Medical device for bringing multiple tissue edges closer

Abstract

To provide a device for approximating multiple tissue edges. [Solution] A device for approximating multiple tissue edges includes a plurality of jaws, each having a first end and a second end, connected to one another at the first end, and configured to transform from an open configuration to a closed configuration, wherein in the open configuration the second ends of the plurality of jaws are spaced apart from one another and in the closed configuration the second ends of the plurality of jaws are proximate to one another.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is related to and claims priority to U.S. Provisional Patent Application No. 61 / 271,457, filed September 25, 2009, which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE INVENTION Embodiments of the present invention relate to tissue approximation clips for use during surgery. Specifically, embodiments of the present invention relate to clips that can be used to approximate tissue edges together to close openings created during surgery. [Background technology]

[0003] In recent years, a major trend in surgery has been the development and application of minimally invasive approaches to traditional surgery. In general surgery, emphasis has been placed on laparoscopic surgical techniques, which can now be applied to most intra-abdominal procedures. The resulting reduction in abdominal wall trauma has a positive impact on patients undergoing abdominal surgery.

[0004] Recently, there has been interest in less traumatic transluminal endoscopic surgery. In transluminal endoscopic surgery, an endoscope is used to carefully breach (puncture) the wall of the stomach or other organ to operate 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 transluminal endoscopic surgery, a flexible endoscope (along with the necessary surgical tools) is inserted into the stomach, for example, through a natural anatomical orifice. Once the endoscope reaches the access site within the stomach or other organ, the organ wall is punctured, and the endoscope is advanced into the abdominal cavity, where remotely controlled surgical tools can be used to perform delicate surgical procedures. Once the surgical procedure is complete, the endoscope and tools are withdrawn through the opening in the organ wall, and the opening is closed.

[0005] Minimally invasive procedures have great potential for reducing the trauma associated with surgery, but several important developments must be made before these procedures can be widely adopted. One such development is a safe and effective method for approximating two tissue edges within a body cavity so that they can be stapled or otherwise joined together. Existing tissue approximation techniques only allow for the joining of two tissue edges that are already approximated to one another. Often, it is necessary to bring one tissue edge from a first location to the location of a second tissue edge in order to join the tissue edges and thereby initiate healing. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] International Publication No. 2008 / 090978 Summary of the Invention [Means for solving the problem]

[0007] An embodiment of the present invention may include a device for approximating multiple tissue edges. The device may include multiple jaws, each having a first end and a second end, connected at the first end. The device may also include a fixation element positioned between the jaws. The jaws may be independently moved relative to the fixation element from an open configuration to a closed configuration. The open configuration may be a configuration in which the second ends of the jaws are positioned away from the fixation element, and the closed configuration may be a configuration in which the second ends of the jaws are interlocked with the fixation element to grasp the tissue edges between the jaws and the fixation element.

[0008] Various embodiments of the invention may include one or more of the following aspects: one end of the fixation element may be coupled to the plurality of jaws at a first end, the first end may be coupled to a distal end of an elongate member, a proximal end of the elongate member may be coupled to an actuation device, the actuation device may be configured to move the jaws relative to the fixation element, the elongate member may be configured to pass through a lumen of the endoscope, and the fixation element may include a barb, the barb may be configured to pierce a tissue edge between the jaw and the fixation element.

[0009] Embodiments of the present invention may also include a device for approximating multiple tissue edges. The device may include multiple jaws, each including a first end and a second end. The jaws may be interconnected at their first ends and configured to transform from an open configuration to a closed configuration. The open configuration may be a configuration in which the second end of one jaw is spaced apart from the second end of another jaw. The closed configuration may be a configuration in which the second end of one jaw is adjacent to the second end of another jaw. The device may also include one or more tools configured to pass between the jaws. The tools may be configured to move relative to the jaws and grasp the tissue edges between the jaws.

[0010] Various embodiments of the present invention may also include one or more of the following aspects: a first end of the jaw may be coupled to a distal end of an elongate member, the elongate member may be configured to pass through a lumen of an endoscope, the first end may include a hole, the elongate member may extend through the hole, a tool may be coupled to the distal end of the elongate segment, a proximal end of the elongate segment may be coupled to an actuation device configured to be located outside the body, the actuation device may be configured to control the tool to grasp the tissue edge.

[0011] Embodiments of the present invention may also include a device for approximating tissue edges. The device may include a plurality of jaws interconnected at a first end and an intermediate portion positioned between the jaws. The intermediate portion may include a plurality of forks coupled together. The forks may be configured to move to engage the jaws and grasp the tissue edges between the forks and the jaws.

[0012] Various embodiments of the invention may also include one or more of the following aspects: the intermediate portion may be coupled to a distal end of the elongate member, the proximal end of the elongate member may be coupled to an actuation device, the actuation device may be configured to move each branch, the distal end of the elongate member may include a groove, a first end of the jaw may be located proximate to the groove, the jaw may be joined at the first end, and the first end may include a hole through which the intermediate portion passes.

[0013] Embodiments of the present invention may also include a device for approximating tissue edges. The device may include a first jaw including a proximal end and a distal end, and a second jaw including a proximal end and a distal end. The first jaw and the second jaw may be configured to transform from an open configuration to a closed configuration. The open configuration may be a configuration in which the distal ends of the jaws are positioned away from each other, and the closed configuration may be a configuration in which the distal ends of the jaws are positioned close to each other. The device may also include a barb including a first end and a second end. The first end may be coupled to the first jaw. The device may include a feature on the jaw, which may be configured to receive the second end of the barb when the jaws are in the closed configuration.

[0014] Various embodiments of the invention may include one or more of the following aspects: the first jaw may move relative to the second jaw, the feature may include a hole, the jaw may include an element configured to increase the tracking of the jaw, the barb may be configured to transform from a first configuration to a second configuration, the first configuration may be a constrained configuration in which the second end of the barb is proximal to the first jaw and the second configuration may be a deployed configuration in which the second end of the barb is distal to the first jaw, the second end of the barb may include a sharp tip, the barb may include a plurality of spikes protruding from a surface of the barb, the first and second jaws may be coupled to ends of an elongate member, and the elongate member may be configured to pass through a lumen of an endoscope.

[0015] Embodiments of the present invention may also include a method of approximating tissue edges. The method may include delivering a clip to a location of the tissue edges. The clip may include a plurality of jaws and a fixation element, and the jaws may be moved from an open configuration to a closed configuration. The method may also include grasping the tissue edges between the jaws and the fixation element and moving the clip with the grasped tissue edges to a location adjacent a second tissue edge. The method may further include grasping the tissue edges between a second jaw and the fixation element and releasing the clip with the tissue edges grasped between the jaws.

[0016] Various embodiments of the invention may also include one or more of the following aspects: a fixation element may be located between the jaws, the jaws may be moved independently relative to the fixation element, the closed configuration of the jaws may be a configuration in which the jaws are interlocked with the fixation element and the open configuration may be a configuration in which the jaws may be positioned away from the fixation element, delivering the clip may include delivering the clip through a lumen of the device extending into the body, extending the clip outside the lumen may convert the jaws to the open configuration, and retracting the clip into the lumen may convert the jaws to the closed configuration, the method may further include retracting the clip into the lumen to convert the jaws to the closed configuration, grasping an edge of tissue between the jaws and the fixation element, and grasping another edge of tissue between the jaws and the fixation element, and the fixation element may include a barb configured to penetrate the tissue edge.

[0017] Embodiments of the present invention may also include another method of approximating tissue edges. The method may include delivering a clip including multiple jaws to the location of the tissue edges and delivering a first tool to the location of the tissue edges. The method may also include grasping the tissue edges using the first tool, retracting the first tool with the grasped tissue edges to a location between the jaws, and delivering a second tool to the location of the tissue edges. The method may further include grasping a second tissue edge using the second tool and retracting the second tool with the grasped tissue edges to a location between the jaws to approximate the tissue edges.

