Tissue anchor

Abstract

To provide systems and methods for securing grafts to blood vessel walls.SOLUTION: A graft securing system 10 includes: at least one expandable frame 40 movable from a collapsed state to an expanded state; and at least one anchor 100 coupled to the frame via an elastic support strut. The anchor includes: an anchor base 142; at least one deflectable prong 140 protruding from the anchor base and having at least one penetration tip; and at least one restraining sleeve 160 at least partially slidably movable along the at least one prong. In the collapsed state, the support strut is biased radially centrally, bringing the at least one anchor to point generally axially, parallel to a longitudinal axial line of the frame.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] In some embodiments, the present invention relates to a system and method for repairing an aneurysm, and more particularly, but not exclusively, to a system and method for securing a graft to a vascular wall portion.

[0002] An aneurysm is a bulging weak spot in the aorta that has the potential risk of rupture. In some cases, the aneurysm is in the

[0003] descending aorta in the abdomen. Open repair requires a large incision in the abdomen to expose the aorta and the application of a graft to repair the aneurysm.

[0004] Endovascular aneurysm repair (EVAR) is a minimally invasive option in which a large incision in the abdomen is replaced with a small incision in the groin. Surgical instruments are pushed through a catheter in an artery in the groin and screwed into the aneurysm. In the aneurysm, a stent and graft are deployed and positioned to support the aneurysm. An

[0005] exemplary EVAR aneurysm repair method is disclosed in U.S. Patent Application No. 12 / 224,601. The foregoing examples of the related art and associated It will result in.

SUMMARY OF THE INVENTION

MEANS FOR SOLVING THE PROBLEM

[0006] CROSS - REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 684,339, filed on Jun. 13, 2018, entitled “GRAFT TO TISSUE S ECURING SYSTEM, APPLIER AND METHOD”, and is related to U.S. Patent Application No. 12 / 224,601, filed on Sep. 2, 2008, entitled “FASTENING DEVICE” and the content of that document is hereby incorporated by reference in its entirety into this specification.

[0007]

[0008] According to aspects of some embodiments of the present invention, a graft fixation system includes at least one expandable frame movable from a folded state to an expanded state, and at least one anchor coupled to the frame via an elastic support strut. The anchor includes an anchor base, at least one deflectable prong protruding from the anchor base and having at least one through - tip, and at least one restraint sleeve movably slidable at least partially along at least one prong. In the folded state, the support strut is biased towards the radial center.​​​​​​​​​​ At least one anchor is generally axially directed parallel to the longitudinal axis of the frame. A graft fixation system is provided that causes this. In some embodiments, in the expanded state, the support strut moves from a radially centered biased state to a free and straight state, directing at least one anchor radially outward.

[0009] According to some embodiments, the system includes a graft that at least partially surrounds the frame. In some embodiments, movement of the frame from the folded state to the expanded state pushes the anchor through the graft into the tissue. In some embodiments, the anchor includes a plurality of prongs that are biased to at least partially deflect away from each other in the open configuration. In some embodiments, in the fully open state, the prongs are deflected away from each other, applying a force radially centering and fixing the graft between the tissue and the frame. In some embodiments, the anchor includes at least two juxtaposed prongs, and the sleeve stop includes at least one elastically outwardly curved proximal portion of the prongs.

[0010] According to some embodiments, at least a portion of the sleeve stop abuts the anchor base. In some embodiments, the sleeve stop interferes with the proximal movement of the restraint sleeve pressed against the sleeve stop at a first force, and at the first force, the anchor partially penetrates the tissue through the graft. In some embodiments, at a second force greater than the first force, the restraint sleeve deflects at least one of the prongs, ​The resilient, outwardly curved proximal portion is pressed radially centered with respect to the prong and configured to slide proximally over the sleeve and over the top. In some embodiments , at a second force, the anchor fully penetrates the tissue through the graft.

[0011] According to some embodiments, the anchor includes at least two juxtaposed prongs including a buckling prevention lock. In some embodiments, the buckling prevention lock includes at least one protrusion, at least one protrusion extending from the first prong and received in a recess in the juxtaposed second prong. In some embodiments, the sleeve is a through-sleeve. In some embodiments, the sleeve includes at least one sharp tapered through tip. In some embodiments, the tip of the anchor is ground along at least one distal edge of at least one prong to form at least one penetration blade. In some embodiments, the distal edge tapers to a point from its narrow side of its width and is flat from its wide side of its width. In some embodiments, the distal edge tapers to a point from both its narrow side and its wide side of its width. In some embodiments, the frame includes a partially expanded state and, in the partially expanded state, is configured to maintain longitudinal stability of the frame during axial

[0012] movement along the vessel wall. According to some embodiments, in the partially expanded state, the frame , including a mounting system from the anchor to the frame. In some embodiments, the anchor to the frame mounting system includes at least one anchor including a cutout, and a pin an elastic support strut including a matching end having a hole, and a lock ing pin, and in the mounted state, the matching end of the elastic support strut of the anchor is screwed inside the cutout, and the locking pin is screwed through the pin hole . In some embodiments, the pin is welded to the matching end of the elastic support strut of the anchor by single point welding .

[0013] According to aspects of some embodiments of the present invention, an applicator for a graft fixation system, comprising a control handle, an applicator head including a container portion, and at least one lumen connecting the handle to the applicator head, the container is sized to accommodate a graft fixation system, including at least one lumen and, the graft fixation system includes at least one expandable frame movable from a folded state to an expanded state, and at least one anchor connected to the frame via a flexible support strut , the anchor includes an anchor base, and at least one deflectable prong protruding from the anchor base and having at least one through tip, and at least one restraint sleeve slidable at least partially along at least one prong, and in the folded state, the support strut is biased towards the radial center and at least one anchor is along the longitudinal direction of the frame ​​​​​An applicator is provided that generally directs axially along an axis parallel to the axis of orientation.

[0014] In some embodiments, the head includes at least one balloon. In some embodiments, the applicator includes a protective sleeve over the balloon. In some embodiments, the protective sleeve is made of silicone. In some embodiments, the balloon is axially movable at least within the container. In some embodiments, the balloon and the frame are concentrically arranged. In some embodiments, the balloon is positioned distal to the frame. In some embodiments, the container includes at least one graft fixation system frame holder and driver, and at least one release sheath slidable over the graft fixation frame holder and driver. In some embodiments, the protective sleeve is made of silicone. In some embodiments, the balloon is axially movable at least within the container. In some embodiments, the balloon and the frame are concentrically arranged. In some embodiments, the balloon is positioned distal to the frame. In some embodiments, the container includes at least one graft fixation system frame holder and driver, and at least one release sheath slidable over the graft fixation frame holder and driver. In some embodiments, the balloon is axially movable at least within the container. In some embodiments, the balloon and the frame are concentrically arranged. In some embodiments, the balloon is positioned distal to the frame. In some embodiments, the container includes at least one graft fixation system frame holder and driver, and at least one release sheath slidable over the graft fixation frame holder and driver. In some embodiments, the balloon and the frame are concentrically arranged. In some embodiments, the balloon is positioned distal to the frame. In some embodiments, the container includes at least one graft fixation system frame holder and driver, and at least one release sheath slidable over the graft fixation frame holder and driver. In some embodiments, the balloon is positioned distal to the frame. In some embodiments, the container includes at least one graft fixation system frame holder and driver, and at least one release sheath slidable over the graft fixation frame holder and driver. In some embodiments, the container includes at least one graft fixation system frame holder and driver, and at least one release sheath slidable over the graft fixation frame holder and driver. In some embodiments, the frame holder and driver include at least one frame retaining pin circumferentially disposed on the outer surface of the holder and driver. In some embodiments, the frame holder and driver include at least one frame retaining pin circumferentially disposed on the outer surface of the holder and driver. In some embodiments, the frame holder and driver include at least one frame retaining pin circumferentially disposed on the outer surface of the holder and driver. In some embodiments, the frame holder and driver include at least one frame retaining pin circumferentially disposed on the outer surface of the holder and driver.

[0015] In some embodiments, the frame includes at least one hole at at least one end, and the at least one hole is sized to receive at least one retaining pin. In some embodiments, at least one release sheath is slidable distally over the frame toward the applicator tip and is configured to lock the frame in place. In some embodiments, at least one release sheath is slidable proximally away from the applicator tip that releases the frame. In some embodiments, the frame includes at least one hole at at least one end, and the at least one hole is sized to receive at least one retaining pin. In some embodiments, at least one release sheath is slidable distally over the frame toward the applicator tip and is configured to lock the frame in place. In some embodiments, at least one release sheath is slidable proximally away from the applicator tip that releases the frame. In some embodiments, the frame includes at least one hole at at least one end, and the at least one hole is sized to receive at least one retaining pin. In some embodiments, at least one release sheath is slidable distally over the frame toward the applicator tip and is configured to lock the frame in place. In some embodiments, at least one release sheath is slidable proximally away from the applicator tip that releases the frame. In some embodiments, at least one release sheath is slidable distally over the frame toward the applicator tip and is configured to lock the frame in place. In some embodiments, at least one release sheath is slidable proximally away from the applicator tip that releases the frame. In some embodiments, at least one release sheath is slidable distally over the frame toward the applicator tip and is configured to lock the frame in place. In some embodiments, at least one release sheath is slidable proximally away from the applicator tip that releases the frame. In some embodiments, at least one release sheath is slidable distally over the frame toward the applicator tip and is configured to lock the frame in place. In some embodiments, at least one release sheath is slidable proximally away from the applicator tip that releases the frame. In some embodiments, at least one release sheath is slidable proximally away from the applicator tip that releases the frame.

