Patent Description:
present disclosure relates to endoscopic devices and, in particular, relates to endoscopic clipping devices for treating tissue.

Physicians have become more willing to perform aggressive interventional and therapeutic endoscopic gastrointestinal (GI) procedures, which may increase the risk of perforating the wall of the GI tract or may require closure of the GI tract wall as part of the procedure. Such procedures may include, for example, the removal of large lesions, tunneling under the mucosal layer of the GI tract to treat issues below the mucosa, full thickness removal of tissue, treatment of issues on other organs by passing outside of the GI tract, and endoscopic treatment/repair of post-surgical issues (e.g., post-surgical leaks, breakdown of surgical staple lines, and anastomotic leaks).

Currently, tissue may be treated via endoscopic closure devices including through-the scope clips or over-the-scope clips. Over-the-scope clips may be particularly useful for achieving closure of larger tissue defects. These endoscopic closure devices can save costs for the hospital and may provide benefits for the patient. In some cases, however, current endoscopic closure devices may be difficult to use, time consuming to position, or insufficient for certain perforations, conditions and anatomies. For example, current over-the-scope clips generally require launching of the clip from a position in which the clip itself is not visible to the operator. That is, prior to clipping the operator may view the target tissue to be clipped and, based on this visualization of the target tissue may determine that the distal end of the device and the clip are in a desired position relative to the target tissue. Based on the observation of the target tissue, the operator then deploys the clip without being able to see the clip itself until it is deployed. Once deployed, such current over-the scope clips are generally incapable of being repositioned. <CIT>, relevant pursuant to Article <NUM>(<NUM>) EPC, discloses a medical device comprising an adapter, a fastener releasably coupled to the adapter and at least one cable coupled to the fastener and the adapter, wherein the fastener includes at least two jaws, the fastener having a first configuration wherein the jaws are open and a second configuration wherein the jaws are closed, the at least one cable being configured to apply tension to the fastener to transition between the first configuration and the second configuration.

Document <CIT> discloses a system for compressing body tissue comprising a surgical clip having at least a first tissue contacting surface and at least a second tissue contacting surface.

The clip is movable from a closed position to an open position, wherein in the open position the clip receives tissue between the first and second tissue contacting surfaces and in the closed position the clip compresses tissue between the first and second tissue contacting surfaces. A clip deployment device is provided having a first clip engagement member and a second clip engagement member engageable with the clip, the first and second clip engagement members movable between first and second positions to controllably move the clip from the closed position to the open position.

The present invention, as defined in claim <NUM>, is directed to a clipping system comprising an adapter extending from a proximal end configured to be mounted on an insertion device to a distal end, the adapter including a clip including first and second jaws. The first jaw and second jaws are connected via first and second hinges so that the first and second jaws are movable between an insertion configuration, in which the first and second jaws are separated from one another and an initial deployed configuration in which the first and second jaws are drawn toward one another, the first and second jaws being biased toward the initial deployed configuration. A deployment member configured to move the clip distally over and off of the adapter so that, as the clip leaves the adapter, the clip moves from the insertion configuration to the initial deployed configuration. An extending member is releasably coupled to the clip and movably connected to the adapter, the extending member being configured to permit the withdrawal of the adapter proximally away from the clip while the extending member remains coupled to the clip to place the system in a review configuration in which the clip is separated from the adapter to enhance visual observation of the clip. The extending member is operable to retract the clip proximally over the adapter so that the clip is forced open as the clip is retracted over the adapter freeing the clip from on which it had been clipped.

According to the invention, the first extending member may be releasably coupled to the first hinge so that, when the clip is observed to be in a desired position, the clip can be finally deployed from the system by separating the first extending member from the clip.

In an embodiment, the system may further comprise a second extending member releasably coupled to the second hinge of the clip and movably connected to the adapter, the second extending member being configured to remain coupled to the clip while the system is moved to the review configuration, the second extending member being operable to cooperate with the first extending member to retract the clip proximally over the adapter from one of the review and initial deployment configurations.

In an embodiment, a distal end of the first extending member may include a loop configured to be hooked to the first hinge.

In an embodiment, a distal end of the first extending member may be biased radially away from a longitudinal axis of the adapter so that, when the loop of the first extending member is released from the first hinge, the distal end of the first extending member springs laterally outward to disengage from the clip.

In an embodiment, the loop of the first extending member may be configured to engage the clip so that a distally directed force applied to the first extending member is transmitted to the clip to move the clip distally over and off of the adapter, the loop of the first extending member being configured so that, when the clip applies a proximally directed force of at least a predetermined magnitude to the first extending member, the loop of the first extending member slides off of the first hinge to disengage the clip from the first extending member.

In an embodiment, the system may further comprise a user interface coupled to a proximal end of the deployment element and a proximal end of the first extending member to control a movement of the clip between the open insertion configuration, the initial deployed configuration and the review configuration.

