connecting tab 116 and slides proximally along the second inclined surface 164. As the connecting tab 116 slides proximally along the second inclined surface 164, the proximal end 146 of the connecting tab 116 moves further away from the longitudinal axis of the capsule 108 toward the deployed configuration, wherein the angle of the connecting tabs 116 relative to the longitudinal axis increases to the extent that they are plastically deformed in such a radially outwardly flared shape. In other words, as Figure 7 As shown, the attachment tabs 116 are permanently deformed radially outwardly so that the sleeve 118 can be disengaged and removed from the bladder 108 without leaving any dislodged portions in the body.

[0041] In one embodiment, the connecting tabs 116 are formed of a metal that is selected to allow for the slight elastic deformation required during loading of the clip 102 into the applicator 104 and to plastically deform during deployment of the clip 102. For example, the connecting tabs 116 may be formed of stainless steel, such as 300 series stainless steel. In one embodiment, the entire capsule 108, including the connecting tabs 116, may be formed of the same material. Those skilled in the art will appreciate that the force required to cause the connecting tabs 116 to plastically deform may be controlled by, for example, adjusting the number of connecting tabs 116 and / or adjusting the amount of material used to form the connecting tabs 116. For example, according to another alternative embodiment, as Figure 8 As shown, balloon 108' may include six connection tabs 116' at proximal end 114' of balloon 108', each connection tab 116' including a window 170' extending therethrough so that connection tabs 116' include less material and will therefore deform outwardly more easily than connection tabs 116 during deployment.

[0042] Prior to being loaded onto the applicator 104, the clip 102 can be stored in a barrel 124 that is configured to facilitate loading the clip assembly 102 onto the applicator 104. The barrel 124 can be configured as a storage container that includes a base 125 and a lid (not shown), wherein a space 172 that is sized and shaped to accommodate the clip 102 is defined. In this embodiment, the clip 102 is stored in the barrel 124 in an open configuration. The barrel 124 includes a proximal opening 174 through which a distal portion of the applicator 104 can be inserted to couple to the clip assembly 102, as will be described in further detail below. The barrel 124 holds the clip 102 in a position that is configured to facilitate loading the clip 102 onto the applicator 104. It should be noted that although Fig. 9 Only the base 125 of the container 124 is shown, but a similar cover may be coupled to the base 125 to completely surround the clip 102 .

[0043] According to an exemplary method for loading the clip 102 onto the applicator 104, the distal portion of the applicator 104 including the bushing 118 is inserted through the proximal opening 174 of the barrel 124. The enlarged distal end 122 of the control member 120 is moved distally through the bushing 118 to be inserted distally through the longitudinal slot 136 of the yoke 126 until the enlarged distal end 122 is received within the cavity 134. The bushing 118 is engaged with the capsule 108 by pulling the capsule 108 proximally relative to the bushing 118 (or moving the bushing 118 distally relative to the capsule 108) so that the engagement element 148 of the connecting tab 116 slides proximally along the first inclined surface 162 of the bushing 118 until the engagement element 148 is received within the recess 150. When the clip 102 is loaded onto the applicator 104, the handle portion 154 of the applicator 104 can be used to pull the control member 120 proximally relative to the capsule 108 to move the clip 102 toward the closed configuration. The entire applicator 104 can then be moved proximally relative to the barrel to pull the clip assembly 102 out of the barrel through the proximal opening 174 in the closed configuration.

[0044] In use, after the clip 102 has been loaded onto the applicator 104, the clip 102 in the closed configuration can be inserted into the body through, for example, a working channel of an endoscope to reach the target tissue. Once the clip 102 has reached the target tissue, the clip 102 can be moved toward the open configuration to receive the target tissue between the distal ends 112 of the clip arms 106. The clip 102 can be moved between the open and closed configurations until the target tissue has been clamped between the clip arms 106 as desired. Once the clip 102 is in the closed configuration to clamp the target tissue as desired, the control member 120 (e.g., via an actuator of the handle portion 154) can be moved proximally relative to the capsule until the locking features of the clip arms 106 engage the corresponding locking features of the capsule 108, locking the clip arms 106 relative to the capsule 108 in the closed configuration.

[0045] To deploy the clip 102, the control member 120 can be pulled further proximally until the balloon 108 is pulled proximally against the bushing 118, causing the distal end 168 of the second inclined surface 164 to apply a distal force to the engagement element 148 received within the recess 150. The force against the engagement element 148 causes the engagement element 148 to bend against the connecting tab 116 and the connecting tab 118 to slide proximally along the second inclined surface 164 until the connecting tab 116 is plastically deformed outwardly in a direction away from the longitudinal axis of the balloon 108. Once the connecting tab 116 has been plastically deformed, the bushing 118 is withdrawn proximally from the balloon 108, leaving the clip 102 in place to clamp the target tissue.

