Patent Description:
Document <CIT>describes a ligation apparatus that ligatures living tissue by a clip. The ligation apparatus includes a clip in which a clip claw member is advanced and retreated relative to a pressing member to be opened and closed, a sheath which is configured to accommodate the clip such that the clip claw member is not exposed to the outside, an advance and retreat restricting mechanism which restricts advance and retreat of the pressing member relative to the sheath at a distal end portion of the sheath and allows advance and retreat of the clip claw member relative to the pressing member according to advance and retreat of the operation wire relative to the sheath so as to allow the clip ligaturing living tissue, and a releasing mechanism which releases at least a portion of the clip in a state that the clip ligatures the living tissue.

The present invention is defined by appended claim <NUM>. Specific embodiments are set forth in the dependent claims.

The present disclosure relates to a system for treating tissue, comprising an applicator and a clip assembly. The applicator includes a catheter and a control member extending therethrough, the catheter extending longitudinally from a proximal end to a distal end and including a lumen extending therethrough, the control member longitudinally movable relative to the catheter and including an abutment structure proximate a distal end thereof. The clip assembly is releasably coupleable to a distal end of the applicator and includes a pair of clip arms, each of the clip arms extending from a proximal end to a distal end, the proximal end of each of the clip arms slidably received within a channel of a capsule and configured to be releasably coupled to the distal end of the control member so that the clip arms are movable relative to the capsule 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, the capsule including proximal tabs movable between a biased non-engaging configuration, in which the proximal tabs extend into the channel, and an engaging configuration, in which the proximal tabs extend laterally outward relative to a longitudinal axis of the capsule to engage an engaging portion of the lumen of the catheter, the proximal tabs configured to move from the non-engaging configuration to the engaging configuration when the abutment structure is received within the capsule.

In an embodiment, the capsule may include distal tabs positioned distally of the proximal tabs.

In an embodiment, the distal tabs may be movable between a non-engaging configuration and an engaging configuration, in which the distal tabs extend laterally outward relative to an exterior surface of the capsule.

In an embodiment, the distal tabs may be formed via cut-outs through a wall of the capsule, the distal tabs extending from a distal end connected to the wall to a free proximal end extending toward the proximal end of the capsule.

In an embodiment not forming a part of the present invention, the capsule may include a plurality of fingers defining a proximal portion thereof, the proximal tabs extending from a proximal end of the fingers.

In an embodiment, the engagement portion of the lumen of the catheter may include a protrusion extending radially into the lumen.

In an embodiment, a distance between the proximal and distal tabs may be selected so that the proximal and distal tabs abut proximal and distal ends of the engagement portion of the catheter.

In an embodiment, the engagement portion of the lumen of the catheter may include a groove extending therein.

In an embodiment, the lumen may include a stop therealong, the stop configured to prevent the capsule from being movable proximally therepast.

In an embodiment, the abutment structure may include a protrusion extending radially from an exterior surface of the control member.

In an embodiment, the abutment structure may include a hypotube extending along a portion of a length of the control member.

In an embodiment, the distal end of the control member may be releasably connected to the proximal ends of the clip arms so that, when a proximal force on the control member exceeds a predetermined threshold value, the control member is disengaged from the clip arms.

The present disclosure also relates to a system for treating tissue, comprising a clip assembly and an applicator on to which the clip assembly is loadable. The clip assembly includes a pair of clip arms, each of the clip arms extending from a proximal end to a distal end, the proximal end of each of the clip arms slidably received within a channel of a capsule so that the clip arms are movable relative to the capsule 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, the channel of the capsule including an engagement portion at a proximal end thereof. The applicator includes a catheter and a control member extending therethrough, the catheter extending longitudinally from a proximal end to a distal end and including a lumen extending therethrough, distal tabs along a distal portion of the catheter movable between a non-engaging configuration and an engaging configuration, in which the distal tabs are moved away from a longitudinal axis of the catheter to engage the engagement portion.

