Patent Description:
The present disclosure relates generally to medical clips, and more specifically, to hemostatic clips delivered to a target site through an endoscope.

Pathologies of the gastrointestinal (GI) system, the biliary tree, the vascular system, and other body lumen and hollow organs are often treated through endoscopic procedures, many of which require hemostasis to control internal bleeding. Hemostasis clips are often employed to control such internal bleeding. These clips grasp tissue surrounding a wound and hold edges of the wound together temporarily to allow natural healing processes to permanently close the wound. Specialized endoscopic clipping devices are often used to deliver clips to desired locations within the body after which the clip delivery device is withdrawn, leaving the clip within the body.

Examples of reloadable hemostasis clips are disclosed in <CIT> and <CIT>.

Often, hemostasis clips include a coupler that connects a clip to a delivery device. By design, the coupler breaks when the clip is deployed to free the clip from the delivery device. One challenge in using a coupler that breaks is that the broken pieces may be small enough that they can be suctioned into the working channel of the endoscope where they can become stuck. As a result, the pieces may stay in the endoscope even after a standard cleaning procedure has been performed, increasing the risk of contaminating the endoscope and infecting patients.

The present invention is directed to a system for treating tissue according to claim <NUM> and to a method for loading a clip assembly onto a catheter assembly, as defined in claim <NUM>. Further embodiments of the invention are recited in the dependent claims.

The present disclosure also relates to a system for treating tissue comprising a clip assembly including a pair of clip arms, each of the clip arms extending from a proximal end to a distal end, proximal ends of the clip arms slidably received within a channel of a capsule to be moved between a tissue receiving configuration, in which distal ends of the clip arms are separated from one another, and a tissue clipping configuration, in which distal ends of the clip arms are moved toward one another, a catheter assembly including a bushing and a control member extending therethrough, the control member including a distal end configured to be connected to the clip arms to move the clip assembly between the tissue receiving configuration and the tissue clipping configuration, and a coupler releasably coupled to a proximal end of the capsule and configured to be coupled to the distal end of the catheter assembly, the coupler configured to fracture when a proximal force exerted on the coupler via the control member exceeds a first predetermined threshold value to disengage the capsule and deploy the clip assembly.

In an embodiment, the proximal ends of the clip arms are connected to one another via a yoke releasably coupleable with an enlarged distal end of the control member.

In an embodiment, a proximal portion of the coupler includes a plurality of fingers mountable over a distal portion of the bushing to couple the coupler to the catheter assembly.

In an embodiment, the coupler includes two sets of V-notches diametrically opposed about a circumference of a distal portion of the coupler, each set of V-notches including a proximal V-notch extending from a proximal end of a wall of the coupler and a distal V-notch extending from a distal end of the wall of the coupler, the sets of V-notches configured to fracture when a proximal force exerted thereon exceeds a threshold value.

In an embodiment, the coupler includes a ramped portion configured to interact with a ridge extending about a circumference of an outer surface of the bushing such that, when a proximal force is exerted on the coupler, the ramped portion is moved proximally over the ridge, expanding the wall of the coupler and causing the V-notch portions to fracture.

In an embodiment, each set of V-notches includes a third V-notch extending into the wall of the coupler from an outer surface thereof.

In an embodiment, the coupler includes a loop portion extending from a first side of each set of V-notches to a second side of each-set of V-notches, the loop portion preventing the coupler from disengaging from the distal end of the bushing when the coupler fractures.

The present disclosure also relates to a system for treating tissue comprising a clip assembly including a pair of clip arms and a capsule, each of the clip arms extending from a proximal end to a distal end, proximal ends of the clip arms slidably received within a channel of the capsule to be moved between a tissue receiving configuration, in which distal ends of the clip arms are separated from one another, and a tissue clipping configuration, in which distal ends of the clip arms are moved toward one another, a catheter assembly including a control member extending therethrough, the control member including a distal end configured to be connected to the clip arms to move the clip assembly between the tissue receiving configuration and the tissue clipping configuration, and a coupler releasably coupled to a proximal end of the clip assembly and configured to be coupled to the distal end of the catheter assembly, the coupler configured to fracture to disengage the capsule and deploy the clip assembly.

