Patent Description:
Embodiments of the present invention relate to tissue approximation clips used during surgery. In particular, embodiments of the present invention relate to clips that may be used to bring tissue edges proximate to one another to close apertures created during surgery.

During recent years, a major drive in surgery has been the development and application of minimally invasive approaches to traditional operations. In general surgery, an emphasis has been on laparoscopic techniques, which can now be applied to a majority of intra-abdominal procedures. The resulting reduction in trauma to the abdominal wall has a positive impact on patients undergoing abdominal operations.

More recently, there has been interest in less traumatic transluminal endoscopic surgical procedures. In transluminal endoscopic surgery, an endoscope is used to deliberately breach (puncture) the wall of the stomach or other organ to work within a body cavity such as the peritoneal cavity. Single point access surgery, is an advanced minimally invasive surgical procedure in which the surgeon operates almost exclusively through a single entry point, such as the patient's navel. In a transluminal endoscopic surgical procedure, a flexible endoscope (along with the required surgical tools) is inserted into the stomach, for example, through a natural anatomic opening. Once the endoscope reaches the access site in the stomach or other organ, the wall of the organ is punctured and the endoscope advanced into the body cavity where the remotely controlled surgical tools can be used to perform delicate surgical procedures. When the surgical procedure is completed, the endoscope and the tools are withdrawn through the aperture in the organ wall and the aperture is closed.

Although minimally invasive surgeries have tremendous potential in reducing trauma associated with surgical procedures, several important developments should be pursued before these procedures can be widely employed. One such development is a safe and effective method of approximating two tissue edges in the body cavity so that they can be stapled or otherwise joined together. Existing tissue approximation techniques only enable joining of two tissue edges which are already in close proximity to one another. There is often a need to bring one tissue edge from a first location to the location of a second tissue edge in order to join them, and thereby, initiate healing.

<CIT> discloses a clip-applying catheter having a three-jaw clip-applying device at its distal end. A clip has a V-shaped structure.

<CIT> discloses a system and method for delivering a surgical clip to a surgical site within a patient's body to compress body tissue.

<CIT> discloses devices, systems and methods for stabilizing and grasping tissues such as valve leaflets.

<CIT> discloses a vascular hemostasis device.

<CIT> discloses procedures that employ a minimally invasive grasping device having an inner lumen for advancing connecting members and other instruments through the device to the distal end thereof.

<CIT> discloses an apparatus for collapsing an aperture in a wall of tissue. The apparatus comprises a base and a plurality of collapsible fingers extending from the base. The collapsible fingers are configured to collapse about tissue adjacent to and defining the aperture so as to close the aperture in the wall of tissue.

<CIT> discloses an apparatus for closing trocar wounds and a method for using such an apparatus. The apparatus includes a fastener having three or more legs attached to a base.

<CIT> discloses a clip for repair of a heart valve. The clip has a plurality of legs j oined at one end to a common attachment, the opposite ends of the legs being free to move. The common attachment may comprise a threaded ferrule, a bent or looped wire segment as well as a cylindrical shell or a ring.

A device to approximate tissue edges as recited in claim <NUM> is provided. The dependent claims define embodiments.

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention.

Reference will now be made in detail to exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Even so, the invention is not limited to the specific embodiments and drawings listed herein.

<FIG> depicts an exemplary endoscope <NUM> performing an exemplary endoscopic surgery. Non-limiting examples of the endoscopic surgery may include choecsyectomies, gastrojejunostomies, stomach resections, polypectomies, vasectomies, tubal ligations, etc. In one embodiment, an endoscope <NUM>, or other suitable device such as a guide tube or a catheter, may be inserted into the stomach <NUM> through the esophagus. Endoscope <NUM> may make an aperture <NUM> on organ wall <NUM>, pass through the aperture <NUM>, and operate at a work site. The work site could include, for instance, part of the small intestine <NUM>. It should be emphasized that the illustrated application of the endoscope <NUM> in <FIG> is exemplary only, and that the inventions of the current disclosure may be applied to any surgical application or medical procedure known in the art.

Endoscope <NUM> may include an elongate member <NUM> extending between a proximal end <NUM> and a distal end <NUM>. In the configuration depicted in <FIG> , the proximal end <NUM> may include the end of endoscope <NUM> external to the body and the distal end <NUM> may include the end of endoscope <NUM> internal to the body. A plurality of lumens <NUM> may run longitudinally through endoscope <NUM>. The lumens <NUM> may extend between the proximal end <NUM> external to the body and the distal end <NUM> internal to the body. In some embodiments, the longitudinal axes of the lumens may be substantially parallel to the longitudinal axes of the endoscope <NUM>.

The lumens <NUM> may provide access to devices and facilities that may aid in performing a diagnostic or therapeutic task inside the body. In general, the lumens may be of any shape or geometry. In some embodiments, some or all lumens may be lined with a polymeric or another layer or coating to facilitate use. These lumens <NUM> may include one or more of, among others, an aspiration lumen, an irrigation lumen, an illumination lumen, a viewing lumen, and working lumens. The illumination lumen may include devices at the distal end configured to illuminate the work site. These devices may include, among others, bulbs, LED's, fiber optic cables and light guides. The viewing lumen may include devices (such as a camera) at the distal end <NUM>, configured to deliver an image of the work site external to the body. In some embodiments the camera may be a digital camera, such as a CCD or a CMOS camera. The illumination and the viewing lumens may also include cables that may run from the distal end <NUM> to the proximal end <NUM>.

The irrigation lumen may be configured to facilitate fluid flow from the proximal end <NUM> to the distal end <NUM>. In some embodiments, the proximal end <NUM> of the irrigation lumen may be attached to a source of fluid, and the distal end <NUM> may be attached to a nozzle to alter fluid flow. The aspiration lumen may be configured to facilitate suction and/or fluid flow through it. In some embodiments, fluid may flow from the proximal end <NUM> to the work site through the irrigation lumen. The fluid may then be removed from the work site through the aspiration lumen. In some embodiments, the aspiration lumen may also be configured to remove biological material along with fluid from the work site. For instance, a tissue sample along with fluid (delivered to the work site via the irrigation lumen) may be extracted out of the body through the aspiration lumen.

The working lumen may include a hollow cavity configured to deliver an endoscopic instrument <NUM> to the work site. The endoscopic instrument <NUM> may include a surgical tool configured to operate at the work site while being remotely controlled from outside the body. The surgical tool may be configured as an end effector <NUM> that may be attached at the distal end of the endoscopic instrument <NUM>. In general, the working lumen may have any suitable shape, size, and configuration. In some embodiments, the working lumen may have a substantially circular cross-section, while in other embodiments, the shape of the working lumen may be configured to pass the end effector <NUM> of the endoscopic instrument <NUM> through it. Some embodiments of the endoscope may include a plurality of working lumens to deliver multiple surgical tools to the work site.

In addition to the end effector <NUM>, an endoscopic instrument <NUM> may also include a mechanism to operate the end effector <NUM> from outside the body. This mechanism may include linkage that connects the end effector <NUM> to an actuation device (not shown) at the proximal end. This linkage may operate the end effector <NUM> in response to actuation by the actuation device. For example, in some embodiments, the end effector <NUM> may include forceps with a pair of jaws rotably coupled to each other. The linkage, in this embodiment, may include a pair of cables, each coupled to a jaw of the forceps at the distal end and to the actuation device at the proximal end. Actuation of the actuation device may move one of the cables relative to the other, causing the jaws of the forceps to open and close.

