Heart valve sealing device and delivery device therefor

Abstract

Improved devices and methods for treating mitral valve regurgitation. The implantable prosthetic device includes a joint portion, a paddle, and a fastener. The paddle is movable from a closed position to an open position. The fastener is also movable from an open position to a closed position. The implantable prosthetic device can be used to repair a native valve, such as a native mitral valve.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application is incorporated herein by reference in its entirety, including U.S. patent application Ser. No. 15 / 884,193, filed January 30, 2018, U.S. patent application Ser. No. 15 / 909,803, filed March 1, 2018, U.S. patent application Ser. No. 15 / 910,951, filed March 2, 2018, U.S. patent application Ser. No. 15 / 914,143, filed March 7, 2018, U.S. patent application Ser. No. 15 / 927,814, filed March 21 ... This application is related to and claims the benefit of U.S. Patent Application No. 15 / 946,604, filed April 5, 2018, U.S. Patent Application No. 15 / 953,220, filed April 13, 2018, U.S. Patent Application No. 15 / 953,263, filed April 13, 2018, U.S. Patent Application No. 15 / 953,283, filed April 13, 2018, and U.S. Provisional Application No. 62 / 486,835, filed April 18, 2017.

[0002] This application relates generally to prosthetic devices and related methods for assisting in sealing native heart valves and preventing or reducing backflow therethrough, and further to devices and related methods for implanting such prosthetic devices. [Background technology]

[0003] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) play a critical role in ensuring an adequate supply of blood flows forward through the cardiovascular system. These heart valves can be damaged by congenital malformations, inflammatory processes, infectious conditions, or disease, resulting in impaired function. Such valve damage can result in severe cardiovascular failure or death. For many years, the definitive treatment for such damaged valves has been surgical repair or replacement of the valves in open-heart surgery. However, open-heart surgery is highly invasive and prone to numerous complications. Therefore, elderly and frail patients with defective heart valves often go untreated. In recent years, transvascular techniques have been developed for introducing and implanting prosthetic devices in a manner that is much less invasive than open-heart surgery. One specific transvascular technique used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter from the right femoral vein up the inferior vena cava into the right atrium, then puncturing the septum and threading the catheter into the left atrium.

[0004] A healthy heart has an overall conical shape tapering to a lower apex. The heart has four chambers: the left atrium, the right atrium, the left ventricle, and the right ventricle. The right and left sides of the heart are separated by a wall commonly called the septum. The natural mitral valve in the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. It includes an annulus, a circular portion of natural valve tissue surrounding the mitral valve opening, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral valve annulus may form a "D"-shaped, oval, or other non-circular cross-sectional shape with long and short axes. The anterior leaflet may be larger than the posterior leaflet, forming an overall "C"-shaped boundary between their abutting free edges when the leaflets are closed together.

[0005] When functioning properly, the anterior and posterior leaflets function together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), oxygenated blood that collects in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricular muscle contracts (also called "ventricular systole" or "systole"), increased blood pressure in the left ventricle pushes the two valve leaflets together, closing the one-way mitral valve. As a result, blood cannot flow back into the left atrium and instead is expelled from the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0006] Mitral regurgitation occurs when the native mitral valve does not close properly during the contraction phase of cardiac contraction, allowing blood to flow from the left ventricle into the left atrium. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has various causes, including leaflet prolapse, papillary muscle dysfunction, and / or stretching of the mitral annulus as a result of left ventricular dilation. Mitral regurgitation in the central portion of the valve leaflets is sometimes referred to as central jet mitral regurgitation, while mitral regurgitation closer to one of the leaflets' commissures (i.e., where the leaflets meet) is sometimes referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the leaflet edges do not meet in the center, resulting in valve failure and regurgitation.

[0007] Some conventional techniques for treating a patient's mitral valve regurgitation involve surgically suturing the edges of the native mitral valve leaflets directly together. Similar to this surgical suturing method, attempts have been made to clip the leaflet edges together using catheter-delivered clips. However, these clips are insufficient because they can only be used to clip the central edges of the leaflets together if they overlap by approximately 2 mm or more. Alternatively, attempts have been made to use multiple clips on the mitral valve commissures when the leaflets can overlap more. This technique results in longer surgical times and restricts blood flow by coapting the patient's leaflets. Furthermore, both surgical and clip procedures are thought to be stressful on the patient's leaflets.

[0008] Despite these conventional techniques, there remains a need for improved devices and methods for treating mitral regurgitation. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] U.S. Patent No. 8,449,599 [Patent Document 2] U.S. Patent Application Publication No. 2014 / 0222136 [Patent Document 3] U.S. Patent Application Publication No. 2014 / 0067052 [Patent Document 4] U.S. Patent Application Publication No. 2016 / 0331523 Summary of the Invention [Means for solving the problem]

[0010] The implantable prosthetic device includes a joint portion, a paddle, and a fastener. The paddle is movable from a closed position to an open position. The fastener is also movable from an open position to a closed position. The implantable prosthetic device can be used to repair a native valve, such as a native mitral valve.

[0011] A further understanding of the nature and advantages of the present invention is presented in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals and in which:

[0012] These and other features and advantages of the present invention will be better understood by considering the following description and accompanying drawings. [Brief explanation of the drawings]

[0013] [Figure 1] 1A-1D are views of an implantable prosthetic device according to a first embodiment at various stages of deployment. [Figure 1A] 1A-1D are views of an implantable prosthetic device according to a first embodiment at various stages of deployment. [Figure 2] 1A-1D are views of an implantable prosthetic device according to a first embodiment at various stages of deployment. [Figure 3] 1A-1D are views of an implantable prosthetic device according to a first embodiment at various stages of deployment. [Figure 4] 1A-1D are views of an implantable prosthetic device according to a first embodiment at various stages of deployment. [Figure 5] 1A-1D are views of an implantable prosthetic device according to a first embodiment at various stages of deployment. [Figure 6] 1A-1D are views of an implantable prosthetic device according to a first embodiment at various stages of deployment. [Figure 7] 2 is a diagram of the implantable prosthetic device of FIG. 1 being delivered and implanted within a native mitral valve. [Figure 8]3 is a diagram of the implantable prosthetic device of FIG. 2 being delivered and implanted within a native mitral valve. [Figure 9] FIG. 4 is a diagram of the implantable prosthetic device of FIG. 3 being delivered and implanted within a native mitral valve. [Figure 10] FIG. 5 is a diagram of the implantable prosthetic device of FIG. 4 being delivered and implanted within a native mitral valve. [Figure 11] FIG. 6 is a diagram of the implantable prosthetic device of FIG. 5 being delivered and implanted within a native mitral valve. [Figure 12] FIG. 7 is a diagram of the implantable prosthetic device of FIG. 6 being delivered and implanted within a native mitral valve. [Figure 13] FIG. 10 is a diagram of another implantable prosthetic device according to a second embodiment. [Figure 13A] FIG. 10 is a diagram of another implantable prosthetic device according to a second embodiment. [Figure 14] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 15] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 16] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 17] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 18] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 19] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 20] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 21]FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 22] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 23] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 23A] FIG. 10 is a view of a portion of mitral valve tissue grasped by a barbed fastener. [Figure 24] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 25] FIG. 10 is a diagram of another implantable prosthetic device according to a third embodiment being delivered and implanted within a native mitral valve. [Figure 26] 1A-1C are diagrams of a barbed fastener for an implantable prosthetic device according to one embodiment. [Figure 27] FIG. 10 is a diagram of a barbed fastener for an implantable prosthetic device according to a second embodiment. [Figure 28] 10A-10C are diagrams of a barbed fastener for an implantable prosthetic device according to a third embodiment. [Figure 29] 1A-1C are side views of a barbed fastener for an implantable prosthetic device in various stages of bending. [Figure 30] 1A-1C are side views of a barbed fastener for an implantable prosthetic device in various stages of bending. [Figure 31] 1A-1C are side views of a barbed fastener for an implantable prosthetic device in various stages of bending. [Figure 32] FIG. 10 is a diagram of a barbed fastener for an implantable prosthetic device according to a fourth embodiment. [Figure 33] FIG. 10 is a diagram of a barbed fastener for an implantable prosthetic device according to a fifth embodiment. [Figure 34] FIG. 10 is a diagram of a barbed fastener for an implantable prosthetic device according to a sixth embodiment. [Figure 35] FIG. 10 is a diagram of a barbed fastener for an implantable prosthetic device according to a seventh embodiment. [Figure 36] FIG. 10 is a diagram of a barbed fastener for an implantable prosthetic device according to an eighth embodiment. [Figure 37] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 38A] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 38B] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 38C] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 38D] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 38E] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 39] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 40A] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 40B] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 40C] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 40D] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 40E] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 41] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 42A]FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 42B] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 42C] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 42D] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 42E] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 43] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 44A] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 44B] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 44C] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 44D] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 44E] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 45] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 46A] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 46B] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 46C] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 46D] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 46E] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 47] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 48A] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 48B] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 48C] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 48D] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 48E] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 49] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 50] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 51A] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 51B] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 51C] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 51D] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 52] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a ninth embodiment. [Figure 53] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a tenth embodiment. [Figure 54]FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a tenth embodiment. [Figure 55] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a tenth embodiment. [Figure 56] FIG. 11 is a diagram of a barbed fastener for an implantable prosthetic device according to an eleventh embodiment. [Figure 56A] 57 is a view of an alternative embodiment of the hinge portion of the barbed fastener of FIG. 56. FIG. [Figure 56B] 57 is a view of an alternative embodiment of the hinge portion of the barbed fastener of FIG. 56. FIG. [Figure 57] FIG. 12 is a diagram of a barbed fastener for an implantable prosthetic device according to a twelfth embodiment. [Figure 57A] FIG. 59 is a diagram of a flat cutout used to make the barbed fastener shown in FIGS. 57 and 58. [Figure 58] FIG. 12 is a diagram of a barbed fastener for an implantable prosthetic device according to a twelfth embodiment. [Figure 59] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a thirteenth embodiment. [Figure 60] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a thirteenth embodiment. [Figure 61] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a thirteenth embodiment. [Figure 61A] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a thirteenth embodiment. [Figure 61B] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a thirteenth embodiment. [Figure 62] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a thirteenth embodiment. [Figure 63] FIG. 13 is a diagram of a barbed fastener for an implantable prosthetic device according to a thirteenth embodiment. [Figure 64]FIG. 14 is a diagram of a barbed fastener for an implantable prosthetic device according to a fourteenth embodiment. [Figure 65] FIG. 14 is a diagram of a barbed fastener for an implantable prosthetic device according to a fourteenth embodiment. [Figure 65A] FIG. 14 is a diagram of a barbed fastener for an implantable prosthetic device according to a fourteenth embodiment. [Figure 66] FIG. 14 is a diagram of a barbed fastener for an implantable prosthetic device according to a fourteenth embodiment. [Figure 67] FIG. 14 is a diagram of a barbed fastener for an implantable prosthetic device according to a fourteenth embodiment. [Figure 68] FIG. 14 is a diagram of a barbed fastener for an implantable prosthetic device according to a fourteenth embodiment. [Figure 69] 10A-10C illustrate exemplary configurations for securing an actuation line to an exemplary barbed fastener for an implantable prosthetic device. [Figure 70A] 10A-10C illustrate exemplary configurations for securing an actuation line to an exemplary barbed fastener for an implantable prosthetic device. [Figure 70B] 10A-10C illustrate exemplary configurations for securing an actuation line to an exemplary barbed fastener for an implantable prosthetic device. [Figure 71] 10A-10C illustrate exemplary configurations for securing an actuation line to an exemplary barbed fastener for an implantable prosthetic device. [Figure 72] 10A-10C illustrate exemplary configurations for securing an actuation line to an exemplary barbed fastener for an implantable prosthetic device. [Figure 73A] 10A-10C illustrate exemplary configurations for securing an actuation line to an exemplary barbed fastener for an implantable prosthetic device. [Figure 73B] 10A-10C illustrate exemplary configurations for securing an actuation line to an exemplary barbed fastener for an implantable prosthetic device. [Figure 74A] 10 illustrates an exemplary barbed fastener being opened using an actuation line. [Figure 74B]10 illustrates an exemplary barbed fastener being opened using an actuation line. [Figure 75] 10A-10C are diagrams of exemplary barbed fasteners of the ninth or tenth embodiment with actuation lines. [Figure 76] FIG. 15 is a diagram of a barbed fastener for an implantable prosthetic device according to a fifteenth embodiment. [Figure 77] FIG. 16 is a diagram of a barbed fastener for an implantable prosthetic device according to a sixteenth embodiment. [Figure 78] FIG. 17 is a diagram of a barbed fastener for an implantable device according to a seventeenth embodiment. [Figure 79] FIG. 17 is a diagram of a barbed fastener for an implantable device according to a seventeenth embodiment. [Figure 80A] FIG. 18 is a diagram of a barbed fastener for an implantable device according to an eighteenth embodiment. [Figure 80B] FIG. 18 is a diagram of a barbed fastener for an implantable device according to an eighteenth embodiment. [Figure 80C] FIG. 18 is a diagram of a barbed fastener for an implantable device according to an eighteenth embodiment. [Figure 80D] FIG. 18 is a diagram of a barbed fastener for an implantable device according to an eighteenth embodiment. [Figure 80E] FIG. 18 is a diagram of a barbed fastener for an implantable device according to an eighteenth embodiment. [Figure 81A] FIG. 20 is a diagram of a barbed fastener for an implantable device according to a nineteenth embodiment. [Figure 81B] FIG. 20 is a diagram of a barbed fastener for an implantable device according to a nineteenth embodiment. [Figure 81C] FIG. 20 is a diagram of a barbed fastener for an implantable device according to a nineteenth embodiment. [Figure 82] 1A-1C are diagrams of exemplary actuation mechanisms for use with the implantable devices described herein. DETAILED DESCRIPTION OF THE INVENTION

[0014] As used herein, when one or more components are described as being connected, coupled, fastened, coupled, attached, or otherwise interconnected, such interconnection may be direct, such as between the components themselves, or indirect, such as through the use of one or more intervening components. Also, as used herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but may include an assembly of multiple components, members, or elements. Also, as used herein, the terms "substantially" and "about" are defined as at least near (and including) a given value or condition (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of).

[0015] The prosthetic device includes a coaptation means or element and at least one anchoring means or anchor. The coaptation element is configured to be positioned within the native heart valve opening to help form a more effective seal between the native valve leaflets, thereby reducing or preventing regurgitation. The coaptation element may have a blood-impermeable structure that can close the native valve leaflets on either side of the coaptation element during ventricular systole, preventing blood from flowing back from the left or right ventricle into the left or right atrium, respectively. The prosthetic device may be configured to seal against two or three native valve leaflets; i.e., the device can be used in native mitral (bicuspid) and tricuspid valves. Because the coaptation element can fill the incomplete space between incompetent native mitral or tricuspid valve leaflets, the coaptation element may be referred to herein as a spacer.

[0016] The coaptation element may have a variety of shapes. In some embodiments, the coaptation element may have an elongated cylindrical shape with a round cross-sectional shape. In other embodiments, the coaptation element may have an oval cross-sectional shape, a crescent cross-sectional shape, or various other non-cylindrical shapes. The coaptation element may have an atrial or upper end positioned in or adjacent to the left atrium, a ventricular or lower end positioned in or adjacent to the left ventricle, and lateral sides extending between the native mitral valve leaflets. In embodiments configured for use with a tricuspid valve, the atrial or upper end is positioned in or adjacent to the right atrium, the ventricular or lower end is positioned in or adjacent to the right ventricle, and the lateral sides extend between the native tricuspid valve leaflets.

[0017] The anchor can be configured to secure the device to one or both native mitral valve leaflets such that the coaptation element is positioned between two native leaflets. In embodiments configured for use with tricuspid valves, the anchor can be configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the coaptation element is positioned between three native leaflets. In some embodiments, the anchor can be attached to the coaptation element adjacent to the ventricular end of the coaptation element. In some embodiments, the anchor can be attached to an actuation means, such as a shaft or actuation wire, to which the coaptation element is also attached. In some embodiments, the anchor and coaptation element can be positioned independently of each other by moving each separately along the longitudinal axis of the shaft or actuation wire. In some embodiments, the anchor and coaptation element can be positioned simultaneously by moving the anchor and coaptation element together along the longitudinal axis of the shaft or actuation wire. The anchor can be configured to be positioned behind the native valve leaflet when implanted so that the leaflet is grasped by the anchor.

[0018] The prosthetic device can be configured to be implanted via a delivery means, such as a delivery sheath. The coaptation elements and anchors can be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device can be configured so that the anchors are initially expanded away from the still-compressed coaptation elements to create a gap between the coaptation elements and the anchors. The native leaflets can then be positioned within this gap. The coaptation elements can be radially expanded to close the gap between the coaptation elements and the anchors and capture the leaflets between them. In some embodiments, the anchors and coaptation elements are optionally configured to self-expand. Implantation methods can vary for various embodiments, as discussed more fully below for each embodiment. Additional information regarding these and other delivery methods can be found in U.S. Pat. No. 8,449,599, and U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, and 2016 / 0331523, each of which is incorporated by reference herein in its entirety.

[0019] The disclosed prosthetic device prevents embolization in the atrium by utilizing tension from the natural chordae tendineae to resist the high systolic pressures that force the device toward the left atrium due to anchors fastened to the leaflets. During diastole, the device can resist embolization into the left ventricle by utilizing the compressive and retaining forces exerted on the leaflets grasped by the anchors.

[0020] 1-6, an implantable prosthetic device 100 is shown in various stages of deployment. The device 100 is deployed from a delivery sheath 102 and includes a coaptation portion 104 and an anchor portion 106. The coaptation portion 104 of the device 100 includes a coaptation element 110 adapted to be implanted between the leaflets of a native mitral valve and slidably attached to an actuation wire or shaft 112. The anchor portion 106 is actuable between an open state and a closed state and can take a variety of forms, such as a paddle, a grasping element, or the like. During implantation, actuation of the actuation wire 112 opens and closes the anchor portion 106 of the device 100 to grasp the mitral valve leaflets. The actuation wire or shaft 112 can take a variety of different forms. For example, the actuation wire or shaft may be threaded such that rotation of the actuation wire or shaft moves the anchor portion 106 relative to the coaptation portion 104. Alternatively, the actuation wire or shaft may not be threaded, and the anchor portion 106 may be moved relative to the interface portion 104 by pushing or pulling the actuation wire or shaft 112 .

[0021] The anchor portion 106 of the device 100 includes an outer paddle or gripping element 120 and an inner paddle or gripping element 122, which are connected between the cap 114 and the joint element 110 by portions 124, 126, and 128. The portions 124, 126, and 128 may be hinged and / or flexible to allow movement between all of the positions described below. An actuation wire 112 extends through the delivery sheath and the joint element 110 to the cap 114 at the distal end of the anchor portion 106. Extending or retracting the actuation wire 112 correspondingly increases or decreases the spacing between the joint element 110 and the cap 114. The joint element 110 is removably attached to the delivery sheath 102 by an attachment means or collar (not shown) so that the joint element 110 slides along the actuation wire 112 during actuation to open and close the paddles 120, 122 of the anchor portion 106.

[0022] 3 , the barbed fastener 130 includes a base or fixed arm 132, a movable arm 134, a barb 136, and a hinge portion 138. The fixed arm 132 is attached to the inner paddle 122, and the hinge portion 138 is disposed proximate to the interface element 110. The hinge portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the barbed fastener 130. The hinge portion 138 can be any suitable hinge, such as a flexible hinge, a spring hinge, a pivot hinge, or the like. In certain embodiments, the hinge portion 138 is a flexible piece of material integrally formed with the fixed arm 132 and the movable arm 134. Fixed arm 132 is attached to inner paddle 122 and remains stationary relative to inner paddle 122 when movable arm 134 is opened to open barbed catch 130 and expose barb 136. Barbed catch 130 is opened by applying tension to actuation line 116 attached to the end of movable arm 134, which causes movable arm 134 to pivot on hinge portion 138.