[0016] According to some aspects of the present invention, a method for deploying the graft fixation system is provided. The method includes a step of positioning a graft fixation system applicator at a desired location. The frame is partially expanded and one or more accesses are inserted through the graft into the tissue. Partially pushing the anchor in and, optionally, determining the location and location of the frame relative to the tissue. The steps of verifying the alignment and orientation, fully extending the frame and assembling the anchors are performed. At least one of the steps of pushing the frame completely into the fabric and retracting the frame and and repositioning the actuator. In the method, prior to the step of positioning the graft fixation system, the method further comprises: In some embodiments, the method includes locking at least one end. partially expanding the frame while one end is locked. In some embodiments, the method includes sliding a release sheath distally over the frame. In some embodiments, the method includes locking the frame by The frame is then removed by proximally retracting the release sheath and exposing the frame. The method includes the step of releasing the

[0017] According to some aspects of the present invention, deploying the graft fixation system comprises: 23. A method for positioning a graft fixation system applicator at a desired location, comprising: Steps for positioning the balloon within the distal portion of the graft fixation system frame. and simultaneously or sequentially attaching at least a portion of the graft fixation system frame to the Partially exposing and enabling self-expansion of at least the distal portion, and whether in a contracted state Expanding the balloon from a contracted state to an expanded state and pressing the partially expanded distal portion of the frame against the graft and tissue; contracting the balloon; completely exposing the frame and enabling self-expansion of the frame; while, simultaneously, releasing the anchor of the graft fixation stem, pushing the anchor of the graft fixation system radially outward, and at least partially penetrating the graft and tissue; axially translating the balloon proximally and positioning the balloon completely within the frame; completely expanding the frame, pressing the frame against the graft and tissue, thereby fully implanting the anchor into the tissue and fixing the graft to the tissue, is provided. According to aspects of some embodiments of the present invention, a graft fixation kit includes at least one graft fixation system and at least one applicator, wherein at least one graft fixation system includes at least one expandable frame movable from a folded state to an expanded state and at least one anchor coupled to the frame via a flexible support strut, the anchor including an anchor base, at least one deflectable prong protruding from the anchor base and having at least one penetrating tip, and at least one restraint sleeve slidably movable at least partially along the at least one prong,

[0018] wherein in the folded state, the support strut is biased radially inward and holds at least one anchor along the longitudinal direction of the frame and at least one applicator includes a balloon configured to be inflated and deflated, wherein the balloon is configured to expand the at least one expandable frame from a contracted state to an expanded state, press the at least one expandable frame against the graft and tissue, and contract the at least one expandable frame from the expanded state to the contracted state. The at least one graft fixation system further includes a graft fixation stem having an anchor at a distal end thereof, wherein the anchor of the graft fixation stem is configured to be released and the anchor of the graft fixation system is configured to be pushed radially outward. The at least one restraint sleeve is configured to be axially translated proximally to position the balloon completely within the at least one expandable frame. The at least one expandable frame is configured to be completely expanded and pressed against the graft and tissue to fully implant the anchor into the tissue and fix the graft to the tissue. In the folded state, the support strut is biased radially inward and holds at least one anchor along the longitudinal direction of the frame Generally directed axially parallel to the axis, at least one applicator is controlled handle, an applicator head including a container portion, and at least one lumen connecting the handle to the applicator he ad, the container including at least one lumen sized to receive at least a graft fixation shi stem, a graft fixation kit is provided.

[0019] In addition to the exemplary aspects and embodiments described above, further aspects and implemen tations will become apparent by reference to the figures and by consideration of the following detailed description.

[0020] Exemplary embodiments are illustrated in the reference figures. The dimensions of the components and featu res shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. The figures are listed below.

Brief Description of the Drawings

[0021]

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Mode for Carrying Out the Invention

[0022] According to some embodiments of the present invention, there is provided a graft fixation system having a frame and a plurality of anchors attached to the frame, and configured to bring the graft close to and attach it to the blood vessel wall. In some embodiments, the blood vessel is the aorta. In some embodiments, the graft is a stent graft. In some embodiments, the graft is sandwiched between the frame and the blood vessel wall. In some embodiments, the frame includes a ring shape. A graft fixation system is provided that has a frame and a plurality of anchors attached to the frame and is configured to bring the graft close to and attach it to the blood vessel wall. In some embodiments, the blood vessel is the aorta. In some embodiments, the graft is a stent graft. In some embodiments, the graft is sandwiched between the frame and the blood vessel wall. In some embodiments, the frame includes a ring shape. A graft fixation system is provided that has a frame and a plurality of anchors attached to the frame and is configured to bring the graft close to and attach it to the blood vessel wall. In some embodiments, the blood vessel is the aorta. In some embodiments, the graft is a stent graft. In some embodiments, the graft is sandwiched between the frame and the blood vessel wall. In some embodiments, the frame includes a ring shape. According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is

[0023] According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is According to some embodiments of the present invention, the frame is expandable to an expanded state and foldable to a retracted state. In some embodiments, in the expanded state, the frame pushes the anchor, and the anchor translates radially outward in parallel and penetrates the wall of a tubular structure (e.g., a blood vessel) through the blood vessel wall from the inner surface (e.g., the endothelial side) of the blood vessel facing the frame. As described in detail elsewhere in this specification, when the anchor penetrates the blood vessel wall, the anchor deforms to engage the outer surface of the blood vessel wall. In some embodiments, the anchor is pushed through the graft before penetrating the wall of the blood vessel, the anchor penetrates the graft, and then penetrates the blood vessel wall to fix the graft to the blood vessel wall. In some embodiments, the frame is An outward radial force is applied to the anchor.

[0024] According to some embodiments of the present invention there is provided a graft fixation system comprising: a frame; and a plurality of anchors attached to the frame, the anchors being attached to the bases of the anchors. One or more prongs projecting from the prongs, and a prong is slidably attached to the prongs. and a captive sleeve surrounding the prong, the prong being distal (away from the frame and and a piercing tip (pointing toward the tissue) and one or more sleeve stops (e.g., restraining and one or more sleeve stops include prongs and / or piercing members. configured to temporarily prevent sliding of the captive sleeve along the tip. A foot fastening system is provided.

[0025] In some embodiments, the anchor piercing tip is located immediately proximal to the piercing tip (on the frame). prongs adjacent to the piercing tip (towards and away from the anchor tip) In some embodiments, the sleeve stop is at least The captive sleeve is formed on one prong and at least a portion of the captive sleeve rides on the piercing tip. In some embodiments, the length of the sleeve is The length of the prongs is shorter than the length of the sleeve, and the sleeve stops and anchor base The prongs are slidable between the prongs.

[0026] In some embodiments, a restraining sleeve is attached from the distal end of the anchor to the proximal end of the anchor. Sliding the anchor moves it from a constrained closed state to an unconstrained open state. In some embodiments, in a constrained configuration, the anchor prongs are juxtaposed in a closed state. In some embodiments, in an unconstrained configuration, the anchor prongs are in an open state, and in the open state, the prongs are at least partially deflected away from each other. In some embodiments, the prongs are elastic. In some embodiments, the prongs are made of a shape memory material. According to some embodiments of the present invention, when the constraint sleeve is pushed towards the base of the anchor, the constraint sleeve slides over the prongs towards the base of the anchor, thereby allowing the prongs to bend freely in any direction.

[0027] According to aspects of some embodiments of the present invention, there is provided a graft fixation system comprising one or more ring-shaped frames and a plurality of anchors projecting radially outwards. In some embodiments, the ring-shaped frame is configured to penetrate tissue when pressed against the tissue by radial expansion of the ring-shaped frame. In some embodiments, the system comprises two or more ring-shaped frames and one or more latches, and the one or more latches are configured to fix at least two rings to each other after being juxtaposed axially.

[0028] According to some embodiments of the present invention, one or more of the rings form a stent-like frame, and the stent-like frame is configured to be fixed to a blood vessel and support the blood vessel. According to some embodiments of the present invention, ​ 、At least one anchor of the ring includes a penetration tip at the distal end, and also includes an anchor base at the proximal end, and includes two or more prongs and a restraint sleeve. The two or more prongs protrude distally from the anchor base and form the penetration tip of the anchor at their distal ends. The restraint sleeve slidably surrounds the anchor prongs and limits the deflection of the prongs. In some embodiments, the restraint sleeve is slidable above and along the prongs between the anchor base and the penetration tip.

[0029] According to aspects of some embodiments of the present invention, there is provided a graft fixation system applicator including one or more lumens connected to an applicator head at the distal end. In some embodiments, the applicator includes a container portion at the proximal end of the applicator lumen. In some embodiments, the graft fixation system is disposed in the container portion before applying the fixation system into the treatment site. In some embodiments, the applicator-container includes one or more axially movable sheaths disposed over at least a portion of the fixation system. In some embodiments, a fixation system holder is disposed at the proximal end of the head lumen.

[0030] According to some embodiments, the graft fixation system is delivered to the treatment site via a catheter delivered by an applicator.

[0031] Graft fixation system ​​​​​​​​​​​​​​​Reference is now made to FIGS. 1A through 1C, which are simplified explanatory views of a top view and a perspective view of a graft fixation system according to some embodiments of the present invention. As shown in FIGS. 1A through 1C, the graft fixation system 10 includes a frame 40 and a plurality of anchors 100. In some embodiments, the anchor 100 includes one or more prongs 140, and the one or more prongs 140 are connected to a base 142 and are held in a configuration restricted by a restraint sleeve 160. In some embodiments, the frame 40 is cylindrical or tubular. According to some embodiments of the present invention, the anchor 100 fixes the graft 80 to the vessel wall 90. In some embodiments, the frame 40 moves the anchor 100 radially outward (away from the frame 40), and the anchor 100 penetrates through the graft 80 and the wall of the vessel. In some embodiments, the anchor 100 converts the radially outward force applied by the frame 40 into a penetrating force and penetrates through the graft 80. The anchor 100 approaches and attaches the graft 80 to the vessel wall 90. In some embodiments, after penetrating through the graft 80 and the vessel wall 90, the anchor 100 assumes an expanded state, and in the expanded state, the prongs 140 of the anchor 100 are deflected to lie against the outer surface 92 of the vessel wall 90 and press the vessel wall radially centrically (toward the frame 40) against the graft 80 and optionally against the frame 40.

[0032]

[0033]

[0034] ​​​​​​​​​​​​​The potential advantages of this configuration for approaching the vessel wall portion 90 and the graft 80 are that, in a fully expanded state, the prongs 140 are deflected away from each other and apply a force to center the graft fixation between the tissue and the frame 40 in the radial direction, the graft 80 and the vessel wall portion 90 being sandwiched between the anchor 100 prongs 140 and the base 142 and the frame 40 struts.

[0035] The vessel wall portion 90 and the graft 80 are fixed to each other at the penetrated vessel wall site by the anchor 100 without requiring physical contact between the frame 40 and the graft. In some embodiments, the graft 80 is a stent graft.

[0036] In the exemplary embodiments shown in FIGS. 1A-1C, the anchor 100 is attached to the frame 40 via one or more anchor support struts 45. In some embodiments, and as shown in FIGS. 1A-1C, the anchor 100 is attached to the anchor support strut 45 at a predetermined angle (e.g., 90 degrees) relative to the longitudinal axis of the frame 40 and faces radially outward. In some embodiments, and as described elsewhere herein, the frame 40 is radially expandable and foldable.

[0037] As shown in FIGS. 1A-1D, according to some embodiments of the present invention, the frame 40 is expandable and foldable. In some embodiments, the frame 40 is a radially expandable fixed ring. Shown in FIGS. 1B, 1C, and 1D In some embodiments as described, the frame 40 is stent-like, however, the frame 40 can include any suitable foldable / expandable structure. In some embodiments, the frame 40 is expandable from a folded state (FIG. 1 D) to an expanded state (FIGS. 1B and 1C). In some embodiments the system includes a stent graft inside or outside the frame 40. In some embodiments, the stent graft lies between the frame 40 and the vessel wall. .

[0038] In some embodiments, and as shown in FIG. 1A, in the folded state of the frame 40, for example, when within the release sheath 1230 described in more detail herein, the anchor support strut 45 is elastically biased towards the radial center, generally aligning the anchor 100 axially parallel to the longitudinal axis of the frame 40.