In an embodiment, the catheter assembly includes a bushing at a distal end thereof, the bushing configured to be coupled to the proximal end of the coupler.

In an embodiment, each set of V-notches includes a third V-notch extending into the wall of the coupler from an outer surface thereof
In an embodiment, the coupler includes a loop portion extending from a first side of each set of V-notches to a second side of each set of V-notches, the loop portion preventing the coupler from disengaging from the distal end of the bushing when the coupler fractures.

In an embodiment, the proximal ends of the clip arms are connected to one another via a yoke releasably couplable with an enlarged distal end of the control member.

The present disclosure also relates to a method of treating tissue comprising loading a clip assembly on a catheter assembly by coupling a proximal end of a coupler to a distal end of the catheter assembly and coupling a distal end of the coupler to a proximal end of the clip assembly, a control member of the catheter assembly being releasably connected to proximal ends of clip arms of the clip assembly, inserting the loaded clip assembly to a target site within a living body via a working channel of an insertion device, moving the clip assembly between a tissue receiving configuration, in which distal ends of the clip arms are separated from one another, and a tissue clipping configuration, in which distal ends of the clip arms are moved toward one another, by moving the control member longitudinally relative to the clip assembly until a target tissue is gripped therebetween, as desired, and releasing the clip assembly from the catheter by drawing the control member proximally relative to the clip arms, beyond a predetermined threshold value, so that the coupler yields to disengage the clip assembly and at least a portion of the coupler remains connected to the catheter assembly.

In an embodiment, the method further comprises drawing the control member further proximally, beyond a predetermined threshold value, until an enlarged distal end of the control member disengages from a yoke of the clip assembly.

The present disclosure may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present disclosure relates to a clipping system and, in particular, relates to a reloadable endoscopic clipping system. Exemplary embodiments of the present disclosure describe a clip assembly that may be loaded onto a distal end of a catheter assembly prior to an endoscopic procedure. Once a clip has been deployed at a desired target area in the body, the catheter assembly may be reloaded with a new clip. In particular, the catheter assembly includes a coupler for releasably coupling a bushing of the catheter assembly to a clip assembly so that multiple clips can be fired using a single catheter assembly. The coupler is pre-assembled with a proximal end of a capsule and is configured to be coupled to a distal end of the bushing. When it is desired to deploy the clip assembly in the body, the control member is drawn proximally with respect to the clip assembly until the coupler disengages from the capsule or fractures to release the capsule from the catheter assembly. In exemplary embodiments, the coupler includes a hoop designed to keep the fractured coupler on the tip of the catheter assembly when the coupler breaks. It should be noted that the terms "proximal" and "distal," as used herein, refer to a direction toward (proximal) and away from (distal) a user of the device.

As shown in <FIG>, a system <NUM> according to an exemplary embodiment of the present disclosure comprises a clip assembly <NUM>, a catheter assembly <NUM> and a coupler <NUM> facilitating a releasable connection between the catheter assembly <NUM> and the clip assembly <NUM>. The clip assembly <NUM> is loadable onto a bushing <NUM> of the catheter assembly <NUM> prior to insertion of the system <NUM> into a living body for the clipping of target tissue. The catheter assembly <NUM> is configured such that, after deployment of the clip assembly <NUM> in the living body, a new clip assembly <NUM> may be loaded onto the catheter assembly <NUM> so that the same catheter assembly <NUM> may be used to deliver multiple clip assemblies <NUM> to further portions of target tissue in the living body. In this embodiment, a capsule <NUM> of the clip assembly <NUM> is pre-assembled with the coupler <NUM> and is configured to be releasably connected to the catheter assembly <NUM>. Once the capsule <NUM> of the clip assembly <NUM> has been coupled to the bushing <NUM> of the catheter assembly <NUM>, a control member <NUM> of the catheter assembly <NUM> releasably connected to clip arms <NUM> of the clip assembly <NUM> is movable longitudinally relative to the catheter assembly <NUM> and capsule <NUM> to move the clip assembly <NUM> between an open tissue receiving configuration in which distal ends <NUM> of the clip arms <NUM> are separated from one another to receive target tissue therebetween and a closed tissue gripping configuration in which the distal ends <NUM> are drawn toward one another to grip target tissue therebetween. Upon clipping of the target tissue, as desired, a compressive force may be exerted on the coupler <NUM> causing a portion of the coupler <NUM> of this embodiment to yield and/or fracture to release the capsule <NUM> from the catheter assembly <NUM>. It is noted that although this exemplary embodiment is shown and described with a coupler <NUM> pre-assembled with the capsule <NUM> of the clip assembly <NUM>, in another embodiment, the coupler <NUM> may be similarly pre-assembled with the bushing <NUM> of the catheter assembly <NUM> to be releasably connected to the capsule <NUM>.