In an embodiment not forming a part of the present invention, a distal portion of the catheter may define a plurality of fingers movable between the non-engaging and engaging configurations, the distal tabs extending laterally outward from a distal end of each of the fingers.

In an embodiment, the engagement portion may be a protrusion extending radially into the lumen so that, in the engaging configuration, the distal tabs engage a distal end of the engagement portion to prevent the capsule from being moved distally with respect to the catheter.

The present disclosure also relates to a method for treating tissue, comprising loading a first clip assembly, including a pair of clip arms with proximal ends slidably received within a capsule, on an applicator by coupling a control member of the applicator to the proximal ends of clip arms and by moving a catheter of the applicator over the capsule until proximal tabs of the capsule engage an engagement portion of the catheter, wherein the proximal tabs are moved from a non-engaging configuration, in which the proximal tabs extend into a channel of the capsule, to an engaging configuration, in which the proximal tabs extend laterally outward away from a longitudinal axis of the capsule, via an abutment surface of the control member when the abutment surface is received within the capsule, inserting the loaded clip assembly to a target site within a living body via a working channel of an endoscope, moving the first 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 catheter until a target tissue is gripped therebetween, as desired, and releasing the first clip assembly from the applicator by drawing the control member proximally relative to the yoke, beyond a predetermined threshold value, so that the control member disengages from the clip arms and the abutment surface is drawn out of the capsule to move the proximal ends toward the non-engaging configuration.

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 an applicator assembly prior to an endoscopic procedure. Once a clip has been deployed at a desired target area in the body, the applicator assembly may be reloaded with a new clip. In particular, the clip assembly includes a capsule configured to releasably engage a catheter of the applicator. The capsule may include a set of tabs moved into engagement with the catheter when an abutting structure is received within the capsule. When the abutting structure is removed therefrom, the capsule of the clip assembly may be separated from the applicator. It should be noted that the terms Aproximal@ and Adistal,@ as used herein, are intended to 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> loadable onto a distal portion of an applicator <NUM> prior to insertion of the system <NUM> into a living body for the clipping of target tissue. The applicator <NUM> and the clip assembly <NUM> are configured so that, after deployment of the clip assembly <NUM> in the living body, a new clip assembly <NUM> may be loaded onto the applicator <NUM> so that the same applicator <NUM> may be used to a deliver a new clip assembly to a second portion of target tissue in the living body. The applicator <NUM> includes a catheter <NUM> and a control member <NUM> (e.g., a control wire) extending therethrough. The clip assembly <NUM> of this embodiment includes a pair of arms <NUM> slidably received within a capsule <NUM>. The capsule <NUM> includes proximal and distal tabs <NUM>, <NUM> tabs for engaging an engagement portion <NUM> of the catheter <NUM>. In particular, the proximal tabs <NUM> are biased laterally inward toward a longitudinal axis of the capsule <NUM> and may be moved toward an engagement configuration when an abutting structure <NUM> of the control member <NUM> is received within the capsule <NUM>. Thus, to load the clip assembly <NUM> onto the applicator <NUM>, the catheter <NUM> is moved distally over the capsule <NUM> while the control member <NUM> is moved distally through the capsule <NUM> to connect to a proximal end of the clip arms <NUM>. As the control member <NUM> is moved distally through the capsule <NUM>, the abutting structure <NUM> is moved into the capsule <NUM>, moving the proximal tabs <NUM> laterally outward toward the engagement configuration to engage the engagement structure <NUM>. In use, the proximal tabs <NUM> engage a proximal end <NUM> of the engagement structure <NUM> while the distal tabs <NUM> engage a distal end <NUM> of the engagement structure <NUM> so that upon engagement, the capsule <NUM> is fixed with respect to the catheter <NUM>. Thus, by moving the control member <NUM> longitudinally relative to the catheter <NUM> and capsule <NUM>, the clip arms <NUM> may be moved between an open, tissue receiving configuration and a closed, tissue gripping configuration. When it is desired to deploy the clip assembly <NUM> from applicator <NUM>, the control member <NUM> may be withdrawn from the capsule <NUM> to remove the abutting structure <NUM> from between the proximal tabs <NUM>, permitting the proximal tabs <NUM> to disengage the engagement feature <NUM>.