[0039] In some embodiments, for example in the expanded state shown in FIG. 1B, the anchor support strut 45 moves from the radially biased state to a free and straight state by an elastic force, and in the free and straight state, the support strut 45 is straightened, realigned with the longitudinal axis of the frame 40, and directs the anchor 100 radially outward. In some embodiments, in the expanded state, the anchor 100

[0040] As shown in FIGS. 1A - 1C, the anchor 100 is attached to the frame 40 00 and two or more adjacent pros and a prong 140 extending from an anchor base 142 and The anchor 100 includes a restraint 140 attached to the prongs 140. In some embodiments, the constraining sleeve 160 is attached to the prong 14. In some embodiments, the restraining sleeve 160 is arranged in opposing directions. Prongs 140 are limited from deflecting.

[0041] 2A to 2D, which illustrate some embodiments of the present invention. FIG. 2 is a simplified illustration of a side view and a perspective view of an implementation of anchor 200 according to the present invention. 2A to 2C, 3A to 3B, 4A to 4C, and 5. For purposes of simplicity of explanation, the anchors are illustrated as being connected to the frame 40 and the anchor support struts. Shown removed from 45.

[0042] As shown in FIG. 2A, the graft 280 and the vessel wall 290 are adjacent to each other. As shown in FIGS. 2A and 2B, anchor 200 is disposed at a radius A force is applied to the anchor base 260 in an outward direction (indicated by arrow 201). 270) against the graft 280 and the vessel wall 290. 201 is generated by the expansion of the frame 40. The penetrating tip 2 of the anchor 200 20 extends from the inner surface 284 of the graft 280 through the graft 280 to the vessel wall 29 2 through the graft 280 into the inner (e.g., endothelial) surface 294 of the vessel wall 290. 0 engages the outer surface 296 opposite.

[0043] As shown in FIG. 2A, the anchor 200 includes one or more prongs 240 and a restraint sleeve 230. In some embodiments, the length of the restraint sleeve 230 is shorter than the length of the prong 240, such that the restraint sleeve 230 is capable of sliding over and along the prong 240 between the penetrating tip 220 and the base 260. In some embodiments, the restraint sleeve 230 is prevented from sliding past the distal ends of the prongs 240-1 and 240-4 by a restraint sleeve stop 245 formed near the tip 220 of the prong 240. In some embodiments, the base 260 of the anchor 200 is wider than the internal cross-section of the restraint sleeve 230, such that the sleeve 230 is restricted from sliding proximally past the base 260 of the anchor 200. In some embodiments, the restraint sleeve stop 245 is shaped as a rib protruding laterally outward from the prong 240 and extending beyond the internal cross-section of the restraint sleeve 230. As shown in FIGS. 2A through 2C, the prong 240 is elastic and made of a shape memory material (e.g., nitinol). The prong 240 is pre-shaped to take on a pre-shaped unrestrained configuration in which the anchor prong 240 is open and deflected away from each other as indicated by the dashed arrow 250.

[0044] FIG. 2A shows an exemplary embodiment in which the anchor 200 is in a fully restrained state​​​​​​​​​​ Yes, and in the most constrained state, the anchor prongs 240-1 through 240-4 are juxtaposed throughout their entire lengths. FIG. 2C is an exemplary embodiment where the anchor 200 is in the most unconstrained state, and FIG. 2B is an exemplary embodiment where the anchor 200 is in a partially constrained state (or, partially unconstrained state). The anchor 200 is configured to assume the most constrained state (FIG. 2A) when the restraint sleeve 230 engages the restraint sleeve stop 245, and also when the restraint sleeve 23 0 engages the anchor base 260 and the restraint sleeve 230 is far from the restraint sleeve stop 245, and is pre-shaped to assume the most unconstrained state (FIG. 2C) when the restraint sleeve 230 is free to bend the prongs 240 into their pre-shaped open (unconstrained) state. In some embodiments as shown in FIG. 2B, the through distal end 220 of any one of the prongs 240-1 through 240-4 is laterally deflected in the partially constrained state. In some embodiments, and as shown in FIGS. 2A-2C, the anchor 2 00 includes four prongs 240 (240-1 through 240-4). Two of the prongs are the inner prongs 240-2 / 240-3, and the inner prongs 240-2 / 240-3 are respectively disposed between two of the prongs 240-1 / 240-3 and 240-2 / 240-4 . In some embodiments, two of the prongs are the outer prongs 240-1 / 240-4, and the outer prongs 240-1 / 240-4 are, respectively,

[0045] In some embodiments, and as shown in FIGS. 2A-2C, the anchor 2 00 includes four prongs 240 (240-1 through 240-4). Two of the prongs are the inner prongs 240-2 / 240-3, and the inner prongs 240-2 / 240-3 are respectively disposed between two of the prongs 240-1 / 240-3 and 240-2 / 240-4 . In some embodiments, two of the prongs are the outer prongs 240-1 / 240-4, and the outer prongs 240-1 / 240-4 are, respectively, They are respectively positioned adjacent to the inner prongs 240-2 / 240-3, and form two pairs of prongs 240-1 / 240-2 and 240-3 / 240-4. In some embodiments, the two pairs of prongs 240-1 / 240-2 and 240-3 / 2 40-4 deflect away from each other when in an unconstrained state. In some embodiments the inner prongs 240-2 and 240-3 are respectively slidable along the adjacent outer prongs 240-1 and 240-4 when deflecting outwardly towards the unconstrained state. In some embodiments, the inner prongs 240-2 and 240 -3 apply a deflecting force to the adjacent outer prongs 240 -1 and 240-4 respectively when deflecting towards the open unconstrained state.

[0046] As shown in FIGS. 2B and 2C, when the restraint sleeve 230 slides towards the anchor base 26 0, the pairs of outer prongs 240-1 / 240-4 and inner prongs 240-2 / 240-3 deflect in the opposite direction towards the unconstrained state, separating the penetration tips 2 20 from each other. In some embodiments, the inner prongs 240-2 / 240- 3 and the outer prongs 240-1 / 240-4 apply outwardly oriented force vectors to respective sides of the anchor 200. In the exemplary embodiments shown in FIGS. 2A-2C, the tip of the anchor 200 includes the dual tips 220 of the two pairs of inner prongs 240-2 / 240-3 and outer prongs 240-1 / 240-4. In some embodiments the force 201 applied to the anchor 200 by expanding the frame 40 is converted into a mechanical change in the anchor 200 configuration, causing the prongs 240 to deflect in the opposite direction ​ Allows bending, with the penetrating tip 220 pressed against the outer surface 296 of the blood vessel wall 290 on the side opposite to the penetrating direction, thereby fixing the blood vessel wall 290 to the graft 280. to it. .

[0047] In some embodiments, the anchor 200 is in a fully expanded state, and the graft 280 is sandwiched between the anchor 200 base 260 and the blood vessel wall 290 when the restraint sleeve 230 is moved towards the base 260. In some embodiments, the sleeve 230 is moved to fully abut against the base 260 as shown in FIG. 2C.

[0048] In some embodiments such as those shown in FIGS. 1A and 2A - 2C, the force applied to the restraint sleeve 160 / 230 causes the restraint sleeve 160 / 230 to slide towards the anchor tip 120 / 220 (distally) or towards the anchor base 142 / 260 (proximally). In the exemplary embodiments shown in FIGS. 2A - 2C, the blood vessel wall 290 and / or the graft 280 resist the penetration of the restraint sleeve 160 / 230 and generate a reaction force on the opposite side of the force 201. In some embodiments, the restraint sleeve 160 / 230 includes a flat surface 232 facing the anchor base. In some embodiments, the restraint sleeve 160 / 230 includes a flat surface 234 facing the anchor tip. In some embodiments, the restraint sleeve 160 / 230 is pushed in the proximal direction by a force applied to the flat surface 232 facing the base or the flat surface 234 facing the tip of the restraint sleeve 160 / 230. ​ In this state, as shown in FIGS. 2A - 2C, the restraint sleeve 230 is flat and has a reduced length, and is configured to remain inside the blood vessel while the prong 240 penetrates through the graft 280 and the vessel wall portion 290, and is pressed against the graft 280. In some embodiments, the sleeve 230 does not engage the inner (endothelial) surface of the vessel wall portion 290.

[0049] In some embodiments, and as shown in FIG. 2D, which is a perspective view of the attachment system from the anchor 200 to the frame 40. In FIG. 2D, the anchor 200 is attached to the frame 40 in an expanded state as shown in FIG. 1B. In some embodiments, the anchor base 260 includes a cutout 265, and the cutout 265 is used to attach the anchor 200 to the anchor support strut 45 of the frame 40 (such as the frame 40 like a stent) by fitting the cutout 265 to the matching end 45 - 1 of the anchor support strut 45. In some embodiments, the locking pin 255 is pushed through a pinhole in the matching end 45 - 1 to lock the anchor 200 to the matching end 45 - 1 of the anchor support strut 45. Since the matching end 45 - 1 and the cutout 265 / 365, and the locking pin 255 share the stress related to the implementation of the system 10, only the movement of the locking pin 255 in the pinhole needs to be fixed. In some embodiments, the pin 255 is adhered, welded, coupled, or attached by any other suitable technique to the support strut 45. ​ . In some embodiments, after the anchor 200 is fitted to the frame 40 , it is locked to the frame 40. In some embodiments, by laser cutting and thermoforming processes, the anchor 200 is integrally formed with the frame 40.

[0050] A potential advantage in the locking mechanism for attaching the support strut 45-1 to the anchor 200 is that the bending or flexing point of the support strut 45 is proximal and relatively far from the attachment, so that the anchor is forced into alignment by the frame 40 and is not affected by the elastic bending forces applied to the support strut 45, while the zone surrounding the locking pin 255 encounters minimal stress and encounters stress that is at least less than the stress encountered by the support strut 45, reducing the potential for weakening, breakage, or detachment of the anchor 100 from the support strut 45. .

[0051] A potential advantage in the locking mechanism for the anchor 200 to the support strut 45-1 is that nitinol when welded is very sensitive to stress (e.g., stress resulting from bending). The attachment solution with the described locking pin 255 includes a single point weld to secure the locking pin 255.

[0052] A potential advantage in the locking mechanism for the anchor 200 to the support strut 45-1 is that the restraint sleeve, as shown in Figure 4E by arrow 450, is from the base of the anchor (which is relatively narrow) to the tip of the anchor (which is relatively wide) in that it can be screwed into the anchor prong in a distal direction towards the wide end).