[0018] Various embodiments of the invention may also include one or more of the following aspects: the jaws may include a first end and a second end and may be configured to transform from an open configuration to a closed configuration, where the open configuration may be a configuration in which the distal ends of the jaws are spaced apart from one another and the closed configuration may be a configuration in which the distal ends of the jaws are proximate to one another; delivering the clip may include delivering the clip through a lumen of a device extending into the body, where the lumen may include one of a lumen of a catheter or a working lumen of an endoscope; extending the clip outside the lumen may transform the jaws into the open configuration and retracting the clip into the lumen may transform the jaws into the closed configuration; The method may further include extending a clip outside the lumen to convert the jaws to an open configuration, and retracting the clip into the lumen to convert the clip to a closed configuration and grasp the tissue edges between the jaws, and the method may further include releasing the tissue edges from the first tool and the second tool, releasing the clip while it is grasping the tissue edges, penetrating the grasped tissue edges with barbs to join the tissue edges together, releasing the tissue edges from the first tool and the second tool, and releasing the barbs while it is penetrating the tissue edges.

[0019] Embodiments of the present invention may also include another method of approximating tissue edges. The method may include delivering a clip to a location of tissue edges, the clip including jaws coupled together, at least one jaw movable relative to the other jaw from an open configuration to a closed configuration, and barbs coupled to the jaws. The method may also include converting the movable jaw to a closed configuration to grasp the tissue edges between the jaws, and penetrating the tissue edges with the barbs. The method may further include moving the clip with the grasped tissue edges to a location adjacent to the other tissue edges, and converting the movable jaw with the grasped tissue edges to an open configuration. The method may also include converting the movable jaw to a closed configuration to grasp the tissue edges between the jaws, and the tissue edges may be penetrated by the barbs.

[0020] Various embodiments of the invention may include one or more of the following aspects: the barbs may penetrate the tissue edges while the movable jaws may be transformed into a closed configuration to grasp the tissue edges, the closed configuration may be a configuration in which a distal end of each of the jaws is proximate to one another, the open configuration may be a configuration in which the distal ends of each of the jaws are spaced apart from one another, the barbs may include a first end and a second end, the first end may be coupled to the jaws, the second end may form a sharp point, the second end of the barbs may be proximate to the first jaw, and the method may further include moving the barbs to a deployed orientation, the second end of the barbs grasping the tissue edges. the barbs may be positioned to penetrate the tissue edges after converting the movable jaw to a closed configuration to close the tissue edges, the method may also include a tracking feature on the jaw, and the barbs may include a plurality of spikes protruding from a surface of the barbs, releasing the clip with the clip gripping the tissue edges and decoupling the barbs from the clip with the barbs penetrating the tissue edges, and delivering the clip includes delivering the clip through a lumen of a device extending into the body, and the device may include one of a catheter or an endoscope.

[0021] Embodiments of the present invention may also include another method of approximating tissue edges. The method may include delivering a clip mounted on an elongate member to a location of the tissue edges, the elongate member may include multiple forks at a distal end and a clip including multiple jaws positioned around the forks, the forks may be moved between a closed configuration and an open configuration. The method may also include moving the forks to the open configuration to grasp the tissue edges between the forks and the jaws, and moving the clip with the grasped tissue edges to a location proximate the tissue edges. The method may also include moving the forks to the open configuration to grasp the tissue edges between the forks and the jaws, and releasing the clip while the clip grasps the tissue edges.

[0022] Various embodiments of the invention may also include one or more of the following aspects: delivering the clip may include delivering the clip through a lumen of a device extending into the body, extending the clip outside the lumen may convert the jaws to an open configuration, and retracting the clip into the lumen may convert the jaws to a closed configuration, the open configuration may be a configuration in which the distal ends of the jaws are positioned away from each other, and the closed configuration may be a configuration in which the distal ends of the jaws are positioned closer to each other, extending the clip outside the lumen and converting the jaws to the closed configuration to convert the jaws to the open configuration; The method may include retracting a clip into the lumen to grasp a tissue edge between the jaws and the forks, and retracting the forks from between the jaws in the closed configuration, wherein delivering the clip may include placing the clip over a groove in the elongate member, the groove may be located proximate to the distal end of the elongate member, and placing a second clip over the groove after releasing the clip, wherein the forks may be moved independently between the closed configuration and the open configuration relative to another fork, and wherein multiple clips may be mounted on the elongate member.

[0023] Embodiments of the present invention may also include another method of approximating tissue edges. The method may include delivering a clip including multiple jaws to a location of the tissue edges, the jaws being configured to convert between an open configuration and a closed configuration, delivering a capturing tool into the body, and engaging the tissue edges using the capturing tool. The method may also include retracting the capturing tool to drag the tissue between the jaws, converting the jaws to a closed configuration to grasp the tissue edges between the jaws, and releasing the clip with the clip grasping the tissue edges.

[0024] Various embodiments of the invention may include one or more of the following aspects: delivering the clip includes delivering the clip through a lumen of a device extending into the body, extending the clip outside the lumen converts the jaws to an open configuration, and retracting the clip into the lumen converts the jaws to a closed configuration, where the open configuration may be a configuration in which the distal ends of the jaws are positioned apart from one another and the closed configuration may be a configuration in which the distal ends of the jaws are positioned closer to one another, extending the clip outside to deploy the jaws to the open configuration and retracting the clip into the lumen to convert the jaws to the closed configuration, and delivering the capturing tool into the body includes delivering a first capturing tool into the body between the jaws. and delivering a second capturing tool into the body between the jaws, wherein hooking the tissue edge may include hooking the tissue edge using the first capturing tool and hooking the tissue edge using the second capturing tool, wherein retracting the capturing tool may include retracting the capturing tool to drag the tissue edge into place between the jaws and retracting the capturing tool to drag the second tissue edge into place between the jaws, wherein delivering a clip includes delivering a clip mounted on an elongate member into the body, and wherein releasing the clip includes sliding the clip off the elongate member. [Brief explanation of the drawings]

[0025] 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. [Figure 1] FIG. 1 is a schematic diagram of an endoscope for performing an exemplary transluminal endoscopic procedure. [Figure 2] 2A and 2B are schematic illustrations of an exemplary clip for closing an opening created during endoscopic surgery. [Figure 3] 3A-3H are illustrations of an exemplary method of using the clip. [Figure 4] FIG. 4 is a schematic diagram of another embodiment of a clip. [Figure 5] 5A-5D are illustrations of an exemplary method of using the clip. [Figure 6] FIG. 6 is a schematic diagram of another embodiment of a clip. [Figure 7] 7A-7E are illustrations of an exemplary method of using the clip. [Figure 8] 8A and 8B are illustrations of another embodiment of the clip and a method of using the clip. [Figure 9] 9A-9D are illustrations of another embodiment of the clip and a method of using the clip. [Figure 10] FIG. 10 is a schematic diagram of another embodiment of a clip. [Figure 11] 11A-11E are illustrations of an exemplary method of using the clip. [Figure 12] 12A-12E are illustrations of another embodiment of the clip and a method of using the clip. [Figure 13] 13A-13E are illustrations of another embodiment of the clip and a method of using the clip. [Figure 14] 14A-14F are illustrations of another embodiment of the clip and a method of using the clip. DETAILED DESCRIPTION OF THE INVENTION

[0026] Reference will now be made in detail to the exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. However, the invention is not limited to the specific embodiments and drawings described herein.

[0027] FIG. 1 illustrates an exemplary endoscope 10 performing an exemplary endoscopic procedure. Non-limiting examples of endoscopic procedures may include cholecystectomy, gastrojejunostomy, gastrectomy, polypectomy, vasectomy, tubal ligation, etc. In one embodiment, endoscope 10, or other suitable device such as a guide tube or catheter, may be inserted through the esophagus into stomach 5. Endoscope 10 may create an opening 80 in an organ wall 70, pass through opening 80, and operate at a work site. The work site may include, for example, a portion of small intestine 50. It should be emphasized that the illustrated application of endoscope 10 in FIG. 1 is exemplary only, and the presently disclosed invention may be applied to any surgical application or medical procedure known in the art.

[0028] The endoscope 10 may include an elongate member 15 extending between a proximal end 60 and a distal end 90. In the configuration shown in FIG. 1 , the proximal end 60 may comprise the end of the endoscope 10 that is outside the body, and the distal end 90 may comprise the end of the endoscope 10 that is within the body. Multiple lumens 20 may extend longitudinally through the endoscope 10. The lumens 20 may extend between the proximal end 60 outside the body and the distal end 90 within the body. In some embodiments, the longitudinal axes of the lumens may be substantially parallel to the longitudinal axis of the endoscope 10.