The clip assembly <NUM> includes a pair of clip arms <NUM>, proximal ends <NUM> of which are connected to a yoke <NUM> slidably received within the capsule <NUM> so that, when the yoke <NUM> is coupled to the control member <NUM> of the catheter assembly <NUM> and the capsule <NUM> is coupled to the bushing of the catheter assembly <NUM> via the coupler <NUM>, longitudinal motion of the control member <NUM> relative to the bushing <NUM> moves the clip assembly <NUM> between the tissue receiving and the tissue gripping configurations. The clip arms <NUM> of this embodiment are biased toward the open tissue receiving configuration so that, when not constrained by the capsule <NUM>, the clip arms <NUM> move under their natural bias to the tissue receiving configuration with distal ends <NUM> of the clip arms <NUM> spread apart from one another. When the clip arms <NUM> are drawn into the capsule <NUM>, the capsule <NUM> constrains the clip arms <NUM>, holding the distal ends <NUM> together in the tissue gripping configuration.

Each of the clip arms <NUM>, as noted above, extends from a proximal end <NUM> to a distal end <NUM>. As would be understood by those skilled in the art, the clip arms <NUM> of this embodiment include optional gripping features configured to enhance the gripping of tissue therebetween. For example, the distal ends <NUM> of one or both of the clip arms <NUM> may include tips extending laterally inward toward the other clip arm <NUM> with the tips including, for example, teeth, protrusions, spikes or other structures) configured to grip tissue between the distal ends <NUM>. One or both of the clip arms <NUM> may also include a locking feature configured to lock the clip arms <NUM> in the tissue gripping configuration after target tissue has been gripped as desired by the clip arms <NUM>. In one embodiment, a proximal part of one or both of the clip arms <NUM> includes a locking tab extending laterally outward therefrom configured to engage a portion of the capsule <NUM> when the clip arms <NUM> have been drawn into the capsule <NUM> by a predetermined distance. For example, the locking tabs may be received within correspondingly sized, shaped and positioned locking windows extending laterally into or through a wall of the capsule <NUM> to lock the clip arms <NUM> relative to the capsule <NUM>, in the tissue gripping configuration.

In one embodiment, the proximal ends <NUM> of the clip arms <NUM> are connected to one another to form one integral piece which is connected to the yoke <NUM>. In another embodiment, the proximal ends <NUM> are formed as separate elements connected to one another via the yoke <NUM>. The yoke <NUM> is connected to the proximal end <NUM> of each of the clip arms <NUM> and is configured to be releasably connected to an enlarged distal end <NUM> of the control member <NUM> of the catheter assembly <NUM>. For example, the yoke <NUM> may include a longitudinal slot <NUM> extending from a proximal opening <NUM> at a proximal end <NUM> of the yoke <NUM> along a longitudinal axis of the yoke <NUM> to a distal portion <NUM> sized and shaped to receive the enlarged distal end <NUM> of the control member <NUM> of the catheter assembly <NUM>. In one exemplary embodiment, the enlarged distal end <NUM> is configured as a ball received within a correspondingly sized and shaped socket of the distal portion <NUM>. A proximal portion <NUM> of the slot <NUM> extending between the proximal opening <NUM> and the distal portion <NUM> has a cross-sectional area (e.g., diameter) smaller than a cross-sectional area of the distal portion <NUM>. The slot <NUM> may be defined via opposed portions <NUM> that are spreadable to receive the enlarged distal end <NUM> and are biased toward one another so that, once the enlarged distal end <NUM> passes distally into the distal portion <NUM>, the opposed portions <NUM> spring back to lock the enlarged distal end <NUM> within the distal portion <NUM>, coupling the control member <NUM> to the yoke <NUM>, Thus, longitudinal movement of the control member <NUM> relative to the capsule <NUM> controls movement of the clip arms <NUM> between the tissue receiving and the tissue clipping configurations. And, in deployment, as increased tension is imparted to the control member <NUM>, this tension is applied by the enlarged end <NUM> against the proximal portion <NUM> of the slot <NUM> until the opposed portions <NUM> are moved apart from one another to allow the control member <NUM> to separate from the yoke <NUM> as the clip assembly <NUM> is deployed.