[0053] According to some embodiments of the present invention as shown in FIGS. 2A - 2C, the anchor 200 includes an even number (4) of prongs 240 (240 - 1 to 240 - 4). In the illustrated embodiment of FIGS. 2A - 2C, two prongs 240 - 2 / 240 - 3 are inner prongs, and the inner prongs are respectively disposed between two other prongs 240 - 1 / 240 - 3 and 240 - 2 / 240 - 4. Two of the prongs 2 40 - 1 / 240 - 4 are outer prongs, and the outer prongs are respectively positioned adjacent to the inner prongs 240 - 2 / 240 - 3, and are configured to form two pairs of prongs 240 - 1 / 240 - 2 and 240 - 3 / 240 - 4. In some embodiments, the anchor includes an odd number of prongs. In some embodiments, the anchor includes an odd number of inner prongs.

[0054] Referring now to FIGS. 3A and 3B, FIGS. 3A and 3B are simplified explanatory views of a side view and a perspective view of an anchor 300 (excluding its restraint sleeve) according to some embodiments of the present invention. As shown in FIGS. 3A and 3B, in some embodiments the anchor 300 includes a pair of outer prongs 340 - 1 / 340 - 2 and no inner prongs. The anchor 300 shown in FIG. 3A at the most constrained position and in FIG. 3B at the most unconstrained position includes two prongs 340 - 1 / 340 - 2. The anchor 30

[0055] As shown in FIG. 3A at the most constrained position and in FIG. 3B at the most unconstrained position, the anchor 300 includes two prongs 340 - 1 / 340 - 2. The anchor 30 The tip 320 of 0 is formed by two tip half - bodies 320 - 1 / 320 - 2, with one half - body in each prong, and the juxtaposed prongs 340 - 1 / 34 0 - 2 cause the tip half - bodies 320 - 1 / 320 - 2 to be juxtaposed and form a single complete tip 320. A potential advantage of this configuration is that the force applied to the anchor 300 by the frame (not shown) acts as a single through - tip 320 when the juxtaposed prong tip half - bodies 320 - 1 / 320 - 2 are in the closed state (Figure 3A), while resulting in maintaining a smaller material (e.g., nitinol) volume and a lower profile in the open, deployed state (Figure 3B). .

[0056] A potential advantage of this configuration is that a single tip, or a single tip including two half - bodies of the tip, has a smaller surface area compared to a double - tip anchor as shown in Figures 2A - 2D, and has reduced resistance when penetrating the graft 280 and the vessel wall portion 290.

[0057] In the exemplary embodiments shown in Figures 3A and 3B, the anchor base 360 includes a rectangular cut 365, and the rectangular cut 365 is used to attach the anchor 3 00 to the anchor support strut 45 of the frame 40 (e.g., a stent or an expandable ring (not shown)). As shown in Figures 3A and 3B, a restraint sleeve (not shown) slides over the anchor penetration tip 320 by a protruding restraint sleeve stop 345 formed at the distal end of the prong 340 - 1 / 2. ​​​is blocked. Additionally, the slide of a restraining sleeve (not shown) towards the base 360 is temporarily restricted by a second protruding restraining sleeve stop 347 formed between the protruding restraining sleeve stop 345 and the anchor base 360.

[0058] Reference is now made to FIGS. 4A - 4E, which are simplified explanatory views of a plan view, a partial cross - sectional view, a side view, and a perspective view of the penetrating portion of the anchor according to some embodiments of the present invention. The embodiments of the restraining sleeve shown in FIGS. 4A - 4C can be modified and combined with any one of the anchors shown in FIGS. 2 and 3 as appropriate.

[0059] In some embodiments (e.g., FIG. 4B), the restraining sleeve 425 has no tapered tip. In some embodiments, and as shown in FIG. 4A, the restraining sleeve 425 of the anchor 420 is a tissue - penetrating restraining sleeve that includes one or more tapered distal penetrating tips 427, and the one or more tapered distal penetrating tips 427 are configured to penetrate the graft and / or tissue. In some embodiments, the penetrating tips 427 include one or more sharp edges. A potential advantage of the tapered penetrating tip is that the tapered tip reduces the level of resistance required to push the anchor 420 through the graft and / or the vessel wall.

[0060] Additionally, and as shown in the exemplary embodiment of FIG. 4A, the restraining sleeve 425 is a tissue - resident restraining sleeve with a base - facing flange 42​ including 6, the flange 426 projects radially outwardly from the outer surface of the sleeve 425 During implantation, the tissue-penetrating restraint sleeve 425 penetrates through the graft 280 and the vessel wall portion 290 until the flange 426 abuts against the inner surface of the graft 280 and further penetration of the tissue-penetrating restraint sleeve 425 into the tissue is stopped During implantation, the tissue-penetrating restraint sleeve 425 penetrates through the graft 280 and the vessel wall portion 290 until the flange 426 abuts against the inner surface of the graft 280 and further penetration of the tissue-penetrating restraint sleeve 425 into the tissue is stopped Continuously applying force to the base 260 by the frame 40 slides the anchor 420 prong 421 axially outwardly relative to the tissue-penetrating restraint sleeve 425, allows the prong 421 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface 296 of the vessel wall portion 290 on the side opposite the penetrating direction, thereby fixing the vessel wall portion 290 to the graft 280 Continuously applying force to the base 260 by the frame 40 slides the anchor 420 prong 421 axially outwardly relative to the tissue-penetrating restraint sleeve 425, allows the prong 421 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface 296 of the vessel wall portion 290 on the side opposite the penetrating direction, thereby fixing the vessel wall portion 290 to the graft 280 Continuously applying force to the base 260 by the frame 40 slides the anchor 420 prong 421 axially outwardly relative to the tissue-penetrating restraint sleeve 425, allows the prong 421 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface 296 of the vessel wall portion 290 on the side opposite the penetrating direction, thereby fixing the vessel wall portion 290 to the graft 280 Continuously applying force to the base 260 by the frame 40 slides the anchor 420 prong 421 axially outwardly relative to the tissue-penetrating restraint sleeve 425, allows the prong 421 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface 296 of the vessel wall portion 290 on the side opposite the penetrating direction, thereby fixing the vessel wall portion 290 to the graft 280 Continuously applying force to the base 260 by the frame 40 slides the anchor 420 prong 421 axially outwardly relative to the tissue-penetrating restraint sleeve 425, allows the prong 421 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface 296 of the vessel wall portion 290 on the side opposite the penetrating direction, thereby fixing the vessel wall portion 290 to the graft 280 Continuously applying force to the base 260 by the frame 40 slides the anchor 420 prong 421 axially outwardly relative to the tissue-penetrating restraint sleeve 425, allows the prong 421 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface 296 of the vessel wall portion 290 on the side opposite the penetrating direction, thereby fixing the vessel wall portion 290 to the graft 280

[0061] In some embodiments, and as shown in the exemplary embodiment shown in FIG. 4B, the restraint sleeve 445 is a lumen-present restraint sleeve, and the lumen-present restraint sleeve 445 lacks a penetrating tip and includes a blunt distal (facing the tip) surface 447 In some embodiments, and as shown in the exemplary embodiment shown in FIG. 4B, the restraint sleeve 445 is a lumen-present restraint sleeve, and the lumen-present restraint sleeve 445 lacks a penetrating tip and includes a blunt distal (facing the tip) surface 447 During implantation, the lumen-present restraint sleeve 445 abuts against the inner surface of the graft 280 and stops the lumen-present restraint sleeve 445 from penetrating the graft 280 or entering the tissue During implantation, the lumen-present restraint sleeve 445 abuts against the inner surface of the graft 280 and stops the lumen-present restraint sleeve 445 from penetrating the graft 280 or entering the tissue During implantation, the lumen-present restraint sleeve 445 abuts against the inner surface of the graft 280 and stops the lumen-present restraint sleeve 445 from penetrating the graft 280 or entering the tissue Continuously applying force to the base 260 by the frame 40 slides the anchor 440 prong 441 axially outwardly relative to the lumen-present restraint sleeve 445, allows the prong 441 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface of the vessel wall portion 290 on the side opposite the penetrating direction Continuously applying force to the base 260 by the frame 40 slides the anchor 440 prong 441 axially outwardly relative to the lumen-present restraint sleeve 445, allows the prong 441 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface of the vessel wall portion 290 on the side opposite the penetrating direction Continuously applying force to the base 260 by the frame 40 slides the anchor 440 prong 441 axially outwardly relative to the lumen-present restraint sleeve 445, allows the prong 441 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface of the vessel wall portion 290 on the side opposite the penetrating direction Continuously applying force to the base 260 by the frame 40 slides the anchor 440 prong 441 axially outwardly relative to the lumen-present restraint sleeve 445, allows the prong 441 to bend freely in the opposite direction, and presses the penetrating tip 220 against the outer surface of the vessel wall portion 290 on the side opposite the penetrating direction Pressed against 296, thereby securing the vessel wall portion 290 to the graft 280.

[0062] As shown in FIGS. 4A and 4C, in some embodiments, the restraint sleeve 4 25 / 465 includes a base-facing flange 426 / 466. As shown in FIGS. 4A and 4B As shown, in some embodiments, the internal prongs 421-3 / 4 and 44 1-3 / 4 are shorter than the external prongs 421-1 / 2 / 441-1 / 2 and include blunt tips. In some embodiments, the anchor 420 includes an internal prong 421-3 / 4 having a blunt tip.

[0063] As shown in FIGS. 4A and 4B, in some embodiments, the anchor 420 / 440 includes buckling prevention locks 428 / 448 at the tips 422 / 442, and the buckling prevention locks 428 / 448 are configured to prevent anchor buckling during penetration into the graft and / or tissue. In some embodiments, the buckling lock 428 is formed by a protrusion (e.g., tongue-shaped) 430 protruding from the first prong 421-2 towards the second prong 421-1 juxtaposed therewith and a recess 431 in the second prong 421-1, and the recess 431 faces the protrusion 430, and in the juxtaposed configuration of the first prong 421- 1 and the second prong 421-2, the protrusion 430 is received by the recess 431 forming the buckling lock 428. During operation, the anchor 420 is pushed by a frame (not shown) into the graft and the vessel wall portion (not shown) against the graft and the vessel wall portion (not shown). Buckling is between the layers of and is thereby prevented. Inducing a shear force (expressed as a longitudinal displacement between adjacent prongs), Lock 428 prevents relative movement (e.g., juxtaposition) between prongs 421-1 / 421-2. to stop the relative axial movement of each prong relative to the prong and thus provide an anchor during penetration of the graft and / or vessel wall. -Prevents buckling of 420.

[0064] As shown in FIGS. 4A-4C, in some embodiments, a constraining sleeve strap may be used. Prong 423 / 443 / 463 is shaped as a rib, and the rib is 1 / 441 / 461 protrudes outward from the surface of the captive sleeve 425 / 445 / 4 65. In some embodiments, the width of the protrusion is greater than the inner width of FIG. As shown in FIG. 4A, prongs 421-1 to 421-4 between protrusions 423 The outer width of the captive sleeve 425 is equal to or less than the outer width of the captive sleeve 425. , so that the rib 423 does not protrude outside the restraining sleeve 425. In this embodiment (FIGS. 4A-4C), the tip 422 / 442 / 462 is a constraining sleeve. It protrudes in the opposite direction from stops 423 / 443 / 463.