The end effector <NUM> may include any medical instrument that may be used in conjunction with the endoscope <NUM>. In some embodiments, the end effector <NUM> may be a purely mechanical medical instrument (for example, biopsy forceps, baskets, graspers, snares, surgical knifes, needles, suturing instruments, etc.), while in others, the end effector <NUM> may also include devices with parts driven by an electric current (for instance, electric motors, heating elements for cutting or cauterizing, hemostasis devices, radio frequency ablation devices, etc.). The end effector <NUM> may also include a surgical instrument, such as a trocar, used to puncture an internal surface of the body.

In the exemplary transluminal endoscopic surgery illustrated in <FIG>, the endoscope <NUM> may be inserted into the body through a natural anatomic opening (such as, mouth, anus, and vagina, etc.) or through the body percutaneously. When the distal end <NUM> of the endoscope <NUM> is proximate to an internal surface (such as, organ wall <NUM>), an endoscopic instrument <NUM>, for example, an end effector suitable for puncturing organ wall <NUM>, may be delivered to the distal end <NUM> of the endoscope <NUM> via the working lumen. The end effector may be used to puncture the organ wall <NUM>. Puncturing the organ wall <NUM> may create cut multiple tissue edges. These tissue edges may include a first tissue edge 70a and a second tissue edge 70b. Once the organ wall <NUM> is punctured, the endoscopic tool <NUM> with the end effector <NUM> may be withdrawn from the working lumen, and the endoscope <NUM> inserted into the abdominal cavity through the aperture <NUM>. When the distal end <NUM> of the endoscope <NUM> is positioned at the desired work site, for instance, the intestine <NUM>, an endoscopic instrument <NUM> with an end effector <NUM> configured to perform a desired task may be delivered to the work site through the working lumen.

The desired operations may be performed at the work site using an end effector <NUM>. If more than one tool is required to complete the desired task, other desired end effectors <NUM> may also be delivered to the work site. After completion of the desired operations, the endoscope <NUM> and tools may be retracted from the abdominal cavity through aperture <NUM>. Aperture <NUM> may now be closed by joining the separated tissue edges (for example, first tissue edge 70a and second tissue edge 70b) to initiate the healing process. To close aperture <NUM>, two or more tissue edges spatially dislocated from each other may have to repositioned close to each other (referred to herein as "approximated") before they can be joined together. A tissue approximation clip according to embodiments of the present disclosure may now be delivered to the access site <NUM> or aperture via the working lumen. The approximation clip may be configured to grasp tissue edges at different locations at the access site <NUM>, bring them in close proximity to each other, and join the tissue pieces together.

The tissue approximation clips of the present disclosure may be made of any suitable biocompatible material. In general, a clip may be comprised of a material having any type of constitutive behavior, such as, a material exhibiting a behavior which is elastic, plastic, elastic-perfectly plastic, hyper-elastic, etc. In some embodiments, a bioabsorbable material may be included. It is also contemplated, that in some embodiments, a clip may be comprised of multiple components made of multiple materials. In some embodiments, a clip may comprise a shape memory alloy (SMA). Non-limiting examples of SMA's included in the clip include alloys of titanium-palladium-nickel, nickel-titanium-copper, gold-cadmium, iron-zinc-copper-aluminum, titanium-niobium-aluminum, iron-manganese-silicon, nickel-titanium, nickel-iron-zinc-aluminum, copper-aluminum-iron, titanium-niobium, etc. In some embodiments, a clip may comprise or consist of nitinol.

In general, clips of the present disclosure may be made by any process known in the art. In some embodiments, arms or jaws of the clip may be formed by a bending operation of material, and holes or cavities through the clip may be formed by a machining or laser drilling operation. In some embodiments, the clip may be subjected to heat treatment or other microstructure modification metallurgical operations during or after the fabrication process. In embodiments, where the clip may comprise a shape memory alloy, the material of the clip or the manufactured clip may be subjected to metallurgical treatments. These metallurgical operations may enable the clip to transform from a first configuration to second configuration by the application of heat or other stimuli. The first configuration may correspond to a martensitic phase and the second configuration may correspond to an austenitic phase of a shape memory alloy. Several embodiments of clips of the present disclosure and their method of operation will now be described in the following paragraphs.

<FIG> illustrates an embodiment of the tissue approximation clip <NUM> that may be delivered to aperture <NUM>. Clip <NUM> may comprise a unitary construction, and may resemble a strip of material folded along a plane <NUM>, at an angle to, and passing through a center of the strip. Clip <NUM> may have two jaws, a second jaw 42a and a first jaw 42b, joined by a midsection <NUM>. Clip <NUM> may further include a through-hole <NUM> therethrough. An inside surface of the two jaws may have an irregular or corrugated surface such as teeth <NUM>. Although the surface corrugation of clip <NUM> is depicted as teeth <NUM>, any kind of surface configurations may also be used. In some embodiments, the second jaw 42a and the first jaw 42b may be symmetric about plane <NUM> which may pass through a center of through-hole <NUM>. However, it is contemplated that, in some embodiments, the two jaws may not be symmetric. The through-hole <NUM> may have any shape. In some embodiments, the through-hole <NUM> may have a circular shape.

Although clip <NUM> is depicted as having two jaws (second jaw 42a and first jaw 42b) and an unvarying cross-section along a thickness direction, it is contemplated that clip <NUM> may have other configurations. For instance, in the embodiment of the clip 40a depicted in <FIG>, clip 40a may resemble the shape of a tulip having at least three jaws, a second jaw 42a, a first jaw 42b, and a third jaw 42c. The jaws may be substantially shaped like petals of the tulip. Other embodiments of the clip 40a may have a different number of jaws. As in the embodiment illustrated in <FIG>, the jaws of clip 40a may be joined by a midsection 43a with a through-hole 46a centrally located therein. An axis 54a may pass through a center of the through-hole 46a, and an inside surface of the three jaws may have a corrugated surface or teeth 45a.

<FIG> illustrate an exemplary method of using a clip <NUM> to approximate tissue edges and join them. One or more clips <NUM> may be loaded on a push-rod <NUM> and delivered to the access site <NUM> though a tubular catheter <NUM>. The clips <NUM> may be constrained to be in a closed configuration while inside the catheter <NUM>. At access site <NUM>, clip <NUM> still mounted on push-rod <NUM> may be extended from within the catheter <NUM>. When clip <NUM> emerges from within the catheter <NUM>, a constraint which holds the clip in a closed configuration may be released, and the clip may expand to an open configuration. It is also contemplated that in some embodiments, a constrain may force the clip to an open configuration when clip <NUM> emerges from catheter <NUM>. The access site <NUM> may have one or more tissue edges, a first tissue edge 70a and a second tissue edge 70b, created while traversing through organ wall <NUM>. The first tissue edge 70a may be grasped between one jaw and the push-rod <NUM> and dragged to the location of the second tissue edge 70b. The second tissue edge 70b may then be grasped between another jaw and the push-rod <NUM>. Push-rod <NUM> may then be pulled out from between clip <NUM> and retracted into catheter <NUM>, releasing clip <NUM> with the tissue edges clutched between its jaws. The released clip <NUM> may now approximate first tissue edge 70a and second tissue edge 70b. Each step of some embodiments of this method of operating clip <NUM> will now be described in greater detail.