According to this embodiment, the enlarged distal end <NUM> of the control member <NUM> is inserted into the distal portion <NUM> via the proximal opening <NUM> of the yoke <NUM>. When the control member <NUM> is pushed distally into the yoke <NUM> beyond a predetermined threshold value, the proximal opening <NUM> of the slot <NUM> deforms via separation of the opposed portions <NUM> to permit the enlarged distal end <NUM> to pass through the proximal portion <NUM> into the distal portion <NUM>. Once the enlarged end <NUM> is received within the distal portion <NUM>, the proximal portion <NUM> of the slot <NUM> reverts to its original size, holding the enlarged end <NUM> of the control member <NUM> in the distal portion <NUM>.

The capsule <NUM> extends from a proximal end <NUM> to a distal end <NUM> and includes a channel <NUM> extending longitudinally therethrough. The channel <NUM> is sized and shaped to slidably receive the yoke <NUM> and at least proximal portions of the clip arms <NUM> therein. As described above, the capsule <NUM> may also include locking features (e.g., locking windows) for engaging corresponding locking features of the clip arms <NUM> (e.g., locking tabs). In this embodiment, the proximal end <NUM> may be pre-assembled with the coupler <NUM>. The capsule <NUM> may include a window (not shown) extending laterally through the proximal end <NUM> thereof for receiving a correspondingly sized and shaped engaging feature of the coupler <NUM>. In one embodiment, the capsule <NUM> includes a pair of diametrically opposed windows for engaging the coupler <NUM>. It will be understood by those of skill in the art, however, that the capsule <NUM> may include any number of windows for receiving any number of corresponding engaging features of the coupler <NUM>. It will also be understood by those of skill in the art that the coupler <NUM> may be pre-assembled with the capsule <NUM> via any one of a variety of couplings.

The coupler <NUM> extends from a proximal end <NUM> to a distal end <NUM> and includes a channel <NUM> extending therethrough. In an embodiment, as noted above, the distal end <NUM> of the coupler <NUM> may be pre-assembled with the proximal end <NUM> of the capsule <NUM> so that the channel <NUM> of the coupler <NUM> is in communication with the channel <NUM> of the capsule <NUM>. Thus, the control member <NUM> of the catheter assembly <NUM> may be passed through the channels <NUM>, <NUM> of the coupler <NUM> and the capsule <NUM>, respectively, to be coupled to the yoke <NUM> during loading of the clip assembly <NUM>. A proximal portion of the capsule <NUM> may be sized and shaped to be received within the channel <NUM> of the coupler <NUM> so that inwardly engaging features at a distal portion of the coupler <NUM> may be receive within the windows (not shown) of the capsule <NUM> to connect the coupler <NUM> thereto. In one embodiment, the coupler <NUM> includes a pair of opposing tabs (not shown) receive within diametrically opposing windows of the capsule <NUM>. The coupler <NUM>, however, may include any number of tabs for connecting the coupler <NUM> to the capsule <NUM>.