The applicator <NUM> includes the catheter <NUM> and a control member <NUM> extending therethrough. The catheter <NUM> may be connected to a distal end of a flexible member (not shown) which connects the catheter <NUM> to a handle member at a proximal end thereof. The flexible member may be formed, for example, as a coil of wire through which the control member <NUM> extends. 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, is sized and shaped to permit it to be passed through a working channel of a flexible endoscope or other insertion device. Although the flexible member is shown and described as a coil of wire, any other suitable flexible structure may be employed so long as the flexible member 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>.

The catheter <NUM> extends longitudinally from a proximal end <NUM> to a distal end <NUM> and including a lumen <NUM> extending therethrough. The lumen <NUM> is sized and shaped to receive the capsule <NUM> therein. The lumen <NUM> includes the engagement portion <NUM> along a distal section thereof. The engagement portion <NUM> may be configured as a protrusion extending radially inward toward a longitudinal axis of the catheter <NUM>. The engagement portion <NUM> extends along a length of the lumen <NUM> from a proximal end <NUM> to a distal end <NUM>. The distal end <NUM> of the engagement portion <NUM> may coincide, for example, with the distal end <NUM> of the catheter <NUM>. Although the engagement portion <NUM> is described and shown as a protrusion, the engagement portion <NUM> may be configured as any structure or feature which reduces a diameter or cross-sectional area of the lumen <NUM> along the length of the engagement structure <NUM>. The lumen <NUM> may also include a stop <NUM> configured as, for example, a shoulder preventing a capsule <NUM> received within the lumen <NUM> from being moved proximally therepast.

The control member <NUM> extends through the catheter <NUM> and the flexible member from an enlarged distal end <NUM> to a proximal end, which may be connected to an actuator along the handle member. Thus, the control member <NUM> may be moved longitudinally with respect to the flexible member and the catheter <NUM>. In one embodiment, the enlarged distal end <NUM> is configured as a ball. Proximally of the enlarged distal end <NUM>, the control member <NUM> includes the abutting structure <NUM> along a portion of a length thereof. The abutting structure <NUM> should be spaced from the enlarged distal end <NUM> by a distance sufficient to permit the enlarged distal end <NUM> to engage the proximal end of the clip arms <NUM> while the abutting structure <NUM> is received within the capsule <NUM>. The abutting structure <NUM> extends radially outward from an exterior surface <NUM> of the control member <NUM> and along a portion of a length of the control member <NUM>. In another embodiment, the abutting structure <NUM> may be configured as a hypotube or other structure fixed over a portion of a length of the control member <NUM>. Cross-sectional areas of both the abutting structure <NUM> and the enlarged distal end <NUM> are larger than a cross-sectional area of a remaining portion of the control member <NUM>. The cross-sectional area of the abutting structure <NUM> is selected so that, when received within the capsule <NUM>, moves the proximal tabs <NUM> to the engaging configuration, as will be described in further detail below. A length of the abutting structure <NUM> is selected so that, the abutting structure <NUM> maintains an engagement with the tabs <NUM>, holding the proximal tabs <NUM> in the engaging configuration, while the clip arms <NUM> are moved relative to the capsule <NUM> between the tissue receiving and tissue gripping configurations and until it is desired to deploy the clip assembly <NUM> from applicator <NUM>.