<FIG> illustrate mounting a clip <NUM> on push-rod <NUM>. Push-rod <NUM> may be an elongate member having a groove <NUM> near its distal end. Past groove <NUM>, the push-rod may include a hinge with two forks, a second fork 24a and a first fork 24b. The two forks may form the distal most part of push-rod <NUM>. Hinge <NUM> may allow each fork to open independent of the other. In some embodiments, opening of the forks may be a purely mechanical operation, while in other embodiments, energy such as heat and/or electricity may be used alone or in combination with mechanical energy to open the forks. While opening, second fork 24a and first fork 24b may rotate about the hinge <NUM>. While closing, the forks may rotate in the opposite manner. Although the forks are described as rotating about hinge <NUM> while opening and closing, it is also contemplated that in some embodiments, the two forks may move in another manner with respect to each other while opening and closing. Opening and closing of the forks may be controlled by an actuation mechanism at the proximal end of push-rod <NUM>. This actuation mechanism may include linkages that connect the forks to the actuation mechanism. These linkages may open and close the forks in response to activation by the actuation device. In some embodiments, linkages may include cables coupled to each fork. In these embodiments, pulling the cable connected to a fork may open the fork. In other embodiments, a push rod may push the forks open. In some embodiments, the forks may be biased to remain in a closed configuration with a spring. In these embodiments, pulling the cable may open the forks, and releasing the cable may close the forks.

The distal end of push-rod <NUM> may be inserted into through-hole <NUM> to load one or more clips <NUM> on the push-rod, such that the jaws of the loaded clips face the forks. In some embodiments, the diameter of through-hole <NUM> and push-rod <NUM> may be such that frictional resistance between the mating surfaces of the clips and the push-rod retains clips <NUM> on the surface of push-rod <NUM>. The clip closest to the two forks may be located on push-rod <NUM> such that through-hole <NUM> of the clip may be positioned on groove <NUM>. While clip <NUM> is in this position, opening a fork of the push-rod may rotate the fork until it rests on teeth <NUM> of a jaw of clip <NUM>. For instance, when clip <NUM> is located on groove <NUM>, opening first fork 24b may rotate this fork in a counterclockwise direction until the first fork rests against teeth <NUM> of first jaw 42b (see <FIG>). Further opening of the first fork 24b may push this fork against first jaw 42b.

Push-rod <NUM> along with the loaded clips may be inserted into a catheter <NUM> as seen in <FIG>. Catheter <NUM> may comprise a hollow tube with an external diameter sized to be inserted into a working lumen of endoscope <NUM>. The jaws of clip <NUM> may deflect inwards from an open configuration to a closed configuration while being inserted into catheter <NUM>. The internal diameter of a distal end of catheter <NUM> may be such that the clips in a closed configuration may slide longitudinally within the catheter freely. Push-rod <NUM> may be inserted into catheter <NUM> such that all the loaded clips are positioned within the catheter, and a proximal end of push-rod <NUM> protrudes from a proximal end of catheter <NUM>. At some distance near the distal end, the internal surface of catheter <NUM> may have a flange <NUM> designed to stop the longitudinal movement of clip <NUM>. In some embodiments, flange <NUM> may be a region of reduced diameter of catheter <NUM>. It is also contemplated that the flange <NUM> can have other configurations, such as, a protrusion of a size that prevents the passage of a loaded clip past the protrusion.

In some embodiments, the distance of flange <NUM> from the distal most end of catheter <NUM> may be factor in determining the number of clips <NUM> that may be loaded on a push-rod positioned within the catheter. The internal dimensions of catheter <NUM> may be configured to facilitate locating a clip on groove <NUM> of push-rod <NUM>. For instance, pulling push-rod <NUM> in a proximal direction from the proximal end of catheter <NUM> may move the push-rod, along with the loaded clips, into the catheter towards the proximal end. During this movement, a loaded clip may run into flange <NUM>. The flange may thus prevent longitudinal movement of the clip towards the proximal end. Further pulling of the push-rod towards the proximal end may cause the push-rod to slide on the through-hole <NUM>, thereby positioning the clip on the groove.

The catheter <NUM> with the inserted push-rod <NUM> may now be delivered to the access site <NUM> through a working lumen of the endoscope <NUM>. The endoscope may be positioned within the body such that the distal end <NUM> of the endoscope <NUM> is proximate the access site <NUM>. <FIG> illustrates one embodiment of delivery of the clip <NUM> to an access site <NUM>. The catheter <NUM> may be delivered such that loaded clip <NUM> extends from the distal end <NUM> of the endoscope <NUM>. While thus positioned, pushing the push-rod <NUM> into the catheter <NUM> from the proximal end may extend the push rod <NUM> with the loaded clip <NUM> out of the distal end of the catheter <NUM>. When the push-rod <NUM> is pushed into the catheter <NUM> to extend the clip <NUM> positioned on the groove <NUM> from the distal end of the catheter <NUM>, the jaws of the clip <NUM> may spring back to its open configuration. It is contemplated that in some embodiments, the jaws may not return completely to their pre-deformed configuration, but may retain some plastic deformation. The distal end <NUM> of the endoscope <NUM> and/or the distal end of the catheter <NUM> may now be maneuvered to position extended clip <NUM> proximate one tissue edge (first tissue edge 70a or second tissue edge 70b).

Clip <NUM> may now be used to grasp these separated tissue edges. <FIG> illustrates grasping second tissue edge 70b between the first fork 24b and the first jaw 42b. To grasp the second tissue edge 70b, the clip <NUM> may be maneuvered to locate the second tissue edge 70b between the first fork 24b and the first jaw 42b. When clip <NUM> is suitably positioned, the actuation device may be used to open first fork 24b. Opening the first fork 24b may rotate the first fork 24b about the hinge <NUM> in a counterclockwise direction. The opening first fork 24b may force the trapped second tissue edge 70b against the teeth <NUM> of the first jaw 42b thereby firmly grasping the second tissue edge 70b between the first fork 24b and the first jaw 42b. While thus grasping the second tissue edge 70b, the endoscope <NUM> or catheter <NUM> may be maneuvered to the location of the first tissue edge 70a. When the clip <NUM> is suitably positioned proximate the first tissue edge 70a, the second jaw 42a may be opened to grasp the first tissue edge 70a between the second jaw 42a and the first fork 24a. <FIG> illustrates clip <NUM> grasping the first tissue edge 70a.

With the two tissue edges firmly grasped between the jaws and the forks, push-rod <NUM> may be pulled towards the proximal end to force clip <NUM> towards the catheter <NUM>. <FIG> illustrates one embodiment of the clip <NUM> being pulled towards the catheter <NUM>. While the clip <NUM> is being retracted into the catheter <NUM>, the open jaws of the clip are pushed inwards by the walls of the catheter <NUM>. The reaction force of the catheter <NUM> on the open jaws of the clip may deform the jaws with the tissue edges and the forks sandwiched between the jaws. In some embodiments, part or all of clip <NUM>, with the tissue edges sandwiched between its jaws, may enter the distal end of catheter <NUM> as the push-rod <NUM> is pulled into the catheter <NUM>.

