Heart valve sealing device and delivery device thereof

Abstract

The present application is entitled "Heart Valve Sealing Device and Delivery Device Thereof." The implantable prosthetic device includes an apposition 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

[0001] This application is a divisional application. The application date of the original application is April 18, 2018, the application number is 2018800180369, and the name of the invention is "Heart valve sealing device and delivery device thereof".

[0002] Cross-reference to related applications

[0003] This application is related to U.S. patent application Ser. No. 15 / 884,193, filed on January 30, 2018, entitled HEART VALVE SEALING DEVICES AND DELIVERY DEVICES THEREFOR, U.S. patent application Ser. No. 15 / 909,803, filed on March 1, 2018, U.S. patent application Ser. No. 15 / 910,951, filed on March 2, 2018, U.S. patent application Ser. No. 15 / 914,143, filed on March 7, 2018, U.S. patent application Ser. No. 15 / 927,814, filed on March 21, 2018, and U.S. patent application Ser. No. 15 / 930,969, filed on April 5, 2018. No. 15 / 946,604 filed on April 13, 2018, U.S. Patent Application No. 15 / 953,220 filed on April 13, 2018, U.S. Patent Application No. 15 / 953,263 filed on April 13, 2018, U.S. Patent Application No. 15 / 953,283 filed on April 13, 2018, and U.S. Provisional Application Serial No. 62 / 486,835 filed on April 18, 2017, and claim any benefit therefrom, the disclosures of which are incorporated herein by reference in their entireties. Technical Field

[0004] The present application generally relates to prosthetic devices and related methods that help seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. Background Art

[0005] Natural heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) play a key role in ensuring an adequate forward flow of blood through the cardiovascular system. These valves can become damaged and less effective due to congenital malformations, inflammatory processes, infectious conditions, or disease. Such valve damage can lead to serious cardiovascular harm or death. For many years, the definitive treatment for such damaged valves was surgical repair or replacement of the valves during open-heart surgery. However, open-heart surgery is highly invasive and prone to numerous complications. Consequently, 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 much less invasive manner than open-heart surgery. One specific transvascular technique used to access the natural mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, advancing along the inferior vena cava, and into the right atrium. The septum is then punctured, and the catheter is passed into the left atrium.

[0006] A healthy heart has a generally conical shape that tapers downward toward the apex. The heart has four chambers, including the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has an anatomical structure that is very different from other natural heart valves. The mitral valve comprises an annular portion, which is an annular portion of natural valve tissue that surrounds the mitral valve orifice; and a pair of cusps or leaflets that extend from the annulus downward into the left ventricle. The mitral annulus can form a "D" shape, an elliptical shape, or another out-of-round cross-sectional shape having a major axis and a minor axis. The anterior leaflet can be larger than the posterior leaflet, thereby forming a generally "C"-shaped boundary between the adjacent free edges of the leaflets when they are closed together.

[0007] When operating properly, the anterior and posterior leaflets work together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expand (also known as "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also known as "ventricular systole" or "systole"), the increased blood pressure in the left ventricle forces the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back into the left atrium and is instead expelled from the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding across the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0008] Mitral regurgitation occurs when the native mitral valve fails to close properly during the systolic phase of systole and blood flows from the left ventricle into the left atrium. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has different causes, such as leaflet prolapse, papillary muscle dysfunction and / or stretching of the mitral annulus due to dilation of the left ventricle. Mitral regurgitation at the central portion of the leaflet may be referred to as central jet mitral regurgitation, and mitral regurgitation closer to one of the leaflets (i.e., the location where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle, and therefore the valve does not close and regurgitation is present.

[0009] Some existing techniques for treating mitral regurgitation in patients involve surgically suturing the edges of the native mitral valve leaflets directly to each other. Catheter-delivered clips have been used in an attempt to clamp the edges of the leaflets together, similar to surgical suturing methods. However, such clips have disadvantages in that they can only be used to clamp the middle edges of the leaflets, where the leaflets overlap by about 2 mm or more. Alternatively, attempts have been made to use multiple clips on the commissures of the mitral valve, where there can be more overlap of the leaflets. This technique results in longer operating times and also joins the patient's leaflets laterally, restricting blood flow. In addition, both surgical and clip treatments are believed to place pressure on the patient's leaflets.

[0010] Despite these prior art techniques, there continues to be a need for improved devices and methods for treating mitral regurgitation. Summary of the Invention

[0011] The implantable prosthetic device includes a coaption 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.

[0012] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] These and other features and advantages of the present invention will become better understood with reference to the following description and accompanying drawings, in which:

[0014] Figure 1-6 shows an implantable prosthetic device in various stages of deployment according to a first embodiment;

[0015] Figure 7-12 Shown being delivered and implanted within the native mitral valve Figure 1-6 implantable prosthetic devices;

[0016] Figure 13-13A Another implantable prosthetic device according to a second embodiment is shown;

[0017] Figure 14-25 shows another implantable prosthetic device being delivered and implanted within a native mitral valve according to a third embodiment;

[0018] Figure 23A shows a portion of mitral valve tissue captured by a barbed fastener;

[0019] Figure 26 A barbed fastener for an implantable prosthetic device is shown according to one embodiment;

[0020] Figure 27 shows a barbed fastener for an implantable prosthetic device according to a second embodiment;

[0021] Figure 28 shows a barbed fastener for an implantable prosthetic device according to a third embodiment;

[0022] Figures 29-31 shows a side view of a barbed fastener for an implantable prosthetic device in various stages of bending;

[0023] Figure 32 shows a barbed fastener for an implantable prosthetic device according to a fourth embodiment;

[0024] Figure 33 shows a barbed fastener for an implantable prosthetic device according to a fifth embodiment;

[0025] Figure 34 shows a barbed fastener for an implantable prosthetic device according to a sixth embodiment;

[0026] Figure 35 shows a barbed fastener for an implantable prosthetic device according to a seventh embodiment;

[0027] Figure 36 shows a barbed fastener for an implantable prosthetic device according to an eighth embodiment;

[0028] Figure 37-52 shows a barbed fastener for an implantable prosthetic device according to a ninth embodiment;

[0029] Figures 53-55 shows a barbed fastener for an implantable prosthetic device according to a tenth embodiment;

[0030] Figure 56shows a barbed fastener for an implantable prosthetic device according to an eleventh embodiment;

[0031] Figures 56A-56B Shown Figure 56 An alternative embodiment of the hinge portion of the barbed fastener;

[0032] Figures 57-58 shows a barbed fastener for an implantable prosthetic device according to a twelfth embodiment;

[0033] Figure 57A Shown for making Figure 57 and 58 The flat cutout of the barbed fastener shown in FIG;

[0034] Figures 59-63 shows a barbed fastener for an implantable prosthetic device according to a thirteenth embodiment;

[0035] Figures 64-68 shows a barbed fastener for an implantable prosthetic device according to a fourteenth embodiment;

[0036] Figure 69-73B An exemplary arrangement for securing an actuation wire to an exemplary barbed fastener for an implantable prosthesis is shown;

[0037] Figures 74A-74B An exemplary barbed fastener is shown opened with an actuation wire;

[0038] Figure 75 An exemplary barbed fastener is shown with a ninth or tenth embodiment of an actuation wire;

[0039] Figure 76 shows a barbed fastener for an implantable prosthetic device according to a fifteenth embodiment;

[0040] Figure 77 shows a barbed fastener for an implantable prosthetic device according to a sixteenth embodiment;

[0041] Figures 78-79 shows a barbed fastener for an implantable device according to a seventeenth embodiment;

[0042] Figures 80A-80E shows a barbed fastener for an implantable device according to an eighteenth embodiment;

[0043] Figures 81A-81C shows a barbed fastener for an implantable device according to a nineteenth embodiment;

[0044] Figure 82Exemplary actuation mechanisms for use with the implantable devices described herein are shown. DETAILED DESCRIPTION

[0045] As disclosed herein, when one or more components are described as being connected, joined, attached, coupled, attached, or otherwise interconnected, such interconnection may be direct between the components or may be indirect (such as through the use of one or more intermediate components). Also, as described herein, references to "member," "component," or "portion" should not be limited to a single structural member, component, or element, but can include an assembly of components, components, or elements. Also, as described herein, the terms "substantially" and "approximately" are defined as at least close to (and including) a given value or state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0046] The prosthetic device has a coaption device or coaption element and at least one anchoring device or anchor. The coaption element is configured to be positioned within the natural heart valve orifice to help form a more effective seal between the natural leaflets, thereby reducing or preventing backflow. The coaption element can have a blood-impermeable structure that allows the natural leaflets to close together on each side of the coaption element during ventricular contraction to prevent blood from flowing back from the left or right ventricle into the left or right atrium, respectively. The prosthetic device can be configured to seal two or three natural valve leaflets; that is, this device can be used for natural mitral (bicuspid) and tricuspid valves. The coaption element is sometimes referred to as a spacer in this article because the coaption element can fill the space between improperly functioning natural mitral or tricuspid valve leaflets that are not fully closed.

[0047] The apposition element can have a variety of shapes. In some embodiments, the apposition element can have an elongated cylindrical shape having a circular cross-sectional shape. In other embodiments, the apposition element can have an elliptical cross-sectional shape, a crescent cross-sectional shape, or various other non-cylindrical shapes. The apposition element can have an atrial end or upper end positioned in or near the left atrium, a ventricular end or lower end positioned in or near the left ventricle, and a side surface extending between the natural mitral valve leaflets. In an embodiment configured for the tricuspid valve, the atrial end or upper end is positioned in or near the right atrium and the ventricular end or lower end is positioned in or near the right ventricle, and the side surface extends between the natural tricuspid valve leaflets.

[0048] The anchor can be configured to secure the device to one or two of the natural mitral valve leaflets so that the apposition element is positioned between the two natural leaflets. In an embodiment configured for the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid valve leaflets so that the apposition element is positioned between the three natural leaflets. In some embodiments, the anchor can be attached to the apposition element at a position adjacent to the ventricular end of the apposition element. In some embodiments, the anchor can be attached to an actuator such as a shaft or an actuator wire, and the apposition element is also attached to the actuator device. In some embodiments, the anchor and the apposition element can be positioned independently relative to each other by moving each of the anchor and the apposition element individually along the longitudinal axis of the shaft. In some embodiments, the anchor and the apposition element can be positioned independently relative to each other by moving each of the anchor and the apposition element individually along the longitudinal axis of the shaft or the actuator wire. In some embodiments, the anchor and the apposition element can be positioned simultaneously by moving the anchor and the apposition element together along the longitudinal axis of the shaft or the actuator wire. The anchor can be configured to be positioned behind the native leaflet upon implantation such that the leaflet is captured by the anchor.