[0065] According to some embodiments of the present invention, the cross section of one or more prongs is rectangular. , flat, circular, triangular, or any other suitable geometric shape. In some embodiments, the cross section of any one of the prongs varies along its length. In some embodiments, the cross section of the restraining sleeve is one of rectangular, flat, and circular. It can be any one of them or a combination of them.

[0066] In some embodiments, and as shown in the exemplary embodiments shown in, for example, FIGS. 4A, 4B, and 4C, the respective tip portions 422, 442, and 462 of the anchors 420, 440, and 460 are each cut (e.g., by a laser) to form a pointed (e.g., triangular) geometric shape. In some embodiments, during manufacture, the distal edges 427 / 467 of the restraint sleeves 425 / 465 are optionally ground to a predetermined shape.

[0067] In some embodiments, and as shown in the exemplary embodiments shown in FIG. 4D, the tip portion 482 of the anchor 480 is ground along the distal edge 484 of the anchor to form a through blade 486. In some embodiments, the distal edge 484 tapers from its narrow side and is flat from its wide side. The blade edge of the anchor tip shown in FIG. 4D improves the penetrability of the anchor through the graft and tissue.

[0068] In some embodiments, and as shown in the exemplary embodiments shown in FIG. 4E, the tip portion 495 of the anchor 490 is ground along both sides of the distal edge 494 of the anchor to form a pointed through blade 496. In some embodiments, the distal edge 494 tapers from both its narrow side and its wide side. The pointed blade edge of the anchor tip shown in FIG. 4E adds additional cutting edges other than the single cutting blade edge of FIG. 4D, improving the penetrability of the graft and tissue Add additional penetrability of the anchor through it. Selection between anchors 480 and 490 depends on the type of tissue and / or graft material that the anchor is expected to penetrate.

[0069] Referring to FIG. 5, FIG. 5 is a simplified explanatory diagram of a perspective view of a 3D anchoring anchor (excluding the restraint sleeve) according to some embodiments of the present invention. The anchor 500 shown in FIG. 5 includes three or more prongs 540-1, 540-2, 540-3, and 5 40-4. In the exemplary embodiment shown in FIG. 5, the anchor 500 includes two pairs of prongs 540, each pair including two diametrically opposed prongs 540 (e.g., , 540-1 / 540-3 and 540-2 / 540-4), and the prongs of each pair are configured to bend in opposite directions along a common plane (e.g., plane G and plane W, respectively). In some embodiments, planes G and W are angled with respect to each other. In some embodiments, planes G and W are perpendicular to each other.

[0070] A potential advantage of the anchor 500 is that it provides at least three points of pressure on the outer surface of the blood vessel. A potential advantage of the anchor 500 is that it prevents the wall portion 290 of the blood vessel from rising or curving along the sides of the prongs 540 and prevents partial detachment of the wall portion 290 of the blood vessel from the graft 280. In some embodiments, the anchor 500 is made of flat / round NiTi wire or is cut and shaped from NiTi tubing.

[0071] ​ In some embodiments, an anchor such as anchor 500 is formed from sheet metal by cutting the anchor and bending the cut piece to form the final anchor. In some embodiments, an anchor such as anchor 500 is formed from a tube by cutting the anchor (e.g., by laser) and forming the final anchor form by heat treatment. The prongs 540-1 through 540-4 are oriented on the base and, thus, each prong is disposed between two other prongs (e.g., 540-1 is disposed between 540-2 and 540-3). In some embodiments, a restraint sleeve stop is formed on the prong. Reference is now made to FIGS. 6A, 6B, and 6C, which are simplified explanatory views of side views of an implementation of the anchor 600 of the fixation system 10 according to some embodiments of the present invention. In the exemplary embodiments of FIGS. 6A-6C, the anchor 600

[0072] is of a double prong type and at least one prong 602 includes a proximal portion 604 that is elastically curved outwardly. In some embodiments, the elastically curved outward proximal portion 604 is adjacent to or abuts the anchor 600 base 616. In some embodiments, the elastically curved outward proximal portion 604 is elastically (centrally and outwardly in the radial direction) and, when pushed radially inwardly, is centered and follows the center and follows the center and follows

[0073] Here, FIGS. 6A, 6B, and 6C are referred to, and FIGS. 6A, 6B, and 6C are simplified explanatory views of side views of an implementation of the anchor 600 of the fixation system 10 according to some embodiments of the present invention. In the exemplary embodiments of FIGS. 6A-6C, the anchor 600 is of a double prong type and at least one prong 602 includes a proximal portion 604 that is elastically curved outwardly. In some embodiments, the elastically curved outward proximal portion 604 is adjacent to or abuts the anchor 600 base 616. In some embodiments, the elastically curved outward proximal portion 604 is elastically (centrally and outwardly in the radial direction) and, when pushed radially inwardly, is centered and follows the center and follows the center and follows the center and follows centrally and elastically outwardly in the radial direction and, when pushed radially inwardly, is centered and follows configured to move axially (increasing the length of the prong 602) intentionally . In some embodiments, the restraint sleeve 625 has a cylindrical geometry and includes a flange 650 attached to the proximal (towards the frame 606) end of the sleeve 625 .

[0074] . In some embodiments, the anchor 600 is deployed into the vessel wall in a two-step process . In the first step, and as shown in FIG. 6A, a low first force (represented by the thin arrow 608) is applied to the frame 606 to push the anchor 600 into the tissue . The low force applied is sufficient to push the anchor 600 into the tissue but insufficient to push the restraint sleeve 625 over the elastic outwardly curved proximal portion 604 . As shown in FIG. 6B, a second force higher than the first low force (represented by the thick arrow 610) is sufficient to press the flange 650 against the graft 612 and the vessel endothelium 614, forcing the restraint sleeve 625 to move proximally over the elastic outwardly curved proximal portion 604 and pushing them in a radially inward direction . The proximal movement of the restraint sleeve 625 further pushes the anchor 600 into the tissue and allows at least a portion of the anchor 600 prong 602 to bend freely away from each other . . . . . . .

[0075] . The exemplary embodiment shown in FIG. 6C shows the final deployment stage, in which the anchor 600 is fully deployed, the restraint sleeve 625 abuts the base 616, the prong 602 is fully free, and outside the vessel wall . . ​is bent against the surface and the graft 612 is fixed to the blood vessel wall portion.

[0076] Ring-shaped anchoring fixation system Reference is now made to FIGS. 7A and 7B, which are simplified explanatory views of perspective views of graft fixation systems according to some embodiments of the present invention. As shown in FIGS. 7A and 7B, the system includes two ring-shaped frames 710 and 7 50, and the two ring-shaped frames 710 and 750 each include a plurality of anchors 730 / 770, and the plurality of anchors 730 / 770 project radially outward from the frame rings 720 / 7 60, and are configured to penetrate the graft 780 and tissue (e.g., blood vessel wall portion) 790 when pushed by the radial expansion of the frame rings 720 and 760. In some embodiments, at least one of the frame rings 720 / 760 has one or more latches 740 / 745. In some embodiments, at least one of the latches 740 / 745 of the first ring frame is configured to interlock with each latch of the second adjacent ring frame when the frame rings 710 / 750 are axially juxtaposed.

[0077] As shown in the exemplary embodiments shown in FIGS. 7A and 7B, the anchors 730 / 770 project at various angles from their respective frame rings 710 / 750. For example, the anchor 770 is perpendicular to the plane defined by the circumferential opening of the ring 750, and the anchor 730 is circumferential of the ring 710. It is angled with respect to the plane defined by the opening in the direction. In some embodiments at least one of the anchors 730 / 770 of the frame rings 720 / 760 at least one of which extends towards one or more of the anchors 73 0 / 770 of the adjacent frame rings, such that when the frame rings 720 / 760 are deployed the anchors 730 / 770 of the deployed frame rings 720 and 760 are interlocked. A potential advantage of this configuration is that the interlocked anchors support each other and prevent axial movement of the system 700. In some embodiments the anchors of at least one of the rings 730 / 770 project at varying angles with respect to the axis of the ring 730 / 770.

[0078] Referring to FIGS. 8A and 8B, FIGS. 8A and 8B are simplified explanatory views of perspective views of a graft fixation system according to some embodiments of the present invention. As shown in FIGS. 8A and 8 B, the system includes a radially expandable base frame 810 shaped as a ring and a radially expandable guide frame 850 shaped as a ring. In some embodiments, at least one of the frames 810 / 850 is foldable. In some embodiments, the base frame 8 10 includes a plurality of anchors 830 projecting generally perpendicular to the plane defined by the circumferential opening of the ring 810. In some embodiments, the guide frame 850 includes a plurality of guide channels 802 disposed in the ring wall 860.

[0079] ​​​​The guide channel 802 is formed generally perpendicular to the plane defined by the circumferential opening of the frame 850 and includes an entry port 872 and an exit port 874 . The anchor 830, when the base ring 810 and the guide ring 850 are axially juxtaposed , after passing through the guide channel 802, penetrates the graft 895 and the tissue 89 0 to connect the tissue (e.g., the vessel wall portion) 890 to the graft 895 . At least one of the frames 810 and 850 is expandable from a retracted state (e.g., in an applicator ) to an expanded state, and in the expanded state, the frame 8 50 is engaged with the graft 895

[0080] . The anchor 830 is shaped and directed into the graft 895 and the tissue 890 by the guide 802 . As shown in FIG. 8B, the guide channel 80 2 is angled with respect to the frame 850 wall and guides the anchor 830 to bend at a predetermined angle and accept an angled configuration after penetration during their deployment through the guide 802 . The anchor 830 enters through the entry port 872 and exits through the exit port 874 during axial displacement of at least one of the frames 810 / 850 towards the other 850 / 810 until the frames 810 / 850 are juxtaposed and is deployed within the guide channel 802 . In some embodiments as shown in FIG. 8B, the anchor 830 is elastic and made of a shape memory material, such as nitinol . FIG. 8 B. In some embodiments as shown in FIG. 8B, the anchor 830 is elastic and made of a shape memory material, such as nitinol

[0081] In some embodiments, the anchor 830 is pre-shaped and assumes a pre-shaped unconstrained configuration when not constrained. In some embodiments, the anchor 830 is held in a constrained position by a constraint sleeve (not shown) prior to entering an anchor guide 870 formed in the guide frame 850. In some embodiments the anchor 830 is formed in accordance with an anchor embodiment described elsewhere herein ( e.g., FIGS. 2A - 5). In some embodiments, when entering the guide 802, the anchor constraint sleeve slides away from the distal tip 8 32 of the anchor 830 such that the anchor 830 assumes an unconstrained state when exiting the guide channel 802 through the port 874. Thereby, when passing through the graft 895 and tissue 890, the anchor 830 connects the tissue 890 to the graft 895 by assuming a fixed configuration in which the tip 832 of the anchor 830 is pressed against the tissue. In some embodiments, the constraint sleeve is parallel to the axis of the constraint sleeve frame. In some embodiments, the components of the graft fixation system are manufactured from one or more biocompatible materials of nitinol, stainless steel, and polymers. For example, in some embodiments, at least one of the frame, anchor, and constraint sleeve is made of metal, e.g., nitinol or stainless steel. In some embodiments, the constraint sleeve is a polymer, e.g., ethylene propylene In some embodiments, the components of the graft fixation system are manufactured from one or more biocompatible materials of nitinol, stainless steel, and polymers. For example, in some embodiments, at least one of the frame, anchor, and constraint sleeve is made of metal, e.g., nitinol or stainless steel. In some embodiments, the constraint sleeve is a polymer, e.g., ethylene propylene

[0082] In some embodiments, the components of the graft fixation system are manufactured from one or more biocompatible materials of nitinol, stainless steel, and polymers. For example, in some embodiments, at least one of the frame, anchor, and constraint sleeve is made of metal, e.g., nitinol or stainless steel. In some embodiments, the constraint sleeve is a polymer, e.g., ethylene propylene steel, and polymers. For example, in some embodiments, at least one of the frame, anchor, and constraint sleeve is made of metal, e.g., nitinol or stainless steel. In some embodiments, the constraint sleeve is a polymer, e.g., ethylene propylene Made from a range of monomers (EPDM), polytetrafluoroethylene (PTFE) and / or nitrile-butadiene rubber (NBR).