In some embodiments, further pulling of the push-rod <NUM> from the proximal end of the catheter <NUM> may further pull the forks out from between the jaws of the clip <NUM>, leaving the tissue edges sandwiched between the deformed jaws of the clip. In embodiments where a part of the deformed clip <NUM> enters the distal end of catheter <NUM> upon retraction of the push-rod <NUM>, retracting the catheter <NUM> away from the access site <NUM> may stretch the organ wall <NUM> to allow the clip <NUM> to be pulled out of the distal end of the catheter <NUM> with the first tissue edge 70a and second tissue edge 70b sandwiched between its jaws. <FIG> illustrates a deformed clip <NUM> with the tissue edges grasped between its jaws. Clip <NUM> may thus close aperture <NUM> by joining the two tissue edges together. The action of retracting the push-rod <NUM> into catheter <NUM> may also position another loaded clip <NUM> in the groove <NUM> of the push-rod <NUM> as described previously.

Although the description above describes the method of closing a puncture with two tissue edges using clip <NUM>, the same general approach can be used to close an aperture <NUM> having more than two tissue edges. To close a puncture with more than two tissue edges, a clip with multiple jaws may be used. For instance, clip 40a with three jaws depicted in <FIG>, may be used to cclose an aperture <NUM> with three tissue edges. In this embodiment, the push-rod <NUM> may include three forks that may be independently opened and closed from outside the body. The clip 40a may be loaded on the push-rod <NUM> and delivered to the access site <NUM> as described earlier. At the access site <NUM>, the first tissue edge may be grabbed between a jaw and a fork and dragged to the location of the second tissue edge. A second tissue edge may then be grabbed between a second jaw and a fork. The distal end of the catheter <NUM> may then be maneuvered to the location of a third tissue edge, where the third tissue edge may be grabbed between the third fork and the jaw. Push rod <NUM> may then be retracted into the catheter to deform the jaws of clip 40a as discussed earlier. The push-rod <NUM> may be further retracted to extract the forks from between the jaws, thereby leaving the tissue edges pressed together by the deformed jaws. Although the description above describes a clip having jaws equal to the number of forks, this is not a requirement. That is, in some embodiments, the number of jaws of a clip may be different than the number of forks.

It is also contemplated that a device with two jaws (such as clip <NUM> depicted in <FIG>) may be used to close an aperture with more than two tissue edges. In such an application, two or more tissue edges may be grabbed between a jaw and a fork. A first tissue edge may be firmly embedded in the teeth <NUM> of the jaw so that it may not be released when the jaw is opened to grasp a second tissue edge.

<FIG> illustrates another embodiment of a tissue approximation clip <NUM> that may be used to close the aperture <NUM>. Clip <NUM> of <FIG> may be attached to a distal end of an elongate member <NUM>, and may be delivered to the access site <NUM> through the working lumen of the endoscope <NUM>. In some embodiments, the elongate member <NUM> with the clip <NUM> may be delivered to the access site <NUM> via a catheter inserted into the working lumen. The elongate member <NUM> may connect the clip <NUM> to an actuation device attached to the proximal end thereof. The elongate member <NUM> may include mechanisms, such as links or cables, that may allow the actuation device to operate the clip <NUM>. These actuation mechanisms may be similar to those discussed with reference to clip <NUM> of <FIG>, or may be different. The clip <NUM> may protrude from the distal end of the endoscope <NUM> to operate on the aperture <NUM>.

Clip <NUM> may include three jaws - a first jaw 142a, a second jaw 142b, and a fixed center jaw <NUM>. The jaws may have a corrugated surface, teeth <NUM>, or other surface modifications on its facing sides. Similar to the opening left and right forks of the embodiment shown in <FIG>, the first jaw 142a and the second jaw 142b may be movable and may be opened and closed using the actuation mechanism. Closing the first jaw 142a may actuate this jaw about a hinge <NUM> until the teeth <NUM> on its surface presses against the teeth <NUM> on the fixed center jaw <NUM>. And, closing the second jaw 142b may actuate this jaw about the hinge <NUM> until its teeth <NUM> meets the teeth <NUM> of the center jaw <NUM>. The jaws may be opened by actuating the jaws in the opposite direction. In some embodiments, the first jaw 142a and the second jaw 142b may be biased to remain in the closed configuration. In these embodiments, the jaws may be opened by applying an opening force to overcome the biasing force. The jaws may actuate to a closed configuration when the opening force is removed. In some embodiments, when a jaw is closed against the center jaw, teeth <NUM> on both jaws lock to keep the jaw in a closed configuration.

<FIG> illustrate a method of using clip <NUM> to approximate tissue edges 70a and 70b and close the aperture <NUM>. The clip <NUM> may be attached to the distal end of the elongate member <NUM> and delivered to the site of an aperture <NUM> via the working lumen of the endoscope <NUM>. <FIG> illustrate the clip <NUM> grasping a tissue edge 70a at the access site <NUM>. At the access site <NUM>, the endoscope <NUM> is maneuvered to position a first tissue edge 70a between the center jaw <NUM> and another jaw of the clip, for instance the first jaw 142a. The actuation device is then actuated to close the first jaw to firmly grasp the first tissue edge 70a between the first jaw 142a and the center jaw <NUM>. In the closed configuration, the teeth <NUM> of the first jaw 142a and the center jaw <NUM> engage, thereby locking the first jaw 142a in the closed configuration.

The clip <NUM> with the grasped first tissue edge 70a is maneuvered to the site of a second tissue edge 70b. The second tissue edge 70b is positioned between the second jaw 142b and the center jaw <NUM>, and the second jaw 142b closed to lock the second tissue edge 70b between the teeth <NUM> of these jaws. <FIG> illustrates the first and second tissue edges 70a and 70b firmly grasped by clip <NUM>. The clip <NUM> may thus close the aperture <NUM> by joining together the tissue edges that form the aperture <NUM>. Once the tissue edges are thus joined, the clip <NUM> may be released. <FIG> illustrates the released clip <NUM>. The released clip <NUM> may keep the aperture <NUM> closed allowing the natural healing process to grow fresh tissue around the joined tissue edges.

In general, a clip may be released from an elongate member by any means. In some embodiments a frangible link or an electrolysis link may be used to release a clip from an elongate member. Clip <NUM> also may be released from the elongate member by any other suitable method, including methods that use the actuation mechanism. In some embodiments, a clasp may retain the clip <NUM> on the distal end of the elongate member <NUM>. In these embodiments, the actuation mechanism may operate the clasp to release the clip <NUM>. In some embodiments, the distal end of the elongate member <NUM> may have threads that mate with threads on a mating face of the clip <NUM>. In these embodiments, rotating the elongate member <NUM> about its longitudinal axis may unscrew the clip <NUM> from the elongate member <NUM>, and release the clip <NUM>.