[0049] The prosthetic device can be configured to be implanted via a delivery device such as a delivery sheath. The apposition element and the anchor can be compressed to a radially compressed state and can expand to a radially expanded state when the compression pressure is released. The device can be configured to cause the anchor to initially radially expand away from the still compressed apposition element so as to create a gap between the apposition element and the anchor. The natural leaflet can then be positioned in the gap. The apposition element can be radially expanded, thereby closing the gap between the apposition element and the anchor and capturing the leaflet between the apposition element and the anchor. In some embodiments, the anchor and the apposition element are optionally configured to expand on their own. The implantation methods of various embodiments can be different, and each embodiment is discussed more fully below. Additional information about these and other delivery methods can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publication Nos. 2014 / 0222136 and 2014 / 0067052, 2016 / 0331523, each of which is fully incorporated herein by reference.

[0050] The disclosed prosthetic device is protected from atrial embolism by hooking the anchors onto the leaflets, utilizing tension from the natural chordae tendineae against high systolic pressures (urging the device toward the left atrium). During diastole, the device can rely on the compression and holding forces exerted on the leaflets captured by the anchors to resist embolism into the left ventricle.

[0051] Now refer to Figure 1-6, shows an implantable prosthetic device 100 in various stages of deployment. The device 100 is deployed from a delivery sheath 102 and includes an apposition portion 104 and an anchor portion 106. The apposition portion 104 of the device 100 includes an apposition element 110 adapted to be implanted between the leaflets of a native mitral valve, the apposition element 110 being slidably attached to an actuation wire or shaft 112. The anchor portion 106 is actuable between open and closed conditions and can take a variety of forms, such as, for example, a paddle, gripping elements, or the like. Actuation of the actuation wire 112 opens and closes the anchor portion 106 of the device 100 to capture the mitral valve leaflets during implantation. The actuation wire or shaft 112 can take a variety of different forms. For example, the actuation wire or shaft can be threaded such that rotation of the actuation wire or shaft moves the anchor portion 106 relative to the apposition portion 104. Alternatively, the actuation wire or shaft may be unthreaded, such that pushing or pulling the actuation wire or shaft 112 moves the anchor portion 106 relative to the apposing portion 104 .

[0052] The anchor portion 106 of the device 100 includes an outer paddle or clamping element 120 and an inner paddle or clamping element 122, which are connected between the cap 114 and the apposition element 110 by portions 124, 126, 128. Portions 124, 126, 128 can be hinged and / or flexible to move between all of the positions described below. An actuation wire 112 extends through the delivery sheath and the apposition element 110 to the cap 114 at the distal end of the anchor portion 106. Extending and retracting the actuation wire 112 increases and decreases the spacing between the apposition element 110 and the cap 114, respectively. An attachment device or collar (not shown) removably attaches the apposition element 100 to the delivery sheath 102 such that the apposition element 100 slides along the actuation wire 112 to open and close the paddles 120 , 122 of the anchor portion 106 during actuation.

[0053] Reference Figure 3, barbed fastener 130 includes a base or fixed arm 132, a movable arm 134, barbs 136, and a hinge portion 138. Fixed arm 132 is attached to inner paddle 122, with hinge portion 138 disposed adjacent to engaging element 110. Hinge portion 138 provides a spring force between the fixed and movable arms 132, 134 of barbed fastener 130. 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, hinge portion 138 is a flexible piece of material integrally formed with fixed and movable arms 132, 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 fastener 130 and expose barbs 136. The barbed fastener 130 is opened by applying tension to an actuation wire 116 attached to the end of a movable arm 134 , thereby causing the movable arm 134 to pivot on a hinge portion 138 .

[0054] During implantation, the paddles 120, 122 open and close to capture the native mitral valve leaflets between the paddles 120, 122 and the apposition element 110. The barbed fasteners 130 further secure the native leaflets by engaging the leaflets with the barbs 136 and clamping the leaflets between the movable and fixed arms 134, 132. The barbs 136 of the barbed fasteners 130 increase friction with the leaflets or can partially or completely pierce the leaflets. The actuation wires 116 are independently actuable, enabling each barbed fastener 130 to open and close independently. The independent operation allows for the capture of one leaflet at a time, or for repositioning the fastener 130 on a leaflet that was not adequately captured, without altering the successful capture on other leaflets. Not only do the barbed fasteners 130 open and close independently of each other, but they can also open and close completely independent of the position of the inner paddle 122, thereby allowing the leaflets to be captured in a variety of positions as required for a particular situation.

[0055] The barbed fastener 130 can be independently opened by pulling an attached actuation device or actuation wire 116 that extends through the delivery sheath 102 to the end of the barbed fastener 130. The actuation wire 116 can take a variety of forms, such as, for example, a thread, suture, wire, rod, catheter, or the like. The barbed fastener 130 can be spring-loaded so that in the closed position, the barbed fastener 130 continues to provide a clamping force on the captured native leaflet. This clamping force remains constant regardless of the position of the inner paddle 122. The barbs 136 of the barbed fastener 130 can pierce the native leaflet to further secure the native leaflet.

[0056] Now refer to Figure 1, shows the device 100 in an extended or fully open condition for deployment from a delivery sheath. The device 100 is loaded into the delivery sheath in the fully open position because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest device 100 for a given catheter size to be used). In the extended condition, the cap 114 is spaced apart from the mate element 110, allowing the paddles 120, 122 of the anchor portion 106 to be inverted or fully opened. In some embodiments, the angle formed between the interior of the outer and inner paddles 120, 122 is approximately 180 degrees. The barbed fastener 130 remains in a closed condition during deployment through the delivery sheath 102 such that the barbs 136 ( Figure 3 ) without getting stuck or damaging the sheath or tissue in the patient's heart.

[0057] Now refer to Figure 1A , showing that in Figure 1 The device 100 is similarly shown in an extended detangling condition, but with the barbed fastener 130 in a fully open position, with the angle between the fixed portion and the movable portion of the barbed fastener 130 ranging from about 140 degrees to about 200 degrees to about 170 degrees to about 190 degrees, or about 180 degrees. Fully opening the device 100 and fastener 130 has been found to improve the ease of detangling the device 100 from the patient's anatomy during implantation.

[0058] Now refer to Figure 2 , shows device 100 in a shortened or fully closed condition. The compact size of device 100 in the shortened condition allows for easier manipulation and placement within the heart. To move device 100 from the extended condition to the shortened condition, actuation wire 112 is retracted to pull cap 114 toward apposition element 110. A hinge or flexible connection 126 between outer paddle 120 and inner paddle 122 is restricted in movement such that compressive forces acting on outer paddle 120 from cap 114 being retracted toward apposition element 110 cause paddles or gripping elements 120, 122 to move radially outward. During movement from the open to the closed position, outer paddle 120 maintains an acute angle with actuation wire 112. Outer paddle 120 may optionally be biased toward the closed position. Inner paddles 122 move through a considerably greater angle during the same motion because they are directed away from apposition element 110 in the open condition and collapsed along the sides of apposition element 110 in the closed condition. In some embodiments, inner paddles 122 are thinner and / or narrower than outer paddles 120, and hinges or flexible portions 126, 128 connected to inner paddles 122 are thinner and / or more flexible to allow for more movement than hinges or flexible portions 124 connecting outer paddle 124 to cap 114.

[0059] Now refer to Figure 3-5 , shows the device 100 in a partially open, ready-to-capture condition. To transition from the fully closed to the partially open condition, the actuation wire 112 extends to push the cap 114 away from the apposition element 110, thereby pulling on the outer paddle 120, which in turn pulls on the inner paddle 122, causing the anchor portion 106 to partially deploy. The actuation wire 116 also retracts to open the catch 130, allowing the leaflet to be captured.

[0060] Now refer to Figure 4 , one of the actuation wires 116 extends to allow one of the clasps 130 to close. Figure 5 , the other actuation wire 116 extends to allow the other fastener 130 to close. Either one or both of the actuation wires 116 can be repeatedly actuated to repeatedly open and close the barbed fastener 130.

[0061] Now refer to Figure 6 , shows the device 100 in a fully closed and deployed condition. The delivery sheath 102 and the actuation wire 112 are retracted, and the paddles 120, 122 and the fastener 130 are maintained in the fully closed position. Once deployed, the device 100 can be maintained in the fully closed position using a mechanical latch, or can be biased to maintain closure through the use of a spring material (such as steel, other metals, plastics, composite materials, etc.) or a shape memory alloy (such as Nitinol). For example, the hinged or flexible portions 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or additional biasing components (see Figure 13 134, and / or the inner and outer paddles 122, and / or additional biasing members (see FIG. Figure 13 Component 224 in the device may be formed of any other suitable resilient material, such as a metal or polymer material, to maintain the device in a closed condition after implantation.

[0062] Now refer to Figure 7-12 , shown being delivered and implanted within the native mitral valve 40 of the heart 10 Figure 1-6 Now referring to the implantable device 100. Figure 7The 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 condition. The actuation wire 112 is then retracted to move the device 100 into the fully open position. Figure 8 In the fully closed condition shown in Figure 9 As seen in FIG, the device 100 is moved into position within the mitral valve 40 into the ventricle 30 and partially opened so that the leaflets 42, 44 can be captured. Referring now to FIG. Figure 10 , the actuation wire 116 extends to close one of the fasteners 130 , capturing the leaflet 42 . Figure 11 Another actuation wire 116 is shown then being extended to close another fastener 130, capturing the remaining leaflet 44. Finally, as can be Figure 12 The delivery sheath 102 and actuation wire 112 are then retracted, and the device 100 is fully closed and deployed in the native mitral valve 400, as seen in FIG.