The clip assembly <NUM> includes the pair of clip arms <NUM>, proximal ends <NUM> of which are slidably received within the capsule <NUM> to move the clip assembly <NUM> between the tissue receiving configuration and the tissue gripping configuration. Each of the clip arms <NUM> extends from a proximal end <NUM> to a distal end <NUM>. Proximal ends <NUM> of the clip arms <NUM> may be connected to one another and configured to be releasably connected to the enlarged distal end <NUM> of the control member <NUM> so that the control member <NUM> may be moved longitudinally with respect to the capsule <NUM> to move the clip assembly <NUM> between the tissue receiving and gripping configurations. The clip arms <NUM> of this embodiment are biased so that the distal ends <NUM> thereof move apart from one another into the tissue receiving configuration when not drawn into the capsule <NUM>. When drawn into the capsule <NUM>, the capsule <NUM> constrains the clip arms <NUM>, holding distal ends <NUM> thereof together in the tissue gripping configuration. The clip arms <NUM> are formed via two separate pieces.

The clip arms <NUM> may include gripping features configured to facilitate the gripping of tissue therebetween. For example, the distal ends <NUM> of the clip arms <NUM> may include tips extending laterally inward toward one another and/or teeth, protrusions, spikes or other structures configured to grip tissue between the distal ends <NUM> of the clip arms <NUM>. The clip arms <NUM> may also include a locking feature configured to lock the clip arms <NUM> in the tissue gripping configuration, once a desired target tissue has been gripped via the clip arms <NUM>. In one embodiment, the clip arms <NUM> may include a locking tab extending laterally outward therefrom. This locking tab may be 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 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 exemplary embodiment, the proximal ends <NUM> of the clip arms <NUM> are connected to one another via a yoke (not shown) slidably received within the capsule <NUM> and configured to receive the enlarged distal end <NUM> of the control member <NUM> therein. The yoke may include a longitudinal slot extending thereinto from a proximal end thereof. In one example, the longitudinal slot is configured as a socket for receiving a ball-shaped enlarged distal end <NUM>. Opposed portions of the yoke may be spreadable to receive the enlarged distal therepast and biased so that, once the enlarged distal end <NUM> passes distally into the socket, the opposed portions spring back to lock the enlarged distal end <NUM> therein, coupling the control member <NUM> to the clip arms <NUM>. Thus, longitudinal movement of the control member <NUM> relative to the capsule <NUM> may control movement of the clip arms <NUM> between the tissue receiving and the tissue gripping configurations.

The capsule <NUM> extends longitudinally 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 receive the proximal ends <NUM> and at least a proximal portion of the clip arms <NUM> therein. As described above, the capsule <NUM> includes proximal tabs <NUM> proximate the proximal end <NUM> and distal tabs <NUM> distal of the proximate tabs <NUM>. In this embodiment, the proximal tabs <NUM> are movable between a non-engaging configuration and an engaging configuration. The proximal tabs <NUM> are biased toward the non-engaging configuration, in which the proximal tabs <NUM> extend laterally inward, toward the longitudinal axis of the capsule. In the engaging configuration, the proximal tabs <NUM> extend laterally outward, beyond an exterior surface <NUM> of the capsule <NUM>. The proximal tabs <NUM> should be sized and shaped so that, when the abutting structure <NUM> is received within the channel <NUM> of the capsule <NUM>, the proximal tabs <NUM> are moved from the non-engaging configuration to the engaging configuration. In one embodiment, the proximal tabs <NUM> extend from a proximal end <NUM> connected to a wall <NUM> of the capsule <NUM> to a free distal end <NUM> movable between the non-engaging and engaging configurations. The proximal end <NUM> may be integrally formed with the wall <NUM> of the capsule <NUM>.