A proximal portion of the coupler <NUM> of this embodiment includes a plurality of fingers <NUM> configured to engage the bushing <NUM> of the catheter assembly <NUM>. The fingers <NUM> are mounted over a distal end <NUM> of the bushing <NUM> so that the bushing <NUM> and the coupler <NUM> are snap fit together. The fingers <NUM> are biased toward an engaging configuration but may be spread apart to permit the distal end <NUM> of the bushing <NUM> to be received therein. In particular, each of the fingers <NUM> includes a groove <NUM> extending along an interior surface thereof, the groove <NUM> sized and shaped to receive a corresponding engaging feature <NUM>, or ridge, of the distal end <NUM> of the bushing <NUM>. The ridge <NUM> extends about a circumference of an exterior surface of the bushing <NUM>, as shown in <FIG>. The fingers <NUM> deflect away from one another as the ridge <NUM> at the distal end <NUM> is being inserted therebetween. Once the ridge <NUM> is received within the grooves <NUM>, however, the fingers <NUM> snap inward under their natural bias so that the grooves <NUM> and the ridge <NUM> engage one another, coupling the bushing <NUM> to the coupler <NUM>. Each of the fingers <NUM> also includes a ramped portion <NUM> at a distal portion of the inner surface thereof, as shown in <FIG>. The ramped portion <NUM> has a thickness that increases from a proximal end <NUM> thereof to a distal end <NUM> thereof and is configured to interface with the ridge <NUM> on the exterior surface of the bushing <NUM>, as will be described in further detail below.

A distal portion of a wall <NUM> of the coupler <NUM> includes two diametrically opposed sets of V-notches <NUM> configured to open (e.g., separate, break or fracture) to release the capsule <NUM> from the coupler <NUM>. Specifically, each set of V-notches <NUM> includes a proximal V-notch <NUM> and a distal V-notch <NUM>. The proximal V-notch <NUM> tapers from a proximal end to a distal end and the distal V-notch <NUM> tapers from a distal end to a proximal end such that the pointed ends of the V-notches <NUM>, <NUM> are closest to one another. The sets of V-notches <NUM> are each configured to open (e.g., separate, fracture or break) when proximal force is applied thereto via proximal movement of the capsule <NUM>. Thus, the coupler <NUM> is configured to open along two diametrically opposed longitudinal axes parallel to a central longitudinal axis of the coupler <NUM>. The opening of the two V-notch sets <NUM> allows expansion of the distal end <NUM> of the coupler <NUM>, allowing engaging features of the coupler <NUM> to be released form the windows of the capsule <NUM>. To prevent the coupler <NUM> from being released from the bushing <NUM> of the catheter assembly <NUM>, a pair of loop portions <NUM>, positioned on a distal side of the wall <NUM>, extend from a first side of the each of the V-notch sets <NUM> to a second side of each of the V-notch sets <NUM>, as shown in <FIG>. Thus, when the V-notches <NUM>, <NUM> open the coupler <NUM> is held together, about the bushing <NUM>, by the loop portions <NUM>.

As shown in <FIG>, the shape of each of the loop portions <NUM> may be changed based on the amount of deflection required for the coupler <NUM> to release the capsule <NUM>. For example, in some instances, greater deflection, or outward expansion of the distal end <NUM> of the coupler <NUM> may be preferred. In other instances, lesser deflection may be preferred. To provide more deflection to the distal end of the coupler <NUM>, the loop portions <NUM> may be formed of a flexible material such as, for example, an injection molded polymer, acrylic, polycarbonate, etc. Contrarily, loop portions <NUM> formed from more rigid materials will result in less expansion. In another embodiment, as shown in <FIG>, shorter loop portions <NUM> can be seen (as compared to loop portions <NUM> of <FIG>), which result in less expansion of the coupler <NUM>. In contrast, the loop portions <NUM> of <FIG>, are longer in length, providing the coupler <NUM> with a greater degree of expansion. Furthermore, the size of the V-notches <NUM>, <NUM> may be varied to increase or decrease the amount of deflection of the distal end <NUM> of the coupler <NUM>. For example, a larger distal V-notch <NUM>, as shown in <FIG>, allows for more deflection of the distal end <NUM>, without fracture, than smaller distal V-notches <NUM> shown in <FIG>.