<FIG> illustrates another embodiment of a tissue approximation clip <NUM> that may be used to close the aperture <NUM>. Clip <NUM> may include a first jaw 242a and a second jaw 242b hinged to an elongate member <NUM> at hinges 226a and 226b (see <FIG>), respectively. The first jaw 242a and the second jaw 242b may also include teeth <NUM> or other surface irregularities on facing surfaces. The clip <NUM> may be located at the distal end of the elongate member <NUM>, and may be delivered to an access site <NUM> within a catheter <NUM>. The catheter <NUM> may be delivered to the access site <NUM> through a working lumen of an endoscope <NUM>. The first jaw 242a and the second jaw 242b may be configured to slide individually on elongate member <NUM> to extend from the distal end of the catheter <NUM>. A hook <NUM> having barbs, may also be located between the first jaw 242a and the second jaw 242b. The barbs may be sharp needle like features that protrude from the distal end of hook <NUM>, or just a raised profile at the distal end of hook <NUM>. Clip <NUM> may close aperture <NUM> by clamping the tissue edges between its jaws. <FIG> illustrate a method of using clip <NUM> to approximate and join tissue edges.

When the distal end of the catheter <NUM> is proximate the first tissue edge 70a, the first jaw 242a along with the hook <NUM> may be extended from within the catheter <NUM>. The jaws may be biased to open when released from within the catheter <NUM>. The catheter <NUM> and/or the endoscope <NUM> may be positioned to locate the first tissue edge 70a between the extended jaw and the hook <NUM>. <FIG> shows device <NUM> with the first tissue edge 70a located between the first jaw 242a and the hook <NUM>. When the tissue is appropriately positioned, the first jaw 242a along with hook <NUM> may be retracted into catheter <NUM>. A catch or a feature on an inside surface of the catheter <NUM> may prevent the second jaw 242b from retracting further into catheter <NUM> when the first jaw 242a is retracted. Withdrawing the catheter <NUM> may force the first jaw 242a to a closed configuration, trapping the tissue between the jaw and the hook <NUM>. <FIG> illustrates the clip <NUM> with the first tissue edge 70a grasped by the first jaw 242a and the hook <NUM>. When the first jaw 242a closes over the first tissue edge 70a, the barbs of hook <NUM> and teeth <NUM> of first jaw 242a may lock, or cooperate together in another manner, to hold first tissue edge 70a firmly in place. In an embodiment of clip having sharp barbs and teeth, these barbs and teeth may pierce through the first tissue edge 70a to firmly hold the tissue edge between the jaw and the hook.

The endoscope <NUM> and/or catheter <NUM> may then be maneuvered to the location of the second tissue edge 70b, and the second jaw 242b extended from within the catheter <NUM> with first jaw 242a, hook <NUM>, and first tissue edge 70a. The second jaw 242b may spring open and position itself over the second tissue edge 70b, when released from within the catheter <NUM>. <FIG> shows clip <NUM> with the second tissue edge 70b located between the second jaw 242b and the hook <NUM>. Once the jaw is appropriately positioned, the second jaw 242b may be retracted into the catheter <NUM> to close the second jaw 242b over the second tissue edge 70b. <FIG> illustrates the clip <NUM> in the retracted configuration. Closing the second jaw 242b over the second tissue edge 70b may also force the second tissue edge 70b against the hook <NUM>, forcing the barbs and the teeth into the second tissue edge 70b.

When the tissue edges are securely joined together, the clip <NUM> may be released and the catheter <NUM> withdrawn from the access site <NUM>. <FIG> illustrates the release of the clip <NUM> from the catheter <NUM>. The clip <NUM> along with the hook <NUM> may be separated from the elongate member <NUM> by activating a detachment mechanism on the actuation mechanism. In some embodiments, retracting the catheter <NUM> and/or elongate member <NUM> may stretch the organ wall <NUM> exerting a force on the clip. This force may break the connection of the clip to the elongate member <NUM>, thereby releasing the clip <NUM> from the catheter <NUM>. As indicated earlier, other detachment mechanisms may also be used to separate clip <NUM> from elongate member <NUM>. The released clip <NUM> may remain in the body closing the aperture <NUM>.

In some embodiments, only the hook <NUM>, with the first tissue edge 70a and the second tissue edge 70b attached to its barbs, is released. In these embodiments, the actuation member activates a detachment mechanism releasing the hook <NUM> from the elongate member <NUM>. In these embodiments, the hook <NUM> may hold the tissue edges together allowing subsequent tissue growth to permanently join the tissue edges together.

<FIG> illustrates another embodiment of a clip <NUM> that may be used to close aperture <NUM>. As in clip <NUM>, clip <NUM> may have two jaws, a first jaw 342a and a second jaw 342b, joined by a midsection having a through-hole <NUM> therein. An inside surface of the two jaws may have a corrugated surface or teeth <NUM>. The first jaw 342a and the second jaw 342b may be symmetric about a plane passing through a center of the through-hole <NUM>. It is also contemplated that in some embodiments, clip <NUM> may have a different structure, for instance, an annular structure.

Clip <NUM> may be delivered to an access site <NUM>, mounted on the surface of a sheath <NUM>. The sheath <NUM> may be delivered to the access site <NUM> via a catheter <NUM> which slides within a working lumen of the endoscope <NUM>. In some embodiments, the catheter <NUM> may be eliminated, and the sheath <NUM> may be delivered to the access site <NUM> directly via the working lumen. As described above with reference to other embodiments, clip <NUM> may transform from a closed configuration within the catheter <NUM> to an open configuration outside the catheter <NUM>. When the sheath <NUM> is pulled into the catheter <NUM>, the clip <NUM> may also retract into the catheter <NUM> until the longitudinal movement of the clip is blocked by flange <NUM>. Flange <NUM> may be a feature on the internal surface of the catheter <NUM> that blocks a clip from sliding from the distal end of the catheter <NUM> to the proximal end of the catheter <NUM>.

The sheath <NUM> may have two lumens running longitudinally therethrough. These lumens may include a first lumen 324a and a second lumen 324b running from a distal end to a proximal end of the sheath <NUM>. Two endoscopic instruments with grasper end effectors, a first grasper 326a, and a second grasper 326b, may be delivered to the access site <NUM> through the lumens of the sheath <NUM>. The grasper end effectors may include any instrument, for example, forceps, barbed needles, etc., configured to grasp any object within the body. In some embodiments, the first grasper 326a may be delivered to the access site <NUM> through the first lumen 324a, and the second grasper 326b through the second lumen 324b. It is also contemplated that, in some embodiments, both graspers may be delivered to the access site <NUM> through the same lumen. The graspers may also be extracted from the access site <NUM> through the lumens. Linkages 322a and 322b may connect the first grasper 326a and the second grasper 326b, respectively, to one or more actuation mechanisms at the proximal end of the endoscope <NUM>. These actuation mechanisms may operate the graspers at the access site <NUM>. Operating the graspers may include translating and rotating the graspers at the access site <NUM>, and moving jaws of the grasper to grasp cut/separated tissue edges between these jaws.

At the access site <NUM>, each grasper may be maneuvered to the location of a piece of tissue. The first grasper 326a may grasp the first tissue edge 70a and the second grasper 326b may grasp the second tissue edge 70b. The graspers, along with the tissue, may then be retracted from the access site <NUM>. The sheath <NUM> may also be pulled into the catheter <NUM>, pulling the grasped tissue edges and the clip <NUM> along with it. <FIG> illustrates the retraction of the sheath <NUM> into the catheter <NUM>. During retraction, the movement of the clip <NUM> may be blocked by the flange <NUM>. Continued retraction of the sheath <NUM> may plastically deform the jaws of the clip <NUM> by forcing them together. The first tissue edge 70a and the second tissue edge 70b may be trapped between the deformed jaws, thereby joining the tissue edges together. The actuation device may then be activated to release the tissue edges from the graspers 326a, 326b.