The distal tabs <NUM> may also be movable between a non-engaging configuration and an engaging configuration. The distal tabs <NUM>, however, are biased toward the engaging configuration, in which the distal tabs <NUM> extend laterally outward, away from a longitudinal axis of the capsule <NUM> and beyond the exterior surface <NUM> thereof. In one embodiment, the distal tabs <NUM> are formed via cut-outs extending through a wall <NUM> of the capsule <NUM>, the cut-outs being angled laterally outward, away from the exterior surface <NUM> and toward the proximal end <NUM> of the capsule <NUM> in the engaging configuration. In other words, the distal tabs <NUM> extend from a distal end <NUM> which remains connected to the wall <NUM> of the capsule <NUM> and a free proximal end <NUM> movable between the non-engaging and engaging configuration. In the non-engaging configuration, the distal tabs <NUM> may be flush with the exterior surface <NUM>.

A distance between the proximal and distal tabs <NUM>, <NUM> corresponds to a length of the engagement portion <NUM> along the interior of the lumen <NUM> of the catheter <NUM>. In particular, the distance between the proximal and distal tabs <NUM>, <NUM> should be only slightly greater than the length of the engagement portion <NUM> so that, when the catheter <NUM> and the capsule <NUM> are engaged to one another, the engagement portion <NUM> is received between the proximal and distal tabs <NUM>, <NUM> and is prevented from any substantial movement relative to the capsule <NUM>. Movement of the proximal and distal tabs <NUM>, <NUM> between the non-engaging and engaging configurations during loading and use of the clip assembly <NUM>, will be described in further detail below.

Although the distal tabs <NUM> are described and shown as being movable between the non-engaging and engaging configurations, in another embodiment, the distal tabs <NUM> may be fixed in the engaging configuration. In this embodiment, the distal tabs <NUM> engage the engagement portion <NUM> during loading of the clip assembly <NUM>. In particular, the distal tabs <NUM> abut the distal end <NUM> of the engagement portion <NUM>, preventing further distal movement of the catheter <NUM> relative thereto during loading of the clip assembly <NUM>. Thus, when the distal tabs <NUM> engage the engagement portion <NUM>, the proximal tabs <NUM> extend proximally of the proximal end <NUM> of the engagement portion <NUM> and are permitted to move toward the engaging configuration.

Prior to being loaded on the applicator <NUM>, the clip assembly <NUM> is stored, for example, in a cartridge configured to facilitate loading of the clip assembly on the applicator <NUM>. The cartridge defines a space therein sized and shaped to house the clip assembly <NUM>. The clip assembly <NUM> may be housed within the cartridge in the tissue receiving configuration. In one embodiment, the cartridge constrains the distal tabs <NUM> of the capsule <NUM> toward the non-engaging configuration. The cartridge includes a proximal opening through which catheter <NUM> and the control member <NUM> may be inserted to be coupled to the capsule <NUM> and the clip arms <NUM>, respectively. The cartridge holds the clip assembly <NUM> in position to facilitate loading onto the applicator <NUM>.

An exemplary method for loading the clip assembly <NUM> to the applicator <NUM> comprises inserting the catheter <NUM> and the control member <NUM> into the cartridge so that the control member <NUM> passes through the channel <NUM> of the capsule <NUM> while the catheter <NUM> is moved distally over the capsule <NUM>. As described above, the distal tabs <NUM> may be constrained in the non-engaging configuration by the cartridge so that the catheter <NUM> may be moved distally over the distal tabs <NUM>. Thus, once the catheter <NUM> is mounted over the capsule <NUM>, a surface of the lumen <NUM> of the catheter <NUM> constrains the distal tabs <NUM> in the non-engaging configuration. In other words, the engagement portion <NUM> extends over the distal tabs <NUM> preventing the distal tabs <NUM> from moving toward the engaging configuration. As the enlarged end <NUM> is passed distally through the capsule <NUM> to releasably coupled to the proximal ends <NUM> of the clip arms <NUM>, the abutment structure <NUM> is received within the channel <NUM> of the capsule <NUM>, moving the proximal tabs <NUM> from the biased non-engaging configuration to the engaging configuration. The proximal tabs <NUM> extend proximally of the engagement structure <NUM>.