[0083] Graft fixation system applicator Reference is now made to FIGS. 9A and 9B, which are simplified explanatory views in perspective, side and cross-section of a graft fixation system applicator according to some embodiments of the present invention. The applicator 1000 includes one or more applicator lumens 1400, which are connected to an applicator head 1200 at a distal end and to an applicator control handle 1600 at a proximal end. As shown in the enlarged view A of FIG. 9A and FIG. 9B (section A-A of FIG. 9A), the applicator head 1200 includes a head lumen 1280, an applicator tip 1205 disposed at the distal end of the head lumen 1280, a container portion 1202 positioned proximal to the applicator tip 1205, an axially movable container sheath 1220 surrounding the container portion 1202, a graft fixation system 1100 frame 40 holder and driver 1240 for transporting the balloon 1300 and graft fixation frame 1100, and a frame 1100 release sheath 1230 disposed between the graft fixation frame 1100 and the movable container sheath 1220. In some embodiments, the balloon 1300 is a non-flexible balloon. In some embodiments, the balloon 1300 is a In some embodiments, the holder and driver 1240 include a lumen sized to receive a guidewire. In some embodiments, the applicator 1000 is guided over the guidewire to a target location for deployment. In some embodiments, the applicator 1000 includes an elastic protective layer 1302 that covers at least a portion of the balloon 1300. In some embodiments, the protective layer 1302 includes a sleeve. In some embodiments, the protective layer 1302 includes a balloon. In some embodiments, the protective layer 1302 is made of a biocompatible material such as fabric, nitinol mesh, nylon, silicone, or any other suitable material. In some embodiments, the protective layer 1302 is between 0.05 and 0.6 mm thick. A potential advantage of the protective layer is to protect the balloon 1300 from being damaged or punctured when in contact with the sharp edges of the frame 40 or the anchor 100.

[0084] In some embodiments, the graft fixation system 1100 is one of the graft fixation systems described elsewhere herein. In some embodiments, prior to applying the graft fixation system 1100 by the applicator 1000, the system 1100 is fitted into the container portion 1202 in a maximally folded state. In some embodiments, the graft encloses one of the graft fixation systems described elsewhere herein that is disposed in a retracted state. In the maximally retracted state, the graft fixation system 1100 is folded. In some embodiments, the protective layer 1302 includes a sleeve. In some embodiments, the protective layer 1302 includes a balloon. In some embodiments, the protective layer 1302 is made of a biocompatible material such as fabric, nitinol mesh, nylon, silicone, or any other suitable material. In some embodiments, the protective layer 1302 is made of a biocompatible material such as fabric, nitinol mesh, nylon, silicone, or any other suitable material. In some embodiments, the protective layer 1302 is between 0.05 and 0.6 mm thick. A potential advantage of the protective layer is to protect the balloon 1300 from being damaged or punctured when in contact with the sharp edges of the frame 40 or the anchor 100. A potential advantage of the protective layer is to protect the balloon 1300 from being damaged or punctured when in contact with the sharp edges of the frame 40 or the anchor 100. In some embodiments, the graft fixation system 1100 is one of the graft fixation systems described elsewhere herein. In some embodiments, the graft fixation system 1100 is one of the graft fixation systems described elsewhere herein. In some embodiments, prior to applying the graft fixation system 1100 by the applicator 1000, the system 1100 is fitted into the container portion 1202 in a maximally folded state. In some embodiments, prior to applying the graft fixation system 1100 by the applicator 1000, the system 1100 is fitted into the container portion 1202 in a maximally folded state. In some embodiments, the graft encloses one of the graft fixation systems described elsewhere herein that is disposed in a retracted state. In some embodiments, the graft encloses one of the graft fixation systems described elsewhere herein that is disposed in a retracted state. In the maximally retracted state, the graft fixation system 1100 is folded. Stacked, with the penetrating tip of the anchor 100 (not shown) disposed in the graft fixation system 11 00, and directed distally in the axial direction toward the tip of the dispenser It is like this. In some embodiments, when the fixation system is released and expanded to the expanded state, the anchor disposed in the graft fixation system 1100 is directed radially outward toward the graft and tissue (e.g., the vessel wall).

[0085] In some embodiments, all the anchors 100 are biased together by the frame 40, for example, as shown in FIGS. 1A to 1C When the frame 40 is folded back again to the retracted state (e.g., repositioned) and covered again by the release sheath 1230 the movement of the release sheath 1230 distally (axially forward) presses the anchor 100 radially centrically into the retracted state, and in the retracted state, the anchor 100 is generally axially oriented with respect to the frame 40 again Here, reference is made to FIGS. 9A, 10A, and 10B, as well as FIGS. 11A to 11D In some embodiments, the container portion 1202 sheath 1220 is axially movable over the container 120

[0086] 2 and takes the following applicator head 1200 states: 1) Closed state (FIG. 9): In the closed state, the container sheath 1220 covers the container 1 202 and has a distal rim 1222 adjacent to the tip 1205 2) Partially open state (FIG. 10A): In the partially open state, the container sheath 1 220 is partially retracted proximally, whereby, partially, the container 12 202 is uncovered, and the distal rim 1222 is axially displaced proximally from the tip 1205, and the container sheath 1220 has a proximal end portion that is axially displaced proximally Expose the graft fixation system 1100 fitted within 02 and the container 1202. Expose. 3) Open state (Figure 10B): In the open state, the container sheath 1220 is fully retracted proximally to fully expose the graft fixation system 1100. In some embodiments, by axially distally or axially proximally sliding the container sheath 1220 over the container 1202 to expose the container 1202, the applicator head 1200 transitions from the closed state to the open state and vice versa. The same also applies.

[0087] In some embodiments of the present invention, the frame 40 is locked onto the frame 40 holder and driver 1240 until the frame 40 is unsheathed and exposed. In some embodiments, the frame 40 is unlocked when the container sheath 1220 is unsheathed. In some embodiments, as shown in Figure 10B, the frame 40 holder and driver 1240 include one or more of the frame 40 retaining pins 1235 circumferentially disposed on the outer surface 1 242 of the holder and driver 1240. In some embodiments, the frame 40 includes one or more holes 1275 at the proximal end of the frame 40 (e.g., the frame 40), and the one or more holes 1275 are sized to fit over and receive the retaining pin 1235. In some embodiments, the frame 40 is axially locked to the frame 40 holder and driver 1240 by one or more of the pins 1235. In some embodiments, the frame 40 is axially locked to the frame 40 holder and driver 1240 by one or more of the pins 1235. In some embodiments, the frame 40 is axially locked to the frame 40 holder and driver By attaching to the proximal pinhole formed at the distal end of the frame 40, the pin 123 is fitted over the 5, and until the frame 40 is released from the pin 1235, the f axial movement or full expansion of the frame 40 is prevented.

[0088] In some embodiments, the applicator head 1200 includes an axially movable release sheath 1230, and the axially movable release sheath 1230 has a closed state (1 0A) (in the closed state, the release sheath 1230 is positioned over the retaining pin 1235 ), a partially open state (FIG. 11B), and an open state (FIGS. 11C and 11D) (in the open state, the release sheath 1230 is retracted proximally, exposing the retaining pin 1235 ). In some embodiments, when the frame 40 is locked within the applicator head 1200, the frame 40 can be reinserted into the sheath by either the release sheath 1230 or the container sheath 1220.

[0089] In some embodiments, as shown in FIG. 9, the frame 40 is expandable by a balloon 130 0, the balloon 1300 is disposed within the lumen 1280, fixed to the holder and driver 1240, and surrounded by the frame 40. In some embodiments, the balloon 1300 is expandable via the lumen 1280, or in some embodiments, expandable via a space created by adding an additional sheath around 1280. FIG. 1 In some embodiments, as shown in 0, the frame 40 is folded on top of the balloon 1300 disposed in a contracted state within the container 1202 before the frame 40 is applied. In some embodiments, the balloon 1300 is a non-flexible balloon. In some embodiments, the balloon 1300 is a non-flexible balloon.

[0090] In some embodiments, the method of delivery and application of the frame 40 by the applicator 1000 includes the following: a) Positioning the applicator head 1200 at the deployment site in the blood vessel. In some embodiments, the marker 1210 disposed at the distal end 1205 assists in the initial positioning of the applicator head. In some embodiments, the marker 1210 disposed at the distal end 1205 assists in the initial positioning of the applicator head. b) Partially sheathing the frame 40 by retracting the container sheath 1260 proximally from the distal end 1200, such that the frame 40 is partially expanded and partially open. b) Partially sheathing the frame 40 by retracting the container sheath 1260 proximally from the distal end 1200, such that the frame 40 is partially expanded and partially open. c) Verifying the positioning of the frame 40 in the blood vessel. d) Optionally, re-sheathing the frame 40 by sliding the container sheath 1260 distally over the frame 40 such that the head 1200 is again closed, and re-positioning the graft fixation system 1100 if required, followed by repeating steps (1) through (3). d) Optionally, re-sheathing the frame 40 by sliding the container sheath 1260 distally over the frame 40 such that the head 1200 is again closed, and re-positioning the graft fixation system 1100 if required, followed by repeating steps (1) through (3). e) Releasing the locking pin 1235 from the fixation system by retracting the release sheath 1230 to its fully open position. f) Sheathing the fixation system 1100 by retracting the container sheath 1260 such that the head 1200 is in a partially open state and the fixation system can expand freely within the treatment site. f) Sheathing the fixation system 1100 by retracting the container sheath 1260 such that the head 1200 is in a partially open state and the fixation system can expand freely within the treatment site. e) Releasing the locking pin 1235 from the fixation system by retracting the release sheath 1230 to its fully open position. e) Releasing the locking pin 1235 from the fixation system by retracting the release sheath 1230 to its fully open position. ​​​​​f) Inflating the actuating balloon 1300 and expanding the frame 40. Pressing the frame 40 against the graft and / or the tissue, thereby fixing the graft to the tissue (e.g., the vessel wall).