In some embodiments, multiple clips <NUM> may be mounted on the surface of sheath <NUM> (as described with reference to clip <NUM> shown in <FIG>). After a first clip is deployed, another clip <NUM> may slide down the sheath <NUM> and extend out of the distal end of the catheter <NUM>. This second clip may be used to join tissue edges as described earlier.

<FIG> illustrate another embodiment of a clip that may be used to close aperture <NUM>. Clip <NUM> of this embodiment may be delivered to the access site <NUM> at the distal end of an elongate member <NUM> extending from a working lumen of the endoscope. Similar to graspers 326a, 326b of the embodiment in <FIG>, a first grasper 426a and a second grasper 426b may also be delivered to the access site <NUM> through the elongate member <NUM>. The graspers 426a, 426b may be operated at the access site <NUM> by one or more actuation mechanisms external to the body. <FIG> illustrates clip <NUM> positioned at the access site <NUM>. The graspers 426a, 426b may extend to the access site <NUM> through holes or cavities in clip <NUM>. In some embodiments, the first grasper 426a may extend into the access site <NUM> through a first through-hole 446a and the second grasper 426b may extend into the access site <NUM> through a second through-hole 446b. It is also contemplated that, in some embodiments, both the first and the second graspers may extend through the same through-hole.

As described with reference to <FIG>, the first grasper 426a may grasp the first tissue edge 70a and draw it into clip <NUM> and the second grasper 426b may grasp the second tissue edge 70b and draw it into the clip <NUM>. The tissue edges may be drawn into the clip by retracting the grasper into the elongate member <NUM>. <FIG> illustrates a view of clip <NUM> with the first and second tissue pieces grasped by the graspers. When both tissue edges are drawn into the clip <NUM>, the actuation mechanism may be activated to release a fastener <NUM> to bind the tissue edges together. Fastener <NUM> may include a barb or any object configured to join the tissue edges. In some embodiments, the fastener <NUM> may be released from the side of clip <NUM> and may penetrate the first and second tissue pieces to join them together. However, it is also contemplated that fastener <NUM> may be released from the clip in another manner. <FIG> illustrates the fastener <NUM> joining the two tissue edges together. After the tissue edges are securely bound together, the fastener <NUM> may be released from the clip <NUM>. In some embodiments, the fastener <NUM> may be released by activating the actuation mechanism. It is also contemplated that, in some embodiments, the clip <NUM> may be retracted after joining the tissue edges together, and the staple may be pulled off the clip by the force of the stretched stomach wall. <FIG> illustrates a view of the released fastener <NUM> joining the two tissue edges together.

<FIG> illustrates an embodiment of a clip having an attached barb <NUM>. The clip <NUM> attached to an elongate member <NUM> may be delivered to the access site <NUM> through the working lumen of the endoscope <NUM>. As in previously described embodiments, the clip <NUM> may transform to an open configuration as it extends from the distal end <NUM> of the endoscope <NUM>. The clip <NUM> may include a first jaw 542a and a second jaw 542b connected at a hinge <NUM>. The elongate member <NUM> may include linkages that connect the jaws to an actuation mechanism outside the body. The actuation mechanism may be configured to move the jaws of clip <NUM> towards each other and, thereby, form a closed configuration.

A barb <NUM> may be attached to one of the jaws, for instance, the first jaw 542a, of clip <NUM>. The barb <NUM> may be hinged to the first jaw 542a at a first end 548a. The second end 548b of the barb <NUM> may form a sharp point or an arrowhead. In some embodiments, barb <NUM> may also include spikes (similar to spikes <NUM> on barb <NUM> of <FIG>) that protrude from a surface of the barb <NUM>. The barb <NUM> may be spring loaded and the second end 548b of the barb <NUM> may be retained on the first jaw 542a by a catch or another mechanism. The actuation device may be configured to release the catch. Upon release of the catch, the barb <NUM> may be configured to transform to a deployed configuration. In the embodiment of clip depicted in <FIG>, the barb <NUM> may rotate about the first end 548a and snap to a second configuration (as seen in <FIG>). In the second configuration, the second end 548b of the barb <NUM> may project from the first jaw 542a and point towards the second jaw 542b.

The second jaw 542b may have a hole <NUM> to enable the second end 548b of the barb to protrude through when the clip <NUM> is in a closed configuration. The second jaw 542b may also features designed to impart some compliance to the second jaw 542b. In <FIG>, these compliant features are depicted as slender members arranged as a cross-hair around the hole <NUM>. These members may bend slightly when an out of plane force is applied on the members, thereby providing compliance to the second jaw 542b. The purpose of the compliance will become clearer in the discussion in reference to the operation of clip <NUM>. In some embodiments, other forms of compliance enhancing features may be incorporated into the second jaw 542b. It is also contemplated that, in some embodiments, the compliance enhancing features may be eliminated.

<FIG> illustrate the use of clip <NUM> to approximate tissue edges (for example, first tissue edge 70a and second tissue edge 70b), and close aperture <NUM>. The endoscope <NUM> may be maneuvered to locate the first tissue edge 70a between the open jaws of clip <NUM>. The actuation device may then be actuated to grasp the first tissue edge 70a by closing the jaws. <FIG> depicts a view of clip <NUM> with the first tissue edge 70a grasped between its jaws. With the tissue firmly grasped, the barb <NUM> may be released from the first jaw 542a. Releasing the barb <NUM> may rotate, or otherwise actuate, the spring loaded barb <NUM> about the first end 548a to the second configuration. While moving to the second configuration, the sharp second end 548b may pierce through the grasped first tissue edge 70a. <FIG> depicts a view of the clip <NUM> with the grasped first tissue edge 70a pierced by the barb <NUM>. In some embodiments, the grasped tissue may be forced against the surface of the second jaw 542b while the barb tries to pierce through the tissue from the opposite side. Compliance enhancement features of the second jaw 542b may enable the barb <NUM> to pierce the tissue without undue trauma.

The clip <NUM> may again be opened using the actuation mechanism. <FIG> illustrates a view of clip <NUM> with the jaws open. The shape of the second end 548b may prevent the pierced first tissue edge 70a from being released when the jaws of the clip <NUM> are opened. The endoscope may again be maneuvered to position the second tissue edge 70b between the jaws of clip <NUM>. The jaws may now be closed to grasp the second tissue edge 70b between the jaws. When the jaws rotate to the closed configuration, the pointed second end 548b of the barb <NUM> may pierce the second tissue edge 70b. <FIG> depicts the clip <NUM> with both tissue edges pierced by the barb <NUM>. The clip <NUM> may again be opened and barb <NUM> detached from the first jaw 542a to release the tissue edges joined together by the barb <NUM>. <FIG> illustrates the tissue pieces joined by the barb <NUM>. In some embodiments, the barb <NUM> may be detached by releasing the first end 548a from the first jaw 542a using the actuation mechanism. In embodiments of clip <NUM> with spikes on the barb <NUM>, these spikes may assist in preventing the tissue edges from slipping off the barb <NUM>. In some embodiments, retracting the clip away from the access site <NUM> may stretch the organ wall <NUM>. The stretched organ wall may then pull the first end 548a off the first jaw 542a.