Once the catheter <NUM> is mounted over the capsule <NUM> and the enlarged distal end <NUM> is coupled to the clip arms <NUM> (e.g., via a yoke), the control member <NUM> may be moved proximally with respect to the catheter <NUM>. This proximal motion of the control member <NUM> moves the clip assembly <NUM> toward the tissue receiving configuration. Proximal motion of the control member <NUM> may also draw the capsule <NUM> further proximally into the lumen <NUM> of the catheter <NUM>, toward an insertion configuration. The capsule <NUM> may be moved proximally until the stop <NUM> prevents further proximal movement thereof. The clip assembly <NUM> may be drawn out of the cartridge in this insertion configuration. Since the capsule <NUM> is drawn farther proximally into the catheter <NUM> in this insertion configuration, a greater portion of the clip arms <NUM> is covered during insertion of the clip assembly <NUM> into a living body, helping to prevent damage to a working channel through which the clip assembly <NUM> is inserted or a surrounding tissue.

In use, after the clip assembly <NUM> has been loaded onto the applicator <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 insertion configuration (e.g., with the catheter <NUM> constraining the distal tabs <NUM> toward the non-engaging 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 by moving the control member <NUM> distally relative to the catheter <NUM> extending the clip arms <NUM> distally out of the capsule <NUM> and moving the clip arms <NUM> to the tissue receiving configuration. Since, in the insertion configuration, the proximal tabs <NUM> of the capsule <NUM> are proximal of the engagement portion <NUM> of the catheter <NUM> and the distal tabs <NUM> are constrained in the non-engaging configuration, the distal motion of the control member <NUM> may also move the capsule <NUM> distally with respect to the catheter <NUM> until the proximal tabs <NUM> abut the proximal end <NUM> of the engagement portion <NUM> and/or the distal tabs <NUM> extend distally of the distal end <NUM> of the engagement portion <NUM>. As the distal tabs <NUM> are moved past the distal end <NUM> of the engagement portion <NUM>, the distal tabs <NUM> are permitted to revert to their biased engaging configuration. Thus, in this engaging configuration, the proximal tabs <NUM> extend proximally of the engagement portion <NUM> while the distal tabs <NUM> extend distally of the engagement portion <NUM>. As described above, the distance between the proximal and distal tabs <NUM>, <NUM> is selected so that, in this engaging configuration, the capsule <NUM> is substantially longitudinally fixed with respect to the catheter <NUM>.

Once the capsule <NUM> and catheter <NUM> are engaged with one another, the clip arms <NUM> are extended distally out of the capsule <NUM> toward the tissue receiving configuration. The control member <NUM> may then be advanced distally and withdrawn proximally to move the clip assembly <NUM> between the tissue receiving and the tissue gripping configurations until a target portion of tissue is received between the distal ends <NUM> of the clip arms <NUM>, as desired. The clip arms <NUM> may then be moved toward the tissue gripping configuration by moving the control member <NUM> proximally relative to the catheter <NUM>. Once the clip assembly <NUM> is in the tissue gripping configuration, the control member <NUM> may be 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 even further proximally until a force exerted thereon exceeds a predetermined threshold value, causing the enlarged distal end <NUM> to disengage the proximal ends <NUM> of the clip arms <NUM>. Disengagement of the control member <NUM> from the clip arms <NUM> permits the control member <NUM> to be drawn proximally out of the capsule <NUM> so that the abutment structure <NUM> is removed therefrom. Removal of the abutment structure <NUM> causes the proximal tabs <NUM> to revert to their biased non-engaging configuration, so that the proximal tabs <NUM> disengage the engagement portion <NUM>. Thus, the applicator <NUM> may be withdrawn proximally from the body, leaving the clip assembly <NUM> clipped over the target tissue. If so desired, a new clip assembly <NUM> is then loaded onto the applicator <NUM>, in the same manner as described above, so that the device may then be used to clip a second portion of tissue. This process may be repeated using the same applicator <NUM> as many times as needed or desired.

