Closure device for tissue openings

Abstract

To provide a device for suturing and closing a hole that can be easily used even in a defined space.SOLUTION: There are described a closure device 22 for closing holes in tissue, for example, in the right atrial appendage. The closure device 22 includes a proximal closing element 32 having a first mesh closure and a distal closing element 32 having a second mesh closure. The first mesh enclosure has a proximal first narrowed end 60 and a distal second narrowed end 58, and the second mesh enclosure has a proximal third narrowed end 40 and a distal fourth narrowed end 38. The closure device 22 is provided with a tether 64 combining the closing element 32 and the closing element 30 to pass the proximal first narrowed end 60 and the distal fourth narrowed end 38. The tether 64 pulls the distal fourth narrowed end 38 toward the first narrowed end 60, while the closure device 22 is provided with a proximal marker arranged in the first narrowed end 60 and a distal marker arranged in the fourth narrowed end, the respective markers being visualized through a patient's tissue.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This application discloses a structure and method for closing an internal tissue opening with minimal invasion. More particularly, a closure device having two connected mesh structures for closing a minimally invasive surgical opening in the heart or other organs is disclosed.

Background Art

[0002] For many treatments involving the placement of medical devices inside a patient or for other therapeutic or diagnostic purposes, minimally invasive surgical procedures have been developed as a way to reduce trauma to the patient. In such procedures, a hole is created, accessed by a catheter or similar device, and a treatment device is sent through the catheter to the site of interest. When the procedure or part of the procedure is complete, the access catheter is removed and the hole is repaired.

[0003] Devices and methods for suturing and closing such holes have been described. However, such devices and methods are commonly very difficult to use in such limited space. To avoid sutures, devices have been developed to plug or cover such holes so that the holes can heal naturally or so that part or all of such plugs can be incorporated into the tissue. Even if such items are effective, they are difficult to install, especially when both sides of the hole must be closed.

[0004] This disclosure addresses these problems.

Summary of the Invention

[0005] Among the many disclosed, a closure device is provided that includes a distal crushable mesh element, a proximal crushable mesh element, and a tether or stem used to connect the two mesh elements and pull them together with a hole to be sealed in between. The distal mesh element has two ends that are inverted into the mesh body. The mesh fibers are fused together at each end by a bonding or fusion operation such as heat shaping, or otherwise narrowed. Radiopaque markers (e.g., cylindrical markers) may be embedded in the fused ends. In certain embodiments, both of these ends are inverted into the body of the distal mesh element. The distal end of the distal mesh element is used to secure the distal end of the tether or stem. The proximal end of the distal mesh may be covered (internally or externally) with a material (e.g., small intestinal submucosa (SIS)) for sealing and / or promoting fusion.

[0006] The proximal mesh element has a distal end that is inverted into the body of the proximal mesh element. This end may be fused in the same or similar manner as the end of the distal mesh element and may also have a radiopaque marker. The distal end of the proximal mesh element may also be covered (internally or externally) with a material for sealing and / or promoting fusion. In certain embodiments, the proximal end of the proximal mesh element is also fused or otherwise narrowed and contains a radiopaque marker, but is not inverted. The proximal fused or narrowed end serves as the final conduit for the tether.

[0007] The tether has a distal end which may be enlarged (e.g., having a bead, knot, or knot) and which can be fixed to the distal end of a distal mesh element, and the proximal end or near the proximal end of the tether has a cross-sectional enlargement (e.g., a bead, knot, or knot). In certain embodiments, the tether further has a loop-shaped feature which is part of or adjacent to the proximal enlargement to allow attachment to a trigger or control wire. The wire is used to pull the tether through the proximal end of the proximal mesh element when a delivery device or delivery apparatus extrudes and compresses the proximal mesh element. The proximal enlargement is pulled through the fused proximal end of the proximal mesh element and provides a lock or stopper for the proximal mesh element when the tension on the tether is released.

[0008] The delivery device delivers the mesh elements in a stacked manner. The closure device is stacked within the delivery device with the distal mesh elements in the distal peel-away catheter (e.g., 14 French) and the proximal mesh elements in the sheath (e.g., 12 French). When the delivery device is inserted through the hole to be closed into the sheath, which is secured by a balloon on the distal side of the hole, the peel-away catheter is removed, and as a result the distal mesh elements sit in the sheath through the hole and are pressed by the sheath holding the proximal mesh elements. The distal mesh elements are pushed out of the sheath through the hole to a point distal to the hole to be sealed. The tether is then slightly retracted, and this retraction compresses the distal mesh elements by pressing them against the sheath holding the proximal mesh elements. The distal mesh elements expand as a result. After the balloon is deflated, the two sheaths are pulled back through the opening, causing the distal mesh element to be pulled and pressed against the tissue to seal the opening.

[0009] In embodiments in which one or both sheaths include a fluid pathway, contrast agent may be advanced through the pathway to the site to allow visualization (e.g., by fluoroscopy) to confirm the sealing created by the distal mesh element. After sealing is confirmed and the sheath tip is confirmed to be on the proximal side of the hole, the proximal mesh element is pushed out of the sheath by using a smaller inner tube or sheath (e.g., 9 French) alone, or by retracting the sheath that was holding the further proximal mesh element. Tension on the tether or stem is maintained throughout via a control wire to ensure that the distal mesh element maintains sealing of the hole. The inner tube or sheath continues to push the proximal end of the proximal mesh element, advancing it over the control wire and eventually advancing it beyond the proximal expansion of the tether or stem, locking the mesh elements together. Once the final contrast agent injection is performed and sealing of the hole is confirmed, the end of the control wire is released to allow the loop to detach from the tether or stem end.