The catheter assembly <NUM> includes the bushing <NUM>, a flexible member <NUM> extending proximally therefrom, and the control member <NUM> extending longitudinally through the flexible member <NUM> and bushing <NUM>. A proximal end (not shown) of the flexible member <NUM> may be connected to a handle portion. A proximal end (not shown) of the control member <NUM> in this embodiment is connected to an actuator of the handle portion so that the longitudinal movement of the control member <NUM> relative to the flexible member <NUM> and the bushing <NUM> may be controlled by a user at the handle portion.

The flexible member <NUM> may be formed as a coil of wire through which the control member <NUM> extends from the enlarged distal end <NUM> to the proximal end (not shown). As would be understood by those skilled in the art, the coil of wire preferably has sufficient flexibility to be passed through even tortuous paths of living body and, in this embodiment (e.g., it will have a flexibility enabling it to pass through a flexible endoscope along any path traversable by the endoscope) is sized and shaped to permit it to be passed through a working channel of an endoscope or other insertion device. Although the flexible member <NUM> is shown and described as a coil of wire, it will be understood by those of skill in the art that any other suitable flexible structure may be employed so long as the flexible member <NUM> is capable of providing a force in compression sufficient to counter the tension to be placed on the control member <NUM> from the clip assembly <NUM>. As would be understood by those skilled in the art, the catheter assembly <NUM> may include any of a variety of actuating mechanisms for moving the control member <NUM> to control movement of the clip arms <NUM>.

The bushing <NUM> extends longitudinally from a proximal end connected to the flexible member <NUM> to the distal end <NUM> configured to be releasably coupled to the coupler <NUM>. The control member <NUM> extends through a lumen <NUM> of the bushing <NUM>. A distal portion <NUM> of the bushing <NUM> may be sized and shaped to be inserted between the fingers <NUM> of the coupler <NUM> so that the ridge <NUM> at the distal end <NUM> of the bushing <NUM> is received and engaged with the grooves <NUM> of the fingers <NUM> of the coupler <NUM>.

When it is desired to disengage the bushing <NUM> from the coupler <NUM> to deploy the clip assembly <NUM> in the body, the coupler <NUM> is moved proximally by drawing the control member <NUM> proximally relative thereto. Specifically, once the clip assembly <NUM> is locked in the tissue gripping configuration, proximal motion of the control member <NUM> draws the capsule <NUM> proximally, via the yoke <NUM>, so that the coupler <NUM> is pulled proximally against the bushing <NUM>. As the proximal force continues, the coupler <NUM> is drawn over the ridge <NUM> of the bushing <NUM> via the ramped portion <NUM>. As the ramped portion <NUM> is drawn further proximally, the fingers <NUM> are deflected radially outward from a longitudinal axis of the coupler <NUM> by the outward force of the ridge <NUM> against the ramped portion <NUM>, causing the V-notches <NUM>, <NUM> to fracture. Fracturing of the V-notches <NUM>, <NUM> allows the distal end <NUM> of the coupler <NUM> to expand, releasing the capsule <NUM>. After the V-notches <NUM>, <NUM> fracture, the loop portions <NUM> prevent the coupler <NUM> from breaking apart from the clip assembly <NUM> and hold the coupler <NUM> onto the bushing <NUM> so that the coupler <NUM> may be drawn out of the body with the catheter assembly <NUM>.

An exemplary method for loading the clip assembly <NUM> onto the catheter assembly <NUM> comprises coupling the control member <NUM> to the yoke <NUM> and coupling the bushing <NUM> to the capsule <NUM> via the coupler <NUM>. The enlarged distal end <NUM> of the control member <NUM> may be coupled to the clip arms <NUM> via the yoke <NUM> by pushing the enlarged distal end <NUM> distally against the proximal opening <NUM> of the yoke <NUM> until a distal force exerted thereon exceeds a predetermined threshold value, causing the oppose portions <NUM> thereof to deflect away from one another to permit the enlarged distal end <NUM> to be moved distally therepast into the distal portion <NUM> of the longitudinal slot <NUM>. Once the enlarged distal end <NUM> is received within the distal portion <NUM>, the opposing portions <NUM> revert to their original position, holding the enlarged distal end <NUM> within the yoke <NUM>. The bushing <NUM> may be coupled to the capsule <NUM> via the coupler <NUM> by inserting a portion of the bushing <NUM> between the fingers <NUM> of the coupler <NUM> so that the coupler <NUM> and the bushing <NUM> engage one another via a snap fit. The proximal end <NUM> of the capsule <NUM> may be inserted into the distal end <NUM> of the coupler <NUM>. Once the bushing <NUM> has been releasably connected to the capsule <NUM> and the enlarged distal end <NUM> is coupled to the yoke <NUM>, the control member <NUM> may be moved proximally to draw the clip assembly <NUM> toward the closed, clipping configuration.