[0063] Now refer to Figure 13 , shows an implantable prosthetic device 200. The implantable device 200 is Figure 1-12 1 and 2. The device 100 of FIG. 1 is schematically illustrated in one of a number of different configurations that the device 100 can assume. The device 200 is deployed from a delivery sheath (not shown) and includes an apposition portion 204 and an anchor portion 206. The device 200 is loaded into the delivery sheath in a fully open position because the fully open position occupies the least space and allows the use of the smallest catheter (or the largest device 200 for a given catheter size). The apposition portion 204 of the device includes an apposition element 210 for implantation between the leaflets of a native mitral valve, the apposition element 210 being slidably attached to an actuation wire or shaft 212. Actuation of the actuation wire 212 opens and closes the anchor portion 206 of the device 200 to capture the mitral valve leaflets during implantation.

[0064] The anchor portion 206 of the device 200 includes an outer paddle 220 and an inner paddle 222 that are hingedly connected to a cap 214 and the apposition element 210. An actuation wire 212 extends through a delivery sheath (not shown), a collar 211, and the apposition element 210 to the cap 214 at the distal end of the anchor portion 206. Extending and retracting the actuation wire 212 increases and decreases the spacing between the apposition element 210 and the cap 214, respectively. 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 shut when the actuation wire 212 is removed to substantially close the device 200 to blood flowing through the interior of the apposition element 210 after implantation. In some embodiments, the collar 2011 removably engages and attaches the apposition element 200 to the delivery sheath, such that the apposition 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 2011 is held closed around the apposition element 2010 by the actuation wire 212, such that removal of the actuation wire 212 allows the fingers of the collar (not shown) to open, releasing the apposition element 210. In some embodiments, the cap 2014 optionally includes a seal 216 and / or an insert 218 that fits within the opening 215 of the apposition element 210, which has a hollow interior. The seal 216 and / or the insert 218 maintain the apposition element 210 substantially closed to blood flow when the actuation wire 212 is withdrawn and the device 200 is implanted.

[0065] The apposition element 210 and paddles 220, 222 are formed from a covering that can be mesh, woven, braided, or formed in any other suitable manner. The covering can be a fabric, a shape memory alloy wire (such as Nitinol) that provides shape-setting capabilities, 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 apposition element 210 and helps wrap the leaflets around the sides of the apposition element 210 for a better seal between the apposition element 210 and the leaflets. In some embodiments, the covering extends around the paddle frame 224.

[0066] Barbed fastener 230 includes a base or fixed arm 232, a movable arm 234, barbs 236, and a hinge portion 238. Fixed arm 232 is attached to inner paddle 222, with hinge portion 238 disposed adjacent to engaging element 210. Fixed arm 232 is attached to inner paddle 222 via hole or slot 233 using suture (not shown). Fixed arm 232 can be attached to inner paddle 222 using any suitable means, such as screws or other fasteners, crimped sleeves, mechanical latches or snaps, welding, adhesives, or the like. When movable arm 234 is opened, fixed arm 232 remains stationary relative to inner paddle 222, thereby opening barbed fastener 230 and exposing barbs 236. The barbed fastener 230 is opened by applying tension to an actuation wire (not shown) attached to a hole 235 provided at the end of the movable arm 234 , thereby causing the movable arm 234 to pivot on the hinge portion 238 .

[0067] During implantation, paddles 220, 222 open and close to capture the native mitral valve leaflets between paddles 220, 222 and apposition element 210. Barbed fasteners 230 further secure the native leaflets by engaging the leaflets with barbs 236 and clamping them between movable and fixed arms 234, 232. Barbs 236 of barbed fasteners 230 increase friction with the leaflets or can partially or completely pierce them. Actuation wires can be independently actuated, enabling each barbed fastener 230 to open and close independently. Independent operation allows for capturing one leaflet at a time or for repositioning a fastener 230 on an inadequately captured leaflet without altering the successful capture of other leaflets. Barbed fasteners 230 not only open and close independently of each other but can also fully open and close independently of the position of inner paddle 222, thereby allowing the leaflets to be captured in a variety of positions as needed for specific situations.

[0068] Now refer to Figure 14-25 , shows an implantable device 300 being delivered and implanted within the native mitral valve 40 of the heart 10. The device 300 is similar to Figure 13 300 has a cover on the apposition element 310, the fastener 330, the inner paddle 322, and / or the outer paddle 320. The device 300 is deployed from a delivery sheath 302 and includes an apposition portion 304 and an anchor portion 306. The apposition portion 304 of the device includes the apposition element 310 for implantation between the leaflets of the native mitral valve, the apposition element 310 being slidably attached to an actuation wire or shaft 312. Actuation of the actuation wire or shaft 312 opens and closes the anchor portion 306 of the device 300 to capture the mitral valve leaflets during implantation.

[0069] 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 apposition element 310. The actuation wire 312 extends through the loop 303 (see Figure 20 ), the delivery sheath 302, and the apposition element 310 reach the cap 314 at the distal end of the anchor portion 306. Extending and retracting the actuation wire 312 increases and decreases the spacing between the apposition element 310 and the cap 314, respectively. The fingers of the loop 303 removably attach the apposition element 300 to the delivery sheath 302, such that the apposition element 300 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 loop is maintained closed around the apposition element 310 by the actuation wire 312, such that removal of the actuation wire 312 allows the fingers of the loop 303 to open, releasing the apposition element 310.

[0070] The apposition element 310 and the paddles 320, 322 are formed of a flexible material that can be meshed, woven, braided, or formed in any other suitable manner. The flexible material can be a fabric, a shape memory alloy wire (such as Nitinol) that provides shape-setting capabilities, or any other flexible material suitable for implantation in the human body.

[0071] Barbed fastener 330 includes a base or fixed arm 332, a movable arm 334, a barb 336 (see Figure 20 ) and hinge portion 338. The fixed arm 332 is attached to the inner paddle 322, wherein the hinge portion 338 is disposed adjacent the engaging element 310. Sutures (not shown) attach the fixed arm 332 to the inner paddle 322. The fixed arm 332 can be attached to the inner paddle 322 using any suitable means, such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welds, adhesives, or the like. When the movable arm 334 is opened, the fixed arm 332 remains stationary to open the barbed fastener 330 and expose the barbs 336. The barbed fastener 330 is opened by applying tension to the actuation wire 316 attached to the end of the movable arm 334, thereby causing the movable arm 334 to pivot on the hinge portion 338.

[0072] During implantation, the paddles 320, 322 open and close to capture the native mitral valve leaflets between the paddles 320, 322 and the apposition element 310. The outer paddle 320 has a wide curved shape that fits around the curved shape of the apposition 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 and fixed arms 334, 332. The barbs 336 of the barbed fasteners 330 increase friction with the leaflets or can partially or completely pierce the leaflets. The actuation wires can be independently actuated so that each barbed fastener 330 can be independently opened and closed. Independent operation allows for the capture of one leaflet at a time, or for repositioning the clip 330 on a leaflet that is not adequately captured, without altering the successful grip on other leaflets. The barbed clips 330 not only open and close independently of each other, but can also open and close completely independently of the position of the inner paddle 322, thereby allowing the leaflets to be captured in a variety of positions as the specific situation requires.

[0073] The device 300 is loaded into the delivery sheath in the fully open position because the fully open position takes up the least space and allows the smallest catheter to be used (or the largest device 300 for a given catheter size to be used). Figure 14 The delivery sheath is inserted through the septum into the left atrium 20 and the device 300 is deployed from the delivery sheath in a fully open condition. The actuation wire 312 is then retracted to move the device 300 into the fully open position. Figure 15-16 The fully closed condition shown in Figure 17 As shown in FIG. 4 , the mitral valve 40 is manipulated toward the mitral valve 40. Referring now to FIG. Figure 18 When the device 300 is aligned with the mitral valve 40, the actuator wire 312 extends to open the paddles 320, 322 to a partially open position, and the actuator wire 316 retracts to open the barbed fastener 330 in preparation for leaflet capture. Figure 19-20 As shown in FIG, the partially opened device 300 is inserted through the mitral valve 40 until the leaflet is properly positioned between the inner paddle 322 and the apposition element 310 and inside the opened barbed fastener 330. Figure 21 The device 300 is shown with both fasteners 330 closed but the barb 336 of one fastener 330 misses one of the leaflets 44. Figure 22-23 As seen in FIG, the improperly positioned fastener 330 opens and closes again to properly capture the missed leaflet 44. When both leaflets 42, 44 are properly captured, the actuation wire 312 retracts to move the device 300 to the position in which the leaflets 42, 44 are properly captured. Figure 24310 . With the device 300 fully implanted in the native mitral valve 40, the actuating wire 312 is withdrawn to release the collar 303 from the upper end or plate 311 of the apposition element 310. Once deployed, the device 300 can be maintained in the fully closed position using a mechanical device such as a latch, or can be biased to maintain closure 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 can be formed from steel or Nitinol shape memory alloy - produced in the form of wire, sheet, tubing or laser sintered powder - and are biased to keep the outer paddle 320 closed around the apposition element 310 and the barbed fastener 330 clamped around the native leaflet.

[0074] Now refer to Figure 23A , shows a close-up view of one of the leaflets 42, 44 captured by one of the clasps 330. The leaflet 42, 44 is captured between the movable and fixed arms 334, 332 of the clasp 330. Figure 23A As shown in FIG, the tissue of the leaflets 42, 44 is not pierced by the barbs 336, but in some embodiments, the barbs 336 may partially or completely pierce the leaflets 42, 44. The angle and height of the barbs 336 relative to the movable arms 334 help secure the leaflets 42, 44 within the fastener 330. Specifically, the force pulling the implant away from the native leaflets will cause the barbs 336 to further engage the tissue, thereby ensuring better retention. When the fastener 330 is closed, the position of the fixed arms 332 near the barbs 336 further improves the retention of the leaflets 42, 44 in the fastener 330. In this arrangement, the fixed and movable arms 332, 334 and the barbs 336 form the tissue into an S-shaped, tortuous path. Thus, the force pulling the leaflets away from the fastener 330 will cause the tissue to further engage the barbs 336 before the leaflets are able to escape.

[0075] Now refer to Figure 26 , shows an exemplary barbed fastener 400 for use in an implantable prosthetic device, such as the devices 100, 200, 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 thinner sheets of material to be used, thereby improving the flexibility of the fastener 400 relative to fasteners formed from a single, thicker sheet, while maintaining the strength of the fastener 400 required to successfully retain the native valve leaflets.

[0076] 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 some embodiments, are attached to each other at the barbed ends 440. The hinged portion 420 is spring-loaded so that when the barbed fastener 400 is in a closed position, the fixed and movable arms 410, 430 are biased toward each other. When assembled into 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 wire attached to the movable arm 430 until the spring force of the hinged portion 420 is overcome.