[0029] The lumens 20 may provide access to devices and equipment that may be useful in performing diagnostic or therapeutic tasks within the body. Generally, the lumens may be of any shape or geometry. In some embodiments, some or all of the lumens may be lined with a polymer or another layer or coating to facilitate use. These lumens 20 may include one or more of aspiration lumens, irrigation lumens, illumination lumens, viewing lumens, and working lumens, among others. The illumination lumens may include a device at the distal end configured to illuminate the work site. These devices may include, among others, a bulb, an LED, a fiber optic cable, and a light guide. The viewing lumens may include a device (such as a camera) at the distal end 90 configured to deliver an image of the work site outside the body. In some embodiments, the camera may be a digital camera, such as a CCD or CMOS camera. The illumination and viewing lumens may also include cables that may extend from the distal end 90 to the proximal end 60.

[0030] The irrigation lumen may be configured to facilitate fluid flow from the proximal end 60 to the distal end 90. In some embodiments, the proximal end 60 of the irrigation lumen may be attached to a fluid source, and the distal end 90 may be attached to a nozzle to modify the fluid flow. The aspiration lumen may be configured to facilitate suction and / or fluid flow therethrough. In some embodiments, fluid may flow from the proximal end 60 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 the fluid from the work site. For example, along with the fluid (delivered to the work site via the irrigation lumen), a tissue sample may be extracted outside the body through the aspiration lumen.

[0031] The working lumen may include a hollow cavity configured to deliver the endoscopic instrument 30 to the work site. The endoscopic instrument 30 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 32 that may be attached to the distal end of the endoscopic instrument 30. 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 allow the end effector 32 of the endoscopic instrument 30 to pass therethrough. Some embodiments of the endoscope may include multiple working lumens to deliver multiple surgical tools to the work site.

[0032] In addition to the end effector 32, the endoscopic instrument 30 may also include a mechanism for manipulating the end effector 32 from outside the body. This mechanism may include a linkage at a proximal end connecting the end effector 32 to an actuation device (not shown). This linkage may manipulate the end effector 32 in response to actuation of the actuation device. For example, in some embodiments, the end effector 32 may include a forceps having a pair of jaws rotatably coupled to one another. The linkage in this embodiment may include a pair of cables, each coupled to a jaw of the forceps at its distal end and to the actuation device at its proximal end. Actuation of the actuation device may move one of the cables relative to the other, opening and closing the jaws of the forceps.

[0033] The end effector 32 may include any medical instrument that may be used in conjunction with the endoscope 10. In some embodiments, the end effector 32 may include a purely mechanical medical instrument (e.g., biopsy forceps, baskets, graspers, snares, surgical knives, needles, suturing instruments, etc.), while in other embodiments, the end effector 32 may also include devices having components activated by electrical current (e.g., electric motors, heating elements for cutting or cauterizing, hemostatic devices, radiofrequency ablation devices, etc.). The end effector 32 may also include surgical instruments, such as trocars, used to puncture interior surfaces of the body.

[0034] In the exemplary transluminal endoscopic procedure shown in FIG. 1 , an endoscope 10 may be inserted into the body through a natural anatomical orifice (such as the mouth, anus, or vagina). Once the distal end 90 of the endoscope 10 is adjacent to an interior surface (such as an organ wall 70), an endoscopic instrument 30, e.g., an end effector suitable for puncturing the organ wall 70, may be delivered to the distal end 90 of the endoscope 10 through the working lumen. The end effector may be used to puncture the organ wall 70. Puncturing the organ wall 70 may create multiple cut tissue edges. These tissue edges may include a first tissue edge 70a and a second tissue edge 70b. Once the organ wall 70 is punctured, the endoscopic tool 30 with the end effector 32 may be withdrawn from the working lumen, and the endoscope 10 may be inserted into the abdominal cavity through the opening 80. Once the distal end 90 of the endoscope 10 is positioned at the desired work site, for example, the small intestine 50, an endoscopic tool 30 having an end effector 32 configured to perform the desired task may be delivered to the work site through the working lumen.

[0035] The desired operation may be performed at the work site using the end effector 32. If more than one tool is needed to complete the desired task, other desired end effectors 32 may also be delivered to the work site. After completion of the desired operation, the endoscope 10 and tools may be retracted from the abdominal cavity through the opening 80. The opening 80 may be closed by joining the separated tissue edges (e.g., first tissue edge 70a and second tissue edge 70b) to initiate the healing process. To close the opening 80, two or more tissue edges that are spatially displaced from one another may need to be repositioned near one another (referred to herein as "approximated") before they can be joined together. Now, a tissue approximation clip according to an embodiment of the present disclosure may be delivered to the access site 55 or opening via the working lumen. The approximation clip may be configured to grasp the tissue edges at different locations at the access site 55, approximate them to one another, and join the tissue pieces together.

[0036] The tissue approximation clips of the present disclosure may be made of any suitable biocompatible material. Generally, the clips may be constructed from materials with any type of structural behavior, such as materials that exhibit elastic, plastic, elastically perfectly plastic, superelastic, etc. In some embodiments, a bioabsorbable material may be included. It is also contemplated that in some embodiments, the clip may be constructed from multiple components made from multiple materials. In some embodiments, the clip may comprise a shape memory alloy (SMA). Non-limiting examples of SMAs included in clips include alloys such as 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, the clip may comprise or be constructed from nitinol.

[0037] In general, clips of the present disclosure may be fabricated by any process known in the art. In some embodiments, the arms or jaws of the clip may be formed by bending the material, and the holes or cavities through the clip may be formed by machining or laser drilling. In some embodiments, the clip may undergo heat treatment or other microstructurally modifying metallurgical operations during or after the manufacturing process. In embodiments in which the clip may include a shape memory alloy, the clip material or the manufactured clip may undergo metallurgical treatments. These metallurgical operations may enable the clip to transform from a first configuration to a second configuration upon application of heat or other stimuli. The first configuration may correspond to the martensite phase of the shape memory alloy, and the second configuration may correspond to the austenite phase. Some embodiments of clips of the present disclosure and their methods of operation are now described in the following paragraphs.

[0038] FIG. 2A shows an embodiment of a tissue approximation clip 40 that can be delivered to an opening 80. The clip 40 may comprise a unitary structure or may resemble a strip of material folded along a plane 54 that is angled relative to and passes through the center of the strip. The clip 40 may have two jaws, a second jaw 42a and a first jaw 42b, joined by an intermediate portion 43. The clip 40 may further include a through hole 46. The inner surfaces of the two jaws may have irregular or wavy surfaces, such as teeth 45. While the surface corrugations of the clip 40 are illustrated as teeth 45, any type of surface configuration may be used. In some embodiments, the second jaw 42a and the first jaw 42b may be symmetrical about a plane 54 that may pass through the center of the through hole 46. However, it is contemplated that in some embodiments, the two jaws may not be symmetrical. The through hole 46 may have any shape. In some embodiments, the through hole 46 may have a circular shape.

[0039] Although clip 40 is illustrated as having two jaws (second jaw 42a and first jaw 42b) and a constant cross-section along the thickness direction, clip 40 is contemplated to have other configurations. For example, in the embodiment of clip 40a shown in FIG. 2B, clip 40a may resemble a tulip having at least three jaws: second jaw 42a, first jaw 42b, and third jaw 42c. The jaws may be shaped substantially like the petals of a tulip. Other embodiments of clip 40a may have a different number of jaws. As in the embodiment shown in FIG. 2A, the jaws of clip 40a may be joined by a middle portion 43a having a centrally located through-hole 46a. A shaft 54a may pass through the center of through-hole 46a, and the inner surfaces of the three jaws may have wavy surfaces or teeth 45a.

[0040] 3A-H illustrate an exemplary method of using clips 40 to approximate and join tissue edges. One or more clips 40 may be mounted on a push rod 22 and delivered to an access site 55 through a tubular catheter 35. The clips 40 may be constrained to a closed configuration while inside the catheter 35. At the access site 55, the clips 40, still mounted on the push rod 22, may be extended from within the catheter 35. As the clips 40 emerge from within the catheter 35, the constraint holding the clip in the closed configuration may be released, allowing the clip to expand to an open configuration. It is also contemplated that in some embodiments, the constraint may force the clip 40 into the open configuration as it emerges from the catheter 35. The access site 55 may have one or more tissue edges, such as a first tissue edge 70a and a second tissue edge 70b, created while traversing through the visceral wall 70. The first tissue edge 70a may be grasped between one jaw and the push rod 22 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 22. The push rod 22 may then be withdrawn from between the clip 40 and retracted into the catheter 35, releasing the clip 40 with the tissue edges grasped between its jaws. The released clip 40 may approximate the first tissue edge 70a and the second tissue edge 70b. The steps of several embodiments of a method of operating the clip 40 will now be described in further detail.