In an embodiment, the user interface may include a first knob connected to the proximal end of the deployment element and a second knob connected to a proximal end of the first extending member.

In an embodiment, the system may further comprise a first lumen extending proximally from the adapter to the user interface, the first extending member extending through the first lumen so that the first extending members is longitudinally movable relative to the first lumen.

In an embodiment, a distal portion of the adapter, over which the clip is configured to be mounted, may include a flat portion extending along an exterior surface thereof to reduce a friction between the clip and the adapter as the clip slides distally along the adapter toward a final deployed configuration.

The present disclosure is also directed to a clipping system for treating tissue, comprising an endoscope including a shaft extending longitudinally from a proximal end to a distal end, an adapter including a proximal portion mounted over the distal end of the shaft of the endoscope and a distal portion extending distally from the proximal portion, and clip including a pair of jaws. Each of the pair of jaws extends along a curve from a first end to a second end, first ends of the pair of jaws connected to one another via a first hinge and second ends of the pair of jaws connected to one another via a second hinge so that the pair of jaws are movable between an open insertion configuration, in which the pair of jaws are separated from one another, and a closed configuration, in which the pair of jaws are moved toward one another, the clip configured to be mounted over the distal portion of the adapter in the open insertion configuration. A deployment member is configured to move the clip distally relative to the adapter from the open insertion configuration to an initial deployed configuration by moving the clip distally off of the adapter so that the clip is moved toward the closed configuration. First and second extending members extend from proximal ends accessible to a user via a user interface at the proximal end of the shaft to distal ends releasably coupled to the clip, so that a distal movement of the extending member relative to the endoscope moves the clip distally away from the distal end of the adapter from the initial deployed configuration to a review configuration by a distance selected so that the clip is visible via the endoscope.

In an embodiment, the first extending member may be releasably coupled to the first hinge of the clip and the second extending member is releasably coupled to the second hinge of the clip.

In an embodiment, distal ends of each of the first and second extending members may be biased radially away from a longitudinal axis of the adapter so that, when the first and second extending member are coupled to the first and second hinges, the distal ends of the first and second extending members are restrained toward an engaging configuration, and, when the distal ends of the first and second extending members are disengaged from the first and second hinges, the distal ends of the first and second extending members revert to their biased configuration to release the clip therefrom in a final deployed configuration.

In an embodiment, the pair of jaws may be biased toward the closed configuration so that, when the clip is mounted over the adapter, an exterior surface of the adapter holds the pair of jaws toward the open configuration and, when the clip is moved toward the initial deployed configuration, the pair of jaws are permitted to revert to the biased closed configuration.

In an embodiment, the system may further comprise first and second lumens extending proximally from the adapter to the user interface, each of the first and second extending members extending through a corresponding one of the first and second lumens so that the extending members are longitudinally movable relative to the lumens, the first and second lumens extending along opposing sides of the shaft of the endoscope.

The present embodiments are also directed to a method for treating tissue. A clip is inserted to a target area in a body lumen via an endoscope, the clip mounted over a distal end of an endoscopic shaft, via an adapter, in an open insertion configuration in which jaws of the clip are separated from one another. A suction force is applied through a working channel of the endoscope so that tissue is drawn into a channel of the adapter and between jaws of the clip. The clip is moved from the open insertion configuration to an initial deployed configuration by pushing the clip distally off of the adapter so that the jaws revert to a biased closed configuration, in which the jaws extend toward one another to grip the tissue received therebetween. Extending members, distal ends of which are releasably coupled to the clip, are moved distally relative to the endoscopic shaft so that the clip is moved distally away from a distal end of the adapter toward a review configuration in which the clip is visible via the endoscope.

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 an over-the-scope endoscopic clipping system, in which an initial placement of a clip may be viewed and adjusted prior to a final deployment thereof. Exemplary embodiments of the present disclosure comprise a clip mountable over a distal end of an endoscope via an adapter and releasably coupled to extending members so that the clip may be moved between an insertion configuration, an initial deployed condition and a review configuration in which the clip can be viewed prior to being finally deployed.

In the insertion configuration, the clip is mounted over the adapter in a proximal position maintained in the insertion configuration ready to receive tissue between jaws thereof while the clip's position minimizes its occlusion of the field of view of the endoscopic vision system. The insertion configuration is configured to facilitate insertion of the endoscope to a target site adjacent to tissue to be clipped while the system allows the clip to be deployed and clipped over tissue in an initial deployed configuration. The device permits the endoscope to be withdrawn proximally away from the clip and the tissue over which it is clipped while the clip remains coupled to the device in a review configuration. As the endoscope is withdrawn proximally while the clip remains in place over the target tissue, the field of view of the vision system of the endoscope widens to show the clip and the tissue clipped thereby so that the operator can determine whether the position of the clip is desirable or in need of adjustment.