[0077] The fixed arm 410 is formed from a tongue 411 of material extending from a hinge portion 420 between two side beams 431 of the movable arm 430. The tongue 411 is biased between the side beams 431 by the hinge portion 420, so that a force must be applied to move the tongue 411 from a neutral position located outside the side beams 431 to a preloaded position substantially parallel to the side beams 431. The tongue 411 is retained in the preloaded position by a T-shaped crossbar 414 attached to the tongue 411 and extending outward to engage the side beams 431. In certain embodiments, the angle between the fixed and movable arms 410, 430 when the tongue is in the neutral position is approximately 30 to approximately 100 degrees, 30 to approximately 90 degrees, or approximately 30 to approximately 60 degrees, or approximately 40 to approximately 50 degrees, or approximately 45 degrees.

[0078] Tongue 411 includes a hole 412 for receiving a suture (not shown) that attaches fixation arm 410 to the implantable device. Fixation arm 410 can be attached to the implantable device by various attachment means such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, or the like. In certain embodiments, hole 412 is an elongated slot or an oval hole to accommodate sliding of layers 402, 404 without damaging the suture that attaches fastener 400 to the implantable device.

[0079] Hinge portion 420 is formed by two beam rings 422 extending from tongue 411 of fixed arm 410 to side beams 431 of movable arm 430. In some embodiments, beam rings 422 are narrower than tongue 411 and side beams 431 to provide additional flexibility. Each beam ring 422 includes a central portion 424 extending from tongue 411 and an outer portion 426 extending to side beams 431. By bending central and outer portions 424, 426 in opposite directions, beam rings 422 are bent into a slightly spiral or convoluted shape, thereby forming an offset or step 428 between tongue 411 and side beams 431. Step 428 provides space between arms 410, 430 to accommodate the native leaflets of the mitral valve after they are captured. In some embodiments, step 428 is approximately 0.5 mm to approximately 1 mm, or approximately 0.75 mm.

[0080] When viewed in a top view, the beam ring has an "Ω-like" shape. This shape of the beam ring 422 allows the fixed and movable arms 410, 430 to move considerably relative to each other without plastically deforming the fastener material. For example, in some embodiments, the tongue 411 can pivot from a neutral position approximately 45 degrees outside the movable arm 430 to a fully open position ranging from approximately 140 degrees to approximately 200 degrees to approximately 170 degrees to approximately 190 degrees, or approximately 180 degrees, from the movable arm 430 without plastically deforming the fastener material. In some embodiments, the fastener material plastically deforms during opening without reducing or substantially reducing the clamping force applied between the fixed and movable arms in the closed position.

[0081] Preloading the tongue 411 enables the clip 400 to maintain a clamping or gripping force on the native leaflet when closed, while also being able to open to more easily capture the native leaflet. The preloading of the tongue 411 provides a significant advantage over prior art clips that provide little or no clamping force when closed. Furthermore, utilizing a spring force to close the clip 400 is a significant improvement over clips that use a one-time locking closure mechanism because the clip 400 can be repeatedly opened and closed to be repositioned on the leaflet while still maintaining sufficient clamping force when closed.

[0082] The barbed portion 440 of the movable arm 430 includes an eyelet 442, a barb 444, and a barb support 446. Positioning the barbed portion of the clip 400 at the distal end of the movable arm 430 increases the space between the barb 444 and the fixed arm 410 when the clip 400 is open, thereby improving the ability of the clip 400 to successfully capture the leaflet during implantation. This distance allows the barb 444 to more reliably separate from the leaflet for repositioning. In certain embodiments, the barbs of the clip can be longitudinally staggered to further distribute the clamping force and localized leaflet stress.

[0083] The barbs 444 are laterally spaced at the same distance from the hinge portion 420, providing better distribution of the clamping force on the leaflet tissue while also allowing the fastener to capture the leaflet more strongly than barbs arranged in longitudinal rows. In some embodiments, the barbs 444 can be staggered to further distribute the clamping force and localized leaflet stress.

[0084] Barbs 444 are formed from the bottom layer 404, and barb supports 446 are formed from the top layer. In some embodiments, the barbs are formed from the top layer 402, and the barb supports are formed from the bottom layer 404. Forming barbs 444 in only one of the two layers 402, 404 allows the barbs to be thinner and, therefore, effectively sharper, than barbs made of twice the thickness of the same material. Barb supports 446 extend along the lower portion of barbs 444 to stiffen barbs 444, further improving penetration and retention of leaflet tissue. In some embodiments, the distal ends of barbs 444 are further sharpened using any suitable sharpening device.

[0085] The barbs 444 are angled away from the movable arm 430 so that they easily penetrate the tissue of the natural leaflet with minimal clamping or gripping force. The barbs 444 extend from the movable arm at an angle of approximately 45 degrees to approximately 475 degrees, or approximately 45 degrees to approximately 60 degrees, or approximately 48 degrees to approximately 56 degrees, or approximately 52 degrees. The angle of the barbs 444 provides a further benefit because the force pulling the implant away from the natural leaflet will encourage the barbs 444 to further engage the tissue, thereby ensuring better retention. The retention of the leaflet in the fastener 400 is further improved by the position of the T-shaped crossbar 414 near the barbs 444 when the fastener 400 is closed. In this arrangement, the tissue penetrated by the barbs 444 is clamped on the movable arm 430 at the position of the crossbar 414, thereby causing the tissue to form an S-shaped tortuous path as it passes over the barbs 444. Thus, the force pulling the leaflet away from the fastener 400 will encourage the tissue to further engage the barbs 444 before the leaflet is able to escape.

[0086] Each layer 402, 404 of the fastener 400 is laser cut from a shape memory alloy sheet (such as Nitinol). The top layer 402 is aligned and attached to the bottom layer 404. In certain embodiments, the layers 402, 404 are attached to the barbed ends 440 of the movable arm 430. For example, the layers 402, 404 may be attached only to the barbed ends 440 to allow the rest of the layers to slide relative to each other. The multiple parts of the combined layers 402, 404 (such as the fixed arm 410, the barbs 444 and the barbed supports 446, and the beam ring 422) are bent into the desired position. The layers 402, 404 can be bent and shaped together or can be bent and shaped separately and then combined together. The fastener 400 then undergoes a shape-setting process so that the internal forces of the material will tend to return to the final shape after being deformed by external forces. After the shape is set, the tongue 411 moves to its preloaded position, enabling attachment of the crossbar 414. Thus, the buckle 400 can be completely flattened for delivery through a delivery sheath and allowed to expand once deployed within the heart.

[0087] The fastener 400 is opened and closed by applying and releasing tension on an actuating device (not shown) such as an actuating wire, suture, wire, rod, catheter, or the like, which is attached to the movable arm 430. The suture is inserted through the eyelet 442 near the barbed portion 440 of the movable arm 430 and wrapped around the end of the movable arm 430 before returning to the delivery sheath. In some embodiments, an intermediate suture loop is passed through the eyelet and the suture is inserted through the intermediate loop. The intermediate loop of suture material reduces the friction experienced by the actuating suture relative to the friction between the actuating suture and the fastener material. When the suture is passed through the eyelet 442 or intermediate loop, the two ends of the actuating suture extend back and through the delivery sheath 102 (see Figure 1 The suture can be removed by pulling one end of the suture proximally until the other end of the suture is pulled through the eyelet or intermediate loop and back into the delivery sheath.

[0088] Now refer to Figure 27 , an exemplary barbed fastener 500 for use in an implantable prosthetic device, such as the devices 100, 200, 300 described above, is shown. Barbed fastener 500 is substantially identical to barbed fastener 400, except that barbed fastener 500 includes a suture pin 543 disposed across an opening 542 rather than a 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 thinner sheets of material to be used, thereby improving the flexibility of fastener 500 relative to fasteners formed from a single, thicker sheet, while maintaining the strength of fastener 500 required to successfully retain native valve leaflets.

[0089] 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 some embodiments, are attached to each other at the barbed ends 540. The hinged portion 520 is spring-loaded so that when the barbed fastener 500 is in a closed position, the fixed and movable arms 510, 530 are biased toward each other. When assembled into 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 actuator or actuation wire attached to the movable arm 530 until the spring force of the hinged portion 520 is overcome.

[0090] The fixed arm 510 is formed from a tongue 511 of material extending from a hinge portion 520 between two side beams 531 of the movable arm 530. The tongue 511 is biased between the side beams 531 by the hinge portion 520, so that a force must be applied to move the tongue 511 from a neutral position located outside the side beams 531 to a preloaded position substantially parallel to the side beams 531. The tongue 511 is retained in the preloaded position by a T-shaped crossbar 514 attached to the tongue 511 and extending outward to engage the side beams 531. In certain embodiments, the angle between the fixed and movable arms 510, 530 when the tongue is in the neutral position is approximately 30 to approximately 100 degrees, 30 to approximately 90 degrees, or approximately 30 to approximately 60 degrees, or approximately 40 to approximately 50 degrees, or approximately 45 degrees.

[0091] Tongue 511 includes a hole 512 for receiving a suture (not shown) that attaches fixation arm 510 to the implantable device. Fixation arm 510 can be attached to the implantable device by various attachment means such as screws or other fasteners, crimp sleeves, mechanical latches or snaps, welding, adhesives, or the like. In certain embodiments, hole 512 is an elongated slot or an oval hole to accommodate sliding of layers 502, 504 without damaging the suture that attaches fastener 500 to the implantable device.

[0092] Hinge portion 520 is formed by two beam rings 522 extending from tongue 511 of fixed arm 510 to side beams 531 of movable arm 530. In some embodiments, beam rings 522 are narrower than tongue 511 and side beams 531 to provide additional flexibility. Each beam ring 522 includes a central portion 524 extending from tongue 511 and an outer portion 526 extending to side beams 531. By bending central and outer portions 524, 526 in opposite directions, beam rings 522 are bent into a slightly spiral or convoluted shape, thereby forming an offset or step 528 between tongue 511 and side beams 531. Step 528 provides space between arms 510, 530 to accommodate the native leaflets of the mitral valve after they are captured. In some embodiments, step 528 is approximately 0.5 mm to approximately 1 mm, or approximately 0.75 mm.