[0091] Releasing the applicator by contracting the balloon 1300, reinserting it into the sheath by means of the sheaths 1 230 and 1220, and retracting the applicator from the treatment site. Here, FIGS. 11A, 11B, 11C, and 11D (collectively referred to as FIG. 11) are referred to, and FIG. 11 is a simplified explanatory diagram of a cross-sectional view of an implementation form of a graft fixation system applicator device 2000 according to some embodiments of the present invention. In some embodiments, as shown in FIG. 11, the applicator 2000 includes an applicator head 2200 and an axially movable balloon 2760, and the axially movable balloon 2760 is distal to the graft fixation system 2100 disposed within the applicator 2000 head 2200 and is positioned within the head 2200. In some embodiments, the applicator 2000 includes a handle coupled to a dedicated wire or carrier and a frame on the handle configured to control the axially movable balloon 2760 via the handle frame. In some embodiments, the balloon 2760 is inflatable or contractible via a conduit 2765. In some embodiments, the balloon 2760 and the frame 40 are concentrically arranged. In some embodiments, the balloon 2760 is positioned distal to the frame 40 (closer to the applicator tip), and the frame 40 is positioned proximal to the balloon 2760. is axially slidable toward and away from the arm 40 .

[0092] In some embodiments, the frame 40 is made of a self-expanding shape memory material and is configured to at least partially self-expand when the outer sheath 1230 is moved proximally by the handle of the fixation system 2100 .

[0093] An exemplary method of deploying and applying the graft fixation system 1100 by the applicator 2000 is shown in FIG. 11. For simplicity of explanation, the embodiment shown in FIG. 11 is shown in a general outline and some components of the applicator 2000 are completely removed

[0094] For a better understanding of the following description of the operation of the applicator 2000 as disclosed in the exemplary embodiment shown in FIG. 11, the arrangement of the components of the applicator 2000 head 2200 from the inside outwards is as follows: a) A guide wire lumen 2763 configured to receive at least one guide wire (not shown) and optionally a balloon inflation lumen 2765. In some embodiments and as shown in FIG. 11, the guide wire lumen 2763 and the balloon inflation lumen 2765 are arranged adjacent to each other along at least a portion of their lengths ; b) At least one balloon ; c) One or more balloon inflation / deflation lumens 2765: one or more balloons ; d) One or more graft delivery lumens 2767: one or more grafts ; The balloon inflation / deflation lumen 2765 is optionally rideable over the guide wire lumen 2763, and in that case, the guide wire lumen 2763 and the balloon inflation lumen 2765 are coaxial. In some embodiments, the balloon inflation / deflation lumen 2765 and the guide wire lumen 2763 are positioned at separate locations along the container portion 12 02 and are disposed generally along one another; d) Frame 40 holder and driver 1240: The frame 40 holder and driver 1240 are configured to support and hold the frame 40 (e.g., in a retracted closed state) and / or to push the frame 40 out of or into the applicator 2000 during deployment; e) A release sheath 1230 that is slidable over the frame 40 as described elsewhere herein. As shown in the exemplary embodiment shown in FIG. 11 and as described in detail herein, the graft fixation system 1100 includes at least two operative elements: a frame 40 and a balloon 2760. In some embodiments, one or more components are configured to move along a guide wire. In some embodiments, the balloon lumen 2765 is axially and controllably movable relative to the frame 40 and over the guide wire lumen 2763.

[0095] In some embodiments, moving the balloon lumen 2765 moves the balloon 27 towards (proximally) or away from (distally) the frame 40. ​​​​​​Translate 60.

[0096] At least the distal portion of the frame 40 is as described elsewhere herein When at least partially expanded, the applicator device 2000 still contracts and moves the balloon 2760 proximally in the axial direction (e.g., by the wire 2730) so as to be disposed within at least the partially expanded portion of the graft fixation system 2100. In some embodiments, expanding the balloon 2760 positioned within the graft fixation system 2 100 expands the graft fixation stem and, as described elsewhere herein, causes it to fix the graft to the blood vessel wall. A potential advantage of the configuration of the applicator 200 0 as shown in FIG. 11 is that the balloon 2760 and the graft fixation system 2100 are mounted tandemly and require a smaller radial space to fit, for example, within a catheter tube, reducing the outer diameter of the applicator head 2200. In some embodiments, the applicator 2000 is configured to allow the graft fixation system 2100 to be re-sheathed by moving the container sheath 1220 distally. In some embodiments, the applicator 2000 includes a sheath lock, which is provided, for example, as a latch, pin, ring, wire, etc. The sheath lock is configured to prevent premature sheathing of the fixation system 1100. In some embodiments, the container sheath 1220 is the applicator In some embodiments, the applicator 2000 includes a sheath lock, which is provided, for example, as a latch, pin, ring, wire, etc. The sheath lock is configured to prevent premature sheathing of the fixation system 1100. In some embodiments, the container sheath 1220 is the applicator to.

[0097] In some embodiments, the applicator 2000 is configured to allow the graft fixation system 2100 to be re-sheathed by moving the container sheath 1220 distally. In some embodiments, the applicator 2000 is configured to allow the graft fixation system 2100 to be re-sheathed by moving the container sheath 1220 distally. In some embodiments, the applicator 2000 includes a sheath lock, which is provided, for example, as a latch, pin, ring, wire, etc. The sheath lock is configured to prevent premature sheathing of the fixation system 1100. In some embodiments, the container sheath 1220 is the applicator includes a sheath lock, which is provided, for example, as a latch, pin, ring, wire, etc. The sheath lock is configured to prevent premature sheathing of the fixation system 1100. In some embodiments, the container sheath 1220 is the applicator configured to prevent premature sheathing of the fixation system 1100. In some embodiments, the container sheath 1220 is the applicator configured to prevent premature sheathing of the fixation system 1100. In some embodiments, the container sheath 1220 is the applicator - It is movable by a nut on the control handle 1600.

[0098] As shown in FIG. 11A, before deployment, the axially movable balloon 2760 is positioned distally of the frame 40 between the frame 40 and the applicator tip 1205 is determined. The anchor 100 is pushed centrally, radially centrally, and is held in place by the release sheath 1230. The method of deploying the frame 40 is, as shown in FIG. 11B to axially proximally move the axially movable balloon 2760 to the contracted state 2760-1 and position the balloon 2760 within the distal portion of the frame 40 distal to the anchor 100 . Simultaneously or sequentially, it includes partially retracting the release sheath 1230 and enabling self-expansion of the distal portion of the frame 40 . It includes expanding the axially movable balloon 2760 from the contracted state 2760-1 to the expanded state 2760-2 and pressing the distal portion of the partially expanded frame 40 against the graft 280 and the vessel wall portion 290 .

[0099] At this point, the method includes verifying the deployment location and orientation of the frame 40 relative to the vessel wall portion 290 .

[0100] As shown in FIG. 11C, the method of deployment is continued by contracting the axially movable balloon 276 0 and simultaneously or sequentially fully retracting the release sheath 1230 . Fully retracting the release sheath 1230 releases the support struts 45, and the support struts 45 maintain their original upright configuration and radially Push the anchor 100 outwardly to at least partially penetrate the graft 280 and the vessel wall portion 290. Additionally, fully retracting the release sheath 1230 releases the frame 40 from the locking pin 1235, allowing the frame 40 to be at least partially freely self-expandable. As shown in FIG. 11D, the method involves expanding the axially movable balloon 2760 from the collapsed state 2760-1 to the expanded state 2760-2, expanding the frame 40 of the graft fixation system 1100 and pressing it against the graft 280 and the vessel wall portion 290, and fully implanting the anchor 100 in place. In some embodiments of the present invention, at least some of the distal ends of the anchors of the graft fixation system 1100 are directed transversely to the graft and / or the vessel wall portion after being de-sheathed and exposed at the treatment site. In some embodiments (not shown), the applicator head 1200 / 2200 includes a plurality of anchor wires, and the plurality of anchor wires have a controllable tension (e.g., through the applicator control handle 1600) by the applicator 1000 / 2000. The anchor wires are connected to a plurality of anchors disposed in the fixation system 1100 at their distal ends. In some embodiments, one or more anchors disposed in the graft fixation system 1100 are selected to be directed towards the graft or the vessel wall portion after positioning the applicator at the treatment site.

[0101]

[0102] ​​​​​​​​​​​​​​​Then, the selected anchor is bent from the folded state (with the tip facing away from the graft / tissue) to the penetrating state by the tension applied to the frame 40 or directly to the anchor by the anchor wire. In some embodiments, the balloon is inflated via a dedicated port on the handle of the applicator. Here, referring to FIG. 12, FIG. 12 is a simplified explanatory view of a perspective view of an anchor release system according to some embodiments of the present invention. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. Here, referring to FIGS. 13A, 13B, 13C, and 13D, FIGS. 13A, 1 .

[0103] In some embodiments, the shape (e.g., longitudinal cross-section) of the frame 40 changes. In some embodiments, the shape of the frame 40 is set at the manufacturing stage, for example, by heat treatment. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape. In some embodiments, the movement of the support strut 45 from the fully bent (closed) state to the fully straight (open) state is controlled via the control wire 1204. The control wire 1204 is generally axially movable, and its movement is controlled by the applicator control handle 1600. The proximal axial movement of the control wire 1204 applies tension to the support strut 45, bends and biases the strut 45 radially inward to the closed state. Alternatively, the distal axial movement of the control wire 1204 releases the tension of the support strut 45, allowing the strut 45 to move radially outward to straighten and acquire its preformed shape.

[0104] In some embodiments, the shape (e.g., longitudinal cross-section) of the frame 40 changes. In some embodiments, the shape of the frame 40 is set at the manufacturing stage, for example, by heat treatment. In some embodiments, the shape (e.g., longitudinal cross-section) of the frame 40 changes. In some embodiments, the shape of the frame 40 is set at the manufacturing stage, for example, by heat treatment. In some embodiments, the shape (e.g., longitudinal cross-section) of the frame 40 changes. In some embodiments, the shape of the frame 40 is set at the manufacturing stage, for example, by heat treatment.