If the operator determines that the clip is positioned as desired, the clip is deployed and left in place clipped over the target tissue. If the operator determines that the position of the clip needs adjustment, the endoscope and the adapter coupled thereto are moved distally to a position adjacent to the clip. The clip is then drawn proximally over the adapter to reopen the clip which is drawn proximally over the distal end of the adapter forcing the clip to open against its natural bias as the clip slides proximally back over the adapter to return to the insertion configuration. After the clip has been removed from the tissue and returned to the insertion configuration, the operator can re-position the endoscope and device as desired, draw target tissue into the adapter (e.g., under suction or a grasper applied via a working channel of the endoscope) and once more deploy the clip from the adapter over the target tissue in the initial deployed position.

The endoscope is then withdrawn proximally once again as the clip remains coupled to the device so that the device moves again into the review configuration. The position of the clip and the clipped tissue are again observed and, this process may be repeated until the clip is positioned as desired. When the operator sees that the tissue over which the clip is closed is the desired portion of tissue, the clip may be deployed and released from the device and endoscope as described below. It will be understood by those of skill in the art that terms proximal and distal, as used herein, are intended to refer to a direction toward and away from, respectively, a user of the device.

As shown in <FIG>, a clipping system <NUM> for treating tissue defects and/or perforations according to an exemplary embodiment comprises a clip <NUM> configured to be mounted to an endoscope <NUM> via an adapter <NUM>. The adapter <NUM> is mounted over a distal end <NUM> of an endoscopic shaft <NUM> of the endoscope <NUM> so that the clip <NUM> is movable between an insertion configuration (<FIG>), in which the clip <NUM> is mounted over the adapter <NUM> with the jaws of the clip <NUM> separated from one another to receive tissue therebetween and an initial deployed configuration (<FIG>), in which the clip <NUM> is moved distally relative to the adapter <NUM> so that the jaws close to grip tissue that has been drawn into the adapter <NUM>.

The clip <NUM> is releasably connected to extending members <NUM>, which facilitate movement of the clip <NUM> between the initial deployed configuration and a review configuration (<FIG>), in which the endoscope is withdrawn proximally as the extending members <NUM> are extended distally away from the endoscope so that the clip <NUM> remains tethered to the device as the distal end <NUM> of the endoscope <NUM> is withdrawn proximally. This widens the field of view of the endoscope vision system relative to the clip and the target tissue and allows for some movement of the endoscope <NUM> relative to the clip to enable more extensive observation of the placement and/or position of the clip <NUM> relative to the target tissue. As described below, if the user determines the position of the clip is incorrect or sub-optimal, the user may move the endoscope <NUM> distally to a position adjacent to the clip <NUM> and then retract the clip <NUM> proximally by withdrawing the extending members <NUM> proximally relative to the adapter <NUM> so that the clip <NUM> is drawn back over the distal end of the adapter <NUM> forcing the clip <NUM> open as it is slid proximally back over the adapter <NUM> to return to the insertion configuration.

The user may then reposition the endoscope <NUM> and the clip <NUM> and repeat these steps so that the placement and/or position of the clip <NUM> relative to a target tissue may be adjusted prior to a final deployment of the clip <NUM>, as shown in <FIG>. That is, if the operator sees in the review configuration that the clip <NUM> is not positioned as desired, the clip <NUM> may be re-opened and removed from the tissue so that the device can be re-positioned until the clip <NUM> is closed over the desired portion of tissue. As will be described in further detail below, movement of the clip <NUM> between the insertion configuration, the initial deployed configuration, the review configuration and a final deployed configuration may be controlled via a user interface <NUM> which, in one embodiment, is coupled to a handle portion <NUM> at a proximal end <NUM> of the endoscopic shaft <NUM> of the endoscope <NUM>.

The clip <NUM> includes a pair of jaws <NUM>, each of the jaws <NUM> including gripping features <NUM> such as, for example, teeth, for gripping target tissue therebetween. The jaws <NUM> in this embodiment are connected to one another via hinges <NUM>. In one embodiment, each of the jaws <NUM> extends along a curve from a first end <NUM> to a second end <NUM> so that a first one of the hinges <NUM> connects the first ends <NUM> of each of the jaws <NUM> to one another, while a second one of the hinges <NUM> connects the second ends <NUM> of each of the jaws <NUM> to one another. According to one exemplary embodiment, each the hinges <NUM> is a substantially C-shaped living hinge with a curve of the C-shape extending toward and between the jaws <NUM>.