[0041] 3A and 3B illustrate the step of placing clip 40 onto push rod 22. Push rod 22 may be an elongated member having a groove 28 near its distal end. Beyond groove 28, push rod 22 may include a hinge with two branches, second branch 24a and first branch 24b. The two branches may form the distal-most portion of push rod 22. Hinge 26 may allow each branch to open independently of the other. In some embodiments, opening of the branches may be a purely mechanical action, while in other embodiments, energy such as heat and / or electricity may be used alone or in combination with mechanical energy to open the branches. During opening, second branch 24a and first branch 24b may rotate about hinge 26. During closing, the branches may rotate in opposite directions. Although the forks are described as rotating about hinge 26 while opening and closing, it is also contemplated that in some embodiments, the two forks may move in other ways relative to one another while opening and closing. The opening and closing of the forks may be controlled by an actuation mechanism at the proximal end of push rod 22. This actuation mechanism may include linkages connecting the forks to the actuation mechanism. These linkages may open and close the forks in response to activation by an actuation device. In some embodiments, the linkages may include cables coupled to each fork. In these embodiments, pulling the cables connected to the forks may open the forks. In other embodiments, the push rod may push the forks open. In some embodiments, the forks may be spring-biased to stay in a closed configuration. In these embodiments, pulling the cables may open the forks, and releasing the cables may close the forks.

[0042] The distal end of the push rod 22 may be inserted into the through hole 46 to load one or more clips 40 onto the push rod, with the jaws of the loaded clip facing the forks. In some embodiments, the diameter of the through hole 46 and the push rod 22 may be such that frictional resistance between the mating surfaces of the clip and the push rod holds the clip 40 on the surface of the push rod 22. The clip closest to the two forks may be positioned on the push rod 22 so that the through hole 46 of the clip may rest above the groove 26. While the clip 40 is in this position, opening the forks of the push rod may rotate the forks until they rest above the teeth 45 of the jaws of the clip 40. For example, when the clip 40 is positioned above the groove 26, opening the first fork 24b may rotate the first fork counterclockwise until it rests against the teeth 45 of the first jaw 42b (see FIG. 3E). Further opening of the first fork 24b may press the fork against the first jaw 42b.

[0043] The push rod 22, along with the loaded clip, may be inserted into the catheter 35, as seen in FIG. 3C . The catheter 35 may comprise a hollow tube having an outer diameter sized for insertion into the working lumen of the endoscope 10. The jaws of the clip 40 may be deflected inward from an open configuration to a closed configuration while inserted into the catheter 35. The inner diameter of the distal end of the catheter 35 may be such that the clip in the closed configuration may freely slide longitudinally within the catheter. The push rod 22 may be inserted into the catheter 35 so that all loaded clips are installed within the catheter and the proximal end of the push rod 22 protrudes from the proximal end of the catheter 35. Some distance near the distal end, the inner surface of the catheter 35 may have a flange 58 designed to stop longitudinal movement of the clip 40. In some embodiments, the flange 58 may be a reduced-diameter region of the catheter 35. It is also contemplated that the flange 58 may have other configurations, such as a protrusion sized to prevent passage of the loaded clip past the protrusion.

[0044] In some embodiments, the distance of the flange 58 from the distal-most end of the catheter 35 may be a factor in determining the number of clips 40 that may be loaded onto the push rod installed within the catheter. The inner diameter of the catheter 35 may be configured to facilitate loading of the clips onto the grooves 28 of the push rod 22. For example, pulling the push rod 22 proximally from the proximal end of the catheter 35 may move the push rod, along with the loaded clip, into the catheter toward the proximal end. During this movement, the loaded clip may pass into the flange 58. Thus, the flange may prevent longitudinal movement of the clip toward the proximal end. Further pulling the push rod toward the proximal end may cause the push rod to slide over the through-hole 46, thereby loading the clip onto the groove.

[0045] Now, the catheter 35 with the inserted push rod 22 may be delivered to the access site 55 through the working lumen of the endoscope 10. The endoscope may be placed within the body such that the distal end 90 of the endoscope 10 is proximate to the access site 55. FIG. 3D illustrates one embodiment of delivery of a clip 40 to the access site 55. The catheter 35 may be delivered such that the loaded clip 40 extends from the distal end 90 of the endoscope 10. Thus, during placement, the push rod 22 with the loaded clip 40 may be extended out the distal end of the catheter 35 by pushing the push rod 22 from the proximal end into the catheter 35. When the push rod 22 is pushed into the catheter 35 such that the clip 40 placed over the groove 28 extends from the distal end of the catheter 35, the jaws of the clip 40 may spring back to their open configuration. It is contemplated that in some embodiments, the jaws may not fully return to their pre-deformed configuration but may retain some plastic deformation. Here, the distal end 90 of the endoscope 10 and / or the distal end of the catheter 35 may be manipulated to place the expansion clip 40 and approximate one tissue edge (first tissue edge 70a or second tissue edge 70b).

[0046] The clip 40 may now be used to grasp these separated tissue edges. FIG. 3E illustrates the step of grasping the second tissue edge 70b between the first fork 24b and the first jaw 42b. To grasp the second tissue edge 70b, the clip 40 may be manipulated to position the second tissue edge 70b between the first fork 24b and the first jaw 42b. Once the clip 40 is properly positioned, an actuation device may be used to open the first fork 24b. Opening the first fork 24b may rotate the first fork 24b about the hinge 26 in a counterclockwise direction. Opening the first fork 24b may force the captured second tissue edge 70b against the teeth 45 of the first jaw 42b, thereby firmly grasping the second tissue edge 70b between the first fork 24b and the first jaw 42b. Thus, while grasping the second tissue edge 70b, the endoscope 10 or catheter 35 may be manipulated to the location of the first tissue edge 70a. Once the clip 40 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. Figure 3F shows the clip 40 grasping the first tissue edge 70a.

[0047] With the two tissue edges firmly grasped between the jaws and the fork, the push rod 22 may be pulled toward the proximal end to urge the clip 40 toward the catheter 35. FIG. 3G shows one embodiment of the clip 40 being pulled toward the catheter 35. While the clip 40 is being retracted into the catheter 35, the clip's opening jaws are pushed inward by the walls of the catheter 35. The reaction force of the catheter 35 against the clip's opening jaws may deform the jaws with the tissue edges and fork clamped between them. In some embodiments, part or all of the clip 40 may enter the distal end of the catheter 35 as the push rod 22 is retracted into the catheter 35 with the tissue edges clamped between its jaws.

[0048] In some embodiments, further retraction of the push rod 22 from the proximal end of the catheter 35 may further withdraw the fork from between the jaws of the clip 40, leaving the tissue edges clamped between the deformed jaws of the clip. In embodiments in which a pair of deformed clips 40 advances into the distal end of the catheter 35 upon retraction of the push rod 22, retracting the catheter 35 away from the access site 55 may stretch the organ wall 70, allowing the clip 40 to be withdrawn from the distal end of the catheter 35 with the first tissue edge 70a and the second tissue edge 70b clamped between the jaws. FIG. 3H shows the deformed clip 40 with the tissue edges clamped between its jaws. The clip 40 may thus close the opening 80 by joining the two tissues together. The act of retracting the push rod 22 into the catheter 35 may also place another mounted clip 40 into the groove 28 of the push rod 22, as previously described.