[0093] When viewed in a top view, the beam ring has an "Ω-like" shape. This shape of the beam ring 522 allows the fixed and movable arms 510, 530 to move relatively significantly relative to each other without plastically deforming the fastener material. For example, in some embodiments, the tongue 511 can pivot from a neutral position approximately 45 degrees outside the movable arm 530 to a fully open position ranging from approximately 140 degrees to approximately 200 degrees to approximately 170 degrees to approximately 190 degrees, or approximately 180 degrees, from the movable arm 530 without plastically deforming the fastener material. In some embodiments, the fastener material plastically deforms during opening without reducing the clamping force applied between the fixed and movable arms in the closed position.

[0094] Preloading the tongue 511 enables the clip 500 to maintain a clamping or gripping force on the native leaflet when closed, while also being able to open to more easily capture the native leaflet. The preloading of the tongue 511 provides a significant advantage over prior art clips that provide little or no clamping force when closed. Furthermore, utilizing a spring force to close the clip 500 is a significant improvement over clips that utilize a one-time locking closure mechanism because the clip 500 can be repeatedly opened and closed to be repositioned on the leaflet while still maintaining sufficient clamping force when closed.

[0095] The barbed portion 540 of the movable arm 530 includes an eyelet 542, a barb 544, and a barb support 546. Positioning the barbed portion of the clip 500 at the distal end of the movable arm 530 increases the space between the barb 544 and the fixed arm 510 when the clip 500 is open, thereby improving the ability of the clip 500 to successfully capture the leaflet during implantation. This distance allows the barb 544 to more reliably separate from the leaflet for repositioning. In certain embodiments, the barbs of the clip can be longitudinally staggered to further distribute the clamping force and localized leaflet stress.

[0096] The barbs 544 are laterally spaced at the same distance from the hinge portion 520, providing better distribution of the clamping force on the leaflet tissue while also enabling the fastener to capture the leaflet more strongly than barbs arranged in longitudinal rows.

[0097] Barbs 544 are formed from the bottom layer 504, and barb supports 546 are formed from the top layer. Forming barbs 544 in only one of the two layers 502, 504 allows the barbs to be thinner and, therefore, effectively sharper, than barbs made of twice the thickness of the same material. Barb supports 546 extend along the lower portion of barbs 544 to stiffen barbs 544, further improving penetration and retention of leaflet tissue. In certain embodiments, the distal ends of barbs 544 are further sharpened using any suitable sharpening device.

[0098] The barbs 544 are angled away from the movable arms 530 so that they easily penetrate the tissue of the natural leaflet with minimal clamping or gripping force. The barbs 544 extend from the movable arms at an angle of approximately 45 degrees to approximately 75 degrees, or approximately 45 degrees to approximately 60 degrees, or approximately 48 degrees to approximately 56 degrees, or approximately 52 degrees. The angle of the barbs 544 provides a further benefit because the force pulling the implant away from the natural leaflet will encourage the barbs 544 to further engage the tissue, thereby ensuring better retention. The retention of the leaflet in the fastener 500 is further improved by the position of the T-shaped crossbar 514 near the barbs 544 when the fastener 500 is closed. In this arrangement, the tissue penetrated by the barbs 544 is clamped on the movable arms 530 at the position of the crossbar 514, thereby causing the tissue to form an S-shaped tortuous path as it passes over the barbs 544. Thus, the force pulling the leaflet away from the fastener 500 will encourage the tissue to further engage the barbs 544 before the leaflet is able to escape.

[0099] Each layer 502, 504 of the fastener 500 is laser cut from a shape memory alloy sheet (such as Nitinol). The top layer 502 is aligned and attached to the bottom layer 504. In certain embodiments, the layers 502, 504 are attached to the barbed ends 540 of the movable arm 530. For example, the layers 402, 404 can be attached only to the barbed ends 440 to allow the rest of the layers to slide relative to each other. The multiple parts of the combined layers 502, 504 (such as the fixed arm 510, the barbs 544 and the barbed supports 546, and the beam ring 522) are bent into the desired position. The fastener 500 then undergoes a shape setting process so that the internal forces of the material will tend to the final shape after being deformed by external forces. After the shape is set, the tongue 511 moves to its preloaded position so that the crossbar 514 can be attached. Thus, the buckle 500 can be completely flattened for delivery through a delivery sheath and allowed to expand once deployed within the heart.

[0100] The fastener 500 is opened and closed by applying and releasing tension on an actuating device (not shown) such as an actuating wire, suture, wire, rod, catheter, or the like, which is attached to the movable arm 530. The suture is inserted through an opening 542 in the movable arm 530 and wrapped around a pin 543 disposed in the opening 542. The smooth circular shape of the pin 543 allows tension to be applied to the movable arm 530 from many directions without causing the suture to wear. In some embodiments, an intermediate suture loop is passed through the opening and around the pin, and the suture is inserted through the intermediate loop. The intermediate loop of suture material reduces the friction experienced by the actuating suture relative to the friction between the actuating suture and the fastener material. As the actuating suture wraps around the pin 543, the two ends of the suture extend back into and through the delivery sheath 102 (see Figure 1 ). The suture can be removed by pulling one end of the suture proximally until the other end of the suture is pulled around the pin 543 and back into the delivery sheath.

[0101] Now refer to Figure 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 past fixed arm 622. Instead of a crossbar, movable arm 620 is held in a closed position with fixed arm 622 by an internal paddle (not shown). To better illustrate the preloading of fastener 600, Figure 28-31 The fixed arm 622 is shown moving relative to the stationary movable arm 620. However, when assembled into an implantable device, the movable arm 620 will move relative to the fixed arm 622 attached to the device.

[0102] Now refer to Figures 28-29 , shows the fastener 600 in a preloaded or shape-setting condition. Before the shape-setting operation is performed, the fixed arm 622 is bent below the movable arm 620 at an angle 610. A force must then be applied to return the fixed arm 622 to a parallel relationship with the movable arm 620. Thus, increasing the preload angle 610 increases the force required to move the fixed arm 622, thereby increasing the preload spring force that clamps 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 by the arms 620, 622 to the captured tissue.

[0103] Now refer to Figure 30-31 , showing the fastener 600 opened to an open angle 612. Figure 30and 31 As can be seen in FIG, when the buckle 600 is opened, the beam loops of the hinge portion 624 tend to separate. Allowing the layers 602, 604 to separate during bending reduces the strain on the material, thereby further increasing the maximum opening angle 612 that can be achieved before plastic deformation of the buckle material. As mentioned above, the hinge portion 624 is shaped to form a slightly spiral or convoluted beam loop, thereby forming a gap or step 614 ( ) between 620, 622 that allows the leaflet tissue to be captured. Figure 29 ).

[0104] When fastener 600 is opened, layers 602, 604 slide relative to each other in fixation arms 622. In some embodiments, the holes through fixation arms 622 are elongated so that the sutures securing fixation arms 622 to the implantable device are not pinched by the sliding movement of the layers, nor are layers 602, 604 restricted from sliding, which reduces the strain experienced by the fastener material.

[0105] Now refer to Figures 32-35 , exemplary barbed fasteners 700, 800, 900, and 1000 are shown. Like fasteners 400, 500, and 600, barbed fasteners 700, 800, 900, and 1000 can be used in the 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 side of the fastener rather than from the top. Laser cutting from the side reduces the number of steps required to manufacture the fastener and allows the thickness of the fastener to be varied to change the bending properties of various parts of the fastener based on the function of each part. For example, the hinge portion can be thinner to provide more flexibility, while the arm can be thicker to provide more rigidity.

[0106] Now refer to Figure 32, shows a laminated barbed fastener 700. Barbed fastener 700 has thick and thin portions 702, 704 and is formed from alternating spacer layers 706 and barbed layers 708 to form a laminated structure. Fastener 700 includes a movable arm 720, a fixed arm 722, and a hinge portion 724. Movable arm 720 includes a barbed portion 726 having barbs 728 formed in barb layer 708. Forming layers 706, 708 by laser cutting from the side allows barbs 728 to be tapered, thereby providing hard barbs with sharp points. Fixed arm 722 includes a hole for securing fastener 700 to an implantable device. When assembled to the implantable device, fixed arm 722 extends through an attached inner paddle so that natural tissue is sandwiched between the movable arm 720 and the inner paddle of the device. The movable and fixed arms 720, 722 are formed at an angle relative to each other so that an extension of the fixed arm 722 will intersect with the movable arm 720. Attaching the fixed arm 722 to the inner paddle effectively extends the distal end of the fixed arm 722, causing the inner paddle to interfere with the movable arm 720. This interference of the components causes the movable arm 720 to move relative to the fixed arm 722, causing the buckle 700 to open, thereby preloading the movable arm 722 so that a clamping force is applied to the inner paddle when the buckle 700 is in the closed position. Thus, a clamping force is generated between the movable and fixed arms 720, 722 without shaping the movable and fixed arms 720, 722 of the buckle 700. Alternatively, the individual layers can be formed with the movable and fixed arms 720, 722 parallel to each other and then bent and shaped so that the movable arm 720 is biased toward the fixed arm 722 when the buckle 700 is attached to the inner paddle.

[0107] Now refer to Figures 33-35 , shows exemplary barbed fasteners 800, 900, 1000. The fasteners 800, 900, 1000 are similar in overall shape, while illustrating the various thicknesses possible when the fasteners are laser cut from the side. The fasteners 800, 900, 1000 have a thin portion 804, 904, 1004 and a thick portion 802, 902, 1002. The fasteners 800, 900, 1000 include a movable arm 820, 920, 1020, a fixed arm 822, 922, 1022, and a hinge portion 824, 924, 1024. The movable arm 820, 920, 1020 includes a barbed portion 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 FIG. Figures 33-35As seen in the figures, holes can be provided in the fixation arms 822, 922, 1022 to secure the fastener 800, 900, 1000 to the implantable device. When assembled to the implantable device, the fixation arms 822, 922, 1022 extend through the attached inner paddle so that the native tissue is sandwiched between the movable arms 820, 920, 1020 of the device and the inner paddle.

[0108] Now refer to Figure 36 , shows an exemplary barbed fastener 1100 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 thick portion 1102 and a thin portion 1104. Barbed fastener 1100 includes a fixed arm 1110, a hinge portion 1120, and a movable arm 1130. Fixed arm 1110 includes an attachment hole 1112 and an optional integral crossbar 1114. Hinge portion 1120 includes an arcuate hinge 1122 formed by thin portion 1104. Movable arm 1130 includes a barbed portion 1140 having barbs 1144. Suture (not shown) can be attached to eyelets 1142 near barbed portion 1140 to open and close fastener 1100.