[0023] During implantation, the paddles 120, 122 are opened and closed to grasp the native mitral valve leaflets between the paddles 120, 122 and the coaptation element 110. The barbed fasteners 130 further secure the native leaflets by engaging the leaflets with their barbs 136 and clamping the leaflets between the movable arm 134 and the fixed arm 132. The barbs 136 of the barbed fasteners 130 increase friction with the leaflets or pierce them partially or completely through the leaflets. The actuation lines 116 can be independently actuated, thereby opening and closing each barbed fastener 130 independently. Independent actuation allows for grasping one leaflet at a time or allows for repositioning of the fasteners 130 for leaflets that were not fully grasped without altering the successful grasp of the other leaflets. The barbed catches 130 not only open and close independently of each other, but can also open and close completely independent of the position of the inner paddle 122, allowing the leaflets to be grasped in a variety of positions depending on the requirements of a particular situation.

[0024] The barbed fasteners 130 can be independently opened by pulling on an attached actuation means or actuation line 116 that extends through the delivery sheath 102 to the end of the barbed fasteners 130. The actuation line 116 can take a variety of forms, such as a line, suture, wire, rod, catheter, etc. The barbed fasteners 130 can be spring-loaded so that in the closed position, the barbed fasteners 130 continue to provide a clamping force against the grasped native leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. The barbs 136 of the barbed fasteners 130 can pierce the native leaflet to further secure it.

[0025] Referring now to FIG. 1 , the device 100 is shown in an elongated or fully open state for deployment from a delivery sheath. The device 100 is loaded into the delivery sheath in the fully open position because it takes up the least space, allowing the smallest catheter (or the largest device 100 used for a given catheter size) to be used. In the elongated state, the cap 114 is spaced from the coaptation element 110 so that the paddles 120, 122 of the anchor portion 106 are everted or fully open. In some embodiments, the angle formed between the inner surfaces of the outer paddle 120 and the inner paddle 122 is approximately 180 degrees. The barbed catch 130 is kept closed during deployment through the delivery sheath 102 to prevent the barbs 136 ( FIG. 3 ) from catching on or damaging the sheath or the patient's heart tissue.

[0026] 1A, which shows an elongated, disentanglement state of device 100 similar to FIG. 1 but with barbed fasteners 130 in a fully open position, which ranges from about 140 degrees to about 200 degrees, to about 170 degrees, to about 190 degrees, or to about 180 degrees between the fixed and movable portions of barbed fasteners 130. Fully opening device 100 and fasteners 130 has been found to improve the ease with which device 100 disentangles from a patient's anatomy during implantation.

[0027] Referring now to FIG. 2 , the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To move the device 100 from the elongated state to the shortened state, the actuation wire 112 is retracted, pulling the cap 114 toward the coaptation element 110. The hinge or flexible connection 126 between the outer paddle 120 and the inner paddle 122 has limited movement such that compressive forces acting on the outer paddle 120 from the retracted cap 114 toward the coaptation element 110 cause the paddles or gripping elements 120, 122 to move radially outward. While moving from the open to the closed position, the outer paddle 120 maintains an acute angle with respect to the actuation wire 112. The outer paddle 120 may optionally be biased toward the closed position. During the same movement, the inner paddle 122 is moved through a comparatively larger angle when directed away from the interface element 110 in the open state, and folded along the side of the interface element 110 in the closed state. In certain embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the hinges or flexible portions 126, 128 connected to the inner paddle 122 are thinner and / or more flexible to allow for greater movement than the hinges or flexible portions 124 connecting the outer paddle 120 to the cap 114.

[0028] 3-5, device 100 is shown in a partially open, ready-to-grasp position. To transition from the fully closed position to the partially open position, actuation wire 112 is extended to push cap 114 away from coaptation element 110, which pulls outer paddle 120, which in turn pulls inner paddle 122, partially deploying anchor portion 106. Actuation line 116 is retracted, opening catch 130 so that the leaflets can be grasped.

[0029] Referring now to Figure 4, one of the actuation lines 116 is extended to allow one of the fasteners 130 to close. Referring now to Figure 5, the other actuation line 116 is extended to allow the other fastener 130 to close. Either or both of the actuation lines 116 may be repeatedly actuated to repeatedly open and close the barbed fasteners 130.

[0030] 6, device 100 is shown in a fully closed, deployed state. Delivery sheath 102 and actuation wire 112 are retracted, leaving paddles 120, 122 and catch 130 in a fully closed position. Once deployed, device 100 may be maintained in a fully closed position using a mechanical latch, or may be biased to remain closed through the use of a spring material such as steel, other metals, plastics, composites, etc., or a shape memory alloy such as Nitinol. For example, hinged or flexible portions 124, 126, 128, 138 and / or inner and outer paddles 122 and 138, and / or additional biasing components (see component 224 in FIG. 13 ), may be formed from a metal such as steel or a shape-memory alloy such as Nitinol—produced as a wire, sheet, tubing, or laser-sintered powder—and are biased to hold outer paddle 120 closed around coaptation element 110 and barbed clasp 130 clamped around the native leaflets. Similarly, fixed arm 132 and movable arm 134 of barbed clasp 130 are biased to clamp the leaflets. In certain embodiments, hinge portions 124, 126, 128, 138, and / or inner and outer paddles 122 and / or additional biasing components (see component 224 in FIG. 13) may be formed from metal or any other suitable resilient material, such as a polymeric material, to maintain the device closed after implantation.

[0031] 7-12, the implantable device 100 of FIGS. 1-6 is shown being delivered and implanted within the native mitral valve 40 of the heart 10. Referring now to FIG. 7, the delivery sheath is inserted through the septum into the left atrium 20, and the device 100 is deployed from the delivery sheath in a fully open position. The actuation wire 112 is then retracted, moving the device 100 to a fully closed position, as shown in FIG. 8. As can be seen in FIG. 9, the device 100 is moved into the ventricle 30 into position within the mitral valve 40 and partially opened to grasp the leaflets 42, 44. Referring now to FIG. 10, the actuation line 116 is extended to close one of the clasps 130 and grasp the leaflet 42. FIG. 11 illustrates the other actuation line 116 then being extended to close the other clasp 130 and grasp the remaining leaflet 44. Finally, as can be seen in FIG. 12, the delivery sheath 102 and actuation wire 112 are then retracted, and the device 100 is fully closed and deployed within the native mitral valve 40.

[0032] Referring now to FIG. 13, an implantable prosthetic device 200 is shown. The implantable device 200 is one of many different configurations that the device 100 shown generally in FIGS. 1-12 can assume. The device 200 is deployed from a delivery sheath (not shown) and includes a coaptation portion 204 and an anchor portion 206. The device 200 is loaded into the delivery sheath in the fully open position because it takes up the least space and allows the smallest catheter (or the largest device 200 used for a given catheter size) to be used. The coaptation portion 204 of the device includes a coaptation element 210 that is slidably attached to an actuation wire or shaft 212 and is implanted between the leaflets of the native mitral valve. During implantation, actuation of the actuation wire 212 opens and closes the anchor portion 206 of the device 200 to grasp the mitral valve leaflets.

[0033] The anchor portion 206 of the device 200 includes an outer paddle 220 and an inner paddle 222 that are hingedly connected to the cap 214 and the coaptation element 210. An actuation wire 212 extends through a delivery sheath (not shown), a collar 211, and the coaptation element 210 to the cap 214 at the distal end of the anchor portion 206. Extending or retracting the actuation wire 212 correspondingly increases or decreases the spacing between the coaptation element 210 and the cap 214. The collar 211 optionally includes a collar seal 213 that forms a seal around the actuation wire or shaft 212 during implantation of the device 200 and seals off after implantation when the actuation wire 212 is removed, substantially closing the device 200 to blood flow through the interior of the coaptation element 210. In some embodiments, the collar 211 removably engages and attaches the coaptation element 210 to the delivery sheath such that the coaptation element 210 slides along the actuation wire 212 during actuation to open and close the paddles 220, 222 of the anchor portion 206. In some embodiments, the collar 211 is held closed around the coaptation element 210 by the actuation wire 212, and removing the actuation wire 212 allows fingers (not shown) on the collar to open and release the coaptation element 210. In some embodiments, the cap 214 optionally includes a seal 216 and / or an insert 218 that fits inside the opening 215 of the coaptation element 210, the coaptation element 210 having a hollow interior. The seal 216 and / or insert 218 maintain the coaptation element 210 substantially closed to blood flow when the actuation wire 212 is withdrawn and the device 200 is implanted.

[0034] The coaptation elements 210 and paddles 220, 222 are formed from a covering material, which may be mesh, woven, knit, or formed in any other suitable manner. The covering material may be fabric, shape-memory alloy wire (e.g., Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body. The paddle frame 224 provides additional clamping force between the outer paddle 222 and the coaptation elements 210 and helps wrap the leaflets around the sides of the coaptation elements 210 for a better seal between the coaptation elements 210 and the leaflets. In some embodiments, the covering material extends around the paddle frame 224.

[0035] The barbed fastener 230 includes a base or fixed arm 232, a movable arm 234, a barb 236, and a hinge portion 238. The fixed arm 232 is attached to the inner paddle 222, and the hinge portion 238 is disposed adjacent to the joint element 210. The fixed arm 232 is attached to the inner paddle 222 through a hole or slot 233 along with a suture (not shown). The fixed arm 232 can be attached to the inner paddle 222 by any suitable means, such as a screw or other fastener, a crimped sleeve, a mechanical latch or snap, welding, adhesive, or the like. The fixed arm 232 remains stationary relative to the inner paddle 222 when the movable arm 234 is opened to open the barbed fastener 230 and expose the barb 236. The barbed fastener 230 is opened by applying tension to an actuation line (not shown) attached to a hole 235 disposed at the end of the movable arm 234, which causes the movable arm 234 to pivot on the hinge portion 238.

[0036] During implantation, the paddles 220, 222 are opened and closed to grasp the native mitral valve leaflets between the paddles 220, 222 and the coaptation element 210. The barbed fasteners 230 further secure the native leaflets by engaging the leaflets with their barbs 236 and clamping the leaflets between the movable arm 234 and the fixed arm 232. The barbs 236 of the barbed fasteners 230 increase friction with the leaflets or puncture the leaflets partially or completely. The actuation lines can be independently actuated, allowing each barbed fastener 230 to be opened and closed independently. Independent actuation allows for grasping one leaflet at a time or allows for repositioning of the fasteners 230 for leaflets that were not fully grasped without altering the successful grasp of the other leaflets. The barbed catches 230 not only open and close independently of each other, but can also open and close completely independent of the position of the inner paddle 222, allowing the leaflets to be grasped in various positions depending on the requirements of a particular situation.

[0037] 14-25, an implantable device 300 is shown being delivered and implanted within a native mitral valve 40 of a heart 10. Device 300 is similar to implantable device 200 of FIG. 13, except that device 300 includes a covering over coaptation element 310, fastener 330, inner paddle 322, and / or outer paddle 320. Device 300 is deployed from a delivery sheath 302 and includes a coaptation portion 304 and an anchor portion 306. Coaptation portion 304 of the device includes coaptation element 310, which is slidably attached to an actuation wire or shaft 312 and is implanted between the leaflets of the native mitral valve. During implantation, actuation of actuation wire or shaft 312 causes anchor portion 306 of device 300 to open and close, thereby grasping the mitral valve leaflets.

[0038] The anchor portion 306 of the device 300 includes an outer paddle 320 and an inner paddle 322 that are flexibly connected to the cap 314 and the joint element 310. An actuation wire 312 extends through the collar 303 (see FIG. 20 ), the delivery sheath 302, and the joint element 310 to the cap 314 at the distal end of the anchor portion 306. Extending or retracting the actuation wire 312 correspondingly increases or decreases the spacing between the joint element 310 and the cap 314. Fingers on the collar 303 removably attach the joint element 310 to the delivery sheath 302 such that the joint element 310 slides along the actuation wire 312 during actuation to open and close the paddles 320, 322 of the anchor portion 306. In some embodiments, the collar 303 is held closed around the coaptation element 310 by an actuation wire 312, and removing the actuation wire 312 allows the fingers of the collar 303 to open and release the coaptation element 310.

[0039] The joint element 310 and paddles 320, 322 are formed from a flexible material, which may be a mesh, woven fabric, knitted fabric, or formed in any other suitable manner, such as fabric, shape memory alloy wire for shape setting, e.g., Nitinol, or any other flexible material suitable for implantation within the human body.

[0040] The barbed fastener 330 includes a base or fixed arm 332, a movable arm 334, a barb 336 (see FIG. 20 ), and a hinge portion 338. The fixed arm 332 is attached to the inner paddle 322, and the hinge portion 338 is disposed adjacent to the joint element 310. A suture (not shown) attaches the fixed arm 332 to the inner paddle 322. The fixed arm 332 can be attached to the inner paddle 322 by any suitable means, such as a screw or other fastener, a crimped sleeve, a mechanical latch or snap, welding, adhesive, or the like. The fixed arm 332 remains stationary when the movable arm 334 is opened to open the barbed fastener 330 and expose the barb 336. The barbed catch 330 is opened by applying tension to an actuation line 316 attached to the end of a movable arm 334 , which causes the movable arm 334 to pivot on a hinge portion 338 .

[0041] During implantation, the paddles 320, 322 are opened and closed to capture the native mitral valve leaflets between the paddles 320, 322 and the coaptation element 310. The outer paddle 320 has a wide, curved shape that fits snugly around the curved shape of the coaptation element 310 to more securely grip the leaflets. The curved shape and rounded edges of the outer paddle 320 also prevent tearing of the leaflet tissue. The barbed fasteners 330 further secure the native leaflets by engaging the leaflets with barbs 336 and clamping the leaflets between the movable arm 334 and the fixed arm 332. The barbs 336 of the barbed fasteners 330 increase friction with the leaflets or puncture the leaflets partially or completely through them. The actuation lines can be independently actuated, allowing each barbed fastener 330 to open and close independently. Independent movement allows for grasping one leaflet at a time, or allows the position of the catch 330 to be changed for a leaflet that was not adequately grasped without altering the successful grasp of the other leaflet. Not only do the barbed catches 330 open and close independently of each other, but they can also be opened and closed completely independent of the position of the inner paddle 322, allowing for grasping of the leaflets in various positions depending on the demands of a particular situation.

[0042] The device 300 is loaded into the delivery sheath in the fully open position because it takes up the least space, allowing the smallest catheter (or largest device 300 used for a given catheter size) to be used. Referring now to FIG. 14, the delivery sheath is inserted through the septum into the left atrium 20, and the device 300 is deployed in the fully open position from the delivery sheath 302. The actuation wire 312 is then retracted to move the device 300 to the fully closed position shown in FIGS. 15-16, and then manipulated toward the mitral valve 40 as shown in FIG. 17. Referring now to FIG. 18, when the device 300 is aligned with the mitral valve 40, the actuation wire 312 is extended to open the paddles 320, 322 to a partially open position, and the actuation line 316 is retracted to open the barbed catch 330 in preparation for grasping the valve leaflets. Next, as shown in FIGS. 19-20 , the partially opened device 300 is inserted through the mitral valve 40 until the leaflets are properly positioned between the inner paddle 322 and the coaptation element 310 and within the open barbed clasps 330. FIG. 21 shows the device 300 with both clasps 330 closed, but the barbs 336 of one clasp 330 do not capture one of the leaflets 44. As can be seen in FIGS. 22-23 , the improperly positioned clasp 330 is opened and then reclosed to properly grasp the uncaptured leaflet 44. Once both leaflets 42, 44 are properly grasped, the actuation wire 312 is retracted, moving the device 300 to the fully closed position shown in FIG. 24 . Once the device 300 is fully implanted within the native mitral valve 40, the actuation wire 312 is withdrawn, releasing the collar 303 from the upper end or plate 311 of the coaptation element 310. Once deployed, the device 300 may be maintained in a fully closed position using mechanical means such as a latch, or may be biased to remain closed through the use of a spring material such as steel and / or a shape memory alloy such as Nitinol.For example, the paddles 320, 322 may be formed from steel or Nitinol shape memory alloy—produced as wire, sheet, tubing, or laser-sintered powder—and are biased to hold the outer paddle 320 closed around the coaptation element 310 and the barbed clasp 330 clamped around the native leaflets.

[0043] Referring now to FIG. 23A , a close-up view of one of the leaflets 42, 44 being grasped by one of the fasteners 330 is shown. The leaflets 42, 44 are grasped between the movable arm 334 and the fixation arm 332 of the fastener 330. As shown in FIG. 23A , the tissue of the leaflets 42, 44 is not perforated by the barbs 336; however, in some embodiments, the barbs 336 may perforate partway through or all the way through the leaflets 42, 44. The angle and height of the barbs 336 relative to the movable arm 334 help secure the leaflets 42, 44 within the fastener 330. In particular, the force pulling the implant away from the native leaflets encourages further engagement of the barbs 336 with the tissue, thereby ensuring better retention. Retention of the leaflets 42, 44 in the fastener 330 is further improved by the positioning of the fixation arms 332 near the barbs 336 when the fastener 330 is closed. In this configuration, the tissue forms an S-shaped, serpentine path with the fixed and movable arms 332, 334 and the barbs 336. Thus, the force pulling the leaflets away from the catches 330 causes the tissue to further engage the barbs 336 before the leaflets can escape.

[0044] 26, there is shown an exemplary barbed fastener 400 for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. The barbed fastener 400 is formed from a top layer 402 and a bottom layer 404. The two-layer design of the fastener 400 allows for the use of a thinner sheet of material, which improves the flexibility of the fastener 400 compared to fasteners formed from a single, thicker sheet, while maintaining the strength of the fastener 400 necessary to successfully retain the leaflets of a native valve.

[0045] The barbed fastener 400 includes a fixed arm 410, a hinged portion 420, and a movable arm 430 having a barbed portion 440. The top and bottom layers 402, 404 have similar shapes and, in certain embodiments, are attached to one another at the barbed end 440. The hinged portion 420 is spring-loaded such that the fixed arm 410 and the movable arm 430 are biased toward one another when the barbed fastener 400 is in a closed position. When assembled to an implantable prosthetic device, the fixed arm 410 is attached to a portion of the prosthetic device. The fastener 400 is opened by pulling an actuation line attached to the movable arm 430 until the spring force of the hinged portion 420 is overcome.

[0046] The fixed arm 410 is formed from a tongue of material 411 that extends from a hinge-like section 420 between two side beams 431 of the movable arm 430. The tongue 411 is biased between the side beams 431 by the hinge section 420 such that a force must be applied to move the tongue 411 from a neutral position beyond the side beams 431 to a preloaded position substantially parallel to the side beams 431. The tongue 411 is held in the preloaded position by a T-shaped crossbar 414 that is attached to the tongue 411 and extends outward to engage the side beams 431. In certain embodiments, the angle between the fixed arm 410 and the movable arm 430 when the tongue is in the neutral position is about 30 degrees to about 100 degrees, 30 degrees to about 90 degrees, or about 30 degrees to about 60 degrees, or about 40 degrees to about 50 degrees, or about 45 degrees.

[0047] Tongue 411 includes holes 412 for receiving sutures (not shown) that attach fixation arms 410 to the implantable device. Fixation arms 410 can be attached to the implantable device by a variety of attachment means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesives, or the like. In certain embodiments, holes 412 are elongated slots or oval-shaped holes to accommodate sliding of layers 402, 404 without damaging the sutures that attach fastener 400 to the implantable device.

[0048] The hinge portion 420 is formed by two beam loops 422 that extend from the tongue 411 of the fixed arm 410 to the lateral beam 431 of the movable arm 430. In certain embodiments, the beam loops 422 are narrower than the tongue 411 and the lateral beam 431 to provide additional flexibility. The beam loops 422 each include a central portion 424 that extends from the tongue 411 and an outer portion 426 that extends to the lateral beam 431. The beam loops 422 are bent into a somewhat spiral or helical shape by bending the central portion 424 and the outer portion 426 in opposite directions, which forms an offset or stepped distance 428 between the tongue 411 and the lateral beam 431. The stepped distance 428 provides space between the arms 410, 430 to accommodate the native leaflet of the mitral valve after it has been grasped. In certain embodiments, the step distance 428 is from about 0.5 millimeters to about 1 millimeter, or about 0.75 millimeters.

[0049] When viewed from the top, the beam loop has an “omega-like” shape. This shape of the beam loop 422 allows the fixed arm 410 and the movable arm 430 to move significantly relative to one another without plastically deforming the fastener material. For example, in certain embodiments, the tongue 411 can pivot from a neutral position of approximately 45 degrees beyond the movable arm 430 to a fully open position ranging from approximately 140 degrees to approximately 200 degrees, approximately 170 degrees, approximately 190 degrees, or approximately 180 degrees from the movable arm 430 without plastically deforming the fastener material. In certain embodiments, the fastener material plastically deforms during opening without reducing or substantially reducing the clamping force exerted between the fixed and movable arms in the closed position.