[0046] The user continues to apply a proximal force on the control member 120 until the yoke 126 breaks, fails, or otherwise separates at point 132, releasing the clamp arm 106 from the control member 120, thereby releasing the clip 102 from the control member 120 and locking the clip 102 closed on the target tissue. The entire applicator 104, including the control member 120 and the proximal portion 128 of the yoke 126, can then be withdrawn proximally from the body, leaving the clip 102 clamped on the target tissue. If necessary, a new clip 102 can be loaded onto the applicator 104 in the same manner as described above, so that the system 100 can then be used to clamp a second portion of tissue. This process can be repeated as many times as needed or desired using the same applicator 104.

[0047] Although the capsule 108 of the clip 102 and the sleeve 118 of the applicator 104 are described and shown as being connected via a connecting tab 116, which includes a laterally inwardly extending engagement element 148 extending from a proximal end 146 of the connecting tab 116, those skilled in the art will understand that the connecting tab 116 of the capsule 108 can have any of a variety of engagement features, so long as the capsule 108 can be engaged with corresponding features of the sleeve 118 and is configured to interface with the first and second inclined surfaces 162, 164 of the sleeve 118, respectively, during loading and deployment of the clip 102, as described above.

[0048] For example, in another embodiment, Fig.10 As shown, the connection tabs 216 at the proximal end 214 of the capsule 208 include a stamped boss 248 formed by stamping each connection tab 216 to include an engagement structure extending inwardly toward the longitudinal axis of the capsule 208. The stamped boss 248 is configured to be received within a correspondingly sized and shaped recess 250 that extends around the periphery of the sleeve 218. Similar to the system 100 described above, during loading of the clip onto the applier, the connection tab 216 including the stamped boss 248 slides proximally along the first inclined surface 262 of the sleeve 218 until the stamped boss 248 snaps into the recess 250. Similar to system 100 , during deployment of the clip, connection tab 216 including stamped boss 248 slides proximally along second inclined surface 264 of bushing 218 until connection tab 216 plastically deforms in an outward configuration wherein connection tab 216 moves in a direction away from the longitudinal axis of capsule 208 .

[0049] It will be appreciated by those skilled in the art that various modifications can be made to the present disclosure without departing from the scope of the present disclosure.

Claims

1. A reloadable clamp system for treating tissue, comprising: a clamp assembly including a pair of clamp arms, a capsule configured to receive proximal ends of the clamp arms therein, and a first deformable tab extending proximally from the proximal end of the capsule, the first deformable tab including a first engagement element extending radially inwardly from the proximal end of the first deformable tab; as well as An applicator having a distal end including an engagement feature, wherein the engagement feature is configured as a first engagement element for receiving the first deformable protrusion therein in a locked form, the distal end of the applicator being configured such that when the first deformable protrusion is pulled proximally beyond the engagement feature, the first deformable protrusion bends and plastically deforms, so that the first deformable protrusion is fixed radially outward and disengaged from the distal end of the applicator.

2. A system according to claim 1, wherein the engagement feature is configured to plastically deform the first engagement element by bending the first engagement element toward the first deformable protrusion, so that the first engagement element is permanently bent into a non-engagement form, in which the first engagement element is radially separated from the distal end of the applicator, so that the capsule can be separated from the applicator.

3. A system according to claim 1, wherein the distal end of the applicator includes a sleeve and the engagement feature is formed on the sleeve, the engagement feature is configured to receive a first engagement element of the first deformable protrusion therein, and when the first engagement element is pulled proximally beyond the engagement feature, the engagement feature causes the first engagement element to plastically deform.

4. A system according to claim 1, wherein the distal end of the applicator includes a first inclined surface and a second inclined surface, the first engaging element is configured to slide along the first inclined surface without plastic deformation, the engaging feature is formed as a narrow groove extending proximally of the first inclined surface, the first engaging element is configured to snap into the narrow groove and enter a locking form, the second inclined surface extends proximally of the engaging feature, and the second inclined surface is configured so that when the first engaging element slides proximally thereon, the first deformable protrusion undergoes plastic deformation.

5. The system of claim 4, wherein the proximal end of the slot comprises a wall configured to engage and plastically deform the first engagement element when the first engagement element is pulled proximally out of the slot.

6. A system according to claim 5, wherein the diameter of the distal end of the applicator at the proximal end of the first inclined surface is larger than the diameter of the distal end of the applicator at the distal end of the second inclined surface.

7. A system according to claim 6, wherein the first deformable protrusion can be elastically deformed when the first engaging element slides along the first inclined surface, so that when the first engaging element moves proximally beyond the proximal end of the first inclined surface, the first engaging element snaps into the narrow groove to connect the capsule to the launcher.