[0049] While the above description describes using clip 40 to close a puncture with two tissue edges, the same general approach can be used to close an opening 80 with more than two tissue edges. A clip with multiple jaws may be used to close a puncture with more than two tissue edges. For example, the three-jaw clip 40a shown in FIG. 2B may be used to close an opening 80 with three tissue edges. In this embodiment, push rod 22 may include three prongs that may be opened and closed independently from outside the body. Clip 40a may be mounted on push rod 22 and delivered to access site 55, as described above. At access site 55, a first tissue edge may be grasped between the jaws and prongs and dragged to the location of a second tissue edge. The second tissue edge may then be grasped between the second jaw and prong. The distal end of catheter 35 may then be manipulated to the location of a third tissue edge, and the third tissue edge may be grasped between the third prong and jaw. The push rod 22 may then be retracted into the catheter to deform the jaws of the clip 40a, as previously discussed. The push rod 22 may further be retracted to extract the forks from between the jaws, thereby leaving the tissue edges compressed together by the deformed jaws. While the above description 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 the clip may be different from the number of forks.

[0050] It is also contemplated that a device having two jaws (such as clip 40 shown in FIG. 2A) may be used to close an opening having more than two tissue edges. In such an application, two or more tissue edges may be grasped between the jaws and forks. A first tissue edge is securely engaged with jaw teeth 45 so that it cannot be released when the jaws are opened to grasp a second tissue edge.

[0051] FIG. 4 illustrates another embodiment of a tissue approximation clip 140 that can be used to close the opening 80. The clip 140 of FIG. 4 may be attached to the distal end of the elongated member 122 and delivered to the access site 55 through the working lumen of the endoscope 10. In some embodiments, the elongated member 122 carrying the clip 140 may be delivered to the access site 55 via a catheter inserted into the working lumen. The elongated member 122 may connect the clip 140 to an actuation device attached to its proximal end. The elongated member 122 may include mechanisms such as links or cables that can enable the actuation device to manipulate the clip 140. These actuation mechanisms may be similar to or different from those discussed with reference to the clip 40 of FIG. 3A. The clip 140 may protrude from the distal end of the endoscope 10 to impinge on the opening 80.

[0052] The clip 140 may include three jaws: a first jaw 142a, a second jaw 142b, and a fixed central jaw 124. The jaws may have corrugated surfaces, teeth 145, or other surface modifications on their opposing faces. Similar to the open left and right forks of the embodiment shown in FIGS. 3A-3H, the first jaw 142a and the second jaw 142b may be movable and may be opened and closed using an actuation mechanism. Closing the first jaw 142a may actuate this jaw about the hinge 126 until the teeth 145 on its surface press against the teeth 145 on the fixed central jaw 124. Closing the second jaw 142b may then actuate this jaw about the hinge 126 until its teeth 145 contact the teeth 145 on the central jaw 124. 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 be actuated to the closed configuration when the opening force is removed. In some embodiments, when the jaws are closed relative to the center jaw, teeth 145 on both jaws lock to keep the jaws in the closed configuration.

[0053] 5A-D illustrate a method of using a clip 140 to approximate tissue edges 70a and 70b to close an opening 80. The clip 140 is attached to the distal end of the elongate member 122 and delivered to the site of the opening 80 via the working lumen of the endoscope 10. FIGS. 5A and 5B show the clip 140 grasping a tissue edge 70a at an access site 55. At the access site 55, the endoscope 10 is manipulated to place the first tissue edge 70a between the central jaw 124 of the clip and another jaw, for example, the first jaw 142a. The actuation device is then actuated to close the first jaw and firmly grasp the first tissue edge 70a between the first jaw 142a and the central jaw 124. In the closed configuration, teeth 145 of the first jaw 142a and the central jaw 124 engage, thereby locking the first jaw 142a in the closed configuration.

[0054] The clip 140, with the first tissue edge 70a grasped, is manipulated to the site of the second tissue edge 70b. The second tissue edge 70b is placed between the second jaw 142b and the central jaw 124, and the second jaw 142b is closed to lock the second tissue edge 70b between the teeth 145 of the jaws. FIG. 5C shows the first and second tissue edges 70a and 70b firmly grasped by the clip 140. The clip 140 may then close the opening 80 by joining the tissue edges forming the opening 80 together. Once the tissue edges are joined, the clip 140 may then be released. FIG. 5D shows the released clip 140. The released clip 140 leaves the opening 80 closed and may allow the natural healing process to grow fresh tissue around the joined tissue edges.

[0055] In general, the clip may be released from the elongate member by any means. In some embodiments, a frangible or electrolytic link may be used to release the clip from the elongate member. Clip 140 may also be released from the elongate member by any other suitable method, including using an actuation mechanism. In some embodiments, a fastener may hold clip 140 on the distal end of elongate member 122. In these embodiments, the actuation mechanism may manipulate the fastener to release clip 140. In some embodiments, the distal end of elongate member 122 may have threads that mate with threads on a mating surface of clip 140. In these embodiments, rotating elongate member 122 about its longitudinal axis may unscrew clip 140 from elongate member 122 and release clip 140.

[0056] FIG. 6 shows another embodiment of a tissue approximation clip 240 that can be used to close the opening 80. The clip 240 may include a first jaw 242a and a second jaw 242b, each hingedly coupled to the elongated member 222 at hinges 226a and 226b (see FIG. 7A ). The first jaw 242a and the second jaw 242b may also include teeth 245 or other surface irregularities on opposing surfaces. The clip 242 may be located at the distal end of the elongated member 222 and delivered within the catheter 35 to the access site 55. The catheter 35 may be delivered to the access site 55 through the working lumen of the endoscope 10. The first jaw 242a and the second jaw 242b may be configured to slide independently over the elongated member 222 and extend from the distal end of the catheter 35. A hook 224 having a barb may also be located between the first jaw 242a and the second jaw 242b. The barb may be a sharp needle like feature protruding from the distal end of the hook 224, or simply a raised profile at the distal end of the hook 224. The clip 240 may close the opening 80 by clamping the tissue edges between its jaws. Figures 7A-E illustrate a method of using the clip 240 to approximate and join tissue edges.

[0057] When the distal end of the catheter 35 is proximate the first tissue edge 70a, the first jaw 242a, along with the hook 224, may be extended from within the catheter 35. The jaws may be biased to open when released from within the catheter 35. The catheter 35 and / or endoscope 10 may be positioned to place the first tissue edge 70a between the dilating jaws and the hook 224. FIG. 7A shows the device 240 with the first tissue edge 70a located between the first jaw 242a and the hook 224. Once the tissue is properly positioned, the first jaw 242a, along with the hook 224, may be retracted into the catheter 35. A catch or feature on the inner surface of the catheter 35 may prevent the second jaw 242b from retracting further into the catheter 35 when the first jaw 242a is retracted. Withdrawing the catheter 35 may urge the first jaw 242a into a closed configuration, trapping the tissue between the jaws and the hook 224. 7B shows clip 240 having first tissue edge 70a grasped by first jaw 242a and hook 224. As first jaw 242a closes over first tissue edge 70a, barbs on hook 224 and teeth 245 on first jaw 242a may lock or otherwise cooperate to hold first tissue edge 70a securely in place. In clip embodiments having sharp barbs and teeth, the barbs and teeth may penetrate first tissue edge 70a to hold the tissue edge securely between the jaw and hook.

[0058] The endoscope 10 and / or catheter 35 may then be manipulated to the location of the second tissue edge 70b, and the second jaw 242b may be extended from within the catheter 35 along with the first jaw 242a, hook 224, and first tissue edge 70a. Once released from within the catheter 35, the second jaw 242b may spring open and position itself over the second tissue edge 70b. FIG. 7C shows the clip 240 with the second tissue edge 70b positioned between the second jaw 242b and the hook 224. Once the jaws are properly positioned, the second jaw 242b may be retracted into the catheter 35 to close the second jaw 242b over the second tissue edge 70b. FIG. 7D shows the clip 240 in a retracted configuration. Closing the second jaw 242b over the second tissue edge 70b may also force the second tissue edge 70b against the hook 224, forcing the barb and tines into the second tissue edge 70b.

[0059] Once the tissue edges are securely joined together, the clip 240 may be released and the catheter 35 may be withdrawn from the access site 55. FIG. 7E illustrates the release of the clip 240 from the catheter 35. The clip 240, along with the hook 224, may be separated from the elongated member 222 by activating a detachment mechanism on the actuation mechanism. In some embodiments, retracting the catheter 35 and / or the elongated member 222 may stretch the organ wall 70, which exerts a force on the clip. This force may sever the clip's connection to the elongated member 222, thereby releasing the clip 240 from the catheter 35. As previously shown, other detachment mechanisms may also be used to separate the clip 240 from the elongated member 222. The released clip 240 may close the opening 80 and remain within the body.