[0010] In certain embodiments, the tether or stem may have multiple extensions (e.g., knots, beads, or knots) to vary the amount by which the mesh elements are tightly bound together. The proximal end of a proximal mesh element may have a relief cut provided to allow some stretching as the extensions (one or more) of the tether or stem are pulled through the proximal end, and / or a tapered hole to facilitate the unidirectional passage of the extensions (one or more) of the tether or stem. Other means of preventing or minimizing gripping, adhesion, or reversal, such as barbs, claws, or corkscrews, may be used on the proximal end of a proximal mesh element to engage with the tether or stem. The handle of the delivery device or delivery tool may have one or more actuators or other mechanisms to facilitate the execution of the deployment process in the correct sequence and to minimize the risk of premature deployment or premature release of any component during the process.

[0011] As an example, a closure for a tissue opening may include a first closure element having a first mesh enclosure having a distal first narrowing end and a proximal second narrowing end and a central volume. Each of the first and second ends is inverted to be located within the central volume of the first mesh enclosure, and each of the first and second ends is surrounded by the respective outer surfaces of the first mesh enclosure. A second closure element has a second mesh enclosure having a distal third narrowing end and a proximal fourth narrowing end and a central volume. The third end is inverted to be located within the central volume of the second mesh enclosure, and each of the third and fourth ends is surrounded by the respective outer surfaces of the second mesh enclosure. A tether joins the first and second closure elements in an initial configuration before the first and second closure elements are delivered to the opening. The tether has a first expanding end and a second expanding end, extending through a first narrowing end, a second narrowing end, and a third narrowing end, such that the first expanding end of the tether is adjacent to or engaged with the first end and outside the first closure element, and the second expanding end of the tether is within the central volume of the second closure element. The first closure element is configured to engage with the distal surface of the tissue having an opening, the second closure element is configured to engage with the proximal surface of the tissue, and the tether is configured to pass through the opening.

[0012] The mesh for the closure elements and the materials for the tethers or stems are preferably biodegradable and absorbable. When the closure elements are formed or prepared, they can be subjected to thermal annealing or shape-fixing so that they expand naturally when deployed from the delivery device, whether compressed within the delivery device or otherwise contained within the delivery device.

[0013] A sheet of biodegradable absorbable material may be fixed to the first closure element adjacent to or covering the second narrowing end. Such a sheet may be fixed to the external portion of the first mesh enclosure. The expanding end of the tether may be a bead or knot, or may include a bead or knot. A control wire may be looped through the second expanding end of the tether and pass through the fourth narrowing end. The closure device is preferably initially housed within the delivery device. The ends of the first closure elements may be aligned with each other, and / or the ends of the second closure elements may be aligned with each other. In other embodiments, the ends of the first closure elements may be laterally offset from each other, or one of their ends may have a larger diameter than the other.

[0014] In one embodiment of a device for closing an opening in tissue, the delivery device comprises a first peel-away catheter, a second tube located within the first peel-away catheter, and an extrusion tube located within the second tube, wherein the closure device disclosed herein is housed within the delivery device. For example, the first closure element may be located within the first peel-away catheter and the second closure element within the second tube. The control line may be looped through the second expanding end of the tether. A control cannula may extend through the extrusion tube with the control line extended through the control cannula. The control line may extend from the control cannula and be folded back from the second expanding end of the tether to the control cannula so that the free end of the control line is located within the control cannula. [Brief explanation of the drawing]

[0015] [Figure 1] This is a perspective view of one embodiment of the closing device described herein. [Figure 2] This is a side view of one embodiment of the mesh portion before it is formed into a part of the embodiment shown in Figure 1. [Figure 3] This is a partial side cross-sectional view of an embodiment shown in Figure 1. [Figure 4] This is a partial side cross-sectional view of a portion of the embodiment of Figure 1, which has an alternative joining member. [Figure 5] Side partial cross-sectional view of an alternative closure element that may be used in the embodiment of FIG. 1. [Figure 6] Side partial cross-sectional view of an alternative closure element that may be used in the embodiment of FIG. 1. [Figure 7] Side partial cross-sectional view of an alternative closure element that may be used in the embodiment of FIG. 1. [Figure 8] Side partial cross-sectional view of a delivery device with an embodiment of the closure device of FIG. 1 contained therein at the initial insertion stage into a patient. [Figure 9] View of the embodiment of FIG. 8 at a later deployment stage compared to FIG. 8. [Figure 10] View of the embodiment of FIG. 8 at a later deployment stage compared to FIG. 9. [Figure 11] View of the embodiment of FIG. 8 at a later deployment stage compared to FIG. 10. [Figure 12] View of the embodiment of FIG. 8 at a later deployment stage compared to FIG. 11. [Figure 13] Schematic representation of a part of the delivery device embodiment shown in FIG. 8. [Figure 14] Side partial cross-sectional view of a part of the delivery device embodiment of FIG. 8 having additional structure. [Figure 15] Side partial cross-sectional view of a part of the delivery device embodiment of FIG. 8 having additional structure.