In one embodiment, the hinges <NUM> are spring biased, biasing the jaws <NUM> toward the initial deployed configuration in which the gripping features <NUM> of one of the jaws <NUM> contact the gripping features of the other jaw <NUM>. In the initial deployed configuration, the jaws <NUM> extend toward one another so that target tissue may gripped between the jaws <NUM> via, for example, the gripping features <NUM>. However, when the clip <NUM> is mounted over the adapter <NUM> in the insertion configuration, the jaws <NUM> extend about opposing portions of the adapter <NUM> so that an exterior surface <NUM> of the adapter <NUM> maintains the clip <NUM> open with the jaws <NUM> separated from one another so that target tissue may be received therebetween. When the clip <NUM> is moved distally off the adapter <NUM>, the clip <NUM> is freed to close under the natural bias of the hinges <NUM>. It will be understood by those of skill in the art that the hinges <NUM> and/or jaws <NUM> of the clips <NUM> may be formed of any of a variety of materials so long as the hinges <NUM> bias the jaws <NUM> toward the initial deployed configuration, as described above and so that the bias is sufficiently strong to maintain the clip <NUM> in position clipped over target tissue after the clip has been finally deployed. In one example, portions of the clip <NUM> (e.g., the hinges <NUM>) are formed of a shape memory alloy such as, for example, Nitinol to provide and/or add to the bias toward the closed configuration.

As discussed above, in one embodiment the clip <NUM> is mounted to an endoscope <NUM> via an adapter <NUM>. The adapter <NUM> is, in this embodiment, sized and shaped to be mounted on the distal end <NUM> of the endoscopic shaft <NUM> of a standard endoscope <NUM> although, as would be understood by those skilled in the art, the adapter <NUM> may be sized and shaped to be mounted over the distal end of any insertion device (flexible or rigid) suitable for accessing a target site within a body at which tissue to be clipped is located. The proximal end <NUM> of the endoscopic shaft <NUM> in this embodiment includes a handle portion <NUM> which may be used via a physician or other user, to guide the flexible endoscope through, for example, a bodily lumen (e.g., gastrointestinal tract) to a target site adjacent to target tissue to be clipped. As would be understood by those skilled in the art, the endoscopic shaft <NUM> in this embodiment is sufficiently flexible to be inserted through even tortuous paths of the bodily lumen and thus, all of the components of this system that are extended through or along the endoscope to the clip <NUM> are also sufficiently flexible to permit this insertion to the target site.

The adapter <NUM> in this embodiment is a substantially tubular structure sized and shaped to be mounted over the distal end of an endoscope. The adapter <NUM> extends from a proximal end <NUM> to a distal end <NUM> and includes a channel <NUM> extending therethrough which, when the adapter <NUM> is mounted over the endoscope is substantially aligned with a longitudinal axis of the endoscope so that, when the adapter <NUM> is mounted on the distal end of the endoscope, the channel <NUM> extends away from the distal end of the endoscope so that occlusion of the field of view of the optical system of the endoscope is minimized. In one embodiment, the adapter <NUM> is substantially circular in cross-section to match a similar shape of the endoscope. As would be understood by those skilled in the art, however, if the endoscope is non-circular (e.g., oval) the adapter may be sized and shaped accordingly to provide, for example, a friction fit with the distal end of the endoscope.

A proximal portion <NUM> of the adapter <NUM> is configured to be mounted over the distal end <NUM> of the endoscopic shaft <NUM> while a distal portion <NUM> of the adapter <NUM> is configured to receive the clip <NUM> thereover and is sufficiently radially stiff to maintain the clip <NUM> in the open configuration against the bias of the hinges <NUM>, as described above. In particular, since the jaws <NUM> of the clip <NUM> extend along curves, the clip <NUM> is mountable over the distal portion <NUM> so that each of the jaws <NUM> extends over a diametrically opposing portion of the adapter <NUM> with the jaws <NUM> held in the open configuration by an exterior surface <NUM> of the adapter <NUM>.

As shown in <FIG>, the exterior surface <NUM> along the distal portion <NUM> of the adapter <NUM> of this embodiment includes a plurality of flat portions <NUM>, each of which extends along all or a portion of a length of the distal portion <NUM> and about a portion of a perimeter (e.g., circumference) of the distal portion <NUM>. In one embodiment, the exterior surface <NUM> includes four flat portions <NUM> extending along the distal portion <NUM>, each of the flat portions <NUM> equally sized and separated from one another about the perimeter of the distal portion <NUM>. It will be understood by those of skill in the art that these distal portions <NUM> are configured to reduce friction between the clip <NUM> and the adapter <NUM> to facilitate a movement of the clip <NUM> distally along the adapter <NUM> so that the clip <NUM> may be drawn distally over the adapter to deploy the clip <NUM> as desired and so that, if necessary, the clip <NUM> may be withdrawn proximally to reopen the clip <NUM> if the clip <NUM> needs to be re-positioned as will be described in further detail below. It will also be understood by those of skill in the art that although the adapter <NUM> is shown and described as including four equally spaced flat portions <NUM> along the exterior surface <NUM> of the distal portion <NUM>, the adapter <NUM> may include any number of flat portions <NUM> along the distal portion <NUM> in any of a variety of configurations so long as the flat portions <NUM> facilitate the movement of the clip <NUM> proximally and distally along the distal portion <NUM> of the adapter <NUM>.