Although the engagement portion <NUM> of the catheter <NUM> is described as extending over the distal tabs <NUM> to constrain the distal tabs <NUM> toward the non-engaging configuration in the insertion configuration, in another embodiment, the proximal and distal tabs <NUM>, <NUM> may both engage the engagement portion <NUM> during loading of the clip assembly <NUM> so that the capsule <NUM> is substantially longitudinally fixed relative to the catheter <NUM>. In this embodiment, the clip assembly <NUM> may be inserted into the body in the tissue gripping configuration so that the capsule <NUM> is fixed relative to the catheter <NUM> until deployment of the clip assembly <NUM>.

As shown in <FIG>, a system <NUM> according to an embodiment not forming a part of the present invention may be substantially similar to the system <NUM>, as described above, comprising an applicator <NUM> which may be loaded with a clip assembly <NUM>. The applicator <NUM> may be substantially similar to the applicator <NUM>, including a catheter <NUM> having an engagement portion <NUM> and a control member <NUM> including an abutment structure <NUM> extending therethrough. The clip assembly <NUM> is also substantially similar to the clip assembly <NUM>, including a pair of clip arms <NUM>, proximal ends <NUM> ends of which are slidably received within a capsule <NUM>. Similarly to the capsule <NUM>, the capsule <NUM> includes proximal tabs <NUM> and distal tabs <NUM>. The capsule <NUM>, however, defines a plurality of fingers <NUM> along a proximal portion thereof with the proximal tabs <NUM> extending laterally outward therefrom. The fingers <NUM> are biased radially inward toward a longitudinal axis of the capsule <NUM> C i.e., toward a non-engaging configuration. The proximal tabs <NUM> themselves are not movable. When the abutment structure <NUM> is received within the capsule <NUM>, the fingers <NUM> are moved radially outward toward an engaging configuration, so that the proximal tabs <NUM> engage the engagement portion <NUM>. The clip assembly <NUM> may be loaded, used and deployed in a manner substantially similar to the method described above with respect to the system <NUM>.

According to another embodiment, as shown in <FIG>, a system <NUM> may be substantially similar to the systems <NUM>, <NUM>, as described above, the system <NUM> comprising an applicator <NUM> onto which a clip assembly <NUM> may be loaded. An engagement portion of a catheter <NUM> of the applicator <NUM>, however, is configured as a groove <NUM> extending about a lumen <NUM> of the catheter <NUM>. The groove <NUM> extends from a proximal end <NUM> that coincides with a stop or shoulder <NUM> of the lumen <NUM>, which prevents a capsule <NUM> of the clip assembly <NUM> from being moved proximally therepast, to a distal end <NUM>. A cross-sectional area (e.g., diameter) of a portion of the lumen <NUM> distal of the groove <NUM> may substantially correspond to a cross-sectional area (e.g., diameter) of an exterior of the capsule <NUM>.

In this embodiment, the capsule <NUM> does not require distal tabs. Rather, the capsule <NUM> is engaged to the catheter <NUM> when the proximal end <NUM> of the capsule <NUM> abuts the shoulder <NUM> and proximal tabs <NUM> are positioned within the groove <NUM>, proximal of the distal end <NUM> of the groove <NUM>, so that the proximal tabs <NUM> are permitted to move toward an engaging configuration to be received within the groove <NUM>, when an abutment structure <NUM> of a control member <NUM> is received within the capsule <NUM>. In this configuration, the capsule <NUM> is substantially fixed relative to the catheter <NUM> so that clip arms <NUM> may be moved between a tissue receiving and a tissue gripping configuration, until the clip assembly <NUM> is deployed from. The clip assembly <NUM> may be loaded, used and deployed in a manner substantially similar to the systems <NUM>, <NUM> described above.