Best Mode for Carrying Out the Invention

[0016] For the purpose of facilitating understanding of the principles of the disclosure, embodiments illustrated in the drawings will be referred to hereinafter and the embodiments will be described using specific terms. However, it should be understood that no limitation of the scope by the claims is intended thereby, and variations and modifications of the illustrated devices and methods and further applications of the principles of the disclosure shown therein may be commonly conceived by those skilled in the relevant field of the disclosure and are considered herein.

[0017] Referring to the drawings as a whole, embodiments of the components of a system 20 for closing a tissue opening, for example, in cardiac tissue, are shown. Such a system may include one or both of a closure device 22 and an installation device 24. As discussed further below, the closure device 22 is initially installed within the installation device 24. Once the installation device 24 is adjacent to or passed through the tissue opening, the closure device 22 is advanced out of the installation device 24 so as to cover the tissue opening and is fixed in place to allow or promote healing.

[0018] The closure device 22 in the illustrated embodiment is a two-piece device having a first or distal closure element 30 and a second or proximal closure element 32. In this context, “distal” and “proximal” refer to the relative positions of the closure device 22 and / or installation device 24 with respect to the direction of travel, where “distal” generally means the side toward or beyond the hole or opening in the tissue to be closed, and “proximal” generally means the side toward the practitioner along the direction of travel. The closure element 30 is intended to engage with and cover the tissue and the opening that penetrates the tissue on the distal side of the tissue, i.e., beyond the hole that penetrates the tissue. The closure element 32 is intended to engage with and cover the tissue and the opening that penetrates the tissue on the proximal side of the tissue, i.e., the side first approached by the installation device 24. The closure elements 30 and 32 are joined together prior to insertion into the patient’s body, or, in certain embodiments as discussed further below, prior to insertion onto or into the delivery device.

[0019] The closure element 30 is made of mesh 34 in the illustrated embodiment and is in certain embodiments a biodegradable absorbable material, a non-biodegradable absorbable material, and / or a biological material. Such materials can be or include copolymers of polypropylene, polyethylene, glycolide / L-lactide copolymer, PTFE, nylon, polyurethane, PEEK, PLGA, PGA, polycaprolactone, carbon button, polydioxanone, or such constituents. The depicted mesh 34 includes a number of gaps 36 along a flexible material that has the appearance of or has a cross (single or plural) strands or similar (single or plural) linear members 37 and yet is a solid.

[0020] The closure element 30 has a first end 38 and a second end 40 in the illustrated embodiment, and they are narrowed or closed. In one embodiment, a sheet or length of the mesh 34 is rolled up, or put another way, formed into a cylindrical or other longitudinally closed shape having open ends 38 and 40 on opposite sides of an axis. In such an embodiment, the mesh 34 has a central volume 42 between ends 38 and 40. End 38 is narrowed or closed to form a tube (e.g., with a passageway), a closed mass, or other tip. For example, the narrowing or closing can be achieved by heat shrinking a portion of end 38 to form a tube with a passageway having a diameter substantially smaller than the standard diameter of the central volume 42, e.g., one-third to one-tenth or less of such a standard diameter. As another example, the narrowing or closing can be achieved by chemically or thermally fusing end 38 to form a closed mass as a tip. Techniques such as those described in U.S. Patent Application Publication No. 2015 / 0374475 (incorporated herein by reference in its entirety) could be used. End 40 is likewise desirably narrowed or closed to form a tube having a thin passageway therethrough. The closure element 30 thus has an intermediate portion 44 of the mesh 34 longitudinally between the narrowed or closed ends 38 and 40, and the volume 42 is within the intermediate portion 44 and is bounded by the mesh 34.

[0021] In certain embodiments, the end 38 (and optionally the other (one or more) ends of the closure elements 30, 32) is or contains a radiopaque marker. For example, such a marker may be a tube of a biocompatible metal (e.g., gold, platinum, tungsten-based metals, zinc-based metals, iron-based metals, and / or magnesium-based metals) or a suitable biodegradable absorbable material. An example marker has an open end and an interior and exterior, and in some embodiments includes a side opening that penetrates the side wall. It is encased in a mesh 34 of a particular closure element. Such integration is possible if the mesh 34 has the ability to exist as a fluid mass and undergo a phase transition to a solid mass. The end portion of the mesh 34 is treated (e.g., by heating, chemical hardening, or application of an electric or magnetic field) to become a fluid mass and pressure is applied to direct the fluid mass, for example, into or around the tubular marker in or through the open end and / or side opening. Next, the fluid mass undergoes a phase change to a solid (by cooling), and as a result, the solid mesh material completely encloses the tubular marker. The interior of the marker may be entirely occupied by the mass, or a lumen may be left through the enclosed marker. In this way, the marker is firmly fixed to the mesh 34, with any rough edges on the marker being covered. Such markers serve to indicate when one or both of the closing elements 30, 32 are pulled together, for example, to indicate the shape of a compressed or crushed mesh and to indicate when the mesh compression is distorted.