[0050] Preloading tongue 411 allows fastener 400 to maintain a clamping or clipping force against the native leaflets when closed, while also allowing it to open wider to more easily grasp the native leaflets. Preloading tongue 411 provides a significant advantage over prior art clips, which provide little or no clamping force when closed. Furthermore, spring-closing fastener 400 is a significant improvement over clips that use a one-time locking closure mechanism, because fastener 400 can be repeatedly opened and closed to reposition itself on the leaflets, while still maintaining sufficient clamping force when closed.

[0051] The barbed portion 440 of the movable arm 430 includes an eyelet 442, a barb 444, and a barb support 446. Locating the barbed portion of the fastener 400 at the end of the movable arm 430 increases the space between the barb 444 and the fixation arm 410 when the fastener 400 is open, thereby improving the fastener's ability to successfully grasp the leaflets during implantation. This distance also allows the barb 444 to more reliably disengage from the leaflets for repositioning. In certain embodiments, the barbs of the fastener may be longitudinally offset to further distribute clamping forces and local leaflet stresses.

[0052] The barbs 444 are spaced laterally at equal distances from the hinge portion 420 to provide excellent distribution of the clamping force against the leaflet tissue while also providing a stronger fastener for grasping the leaflet than barbs arranged in longitudinal rows. In some embodiments, the barbs 444 can be offset from one another to further distribute the clamping force and local leaflet stress.

[0053] The barbs 444 are formed from the bottom layer 404, and the barb supports 446 are formed from the top layer. In certain embodiments, the barbs are formed from the top layer 402, and the barb supports are formed from the bottom layer 404. Forming the barbs 444 on only one of the two layers 402, 404 allows the barbs to be thinner, and therefore effectively sharper, than barbs formed from twice the thickness of the same material. The barb supports 446 extend along the lower portion of the barbs 444 to stiffen the barbs 444, further improving penetration and retention of leaflet tissue. In certain embodiments, the ends of the barbs 444 are further sharpened using any suitable sharpening means.

[0054] The barbs 444 are angled away from the movable arms 430 so that they easily penetrate the tissue of the native leaflets with minimal clamping or clipping force. The barbs 444 extend from the movable arms at an angle of about 45 degrees to about 75 degrees, or about 45 degrees to about 60 degrees, or about 48 degrees to about 56 degrees, or about 52 degrees. This angle of the barbs 444 provides an additional benefit in that the force pulling the implant away from the native leaflets encourages further engagement of the barbs 444 with the tissue, thereby ensuring better retention. Leaflet retention in the fastener 400 is further improved by the positioning of the T-shaped crossbar 414 near the barbs 444 when the fastener 400 is closed. In this configuration, tissue penetrated by barbs 444 is clamped against movable arms 430 at crossbar 414, causing the tissue to follow an S-shaped, serpentine path as it passes over barbs 444. Thus, the force pulling the leaflets away from fastener 400 further engages the tissue with barbs 444 before the leaflets can escape.

[0055] Each layer 402, 404 of the fastener 400 is laser cut from a sheet of a shape memory alloy, such as Nitinol. The top layer 402 is aligned with and attached to the bottom layer 404. In certain embodiments, the layers 402, 404 are attached at the barbed end 440 of the movable arm 430. For example, the layers 402, 404 may be attached only at the barbed end 440 so that the remaining layers can slide relative to each other. The combined portions of the layers 402, 404, such as the fixed arm 410, the barbs 444 and barb supports 446, and the beam loop 422, are bent into a desired position. The layers 402, 404 can be bent and shape-set together, or they can be bent and shape-set separately and then joined together. The fastener 400 then undergoes a shape-setting process, which causes the internal forces of the material to tend to return to a set shape after being deformed by an external force. After shape setting, tongue 411 is moved to its preloaded position to allow for attachment of crossbar 414. This allows fastener 400 to be delivered completely flat through a delivery sheath, deployed within the heart, and then expanded.

[0056] The fastener 400 is opened and closed by applying or releasing tension to an actuation means, such as an actuation line, suture, wire, rod, catheter, or the like (not shown), attached to the movable arm 430. The suture is inserted through an eyelet 442 near the barbed portion 440 of the movable arm 430, wrapped around the end of the movable arm 430, and then returned to the delivery sheath. In certain embodiments, an intermediate suture loop is created through the eyelet, and the suture is threaded through this intermediate loop. The intermediate loop of suture material reduces the friction experienced by the actuation suture compared to the friction between the actuation suture and the fastener material. Upon looping the suture through the eyelet 442 or intermediate loop, both ends of the actuation suture are passed back into and extended through the delivery sheath 102 (see FIG. 1 ). The suture can be removed by pulling one end of the suture proximally until the other end of the suture is pulled back through the eyelet or mid-loop and into the delivery sheath.

[0057] 27, an exemplary barbed fastener 500 is shown for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. Barbed fastener 500 is substantially similar to barbed fastener 400, except that barbed fastener 500 includes a suture pin 543 disposed across opening 542 instead of hole 442. Barbed fastener 500 is formed from a top layer 502 and a bottom layer 504. The two-layer design of fastener 500 allows for the use of a thinner sheet of material, which improves the flexibility of fastener 500 compared to fasteners formed from a single, thicker sheet, while maintaining the strength of fastener 500 necessary to successfully retain the leaflets of a native valve.

[0058] The barbed fastener 500 includes a fixed arm 510, a hinged portion 520, and a movable arm 530 having a barbed portion 540. The top and bottom layers 502, 504 have similar shapes and, in certain embodiments, are attached to one another at the barbed end 540. The hinged portion 520 is spring-loaded such that the fixed and movable arms 510, 530 are biased toward one another when the barbed fastener 500 is in a closed position. When assembled to an implantable prosthetic device, the fixed arm 510 is attached to a portion of the prosthetic device. The fastener 500 is opened by pulling an actuation means or actuation line attached to the movable arm 530 until the spring force of the hinged portion 520 is overcome.

[0059] The fixed arm 510 is formed from a tongue of material 511 that extends from a hinge-like section 520 between two side beams 531 of the movable arm 530. The tongue 511 is biased between the side beams 531 by the hinge section 520 such that a force must be applied to move the tongue 511 from a neutral position beyond the side beams 531 to a preloaded position substantially parallel to the side beams 531. The tongue 511 is held in the preloaded position by a T-shaped cross bar 514 that is attached to the tongue 511 and extends outward to engage the side beams 531. In certain embodiments, the angle between fixed arm 510 and movable arm 530 when the tongue is in a neutral position is from about 30 degrees to about 100 degrees, or from about 30 degrees to about 90 degrees, or from about 30 degrees to about 60 degrees, or from about 40 degrees to about 50 degrees, or about 45 degrees.

[0060] Tongue 511 includes holes 512 for receiving sutures (not shown) that attach fixation arms 510 to the implantable device. Fixation arms 510 can be attached to the implantable device by a variety of attachment means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesives, or the like. In certain embodiments, holes 512 are elongated slots or oval-shaped holes to accommodate sliding of layers 502, 504 without damaging the sutures that attach fastener 500 to the implantable device.

[0061] The hinge portion 520 is formed by two beam loops 522 that extend from the tongue 511 of the fixed arm 510 to the lateral beams 531 of the movable arm 530. In certain embodiments, the beam loops 522 are narrower than the tongue 511 and the lateral beams 531 to provide additional flexibility. The beam loops 522 each include a central portion 524 that extends from the tongue 511 and an outer portion 526 that extends to the lateral beam 531. The beam loops 522 are bent into a somewhat spiral or helical shape by bending the central portion 524 and the outer portion 526 in opposite directions, which forms a stepped distance 528 between the tongue 511 and the lateral beam 531. The stepped distance 528 provides space between the arms 510, 530 to accommodate the native leaflet of the mitral valve after it has been grasped. In certain embodiments, the step distance 528 is from about 0.5 millimeters to about 1 millimeter, or about 0.75 millimeters.

[0062] When viewed from the top, the beam loop has an “omega-like” shape. This shape of the beam loop 522 allows the fixed arm 510 and the movable arm 530 to move significantly relative to one another without plastically deforming the fastener material. For example, in certain embodiments, the tongue 511 can pivot from a neutral position of approximately 45 degrees beyond the movable arm 530 to a fully open position ranging from approximately 140 degrees to approximately 200 degrees, approximately 170 degrees, approximately 190 degrees, or approximately 180 degrees from the movable arm 530 without plastically deforming the fastener material. In certain embodiments, the fastener material plastically deforms during opening without reducing the clamping force exerted between the fixed and movable arms in the closed position.

[0063] Preloading tongue 511 allows fastener 500 to maintain a clamping or clipping force against the native leaflets when closed, while also allowing it to open wider to more easily grasp the native leaflets. Preloading tongue 511 provides a significant advantage over prior art clips, which provide little or no clamping force when closed. Furthermore, spring-closing fastener 500 is a significant improvement over clips that use a one-time locking closure mechanism, because fastener 500 can be repeatedly opened and closed to reposition itself on the leaflets, while still maintaining sufficient clamping force when closed.

[0064] The barbed portion 540 of the movable arm 530 includes an eyelet 542, a barb 544, and a barb support 546. Locating the barbed portion of the fastener 500 at the end of the movable arm 530 increases the space between the barb 544 and the fixation arm 510 when the fastener 500 is open, thereby improving the fastener's ability to successfully grasp the leaflets during implantation. This distance also allows the barbs 544 to more reliably disengage from the leaflets for repositioning. In certain embodiments, the barbs of the fastener may be longitudinally offset to further distribute clamping forces and localized leaflet stresses.

[0065] The barbs 544 are spaced laterally at the same distance from the hinge portion 520 to provide excellent distribution of the clamping force against the leaflet tissue while also providing a stronger fastener for grasping the leaflet than barbs arranged in longitudinal rows.

[0066] The barbs 544 are formed from the bottom layer 504, and the barb supports 546 are formed from the top layer. Forming the barbs 544 on only one of the two layers 502, 504 allows the barbs to be thinner, and therefore effectively sharper, than barbs formed from twice the thickness of the same material. The barb supports 546 extend along the lower portions of the barbs 544 to stiffen the barbs 544, further improving penetration and retention of leaflet tissue. In certain embodiments, the ends of the barbs 544 are further sharpened using any suitable sharpening means.

[0067] The barbs 544 are angled away from the movable arms 530 so that they easily penetrate the tissue of the native leaflets with minimal clamping or clipping force. The barbs 544 extend from the movable arms at an angle of about 45 degrees to about 75 degrees, or about 45 degrees to about 60 degrees, or about 48 degrees to about 56 degrees, or about 52 degrees. This angle of the barbs 544 provides an additional benefit in that the force pulling the implant away from the native leaflets encourages further engagement of the barbs 544 with the tissue, thereby ensuring better retention. Leaflet retention in the fastener 500 is further improved by the positioning of the T-shaped crossbar 514 near the barbs 544 when the fastener 500 is closed. In this configuration, tissue penetrated by barbs 544 is clamped against movable arms 530 at crossbar 514, causing the tissue to follow an S-shaped, serpentine path as it passes over barbs 544. Thus, the force pulling the leaflets away from fastener 500 further engages the tissue with barbs 544 before the leaflets can escape.

[0068] Each layer 502, 504 of the fastener 500 is laser cut from a sheet of a shape memory alloy, such as Nitinol. The top layer 502 is aligned with and attached to the bottom layer 504. In certain embodiments, the layers 502, 504 are attached at the barbed end 540 of the movable arm 530. For example, layers 402, 404 may be attached only at the barbed end 440, allowing the remaining layers to slide relative to one another. The interlocking portions of the layers 502, 504, including the fixed arm 510, the barbs 544 and barb supports 546, and the beam loop 522, are bent into a desired position. The fastener 500 then undergoes a shape-setting process, which causes the internal forces of the material to tend to return to a set shape after being deformed by an external force. After shape-setting, the tongue 511 is moved to its preloaded position so that the crossbar 514 can be attached. As a result, fastener 500 can be delivered completely flat through a delivery sheath and expanded once deployed within the heart.

[0069] The fastener 500 is opened and closed by applying or releasing tension to an actuation means, such as an actuation line, suture, wire, rod, catheter, or the like (not shown), attached to the movable arm 530. The suture is threaded through an opening 542 in the movable arm 530 and looped around a pin 543 disposed within the opening 542. The smooth, round shape of the pin 543 allows tension to be applied to the movable arm 530 from multiple directions without wearing out the suture. In certain embodiments, an intermediate suture loop is created around the pin through the opening, and the suture is threaded through this intermediate loop. The intermediate loop of suture material reduces the friction experienced by the actuation suture compared to the friction between the actuation suture and the fastener material. When the suture is looped around the pin 543, both ends of the suture are passed back into and extended through the delivery sheath 102 (see FIG. 1 ). The suture can be removed by pulling one end of the suture proximally until the other end of the suture is pulled back around pin 543 and into the delivery sheath.

[0070] 28-31 , an exemplary barbed fastener 600, similar to barbed fasteners 400 and 500, is shown in various bent positions to illustrate the independent movement of the layers forming barbed fasteners 400, 500, and 600. Barbed fastener 600 is formed from a top layer 602 and a bottom layer 604. Barbed fastener 600 includes a movable arm 620, a fixed arm 622, and a hinge portion 624. Movable arm 620 includes a barbed portion 626 having barbs 628. Barbed fastener 600 does not include a crossbar to prevent movable arm 620 from moving beyond fixed arm 622. Instead, movable arm 620 is held in a closed position with fixed arm 622 by an inner paddle (not shown). To better illustrate the preloading of fastener 600, Figures 28-31 show the movement of fixed arm 622 relative to a stationary movable arm 620. However, when assembled to an implantable device, movable arm 620 will move relative to fixed arm 622 attached to the device.

[0071] 28-29, the fastener 600 is shown in a preloaded or shape-set state. The fixed arm 622 is bent downward at an angle 610 relative to the movable arm 620 prior to the shape-setting operation. A force must be applied to return the fixed arm 622 to a parallel relationship with the movable arm 620. In this case, increasing the preload angle 610 increases the force required to move the fixed arm 622, which in turn increases the preload spring force that holds the arms 620, 622 together when the fastener 600 is closed. In other words, the greater the angle 610, the greater the spring force applied to tissue grasped by the arms 620, 622.

[0072] 30-31, fastener 600 is shown opened to an opening angle 612. As can be seen in FIGS. 30 and 31, the beam loops of hinge portion 624 tend to separate as fastener 600 is opened. By allowing layers 602, 604 to separate during bending, material strain is relieved, which further increases the maximum opening angle 612 achievable before plastic deformation of the fastener material. As noted above, hinge portion 624 is shaped to form a somewhat spiral or helical beam loop, which creates a gap or step distance 614 between arms 620, 622 (FIG. 29) that allows for grasping of leaflet tissue.

[0073] As the fastener 600 is opened, the layers 602, 604 of the fixation arm 622 slide relative to one another. In some embodiments, the holes through the fixation arm 622 are elongated so that the sliding of the layers does not pinch or restrict the sliding of the layers 602, 604, thereby reducing the strain experienced by the fastener material.

[0074] 32-35, exemplary barb fasteners 700, 800, 900, and 1000 are shown. Barb fasteners 700, 800, 900, and 1000, like fasteners 400, 500, and 600, can be used in implantable devices 100, 200, and 300 described above. However, unlike barbed fasteners 400, 500, and 600, barbed fasteners 700, 800, 900, and 1000 are formed by laser cutting material from the sides of the fastener rather than from the top. Laser cutting from the sides reduces the labor required to manufacture the fastener and allows for the thickness of the fastener to vary to change the bending characteristics of sections of the fastener based on each section's function. For example, the hinge section may be thinner to provide greater flexibility, while the arms may be thicker to provide greater stiffness.

[0075] Referring now to FIG. 32 , a stacked barb fastener 700 is shown. The barb fastener 700 has thicker and thinner sections 702 and 704, with alternating spacer layers 706 and barbed layers 708 formed to form a stacked structure. The fastener 700 includes a movable arm 720, a fixed arm 722, and a hinge portion 724. The movable arm 720 includes a barbed portion 726 with barbs 728 formed in the barbed layer 708. Laser cutting the layers 706, 708 from the lateral contours allows the barbs 728 to be tapered, resulting in a robust barb with a sharp apex. The fixed arm 722 includes a hole for securing the fastener 700 to an implantable device. When assembled to an implantable device, the attached inner paddle extends the fixed arm 722, thereby clamping native tissue between the device's movable arm 720 and inner paddle. The movable arm 720 and fixed arm 722 are angled relative to each other so that the fixed arm 722 intersects with the movable arm 720 when extended. Attaching the fixed arm 722 to the inner paddle effectively extends the end of the fixed arm 722 so that the inner paddle interferes with the movable arm 720. This interference between the components moves the movable arm 720 relative to the fixed arm 722, opening the fastener 700 and preloading the movable arm 722 to apply a clamping force against the inner paddle when the fastener 700 is in the closed position. This creates a clamping force between the movable arm 720 and the fixed arm 722 without requiring any shaping of the movable arm 720 and the fixed arm 722 of the fastener 700. Alternatively, the individual layers are formed so that the movable arm 720 and fixed arm 722 are parallel to one another, and then bent and shaped so that the movable arm 720 is biased toward the fixed arm 722 when the fastener 700 is attached to the inner paddle.

[0076] 33-35, exemplary barb fasteners 800, 900, 1000 are shown. While the fasteners 800, 900, 1000 are similar in overall shape, a side view illustrates the various thicknesses possible when laser cutting the fasteners. The fasteners 800, 900, 1000 have thin sections 804, 904, 1004 and thick sections 802, 902, 1002. The fasteners 800, 900, 1000 include movable arms 820, 920, 1020, fixed arms 822, 922, 1022, and hinged sections 824, 924, 1024. The movable arms 820, 920, 1020 include barbed portions 826, 926, 1026 having barbs (not shown) similar to the barbs 728 of the barbed portion 726 of the fastener 700. As can be seen in Figures 33-35, the locking arms 822, 922, 1022 can be provided with holes for securing the fastener 800, 900, 1000 to an implantable device. When assembled to an implantable device, the attached inner paddle extends the locking arms 822, 922, 1022, thereby clamping native tissue between the movable arms 820, 920, 1020 and the inner paddle of the device.

[0077] Referring now to FIG. 36 , an exemplary barbed fastener 1100 is shown, similar to barbed fasteners 400, 500, and 600. However, unlike barbed fasteners 400, 500, and 600, barbed fastener 1100 is formed from a single layer of material that varies in thickness between a thicker portion 1102 and a thinner portion 1104. Barbed fastener 1100 includes a fixed arm 1110, a hinge portion 1120, and a movable arm 1130. Fixed arm 1110 includes mounting holes 1112 and an optional integral crossbar 1114. Hinge portion 1120 includes an arcuate hinge 1122 formed from thin portion 1104. Movable arm 1130 includes a barbed portion 1140 having barbs 1144. An eyelet 1142 near the barbed portion 1140 can be attached to a suture (not shown) for opening and closing the fastener 1100 .

[0078] To form the barbed fastener 1100, a sheet of material is thinned to form the thin section 1104. The shape of the fastener 1100 is then laser cut from the sheet of material such that the hinge section 1120 is aligned with the thin section 1104. The barb 1144 and fixed arm 1110 are then bent into the position shown in FIG. 36 before shape setting. The optional T-shaped crossbar 1114 of the fixed arm 1110 must be twisted to insert and shape set through the slot in the movable arm 1130 and to move the arms 1110, 1130 from the preloaded position to the closed position. In certain embodiments, the optional T-shaped crossbar 1114 is omitted, smaller, or alternatively replaced with a contour in the movable arm 1130 to enhance ease of manufacturing and shape setting. After shape setting, the crossbar is twisted and moved back through the slot and positioned over the thick section 1102. Crossbar 1114 is positioned in much the same manner as crossbar 414 (see FIG. 26).

[0079] Like fasteners 400 and 500 described above, fastener 1100 can be fully opened without plastically deforming the fastener material while still providing clamping force when closed. Compared to the fasteners described above, fewer steps are required to manufacture fastener 1100 because fastener 1100 is cut from a single sheet of material and does not require a welding step to weld layers of material together.