[0060] In some embodiments, only the hook 224 is released, leaving the first tissue edge 70a and the second tissue edge 70b attached to its barb. In these embodiments, an actuation member activates a detachment mechanism that releases the hook 224 from the elongate member 222. In these embodiments, the hook 242 holds the tissue edges together, allowing subsequent tissue growth to permanently join the tissue edges together.

[0061] 8A shows another embodiment of a clip 340 that may be used to close opening 80. As with clip 40, clip 340 may have two jaws, first jaw 342a and second jaw 342b, joined by a middle portion having a through hole 346 therein. The inner surfaces of the two jaws may have wavy surfaces or teeth 345. First jaw 342a and second jaw 342b may be symmetrical about a plane passing through the center of through hole 46. It is also contemplated that in some embodiments, clip 340 may have a different structure, for example, an annular structure.

[0062] The clip 340 may be delivered to the access site 55 mounted on the surface of the sheath 324. The sheath 324 may be delivered to the access site 55 via the catheter 35, which slides within the working lumen of the endoscope 10. In some embodiments, the catheter 35 may be eliminated, and the sheath 324 may be delivered to the access site 55 via the working lumen. As described above with reference to other embodiments, the clip 340 may transform from a closed configuration within the catheter 35 to an open configuration outside the catheter 35. As the sheath 324 is retracted into the catheter 35, the clip 340 may also retract into the catheter 35 until longitudinal movement of the clip is prevented by a flange 58. The flange 58 may be a feature on the interior surface of the catheter 35 that prevents the clip from sliding from the distal end of the catheter 35 to the proximal end of the catheter 35.

[0063] Sheath 324 may have two lumens extending longitudinally therethrough. These lumens may include first lumen 324a and second lumen 324b extending from the distal end to the proximal end of sheath 324. Two endoscopic instruments having grasper end effectors, first grasper 326a and second grasper 326b, may be delivered to access site 55 through the lumens of sheath 324. The grasper end effectors may include any instrument configured to grasp any object within the body, such as forceps, barbed needles, etc. In some embodiments, first grasper 326a may be delivered to access site 55 through first lumen 324a and second grasper 326b through second lumen 324b. It is also contemplated that in some embodiments, both graspers may be delivered to access site 55 through the same lumen. The graspers may also be extracted from access site 55 through the lumen. Links 322a and 322b may connect first grasper 326a and second grasper 326b, respectively, to one or more actuation mechanisms at the proximal end of endoscope 10. These actuation mechanisms may manipulate the graspers at access site 55. Manipulating the graspers may include translating and rotating the graspers at access site 55 and moving the jaws of the graspers to grasp the cut / separated tissue edges between the jaws.

[0064] At the access site 55, each grasper may be manipulated to the location of the tissue piece. 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 55. The sheath 324 may also be retracted into the catheter 35, pulling the grasped tissue edges and clip 340 with it. FIG. 8B shows the retraction of the sheath 324 into the catheter 35. During retraction, movement of the clip 340 may be blocked by the flange 58. Continued retraction of the sheath 324 may plastically deform the jaws of the clip 340 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.

[0065] In some embodiments, multiple clips 340 (as described with reference to clip 40 shown in FIGS. 2A-3H) may be mounted on the surface of sheath 324. After the first clip is deployed, another clip 340 may slide down sheath 324 and extend out the distal end of catheter 35. This second clip may be used to join tissue edges as described above.

[0066] 9A-9D show another embodiment of a clip that can be used to close opening 80. Clip 440 of this embodiment may be delivered to access site 55 at the distal end of elongate member 424 extending from the working lumen of the endoscope. Similar to graspers 326a, 326b of the embodiment of FIGS. 8A-8B, first grasper 426a and second grasper 426b may also be delivered to access site 55 through elongate member 424. The graspers 426a, 426b may be manipulated at access site 55 by one or more actuation mechanisms outside the body. FIG. 9A shows clip 440 installed at access site 55. The graspers 426a, 426b may be delivered to access site 55 through holes or cavities in clip 440. In some embodiments, the first retainer 426a may extend through the first through-hole 446a into the access site 55, and the second retainer 426b may extend through the second through-hole 446b into the access site 55. It is also contemplated that in some embodiments, both the first and second retainers may extend through the same through-hole.

[0067] As described with reference to FIG. 8B , the first retainer 426a may grasp the first tissue edge 70a and pull it into the clip 440, and the second retainer 426b may grasp the second tissue edge 70b and pull it into the clip 440. The tissue edges may be pulled into the clip by retracting the retainers into the elongate member 424. FIG. 9B shows the clip 440 with the first and second tissue pieces grasped by the retainers. Once both tissue edges are pulled into the clip 440, the actuation mechanism can be activated to release the fasteners 450 and join the tissue edges together. The fasteners 450 may include barbs or any object configured to join the tissue edges. In some embodiments, the fasteners 450 may be released from the side of the clip 440 and may penetrate the first and second tissue pieces to join them together. However, it is also contemplated that the fastener 450 may be released from the clip in other manners. FIG. 9C shows the fastener 450 joining two tissue edges together. After the tissue edges are securely joined together, the fastener 450 may be released from the clip 440. In some embodiments, the fastener 450 may be released by activating an actuation mechanism. It is also contemplated that in some embodiments, the clip 440 may be retracted after joining the tissue edges together, and the staples may be pulled away from the clip by the force of the stretched stomach wall. FIG. 9D shows the released fastener 450 joining two tissue edges together.

[0068] 10 shows an embodiment of a clip having an attached barb 550. The clip 540 attached to the elongate member 524 may be delivered to the access site 55 through the working lumen of the endoscope 10. As with previously described embodiments, the clip 540 may transform to an open configuration as it extends from the distal end 90 of the endoscope 10. The clip 540 may include a first jaw 542a and a second jaw 542b connected at a hinge 526. The elongate member 524 may include a linkage connecting the jaws to an actuation mechanism outside the body. The actuation mechanism may be configured to move the jaws of the clip 540 toward each other, thereby forming a closed configuration.

[0069] The hook 550 may be attached to one of the jaws of the clip 540, for example, the first jaw 542a. The hook 550 may be hinged to the first jaw 542a at a first end 548a. The second end 548b of the hook 550 may form a sharp point or an arrowhead. In some embodiments, the hook 550 may also include a spike (similar to the spike 652 on the hook 650 in FIG. 12A ) protruding from a surface of the hook 550. The hook 550 may be spring-loaded, and the second end 548b of the hook 550 may be held on the first jaw 542a by a catch or another mechanism. An actuation device may be configured to release the catch. Upon release of the catch, the hook 550 may be configured to transform to the deployed configuration. In the clip embodiment shown in Figure 10, the barb 550 may rotate about the first end 548a and quickly assume a second configuration (as seen in Figure 11B), in which the second end 548b of the barb 550 may protrude from the first jaw 542a and point toward the second jaw 542b.

[0070] The second jaw 542b may have a hole 528 to allow the second end 548b of the barb to protrude therethrough when the clip 540 is in the closed configuration. The second jaw 542b may also have features designed to impart some compliance to the second jaw 542b. In FIG. 10 , these compliance features are shown as thin members arranged as a cross around the hole 528. These members may flex slightly when an out-of-plane force is applied to them, thereby providing compliance to the second jaw 542b. The purpose of compliance will become clearer in the discussion with reference to the operation of the clip 540. 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, compliance-enhancing features may be eliminated.

[0071] 11A-E illustrate the use of a clip 540 to approximate tissue edges (e.g., first and second tissue edges 70a, 70b) and close an opening 80. The endoscope 10 may be manipulated to place the first tissue edge 70a between the open jaws of the clip 540. The actuation device may then be actuated to grasp the first tissue edge 70a by closing the jaws. FIG. 11A shows the clip 540 with the first tissue edge 70a grasped between its jaws. With the tissue securely grasped, the barb 550 may be released from the first jaw 542a. Releasing the barb 550 may rotate or otherwise actuate the spring-loaded barb 550 about the first end 548a to a second configuration. While moving to the second configuration, the sharp second end 548b may pierce the grasped first tissue edge 70a. 11B shows clip 540 with a grasped first tissue edge 70a penetrated by barbs 550. In some embodiments, the grasped tissue may be forced against a surface of second jaw 542b while the barbs attempt to penetrate the tissue from the opposite side. Compliance enhancing features of second jaw 542b may allow barbs 550 to penetrate the tissue without undue trauma.