The adapter <NUM> of this embodiment also includes a tab <NUM> extending from the exterior surface <NUM> of the adapter <NUM> toward the distal end <NUM> thereof so that a groove <NUM> is formed between the tab <NUM> and the exterior surface <NUM> along the distal portion <NUM>. In the insertion configuration, the clip <NUM> of this embodiment is mounted over the distal portion <NUM> so that one of the jaws <NUM> is received within the groove <NUM>. The tab <NUM> also includes a hole <NUM> extending therethrough, the hole <NUM> configured to receive a deployment element <NUM> such as, for example, a thread, strand, filament or other similar flexible longitudinal element used to move the clip <NUM> from the insertion configuration to the initial deployed configuration.

A first end of the deployment element <NUM> is releasably anchored (e.g., knotted) to the tab <NUM> via the hole <NUM> so that the deployment element <NUM> extends from the tab <NUM>, across the groove <NUM> and through a working channel of the endoscope <NUM> via the channel <NUM> of the adapter <NUM> to a second end coupled to the user interface <NUM>. In one embodiment, the deployment element <NUM> extends into the channel <NUM> via an opening of the channel <NUM> at the distal end <NUM> of the adapter <NUM>. In another embodiment, the deployment element <NUM> extends into the channel <NUM> via a corresponding hole <NUM> extending through a wall of the distal portion <NUM> of the adapter <NUM>. The corresponding hole <NUM> in this embodiment is coaxially aligned with the hole <NUM> extending through the tab <NUM>, and is in communication with the channel <NUM>.

In the insertion configuration, the deployment element <NUM> is slackened and extends across the groove <NUM> from the tab <NUM> to the working channel of the endoscope <NUM> proximally of the jaw <NUM>. When it is desired to move the clip <NUM> from the insertion configuration to the initial deployed configuration, the user tensions the deployment element <NUM> so that the tensioned deployment element <NUM> draws the clip <NUM> distally to pull the clip <NUM> distally off of the adapter <NUM> to the initial deployed configuration. In the initial deployed configuration, the jaws of the clip <NUM> are closed and the clip <NUM> is positioned immediately distally of the distal end <NUM> of the adapter <NUM>.

The movement of the clip <NUM> from the initial deployed configuration to the review configuration is achieved via the extending members <NUM>. As will be described in further detail below, the extending member <NUM> also facilitate movement of the clip <NUM> from the review configuration back to the insertion configuration if, upon review of position of the clip <NUM> in the initial deployed configuration, it is desired to adjust a placement and/or position of the clip <NUM> relative to the target tissue. The extending members <NUM> extend from a distal end <NUM> releasably coupled to the clip <NUM> to a proximal end (not shown) coupled to the user interface <NUM>. Each extending member <NUM> in this embodiment extends through, for example, a lumen <NUM> extending along a length of the endoscopic shaft <NUM> from the adapter <NUM> to the user interface <NUM> so that the extending member <NUM> is longitudinally movable relative to the lumen <NUM>, and thereby the endoscopic shaft <NUM>, to control movement of the clip <NUM> relative thereto.

In one embodiment, the system <NUM> includes two lumens <NUM> and two extending members <NUM>, each of the lumens <NUM> being sized, shaped and configured to slidably accommodate a corresponding one of the extending members <NUM> therein. The lumens <NUM> in this embodiment extend along opposing longitudinal sides of the endoscopic shaft <NUM> so that positions of the lumens <NUM> are substantially aligned with the hinges <NUM> when the clip <NUM> is mounted over the adapter <NUM> in the insertion configuration. However, those skilled in the art will understand that any arrangement of the lumens <NUM> may be employed so long as the extending members <NUM> are slidably housed therein and are delivered to desired locations on the clip <NUM> as described above.

Each of the extending members <NUM> extends from the user interface <NUM> through a corresponding one of the lumens <NUM> so that its distal end <NUM> engages the clip <NUM> at a selected location. In an exemplary embodiment, the extending members <NUM> are formed as flexible strands, filaments or coils formed of, for example, a metal or polymer. In one exemplary embodiment, each extending member <NUM> is comprised of a flexible strand, filament or coil configured to form a loop <NUM> at the distal end <NUM> thereof for engaging the C-shaped hinge <NUM> of the clip <NUM>. In this embodiment, each loop <NUM> is hooked over the C-shaped portion of a corresponding one of the hinges <NUM> and engages the corresponding hinge <NUM> (e.g., via a friction fit) so that, when the extending members <NUM> are extended distally relative to the adapter <NUM>, the extending members <NUM> push the clip <NUM> distally over the adapter <NUM>. In one embodiment, distal ends <NUM> of the extending members <NUM> are biased to deflect away from one another and away from a longitudinal axis of the adapter <NUM> and a longitudinal axis of the endoscope <NUM>, toward a release configuration.