[0080] 37-52, an exemplary barbed fastener 1200 is shown for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. The barbed fastener 1200 is formed from a single layer of material 1202. The barbed fastener 1200 includes a fixed arm 1210, a hinged portion 1220, and a movable arm 1230 having a barbed portion 1240. The hinged portion 1220 is spring-loaded such that the fixed arm 1210 and the movable arm 1230 are biased toward each other when the barbed fastener 1200 is in a closed position. When assembled to an implantable prosthetic device, the fixed arm 1210 is attached to a portion of the prosthetic device. The fastener 1200 is opened by pulling an actuation means, such as an actuation line or suture attached to the movable arm 1230, until the spring force of the hinged portion 1220 is overcome.

[0081] The fixed arm 1210 is formed from a tongue of material 1211 that extends from a hinged portion 1220 between two lateral beams 1231 of the movable arm 1230 to an end 1214. In some embodiments, the movable arm is formed from a tongue of material that extends between the two lateral beams of the fixed arm. The tongue 1211 is biased by the hinged portion 1220 between the lateral beams 1231 such that a force must be applied to move the tongue 1211 from a neutral position beyond the lateral beams 1231 to a preloaded position approximately parallel or parallel to the lateral beams 1231, as can be seen in FIGS. 39-40E. The tongue 1211 is held in the preloaded position when attached to the paddle of the implantable prosthetic device. End 1214 of tongue 1211 optionally has a T-shaped cross member that engages lateral beam 1231 to hold tongue 1211 in a preloaded position.

[0082] In certain embodiments, the angle between the fixed arm 1210 and the movable arm 1230 when the tongue 1211 is in a neutral position is from about 30 degrees to about 120 degrees, from 40 degrees to about 110 degrees, or from about 50 degrees to about 100 degrees, or from about 60 degrees to about 90 degrees, or about 90 degrees. The tongue 1211 includes a hole 1212 for receiving a suture (not shown) that attaches the fixed arm 1210 to an implantable device.

[0083] The hinge portion 1220 is formed by a plurality of torsion spring segments 1222 arranged in a repeating pattern that extend from the tongue 1211 of the fixed arm 1210 to the side beam 1231 of the movable arm 1230. Each spring segment 1222 is connected to another spring segment 1222 to form the repeating pattern. Connecting the multiple segments 1222 together allows the hinge portion 1220 to flex a significant amount while avoiding plastic deformation of the material as the individual torsion spring segments 1222 are twisted. For example, in certain embodiments, the tongue 1211 can pivot from a neutral position of approximately 90 degrees beyond the movable arm 1230 to a fully open position ranging from approximately 140 degrees to approximately 200 degrees, to approximately 170 degrees, to approximately 190 degrees, or to approximately 180 degrees from the movable arm 1230 without plastically deforming the fastener material. In certain embodiments, the fastener material can plastically deform during opening without reducing or substantially reducing the clamping force exerted between the fixed and movable arms in the closed position. Pattern spring segments 1222 are formed from open and closed cutouts 1224 in hinge portion 1220. Exemplary spring segments and their patterned configurations are described below and illustrated in Figures 51A-52.

[0084] Preloading the tongues 1211 allows the fastener 1200 to maintain a clamping or clipping force against the native leaflets when closed, while also allowing it to open wider to more easily grasp the native leaflets. Preloading the tongues 1211 provides a significant advantage over prior art clips that provide little or no clamping force when closed. Furthermore, spring-closing the fastener 1200 is a significant improvement over clips that use a one-time locking closure mechanism because the fastener 1200 can be repeatedly opened and closed to reposition itself on the leaflets, while still maintaining sufficient clamping force when closed.

[0085] The barbed portion 1240 of the movable arm 1230 includes an eyelet 1242 and a barb 1244. Locating the barbed portion of the fastener 1200 at the end of the movable arm 1230 increases the space between the barb 1244 and the fixation arm 1210 when the fastener 1200 is open, thereby improving the fastener 1200's ability to successfully grasp the leaflet during implantation. This distance also allows the barb 1244 to more securely disengage from the leaflet for repositioning. In certain embodiments, the barbs of the fastener may be longitudinally offset to further distribute clamping forces and local leaflet stresses. In certain embodiments, the ends of the barbs 1244 are further sharpened using any suitable sharpening means.

[0086] The barbs 1244 are spaced laterally at equal distances from the hinge portion 1220 to provide excellent distribution of the clamping force against the leaflet tissue while also making the fastener more robust against grasping the leaflet than barbs arranged in longitudinal rows. In some embodiments, the barbs 1244 can be offset from one another to further distribute the clamping force and local leaflet stress.

[0087] The barbs 1244 are angled away from the movable arms 1230 at an angle 1246 ( FIG. 38A ), so that they easily engage the tissue of the native leaflet with minimal clamping or clipping force. During use, the barbs 1244 may penetrate the native leaflet tissue, although penetration of the tissue is not required for the fastener 1200 to securely grip the leaflet. The barbs 1244 extend from the movable arms at an angle 1246 of about 20 degrees to about 90 degrees, or about 40 degrees to about 70 degrees, or about 50 degrees to about 60 degrees, or about 53 degrees. This angle of the barbs 1244 provides an additional benefit in that the force pulling the implant away from the native leaflet encourages further engagement of the barbs 1244 with the tissue, thereby ensuring a better retention. Retention of the leaflets in the fastener 1200 is further improved by the position of the end 1214 of the fixation arm 1210 when the fastener 1200 is closed. In this configuration, tissue engaged by the barbs 1244 is clamped against the movable arm 1230 at the location of the end 1214, causing the tissue to form an S-shaped, serpentine path as it passes over the barbs 1244. Thus, the force pulling the leaflets away from the fastener 1200 further engages the tissue with the barbs 1244 before the leaflets can escape. The end 1214 can optionally be shaped with a slight bend toward the movable arm 1230 to accentuate the S-shape of the serpentine path of the tissue grasped between the fixation arm 1210 and the movable arm 1230.

[0088] The layer 1202 of material for fastener 1200 is laser cut from a sheet of a shape-memory alloy, such as Nitinol. Portions of layer 1202, such as fixation arms 1210, hinge portions 1220, and barbs 1244, are bent into a desired position. Fastener 1200 then undergoes a shape-setting process in which the internal forces of the material cause it to tend to return to a set shape after being deformed by an external force. After shape-setting, tongues 1211 are moved to their preloaded, closed, or open positions and attached to an implantable device. As a result, fastener 1200 can be delivered substantially flat in the closed position through a delivery sheath and deployed within the heart after expansion.

[0089] The fastener 1200 is opened and closed by applying or releasing tension to an actuating line or suture (e.g., suture 2504 in FIG. 71 ) attached to the movable arm 1230. The suture is threaded through at least one of the eyelets 1242 located near the barbed portion 1240 of the movable arm 1230 and then returned to the delivery sheath. In certain embodiments, intermediate suture loops are created through one or more of the eyelets 1242, and the actuating suture is threaded through one or more of the intermediate loops. The intermediate loop of suture material reduces the friction experienced by the actuating suture compared to the friction between the actuating suture and the fastener material. Upon looping the suture through the eyelets 1242 or intermediate loop, both ends of the actuating suture are passed back into and extended through the delivery sheath 102 (see, e.g., FIG. 1 ). The suture can be removed by pulling one end of the suture proximally until the other end of the suture is pulled back through the eyelet or mid-loop and into the delivery sheath.

[0090] Like fasteners 400 and 500 described above, fastener 1200 can be fully opened without plastically deforming the fastener material while still providing clamping force when closed. Compared to the fasteners described above, fastener 1200 requires fewer steps to manufacture because it is cut from a single sheet of material and does not require a welding step to weld layers of material together.

[0091] 37-48E, the fastener 1200 is shown in various bent positions ranging from a neutral position (FIGS. 37-38E) to a fully open position (FIGS. 47-48E). Although the locking arm 1210 is shown in various positions in FIGS. 37-48E, once installed in an implantable device, the movable arm 1230 is actuated by the surgeon to move relative to the device, while the locking arm 1210 remains fixed relative to the device.

[0092] 37-38E show the fastener 1200 in a neutral position for shape setting. During shape setting, the tongue 1211 of the fixed arm 1210 is bent downwardly below the lateral beam 1231 of the movable arm 1230 to a tongue angle 1216 that is about 60 degrees to about 120 degrees, or about 90 degrees. After shape setting, the tongue 1211 remains in the shape-set or neutral position unless a force acts to urge the tongue 1211 to another position. Thus, when the tongue 1211 is moved toward the preloaded or closed position (FIGS. 39-40E), an internal force in the fastener material is exerted in the closing direction, which creates a clamping force when the fastener 1200 is in the closed or preloaded state. During implantation of a medical device including fastener 1200, movable arm 1230 is actuated by a suture (not shown) to change the angle 1216 between fixed arm 1210 and movable arm 1230. Fastener 1200 is shown in a quarter-open position in FIGS. 41-42E, a half-open position in FIGS. 43-44E, a three-quarter-open position in FIGS. 45-46E, and a fully open position in FIGS. 47-48E. In the fully open position, angle 1216 between fixed arm 1210 and movable arm 1230 can be from about 140 degrees to about 200 degrees, to about 170 degrees, to about 190 degrees, or to about 180 degrees. That is, fastener 1200 can be opened substantially completely flat without plastically deforming the fastener material.

[0093] 49-50, the layer of material 1202 for forming the fastener 1200 is shown in its pre-shape setting state, i.e., in its substantially flat state after being laser cut from a sheet of material. Figure 50 particularly clearly shows the repeating nature of the pattern of spring segments 1222 and cutouts 1224 that form the hinge portion 1220.

[0094] 51A-51D, exemplary torsion spring segments 1300, 1400, 1500, and 1600 are shown for a patterned hinge portion (e.g., hinge portion 1220 of fastener 1200). Spring segments 1300, 1400, 1500, and 1600 can be configured as a repeating pattern cut from a single piece, with no physical seams between the individual segments. In this case, the shapes of spring segments 1300, 1400, 1500, and 1600 are defined by imaginary boundaries at the cutouts in the hinge portion and the "joints" between the segments.

[0095] 51A , spring segments 1300 are formed by cutouts 1301 made in a layer of material 1302, resulting in a substantially rotationally symmetric, S-shaped configuration. Each spring segment 1300 extends from a first end 1310 to a second end 1320 between a first side 1330 and a second side 1340. A first end connection location 1312 is located at the first end 1310 adjacent to the first side 1330. A first side connection location 1332 is located at the first side 1330 adjacent to the first end 1310. A second end connection location 1322 is located at the second end 1320 adjacent to the second side 1340. A second side connection location 1342 is located at the second side 1340 adjacent to the second end 1320. The side surface 1304 extends between a first end attachment location 1312 and a second side attachment location 1342, and between a second end attachment location 1322 and a first side attachment location 1332. An interior corner 1306 is formed near each side attachment location 1332, 1342.

[0096] 51B-51D, spring segments 1400, 1500, and 1600 are shown. These spring segments 1400, 1500, and 1600 are similar in structure to spring segment 1300 described above, except that spring segments 1400, 1500, and 1600 include exterior corners 1408, 1508, and 1608 near each end connection location opposite the side connection locations. The configurations of spring segments 1300, 1400, 1500, and 1600 differ in the size and shape of the side surfaces 1304, 1404, 1504, and 1604, the rounded interior corners 1306, 1406, 1506, and 1606, and the rounded exterior corners 1408, 1508, and 1608. For example, sides 1304, 1404 are substantially straight, while sides 1504, 1604 are concave. These differences in shape change the stress distribution in the hinge portion formed from the pattern of differently shaped spring segments.

[0097] Referring now to FIG. 52, an exemplary spring assembly 1700 is shown for spring segment 1300. As can be seen in FIG. 52, side connection portions 1332, 1342 are connected to other side connection portions 1332, 1342, and end connection portions 1312, 1322 are connected to other end connection portions 1312, 1322. The substantially rotationally symmetrical shape of spring segment 1300 allows any end 1310, 1320 or side 1330, 1340 of one segment to any end 1310, 1320 or side 1330, 1340 of another segment. This allows for various patterns to be formed, such as the H-pattern formed by assembly 1700 of FIG. 52. Segments 1300, 1400, 1500, 1600 are substantially rotationally symmetric, although individual segments in the segment pattern may be modified to form rounded outer edges of hinge portions or to fit fixed or movable arms of a fastener.

[0098] When spring assembly 1700 is subjected to bending force 1710, each of segments 1300 is twisted in the direction indicated by arrow 1720. As a result, the individual spring segments 1300 are subjected to torsional strain, but not bending strain. It can also be seen that the deformation of material 1302 is reduced compared to the bending of a flat sheet of material being bent in a similar manner, while maintaining the spring force of the hinge portion of the fastener. As a result, the hinge portion formed from the pattern of torsion spring segments is both strong and flexible.

[0099] To form a patterned hinge portion, such as hinge portion 1220 described above, a pattern comprising multiple spring segments is arranged in rows and columns. The spring segments are arranged so that their longitudinal and lateral axes are aligned, as can be seen in FIGS. 49-50 and 52. In certain embodiments, the spring segments may be rotated relative to one another to form different spring patterns. The spring segments are organized in rows and columns. The rows are defined along the longitudinal axis of the fastener, while the lateral columns are defined along the lateral axis of the fastener. In this case, the rows of spring segments have a width equal to the maximum dimension of an individual spring segment, while the lateral columns have a height equal to the minimum dimension of an individual spring segment. For example, fastener 1200 shown in FIG. 50 includes three rows and seven columns of spring segments (not including partial lateral columns connecting the hinge portion to the fixed and movable arms). When the ends of the segments border the edge of the fastener, two segments in adjacent horizontal rows are joined together at one point to form a U-shaped cluster. Individual spring segments or clusters of spring segments may be modified to deviate from their rotational symmetry to enhance the smoothness and / or roughness of the hinge portion edges. When the ends of a segment are located at the intersection of two vertical rows, the segment can be joined to up to three other segments to form an X-shaped cluster, such as cluster 1700 shown in FIG. 52. A patterned hinge may include any suitable number of horizontal and vertical rows of spring segments. The size and shape of each segment can be adjusted to adjust the spring parameters of the patterned hinge. The size and shape of the spring segments may be uniform throughout the patterned hinge or may vary based on the location of the spring segment within the pattern.

[0100] 53-55, an exemplary barbed fastener 1800 is shown cut from a tube 1802 of material using four-axis laser cutting (X, Y, Z, and rotational axes) and five-axis laser cutting (X, Y, Z, and two tilt axes of the laser head). The tube can first be cut into multiple segments, and then each segment is cut much like cutting a flat piece of stock or blank, i.e., the tube provides a curved blank instead of a flat blank. The additional degrees of freedom of the laser cutter allow for the tube to be rotated or the laser cutter head to be tilted during laser cutting. Rotating the tube or tilting the laser cutting head allows the barbs to be cut with a sharper barb configuration, as shown in FIG. 55, without the need for a separate sharpening operation. Fastener 1800 is similar in construction to fastener 1200, described in detail above. The tube of material 1802 has an inner diameter 1804, an inner surface 1801, and an outer surface 1803. The fastener 1800 is cut from the tube of material 1802 to create a cup-like or concave profile when viewed from end, as shown in FIG. 54. One advantage of the concave profile is that the elongated portions of the fixed arm 1810 and the moving arm 1830 increase the stiffness of the hinge portion 1820 without substantially affecting its flexibility. The concave profile also results in barbs 1844 with sharper apexes or tips 1846 without a separate sharpening operation—i.e., barbs with chamfered edges are formed without sharpening. The sharpened apexes 1846 allow for improved engagement with the native leaflet tissue. 55 , the sharp apex 1846 is formed during laser cutting because the cut surfaces forming the first side 1847 and second side 1848 of the barb 1844 meet at the tip 1846, thereby forming a triangular pyramidal shape with an apex that is not possible when the cut surfaces forming the sides of the barb are parallel and do not intersect. In this case, the barb 1844 of the fastener 1800 has a strong base 1845 and a sharp apex 1846 in a single layer of material without any secondary sharpening operation.

[0101] Referring now to FIG. 56, an exemplary fastener 1900 is shown. Fastener 1900 is similar in structure to fastener 1200, described in detail above, but has a differently constructed hinge portion 1920. Hinge portion 1920 includes a plurality of beams 1922 formed by a series of elongated cutouts 1924. Referring now to FIGS. 56A-56B, an alternative embodiment of beam 1922 of hinge portion 1920 is shown. FIG. 56A shows a rectangular beam 1922 having a curved portion 1926. FIG. 56B shows a rectangular beam 1922 having a curved portion 1926 that is further twisted approximately 90 degrees so that the cross section of the beam at curved portion 1926 is perpendicular to the portion of beam 1922 at that end. As shown in Figure 56B, twisting the beam 1922 relieves bending strain in the beam 1922, thereby increasing its flexibility.

[0102] 57-58, an exemplary barbed fastener 2000 is shown for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. The barbed fastener 2000 includes a fixed arm 2010 that is attached to the implantable device. The barbed fastener 2000 differs from other fasteners in that the fastener 2000 includes multiple movable arms 2030, each having a hinged portion 2020 and a barbed portion 2040 with a single barb 2042. The independent arms 2030 of the fastener 2000 individually grip the tissue of the native valve leaflets, allowing for improved engagement of tissue of uneven thickness. The arms 2030 can also be configured into a wide or extended configuration that allows the barbs 2042 to be spaced laterally farther apart than would be possible if the arms were rigidly connected, and can be compressed into a narrow configuration for deployment. In certain embodiments, the arms 2030 include optional holes or notches (not shown) that an actuating suture can engage to cinch the arms 2030 together during deployment.

[0103] The fixed arm 2010 is formed from a tongue 2011 from which extend a beam 2031 that forms the movable arm 2030. The hinged portion 2020 is formed by bending each of the beams 2031 to form a curved portion 2022. The hinged portion 2020 is spring loaded so that the fixed arm 2010 and the movable arm 2030 are biased toward each other when the barbed fastener 2000 is in the closed position. In certain embodiments, the tongue 2011 is formed from a wide plate of material to provide a larger area for clamping the independent arms 2030.

[0104] The barbed fastener 2000 is laser cut from a layer 2002 of a shape memory alloy, such as Nitinol. As shown in FIG. 57A , the barbs 2042 lie flat in the same plane as the rest of the fastener 2000 when cut from the layer 2002 of material. The movable arms 2030 and barbs 2040 are then bent and twisted into the shape shown in FIG. 57 and then undergo a shape-setting process. As noted above, the individual arms 2030 of the fastener 2000 can be shape-set to be wider or narrower as desired. In certain embodiments, individual arms 2030 may be longer or shorter than others, and the arms 2030 may be spaced apart or evenly.

[0105] Cutting barbs 2042 from a sheet of material and then twisting them into place also allows for the formation of larger barbs of various shapes. In certain embodiments, barbed portion 2040 may include multiple smaller barbs arranged in series, which may or may not face the same direction. In certain embodiments, the ends of barbs 2042 are further sharpened using any suitable sharpening means. In certain embodiments, hinge portion 2020 of beam 2031 includes twisted portion 2024. Twisted portion 2024 can act as a torsion spring to resist lateral forces on the ends of barbs 2042, thereby helping to maintain the alignment of barbs 2042 as they engage the tissue of the native leaflet.

[0106] 59-63, an exemplary barbed fastener 2100 is shown for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. The fastener 2100 is expandable between a collapsed state and an expanded state and is shaped in the expanded state such that the fastener 2100 automatically expands from the collapsed state to the expanded state. As can be seen in FIG. 61A, the fastener 2100 can be deployed in a collapsed state from a delivery sheath 2150 and self-expand to the expanded state.

[0107] Fastener 2100 has many features similar to fastener 1200 described in detail above, such as a patterned hinge portion 2120 formed by a plurality of spring segments 2122 and a notch 2124, a locking arm 2110 including a tongue 2111 with a hole 2112 for attaching the locking arm 2110 to an implantable device, and an end 2114 having a T-shape for holding the locking arm 2110 in a preloaded position. Fastener 2100 also has a movable arm 2130 including a barbed portion 2140 with a plurality of barbs 2142.