In use, after the clip assembly <NUM> has been loaded onto the catheter assembly <NUM>, the clip assembly <NUM> is inserted through a working channel of an endoscope (or any other insertion device) and inserted into the body (e.g., through a natural body lumen) to a site adjacent to a target portion of tissue to be clipped. The clip assembly <NUM> is inserted to the target tissue in the tissue gripping configuration to reduce damage and facilitate its passage through the working channel. Upon reaching the site of the target tissue, the clip assembly <NUM> is advanced out of the distal end of the working channel and the control member <NUM> is moved distally relative to the bushing <NUM> to extend the clip arms <NUM> distally out of the capsule <NUM> in to the tissue receiving configuration. Once the clip assembly <NUM> has been positioned so that target tissue is received between the clip arms <NUM>, the clip assembly <NUM> is moved toward the tissue gripping configuration (by drawing the control member <NUM> proximally) so that the target tissue is gripped between the distal ends thereof. The clip arms <NUM> are moved toward the tissue gripping configuration by drawing the control member <NUM> proximally with respect to the bushing <NUM> and the capsule <NUM>. Once the clip assembly <NUM> is in the tissue gripping configuration, the control member <NUM> is drawn further proximally to lock the clip arms <NUM> with respect to the capsule <NUM>.

To deploy the clip assembly <NUM>, the control member <NUM> is drawn proximally into the capsule until the coupler <NUM> attached to the capsule <NUM> is drawn proximally against the bushing <NUM>. Further proximal motion of the coupler <NUM> causes the ridge <NUM> of the bushing <NUM> to slide distally against the ramped portion <NUM> of the coupling fingers <NUM> deflecting the fingers <NUM> radially outward. The coupler <NUM> is then moved even further proximally, causing the ridge <NUM> of the bushing <NUM> to expand the fingers <NUM> of the coupler <NUM> until tension applied to the V-notch sets <NUM> cause the V-notch sets <NUM> to open. Opening of the V-notch sets <NUM> allows the distal end of the coupler <NUM> to expand enough to release the capsule <NUM> therefrom while the loop portions <NUM> hold the fractured coupler <NUM> together and prevent the proximal end of the coupler <NUM> from expanding enough to be released from the distal end of the bushing <NUM>.

Once the capsule <NUM> has disengaged from the coupler <NUM>, the control member <NUM> is drawn even further proximally until the enlarged distal end <NUM> disengages from the yoke <NUM>. In particular, when the force exerted on the yoke <NUM> by the enlarged distal end <NUM> exceeds a predetermined threshold value, opposed portions <NUM> spread apart, releasing the enlarged distal end therefrom. Alternatively, the yoke <NUM> may fracture to release the clip assembly <NUM> from the control member <NUM>. The entire catheter assembly <NUM>, including the control member <NUM> and the bushing <NUM>, may then be withdrawn proximally from the body, leaving the clip assembly <NUM> (and any portions of the coupler <NUM> remaining attached thereto) clipped over the target tissue. The coupler <NUM> may be manually removed from the tip of the catheter assembly <NUM> and, if so desired, a new clip assembly <NUM> can be loaded onto the catheter assembly <NUM> in the same manner described above. This process may be repeated using the same catheter assembly <NUM> as many times as needed or desired.