[0109] To form the barbed fastener 1100, a sheet of material is thinned to form a thin portion 1104. The shape of the fastener 1100 is then laser cut from the sheet of material so that the hinge portion 1120 is aligned with the thin portion 1104. The barbs 1144 and the securing arms 1110 are then bent into place before the shape is set. Figure 36 1102 is positioned as shown in FIG. The optional T-shaped crossbar 1114 of the fixed arm 1110 must be twisted to insert it through the slot in the movable arm 1130 for shape setting 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 optionally replaced with a relief slot in the movable arm 1130 to facilitate ease of manufacturing and shape setting. After shape setting, the crossbar is twisted, moved back through the slot, and positioned on top of the thick portion 1102. The crossbar 1114 is aligned with the crossbar 414 (see FIG. Figure 26 ) are positioned in roughly the same way.

[0110] Like the fasteners 400 and 500 described above, the fastener 1100 can be fully opened without plastically deforming the fastener material while still providing a clamping force when closed. Compared to the above fasteners, fewer steps are required to manufacture the fastener 1100 because the fastener 1100 is cut from a single sheet of material and does not require a welding step to weld the material layers together.

[0111] Now refer to Figure 37-52 , shows an exemplary barbed fastener 1200 for an implantable prosthetic device, such as devices 100, 200, and 300 described above. Barbed fastener 1200 is formed from a single layer 1202 of material. Barbed fastener 1200 includes a fixed arm 1210, a hinged portion 1220, and a movable arm 1230 having a barbed portion 1240. Hinge portion 1220 is spring-loaded such that the fixed and movable arms 1210, 1230 are biased toward each other when barbed fastener 1200 is in a closed condition. When assembled into an implantable prosthetic device, fixed arm 1210 is attached to a portion of the prosthetic device. Fastener 1200 is opened by pulling an actuating means, such as an actuating wire or suture, attached to movable arm 1230 until the spring force of hinge portion 1220 is overcome.

[0112] The fixed arm 1210 is formed of a tongue 1211 of material that extends from a hinge portion 1220 between two side beams 1231 of the movable arm 1230 to a distal end 1214. In some embodiments, the movable arm is formed of a tongue of material that extends between the two side beams of the fixed arm. The tongue 1211 is biased between the side beams 1231 by the hinge portion 1220 so that a force must be applied to move the tongue 1211 from a neutral position located outside the side beams 1231 to a preloaded position that is nearly parallel or parallel to the side beams 1231, as shown. Figure 39-40E . When the tongue 1211 is attached to the paddle of the implantable prosthetic device, it is maintained in the preloaded position. The end 1214 of the tongue 1211 may optionally have a T-shaped cross-member that engages the side beams 1231 to maintain the tongue 1211 in the preloaded position.

[0113] In certain embodiments, the angle between the fixed and movable arms 1210, 1230 is about 30 to about 120 degrees, 40 to about 110 degrees, or about 50 to about 100 degrees, or about 60 to about 90 degrees, or about 90 degrees when the tongue 1211 is in a neutral position. The tongue 1211 includes a hole 1212 for receiving a suture (not shown) for attaching the fixed arm 1210 to the implantable device.

[0114] The hinge portion 1220 is formed from a plurality of torsion spring segments 1222 arranged in a repeating pattern extending from the tongue 1211 of the fixed arm 1210 to the side beams 1231 of the movable arm 1230. Each spring segment 1222 is bonded to other spring segments 1222 to form the repeating pattern. Bonding the multiple segments 1222 together allows the hinge portion 1220 to flex a significant amount while avoiding plastic deformation of the material when individual torsion spring segments 1222 are twisted. For example, in certain embodiments, the tongue 1211 can pivot from a neutral position approximately 90 degrees outward from 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 approximately 180 degrees, from the movable arm 1230 without plastically deforming the fastener material. In certain embodiments, the fastener material may plastically deform during opening without reducing or substantially reducing the clamping force applied between the fixed and movable arms in the closed position. The patterned spring section 1222 is formed by the opening and closing cutouts 1224 in the hinge portion 1220. Figures 51A-52 Exemplary spring segments and their pattern arrangements are shown in .

[0115] Preloading the tongue 1211 enables the clip 1200 to maintain a clamping or gripping force on the native leaflet when closed, while also being able to open to more easily capture the native leaflet. Preloading the tongue 1211 provides a significant advantage over prior art clips that provide little or no clamping force when closed. Furthermore, utilizing a spring force to close the clip 400 is a significant improvement over clips that use a one-time locking closure mechanism because the clip 1200 can be repeatedly opened and closed to be repositioned on the leaflet while still maintaining sufficient clamping force when closed.

[0116] The barbed portion 1240 of the movable arm 1230 includes an eyelet 1242 and a barb 1244. Positioning the barbed portion of the fastener 1200 at the end of the movable arm 1230 increases the space between the barb 1244 and the fixed arm 1210 when the fastener 1200 is open, thereby improving the ability of the fastener 1200 to successfully capture the leaflet during implantation. This distance also allows the barb 1244 to be more reliably separated from the leaflet for repositioning. In some embodiments, the barbs of the fastener can be staggered longitudinally to further distribute the clamping force and localized leaflet stress. In some embodiments, the ends of the barbs 1244 are further sharpened using any suitable sharpening device.

[0117] The barbs 1244 are laterally spaced at the same distance from the hinge portion 1220, providing better distribution of the clamping force on the leaflet tissue while also allowing the fastener to capture the leaflet more strongly than barbs arranged in longitudinal rows. In some embodiments, the barbs 1244 can be staggered to further distribute the clamping force and localized leaflet stress.

[0118] Barb 1244 is angled away from movable arm 1230 at angle 1246 ( Figure 38A ), so that they easily engage the tissue of the native leaflet with minimal clamping or gripping force. In use, while the barbs 1244 can pierce the native leaflet tissue, piercing the tissue is not necessary for the fastener 1200 to securely grasp the leaflet. The barbs 1244 extend from the movable arm at an angle 1246 of about 20 degrees to about 90 degrees, or about 40 degrees to about 70 degrees, or about 50 to about 60 degrees, or about 53 degrees. The angle of the barbs 1244 provides a further benefit because the force pulling the implant away from the native leaflet will encourage the barbs 1244 to further engage the tissue, thereby ensuring better retention. The retention of the leaflet in the fastener 1200 is further improved by the position of the distal end 1214 of the fixed arm 1210 when the fastener 1200 is closed. In this arrangement, tissue engaged by barbs 1244 is clamped onto movable arm 1230 at tip 1214, thereby causing the tissue to form an S-shaped, tortuous path as it passes over barbs 1244. Thus, the force pulling the leaflet away from fastener 1200 will encourage the tissue to further engage barbs 1244 before the leaflet can escape. Tip 1214 can optionally be shaped to be slightly curved toward movable arm 1230 to accentuate the S-shaped, tortuous path of the tissue captured between fixed and movable arms 1210, 1230.

[0119] The material layer 1202 of the fastener 1200 is laser cut from a shape memory alloy sheet (such as Nitinol). Portions of the layer 1202, such as the fixed arm 1210, the hinge portion 1220, and the barbs 1244, are bent into the desired position. The fastener 1200 is then subjected to a shape setting process so that the internal forces of the material will tend to the set shape after being deformed by external forces. After shape setting, the tongue 1211 is moved to its preloaded position, closed position, or open position to attach to the implantable device. Thus, the fastener 1200 can be substantially flattened in the closed position for delivery through the delivery sheath and allowed to expand once deployed in the heart.

[0120] The fastener 1200 is activated by applying and releasing an actuating wire or suture (e.g., Figure 71The suture is opened and closed by tension on the suture 2504 of the movable arm 1230 before being returned to the delivery sheath. The suture is inserted through at least one of the eyelets 1242 near the barbed portion 1240 of the movable arm 1230 before returning to the delivery sheath. In some embodiments, the intermediate suture loop is passed through one or more of the eyelets 1242 and the actuation wire is inserted through one or more of the intermediate loops. The intermediate loop of suture material reduces the friction experienced by the actuation suture relative to the friction between the actuation suture and the fastener material. When the suture is passed through the eyelets 1242 or intermediate loops, the two ends of the actuation suture extend back and through the delivery sheath 102 (see Figure 1 The suture can be removed by pulling one end of the suture proximally until the other end of the suture is pulled through the eyelet or intermediate loop and back into the delivery sheath.

[0121] Like the fasteners 400 and 500 described above, the fastener 1200 can be fully opened without plastically deforming the fastener material while still providing a clamping force when closed. Compared to the above fasteners, fewer steps are required to manufacture the fastener 1200 because the fastener 1200 is cut from a single sheet of material and does not require a welding step to weld the material layers together.

[0122] Now refer to Figure 37-48E , showing the Figure 37-38E ) to the fully open position ( Figure 47-48E ) range of various bending positions of the fastener 1200. Although Figure 37-48E The fixed arm 1210 is shown in different positions in FIG, but once installed in the implantable device, the movable arm 1230 is actuated by the surgeon to move relative to the device while the fixed arm 1210 remains stationary relative to the device.

[0123] Figure 37-38E The fastener 1200 is shown in a neutral position for shape setting. During shape setting, the tongue 1211 of the fixed arm 1210 is bent to a tongue angle 1216 that is about 60 degrees to about 120 degrees, or about 90 degrees, below the side beam 1231 of the movable arm 1230. After shape setting, the tongue 1211 remains in the shape setting position or neutral position unless a force is applied to move the tongue 1211 to another position. Therefore, when the tongue 1211 is moved to the preloaded or closed position ( Figure 39-40E ), the internal force of the fastener material is applied in the closing direction, thereby generating a clamping force when the fastener 1200 is in the closed or preloaded condition. During implantation of a medical device including the fastener 1200, the movable arm 1230 is actuated with a suture (not shown) to change the angle 1216 between the fixed and movable arms 1210, 1230. The fastener 1200 is Figure 41-42E In the middle, it is shown in the quarter open state, Figure 43-44EIn the middle, it is half open. Figure 45-46E In the middle, it is shown in the three-quarters open state, and in Figure 47-48E 1200 is shown in a fully open condition. The angle 1216 between the fixed and movable arms 1210, 1230 in the fully open position can be about 140 degrees to about 200 degrees to about 170 degrees to about 190 degrees, or about 180 degrees. That is, the fastener 1200 can be opened substantially completely flat without plastically deforming the fastener material.