Those skilled in the art will understand that the loops of the extending members <NUM> are configured to engage the clip <NUM> so that, as the endoscope <NUM> and the adapter <NUM> are moved proximally away from a clip <NUM> that has been clipped to tissue, the clip <NUM> remains coupled to the device due to the connection of the loops over the hinges of the clip <NUM>. The loops of the extending members <NUM> may be maintained in place on the clip <NUM> via, for example, a friction fit. The loops of the extending members <NUM> are configured so that, when the clip <NUM> applies a proximally directed force of at least a predetermined magnitude to the extending members <NUM> (e.g., when the extending members <NUM> are urged distally against the clip <NUM> while further distal movement of the clip <NUM> is prevented by the tissue to which it is clipped), the loops of the extending members <NUM> slide distally over and off of the hinges of the clip <NUM> to disengage the clip <NUM> from the extending members. This frees the clip <NUM> entirely from the system and permits the adapter <NUM>, extending members <NUM> and the endoscope <NUM> to be withdrawn from the body as the clip <NUM> is left in place clipped on target tissue.

When the loops <NUM> are hooked over the C-shaped hinges <NUM>, however, the distal ends <NUM> are restrained and pushed toward these longitudinal axes by the C-shaped hinges <NUM> in an engaged configuration. After the clip <NUM> has been clipped on target tissue and the adapter <NUM> and the clip <NUM> have been moved to the review configuration, the user can visually observe the position of the clip <NUM> on the tissue to determine if the clip <NUM> is in the desired position. If the user determines that the clip <NUM> is positioned as desired over the target tissue, the operator pushes the extending members <NUM> distally pressing the clip <NUM> into the target tissue. As the tissue provides resistance to further distal movement of the clip <NUM>, the loops <NUM> are forced distally over the C-shaped hinges <NUM> until the distal ends of the loops <NUM> pass the distal ends of the hinges <NUM>. At this point, the loops <NUM> are freed to spring radially outward away from the clip <NUM> de-coupling the clip <NUM> from the extending members <NUM> and from the device <NUM>. That is, in the release configuration shown in <FIG>, a distance between the distal ends <NUM> is greater than when the extending members <NUM> are restrained by the hinges <NUM> in the engaged configuration as the distal ends spring radially outward from the clip <NUM>.

The lumens <NUM> may be fixed with respect to the endoscopic shaft <NUM> so that when the extending members <NUM> are longitudinally translated relative to the lumens <NUM>, the extending members <NUM> move the clip <NUM> relative to the endoscope <NUM>. In particular, the extending members <NUM> are formed of a material having a longitudinal stiffness sufficient so that, as the extending members <NUM> are moved distally with respect to the lumens <NUM>, the clip <NUM> is pushed distally over the adapter <NUM> and when the extending members <NUM> are moved proximally with respect to the lumens <NUM>, the clip <NUM> is drawn proximally with respect to the endoscope <NUM> over the adapter <NUM>. In one embodiment, each of the lumens <NUM> includes a multi-lumen Bowden housing via which, for example, a strand of each extending member <NUM> is passed to create the loop <NUM> at the distal end <NUM>.

According to one embodiment, the Bowden housing, as shown in <FIG>, includes an exterior plastic insulation <NUM>, an interior braiding <NUM>, a flexible coil therein <NUM>, and a dual channel tube <NUM> extending longitudinally therethrough for accommodating portions of the extending member <NUM> to form the loop <NUM> at the distal end <NUM> of the extending member <NUM>. The Bowden housing of the lumens <NUM> facilitate translational movement of the extending members <NUM> relative thereto while also preventing kinking of the extending members <NUM>. Thus, to move the clip <NUM> from the initial deployed configuration to the review configuration, the extending members <NUM> are moved distally relative to the lumens <NUM> so that the endoscope <NUM> and the adapter <NUM> may be withdrawn proximally while the clip <NUM> remains coupled to the device and is positioned distally further from the distal end <NUM> of the adapter <NUM> and the distal end <NUM> of the endoscopic shaft <NUM>. In this position, the clip <NUM> is more easily viewable via the optical system of the endoscope <NUM>. If, upon review, it is desired to adjust a position/placement of the clip <NUM>, the extending members <NUM> may be moved proximally with respect to the lumens <NUM> until the clip <NUM> is drawn proximally over the adapter <NUM> toward the insertion configuration.

As will be understood by those of skill in the art, a distally directed force applied by the distal end <NUM> of the adapter <NUM> against the jaws <NUM> as the clip <NUM> is drawn proximally will force the jaws <NUM> open against their natural bias. That is, as the clip <NUM> is drawn proximally over the adapter <NUM>, the jaws <NUM> are pushed diametrically apart to slide over diametrically opposed portions of the adapter <NUM> as the clip <NUM> returns to the insertion configuration. The endoscope <NUM> and the adapter <NUM> may then be repositioned and, when the user feels the device is positioned as desired relative to target tissue to be clipped, the clip <NUM> may be moved, once again, to the initial deployed configuration and then to the review configuration, as described above, to confirm whether the clip <NUM> has been placed in a desired position relative to the target tissue.