8. A system according to claim 7, wherein when the first deformable protrusion and the first engaging element are plastically deformed as the first deformable protrusion moves proximally out of the narrow groove and onto the second inclined surface, the first deformable protrusion moves to a deployed form, in which the first deformable protrusion is radially fixed outward and disengaged from the distal end of the launcher.

9. The system of claim 7, wherein in the locked configuration, the first engagement element extends substantially perpendicular to a longitudinal axis of the balloon.

10. The system of claim 9, wherein the first engagement element of the first deformable tab comprises a stamped boss that extends inwardly toward the longitudinal axis of the capsule in the locked configuration.

11. The system of claim 4, wherein the first and second inclined surfaces each define a tapered portion of the applicator, the first and second inclined surfaces each tapering toward a distal end of the applicator.

12. A system according to claim 1, wherein the clamping assembly includes at least one additional deformable protrusion extending proximally from the proximal end of the capsule, and the at least one additional deformable protrusion includes an additional engagement element extending radially inward from the proximal end of the at least one additional deformable protrusion.

13. A system according to claim 12, wherein the engagement feature is configured to cause the additional engagement element to deflect and plastically deform when the additional deformable protrusion moves proximally beyond the engagement feature, so that at least one additional deformable protrusion is radially fixed outward and disengaged from the distal end of the launcher.

14. The system of claim 1, wherein the proximal ends of the clamp arms are connected to each other via a yoke that is couplable to an enlarged distal end of a control member extending through an elongated flexible member of the applicator.

15. The system of claim 14, wherein the yoke includes a proximal portion and a distal portion connected to each other at a point configured to separate when a predetermined force is applied thereto.

16. A clamp device comprising: a pair of clamp arms, each of the clamp arms extending from a proximal end to a distal end; a capsule configured to receive the proximal end of the clamp arm therein; as well as A first deformable protrusion extends proximally from the proximal end of the capsule, the first deformable protrusion including a first engagement element, the first engagement element extending radially inward from the proximal end of the first deformable protrusion toward the longitudinal axis of the capsule to engage an engagement feature at the distal end of the applicator, such that when a proximal force is applied to the first deformable protrusion to pull the first deformable protrusion proximally beyond the engagement feature, the first deformable protrusion is configured to bend and plastically deform so that the first deformable protrusion is fixed radially outward to disengage from the distal end of the applicator.

17. A device according to claim 16, wherein in a locked form, the first engagement element extends substantially perpendicularly relative to the longitudinal axis of the capsule, and wherein in a deployed form, the first deformable protrusion and the first engagement element are plastically deformed and the first deformable protrusion is fixed radially outward and disengaged from the distal end of the applicator.

18. The apparatus according to claim 16, further comprising: At least one additional deformable protrusion extends proximally from the proximal end of the capsule, and the at least one additional deformable protrusion includes an additional engagement element extending radially inward from the proximal end of the at least one additional deformable protrusion, so that when the additional deformable protrusion is pulled proximally beyond the engagement feature, the additional engagement element plastically deforms, and the additional deformable protrusion bends and plastically deforms, so that the first deformable protrusion is fixed radially outward to disengage from the distal end of the applicator.

19. The device of claim 16, wherein the first engagement element includes a window extending therethrough.

20. The device of claim 16, wherein the proximal ends of the clamp arms are connected to each other via a yoke, the yoke being coupleable to an enlarged distal end of a control member of the applicator.

21. A clamp device comprising: a pair of clamp arms, each of the clamp arms extending from a proximal end to a distal end; a balloon extending longitudinally from a proximal end to a distal end and including a passage extending therethrough such that the proximal end of the clamp arm is slidably received within the passage to move between an open configuration and a closed configuration; and a plurality of connecting tabs extending proximally from the proximal end of the capsule, each of the connecting tabs including an engagement feature extending therefrom toward the longitudinal axis of the capsule to engage a recess extending around the periphery of the sleeve of the applicator, the connecting tabs being movable from an initial configuration to a deployed configuration in which the connecting tabs are plastically deformed in a direction away from the longitudinal axis of the capsule to release the sleeve therefrom, Wherein each engagement feature of the connection tab is configured to bend and deform against the connection tab when the connection tab moves to the deployed configuration, and the engagement feature extends from the connection tab.

22. The device according to claim 21, wherein The engagement features of the connection tabs include an engagement element extending radially inwardly from a proximal end of each connection tab substantially perpendicular to the longitudinal axis of the balloon.

23. The device of claim 21, wherein the engagement feature of the connection tab comprises a stamped boss.

24. The device of claim 21 wherein each of said connection tabs includes a window extending therethrough.

25. The device of claim 21, wherein the proximal ends of the clamp arms are connected to each other via a yoke, the yoke being coupleable to an enlarged distal end of a control member.

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