[0124] Now refer to Figures 49-50 , after being laser cut from the sheet of material, the layer of material 1202 used to form the fastener 1200 is shown in a pre-shape-set condition, ie, in a substantially flat condition. Figure 50 The repeating nature of the pattern of spring segments 1222 and cutouts 1224 forming hinge portion 1220 is particularly clearly shown.

[0125] Now refer to Figures 51A-51D , shows exemplary torsion spring segments 1300, 1400, 1500, 1600 of a patterned hinge portion (e.g., hinge portion 1220 of clasp 1200). Spring segments 1300, 1400, 1500, 1600 can be arranged in a repeating pattern cut from a single piece, such that there are no physical gaps between the individual segments. Thus, the shape of spring segments 1300, 1400, 1500, 1600 is defined by the cutouts in the hinge portion and the imaginary boundaries at the "joints" between the segments.

[0126] Now refer to Figure 51A Spring segments 1300 are formed by cutouts 1301 created in material layer 1302, resulting in a substantially rotationally symmetrical S-like shape. 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 bonding location 1312 is located at first end 1310 adjacent to first side 1330. A first side bonding location 1332 is located at first side 1330 adjacent to first end 1310. A second end bonding location 1322 is located at second end 1320 adjacent to second side 1340. A second side bonding location 1342 is located at second side 1340 adjacent to second end 1320. Side surfaces 1304 extend between first end bonding location 1312 and second side bonding location 1342, and between second end bonding location 1322 and first side bonding location 1332. An inner corner 1306 is formed near each side bonding location 1332, 1342.

[0127] Now refer to Figures 51B-51D, spring segments 1400, 1500, 1600 are shown. While these spring segments 1400, 1500, 1600 are structurally similar to the spring segment 1300 described above, the spring segments 1400, 1500, 1600 include outer corners 1408, 1508, 1608 at opposite side joints near each end joint. The shape of the spring segments 1300, 1400, 1500, 1600 can vary in the size and shape of the side surfaces 1304, 1404, 1504, 1604, the rounded inner corners 1306, 1406, 1506, 1606, and the rounded outer corners 1408, 1508, 1608. For example, the side surfaces 1304, 1404 can be substantially straight, while the side surfaces 1504, 1604 can be concave. These differences in shape change the stress distribution in the hinge portion formed by the pattern of differently shaped spring sections.

[0128] Now refer to Figure 52 , shows an exemplary spring grouping 1700 of the spring segment 1300. Figure 52 As shown in FIG, side bonding locations 1332, 1342 bond to other side bonding locations 1332, 1342, and end bonding locations 1312, 1322 bond to other end bonding locations 1312, 1322. The substantially rotationally symmetrical shape of spring segment 1300 allows the ends 1310, 1320 or sides 1330, 1340 of one segment to bond to the ends 1310, 1320 or sides 1330, 1340 of another segment. Various patterns can then be formed, such as by Figure 52 Although segments 1300, 1400, 1500, 1600 are substantially rotationally symmetrical, individual segments in the segment pattern may be modified to form rounded outer edges of hinge portions or to accommodate fixed or movable arms of a buckle.

[0129] When spring group 1700 is subjected to bending force 1710, each of segments 1300 twists in the direction indicated by arrow 1720. Thus, the individual spring segments 1300 experience torsional strain rather than bending strain. It can also be seen that the deformation of material 1302 is reduced relative to the bending of a similarly bent flat sheet of material, while maintaining the spring force of the hinge portion of the buckle. Thus, the hinge portion formed by the pattern of torsion spring segments is both strong and flexible.

[0130] To form a patterned hinge portion, such as hinge portion 1220 described above, a pattern comprising a plurality of spring segments is arranged in rows and columns. Figures 49-50As shown in Figures 5 and 52, the spring segments are arranged with their longitudinal and transverse axes in the same orientation. In some embodiments, the spring segments can be rotated relative to each other to form different spring patterns. The spring segments are organized into columns and rows. The columns are defined along the longitudinal axis of the fastener, while the rows are defined along the transverse axis of the fastener. Thus, a column of spring segments is as wide as the longest dimension of the individual spring segments, while a row of spring segments is as high as the shortest dimension of the individual spring segments. For example, Figure 50 The fastener 1200 shown in FIG includes three columns and seven rows of spring segments (excluding the partial rows connecting the hinge portion to the fixed and movable arms). Where the ends of a segment border the edge of the fastener, two segments of adjacent rows are joined together at one location to form a U-shaped group. Individual spring segments or groups of spring segments can be modified away from their rotationally symmetrical structure to increase the smoothness and / or robustness of the edge of the hinge portion. Where the ends of a segment are located at the intersection of two columns, the segment can be joined with up to three additional segments to form an X-shaped group, as in FIG. Figure 62 The patterned hinge may include any suitable number of rows and columns of spring segments. The size and shape of each segment may 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 position of the spring segments in the pattern.

[0131] Now refer to Figures 53-55 , shows an exemplary barbed fastener 1800 cut from a tube of material 1802 using four-axis laser cutting (X, Y, Z and rotational axes) and five-axis laser cutting (X, Y, Z axes and two tilt axes for the laser head). The tube can first be cut into sections, and then each section is cut in much the same way as a flat piece of stock or blank material; that is, the tube provides a curved blank rather than a flat blank. The additional degrees of freedom of the laser cutter allow the tube to be rotated or the head of the laser cutter to be tilted during laser cutting. Rotating the tube or tilting the laser cutting head allows the barbs to be cut into Figure 55 The sharper barb configuration shown in FIG. 1 is provided without the need for a separate sharpening operation. Fastener 1800 is similar in structure to fastener 1200 described above. Material tube 1802 has an inner diameter 1804, an inner surface 1801, and an outer surface 1803. When viewed from the bottom, as shown in FIG. Figure 54As shown in , cutting the fastener 1800 from the tube of material 1802 provides a concave profile or recessed profile. One effect of the recessed profile is that the elongated portions of the fixed and movable arms 1810, 1830 have increased stiffness without substantially affecting the flexibility of the hinge portion 1820. The recessed profile also results in the barbs 1844 having sharper points or tips 1846 without requiring a separate sharpening operation - that is, the barbs are formed with beveled edges without sharpening. The sharpened points 1846 enable improved engagement with native lobule tissue. Figure 55 Sharp point 1846 is formed during laser cutting because the cutting planes of the first and second sides 1847, 1848 forming barb 1844 intersect at tip 1846, thereby forming a triangular pyramid shape converging into a point, which would not be possible if the cutting planes of the sides forming the barb were parallel and non-intersecting. Thus, in a single layer of material, barb 1844 of fastener 1800 has a strong base 1845 and a sharp point 1846 without the need for a secondary sharpening operation.

[0132] Now refer to Figure 56 , shows an exemplary fastener 1900. Fastener 1900 is similar in structure to fastener 1200 described in detail above, with a structurally different hinge portion 1920. Hinge portion 1920 includes a plurality of beams 1922 formed by a series of elongated cuts 1924. Referring now to Figures 56A-56B , an alternative embodiment of the beam 1922 of the hinge portion 1920 is shown. Figure 56A A rectangular beam 1922 having a curved portion 1926 is shown. Figure 56B A rectangular beam 1922 is shown having a curved portion 1926 that is also twisted approximately 90 degrees so that the cross section of the beam in the curved portion 1926 is perpendicular to the portion of the beam 1922 at its end. Figure 56B As shown in , twisting the beam 1922 reduces the bending strain in the beam 1922, thereby increasing its flexibility.

[0133] Now refer to Figures 57-58, shows an exemplary barbed fastener 2000 for an implantable prosthetic device such as devices 100, 200, 300 described above. Barbed fastener 2000 includes fixed arms 2010 that are attached to the implantable device. Barbed fastener 2000 differs from other fasteners in that fastener 2000 includes a plurality of movable arms 2030, each having a hinged portion 2020, and a barbed portion 2040 having a single barb 2042. The individual arms 2030 of fastener 2000 individually clamp the tissue of the native leaflet, which allows for improved engagement of tissue that is non-uniform in thickness. The arms 2030 are also shaped in a wide or expanded arrangement and crimped into a narrow configuration for deployment so that the barbs 2042 are spaced apart in the transverse direction—not just in a spaced manner as would occur if the arms were rigidly connected. In certain embodiments, the arms 2030 include optional holes or indentations (not shown) that can be engaged by an actuated suture to tie the arms 2030 together during deployment.

[0134] The fixed arm 2010 is formed by a tongue 2011 from which a beam 2031 forming the movable arm 2030 extends. The hinge portion 2020 is formed by bending each of the beams 2031 to form a curved portion 2022. The hinge portion 2020 is spring-loaded so that the fixed and movable arms 2010, 2030 are biased toward each other when the barbed fastener 2000 is in a closed condition. In some embodiments, the tongue 2011 is formed from a wide sheet of material to provide a larger lateral area as a clamping location for the independent arm 2030.

[0135] The barbed fastener 2000 is cut from a layer 2002 of a shape memory alloy such as Nitinol. Figure 57A As shown in FIG, when cut from the material layer 2002, the barbs 2042 lie flat in the same plane as the rest of the fastener 2000. The movable arms 2030 and barbs 2040 are then bent and twisted into Figure 57 , and then undergo a shape setting process. As described above, the individual arms 2030 of the fastener 2000 can be shaped to be wide or narrow as needed. In some embodiments, an individual arm 2030 can be longer or shorter than the other arms, and the spacing of the arms 2030 can vary or be uniform.

[0136] Cutting the 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 some embodiments, the barbed portion 2040 may include a plurality of smaller barbs arranged in series that may or may not face in the same direction. In some embodiments, the ends of the barbs 2042 are further sharpened using any suitable sharpening device. In some embodiments, the hinge portion 2020 of the beam 2031 includes a twisting portion 2024. The twisting portion 2024 can act as a torsion spring to resist lateral forces applied to the ends of the barbs 2042, thereby helping to maintain the alignment of the barbs 2042 when engaging the tissue of the native leaflet.