[0105] Here, FIGS. 13A, 13B, 13C, and 13D are referred to, and FIGS. 13A, 1 3B, FIG. 13C, and FIG. 13D are simplified explanatory views of cross-sectional views of frame types according to some embodiments of the present invention. In some embodiments, and as shown in FIG. 13A, frame 40 includes a partially expanded state, and in the partially expanded state, frame 40 takes a bottleneck shape. In some embodiments, in the bottleneck shape, the proximal portion 40-2 of frame 40 is at least partially folded, and the distal portion 40-1 of frame 40 is sufficiently expanded to be in contact with the vessel wall portion 290, and the anchor 100 extends radially outward, but is far from the graft 80 / 280 / 612 / 780 / 895 and / or the vessel wall portion 290 and does not contact the graft 80 / 280 / 612 / 780 / 895 and / or the vessel wall portion 290. A potential advantage of this configuration is that the accurate insertion of the anchor 100 into the graft 80 / 280 / 612 / 780 / 895 and / or the vessel wall portion 290 is known, and for example, by pulling the frame 40 proximally as indicated by arrow 1250, the frame 40 can be positioned in the vessel accordingly without damaging the vessel wall by, for example, the anchor 100. In this configuration, the peripheral portion of the distal portion 40-1 of the frame 40 is in contact with the vessel wall portion 290, maintaining longitudinal stability when the frame 40 is axially moved along the vessel wall portion 290. In the exemplary embodiment shown in FIG. 13B, the frame 40 has an hourglass-shaped partial shape. For example, by pulling the frame 40 proximally as indicated by arrow 1250, the frame 40 can be positioned in the vessel accordingly without damaging the vessel wall by, for example, the anchor 100. In this configuration, the peripheral portion of the distal portion 40-1 of the frame 40 is in contact with the vessel wall portion 290, maintaining longitudinal stability when the frame 40 is axially moved along the vessel wall portion 290. In the exemplary embodiment shown in FIG. 13B, the frame 40 has an hourglass-shaped partial shape.

[0106] In the exemplary embodiment shown in FIG. 13B, the frame 40 has an hourglass-shaped partial including the state of being expanded into, and in the hourglass-shaped partially expanded state, within the frame 40 the intermediate portion 40-4 of the frame 40 is at least partially folded, and the proximal portion 40- 5 and the distal portion 40-3 of the frame 40 are fully expanded so as to be in contact with the blood vessel wall portion 290 and the anchor 100 extends radially outward, but is far from the graft 80 / 280 / 612 / 780 / 895 and / or the blood vessel wall portion 290 and does not contact the graft 80 / 280 / 612 / 780 / 895 and / or the blood vessel wall portion 290 A potential advantage of this configuration is that the accurate insertion of the anchor 100 into the graft 80 / 280 / 612 / 780 / 895 and / or the blood vessel wall portion 290 is known, for example, by pulling the frame 40 proximally as indicated by the arrow 1250 so that, for example, the frame 40 can be positioned in the blood vessel accordingly without damaging the blood vessel wall by the anchor 100 In this configuration, the peripheral portions of both the proximal portion 40-5 and the distal portion 40-3 of the frame 40 are in contact with and maintained in contact with the blood vessel wall portion 2 90 In some embodiments, and as shown in FIGS. 13C and 13D, the graft 80 / 280 / 612 / 780 / 895 follows the shape of the frame 40 over the entire length of the frame 40 (FIG. 13C). Alternatively, and optionally, in

[0107] some embodiments, the graft 80 / 280 / 612 / 780 / 895 follows only the shape of the proximal portion 40-5 and the distal portion 40-3 of the frame 40 (FIG. 13D) and is freely stretched between the gaps of the recesses formed by the portion 40-4 of the frame 40 and is stretched freely between the gaps of the recesses formed by the portion 40-4 of the frame 40 In some embodiments, and optionally, in some embodiments, the graft 80 / 280 / 612 / 780 / 895 follows only the shape of the proximal portion 40-5 and the distal portion 40-3 of the frame 40 (FIG. 13D) and is stretched freely between the gaps of the recesses formed by the portion 40-4 of the frame 40 and is stretched freely between the gaps of the recesses formed by the portion 40-4 of the frame 40 is provided.

[0108] In all embodiments described herein, when the frame 40 is fully expanded all of its portions are in contact with the vessel wall portion 290 either directly or indirectly (via the grafts 80 / 280 / 612 / 780 / 895). In some embodiments, the expansion of a balloon (e.g., balloon 1300) causes the frame 40 to expand and presses the frame 40 against the vessel wall portion 290 either directly or indirectly (via the grafts 80 / 280 / 612 / 78 0 / 895) along its entire length. 0 / 895) along its entire length. 0 / 895) along its entire length.

[0109] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and simplicity and should not be construed as an inflexible limitation on the scope of the present invention. Accordingly, a recitation of a range should be considered to have specifically disclosed all the possible subranges, as well as the individual numerical values within that range. For example, a range recitation such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as the individual numbers within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range. Whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range. The first recited number should be considered to be the lower limit and the last recited number should be considered to be the upper limit. 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as the individual numbers within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the width of the range. should be considered to be the lower limit and the last recited number should be considered to be the upper limit. should be considered to be the lower limit and the last recited number should be considered to be the upper limit.

[0110] Whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range. The first recited number should be considered to be the lower limit and the last recited number should be considered to be the upper limit. "ranging / ranges" between the first display number and the second display number, and, the phrase "ranging / ranges" from the first display number "to" the second display number is used interchangeably herein and means including the first and second display numbers, as well as all fractions and integers therebetween.

[0111] In the specification and claims of this application, each of the words "comprise", "include", and "have", and their forms, are not necessarily limited to the members in the list to which the words may be associated. Additionally, if there is a conflict between this application and any document incorporated by reference, this application is intended to govern.

[0112] Descriptions of various embodiments of the invention have been presented for purposes of illustration, but are not intended to be exclusive or limited to the disclosed embodiments. Many modifications and variations will become apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles of the embodiments, practical applications, or technical improvements over the technology found in the marketplace, or to enable one skilled in the art to understand the embodiments disclosed herein.

Description of the Reference Numerals

[0113] 10 Graft fixation system 40 Frame 40-1 Distal portion 40-2 Proximal part 40-3 Distal part 40-4 Intermediate part 40-5 Proximal part 45 Anchor support strut 45-1 Matching end 80 Graft 90 Vessel wall part 92 Outer surface 100 Anchor 120 Penetrating tip 140 Prong 142 Anchor base 160 Restraining sleeve 200 Anchor 201 Force 220 Penetrating tip 230 Restraining sleeve 232 Flat surface facing the anchor base 234 Flat surface facing the anchor tip 240 Prong 240-1, 240-4 External prongs 240-2, 240-3 Internal prongs 245 Restraining sleeve stop 250 Dashed arrow 255 Locking pin 260 Anchor base 265 Cutout 280 Graft 284 Inner surface 290 Vessel wall part 294 Inner surface 296 External surface 300 Anchor 320 Penetrating tip 320-1, 320-2 Prong tip half parts 340-1, 340-2 Prongs 345 Restraining sleeve stop 347 Restraining sleeve stop 360 Anchor base 365 Cutout, rectangular cut 420 Anchor 421 Prong 421-1, 421-2 External Prong 421-3, 421-4 Internal Prong 422 Tip 423 Restraint Sleeve Stop 425 Restraint Sleeve 426 Flange 427 Tapered Distal Penetration Tip 428 Buckling Prevention Lock 430 Projection 431 Recess 440 Anchor 441 Prong 441-1, 441-2 External Prong 441-3, 441-4 Internal Prong 442 Tip 443 Restraint Sleeve Stop 445 Restraint Sleeve 447 Blunt Distal Surface 448 Buckling Prevention Lock 450 Arrow 460 Anchor 461 Prong 462 Tip 463 Restraint Sleeve Stop 465 Restraint Sleeve 466 Flange 467 Distal Edge 480 Anchor 482 Tip 484 Distal Edge 486 Penetration Blade 490 Anchor 494 Distal Edge 495 Tip 496 Penetration Blade 500 Anchor 540 Prong 540-1, 540-2, 540-3, 540-4 Prong 600 Anchor 602 Prong 604 Elastic Outwardly Curved Proximal Portion 606 Frame 608 Arrow 610 Arrow 612 Graft 614 Vascular Endothelium 616 Anchor Base 625 Restraint Sleeve 650 Flange 700 System 710 Frame Ring 720 Frame Ring 730 Anchor 740 Latch 745 Latch 750 Frame Ring 760 Frame Ring 770 Anchor 780 Graft 790 Tissue, Vascular Wall Portion 802 Guide Channel 810 Base Frame, Base Ring 830 Anchor 832 Distal Tip 850 Guide Frame, Guide Ring 860 Ring Wall Portion 872 Entry Port 874 Exit Port 890 Tissue, Vascular Wall Portion 895 Graft 1000 Applicator 1100 Graft Fixation System 1200 Applicator Head 1202 Container Portion 1204 Control Wire 1205 Applicator Tip 1210 Marker 1220 Container Sheath 1222 Distal Rim 1230 Release Sheath 1235 Retaining Pin 1240 Holder and Driver 1242 External Surface 1250 Arrow 1260 Container sheath 1275 Hall 1280 Headroom 1300 Balloon 1302 Elastic protection layer 1400 Applicator room 1600 Applicator control handle 2000 Applicator 2200 Applicator head 2760 Balloon 2760-1 Shrink state 2760-2 Expansion state 2763 Guide wire room 2765 Balloon inflation / deflation room

Claims

1. (a) an anchor base; (b) at least two prongs protruding from the anchor base, the at least two prongs having at least one penetrating tip and a buckling prevention lock for preventing buckling when the at least two prongs penetrate tissue; (c) at least one restraint element for maintaining the at least two prongs parallel to each other and being movable along the at least two prongs, thereby releasing the at least two prongs and deflecting them away from each other comprising the at least two prongs comprising two outer prongs and two inner prongs; a tissue anchor.

2. The tissue anchor according to claim 1, wherein the buckling prevention lock includes at least one protrusion on a first prong and a recess on a second prong of the at least two prongs.

3. The tissue anchor according to claim 1, wherein the at least two prongs further include a first sleeve stop for preventing the at least one restraint element from sliding over the penetrating tip.

4. The system according to claim 3, wherein the at least two prongs further include a second sleeve stop, and a proximal movement of the restraint sleeve over the second sleeve stop requires a force of a predetermined magnitude.

5. The tissue anchor according to claim 1, wherein the penetrating tip is ground along at least one distal edge of at least one prong to form a penetrating blade.

6. The tissue anchor according to claim 5, wherein the distal edge is pointed at the narrow side of its width and flat at the wide side of its width.

7. The tissue anchor according to claim 5, wherein the distal edge is pointed at both the narrow side and the wide side of its width.

8. The tissue anchor according to claim 1, further comprising a support portion attached to the anchor base, the support portion being for attaching the tissue anchor to a frame.

9. The tissue anchor according to claim 8, wherein the support portion includes at least one elastic strut.

10. The tissue anchor according to claim 1, wherein each of the at least two prongs includes a penetrating tip.

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