[0072] The clip 540 may be reopened using the actuation mechanism. FIG. 11C shows the clip 540 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 540 are opened. The endoscope may again be manipulated to place the second tissue edge 70b between the jaws of the clip 540. The jaws may now be closed to grasp the second tissue edge 70b between the jaws. When the jaws are rotated to the closed configuration, the pointed second end 548b of the barb 550 may penetrate the second tissue edge 70b. FIG. 11D shows the clip 540 with both tissue edges penetrated by the barb 550. The clip 540 may be reopened, and the barb 550 may be detached from the first jaw 542a to release the tissue edges joined together by the barb 550. 11E shows pieces of tissue joined by barbs 550. In some embodiments, the barbs 550 may be attached or detached by using an actuation mechanism to release the first end 548a from the first jaw 542a. In embodiments of the clip 540 having spikes on the barbs 550, the spikes may help prevent the tissue edges from sliding off the barbs 550. In some embodiments, the visceral wall 70 may be stretched by retracting the clip away from the access site 55. The stretched visceral wall may then pull the first end 548a away from the first jaw 542a.

[0073] In some embodiments, the entire clip 550 may be released from the elongate member 524 after the tissue edges have been joined together with the barbs. Releasing the clip 540 may be accomplished by an actuation device or by force exerted by the stretched organ wall 70.

[0074] 12A-12E show another embodiment of a clip having a barb 650 used to join cut / separated tissue edges. In the embodiment of FIG. 12A, the clip 640 may include a first jaw 642a and a second jaw 642b attached together at a hinge 626. The clip 640 may be delivered and manipulated at the access site 55 similar to the clip 540 of the previous embodiment. The barb 650 may be attached to the first jaw 642a at a first end 648a. The first end 648a may be pointed or may be retained on the first jaw 642a by a catch or other retention feature on the first jaw 642a. The second end 648b of the barb 650 may protrude from the first jaw 642a and point toward the second jaw 642b. The second end 648b of the barb 650 may also be pointed. The second jaw 642b may also include a retention feature coupled to the second end 648b and configured to retain the barb 650 in the second jaw 642b. The barb 650 may also include spikes 652 on a surface thereof. The barb 650 may include spikes 652 directed toward both the first end 648a and the second end 648b.

[0075] A second tissue edge 70b can be placed between the jaws of the clip 640, and the jaws can be closed. While closed, the barb 650 can penetrate the second tissue edge 70b. FIG. 12B shows the clip 640 with the second tissue edge 70b grasped. While in the closed configuration, the second end 648b of the barb 650 can engage with a retention feature on the second jaw 642b. The jaws can be reopened to grasp the first tissue edge 70a. FIG. 12C shows the clip 640 with the jaws opened. Here, the barb 650 can be retained by the retention feature on the second jaw 642b. The spike 652 on the barb 650 can prevent the second tissue edge 70b from being released when the jaws are opened. A first tissue edge 70a can be placed between the jaws, and the jaws can be reopened to grasp the first tissue edge 70a. 12D shows first and second tissues grasped between the jaws of clip 640. Sharp first end 648a of barb 650 can pierce first tissue edge 70a when the jaws are closed. Thus, barb 650 can pierce and join first tissue edge 70a and second tissue edge 70b. As in the previous embodiment, clip 640 can now be opened and barb 650 can be released from clip 640. Barb 650 can hold first tissue edge 70a and second tissue edge 70b together. In some embodiments, the entire clip 640 can be released from elongate member 624 to leave clip 640 joining the two tissue edges together.

[0076] 13A-13E show another embodiment of a clip used to attach tissue edges. As with the previous embodiment, clip 740 may also include first and second jaws 742a and 742b connected by hinge 726. Clip 740, attached to elongate member 722, may also be delivered to access site 55 through the working lumen of endoscope 10 and operated by an actuation mechanism outside the body. As with clip 40, clip 740 may also include a hollow through-hole 746 between the jaws.

[0077] A claw 750 attached to the flexible portion 724 may be delivered to the access site 55 through the through-hole 746. The flexible portion 724 may be manipulated from outside the body to control the claw 750 at the access site 55. With the jaws of the clip 740 open, the claw 750 attached to the flexible portion 724 may be advanced through the opening 80. FIG. 13B shows the claw 750 on the opposite side of the puncture. Here, the flexible portion 724 and claw 750 may be retracted into the elongate member 722. The claw 750 may hook the opening 80 with the first tissue edge 70 a and the second tissue edge 70 b and drag them into the clip 740. The claw 750 may have any shape configured to hook the tissue edges and drag them into the clip 740.

[0078] Figure 13C shows clip 740 with the hooked stomach wall positioned between its jaws. Once first tissue edge 70a and second tissue edge 70b are properly positioned between the jaws, clip 740 may be closed. Figure 13D shows clip 740 in a closed configuration. The closed clip 740 may grasp the tissue edges, thereby joining them together. Clip 740 may now be released, and the endoscope may be retracted from the body.

[0079] 14A-14F show another embodiment of a clip 840 used to fasten a first tissue edge 70a and a second tissue edge 70b at an access site 55. The clip 840 may be comprised of multiple arms, for example, a first arm 842a and a second arm 842b. While the clip 840 is shown with two arms, different embodiments of the clip 840 may have a different number of arms. The clip 840 may also include a central arm 850 disposed between the first arm 842a and the second arm 842b. The central arm 850 may include a barb 858 disposed thereon. In some embodiments, the barb 858 may be disposed at the distal end of the central arm 850. While the barb 858 is shown as a protrusion on the central arm 850 in FIG. 14A, the barb 858 may have any shape and configuration. For example, barb 858 may be sharp or needle-like in some embodiments. First arm 842a and second arm 842b may be attached to central arm 850 at attachment segments 846a and 846b, respectively, at a proximal region of central arm 850. Any attachment mechanism may be used to attach first and second arms 842a and 842b to central arm 850. Proximal to attachment segments 846a and 846b, central arm 850 may include radially extending protrusions 852a and 852b. In some embodiments, these protrusions may be spring loaded. In these embodiments, protrusions 852a and 852b may be configured to compress or depress inward toward central arm 850 upon application of a radially inward force. In other embodiments, protrusions 852a and 852b may not be spring loaded, but may be configured differently to move toward central arm 850 upon application of a radially inward force. For example, protrusions 852a and 852b may be constructed from a compressible material.

[0080] From each attachment section at the proximal region of central arm 850, first and second arms 842a and 842b may extend longitudinally and distally a distance along the length of central arm 850. First and second arms 842a and 842b may then be bent away from central arm 850 so that the distal regions of these arms form an angle with the distal region of central arm 850. First arm 842a may be bent away from central arm 850 at first section 844a, and second arm 842b may be bent away from central arm 850 at second section 844b. First section 844a may be longitudinally displaced or offset from second section 844b.

[0081] A push rod 822 coupled to the proximal end of clip 840 may be configured to extend clip 840 from the distal end of catheter 835 or endoscope to access site 55. Actuating push rod 822 distally may move push rod 822 into the body and extend clip 840 out the distal end of catheter 835. Actuating push rod 822 proximally may retract the distal end of push rod 822, along with clip 840, into catheter 835.

[0082] Clip 840 may also include an end cap 860 mounted on the proximal ends of first and second arms 842a and 842b. Push rod 822 may couple to the proximal end of clip 840 by passing through a through-hole 866 on end piece 864 mounted on the proximal end of end cap 860. In some embodiments, end piece 864 may be integral with end cap 860, while in other embodiments, end piece 864 may be a separate piece from end cap 860. End cap 860 may be mated with end piece 864 by any means, but in some embodiments, end piece 864 may have an interference fit with the proximal end of end cap 860. Actuating push rod 822 in a proximal direction may retract clip 840 at least into end cap 860. As clip 840 slides into end cap 860, the walls of end cap 860 may contact first and second arms 842 a and 842 b and apply a radially inward force to the arms. This radially inward force may bias the arms toward central arm 850. As first section 844 a and second section 844 b of the two arms are longitudinally displaced from one another, end cap 860 may contact and at least partially deflect one of the arms toward central arm 850 before contacting and deflecting the other arm toward central arm 850.