As shown in <FIG>, a coupler <NUM> according to another exemplary embodiment of the present disclosure is substantially similar to the coupler <NUM>, except that each set of V-notches <NUM> includes a third v-notch <NUM> extending laterally into the wall <NUM>. Specifically, as with coupler <NUM>, the wall <NUM> of the coupler <NUM> includes two diametrically opposed sets of V-notches <NUM> configured to break or fracture to release the capsule <NUM> from the coupler <NUM>. Specifically, each set of V-notches includes a proximal V-notch <NUM> and a distal V-notch <NUM>. The proximal V-notch tapers from a proximal end to a distal end and the distal V-notch <NUM> tapers from a distal end to a proximal end such that the pointed ends of the V-notches <NUM>, <NUM> are closest to one another. Additionally, as can be seen in <FIG>, the sets of V-notches <NUM> include a third V-notch <NUM> is cut laterally into the wall <NUM>. The third V-notch <NUM>, as shown in the figure, extends from a proximal end of the wall <NUM> to a distal end of the wall <NUM>, connecting the proximal and distal V-notches <NUM>, <NUM>. The third V-notch <NUM> only extends partially through the thickness of the wall <NUM> (i.e., a dimension extending perpendicular to a longitudinal axis of the coupler <NUM> between an inner and outer surface of the coupler <NUM>). The depth of the third V-notch <NUM> into the wall <NUM> may vary depending on the preferred amount of force required to fracture the coupler <NUM>. That is, the third V-notch <NUM> allows the user to have more control over the amount of force required to open the coupler <NUM>. A shallower third V-notch <NUM> will require a greater amount of force than a deeper third V-notch <NUM>. The sets of V-notches <NUM> are each configured to open (separate, fracture or break) when proximal compressive force is applied thereto via the capsule <NUM>. Thus, the coupler <NUM> is configured to open along two diametrically opposed longitudinal axes parallel to a central longitudinal axis of the coupler <NUM>. Opening of the two V-notch sets <NUM> allows expansion of the distal end <NUM> of the coupler <NUM>, allowing the capsule <NUM> to be released from the coupler <NUM>.

Although exemplary embodiments show and describe specific systems configured for loading clip assemblies onto an catheter assembly via a coupler, it will be understood by those of skill in the art that the present disclosure includes any variety of couplers for coupling a capsule of a clip assembly to an catheter assembly, so long as the coupler may be pre-assembled with the capsule and yields, fractures and/or is otherwise separable from the capsule during deployment of the clip assembly. Once the clip assembly has been deployed, the coupler (or a remaining portion thereof) may be removed from the bushing of the catheter assembly so that the catheter assembly may be loaded with a new clip assembly.

Claim 1:
A system (<NUM>) for treating tissue, comprising:
a clip assembly (<NUM>) including a pair of clip arms (<NUM>) and a capsule (<NUM>, <NUM>), each of the clip arms extending from a proximal end to a distal end (<NUM>), proximal ends of the clip arms slidably received within a channel (<NUM>) of the capsule to be moved between a tissue receiving configuration, in which distal ends of the clip arms are separated from one another, and a tissue clipping configuration, in which distal ends of the clip arms are moved toward one another;
a catheter assembly (<NUM>) including a control member (<NUM>) extending therethrough, the control member including a distal end (<NUM>) configured to be connected to the clip arms to move the clip assembly between the tissue receiving configuration and the tissue clipping configuration; and
a coupler (<NUM>, <NUM>) releasably coupled to a proximal end of the clip assembly and configured to be coupled to the distal end of the catheter assembly, the coupler configured to fracture to disengage the capsule and deploy the clip assembly,
wherein the catheter assembly includes a bushing (<NUM>) at the distal end thereof, the bushing configured to be coupled to the proximal end of the coupler, and
wherein a proximal portion of the coupler includes a plurality of fingers (<NUM>) mountable over a distal portion of the bushing to couple the coupler to the catheter assembly,
characterised in that
the coupler includes two sets of V-notches (<NUM>, <NUM>) diametrically opposed about a circumference of a distal portion of the coupler, each set of V-notches including a proximal V-notch (<NUM>, <NUM>) extending from a proximal end of a wall (<NUM>, <NUM>) of the coupler and a distal V-notch (<NUM>, <NUM>) extending from a distal end of the wall of the coupler, the sets of V-notches configured to fracture when a proximal force exerted thereon exceeds a threshold value.