According to one embodiment, when it is desired to release the clip <NUM> from the extending members <NUM> in a final deployed configuration, the extending members <NUM> may be moved distally relative to the clip <NUM> until the loops <NUM> are moved distally out of engagement with the hinges <NUM>. In this embodiment, as the loops <NUM> are moved distally of the C-shaped hinges <NUM> and out of engagement therewith, the distal ends <NUM> of the extending members <NUM> are released from the hinges <NUM> and permitted to revert to their biased configuration, in which the distal ends <NUM> move radially away from one another. Since, at this point, the distal ends <NUM> extend radially away from one another and no longer engage the clip <NUM>, as shown in <FIG>, the clip <NUM> is fully separated from the device and the extending members <NUM> may be moved proximally away from the clip <NUM> without re-engaging the clip <NUM>. Thus, the clip <NUM> may be left within the body clipped to target tissue while the endoscope <NUM> and the adapter <NUM> including the extending members <NUM> are withdrawn from the body.

It will be understood by those of skill in the art that although the clip <NUM> is described and shown as having C-shaped hinges <NUM>, the hinges <NUM> may have any of a variety of shapes and configurations so long as the hinges <NUM> are configured to bias the jaws <NUM> of the clip <NUM> toward the closed configuration, as described above, and can be releasably engaged by the extending members <NUM>. Similarly, it will be understood by those of skill in the art that the distal ends <NUM> of the extending members <NUM> may have any of a variety of shapes and configurations so long as the distal ends <NUM> are configured to releasably engage the hinges <NUM>, as described above.

As described above, the user interface <NUM> may be used to actuate the deployment element <NUM> and the extending members <NUM>. As shown in <FIG>, the user interface <NUM> may be coupled to the handle portion <NUM> of the endoscope <NUM> via any of a number of coupling mechanisms including, for example, a snap interface <NUM>. In one embodiment, the user interface <NUM> includes two actuating elements - e.g., a first knob <NUM> for controlling the deployment element <NUM> and a second knob <NUM> for controlling the extending members <NUM>. The first and second knobs <NUM>, <NUM> may be configured, for example, as thumb wheels so that the user of the system <NUM> may easily control a movement of the deployment element <NUM> and extending members <NUM> as they are holding the endoscope <NUM> via the handle <NUM>.

As will be understood by those of skill in the art, a proximal end of the deployment element <NUM> may extend proximally from the working channel of the endoscopic shaft <NUM> to be wound around a first rotary wheel <NUM> that is connected to the first knob <NUM> so that a rotation of the first knob <NUM> correspondingly rotates the first rotary wheel <NUM>, thereby moving the deployment element <NUM> as desired. For example, a rotation of the first knob <NUM> in a first direction may slacken the deployment element <NUM> when, for example, the clip <NUM> is mounted over the adapter <NUM> toward the insertion configuration. A rotation of the first knob <NUM> in a second direction opposite the first direction may tension the deployment element <NUM> when, for example, it is desired to move the clip <NUM> from the insertion configuration to the initial deployed configuration.

Similarly, the second knob <NUM> may be connected to a second rotary wheel <NUM> about which proximal ends of the extending members <NUM> may be wound so that a rotation of the second knob <NUM> controls a movement of the extending members <NUM>, and thereby the clip <NUM>. For example, proximal ends <NUM> of the lumens <NUM> may be connected to the user interface <NUM> so that proximal ends of the extending members <NUM> extend from the proximal ends <NUM> of the lumens <NUM> to be wound about the second rotary wheel <NUM>. Thus, a rotation of the second knob <NUM> in a first direction may translate the extending members <NUM> distally with respect to the lumens <NUM> and endoscopic shaft <NUM> so that the clip <NUM> may be moved from the initial deployed configuration to the review configuration. Rotation of the second knob <NUM> in a second direction opposite the first direction will translate the extending members <NUM> in a proximally relative to the lumens <NUM> and the endoscopic shaft <NUM> so that the clip <NUM> may be drawn proximally from review configuration toward the insertion configuration to, for example, reposition the clip <NUM>.

According to an exemplary method for tissue closure utilizing the clipping system <NUM>, the clip <NUM> may be inserted through a body lumen such as, for example, the GI tract, to a target area within the body lumen via the endoscope <NUM>. As described above, in the insertion configuration, as shown in <FIG>, the clip <NUM> is mounted to the distal end <NUM> of the endoscopic shaft <NUM> via the adapter <NUM>, so that the jaws <NUM> are separated from one another toward the open configuration. The clip <NUM> is guided to the target area via the endoscope <NUM>, and positioned over a target tissue. A suction force may be applied through a working channel of the endoscope <NUM> so that the target tissue may be drawn into the channel <NUM> of the adapter <NUM>. Thus, when the clip <NUM> is moved toward the initial deployed configuration via, for example, the first knob <NUM>, jaws <NUM> of the clip <NUM> are permitted to revert to their biased closed configuration, as shown in <FIG>, so that the tissue suctioned into the channel <NUM> is gripped by the jaws <NUM> of the clip <NUM>. In one embodiment, as described above, the clip <NUM> may be moved toward the initial deployed configuration by tensioning the deployment element <NUM> so that the deployment element <NUM> pushes distally against the clip <NUM>. The clip <NUM> is thereby pushed distally off of the adapter <NUM> and is permitted to revert to its biased closed configuration.