[0022] The closure element 30 in the illustrated embodiment is of the double-reversible type, meaning that each end 38, 40 is reversed such that the narrowed or closed portion faces into or is inside the volume 42. For example, the closure element 30 may be made by forming a sheet of mesh 34 into the shape of a tube having open ends (which will be ends 38 and 40). In this tube configuration, an outer surface 46 with a rim 47 surrounds an inner space, which will form the volume 42 of the closure element 30. The inner surface 48 faces the volume 42. The step of forming the reversed ends includes folding the rim 47 into the inner space, so that the rim is inside a portion of the inner surface 48. The ends are narrowed or closed as described above (e.g., by heat shrinkage, chemical treatment), so that the rim remains inside the volume 42 of the closure element 30. In such embodiments, a portion of the outer 46 of the mesh 34 folds over, and the bent or folded portion of the outer 46 forms the outer end 50 of the closing element 30, with the end 38 inverted into the volume 42. It is important to understand that the narrowing or closing of the (one or more) ends may occur before or after the inversion. As mentioned, since the closing element 30 is of the double-invert type, the end 40 is also inverted in the same way as the end 38.

[0023] In certain embodiments, part or all of the closure element 30 includes a sheet or mass of therapeutic or healing material 54 that can at least partially block fluid flow and / or support tissue growth and contribute to or assist the healing process. For example, a sheet, layer, or other part of SIS (submucosal tissue of the small intestine) may be installed as a lining inside the mesh 34 (e.g., within volume 42) or fixed to an external portion of the mesh 34. Figure 1 shows that the layer 54 is fixed to the outside of the mesh 34 so as to cover most or all of the surface around the end 40, or at least so as to cover at least a portion of the tissue opening to be repaired or healed when the closure element 30 is flattened as further discussed below.

[0024] The closure element 32 is for proximal placement, that is, it is placed on the side of the tissue face that is first reached or approached by the installation device 24, and is similar to the closure element 30 in certain embodiments. For example, the closure element is identical or essentially identical to the closure element 30 described above, and has a mesh 34 as a body surrounding the central volume 52, together with a first end 58 and a second end 60, the first end 58 and the second end 60 being narrowed or closed in the illustrated embodiments. In certain embodiments, the closure element 32 is similar to the closure element 30 described above, but has one inverted end 58 and one non-inverted end 60 (see Figures 1 and 4). The end 58 is inverted and closed or narrowed as described above. The end 60 is closed or narrowed as described above, but the outer surface of the mesh 34 of the closure element 32 is not overlapped and folded, and therefore the end 60 does not enter into the volume 52 or face inward. Rather, in this embodiment, the end 60 generally faces away from the volume 52. In certain embodiments, ends 58 and 60 are aligned along a common longitudinal axis extending through volume 52. In other embodiments, it should be noted that the closing element 32 is a double-reversing type, like closing element 30, rather than a single-reversing type.

[0025] Closure elements 30 and 32 are joined in certain embodiments by a filament or tether 64. The tether 64 has two ends 66, 68 that are enlarged like a knot or bead, and these ends are at least slightly larger than any opening that passes through the ends 38, 40, 58, 60 of the closure elements 30 and 32. An additional bead, knot, or other enlargement may be present between ends 66 and 68 for adjustability when locking the closure elements 30 and 32. The tether 64 extends through the end 38 of the closure element 30, and the end 66 of the tether 64 is outside the volume 42 and is either inside the end 38 of element 30, engaged with the end 38, or beyond the end 38, so as to be fixed to the end 38 or otherwise connected. From end 38, the tether 64 passes through the end 38 and the end 40 and the volume 42 of element 30. From the closing element 30, the tether 64 extends through the end 58 of the closing element 32 into the volume 52, spanning any gap that may exist between the closing element 30 and the closing element 32. It should be understood that in embodiments where the tether 64 is fixed to the end 38 of the closing element 30, other methods of fastening, such as adhesive or fusion, may be used to fix the tether 64 to the end 38 of the closing element 30 or another part. In the embodiment illustrated, the tether 64 is connected to the end 38 at a point in the inner space created by the inverted fold of the end 38. The tether 64 is not fixed to the end 40 of the closing element 30, but can be moved through the end 40 by pulling. Similarly, the tether 64 is not fixed to the end 58 of the closing element 32, but can be moved through the end 58, and the end 68 of the tether 64 can be forced through the end 60 of the closing element 32 by pulling. The tension applied to the tether 64 can crush the closing element 30 toward the closing element 32 and toward the tissue between member 30 and member 32.

[0026] As further discussed below, the tension line or control line 70 is looped through the end 68 of the tether 64 and passed into the closure element 32, and exits the closure element 32 through an opening that penetrates the end 50 of the closure element 32. In certain embodiments, the line 70 passes through a curve, hole, or knot in the tether 64. When the line 70 is pulled or otherwise tensioned, it tensions the tether 64, thereby pulling the end 38 of the closure member 30, pulling or flattening the closure member 30 toward the tissue and the closure member 32. The control line 70 is also part of the process of flattening the closure element 32 toward the tissue, as further discussed below.