As shown in <FIG>, a system <NUM> according to an embodiment not forming a part of the present invention may be substantially similar to the systems <NUM> - <NUM> described above, comprising an applicator <NUM> onto which a clip assembly <NUM> may be loaded. Similar to the applicators <NUM> - <NUM> described above, the applicator <NUM> includes a catheter <NUM> through which a control member <NUM> having an abutment structure <NUM> extends. Similarly to the clip assemblies <NUM> - <NUM>, the clip assembly <NUM> may include clip arms <NUM>, proximal ends <NUM> of which are slidably received within a capsule <NUM>. Rather than the capsule <NUM> being received within the catheter <NUM>, however, the catheter <NUM> is received within a channel <NUM> of the capsule <NUM> during loading of the clip assembly <NUM>. A proximal portion of the channel <NUM> of the capsule <NUM> includes an engagement portion <NUM> extending radially inward resulting in, for example, a reduced diameter portion.

A distal portion of the catheter <NUM> defines a plurality of fingers <NUM> extending therealong. The fingers <NUM> are biased toward a non-engaging configuration in which they extend radially inward toward a longitudinal axis of the capsule <NUM>. Distal tabs <NUM> extend laterally outward from distal ends <NUM> of the fingers <NUM> so that, when the abutment structure <NUM> is received within the catheter <NUM>, the fingers <NUM> are moved radially outward toward an engaging configuration so that the distal tabs <NUM> engage the distal end <NUM> of the engagement portion <NUM>, as shown in <FIG>. In another embodiment, the distal tabs <NUM> themselves may be movable between a non-engaging and engaging configuration so that plurality of fingers <NUM> are not required. The system <NUM> may be used in manner substantially similar to the systems <NUM> - <NUM> described above.

Claim 1:
A system (<NUM>, <NUM>) for treating tissue, comprising:
an applicator (<NUM>, <NUM>) including a catheter (<NUM>, <NUM>) and a control member (<NUM>, <NUM>) extending therethrough, the catheter (<NUM>, <NUM>) extending longitudinally from a proximal end (<NUM>) to a distal end (<NUM>) and including a lumen (<NUM>, <NUM>) extending therethrough, the control member (<NUM>, <NUM>) longitudinally movable relative to the catheter (<NUM>, <NUM>) and including an abutment structure (<NUM>, <NUM>) proximate a distal end thereof; and
a clip assembly (<NUM>, <NUM>) releasably coupleable to a distal end of the applicator (<NUM>, <NUM>), the clip assembly (<NUM>, <NUM>) including a pair of clip arms (<NUM>, <NUM>), each of the clip arms (<NUM>) extending from a proximal end (<NUM>) to a distal end (<NUM>), the proximal end (<NUM>) of each of the clip arms (<NUM>, <NUM>) slidably received within a channel (<NUM>) of a capsule (<NUM>, <NUM>) and configured to be releasably coupled to the distal end of the control member (<NUM>, <NUM>) so that the clip arms (<NUM>, <NUM>) are movable relative to the capsule (<NUM>, <NUM>) between a tissue receiving configuration, in which distal ends (<NUM>) of the clip arms (<NUM>, <NUM>) are separated from one another, and a tissue clipping configuration, in which distal ends (<NUM>) of the clip arms are moved toward one another;
the capsule (<NUM>, <NUM>) including proximal tabs (<NUM>, <NUM>) movable between a biased non-engaging configuration, in which the proximal tabs (<NUM>, <NUM>) extend into the channel (<NUM>), and an engaging configuration, in which the proximal tabs (<NUM>, <NUM>) extend laterally outward relative to a longitudinal axis of the capsule (<NUM>, <NUM>) to engage an engaging portion (<NUM>) of the catheter (<NUM>, <NUM>), wherein the abutment structure (<NUM>, <NUM>) maintains an engagement with the proximal tabs (<NUM>, <NUM>), holding the proximal tabs (<NUM>, <NUM>) in the engaging configuration, while the abutment structure (<NUM>, <NUM>) is received within the capsule (<NUM>, <NUM>);
characterised in that the clip arms are formed via two separate pieces.