[0108] The hoop-like shape of the movable arm 2130 can provide a wider barbed portion 2140 that can include more barbs 2142 at the same or greater lateral spacing than other fasteners. The wider spacing of the barbs 2142 improves grasping of the native leaflets. In certain embodiments, the hoop shape of the movable arm 2130 is similar to the shape of the wide outer paddle of the implantable device, which spreads the clamping force of the paddle evenly across the barbs, further improving retention of the native leaflets. Some of the barbs 2142 may also be longitudinally offset from one another as a result of their position in the hoop-like shape of the movable arm 2130. In certain embodiments, the ends of the barbs 2142 are further sharpened using any suitable sharpening means. In certain embodiments, the tongue 2111 is formed from a wide plate of material to provide a larger clamping area.

[0109] The movable arm 2130 is provided in the shape of a hoop or loop. The movable arm 2130 includes a lateral beam 2131 that is thinner and more flexible, particularly in the lateral direction, than the lateral beam 1231 of the fastener 1200 described above. The lateral beam 2131 includes a first hinge portion 2132 disposed toward the proximal end of the movable arm 2130 and a second hinge portion 2136 disposed at the distal end of the movable arm 2130. The first hinge portion 2132 is formed by one or more bends in the lateral beam 2131. In certain embodiments, the second hinge portion 2136 includes a thinner—and therefore more flexible—portion to reduce the force required to collapse the fastener 2100. The movable arm 2130 includes a hole 2134 disposed between the first hinge portion 2132 and the second hinge portion 2136 for receiving an actuation suture 2152 used to collapse the movable arm 2130. The hole 2134 is located laterally farther from the center of the fastener 2130 than the hinge portions 2132, 2136 to provide a mechanical advantage when force is applied through the suture 2152. In certain embodiments, the hole 2134 is located at what would be the lateral ends of the lateral beams 2131.

[0110] The rounded hoop shape of the fastener 2100 allows it to be collapsed by simply pulling the fastener 2100 back into the delivery sheath. In certain embodiments, the expansion and contraction of the fastener 2100 is controlled by an actuation suture 2152. To control the direction of force applied along the suture 2152 to tighten the movable arm 2130 in the collapsed position, the suture 2152 can be routed through an opening 2156 in a guide 2154 and up to a hole 2134 in the movable arm 2130. For example, by positioning the guide 2154 closer to the connection point of the suture 2152 to the fastener 2100, the force applied by the suture 2152 to the fastener 2100 will be directed more laterally rather than longitudinally. Alternatively, as can be seen in FIG. 61B, a single suture loop 2153 can be routed through the opening 2156 in the guide 2154, through each of the holes 2134 in the movable arm 2130, and then back through the guide 2154 so that actuation of the single loop 2153 tightens the movable arm 2130 in the collapsed position.

[0111] 64-68, an exemplary barbed fastener 2200 is shown for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. Barbed fastener 2200 includes elements of fasteners 1200 and 2000 described above. Barbed fastener 2200 includes a locking arm 2210 that is attached to the implantable device and a hinge portion 2220 that allows fastener 2200 to open and close. Hinge portion 2220 is formed from a repeating pattern of spring segments 2222 and cutouts 2224, similar to fastener 1200.

[0112] The barbed fastener 2200 also includes similar features to fastener 2000, such as multiple independently movable arms 2230, each having a barbed portion 2240 with a single barb 2244. The individual arms 2230 of fastener 2200 individually clamp the tissue of the native valve leaflets, allowing for improved engagement of tissue of uneven thickness. The arms 2230 can also be configured into a wide or extended configuration, allowing the barbs 2244 to be spaced laterally farther apart than would be possible if the arms were rigidly connected, and compressed into a narrow configuration for deployment. The barbed portion 2240 of each arm 2230 includes a hole 2242 for receiving an actuating suture 2252 ( FIG. 65A ).

[0113] The fastener 2200 is expandable between a collapsed state and an expanded state and is shaped in the expanded state such that the fastener 2200 automatically expands from the collapsed state to the expanded state. As can be seen in FIG. 65A , the fastener 2200 can be deployed in a collapsed state from a delivery sheath 2250 and self-expand to the expanded state. The expansion and contraction of the fastener 2200 is controlled by an actuating suture 2252, which fastens the independent arms 2230 together to collapse the fastener 2200 so that it fits within the delivery sheath 2250. In some embodiments, the independent arms collapse together by simply pulling the fastener 2200 back into the delivery sheath.

[0114] The fixation arm 2210 is formed from a tongue 2211 that extends from the hinge portion 2220 to an end 2214. The tongue 2211 includes a hole 2212 for securing the tongue 2211 to the implantable device. In certain embodiments, the tongue 2211 is formed from a wide plate of material to provide a larger area for clamping. In certain embodiments, the end 2214 of the tongue 2211 includes a T-shaped cross member similar to that of the fastener 2100.

[0115] The barbed fastener 2200 is laser cut from a layer 2202 of a shape memory alloy, such as Nitinol. Similar to the fastener 2100 shown in FIG. 57A , the barbs 2242 lie flat in the same plane as the rest of the fastener 2200 when cut from the layer 2202 of material. The movable arms 2230 and barbed portion 2240 are then bent and twisted into the shape shown in FIGS. 64-68 and then undergo a shape-setting process. In some embodiments, the barbs of the individual arms are cut so that they bend upward, similar to the barbs of fastener 1200, thereby eliminating the need to twist the individual arms. As noted above, the individual arms 2230 of fastener 2200 can be shape-set to be wider or narrower as desired. In certain embodiments, individual arms 2230 may be longer or shorter than others, and the spacing between the arms 2230 may be varied or uniform.

[0116] It is also possible to form larger barbs of various shapes by cutting barbs 2244 from a sheet of material and then twisting them into place. In certain embodiments, barbed portion 2240 may include multiple smaller barbs arranged in series, which may or may not face the same direction. In certain embodiments, the ends of barbs 2244 are further sharpened using any suitable sharpening means. In certain embodiments, beam 2231 includes twisted portion 2232. Twisted portion 2232 can act as a torsion spring to resist lateral forces on the ends of barbs 2244, thereby helping to maintain the alignment of barbs 2244 as they engage the tissue of the native valve leaflet.

[0117] 69-73B, various configurations for attaching an actuating suture to an exemplary barbed fastener are shown. In these embodiments, intermediate suture loops are created through one or more of the eyelets of the barbed fastener, and the actuating suture is threaded through one or more of the intermediate loops. By connecting to the fastener through an intermediate loop of suture material, the actuating suture experiences less friction compared to the friction between the actuating suture and the fastener material. Both ends of the actuating suture are pulled back into and extended into a delivery sheath (not shown). The suture can be removed by pulling one end of the suture proximally until the other end of the suture is pulled back into the delivery sheath through the eyelet or intermediate loop.

[0118] 69 , an exemplary suture configuration 2300 is shown attached to the barbed fastener 400 described above. The suture configuration 2300 includes an intermediate suture loop 2302 that is threaded through an eyelet 442 and encircles the end of the barbed portion 440. Alternatively, the intermediate suture loop 2302 may be inserted through the eyelet 442 and between the lateral beams of the movable arm. An actuating suture 2304 is threaded through the intermediate suture loop 2302 from the delivery sheath and back into the delivery sheath. When tension on the actuating suture 2304 overcomes the force holding the spring fastener 400 closed, the fastener 400 opens. Releasing tension on the actuating suture 2304 allows the fastener 400 to close under spring force. The rounded shape of the barbed portion 440 of the fastener 400 prevents the fastener 400 from catching on native tissue or other parts of the implantable device.

[0119] 70A-70B, an exemplary suture configuration 2400 is shown attached to the barb fastener 1200 described above. The suture configuration 2400 includes an intermediate suture loop 2402 that is threaded through the central eyelet 1242 and between the lateral beams 1231 of the movable arm 1230. An actuating suture 2404 is threaded through the intermediate suture loop 2402 from the delivery sheath and back into the delivery sheath. The fastener 1200 opens when tension applied to the actuating suture 2404 overcomes the force holding the spring fastener 1200 closed. Releasing the tension on the actuating suture 2404 allows the fastener 1200 to close under spring force.

[0120] FIG. 70A is a side view of a suture configuration 2400 showing that a gap or recess 2406 can be formed between the end of the fastener and the actuating suture 2404 of the suture configuration 2400 described above. In particular, the gap 2406 can be formed when the actuating suture 2404 is angled relative to the barbed portion of the fastener 1200. FIG. 70B is a front view of the suture configuration 2400 showing that a lateral gap or recess 2408 is formed between the actuating suture 2404 and the side of the barbed portion 1240 of the fastener 1200. Under certain conditions, the gap or recess 2406, 2408 can become a trapping point—i.e., a location that can trap or snag native tissue or other parts of the implantable device during deployment and placement and / or the wall of the catheter during retrieval. In particular, sharp angles and edges can become trapping points. As can be seen in Figure 70B, rounding the corners of fastener 1200 reduces the likelihood of capture by fastener 1200. In some embodiments, the device does not include any recesses having a depth greater than one-third the width of the device.

[0121] 71 , a front view of an exemplary suture configuration 2500 attached to the barbed fastener 1200 described above is shown. The suture configuration 2500 includes an intermediate suture loop 2502 that is threaded through a central eyelet 1242 and encircles the end of the barbed portion 1240. An actuating suture 2504 is threaded from the delivery sheath through the intermediate suture loop 2502 and back into the delivery sheath. The fastener 1200 opens when tension applied to the actuating suture 2504 overcomes the force holding the spring fastener 1200 closed. Releasing the tension on the actuating suture 2504 allows the fastener 1200 to close under spring force.

[0122] Forming the intermediate suture loop 2502 around the end of the barbed portion 1240 eliminates the possibility of a gap (e.g., gap 2406 shown in FIG. 70A ) forming between the actuating suture and the fastener. Similar to the suture configuration 2400 described above and shown in FIG. 70B , FIG. 71 shows that a side gap 2508 forms between the actuating suture 2504 and the side of the barbed portion 1240 of the fastener 1200. Under certain conditions, the gap 2508 can become an entrapment point—i.e., a location that can catch or snag native tissue or other parts of the implantable device during deployment and placement and / or a catheter during retrieval. Sharp angles and edges, in particular, can become entrapment points. As can be seen in FIG. 71 , rounding the corners of the fastener 1200 reduces the possibility of the fastener 1200 catching native tissue or other parts of the device.

[0123] 72-73B, an exemplary suture configuration 2600 is shown attached to the barbed fastener 1200 described above. The suture configuration 2600 includes an intermediate suture loop 2602 that is threaded through an eyelet 1242 adjacent the side of the fastener 1200 and around the end of the barbed portion 1240. An actuating suture 2604 is threaded through the intermediate suture loop 2602 from the delivery sheath and back into the delivery sheath. The fastener 1200 opens when tension applied to the actuating suture 2604 overcomes the force holding the spring fastener 1200 closed. Releasing the tension on the actuating suture 2604 allows the fastener 1200 to close under spring force.

[0124] Suture configuration 2600 reduces or eliminates gaps that can become entrapment points, as shown in Figures 70A-71. Forming intermediate suture loop 2602 around the end of barbed portion 1240 eliminates the possibility of gaps, such as gap 2406 shown in Figure 70A, forming between fastener 1200 and actuating suture 2604. Suture configuration 2600 also reduces or eliminates lateral gaps between actuating suture 2604 and the sides of fastener 1200, such as lateral gap 2508 shown in Figures 70B and 71.

[0125] 74A-75, exemplary barb fasteners and implantable devices are shown. As noted above, an entrapment point is a location on an implantable device that may capture or snag native tissue, other portions of the implantable device, and / or a delivery catheter during deployment and placement and / or regrasping or retrieval. In addition to entrapment points that may be formed on individual components of an implantable device, such as those described above, entrapment points may also be formed by the assembly of two or more components.

[0126] 74A-74B, an exemplary implantable device 2700 is shown assembled with two barb fasteners 400. The barb fasteners 400 are attached to an inner paddle 2720 of the implantable device 2700, which extends from a joining element 2710. The suture arrangement 2730 includes an intermediate suture loop 2732 attached to the barbed portion 440 of the fastener 400 and an actuating suture 2734 that extends from the delivery sheath 2702, through the intermediate suture loop 2732, and back into the sheath 2702. When the fastener 400 is in a closed position, the hinge portion 420 is offset, creating a gap 2740 between the fastener 400 and the joining element 2710 that can serve as a trapping point. As can be seen in FIG. 74B , when the fasteners 400 are partially opened, the gap 2740 is reduced or eliminated, but the overall width of the device 2700 increases as the fasteners 400 open. Thus, by partially opening the fasteners 400 as shown in FIG. 74B , it is possible to eliminate a trapping point during regrasping or retrieval. Partially opening the fasteners when retracting the device into the sheath has the added benefit of engaging the actuation line or suture with the opening 2703 in the delivery sheath 2702, thereby widening the opening 2703 and providing a larger opening through which the device 2700 can be withdrawn. A suture configuration such as that shown in FIGS. 70B and 71 engages the opening 2703 in two places because the suture extends from two points on the fastener, thereby expanding the opening 2703 into a substantially diamond shape. 72 engages the opening 2703 in four places because the suture extends from four points on the fastener, causing the opening 2703 to expand into a substantially rectangular shape. The actuating suture 2734 can be relaxed after the hinge portion 420 is inside the catheter.

[0127] 75 , an exemplary implantable device 2800 is shown assembled with two barb fasteners 1200. The barb fasteners 1200 are attached to an inner paddle 2820 of the implantable device 2800, which extends from a joint element 2810. The suture arrangement 2830 includes an intermediate suture loop 2832 attached to the barbed portion 1240 of the fastener 1200, and an actuating suture 2834 that extends from the delivery sheath 2802, through the intermediate suture loop 2832, and back into the sheath 2802. The rounded shape of the hinge portion 1220 of the fastener 1200 prevents a trap from forming at the intersection between the hinge portion 1220 and the joint element 2810. In this case, the shape of the fastener 1200 reduces or eliminates potential trapping gaps, such as gap 2740 shown in FIG. 74B, eliminating the need to partially open the fastener 1200 during retrieval or re-grasping.

[0128] In certain embodiments, rather than intermediate suture loops, the actuating line or suture is attached to a portion of the covering that surrounds the fastener of the implantable device. For example, the actuating line or suture can be threaded through an opening in the loop or covering. The covering can be formed from a flexible material, which can be mesh, woven, knitted, or formed in any other suitable manner. The flexible material can be fabric, shape memory alloy wire—e.g., nitinol—to achieve shape-setting functionality, or any other flexible material suitable for implantation within the human body.

[0129] Referring now to FIG. 76 , a side view of an exemplary barbed fastener 2900 is shown. While fastener 2900 is shown in the shape of fastener 1200 described above, fastener 2900 may have any shape suitable for use as a barbed fastener formed from laminated layers of material, such as any of the fasteners described above. Fastener 2900 has a fixed arm 2910, a hinged portion 2920, a movable arm 2930, and a barbed portion 2940. Fastener 2900 is formed from a first layer of material 2902 and a second layer of material 2904. Layers 2902, 2904 may be formed from similar or different materials and may have the same or different thicknesses. In certain embodiments, additional layers of material may also be provided.

[0130] Referring now to FIG. 77 , a side view of an exemplary double-ended barbed fastener 3000 is shown. The double-ended fastener 3000 includes a fixed arm 3010 having a hinge portion 3020 and a movable arm 3030 extending from each end. Each movable arm 3030 includes a barbed portion 3040 including at least one barb 3042. While the barbs 3042 are shown facing outward, in other embodiments, the barbs 3042 face inward. The fastener 3000 is formed from a first layer 3002 and a second layer 3004 of material, although in certain embodiments, the fastener is formed from a single layer, and in certain other embodiments, it is formed from three or more layers. The hinge portion 3020, movable arm 3030, and barbed portion 3040 may be formed in any of the fastener shapes described above.

[0131] 78-79, an exemplary barbed fastener 3102 is shown for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. The barbed fastener 3102 includes elements of fastener 1200 described above. The barbed fastener 3102 includes a fixed arm 3110 that is attached to the implantable device and a hinge portion 3120 that allows the fastener 3102 to open and close. The hinge portion 3120 is formed from a repeating pattern of spring segments 3122 and cutouts 3124, as in fastener 1200. The barbed fastener 3102 also includes a pair of independent first and second movable arms 3130 and 3132 that extend from the hinge portion 3120 to a barbed portion 3140 having barbs 3144.

[0132] The fixation arm 3110 is formed from a tongue 3111 that extends from the hinge portion 3120 to an end 3114. The tongue 3111 includes a hole 3112 for securing the tongue 3111 to the implantable device. In certain embodiments, the tongue 3111 is formed from a wide plate of material to provide a larger area for clamping. In certain embodiments, the end 3114 of the tongue 3111 includes a T-shaped cross member similar to that of the fastener 3102.

[0133] The individual movable arms 3130, 3132 of fastener 3102 individually clamp the tissue of the native valve leaflets, allowing for improved engagement of tissue of uneven thickness. In some embodiments, the movable arms 3130, 3132 are formed from a single movable arm similar to movable arm 1230 of fastener 1200, separated into first and second movable arms 3130, 3132 by a slit 3148 so that the first and second movable arms 3130, 3132 can open and close independently of each other. In some embodiments, hinge portion 3120 is also separated into first and second hinge portions (not shown).

[0134] 79 , an exemplary implantable device 3100 is shown assembled with two barb fasteners 3102. The barb fasteners 3102 are attached to an inner paddle 3108 of the implantable device 3100, which extends from a coaptation element 3106. The actuation arrangement 3150 includes an intermediate suture loop 3152 and first and second actuation sutures 3154, 3156 attached to holes 3146 in the barbed portions 3140 of the first and second movable arms 3130, 3132. The first and second actuation sutures 3154, 3156 extend from the delivery sheath 3104, through the intermediate suture loop 3152, and back into the delivery sheath 3104. Each of the movable arms 3130, 3132 can be opened individually by applying tension to the first and second actuating sutures 3154, 3156, respectively. Opening the first and second movable arms 3130, 3132 individually allows the gripping force of the fastener 3102 on the native tissue to be adjusted based on the thickness of the tissue and the orientation of the fastener 3100.

[0135] 80A-80E, an exemplary barbed fastener 3200 is shown for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. The fastener 3200 is configured to tension native tissue when an implantable prosthetic device, such as any of the devices described herein, is attached to the native tissue. Similar to the barbed fasteners described above, the barbed fastener 3200 includes a fixed arm 3210, a hinged portion 3220, and a movable arm 3230 having a barbed portion 3240. The fixed arm 3210 of the fastener 3200 is slidably connected to a paddle 3202 of the implantable device, allowing the fastener 3200 to move in a direction 3204 along the paddle 3202. For example, an actuation line 3250 can be used to move the fastener 3200 in a direction 3204 along the paddle 3202. An actuation line 3250 may also be used to move the movable arm 3230 between a closed position (as shown in FIG. 80A ) and an open position (as shown in FIG. 80B ). The actuation line 3250 may take any of the forms described herein. In some embodiments, the catch 3200 includes an optional biasing member 3260 (e.g., a spring) configured to maintain the catch 3200 in a desired position along the paddle 3202 (e.g., the position shown in FIGS. 80A and 80E ).

[0136] 80A , the fastener 3200 is shown in a first position on the paddle 3202 and in a closed position. Referring to FIG. 80B , the fastener 3200 is shown after the actuation line 3250 has caused the movable arm 3230 to move in direction 3203 to an open position. Referring to FIG. 80C , the fastener 3200 is shown after being moved in direction 3205 along the paddle 3202 to a second position. In some embodiments, the fastener 3200 is moved in direction 3205 along the paddle 3202 by the actuation line 3250 or a separate mechanism. In embodiments including a biasing member 3260, a force is applied to the fastener 3200 sufficient to move the fastener 3200 in direction 3205, which causes the biasing member 3260 to expand and create tension on the fastener 3200 in a direction 3206 opposite direction 3205. While the illustrated embodiment shows the fastener 3200 being moved to an open position (as shown in FIG. 80B ) before being moved along the paddle 3202 in direction 3205 to a second position (as shown in FIG. 80C ), it should be understood that the fastener 3200 can be moved in direction 3205 to a second position before the movable arm 3230 of the fastener 3200 is moved in direction 3203 to an open position, or these movements may occur simultaneously. Referring to FIG. 80D , the movable arm 3230 is moved in direction 3207 by the actuation line 3250 to a closed position to secure the barbed portion 3240 of the fastener 3200 to valve tissue (not shown). 80D , the biasing member 3260 is maintained in an extended position (e.g., a force is applied to the fastener 3200 by the actuation line 3250 or another mechanism, holding the fastener 3200 in the second position), meaning that the biasing member 3260 applies a tension force to the fastener 3200 in the direction 3206. Referring to FIG. 80E , after the barbed portion 3240 of the fastener 3200 is secured to the native tissue, the force maintaining the fastener 3200 in the second position is released, causing the tension applied by the biasing member 3260 to move the fastener 3200 along the paddle 3202 in the direction 3208.Movement of fastener 3200 in direction 3208 causes barbed portion 3240 to create tension on the native tissue in direction 3209. This tension on the native tissue allows the implantable device to maintain a secure connection to the native tissue.