[0083] 14B shows a configuration of clip 840 in which clip 840 is partially retracted into end cap 860. In the embodiment of clip 840 shown in FIG. 14B, end cap 860 contacts second arm 842b, deflecting it toward central arm 850, before end cap 860 contacts first arm 842a. When used in a procedure to fasten tissue pieces 70a and 70b, endoscope 10 or catheter 835 having clip 840 may be manipulated to place one of these tissue edges, e.g., the second tissue edge in FIG. 14B, between central arm 850 and second arm 842b. Push rod 822 may then be actuated proximally to retract clip 840 partially into end cap 860. As clip 840 slides within end cap 860, the inner wall of end cap 860 may slide over protrusions 852a and 852b, applying a radially inward force to the protrusions. This radially inward force may press protrusions 852a and 852b radially inward toward central arm 850, thereby allowing clip 840 to slide within end cap 860. The wall of end cap 860 may also contact and apply a radially inward force to second arm 842b, deflecting it toward central arm 850. As second arm 842b deflects toward central arm 850, second tissue edge 70b may be captured between the arms. FIG. 14C shows an embodiment of clip 840 having second tissue edge 70b captured between central arm 850 and second arm 842b.

[0084] The distal end of endoscope 10 or catheter 835 can then be repositioned so that another tissue edge, for example, first tissue edge 70a, can be placed between first arm 842a and central arm 850. Further actuation of push rod 822 toward the proximal end may move clip 840 further into end cap 860. As clip 840 moves further into end cap 860, the wall of end cap 860 may contact first arm 842a and deflect toward central arm 850, carrying first tissue edge 70a between first arm 842a and central arm 850. Further actuation of push rod 822 toward the proximal end causes protrusions 852a and 852b on central arm 850 to engage mating features 862a and 862b on end cap 860. In some embodiments, the mating features 862a and 862b may be cavities in the end cap 860 that are sized to fit the protrusions 852a and 852b therein. Alignment of the protrusions with the mating features may relieve the binding force from the protrusions, allowing them to spring back or recover to their original pre-depression configuration. Engagement of the protrusions 852a and 852b with the mating features on the end cap may lock the first and second arms 842a and 842b in a closed configuration, which compress the central arm 850 with the first and second tissue pieces 70a and 70b firmly grasped therebetween. In embodiments in which the central arm 850 includes a barb 858, the barb 858 may also help secure the tissue edges between the arms. FIG. 14D shows an embodiment of a clip 840 with the arms locked in a closed configuration.

[0085] The engagement of protrusions 852a and 852b with mating features 862a and 862b on end cap 860 may also prevent clip 840 from sliding further into end cap 860 upon further actuation of push rod 822 toward the proximal end. Further actuation of push rod 822 may stretch organ wall 70 and exert a force on the proximal end of clip 840. This force may detach the distal end of push rod 822 from the proximal end of clip 840. As with other embodiments, any clip release mechanism (threaded connection, frangible link, electrolytic link, etc.) may be used to separate push rod 822 from clip 840. FIG. 14E shows an embodiment of clip 840 with push rod 822 detached from clip 840.

[0086] After the push rod 822 is detached from the clip 840, further retraction of the push rod 822 toward the proximal end may cause the protrusion 824 on the push rod 822 to abut the end portion 864. In some embodiments, the push rod 822 and end cap 860 may be dimensioned such that the protrusion 824 of the push rod abuts the end portion 864 when the push rod 822 is detached from the clip 840. Although the protrusion 824 is shown as a bend in the push rod 822, the protrusion 824 may be of any form. Further actuation of the push rod 822 may urge the protrusion 824 against the end portion 864, causing the end portion 864 to unseat from the proximal end of the end cap 860. FIG. 14F shows an embodiment of the clip 840 with the end portion 864 separated from the end cap 860. The push rod 822 can now be retracted outside the body through a catheter or endoscope.

[0087] Other methods may also be used to disengage the push rod 822 from the end cap 860. In some embodiments, the through hole 866 may be configured to allow the push rod 822 to be rotated and extracted from the end cap 860. For example, the through hole 866 may have two different cross-sectional shapes along two directions. In these embodiments, the cross-section of the through hole along one direction may correspond to the diameter of the push rod 822, and the cross-section of the through hole along another direction may correspond to the thickest region of the protrusion 824. Rotating the push rod 822 to align the protrusion 824 with the direction having the matching cross-section of the through hole allows the push rod to be removed from the end cap 860. In some embodiments, the protrusion 824 may be a C-shaped bend on the push rod 822, and the cross-sectional shapes of the through hole 866 along the two different directions may correspond to the diameter of the push rod 822 and the dimensions of the C-shaped bend on the push rod 822. In such embodiments, rotation of push rod 822 may extract push rod 822 through through hole 866. In some embodiments, rotation of push rod 822 may extract push rod 822 partially through through hole 866 and engage end end 864 with push rod 822. In these embodiments, further actuation of push rod 822 detaches end end 864 from end cap 860, leaving clip 840 in a locked configuration grasping first and second tissue edges 70a and 70b.

[0088] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed systems and processes without departing from the scope of the invention. For example, adhesives, tissue growth promoters, or other agents may be used in conjunction with any clip to fasten tissue edges or promote the healing process. Also, any portion of the clip may be bioabsorbable or may conduct heat and / or electricity to assist in the tissue fastening or healing process. While this disclosure discusses several embodiments of clips generally used in endoscopic surgery, the disclosed clips may be used to approximate tissue edges in any medical procedure, such as conventional surgery or other types of medical procedures. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope of the invention being indicated by the following claims.

Claims

1. 1. A device for approximating multiple tissue edges (70a, 70b), comprising: a plurality of jaws (342a, 342b), each having a first end and a second end, coupled to one another at the first ends and configured to transform from an open configuration to a closed configuration, wherein in the open configuration the second ends of the plurality of jaws (342a, 342b) are spaced apart from one another and in the closed configuration the second ends of the plurality of jaws (342a, 342b) are proximate to one another; a plurality of tools (326a, 326b) configured to pass between the plurality of jaws (342a, 342b) and configured to move relative to the plurality of jaws (342a, 342b) to grasp and position a plurality of tissue edges (70a, 70b) between the plurality of jaws (342a, 342b); A device wherein each tool (326a, 326b) of said plurality of tools is configured to operate independently.

2. 2. The device of claim 1, wherein first ends of the plurality of jaws (342a, 342b) are coupled to a distal end of a sheath (324), the sheath (324) being configured to pass through a lumen of an endoscope (10).

3. The device of claim 2, wherein a first end of the plurality of jaws (342a, 342b) has a hole (346) through which the sheath (324) extends.

4. 2. The device of claim 1, wherein each tool (326a, 326b) of the plurality of tools is coupled to a distal end of an elongated segment, the proximal end of which is coupled to an actuation device configured to be located outside the body, and the actuation device is configured to control each tool (326a, 326b) of the plurality of tools to grasp the plurality of tissue edges (70a, 70b).

5. 5. The device of claim 3, wherein the plurality of jaws (342a, 342b) are part of a clip (340) having a first jaw (342a) and a second jaw (342b) joined by an intermediate portion having the hole (346) therein.

6. The device of claim 5, wherein the first jaw (342a) and the second jaw (342b) have corrugated surfaces or teeth (345) on their inner surfaces.

7. 7. The device of claim 5 or 6, wherein the first jaw (342a) and the second jaw (342b) are symmetrical about a plane passing through the center of the hole (346).

8. The device of any one of claims 5 to 7, wherein the clip (340) is mounted on a surface of the sheath (324) and deliverable to an access site (55).

9. 9. The device of claim 8, wherein the plurality of tools are endoscopic instruments having grasper end effectors deliverable through the lumen of the sheath to the access site, the grasper end effectors comprising forceps or barbed needles configured to grasp any object within the body.

10. The device of any one of claims 5 to 9, wherein the clip (340) comprises a shape memory alloy.

11. 11. The device of claim 10, wherein the shape memory alloy comprises 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.

12. 12. The device of claim 10 or 11, wherein the clip (340) comprises or is constructed from nitinol.

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