In some embodiments, the entire clip <NUM> may be released from the elongate member <NUM> after the tissue edges are joined together with the barb. Releasing the clip <NUM> may be accomplished by the actuation device or the force exerted by the stretched organ wall <NUM>.

<FIG> illustrate another embodiment of a clip with a barb <NUM> used to join cut/separated tissue edges. In the embodiment of <FIG>, the clip <NUM> may include a first jaw 642a and a second jaw 642b attached together at a hinge <NUM>. Clip <NUM> may be delivered and operated at the access site <NUM> similar to clip <NUM> of the previous embodiment. A barb <NUM> may be attached to the first jaw 642a at a first end 648a. The first end 648a may be pointed and may be retained on first jaw 642a by a catch or other retention features on first jaw 642a. The second end 648b of the barb <NUM> may project from the first jaw 642a and point towards the second jaw 642b. The second end 648b of the barb <NUM> may also be pointed. The second jaw 642b may also include retention features that are configured to couple to the second end 648b and retain the barb <NUM> to the second jaw 642b. The barb <NUM> may also include spikes <NUM> on its surface. The barb <NUM> may include spikes <NUM> pointed to both the first end 648a and the second end 648b.

The second tissue edge 70b may be positioned between the jaws of the clip <NUM> and the jaws closed. While closing, the barb <NUM> may pierce through the second tissue edge 70b. <FIG> illustrates a view of clip <NUM> with the grasped second tissue edge 70b. While in the closed configuration, the second end 648b of the barb <NUM> may engage with the retention features on the second jaw 642b. The jaws may again be opened to grasp the first tissue edge 70a. <FIG> illustrates a view of the clip <NUM> with the jaws opened. Barb <NUM> may now be retained by the retention features of the second jaw 642b. The spikes <NUM> on the barb <NUM> may prevent the second tissue edge 70b from being released when the jaws are opened. The first tissue edge 70a may be positioned between the jaws and the jaws closed again to grasp the first tissue edge 70a. <FIG> illustrates the first and second tissues grasped between the jaws of clip <NUM>. The sharp first end 648a of barb <NUM> may pierce through the first tissue edge 70a when the jaws are closed. The barb <NUM> may thus pierce through and join the first tissue edge 70a and second tissue edge 70b. As in the previous embodiment, the clip <NUM> may now be opened and the barb <NUM> released from the clip <NUM>. The barb <NUM> may keep first tissue edge 70a and second tissue edge 70b joined. In some embodiments, the entire clip <NUM> may be released from the elongate member <NUM> to leave behind the clip <NUM> joining the two tissue edges together.

<FIG> illustrate another embodiment of a clip used to attach tissue edges. As in embodiments above, clip <NUM> may also include a first jaw 742a and a second jaw 742b connected by a hinge <NUM>. Clip <NUM> attached to an elongate member <NUM> may also be delivered to the access site <NUM> through the working lumen of an endoscope <NUM> and may be operated by an actuation mechanism external to the body. As in clip <NUM>, clip <NUM> may also include a hollow through-hole <NUM> at a location between the jaws.

A claw <NUM> attached to a flexible part <NUM> may be delivered to the access site <NUM> through the through-hole <NUM>. The flexible part <NUM> may be manipulated external to the body to control the claw <NUM> at the access site <NUM>. With the jaws of the clip <NUM> open, the claw <NUM> attached to the flexible part <NUM> may be advanced through an aperture <NUM>. <FIG> shows the claw <NUM> on an opposite side of the puncture. The flexible part <NUM> and the claw <NUM> may now be retracted into the elongate member <NUM>. The claw <NUM> may snag and drag the aperture <NUM> along with the first tissue edge 70a and second tissue edge 70b into clip <NUM>. Claw <NUM> may have any shape configured to snag the tissue edges and draw them into the clip <NUM>.

<FIG> illustrates a view of the clip <NUM> with the snagged stomach wall positioned between its jaws. Once the first tissue edge 70a and the second tissue edge 70b are appropriately positioned between the jaws, clip <NUM> may be closed. <FIG> illustrates the clip <NUM> in a closed configuration. The closed clip <NUM> may grasp the tissue edges, thereby joining them together. The clip <NUM> may now be released and the endoscope retracted from within the body.

<FIG> illustrate another embodiment of a clip <NUM> used to fasten first tissue edge 70a and second tissue edge 70b at access site <NUM>. Clip <NUM> may be comprised of multiple arms, for instance, a first arm 842a and a second arm 842b. Although clip <NUM> is depicted with two arms, different embodiments of clip <NUM> may have a different number of arms. Clip <NUM> may also include a center arm <NUM> positioned between first arm 842a and second arm 842b. Center arm <NUM> may include a barb <NUM> positioned thereon. In some embodiments, barb <NUM> may be positioned at a distal end of center arm <NUM>. Although in <FIG>, barb <NUM> is shown as a projection on center arm <NUM>, barb <NUM> may have any shape and configuration. For instance, barb <NUM> may be sharp and needle shaped in some embodiments. First arm 842a and second arm 842b may be attached to the center arm <NUM> at attachment sections 846a and 846b respectively, at a proximal region of the center arm <NUM>. Any attachment mechanism may be used to attach the first and second arms 842a and 842b to the center arm <NUM>. Proximal to attachment sections 846a and 846b, center arm <NUM> may include protrusions 852a and 852b extending in a radial direction. In some embodiments, these protrusions may be spring loaded. In these embodiments, the protrusions 852a and 852b may be configured to compress or depress inwards towards center arm <NUM> upon the application of a radially inward force. In other embodiments, protrusions 852a and 852b may not be spring loaded, but may be otherwise configured to move towards the center arm <NUM> upon the application of a radially inward force. For example, protrusions 852a and 852b may be comprised of a compressible material.

From their respective attachment sections at the proximal region of center arm <NUM>, the first and second arms 842a and 842b may extend a distance longitudinally, and distally, along the length of center arm <NUM>. The first and second arms 842a and 842b may then be bent away from the center arm <NUM> such that distal regions of these arms make an angle with a distal region of center arm <NUM>. The first arm 842a may be bent away from the center arm <NUM> at a first section 844a, and the second arm 842b may be bent away from center arm <NUM> at a second section 844b. The first section 844a may be displaced longitudinally, or offset, from second section 844b.

A push-rod <NUM>, coupled to a proximal end of clip <NUM>, may be configured to extend the clip <NUM> from the distal end of a catheter <NUM> or an endoscope to access site <NUM>. Actuating the push-rod <NUM> in a distal direction may move the push-rod <NUM> into the body, and may extend clip <NUM> out of the distal end of catheter <NUM>. Actuating the push-rod in a proximal direction may retract the distal end of the push-rod <NUM> along with clip <NUM> into the catheter <NUM>.

Clip <NUM> may also include an end cap <NUM> positioned at a proximal end of first and second arms 842a and 842b. The push-rod <NUM> may pass through a through-hole <NUM> on an end piece <NUM> positioned at a proximal end of the endcap <NUM>, to couple with the proximal end of clip <NUM>. In some embodiments, end piece <NUM> may be integral with end cap <NUM>, while in other embodiments, end piece <NUM> may be a part separate from end cap <NUM>. Although end cap <NUM> may be fitted with the end piece <NUM> by any means, in some embodiments, the end piece <NUM> may be interference fitted with the proximal end of the end cap <NUM>. Actuating push-rod <NUM> in a proximal direction may pull clip <NUM> at least partially into end cap <NUM>. As clip <NUM> slides into end cap <NUM>, the walls of the end cap <NUM> may contact the first and second arms 842a and 842b, and apply a radially inward force on the arms. This radially inward force may deflect these arms towards center arm <NUM>. Since first section 844a and second section 844b of the two arms are longitudinally displaced from each other, end cap <NUM> may contact and deflect one of these arms towards the center arm <NUM> at least partially before contacting and deflecting the other arm towards the center arm <NUM>.