[0137] 81A-81C, an exemplary barbed fastener 3300 is shown for use in an implantable prosthetic device, such as devices 100, 200, and 300 described above. The fastener 3300 is configured to tension native tissue when an implantable prosthetic device, such as any of the devices described herein, is attached to the native tissue. Similar to the barbed fasteners described above, the barbed fastener 3300 includes a fixed arm 3310, a hinge portion 3320, and a movable arm 3330 having a barbed portion 3340. The movable arm 3330 includes a flexible portion 3332 disposed between the hinge portion 3320 and the barbed portion 3340. The flexible portion 3332 may, for example, comprise a cutout portion of the movable arm 3330, may comprise a different material than the remainder of the movable arm 3330, or may take any other suitable form such that the flexible portion 3332 can have greater flexibility than the remainder of the movable arm 3330. In some embodiments, the flexible portion 3332 is omitted, and the actuation mechanism 3350 can still bend the barbed portion 3340 of the movable arm 3330, as shown in FIGS.

[0138] The actuation mechanism 3350 includes an actuation line 3352 (e.g., a suture) and a push / pull link 3354 configured to receive the line 3352. The push / pull link 3354 can be a catheter, a wire with a loop (as shown in FIG. 82 ), or any other link capable of receiving the line 3352 and pushing or pulling the movable arm 3330 of the fastener 3300. The actuation line 3352 extends from a delivery sheath (not shown) at a first end 3351 and is removably attached to the movable arm 3330 at a first connection point 3356 located proximate the barbed portion 3340. The actuation line 3352 also extends from the first connection point 3356 and is removably attached to the movable arm 3330 at a second connection point 3358 located between the flexible portion 3332 and the hinge portion 3320. The actuation line 3352 then extends from the second connection point 3358 and is threaded at the second end 3353 through the push / pull link 3354 .

[0139] 81A , the fastener 3300 is shown in an open position with native tissue 3302 disposed within the opening 3304 between the movable arm 3330 and the fixed arm 3310. The fastener 3300 can be moved to the open position by pulling the line 3352. Referring to FIG. 81B , the link 3354 and line 3352 of the actuation mechanism 3350 are used to move the movable arm 3330 in a closing direction 3306 to the closed position and to bend the barbed portion 3340 in an opening direction 3308. In doing so, the first end 3351 of the line 3352 is pulled in the opening direction 3308 while the link 3354 is pushed in the closing direction 3306, causing the barbed portion 3340 of the movable arm 3330 to pivot or bend in an upward direction 3303 at the flexible portion 3332 as it opens. 81B, the link 3354 and line 3352 are moved such that the barbed portion 3340 engages or pierces the native tissue 3302 when the movable arm 3330 is moved to the closed position and the barbed portion 3340 is in the bent position.

[0140] 81C , the first end 3351 of the line 3352 is released, allowing the barbed portion 3340 of the movable arm 3330 to pivot about the flexible portion 3332. As the barbed portion 3340 pivots, the native tissue 3302 is drawn in a downward or inward direction 3305, which creates tension on the native tissue in the inward direction 3305. After the movable arm 3330 is secured to the native tissue 3302 (as shown in FIG. 81C ), the link 3354 and line 3352 are removed from the fastener 3300.

[0141] 82 , an exemplary barbed actuation mechanism 3400 is shown for use in an implantable prosthetic device, such as devices 100, 200, 300 described above. The mechanism 3400 includes a first control member 3410 and a second control member 3420 extending from a delivery device 3402. The delivery device 3402 may be any suitable device, such as a sheath or a catheter. The first control member 3410 and the second control member 3420 include first and second sutures 3412, 3422, and first and second flexible wires 3414, 3424. A first flexible wire 3414 and a second flexible wire 3424 extend from the delivery device 3402 and each include loops 3416, 3426 for receiving the first suture 3412 and the second suture 3422 and for engaging a fastener (e.g., fastener 1200, described above). Each of the first suture 3412 and the second suture 3422 extends from the delivery device 3402 through one of the first loop 3416 and the second loop 3426, respectively, and back into the delivery device 3402. In some embodiments, the first control member 3412 and the second control member 3422 extend through separate delivery devices 3402. The sutures 3412, 3422 are removably attached to movable arms of the exemplary barbed fasteners described above. The first loop 3416 of the wire 3414 and the second loop 3426 of the wire 3424 can move along the corresponding sutures 3412, 3422 such that the loops 3416, 3426 can engage corresponding barbed fasteners and engage the movable arms. That is, the sutures 3412, 3422 are used to pull the movable arms open, and the wires 3414, 3424 are used to push the movable arms closed. The wires 3414, 3424 can be made from, for example, a steel alloy, a nickel-titanium alloy, or any other metal or plastic material. In certain embodiments, the wires 3414, 3424 can have a diameter of between about 0.10 mm and about 0.35 mm, between about 0.15 mm and about 0.30 mm, and between about 0.20 mm and about 0.25 mm.

[0142] While various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as being embodied in combination in exemplary embodiments, these various aspects, concepts, and features can be used in many alternative embodiments, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Furthermore, while various alternative embodiments of various aspects, concepts, and features of the present disclosure—e.g., alternative materials, structures, configurations, methods, devices, and components, form, fit, and function, etc.—may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether currently known or later developed. Those skilled in the art may readily employ one or more of the inventive aspects, concepts, or features in additional embodiments and uses within the scope of the present application, even if such embodiments are not explicitly disclosed herein.

[0143] Furthermore, while certain features, concepts, or aspects of the present disclosure may be described herein as preferred configurations or methods, such description is not intended to imply that such features are necessary or essential unless expressly stated to be so. Furthermore, while example or representative values ​​and ranges may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be critical values ​​or ranges only when expressly stated to be so.

[0144] Furthermore, while various aspects, features, and concepts may be expressly recognized herein as inventive or forming part of a particular disclosure, such recognition is not intended to be exhaustive; rather, there may be inventive aspects, concepts, and features that are fully described herein but are not expressly recognized as inventive or part of a particular disclosure; instead, such disclosure is set forth in the appended claims. The description of an exemplary method or process is not limited to the inclusion of every step as required in all instances, nor should the order in which those steps are presented be construed as necessary or mandatory unless expressly stated to be so. The words used in the claims have their ordinary and full meaning and are not limited in any way by the description of embodiments herein. [Explanation of symbols]

[0145] 10. Heart 20 left atrium 40 Mitral valve 42 Valve leaflet 44 Valve leaflets 100 Implantable prosthetic devices 102 Delivery sheath 104 Joint part 106 Anchor part 110 Joint Elements 112 Actuation wire 120 outer paddle 122 Inner Paddle 124 Hinged or flexible parts 126 Hinged or flexible parts 128 Hinged or flexible parts 130 Barbed fastener 132 Fixed Arm 134 Movable Arm 136 with return 138 Hinged or flexible parts 200 Implantable Prosthetic Devices 204 Joint part 206 Anchor part 210 Joint Elements 211 Color 212 Actuation wire 213 Color Stickers 214 Cap 215 Opening 216 Stickers 218 Insert 220 outer paddle 222 Inner Paddle 224 Paddle Frame 230 Barbed fastener 232 Base or Fixed Arm 234 Movable Arm 236 Return 238 Hinge part 300 Implantable Devices 302 Delivery Sheath 303 Color 304 Joint part 306 Anchor part 310 Joint Elements 311 Color 312 Actuating wire or shaft 313 Color Sticker 314 Cap 315 Opening 316 Operating Line 318 Insert 320 outer paddle 322 Inner Paddle 324 Paddle Frame 330 Fasteners 332 Base or fixed arm 334 Movable Arm 336 Return 338 Hinge part 400 barbed fastener 402 Top layer 404 Bottom layer 410 Fixed Arm 411 Tongue 412 holes 414 Crossbar 420 Hinge-like part 422 Beam Loop 424 Central part 426 Outer part 428 step distance 430 Movable Arm 431 Side Beam 440 barbed end 442 eyelet 444 Return 446 Return support part 500 barbed fastener 502 Top layer 504 Bottom layer 510 Fixed Arm 511 Tongue 512 holes 514 Crossbar 520 Hinge-like part 522 Beam Loop 524 Central part 526 Outer part 528 step distance 530 Movable Arm 531 Side Beam 540 barbed end 542 Opening, eyelet 543 Suture Pin 544 Return 546 Return support part 600 barbed fastener 602 Top layer 604 Bottom layer 610 angle 612 Opening angle 614 step distance 620 Movable Arm 622 Fixed Arm 624 Hinge part 626 Turned part 628 Return 700 Reverse fastener 702 thick part 704 Thin part 706 Spacer layer 708 Turned Layer 720 Movable Arm 722 Fixed Arm 726 Turned part 728 Return 800 Reverse fastener 802 thick part 804 Thin part 820 Movable Arm 822 Fixed Arm 824 Hinge part 826 Return part 900 Back fastener 902 thick part 904 Thin part 920 Movable Arm 922 Fixed Arm 924 Hinge part 926 Return part 1000 Reverse Clasp 1002 thick part 1004 Thin part 1020 Movable Arm 1022 Fixed Arm 1024 Hinge part 1026 Return part 1100 barbed fastener 1102 thick part 1104 Thin part 1110 Fixed arm 1112 Mounting holes 1114 Integrated Crossbar 1120 Hinge part 1122 Hinge 1130 Movable Arm 1140 Turned part 1142 Eyelet 1200 barbed fastener 1202 layers 1210 Fixed Arm 1211 Tongue 1212 holes 1214 End 1216 Angle 1220 Hinge-like part 1222 Spring Segment 1224 Notch 1230 Movable Arm 1231 Side Beam 1240 Turned part 1242 Eyelet 1244 Return 1246 angle 1300 Torsion Spring Segment 1301 Notch 1302 layers 1304 Side 1306 Inner corner 1310 first end 1312 Connection location 1320 Second End 1322 Connection location 1330 first side 1332 Connection location 1340 Second Side 1342 Connection location 1400 Torsion Spring Segment 1404 Side 1406 Inner corner 1408 outer corner 1500 Torsion Spring Segments 1504 Side 1506 Inner corner 1508 outer corner 1600 Torsion Spring Segment 1604 Side 1606 Inner corner 1608 outer corner 1700 Spring assembly 1710 bending force 1720 Arrow 1800 Reverse fastener 1801 Inside 1802 Tube 1803 Exterior 1804 Inner diameter 1810 Fixed Arm 1820 Hinge part 1830 Moving Arm 1844 Return 1845 base 1846 apex or tip 1847 First Aspect 1848 Second Aspect 1900 fasteners 1920 Hinge part 1922 Beam 1926 Bent Part 2000 barbed fastener 2002 layer 2010 Fixed Arm 2011 Tongue 2020 Hinge-like part 2022 Bent part 2030 Movable Arm 2031 Beam 2040 Turned part 2042 return 2100 barbed fastener 2110 Fixed Arm 2111 Tongue 2112 holes 2114 End 2120 Hinge part 2122 Spring Segment 2124 Notch 2130 Movable Arm 2131 Side beam 2132 First hinge part 2134 holes 2136 Second hinge part 2140 Returned part 2142 return 2150 Delivery Sheath 2152 Actuating suture 2153 Loop 2154 Guide 2156 Aperture 2200 barbed fastener 2202 layers 2210 Fixed Arm 2211 Tongue 2212 holes 2214 End 2220 Hinge part 2222 Spring Segment 2224 Notch 2230 Movable Arm 2231 Beam 2232 Twisted part 2240 Turned part 2242 return 2244 return 2250 Delivery Sheath 2252 Actuating suture 2300 Suture Configuration 2302 Intermediate suture loop 2304 Actuating suture 2400 Suture Configuration 2402 Intermediate suture loop 2404 Actuating suture 2406 Gap or recess 2408 Lateral gap or recess 2500 Suture Configuration 2502 Intermediate suture loop 2504 Actuating suture 2508 Lateral gap 2600 Suture Configuration 2602 Intermediate suture loop 2604 Actuating suture 2700 Implantable Devices 2702 Delivery sheath 2703 Opening 2710 Joint Elements 2720 ​​Inner Paddle 2730 Suture composition 2732 Intermediate suture loop 2734 Actuating suture 2740 Gap 2800 Implantable Devices 2802 Delivery sheath 2803 Opening 2810 Joint Elements 2820 Inner Paddle 2830 Suture composition 2832 Intermediate suture loop 2834 Actuating suture 2900 Reverse fastener 2902 First Layer 2904 Second Layer 2910 Fixed Arm 2920 Hinge-like part 2930 Movable Arm 2940 Turned part 3000 Double-headed clasp 3002 first layer of material 3004 Second layer of material 3010 Fixed Arm 3020 Hinge part 3030 Movable Arm 3040 Turned part 3042 return 3100 Implantable Devices 3102 Closure with bar 3104 Delivery sheath 3106 Connection elements 3108 Inner paddle 3110 Fixed Arm 3111 Tongue 3112 holes 3114 End 3120 Hinge part 3122 Spring Segment 3124 Notch 3130 First movable arm 3132 Second Movable Arm 3140 Turned part 3144 return 3146 holes 3148 cut 3150 Operational Configuration 3152 Intermediate suture loop 3154 First working suture 3156 Secondary working suture 3200 barbed fastener 3202 Paddle 3203 direction 3204 direction 3205 direction 3206 direction 3207 direction 3208 direction 3209 direction 3210 Fixed Arm 3220 Hinge part 3230 Movable Arm 3240 Turned part 3250 operating line 3260 Pressurizing member 3300 Barbed fastener 3302 Innate Organization 3303 Upward direction 3304 Opening 3305 downward or inward direction 3306 Closing direction 3308 Opening direction 3310 Fixed Arm 3320 Hinge part 3330 Movable Arm 3332 Flexible part 3340 Turned part 3350 Operating mechanism 3351 First end 3352 Line 3353 Second end 3354 Push and pull link 3356 First connection point 3358 Second connection point 3400 Barbed operating mechanism 3402 Delivery Devices 3410 first control member 3412 First suture 3414 First flexible wire 3416 First Loop 3420 second control member 3422 Second suture 3424 second flexible wire 3426 Second Loop

Claims

1. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, a fixed arm attached to the inner portion of the paddle; a movable arm having a barbed portion; and a hinge portion hingeably connecting the fixed arm to the movable arm; a catch, wherein the movable arm is substantially parallel to the fixed arm when the catch is in a closed position; An implantable prosthetic device comprising:

2. 10. The implantable prosthetic device of claim 1, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

3. 3. The implantable prosthetic device of claim 2, wherein the top and bottom layers are connected at only one point such that the top and bottom layers can slide relative to each other while the fasteners are open.

4. 4. The implantable prosthetic device of claim 3, wherein the top layer and the bottom layer are connected at the end of the movable arm.

5. 5. The implantable prosthetic device of claim 2, wherein the barbed portion comprises a barb and a barb support, the barb being formed from the bottom layer and the barb support being formed from the top layer.

6. 5. The implantable prosthetic device of claim 2, wherein the barbed portion comprises a barb and a barb support, the barb being formed from the top layer and the barb support being formed from the bottom layer.

7. the movable arm comprises two lateral beams; The hinge portion includes two beam loops, each beam loop having: a central portion extending from the fixed arm; an outer portion extending from the central portion to one of the two side beams of the movable arm; 7. An implantable prosthetic device according to any one of claims 1 to 6.

8. 8. The implantable prosthetic device of claim 1, wherein the ends of the fixed and movable arms adjacent the hinge portion are offset from each other by an offset distance.

9. 9. The implantable prosthetic device of claim 1, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is substantially parallel to the movable arm.

10. 10. The implantable prosthetic device of claim 8 or 9, wherein the fixation arms are bent in the closing direction past the closed position to the preloaded position.

11. 10. The implantable prosthetic device of claim 9, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 45 degrees.

12. 10. The implantable prosthetic device of claim 9, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 90 degrees.

13. 10. The implantable prosthetic device of claim 9, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

14. 14. The implantable prosthetic device of claim 13, wherein the cross member is a unitary cross member.

15. 15. The implantable prosthetic device of claim 1, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

16. 10. The implantable prosthetic device of claim 1, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

17. 17. The implantable prosthetic device of claim 16, wherein the fastener is formed from multiple layers having thicker and thinner portions.

18. 18. The implantable prosthetic device of claim 17, wherein the layers are stacked across the width of the fastener.

19. 19. The implantable prosthetic device of any one of claims 16 to 18, wherein at least two of the plurality of layers are barbed.

20. 20. The implantable prosthetic device of any one of claims 1 to 19, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

21. 21. The implantable prosthetic device of any one of claims 1 to 20, wherein the hinge portion is formed from a portion of a generally circular loop.

22. 22. The implantable prosthetic device of any one of claims 1 to 21, wherein the fastener holes extend across the width of the fastener.

23. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, a fixed arm attached to the inner portion of the paddle; a movable arm having a barbed portion; and a fastener comprising: a hinge portion hingeably connecting the fixed arm to the movable arm, the hinge portion comprising a plurality of spring segments, each spring segment connected to a plurality of spring segments; An implantable prosthetic device comprising:

24. 24. The implantable prosthetic device of claim 23, wherein the spring segments are torsion spring segments.

25. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 25. An implantable prosthetic device according to claim 23 or 24.

26. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

26. An implantable prosthetic device according to any one of claims 23 to 25.

27. the spring segments are arranged in a plurality of horizontal rows and at least one vertical row; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment.

27. The implantable prosthetic device of claim 26.

28. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 28. An implantable prosthetic device according to any one of claims 23 to 27.

29. 29. The implantable prosthetic device of any one of claims 23 to 28, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

30. 30. The implantable prosthetic device of claim 29, wherein the top and bottom layers are connected at only one point such that the top and bottom layers can slide relative to one another while the fasteners are open.

31. 31. The implantable prosthetic device of any one of claims 23 to 30, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is substantially parallel to the movable arm.

32. 32. The implantable prosthetic device of claim 31, wherein the fixation arms are bent in the closing direction past the closed position to the preloaded position.

33. 33. The implantable prosthetic device of claim 32, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 45 degrees.

34. 33. The implantable prosthetic device of claim 32, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 90 degrees.

35. 33. The implantable prosthetic device of claim 32, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

36. 36. The implantable prosthetic device of claim 35, wherein the cross member is a unitary cross member.

37. 37. The implantable prosthetic device of any one of claims 23 to 36, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

38. 38. The implantable prosthetic device of any one of claims 23 to 37, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

39. 30. The implantable prosthetic device of claim 29, wherein both the top layer and the bottom layer are barbed.

40. 40. The implantable prosthetic device of any one of claims 23 to 39, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

41. 41. The implantable prosthetic device of any one of claims 23 to 40, wherein the barbs of the barbed portion terminate in an apex.

42. A fixed arm; a movable arm having a barbed portion; a hinge portion hingedly connecting the fixed arm to the movable arm, the hinge portion comprising a plurality of spring segments, each spring segment connected to a plurality of spring segments; A fastener for an implantable prosthetic device comprising:

43. 43. The fastener of claim 42, wherein the spring segments are torsion spring segments.

44. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 44. The fastener of claim 42 or 43.

45. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

45. The fastener of any one of claims 42 to 44.

46. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment.

45. The fastener of claim 44.

47. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 47. The fastener of any one of claims 42 to 46.

48. 48. The fastener of any one of claims 42 to 47, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

49. 49. The fastener of claim 48, wherein the top and bottom layers are connected at only one point such that the top and bottom layers can slide relative to one another while the fastener is open.

50. 50. The fastener of any one of claims 42 to 49, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is substantially parallel to the movable arm.

51. 51. The fastener of claim 50, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position.

52. 52. The fastener of claim 51, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 45 degrees.

53. 52. The fastener of claim 51, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 90 degrees.