It will be understood by those of skill in the art that suctioning and/or gripping of the tissue in this initial deployed configuration obstructs an imaging/optical lens of the endoscope <NUM> so that the user is unable to visualize and/or confirm whether a desired target tissue has been properly clipped. When the clip <NUM> is moved toward the review configuration, as shown in <FIG>, however, the extending members <NUM> are moved distally relative to the endoscopic shaft <NUM> so that the clip <NUM> is moved away from the distal end <NUM> of the endoscopic shaft <NUM>. In particular, extending the extending members <NUM> distally relative to the endoscopic shaft <NUM> via, for example, the second knob <NUM>, allows the endoscope <NUM> to be drawn proximally away from the clip <NUM> while the clip <NUM> remains clipped on the tissue and the distal portion <NUM> of the adapter <NUM> is extended distally from the proximal portion of the adapter <NUM>, creating distance between the clip <NUM> and the distal end <NUM> of the endoscopic shaft <NUM> selected so that the clip <NUM> may be visualized via the optical system of the endoscope <NUM>.

If, upon visualization, the user determines that the clip <NUM> requires an adjustment and/or a repositioning relative to the target tissue, the extending members <NUM> may be translated proximally relative to the endoscope <NUM> until the clip <NUM> is moved proximally over the distal portion <NUM> of the adapter <NUM>, as described above, toward the open configuration. The clip <NUM> may then be repositioned over the target tissue, as desired, and the clip <NUM> once again moved toward the initial deployed configuration, and then toward the review configuration. This process may be repeated, as necessary, until the user is able to visually confirm that the clip <NUM> has been clipped over the target tissue, as desired.

Once the user confirms that the target tissue has been clipped, as desired, the clip <NUM> may be moved from the review configuration to the final deployed configuration, as shown in <FIG>, by releasing the clip <NUM> from the extending members <NUM>. As described above, to release the clip <NUM>, the extending members <NUM> are moved further distally relative to the endoscopic shaft <NUM>. Since in the review configuration the clip <NUM> is clipped over the target tissue and thereby abuts against a tissue surface, moving the extending members <NUM> further distally causes the extending members <NUM> to also be moved distally relative to the clip <NUM>. The extending members <NUM> are moved distally relative to the clip <NUM> until the distal ends <NUM> of the extending members <NUM> disengage the hinges <NUM> of the clip <NUM>. According to one embodiment, the extending members <NUM> may be moved distally with respect to the clip <NUM> until the loops <NUM> at the distal end <NUM> disengage the hinges <NUM>. Once the loops <NUM> have been released from, for example, the C-shaped hinges <NUM>, the distal ends <NUM> are permitted to revert to their biased configuration, moving radially away from one another. Thus, extending members <NUM>, and the endoscope <NUM>, may be withdrawn from the body so that just the clip <NUM> remains clipped over the target tissue.

Claim 1:
A clipping system (<NUM>) for treating tissue, comprising:
an adapter (<NUM>) extending longitudinally from a proximal end (<NUM>) configured to be mounted over a distal end of an insertion device (<NUM>) to a distal end (<NUM>);
a clip (<NUM>) including first and second jaws (<NUM>), a first end (<NUM>) of the first jaw being connected to a first end (<NUM>) of the second jaw via a first hinge (<NUM>) and a second end (<NUM>) of the first jaw being connected to a second end (<NUM>) of the second jaw via a second hinge (<NUM>) so that the first and second jaws are movable between an insertion configuration, in which the first and second jaws are separated from one another to receive tissue therebetween and an initial deployed configuration in which the first and second jaws are drawn toward one another to grip tissue therebetween, at least one of the first and second hinges being biased to draw the clip toward the initial deployed configuration;
a deployment member (<NUM>) configured to move the clip distally over and off of the adapter so that, as the clip leaves the adapter, the clip moves from the insertion configuration to the initial deployed configuration; and
a first extending member (<NUM>) releasably coupled to the clip and movably connected to the adapter, the first extending member being configured to permit withdrawal of the adapter proximally away from the clip while the first extending member remains coupled to the clip to place the system in a review configuration in which the clip is physically separated from the adapter to enhance visual observation of the clip, the first extending member being operable to retract the clip proximally over the adapter so that the clip is forced open as the clip is retracted over the adapter freeing the clip from tissue on which it had been clipped,
wherein the first extending member is releasably coupled to the first hinge so that, when the clip is observed to be in a desired position, the clip can be finally deployed from the system by separating the first extending member from the clip.