<FIG> illustrates a configuration of clip <NUM> with clip <NUM> partially retracted into end cap <NUM>. In the embodiment of clip <NUM> illustrated in <FIG>, the end cap <NUM> contacts and deflects the second arm 842b towards center arm <NUM> before the end cap <NUM> contacts the first arm 842a. When used in a procedure to fasten tissue segments 70a and 70b, endoscope <NUM> or catheter <NUM> with clip <NUM> may be maneuvered to locate one of these tissue edges, for example second tissue edge 70b in <FIG>, between center arm <NUM> and second arm 842b. The push-rod <NUM> may then be actuated in a proximal direction to retract clip <NUM> partially into end cap <NUM>. As the clip <NUM> slides within end cap <NUM>, internal walls of the end cap <NUM> may slide on the protrusions 852a and 852b, and apply a radially inward force on these protrusions. This radially inward force may depress the protrusions 852a and 852b radially inwards towards center arm <NUM>, thereby allowing the clip <NUM> to slide within end cap <NUM>. Walls of end cap <NUM> may also contact and apply a radially inward force on second arm 842b to deflect the second arm towards center arm <NUM>. As the second arm 842b deflects towards center arm <NUM>, second tissue edge 70b may get held between these arms. <FIG> illustrates an embodiment of clip <NUM> with second tissue edge 70b held between center arm <NUM> and second arm 842b.

The distal end of endoscope <NUM> or catheter <NUM> may then be repositioned so that another tissue edge, for instance first tissue edge 70a, may be positioned between first arm 842a and center arm <NUM>. Further actuation of the push-rod <NUM> towards the proximal end may move the clip <NUM> further into end cap <NUM>. As the clip <NUM> moves further into the end cap <NUM>, walls of the end cap <NUM> may contact and deflect the first arm 842a towards the center arm <NUM> with first tissue edge 70a between the first arm 842a and center arm <NUM>. Further actuation of the push-rod <NUM> towards the proximal end may engage the protrusions 852a and 852b of center arm <NUM> with mating features 862a and 862b on end cap <NUM>. In some embodiments, mating features 862a and 862b may be cavities in end cap <NUM> that are dimensioned to fit the protrusions 852a and 852b therein. Alignment of the protrusions with the mating features may relieve any constraining force from the protrusions, and allow the protrusions to spring back, or recover, to their original pre-depressed configuration. Engagement of the protrusions 852a and 852b with the mating features on end cap may lock the first and second arms 842a and 842b in a closed configuration, where these arms press against center arm <NUM> with the first and second tissue pieces 70a and 70b firmly grasped between them. In embodiments where center arm <NUM> includes a barb <NUM>, the barb <NUM> may also assist in firmly securing the tissue edges between the arms. <FIG> illustrates an embodiment of clip <NUM> with the arms locked in a closed configuration.

Engagement of the protrusions 852a and 852b with the mating features 862a and 862b on end cap <NUM> may also prevent the clip <NUM> from sliding further into the end cap <NUM> upon further actuation of the push-rod <NUM> towards the proximal end. Further actuation of push-rod <NUM> may stretch organ wall <NUM> and exert a force on the proximal end of clip <NUM>. This force may detach the distal end of push-rod <NUM> from the proximal end of clip <NUM>. As in other embodiments, any clip release mechanism (such as, threaded connections, frangible link, electrolysis link, etc.) may be used to separate push-rod <NUM> from the clip <NUM>. <FIG> illustrates an embodiment of clip <NUM> with the push-rod <NUM> detached from clip <NUM>.

After the push-rod <NUM> detaches from clip <NUM>, further retraction of the push-rod <NUM> towards the proximal end may cause a protrusion <NUM> on the push-rod <NUM> to abut against end piece <NUM>. In some embodiments, the push-rod <NUM> and end cap <NUM> may be dimensioned such that protrusion <NUM> of the push-rod abuts against end piece <NUM> when the push-rod <NUM> detaches from clip <NUM>. Although protrusion <NUM> is depicted as a bend in push-rod <NUM>, the protrusion <NUM> may be of any form. Further actuation of the push-rod <NUM> may force the protrusion <NUM> against end piece <NUM> and cause the end piece <NUM> to be dislodged from the proximal end of the end cap <NUM>. <FIG> illustrates an embodiment of clip <NUM> with the end piece <NUM> separated from end cap <NUM>. The push-rod <NUM> may now be retracted out of the body through the catheter or endoscope.

Other methods may also be used to disengage the push-rod <NUM> from the end cap <NUM>. In some embodiments, through-hole <NUM> may be configured to allow the push-rod <NUM> to be rotated and extracted from the end cap <NUM>. For example, the through-hole <NUM> may have two different cross-sectional shapes along two directions. In these embodiments, a cross-section of the through-hole along one direction may correspond to a diameter of the push-rod <NUM>, and the cross-section of the through-hole along another direction may correspond to the thickest region of the protrusion <NUM>. Rotating the push-rod <NUM> to align protrusion <NUM> with the direction having a matching cross-section of the through-hole will allow the push-rod to be removed from end cap <NUM>. In some embodiments, the protrusion <NUM> may be a c-shaped bend on push-rod <NUM> and the through-hole <NUM> cross-sectional shapes along two different directions may correspond to a diameter of the push-rod <NUM> and a dimension of the c-shaped bend on push-rod <NUM>. In such an embodiment, rotation of the push-rod <NUM> may extract the push-rod <NUM> through the through-hole <NUM>. In some embodiments, rotation of the push-rod <NUM> may retract the push-rod <NUM> partly through the through-hole <NUM> and engage the end piece <NUM> with the push-rod <NUM>. In these embodiments, further actuation of the push-rod <NUM> may detach the end piece <NUM> from the end cap <NUM>, leaving clip <NUM> in a locked configuration grasping the first and second tissue edges 70a and 70b.

Claim 1:
A device to approximate multiple tissue edges (70a, 70b), comprising:
a plurality of jaws (342a, 342b) each including a proximal first end and a distal second end, the jaws (342a, 342b) being coupled to each other at their first ends and configured to transform from an open configuration to a closed configuration, the open configuration being a configuration where the second ends of the jaws (342a, 342b) are located away from each other, and the closed configuration being a configuration where the second ends of the jaws (342a, 342b) are proximate to each other, wherein the plurality of jaws (<NUM>, 342b) are part of a clip (<NUM>) having a first jaw (342a) and a second jaw (342b), joined by a midsection having a through-hole (<NUM>; <NUM>) therein; and
one or more tools (326a, 326b) configured to pass between the jaws (342a, 342b), the one or more tools (326a, 326b) being configured to move relative to the jaws (342a, 342b) and grasp one or more tissue edges (70a, 70b) to position the tissue edges between the jaws (342a, 342b).