54. 52. The fastener of claim 51, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

55. 55. The fastener of claim 54, wherein the cross member is a unitary cross member.

56. 56. The fastener of any one of claims 42 to 55, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

57. 43. The fastener of claim 42, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

58. 49. The fastener of claim 48, wherein at least two of the plurality of layers are barbed.

59. 59. The fastener of any one of claims 42 to 58, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

60. 60. The fastener of any one of claims 42 to 59, wherein the barbs of the barbed portion terminate in an apex.

61. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, the fastener having a concave upper surface and a convex lower surface, a fixed arm attached to the inner portion of the paddle; a movable arm having a barbed portion; and a fastener comprising a hinge portion hingeably connecting the fixed arm to the movable arm; An implantable prosthetic device comprising:

62. 62. The implantable prosthetic device of claim 61, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

63. 63. The implantable prosthetic device of claim 62, wherein the spring segments are torsion spring segments.

64. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 64. An implantable prosthetic device according to claim 62 or 63.

65. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

65. An implantable prosthetic device according to any one of claims 62 to 64.

66. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment.

65. The implantable prosthetic device of claim 64.

67. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 67. An implantable prosthetic device according to any one of claims 62 to 66.

68. 68. The implantable prosthetic device of any one of claims 61 to 67, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

69. 69. The implantable prosthetic device of claim 68, wherein the top layer and the bottom layer are connected at only one point such that the top layer and the bottom layer can slide relative to each other while the fasteners are open.

70. 70. The implantable prosthetic device of any one of claims 61 to 69, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is substantially parallel to the movable arm.

71. 71. The implantable prosthetic device of claim 70, wherein the fixation arms are bent in the closing direction past the closed position to the preloaded position.

72. 72. The implantable prosthetic device of claim 71, wherein the locking arms are bent up to about 45 degrees in the closing direction past the closed position to the preloaded position.

73. 72. The implantable prosthetic device of claim 71, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 90 degrees.

74. 72. The implantable prosthetic device of claim 71, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

75. 75. The implantable prosthetic device of claim 74, wherein the cross member is a unitary cross member.

76. 76. The implantable prosthetic device of any one of claims 61 to 75, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

77. 62. The implantable prosthetic device of claim 61, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

78. 69. The implantable prosthetic device of claim 68, wherein at least two of the plurality of layers are barbed.

79. 79. The implantable prosthetic device of any one of claims 61-78, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

80. 70. The implantable prosthetic device of any one of claims 61 to 69, wherein the barbs of the barbed portion terminate in an apex.

81. 81. The implantable prosthetic device of any one of claims 61 to 80, wherein the fasteners are cut from a tubular piece of material.

82. 82. The implantable prosthetic device of claim 81, wherein the fasteners are cut using a four-axis laser cutter.

83. 83. The implantable prosthetic device of any one of claims 61 to 82, wherein the fasteners are cut using a five-axis laser cutter.

84. 70. The implantable prosthetic device of any one of claims 61 to 69, wherein the barbs of the barbed portion have chamfered edges.

85. 1. A fastener for an implantable prosthetic device, comprising: a fixed arm having a concave surface along the length of the fixed arm; a movable arm having a concave surface and a barbed portion along the length of the movable arm; When the catch is in a closed position, the concave surface of the fixed arm faces the concave surface of the movable arm, and the catch further comprises: A fastener comprising a hinge portion hingedly connecting the fixed arm to the movable arm, the hinge portion biasing the fastener toward the closed position.

86. 83. The fastener of claim 82, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

87. 84. The fastener of claim 83, wherein the spring segments are torsion spring segments.

88. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 85. The fastener of claim 83 or 84.

89. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

86. The fastener of any one of claims 83 to 85.

90. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment.

86. The fastener of claim 85.

91. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 88. The fastener of any one of claims 83 to 87.

92. 89. The fastener of any one of claims 82 to 88, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

93. 90. The fastener of claim 89, wherein the top and bottom layers are connected in only one location such that the top and bottom layers can slide relative to one another while the fastener is open.

94. 91. The fastener of any one of claims 82 to 90, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is substantially parallel to the movable arm.

95. 92. The fastener of claim 91, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position.

96. 93. The fastener of claim 92, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 45 degrees.

97. 93. The fastener of claim 92, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 90 degrees.

98. 93. The fastener of claim 92, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

99. 75. The fastener of claim 74, wherein the cross member is a unitary cross member.

100. 97. The fastener of any one of claims 82 to 96, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

101. 93. The fastener of claim 92, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

102. 99. The fastener of claim 98, wherein at least two of the plurality of layers are barbed.

103. 100. The fastener of any one of claims 82 to 99, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

104. 101. The fastener of any one of claims 82 to 100, wherein the barbs of the barbed portion terminate in an apex.

105. 102. The fastener of any one of claims 82 to 101, wherein the fastener is cut from a tubular piece of material.

106. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, a fixed arm attached to the inner portion of the paddle; a hoop-shaped movable arm extending from a first end to a second end and having a barbed portion; a fastener comprising a hinge portion hingeably connecting the fixed arm to the movable arm; An implantable prosthetic device comprising:

107. 107. The implantable prosthetic device of claim 106, wherein the hoop-shaped movable arm is collapsed by retracting the fastener into a delivery sheath.

108. 108. The implantable prosthetic device of claim 106 or 107, wherein actuation of an actuation suture causes the hoop-shaped movable arm to collapse laterally.

109. 107. The implantable prosthetic device of claim 106, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

110. 110. The implantable prosthetic device of claim 109, wherein the spring segments are torsion spring segments.

111. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 111. An implantable prosthetic device according to claim 109 or 110.

112. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

112. An implantable prosthetic device according to any one of claims 109 to 111.

113. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment.

113. The implantable prosthetic device of claim 112.

114. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 114. An implantable prosthetic device according to any one of claims 109 to 113.

115. 115. The implantable prosthetic device of any one of claims 106 to 114, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

116. 116. The implantable prosthetic device of claim 115, wherein the top and bottom layers are connected at only one point such that the top and bottom layers can slide relative to one another while the fasteners are open.

117. 117. An implantable prosthetic device according to any one of claims 106 to 116, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is substantially parallel to the movable arm.

118. 118. The implantable prosthetic device of claim 117, wherein the fixation arms are bent in the closing direction past the closed position to the preloaded position.

119. 119. The implantable prosthetic device of claim 118, wherein the locking arms are bent up to about 45 degrees in the closing direction beyond the closed position to the preloaded position.

120. 119. The implantable prosthetic device of claim 118, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 90 degrees.

121. 119. The implantable prosthetic device of claim 118, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

122. 122. The implantable prosthetic device of claim 121, wherein the cross member is a unitary cross member.

123. 123. The implantable prosthetic device of any one of claims 106 to 122, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

124. 107. The implantable prosthetic device of claim 106, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

125. 116. The implantable prosthetic device of claim 115, wherein at least two of the plurality of layers are barbed.

126. 113. The implantable prosthetic device of claim 111 or 112, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

127. 127. The implantable prosthetic device of any one of claims 106 to 126, wherein the barbs of the barbed portion terminate in an apex.

128. 128. The implantable prosthetic device of any one of claims 106 to 127, wherein the fasteners are cut from a tubular piece of material.

129. A fixed arm; a hoop-shaped movable arm extending from a first end to a second end and having a barbed portion; a hinge portion hingeably connecting the fixed arm to the movable arm; A fastener comprising:

130. 130. The fastener of claim 129, wherein the hoop-shaped movable arms are collapsed by pulling the fastener into a delivery sheath.

131. 131. The fastener of claim 129 or 130, wherein actuation of an actuation suture causes the hoop-shaped movable arm to collapse laterally.

132. 130. The fastener of claim 129, wherein the hinge portion comprises a plurality of spring segments, each spring segment being connected to a plurality of spring segments.

133. 133. The fastener of claim 132, wherein the spring segments are torsion spring segments.

134. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 134. The fastener of claim 132 or 133.

135. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

135. The fastener of any one of claims 132 to 134.

136. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment.

136. The fastener of claim 135.

137. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 137. The fastener of any one of claims 132 to 136.

138. 138. The fastener of any one of claims 129 to 137, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

139. 139. The fastener of claim 138, wherein the top and bottom layers are connected in only one location such that the top and bottom layers can slide relative to one another while the fastener is open.

140. 140. The fastener of any one of claims 129 to 139, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is substantially parallel to the movable arm.

141. 141. The fastener of claim 140, wherein the locking arms are bent in the closing direction beyond the closed position to the preloaded position.

142. 133. The fastener of claim 132, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 45 degrees.

143. 133. The fastener of claim 132, wherein the locking arms are bent in the closing direction past the closed position to the preloaded position by approximately 90 degrees.

144. 133. The fastener of claim 132, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

145. 145. The fastener of claim 144, wherein the cross member is a unitary cross member.

146. 146. The fastener of any one of claims 129 to 145, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

147. 130. The fastener of claim 129, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

148. 139. The fastener of claim 138, wherein at least two of the plurality of layers are barbed.

149. 149. The fastener of any one of claims 129 to 148, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

150. 150. The fastener of any one of claims 129 to 149, wherein the barbs of the barbed portion terminate in an apex.

151. 151. The fastener of any one of claims 129 to 150, wherein the fastener is cut from a tubular piece of material.

152. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, a fixed arm attached to the inner portion of the paddle; a plurality of movable arms each having a barbed portion; a fastener comprising a plurality of hinge portions hingeably connecting the fixed arm to the plurality of movable arms; A fastener for an implantable prosthetic device comprising:

153. 153. The implantable prosthetic device of claim 152, wherein the movable arm is bent to form the hinge portion.

154. 154. The implantable prosthetic device of claim 152 or 153, wherein the movable arm comprises a twisted portion.

155. 155. The implantable prosthetic device of any one of claims 152 to 154, wherein the fastener is cut from a flat piece of material and the movable arm is bent and twisted prior to shape setting so that the barb is substantially perpendicular to the fixed arm.

156. 156. An implantable prosthetic device according to any one of claims 152 to 155, wherein the fastener comprises four movable arms, each movable arm having a hinge portion.

157. 157. The implantable prosthetic device of any one of claims 152 to 156, wherein actuation of an actuation suture causes the movable arms to fold laterally together.

158. 153. The implantable prosthetic device of claim 152, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

159. 159. The implantable prosthetic device of claim 158, wherein the spring segment is a torsion spring segment.

160. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 160. An implantable prosthetic device according to claim 158 or 159.

161. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

161. An implantable prosthetic device according to any one of claims 158 to 160.

162. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment.

161. An implantable prosthetic device as described in claim 160.

163. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 163. An implantable prosthetic device according to any one of claims 158 to 162.

164. 164. The implantable prosthetic device of any one of claims 152 to 163, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

165. 165. The implantable prosthetic device of claim 164, wherein the top layer and the bottom layer are connected at only one point such that the top layer and the bottom layer can slide relative to each other while the fasteners are open.

166. 154. An implantable prosthetic device as described in claim 152 or 153, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

167. 167. The implantable prosthetic device of claim 166, wherein the fixation arms are bent in the closing direction beyond the closed position to the preloaded position.

168. 168. The implantable prosthetic device of claim 167, wherein the fixation arms are bent up to about 45 degrees in the closing direction beyond the closed position and into the preloaded position.

169. 168. The implantable prosthetic device of claim 167, wherein the fixation arms are bent in the closing direction by approximately 90 degrees beyond the closed position to the preloaded position.

170. 168. The implantable prosthetic device of claim 167, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

171. 171. The implantable prosthetic device of claim 170, wherein the cross member is a unitary cross member.

172. 172. The implantable prosthetic device of any one of claims 152 to 171, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

173. 153. The implantable prosthetic device of claim 152, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

174. 165. The implantable prosthetic device of claim 164, wherein at least two of said plurality of layers are barbed.

175. 175. The implantable prosthetic device of any one of claims 152-174, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

176. 176. The implantable prosthetic device of any one of claims 152-175, wherein the barbs of the barbed portion terminate in an apex.

177. 177. The implantable prosthetic device of any one of claims 152 to 176, wherein the fasteners are cut from a tubular piece of material.

178. A fixed arm; a plurality of movable arms each having a barbed portion; a plurality of hinge portions connecting the fixed arm to the plurality of movable arms; A fastener comprising:

179. 179. The fastener of claim 178, wherein the movable arm is bent to form the hinge portion.

180. 180. The fastener of claim 178 or 179, wherein the movable arms each include a twisted portion.

181. 180. A fastener as described in claim 178 or 179, wherein the fastener is cut from a flat piece of material and the movable arm is bent and twisted before shape setting so that the barb is substantially perpendicular to the fixed arm.

182. 182. A fastener according to any one of claims 178 to 181, wherein the fastener includes four movable arms, each of the movable arms having a hinge portion.

183. 183. The fastener of any one of claims 178 to 182, wherein actuation of an actuating suture causes the movable arms to fold laterally and together.

184. 179. The fastener of claim 178, wherein the hinge portion comprises a plurality of spring segments, each spring segment being connected to a plurality of spring segments.

185. 185. The fastener of claim 184, wherein the spring segment is a torsion spring segment.

186. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 186. The fastener of claim 184 or 185.

187. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

187. The fastener of any one of claims 184 to 186.

188. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. The fastener of claim 186.

189. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 189. A fastener according to any one of claims 186 to 188.

190. 190. The fastener of claim 188 or 189, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

191. 189. The fastener of claim 188, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to one another while the fastener is open.

192. 192. The fastener of any one of claims 188 to 191, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

193. 193. The fastener of claim 192, wherein the locking arms are bent in the closing direction beyond the closed position to the preloaded position.

194. 194. The fastener of claim 193, wherein the locking arms are bent up to about 45 degrees in the closing direction beyond the closed position to the preloaded position.

195. 194. The fastener of claim 193, wherein the locking arms are bent in the closing direction by approximately 90 degrees beyond the closed position to the preloaded position.

196. 194. The fastener of claim 193, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

197. 197. The fastener of claim 196, wherein the cross member is a unitary cross member.

198. 198. The fastener of any one of claims 178 to 197, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

199. 179. The fastener of claim 178, wherein the fastener is formed from a shape memory material having thick and thin portions.

200. 191. The fastener of claim 190, wherein at least two of the plurality of layers are formed with barbs.

201. 201. The fastener of any one of claims 178 to 200, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

202. 202. The fastener of any one of claims 178 to 201, wherein the barbs of the barbed portion terminate in an apex.

203. 203. The fastener of any one of claims 178 to 202, wherein the fastener is cut from a tubular piece of material.

204. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, a fixed arm attached to the inner portion of the paddle; a movable arm having a barbed portion, a first eyelet, and a second eyelet; a fastener comprising a hinge portion hingeably connecting the fixed arm to the movable arm; a first intermediate suture loop attached to the first eyelet; a second intermediate suture loop attached to the second eyelet; and at least one working suture attached to the first intermediate suture loop and the second intermediate suture loop; An implantable prosthetic device comprising:

205. 205. The implantable prosthetic device of claim 204, wherein the first eyelet is positioned adjacent to a first side of the fastener and the second eyelet is positioned adjacent to a second side of the fastener.

206. a first lateral gap between a first side of the fastener and the first eyelet, and a second lateral gap between a second side of the fastener and the second eyelet; 205. The implantable prosthetic device of claim 204, wherein the first lateral gap and the second lateral gap are less than one-third the width of the fastener.

207. 207. The implantable prosthetic device of any one of claims 204 to 206, wherein the first intermediate suture loop and the second intermediate suture loop are wrapped around the ends of the movable arm.

208. 208. The implantable prosthetic device of any one of claims 204 to 207, wherein the first intermediate suture loop and the second intermediate suture loop extend through openings in the movable arm.

209. 205. The implantable prosthetic device of claim 204, wherein the ends of the movable arms are rounded.

210. 205. The implantable prosthetic device of claim 204, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

211. 211. The implantable prosthetic device of claim 210, wherein the spring segment is a torsion spring segment.

212. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 212. An implantable prosthetic device according to claim 210 or 211.

213. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

213. An implantable prosthetic device according to any one of claims 210 to 212.

214. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment.

213. An implantable prosthetic device as described in claim 212.

215. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 215. An implantable prosthetic device according to any one of claims 210 to 214.

216. 216. An implantable prosthetic device according to any one of claims 204 to 215, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

217. 217. The implantable prosthetic device of claim 216, wherein the top layer and the bottom layer are connected at only one point such that the top layer and the bottom layer can slide relative to each other while the fasteners are open.

218. 218. An implantable prosthetic device according to any one of claims 204 to 217, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

219. 219. The implantable prosthetic device of claim 218, wherein the fixation arms are bent in the closing direction beyond the closed position to the preloaded position.

220. 220. The implantable prosthetic device of claim 219, wherein the fixation arms are bent up to about 45 degrees in the closing direction beyond the closed position and into the preloaded position.

221. 220. The implantable prosthetic device of claim 219, wherein the fixation arms are bent in the closing direction by approximately 90 degrees beyond the closed position and into the preloaded position.

222. 220. The implantable prosthetic device of claim 219, wherein after shape setting, the fixation arms are prevented from returning to the preloaded position by a cross member.

223. 223. The implantable prosthetic device of claim 222, wherein the cross member is a unitary cross member.

224. 224. The implantable prosthetic device of any one of claims 204 to 223, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

225. 205. The implantable prosthetic device of claim 204, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

226. 217. The implantable prosthetic device of claim 216, wherein at least two of said plurality of layers are barbed.

227. 227. The implantable prosthetic device of any one of claims 204 to 226, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

228. 228. The implantable prosthetic device of any one of claims 204 to 227, wherein the barbs of the barbed portion terminate in an apex.

229. 224. The implantable prosthetic device of any one of claims 204 to 223, wherein the fasteners are cut from a tubular piece of material.

230. A fixed arm; a movable arm having a barbed portion, a first eyelet, and a second eyelet; a hinge portion hingeably connecting the fixed arm to the movable arm; a first suture loop attached to the first eyelet; a second suture loop attached to the second eyelet; and at least one working suture attached to the first intermediate suture loop and the second intermediate suture loop; A fastener comprising:

231. 231. The fastener of claim 230, wherein the first eyelet is positioned adjacent to a first side of the fastener and the second eyelet is positioned adjacent to a second side of the fastener.

232. a first lateral gap between a first side of the fastener and the first eyelet, and a second lateral gap between a second side of the fastener and the second eyelet; 231. The fastener of claim 230, wherein the first and second side gaps are less than one-third the width of the fastener.

233. 233. The fastener of any one of claims 230 to 232, wherein the first intermediate suture loop and the second intermediate suture loop are wrapped around ends of the movable arm.

234. 234. The fastener of any one of claims 230 to 233, wherein the first intermediate suture loop and the second intermediate suture loop extend through openings in the movable arm.

235. 231. The fastener of claim 230, wherein the ends of the movable arms are rounded.

236. 231. The fastener of claim 230, wherein the hinge portion comprises a plurality of spring segments, each spring segment being connected to a plurality of spring segments.

237. The fastener of claim 236, wherein the spring segment is a torsion spring segment.

238. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 238. A fastener as described in claim 236 or 237.

239. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location. A fastener as described in any one of claims 236 to 238.

240. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. A fastener as described in claim 238.

241. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 241. A fastener according to any one of claims 236 to 240.

242. 242. The fastener of claim 240 or 241, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

243. 243. The fastener of claim 242, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to each other while the fastener is open.

244. 244. The fastener of any one of claims 230 to 243, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

245. 245. The fastener of claim 244, wherein the locking arms are bent in the closing direction beyond the closed position to the preloaded position.

246. 246. The fastener of claim 245, wherein the locking arms are bent up to about 45 degrees in the closing direction beyond the closed position to the preloaded position.

247. 246. The fastener of claim 245, wherein the locking arms are bent in the closing direction by approximately 90 degrees beyond the closed position to the preloaded position.

248. 246. A fastener as described in claim 245, wherein after shape setting, the locking arms are prevented from returning to the preloaded position by a cross member.

249. The fastener of claim 248, wherein the cross member is a unitary cross member.

250. 250. A fastener as described in any one of claims 230 to 249, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

251. The fastener of claim 230, wherein the fastener is formed from a shape memory material having thick and thin portions.

252. The fastener of claim 242, wherein at least two of the plurality of layers are formed with barbs.

253. 253. A fastener as described in any one of claims 230 to 252, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

254. 254. The fastener of any one of claims 230 to 253, wherein the barbs of the barbed portion terminate in an apex.