[0027] In an alternative embodiment, a filament in the form of a solid stem 64' is provided instead of the tether 64. In the illustrated embodiment, the stem 64' has an elongated body 65' having a flattened end 66' and the opposite end 68'. In the illustrated embodiment, the body 65' and the ends 66' and 68' are monolithic and are formed or fabricated, for example, as a single piece of the same material. Such a material is preferably a biodegradable and absorbable material having sufficient strength to hold the two closure elements 30, 32 together for a sufficient amount of time to allow the closure elements 30, 32 to be wrapped and sealed by body tissue. The body 65' includes one or more projections 69' between the end 68' and the flattened end 66' that serve as stopper points or reverse spines. In a particular embodiment, the projections 69' have a surface facing the flattened end 66', which is perpendicular or acute to the longitudinal axis of the body 65' to form a stopper surface, as further discussed below. The end 68' is adapted to engage with a suture or control line 70 (further discussed below) and has, for example, a loop, curve, or eye through which the control line 70 can extend and / or through which the control line 70 is attached to the body 65'. In certain embodiments, the flat end 66' is substantially planar along the surface 71' adjacent to the body 65' and convexly curved along the surface 72' opposite to the surface 71'.

[0028] In this embodiment, the stem filament 64' is fixed to the closure element 30 or otherwise engaged with the closure element 30. For example, the body 65' is inserted through the closing or narrowing end 38 of the closure element 30, with its flattened end 66' abutting the portion distal to the inverted end 38 of the closure element 30 to anchor the stem 64 to the closure element 30. Initially, the body 65' extends through the closure element 30 into or through the closure element 32, and when placed in the body, it extends through and away from the end 60 of the closure element 32. In certain embodiments, the body 65' can extend through the ends 38, 40, 58, and 60 of the closure elements 30 and 32, and in other embodiments, the body 65' does not need to pass through one or more of those ends, and may pass through the mesh of one or more portions of the closure elements 30 and 32.

[0029] When the closure device 22 is first prepared, the end 68 of the tether 64 or the projection 69' of the body 62' extends at least through the end 38 into the volume 42 of the closure element 30. A control line 70 extends from the tether 64 or body 65', and depending on how far the tether 64 or body 65' is initially installed through the closure elements 30 / 32, the line 70 extends through the closure elements 30 and 32 and exits the closure element 32 via the narrowing end or closing end 60. When the closure elements 30, 32 are installed, they are compressed, and the tether 64 or stem 64' holds one or both of them in a compressed state. For example, once the closure element 30 is installed (as further discussed below), a line 70 is drawn, which in turn draws the tether 64 or stem 64', forcing one or more projections 69' of the end 66 or body 65' of the tether 64 through the end 60 or another part of the closure element 32. The flattened end 66' of the end 66 or stem 64' of the tether 64 pulls the distal portion (or end 38) of the closure element 30 toward the proximal portion (or end 40), compressing the closure element 30. One or more projections 69' can engage with the proximal portion (or end 40) of the closure element 30 to prevent the closure element 30 from being redeployed. Similarly, the further step of pulling the line 70 allows the body 65' to be pulled through the distal portion (or end 58) of the closure element 32 and / or through the proximal portion (or end 60) of the closure element 32, compressing the closure element 32 toward itself and / or toward the closure element 30, and finally securing the closure device 22 to the tissue. In this way, the tether 64 or stem 64' is passed between the closure element 30 and the closure element 32, with the end 66 of the tether 64 or the flattened end 66 of the stem 64' extending distally out of the closure element 30 and at least one projection 69' of the body 65' extending proximal out of the closure member 32.

[0030] The inventors have further found that some uses of the closure device 22 have the advantage of reducing the compressed height when using one or both of the closure elements 30, 32. In this context, “height” means the dimension measured outward from the tissue to which the closure element is applied. To address cases where space is minimal or otherwise a smaller closure is desirable, the closure element 30 is prepared such that its ends 38 and 40 are offset from each other within the volume 42. As seen in Figure 5, the ends 38 and 40 are inverted and narrowed or closed as described above but are arranged asymmetrically, with each end 38 and 40 shifted to one side of the other. This allows the closure element 30 to be compressed so that the ends 38 and 40 move past each other with less or no contact or other interference with each other compared to the above configuration in which the ends 38 and 40 are aligned or coaxial. In this embodiment, the tether 64 or stem 64' is fixed to the end 38 as discussed above, but does not extend through the end 40. Rather, the tether or stem 64' passes through the mesh 34 near the end 40 and reaches the side of the closure element 32 as described above. It should be understood that a similar configuration may also be applied to the closure element 32, either in the same way or instead.

[0031] In another embodiment (Figure 6), the closing element 30 has aligned ends 38 and 40, but one of the ends, 38 or 40, has a larger diameter than the other. For example, end 40 is inverted as described above and narrowed to a given diameter. End 38 is inverted as described above and narrowed to a diameter smaller than the diameter of the narrowed end 40. The tether 64 or stem 64' extends through both ends 38 and 40. When the closing element 30 is compressed, as end 38 is pulled toward end 40, end 38 enters at least partially into end 40. It should be understood that in other embodiments, end 40 may be smaller than end 38, and similar (one or more) configurations may also be applied to the closing element 32, either as or instead.