255. 255. The fastener of any one of claims 230 to 254, wherein the fastener is cut from a tubular piece of material.

256. 233. The fastener of claim 232, wherein the first and second side gaps are less than one-quarter of the width of the fastener.

257. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, a fixed arm attached to the inner portion of the paddle; a movable arm having a barbed portion and a rounded end; a fastener having a hinge portion hingeably connecting the fixed arm to the movable arm; An implantable prosthetic device comprising:

258. The implantable prosthetic device of claim 257, wherein the edges of the movable arm are rounded.

259. 258. The implantable prosthetic device of claim 257, wherein the end of the movable arm has a convexly curved shape formed from a single radius.

260. 258. The implantable prosthetic device of claim 257, wherein the end of the movable arm has a semicircular shape.

261. 258. The implantable prosthetic device of claim 257, wherein the end of the movable arm has a semi-elliptical shape.

262. 258. The implantable prosthetic device of claim 257, wherein the end of the movable arm has a rounded triangular shape.

263. 258. The implantable prosthetic device of claim 257, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

264. 264. The implantable prosthetic device of claim 263, wherein the spring segment is a torsion spring segment.

265. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 265. An implantable prosthetic device according to claim 263 or 264.

266. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

266. An implantable prosthetic device according to any one of claims 263 to 265.

267. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. An implantable prosthetic device as described in claim 265.

268. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 268. An implantable prosthetic device according to any one of claims 263 to 267.

269. 269. An implantable prosthetic device according to any one of claims 257 to 268, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

270. 270. The implantable prosthetic device of claim 269, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to each other while the fasteners are open.

271. 271. An implantable prosthetic device according to any one of claims 257 to 270, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

272. 272. The implantable prosthetic device of claim 271, wherein the fixation arms are bent in the closing direction beyond the closed position to the preloaded position.

273. 273. The implantable prosthetic device of claim 272, wherein the fixation arms are bent up to about 45 degrees in the closing direction beyond the closed position and into the preloaded position.

274. 273. The implantable prosthetic device of claim 272, wherein the fixation arms are bent in the closing direction by approximately 90 degrees beyond the closed position and into the preloaded position.

275. 273. The implantable prosthetic device of claim 272, wherein after shape setting, the fixation arms are prevented from returning to the preloaded position by a cross member.

276. 276. The implantable prosthetic device of claim 275, wherein the cross member is a unitary cross member.

277. 277. The implantable prosthetic device of any one of claims 257 to 276, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

278. The implantable prosthetic device of claim 257, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

279. The implantable prosthetic device of claim 269, wherein at least two of the plurality of layers are formed with barbs.

280. 280. The implantable prosthetic device of any one of claims 257-279, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

281. 281. The implantable prosthetic device of any one of claims 257-280, wherein the barbs of the barbed portion terminate in an apex.

282. 282. The implantable prosthetic device of any one of claims 257 to 281, wherein the fasteners are cut from a tubular piece of material.

283. A fixed arm; a movable arm having a barbed portion and a rounded end; a hinge portion connecting the fixed arm to the movable arm; A fastener comprising:

284. A fastener as described in claim 283, wherein the edges of the movable arm are rounded.

285. A fastener as described in claim 283, wherein the end of the movable arm has a convexly curved shape formed from a single radius.

286. A fastener as described in claim 283, wherein the end of the movable arm has a semicircular shape.

287. A fastener as described in claim 283, wherein the end of the movable arm has a semi-elliptical shape.

288. A fastener as described in claim 283, wherein the end of the movable arm has a rounded triangular shape.

289. A fastener as described in claim 283, wherein the hinge portion comprises a plurality of spring segments, each spring segment being connected to a plurality of spring segments.

290. A fastener as described in claim 289, wherein the spring segment is a torsion spring segment.

291. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; A fastener as described in claim 289 or 290.

292. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location. A fastener described in any one of claims 289 to 291.

293. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. A fastener as described in claim 291.

294. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; A fastener described in any one of claims 289 to 293.

295. 295. The fastener of any one of claims 289 to 294, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

296. 296. The fastener of claim 295, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to each other while the fastener is open.

297. 296. The fastener of any one of claims 293 to 295, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

298. 298. The fastener of claim 297, wherein the locking arms are bent in the closing direction beyond the closed position to the preloaded position.

299. 299. The fastener of claim 298, wherein the locking arm is bent up to about 45 degrees in the closing direction beyond the closed position to the preloaded position.

300. 299. The fastener of claim 298, wherein the locking arms are bent up to approximately 90 degrees in the closing direction beyond the closed position to the preloaded position.

301. 299. The fastener of claim 298, wherein after shape setting, the locking arm is prevented from returning to the preloaded position by a cross member.

302. The fastener of claim 301, wherein the cross member is a unitary cross member.

303. 303. The fastener of any one of claims 283 to 302, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

304. A fastener as described in claim 283, wherein the fastener is formed from a shape memory material having thick and thin portions.

305. The fastener of claim 295, wherein at least two of the plurality of layers have barbs formed thereon.

306. 306. A fastener as described in any one of claims 283 to 305, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

307. 307. The fastener of any one of claims 283 to 306, wherein the barbs of the barbed portion terminate at an apex.

308. A fastener as described in any one of claims 283 to 307, wherein the fastener is cut from a tubular piece of material.

309. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, a fixed arm attached to the inner portion of the paddle; a movable arm having a barbed portion; and a fastener comprising a hinge portion hingeably connecting the fixed arm to the movable arm; 1. An implantable prosthetic device comprising: An implantable prosthetic device that does not include a trap when the anchor portion is in the open position and the fastener is in the closed state.

310. 310. An implantable prosthetic device as described in claim 309, wherein the device does not include any recesses having a depth greater than one-third the width of the device.

311. 310. The implantable prosthetic device of claim 309, wherein the hinge portion is rounded when the fastener is in the closed position.

312. 310. The implantable prosthetic device of claim 309, wherein the device does not include any barbed protrusions.

313. The implantable prosthetic device of claim 309, wherein the device does not include any hook-shaped protrusions.

314. The implantable prosthetic device of claim 309, wherein the device does not include any needle-shaped protrusions.

315. 310. The implantable prosthetic device of claim 309, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

316. 316. The implantable prosthetic device of claim 315, wherein the spring segment is a torsion spring segment.

317. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 317. An implantable prosthetic device according to claim 315 or 316.

318. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

318. An implantable prosthetic device according to any one of claims 315 to 317.

319. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. An implantable prosthetic device as described in claim 317.

320. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 320. An implantable prosthetic device according to any one of claims 315 to 319.

321. 321. The implantable prosthetic device of any one of claims 309 to 320, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

322. 322. The implantable prosthetic device of claim 321, wherein the top layer and the bottom layer are connected at only one point such that the top layer and the bottom layer can slide relative to each other while the fasteners are open.

323. An implantable prosthetic device according to any one of claims 309 to 322, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

324. 324. The implantable prosthetic device of claim 323, wherein the fixation arms are bent in the closing direction beyond the closed position to the preloaded position.

325. 325. The implantable prosthetic device of claim 324, wherein the fixation arms are bent up to about 45 degrees in the closing direction beyond the closed position to the preloaded position.

326. 325. The implantable prosthetic device of claim 324, wherein the fixation arms are bent in the closing direction by approximately 90 degrees beyond the closed position and into the preloaded position.

327. 325. The implantable prosthetic device of claim 324, wherein after shape setting, the fixation arms are prevented from returning to the preloaded position by a cross member.

328. The implantable prosthetic device of claim 327, wherein the cross member is a unitary cross member.

329. 329. The implantable prosthetic device of any one of claims 309 to 328, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

330. An implantable prosthetic device as described in claim 309, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

331. 322. The implantable prosthetic device of claim 321, wherein at least two of the plurality of layers are barbed.

332. 332. The implantable prosthetic device of any one of claims 309-331, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

333. 333. The implantable prosthetic device of any one of claims 309-332, wherein the barbs of the barbed portion terminate in an apex.

334. The implantable prosthetic device of any one of claims 309 to 333, wherein the fasteners are cut from a tubular piece of material.

335. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; A fastener, Fixed arm, a plurality of movable arms each having a barbed portion; a fastener comprising a plurality of hinge portions hingeably connecting the movable arm to the fixed arm; An implantable prosthetic device comprising:

336. The implantable prosthetic device of claim 335, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

337. The implantable prosthetic device of claim 336, wherein the top layer and the bottom layer are connected at only one point such that the top layer and the bottom layer can slide relative to each other while the fasteners are open.

338. 338. The implantable prosthetic device of claim 336 or 337, wherein the barbed portion comprises a barb and a barb support, the barb being formed from the bottom layer and the barb support being formed from the top layer.

339. 338. The implantable prosthetic device of claim 336 or 337, wherein the barbed portion comprises a barb and a barb support, the barb being formed from the top layer and the barb support being formed from the bottom layer.

340. 336. The implantable prosthetic device of claim 335, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

341. The implantable prosthetic device of claim 340, wherein the spring segment is a torsion spring segment.

342. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 342. An implantable prosthetic device according to claim 340 or 341.

343. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

343. An implantable prosthetic device according to any one of claims 340 to 342.

344. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. An implantable prosthetic device as described in claim 342.

345. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 345. An implantable prosthetic device according to any one of claims 340 to 344.

346. 346. An implantable prosthetic device according to any one of claims 335 to 345, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

347. The implantable prosthetic device of claim 346, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to each other while the fasteners are open.

348. An implantable prosthetic device as described in any one of claims 335 to 347, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

349. The implantable prosthetic device of claim 348, wherein the fixation arms are bent in the closing direction beyond the closed position to the preloaded position.

350. 350. The implantable prosthetic device of claim 349, wherein the fixation arms are bent up to about 45 degrees in the closing direction beyond the closed position and into the preloaded position.

351. 350. The implantable prosthetic device of claim 349, wherein the fixation arms are bent in the closing direction by approximately 90 degrees beyond the closed position and into the preloaded position.

352. 350. The implantable prosthetic device of claim 349, wherein after shape setting, the fixation arms are prevented from returning to the preloaded position by a cross member.

353. The implantable prosthetic device of claim 352, wherein the cross member is a unitary cross member.

354. 354. The implantable prosthetic device of any one of claims 335 to 353, wherein the plastic limit of the fastener material is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

355. The implantable prosthetic device of claim 335, wherein the fastener is formed from a shape memory material having thicker and thinner portions.

356. 356. The implantable prosthetic device of any one of claims 335 to 355, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

357. 357. The implantable prosthetic device of any one of claims 335-356, wherein the barbs of the barbed portion terminate in an apex.

358. The implantable prosthetic device of any one of claims 335 to 357, wherein the fasteners are cut from a tubular piece of material.

359. A fixed arm; a plurality of movable arms each having a barbed portion; a plurality of hinge portions connecting the movable arm to the fixed arm; A fastener comprising:

360. The fastener of claim 359, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

361. 361. The fastener of claim 360, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to each other while the fastener is open.

362. 362. The fastener of claim 360 or 361, wherein the barbed portion includes a barb and a barb support, the barb being formed from the bottom layer and the barb support being formed from the top layer.

363. 362. The fastener of claim 360 or 361, wherein the barbed portion includes a barb and a barb support, the barb being formed from the top layer and the barb support being formed from the bottom layer.

364. A fastener as described in claim 359, wherein the hinge portion comprises a plurality of spring segments, each spring segment being connected to a plurality of spring segments.

365. A fastener as described in claim 364, wherein the spring segment is a torsion spring segment.

366. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; A fastener as described in claim 364 or 365.

367. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location. A fastener described in any one of claims 364 to 366.

368. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. A fastener as described in claim 366.

369. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; A fastener described in any one of claims 364 to 368.

370. 370. The fastener of any one of claims 359 to 369, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

371. 371. The fastener of claim 370, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to each other while the fastener is open.

372. 372. The fastener of any one of claims 359 to 371, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

373. 373. The fastener of claim 372, wherein the locking arms are bent in the closing direction beyond the closed position to the preloaded position.

374. 374. The fastener of claim 373, wherein the locking arm is bent up to approximately 45 degrees in the closing direction beyond the closed position to the preloaded position.

375. 374. The fastener of claim 373, wherein the locking arm is bent up to approximately 90 degrees in the closing direction beyond the closed position to the preloaded position.

376. A fastener as described in claim 373, wherein after shape setting, the locking arm is prevented from returning to the preloaded position by a cross member.

377. The fastener of claim 376, wherein the cross member is a unitary cross member.

378. 378. A fastener as described in any one of claims 359 to 377, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

379. A fastener as described in claim 359, wherein the fastener is formed from a shape memory material having thick and thin portions.

380. 380. A fastener as described in any one of claims 359 to 379, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

381. 381. The fastener of any one of claims 359 to 380, wherein the barbs of the barbed portion terminate in an apex.

382. A fastener as described in any one of claims 359 to 381, wherein the fastener is cut from a tubular piece of material.

383. The joint part and an anchor portion comprising a plurality of paddles, the paddles having outer and inner portions and extendable from a folded, closed position to an open position; a fastener attached to each of the plurality of paddles, a fixed arm attached to the inner portion of the paddle; a movable arm having a barbed portion; and a fastener comprising a hinge portion hingeably connecting the fixed arm to the movable arm; a cover enclosing at least a portion of the movable arm of the fastener; at least one actuating suture attached to said cover; An implantable prosthetic device comprising:

384. The implantable prosthetic device of claim 383, wherein the cover comprises a flexible mesh.

385. a first lateral gap between a first side of the fastener and a first attachment location on the cover, and a second lateral gap between a second side of the fastener and a second attachment location on the cover; The implantable prosthetic device of claim 383, wherein the first lateral gap and the second lateral gap are less than one-third the width of the fastener.

386. The implantable prosthetic device of claim 385, wherein the first lateral gap and the second lateral gap are less than one-quarter the width of the fastener.

387. 387. The implantable prosthetic device of any one of claims 383 to 386, wherein the cover wraps around the end of the movable arm.

388. 388. The implantable prosthetic device of any one of claims 383 to 387, wherein at least a portion of the cover forms at least a portion of the interface.

389. The implantable prosthetic device of claim 383, wherein the end of the movable arm is rounded.

390. The implantable prosthetic device of claim 383, wherein the hinge portion comprises a plurality of spring segments, each spring segment connected to a plurality of spring segments.

391. The implantable prosthetic device of claim 390, wherein the spring segment is a torsion spring segment.

392. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; 392. An implantable prosthetic device according to claim 390 or 391.

393. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location.

393. An implantable prosthetic device according to any one of claims 390 to 392.

394. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. An implantable prosthetic device as described in claim 392.

395. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; 395. An implantable prosthetic device according to any one of claims 390 to 394.

396. 396. An implantable prosthetic device according to any one of claims 383 to 395, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

397. The implantable prosthetic device of claim 396, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to each other while the fasteners are open.

398. An implantable prosthetic device as described in any one of claims 383 to 397, wherein the fastener is formed from a shape memory material and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

399. The implantable prosthetic device of claim 398, wherein the fixation arms are bent in the closing direction beyond the closed position to the preloaded position.

400. 399. The implantable prosthetic device of claim 399, wherein the fixation arms are bent up to about 45 degrees in the closing direction beyond the closed position and into the preloaded position.

401. 399. The implantable prosthetic device of claim 399, wherein the fixation arms are bent in the closing direction by approximately 90 degrees beyond the closed position and into the preloaded position.

402. 399. The implantable prosthetic device of claim 399, wherein after shape setting, the fixation arms are prevented from returning to the preloaded position by a cross member.

403. The implantable prosthetic device of claim 402, wherein the cross member is a unitary cross member.

404. An implantable prosthetic device according to any one of claims 383 to 403, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

405. An implantable prosthetic device as described in claim 383, wherein the fastener is formed from a shape memory material having thick and thin portions.

406. The implantable prosthetic device of claim 396, wherein at least two of the plurality of layers are formed with barbs.

407. 407. The implantable prosthetic device of any one of claims 383 to 406, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

408. 408. The implantable prosthetic device of any one of claims 383 to 407, wherein the barbs of the barbed portion terminate in an apex.

409. The implantable prosthetic device of any one of claims 383 to 408, wherein the fasteners are cut from a tubular piece of material.

410. A fixed arm; a movable arm having a barbed portion; a hinge portion hingeably connecting the fixed arm to the movable arm; a cover surrounding at least a portion of the movable arm; at least one actuating suture attached to said cover; A fastener comprising:

411. 411. The fastener of claim 410, wherein the first eyelet is positioned adjacent to a first side of the fastener and the second eyelet is positioned adjacent to a second side of the fastener.

412. a first lateral gap between a first side of the fastener and the first eyelet, and a second lateral gap between a second side of the fastener and the second eyelet; 411. The fastener of claim 410, wherein the first lateral gap and the second lateral gap are less than one-third the width of the fastener.

413. 413. The fastener of any one of claims 410 to 412, wherein the first intermediate suture loop and the second intermediate suture loop are wrapped around ends of the movable arm.

414. 414. The fastener of any one of claims 410 to 413, wherein the first intermediate suture loop and the second intermediate suture loop extend through openings in the movable arm.

415. The fastener of claim 410, wherein the end of the movable arm is rounded.

416. 411. The fastener of claim 410, wherein the hinge portion comprises a plurality of spring segments, each spring segment being connected to a plurality of spring segments.

417. The fastener of claim 416, wherein the spring segment is a torsion spring segment.

418. the spring segment having a first end and a second end; the first end of one spring segment is connected to at least one of the first end and the second end of another spring segment; A fastener as described in claim 416 or 417.

419. the spring segment having a first end, a second end, a first side, and a second side; a first side connection location adjacent the first end; a first end connection location adjacent the first side; a second side connection location adjacent the second end; The second side is adjacent to a second end connection location. A fastener described in any one of claims 416 to 418.

420. the spring segments are arranged in a plurality of rows and columns; The first end or the second end of the spring segment adjacent to the side edge of the fastener is connected to one other spring segment; The first end or the second end of adjacent spring segments in adjacent vertical rows is connected to at least one other spring segment. A fastener as described in claim 418.

421. the spring segments are arranged in a pattern having three vertical rows and seven horizontal rows of spring segments; A fastener described in any one of claims 416 to 420.

422. 422. The fastener of any one of claims 410 to 421, wherein the fastener is formed from a top layer and a bottom layer, the top layer and the bottom layer being formed from a shape memory material.

423. 423. The fastener of claim 422, wherein the top layer and the bottom layer are connected at only one point so that the top layer and the bottom layer can slide relative to each other while the fastener is open.

424. A fastener as described in claim 422 or 423, wherein the fastener is formed from a shape memory material, and the fixed arm and the movable arm are shaped in a preloaded position such that a clamping force exists between the fixed arm and the movable arm when the fixed arm is approximately parallel to the movable arm.

425. 425. The fastener of claim 424, wherein the locking arms are bent in the closing direction beyond the closed position to the preloaded position.

426. 426. The fastener of claim 425, wherein the locking arms are bent up to approximately 45 degrees in the closing direction beyond the closed position to the preloaded position.

427. 426. The fastener of claim 425, wherein the locking arms are bent in the closing direction by approximately 90 degrees beyond the closed position to the preloaded position.

428. A fastener as described in claim 425, wherein after shape setting, the locking arm is prevented from returning to the preloaded position by a cross member.

429. The fastener of claim 428, wherein the cross member is a unitary cross member.

430. 430. A fastener as described in any one of claims 410 to 429, wherein the plastic limit of the material of the fastener is not exceeded when the movable arm is opened approximately 140 degrees from the fixed arm to a fully open position.

431. The fastener of claim 410, wherein the fastener is formed from a shape memory material having thick and thin portions.

432. The fastener of claim 422, wherein at least two of the plurality of layers have barbs formed thereon.

433. 433. A fastener as described in any one of claims 410 to 432, wherein the barbs of the barbed portion taper in the direction of the length of the fastener.

434. 434. The fastener of any one of claims 410 to 433, wherein the barbs of the barbed portion terminate in an apex.

435. A fastener as described in any one of claims 410 to 434, wherein the fastener is cut from a tubular piece of material.

436. A fastener comprising any combination of any of the features recited in any one of claims 1 to 435.

437. A method of repairing a mitral valve comprising any combination of the features and steps recited in any one of claims 1 to 436.

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