[0032] In another embodiment (Figure 7), the closure element 30 is not a double inverted member, but rather a single inverted member, as in the embodiment of the closure element 32 shown. Thus, in this embodiment, end 38 is inverted as discussed above, but end 40 is the same as end 60 of closure element 32 and is not inverted. One or both of ends 58 and 60 of closure element 32 have a diameter larger than the diameter of end 40 of closure member 30, as discussed above. The tether 64 or stem 64' initially passes through ends 40 and 58 respectively, and during use, in this embodiment, passes through end 60. When closure elements 30, 32 are compressed, end 40 of closure element 32 passes through the tissue pore to be closed or sealed and enters one or both of ends 58 and 60 of closure element 32.

[0033] The closure device 22 can be minimally invasively placed in the body by a step of obtaining percutaneous access to a blood vessel, organ, or other part of the body, and a step of advancing the closure device 22 to the desired location using or through a catheter or other tube. It should be understood that the closure device 22 can also be placed in the desired location in the body via open surgery or other procedures. A certain embodiment of an installation device 24 for minimally invasive placement of the closure device 22 is schematically shown in Figures 8-13. This embodiment of the installation device 24 is intended to be inserted through a pre-installed sheath 100 that allows access to or placement through an opening H in the tissue T to be closed. In this embodiment, the sheath 100 extends from the inside of the right atrial appendage (RAA) through the opening H in the tissue T to the pericardial cavity, and a balloon 101 of the sheath 100 is inflated to fix the sheath 100.

[0034] The apparatus 24 includes tubular members 102, 104, and 106, to which a handle 108 is connected in the illustrated embodiment. The apparatus 24 is inserted through a delivery sheath 100 that is advanced through and fixed to the hole H, as further discussed below. In one embodiment, the delivery sheath 100 is a 14-French tubular sheath. In this embodiment, the tubular member 102 is a 14-French peel-away tube around the distal end of member 104, and member 104 can be a 12-French delivery sheath. Member 106 is an extrusion member and / or guide cannula that is slidable within member 104. Thus, member 104 is initially at least partially inside the peel-away member 102, and member 106 is inside member 104. In a particular embodiment, a further tubular member 110 extending through member 106 is provided as a guide cannula for the control line 70. The control line 70 extends through member 110, and in a particular embodiment, the line 70 is a thin braided stainless steel cable. The line 70 has a proximal end connected to a handle 108, extends out from the open end of member 110 through the end 60 of the closing element 32, forms a loop through the tether 64 or stem 64' (described above), and folds back into member 100 through the end 60. In this manner, the line 70 is initially doubled within member 110, so that the free end 111 is inside member 110 and generally oriented proximal. Member 104 can be housed within the sheath 100 while containing the closing device 22. In the initial (pre-use) configuration, the closing element 30 is inside member 102, and the closing element 32 is inside member 104 directly adjacent to or closely adjacent to the closing element 30. The extrusion member 106 is initially located proximal or rearward of the closing element 32. As the device 24 is inserted into the delivery sheath 100, the peel-away member 102 is pulled away and detached, leaving the closing element 30 inside the sheath 100, and the delivery member 104 (containing the closing element 32) also remains inside the sheath 100 behind the closing element 30.

[0035] Embodiments of System 20 (e.g., one or both of the installation device 24 and / or the closing elements 30, 32) may be configured to accommodate the passage of a wire guide. For example, such a wire guide may pass through each closing element 30, 32, through the installation device 24, and into the sheath 100 located in the hole H. The wire guide may extend alongside or within the extrusion member 106, or through the device 24 or through a separate lumen aligned along the device 24. If the wire guide passes through the closing elements 30, 32, it may pass through the mesh 34 at one or more locations other than one or more of the ends 38, 40, 58, 60. Such a wire guide serves to assist in aligning the closing elements 30, 32 and also to provide a navigation path to leave behind if it is necessary to abandon the use of System 20 and redo the closing process. In such cases, the wire guide provides a guide path for the next closing device to approach and close hole H.

[0036] As noted, the illustrated embodiment of the sheath 100 includes a balloon 101 at or near the distal end for anchoring the delivery sheath 100. When the sheath 100 is extended through the opening to deliver a therapeutic device or therapeutic composition or for other purposes, the balloon 101 is inflated on the distal side of the opening to anchor the delivery sheath 100 in place. Once the sheath 100 is thus anchored and all desired procedures via the sheath 100 have been performed, the user inserts the installation device 24 into the sheath 100 and peel-away member 102 in its initial form, as shown above. Such insertion and advancement into the sheath 100 can be achieved through the device 24 or via a wire guide passed along the device 24. Next, the device 24 without member 102 (i.e., members 104 and 106 connected to the handle 108, and including the above features in members 104 and / or 106) is pushed out through the sheath 100, resulting in the closure element 30 appearing from the distal end of the sheath 100. In certain embodiments, the closure element 30 is pushed out by advancing the delivery member 104 from the handle 108 or using the handle 108 to push it forward, resulting in the closure element 30 being pushed out of the sheath 100. It is desirable that member 104 and / or the handle 108 connected thereto be locked to the sheath 100 outside the patient's body, and that the deployment of the closure element 30 be made visible (e.g., by fluoroscopy).

[0037] When the closure element 30 emerges from member 104, the distal end 38 is generally away from the tissue T through which the hole H extends. Since the end 40 is oriented toward the tissue T, the outer end 40 (having the folded mesh and, in some embodiments, the bonding material, as described above) faces the hole H. Tension is maintained in the tether 64 by pulling member 100 (which may be connected to or locked to member 104 and / or member 106) at least slightly backward. Such pulling brings tension to the tether 64 via the control line 70 and toward the end 38 side of the closure element 30, pressing the closure element 30 against the distal end of the sheath 100 and flattening it.

[0038] At this point, the balloon 101 is deflated to allow the sheath 100 to retract from the hole H. The sheath 100 and the device 24 are retracted together until the closure element 30 engages with the distal surface of tissue T (e.g., the pericardial side of the RAA wall). Again, the user can visualize the area to confirm that the closure element 30 is pressed against the tissue and / or that the sheath 100 is outside the hole H (e.g., entirely on the cardiac side of the RAA wall). The member 104 and the sheath 100 are then retracted further to expose and deploy the middle portion of the tether 64, while maintaining the positions of member 106 (e.g., integrally with member 110) and line 70. The user can confirm (by visualization under fluorescence fluoroscopy) the clearance between the closure element 30 and the distal end of member 104 and / or that the distal end of member 104 is not interfering with the RAA wall. With the positions of member 106 (integrated with member 110) and line 70 maintained, member 104 and sheath 100 are further retracted to expose and deploy the closing element 32 from within member 104. This deployment can then be visualized.

[0039] With the closure element 32 extending out of member 104 and its distal end 58 facing the tissue T, the practitioner maintains the position of line 70 and advances the extrusion member 106 against the proximal end 60 of the closure element 32. Member 106 pushes the end 60 beyond the expanding end 68 of the tether 64, forcing the end 68 through and flattening the closure element 32. As described above, since the expanding end 68 of the tether 64 is larger than the opening that penetrates the end 60 of the closure element 32, the closure device 22 is locked once the tether end 68 has pushed through the end 60. That is, the closure elements 30 and 32 are pressed against each other and flattened against the respective sides of the tissue T, and the tether 64 locks them together, preventing the ends of the closure elements from slipping through the expanding ends 66, 68 of the tether 64.

[0040] With the closure device 22 locked, the line 70 is held in place, during which time the member 110 is retracted sufficiently to allow the free end 111 of the line 70 to escape from the distal end of the member 110. The line 70 is looped so as described above, having the free end 111 inside the member 110, and in certain embodiments, the free end 111 bends outward once free from the member 110. With the free end 111 outside the member 110, the line 70 is retracted (e.g., via the handle 108). The free end 111 is pulled away from the closure element 32 through the end 68 of the tether 64 and away from the treatment site. The remainder of the device 24 (including members 104 and 106) and the sheath 100 are then retracted, over the wire guide, if present. The closure device 22 remains locked as described above to allow the hole H to heal.

[0041] Figure 13 schematically shows an exemplary embodiment of the operating (distal) end of the device 24. The peel-away sheath 102 is shown as the outermost part and contains the distal closure element 30. The inner catheter or tube 104 is located within the peel-away sheath 102, with its distal end closely adjacent to the closure element 30. The proximal closure element 32 is located within the inner catheter or tube 104. The extrusion member or guide tube or cannula 106 is located within the inner catheter or tube 104, and in certain embodiments, a cannula 110 for a control line 70 is provided. The control line 70 extends through member 106 and / or member 110, passing under the end 68 of the tether 64 and folding back to member 106. Proximal to member 104, member 106 (and member 110, if present) and line 70 are connected to a handle 108.

[0042] The representation of the handle 108 indicates that the extrusion catheter 106 is directly connected to the handle and the peelaway sheath 102 and the inner catheter or tube 104 are around the extrusion catheter 106. In certain embodiments, a lock 120 connects the handle 108 to the tube 104. The connection between the handle 108 and the line 70 is not shown in the figure. In the embodiment shown, the handle 108 includes a body 150 of a shape and configuration that is held and operated by hand. Three actuators are installed on or inside the handle 108. The control line actuator 152 may include a pull ring and a shaft connected to the line 70. The actuator 152 holds the line 70 in place, and by pulling the actuator 152, the line 70 is pulled or placed under tension. Additional actuators may be connected to members 104 and / or member 106 to allow their relative movement to each other or to other parts of the device 24. It should be understood that one or more actuators can be assembled in series to automate several actions essentially into a single action.

[0043] One problem that arose with the placement of a delivery sheath or similar device through a tissue opening was that, as the sheath was retracted, the friction of the retracting sheath stretched or moved the tissue plane through which the opening extended. For example, in a procedure in which a hole for a delivery device is formed in the thin wall of the right atrial appendage, when the sheath is retracted through the hole, the atrial appendage wall tends to invaginate into the right atrium, which is undesirable. To solve this problem, an outer sheath 170 may be placed over the delivery sheath (100 in the illustrated embodiment) which is secured by a balloon 101. While the balloon 101 is inflated, the sheath 170 is moved to a position where its distal end is just proximal to the hole (for example, engaged with or closely adjacent to the tissue around the hole). When the delivery sheath 100 is retracted (following the deflation of the balloon 101), the distal end of the sheath 170 supports the wall of the tissue plane from which the sheath 100 is pulled.

[0044] Alternatively, the delivery sheath 100 may include a lumen (which may be the same as or different from the lumen containing the device 24) and a communicating side port 180 located a distance below the balloon 101 such that the balloon 101 is at least partially below the inner tissue wall surface when it is inflated and anchored to the outer tissue wall surface. A wire 182 made of a shape memory material (e.g., nitinol) is located in the lumen in an undeployed or constrained shape or configuration. When retraction of the sheath 100 is desired, the wire 182 is advanced through the lumen so that at least a portion of it exits the port 180. When the wire 182 emerges from the port 180, it takes on an expanded shape, e.g., an expanded helical shape. As the wire 182 advances, it presses against the wall of the tissue plane, providing counter-support for the tissue as the sheath 100 is retracted.

[0045] It should be understood that port 180 may also be used for other purposes in addition to or instead of installing wire 182. For example, once the sheath 100 is in place or close to it, contrast agent may be injected through the lumen and lateral port 180 to help visualize the hole or the tissue surrounding the hole. Similarly, lateral port 180 may be used as a flushing port.

[0046] The above discussion on the closure of holes in organs or other tissues is generally applicable to many types of openings, whether they are naturally occurring (e.g., fistulas) or artificially created (e.g., holes through trauma, or holes for passing therapeutic or diagnostic devices). In certain embodiments, as mentioned above, the devices and methods described herein can be used to repair a hole that penetrates the right atrial appendage, which has been opened to deliver a therapeutic device to the heart. In such embodiments, tissue T is the portion of the right atrial appendage that separates the interior of the appendage from the pericardial cavity.

[0047] While the subject matter has been illustrated in the diagrams and described in detail in the preceding explanation, it should be understood that the diagrams and explanations are for illustrative purposes only and not inherently limiting. They merely show and describe preferred (one or more) embodiments, and it is desirable that all changes and modifications that fall within the scope of the disclosure be protected. In particular, the structures, methods, and other features described in relation to one embodiment should be understood to also be used or incorporated in or relating to other embodiments. [Explanation of Symbols]

[0048] 20 Systems for closing pores in tissues 22 Closure device (occluder) 24 Installation equipment 30 First or distal closure element 32 Second or proximal closure element 34 mesh (mesh enclosure) 36 Gap 37 Strands or similar linear members 38 1st end 40 2nd end 42 Central volume 44 Middle part 46 External 47 En 48 Internal surface 50 External end 52 Central volume 54 Sheet or block-type therapeutic or healing materials 58 1st end 60 2nd end 64 tether 64' Solid Stem 65' Long and slender body 66, 68 edge 66' flat end 68' Flat end, opposite end to 66' 69' protrusion 70. Tension line or control line 71' Flat end 66', surface adjacent to the main body 65' 72' Surface opposite to surface 71' 100 sheaths 101 Balloons 102, 104, 106, 110 Tubular members 108 Handle 111 Free end 120 Rock 150 Handle Body 152 Control line actuator 170 Outer sheath 180 side ports 182 wire H hole T organization

Claims

1. A closure device for an opening in tissue, A proximal closure element having a first mesh enclosure, wherein the first mesh enclosure has a proximal first narrowing end and a distal second narrowing end, the distal second narrowing end is inverted so as to be located within the central volume of the first mesh enclosure, and the distal second narrowing end is surrounded by the outer surface of the first mesh enclosure. A distal closure element having a second mesh enclosure, wherein the second mesh enclosure has a proximal third narrowing end and a distal fourth narrowing end, the distal fourth narrowing end is inverted so as to be located within the central volume of the second mesh enclosure, and the distal fourth narrowing end is surrounded by the outer surface of the second mesh enclosure. A tether connecting the proximal closing element and the distal closing element, passing through the proximal first narrowing end, the distal second narrowing end, the proximal third narrowing end, and the distal fourth narrowing end, having a first expanding end adjacent to the proximal first narrowing end and located outside the proximal closing element, and having a size such that it prevents it from slipping through the proximal first narrowing end, and the tether being such that it pulls the distal fourth narrowing end toward the proximal first narrowing end, A proximal marker positioned at the first narrowing end of the proximal portion, The distal marker located at the distal fourth narrowing end, A therapeutic sheet disposed between the proximal closing element and the distal closing element, which at least partially blocks the fluid flow through the opening and / or supports tissue growth and contributes to or assists the healing process, It is equipped with, A closure device that allows the proximal and distal markers to be visualized through patient tissue.

2. The closure device according to claim 1, wherein the proximal marker is a radiopaque marker and the distal marker is a radiopaque marker.

3. The closure device according to claim 1, further comprising markers positioned at the distal second narrowing end and the proximal third narrowing end.

4. The closure device according to claim 2, wherein each of the radiopaque markers is made of a non-biodegradable absorbable material.

5. The closure device according to claim 2, wherein each of the radiopaque markers is made of a biocompatible metal.

6. The closure according to claim 2, wherein each of the radiopaque markers is made of platinum.

7. The closure device according to claim 1, wherein the proximal marker is a tubular marker that defines a lumen, and the tether passes through the lumen.

8. The closure device according to claim 1, wherein the first mesh enclosure and the second mesh enclosure are made of a biodegradable absorbable mesh material.

9. The closure device according to claim 8, wherein the proximal marker and the distal marker are encased in the biodegradable absorbable mesh material.

10. The closure device according to claim 1, wherein the tether has a second expanding end positioned distal to the distal fourth narrowing end and sized to prevent it from slipping through the distal fourth narrowing end.

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