[0137] Now refer to Figures 59-63 , shows an exemplary fastener 2100 for an implantable prosthetic device such as the devices 100, 200, 300 described above. The fastener 2100 is expandable between a collapsed condition and an expanded condition, and is shape-set in the expanded condition such that the fastener 2100 automatically expands from the collapsed condition to the expanded condition. Figure 61A As shown in , the fastener 2100 can be deployed from a delivery sheath 2150 in a collapsed condition and allowed to self-expand to an expanded condition.

[0138] Clamp 2100 has several features similar to clamp 1200 described in detail above, such as a patterned hinge portion 2120 formed by a plurality of spring segments 2122 and cutouts 2124, and a fixed arm 2110 including a tongue 2111 having a hole 2112 for attaching fixed arm 2110 to an implantable device and a T-shaped end 2114 for retaining fixed arm 2110 in a preloaded position. Clamp 2100 also has a movable arm 2130 including a barbed portion 2140 with a plurality of barbs 2142.

[0139] The hoop-like shape of the movable arm 2130 provides a wider barbed portion 2140 that may include more barbs having the same or greater lateral spacing than other fasteners. The wider spacing of the barbs 2142 improves capture of the native leaflet. 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, so that the clamping force of the paddle is evenly distributed across the barbs, further improving retention of the native leaflet. Due to the position of the barbs 2142 on the hoop-like shape of the movable arm 2130, some of the barbs 2142 can also be longitudinally staggered. In certain embodiments, the ends of the barbs 2142 are further sharpened using any suitable sharpening device. In certain embodiments, the tongue 2111 is formed from a wide plate material to provide a larger lateral area as a clamping location.

[0140] The movable arm 2130 is provided in the shape of a hoop or ring. The movable arm 2130 includes a side beam 2131 that is thinner and more flexible, particularly in the transverse direction, than the side beam 1231 of the buckle 1200 described above. The side 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 side beam 2132. In certain embodiments, the second hinge portion 2136 includes a thinner and therefore more flexible portion to reduce the force required to collapse the buckle 2100. The movable arm 2130 includes a hole 2134 disposed between the first and second hinge portions 2132, 2136 for receiving an actuation suture 2152 for collapsing the movable arm 2130. The hole 2134 is disposed further laterally from the center of the fastener 2130 than the hinge portions 2132, 2136 to provide a mechanical advantage when force is applied via the suture 2152. In certain embodiments, the hole 2134 is located at the most lateral location of the side rail 2131.

[0141] The hoop shape of the fastener 2100 allows the fastener 2100 to be collapsed simply by retracting the fastener 2100 into the delivery sheath. In certain embodiments, the expansion and contraction of the fastener 2100 is controlled by actuating the suture 2152. The suture 2152 can pass through the hole 2156 of the guide 2154 to the hole 2134 in the movable arm 2130 to control the direction of application of the force applied along the suture 2152 to tie the movable arm 2130 into the collapsed position. For example, positioning the guide 2154 closer to the point of attachment of the suture 2152 to the fastener 2100 causes the force applied to the fastener 2100 by the suture 2152 to be directed in a more lateral direction rather than a longitudinal direction. Alternatively, as Figure 61B As shown in FIG, a single suture loop 2153 can be passed through the hole 2156 of 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 will tie the movable arm 2130 to the collapsed position.

[0142] Now refer to Figures 64-68 , shows an exemplary barbed fastener 2200 for 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 securing arm 2210 that attaches to the implantable device and a hinge portion 2220 that allows fastener 2200 to open and close. Hinge portion 2220 is formed by a repeating pattern of spring segments 2222 and cutouts 2224, as in fastener 1200.

[0143] The barbed fastener 2200 also includes similar features to fastener 2000, such as a plurality of independently movable arms 2230, each having a barbed portion 2240 with a single barb 2244. The independent arms 2230 of the fastener 2200 individually grip the tissue of the native leaflet, which allows for improved engagement of tissues of uneven thickness. The arms 2230 can also be shaped and crimped into a narrow configuration for deployment in a wide or expanded arrangement so that the barbs 2244 can be spaced apart in the transverse direction—not just in a spaced manner as would be the case if the arms were rigidly connected. The barbed portion 2240 of each arm 2230 includes an aperture 2242 for receiving an actuation suture 2252 ( Figure 65A ).

[0144] Fastener 2200 is expandable between a collapsed condition and an expanded condition and is shaped in the expanded condition such that fastener 2200 automatically expands from the collapsed condition to the expanded condition. Figure 65A As shown in FIG, the fastener 2200 can be deployed from a delivery sheath 2250 in a collapsed condition and allowed to self-expand to an expanded condition. The expansion and contraction of the fastener 2200 is controlled by actuating sutures 2252, which tie the independent arms 2230 together to collapse the fastener 2200 so that the fastener 2200 fits within the delivery sheath 2250. In some embodiments, the independent arms are collapsed together simply by retracting the fastener 2100 into the delivery sheath.

[0145] The securing arm 2210 is formed by a tongue 2211 extending from a hinge portion 2220 to a distal end 2214. The tongue 2211 includes a hole 2212 for securing the tongue 2211 to an implantable device. In some embodiments, the tongue 2211 is formed from a wide sheet of material to provide a larger lateral area for clamping. In some embodiments, the distal end 2214 of the tongue 2211 includes a T-shaped transverse element, as in the fastener 2100.

[0146] The barbed fastener 2200 is cut from a layer 2202 of a shape memory alloy such as Nitinol. Figure 57A In the fastener 2100 shown in FIG, when cut from the material layer 2002, the barbs 2242 lie flat in the same plane as the rest of the fastener 2200. The movable arm 2230 and the barbed portion 2240 are then bent and twisted into Figures 64-68 , and then undergoes a shape setting process. In some embodiments, the barbs of the independent arms are cut [?] so that the barbs bend upward like the barbs of the fastener 1200, thereby eliminating the need to twist the independent arms. As described above, the independent arms 2230 of the fastener 2200 can be shaped to be wide or narrow as needed. In certain embodiments, an individual arm 2230 can be longer or shorter than the other arms, and the spacing between the arms 2230 can vary or be uniform.

[0147] Cutting the barbs 2244 from a sheet of material and then twisting them into place also allows for the formation of larger barbs of various shapes. In some embodiments, the barbed portion 2240 may include a plurality of smaller barbs arranged in series that may or may not face in the same direction. In some embodiments, the ends of the barbs 2244 are further sharpened using any suitable sharpening device. In some embodiments, the beam 2231 includes a twisted portion 2232. The twisted portion 2232 can act as a torsion spring to resist lateral forces applied to the ends of the barbs 2244, thereby helping to maintain the alignment of the barbs 2244 when engaging the tissue of the natural leaflet.

[0148] Now refer to Figure 69-73B , shows various arrangements for attaching an actuating suture to an exemplary barbed fastener. In these embodiments, the intermediate suture loop is passed through one or more of the eyelets in the barbed fastener, and the actuating suture is inserted through one or more of the intermediate loops. Connecting to the fastener via the intermediate loop of suture material reduces the friction experienced by the actuating suture relative to the friction between the actuating suture and the fastener material. Both ends of the actuating suture extend back into and through 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 through the eyelet or intermediate loop and back into the delivery sheath.

[0149] Now refer to Figure 69 , an exemplary suture arrangement 2300 is shown attached to the aforementioned barbed fastener 400. The suture arrangement 2300 includes a central suture loop 2302 that is inserted through the eyelet 442 and around the end of the barbed portion 440. Alternatively, the central suture loop 2302 can be inserted through the eyelet 442 and between the side beams of the movable arm. An actuation suture 2304 can be passed from the delivery sheath through the central suture loop 2302 and back into the delivery sheath. When the spring force holding the fastener 400 closed is overcome, the tension applied to the actuation suture 2304 opens the fastener 400. The tension on the actuation suture 2304 is released, allowing the fastener 400 to spring shut. The rounded shape of the barbed portion 440 of the fastener 400 prevents the fastener 400 from grabbing onto native tissue or other parts of the implantable device.

[0150] Now refer to Figures 70A-70B, an exemplary suture arrangement 2400 is shown attached to the aforementioned barbed fastener 1200. The suture arrangement 2400 includes a central suture loop 2402 inserted through the central eyelet 1242 and between the side beams 1231 of the movable arm 1230. An actuation suture 2404 is passed from the delivery sheath through the central suture loop 2402 and back into the delivery sheath. When the spring force holding the fastener 1200 closed is overcome, the tension applied to the actuation suture 2404 opens the fastener 1200. The release of the tension on the actuation suture 2404 allows the fastener 1200 to spring open and close.

[0151] Figure 70A 1200 and 1200. FIG2 is a side view of a suture arrangement 2400 showing that a gap or recess 2406 can be formed between the end of the fastener and the actuation suture 2404 of the above-described suture arrangement 2400. Specifically, the gap 2406 can be formed when the actuation suture 2404 is angled with the barbed portion of the fastener 1200. Figure 70B 2404 and the side of the barbed portion 1240 of the fastener 1200. In some cases, the gaps or grooves 2406, 2408 can become catch points - that is, locations with the potential to grab or hold onto native tissue or other parts of the implantable device during deployment and installation and / or during retraction on the catheter wall. In particular, sharp angles and edges can become catch points. Figure 70B As shown in , rounding the corners of the fastener 1200 reduces the chance that the fastener 1200 will catch. In some embodiments, the device does not include any grooves that are deeper than one-third of the width of the device.

[0152] Now refer to Figure 71 , a front view of an exemplary suture arrangement 2500 is shown attached to the aforementioned barbed fastener 1200. The suture arrangement 2500 includes a central suture loop 2502 that is inserted through the central eyelet 1242 and around the end of the barbed portion 1240. An actuation suture 2504 is passed from the delivery sheath through the central suture loop 2502 and back into the delivery sheath. When the spring force holding the fastener 1200 closed is overcome, the tension applied to the actuation suture 2504 opens the fastener 1200. The tension on the actuation suture 2504 is released, allowing the fastener 1200 to spring open and close.

[0153] Forming an intermediate suture loop 2502 around the end of the barbed portion 1240 eliminates gaps (e.g., Figure 70A The gap 2406 shown in FIG will be formed between the actuating suture and the fastener. Figure 70B The stitch arrangement shown in 2400, Figure 71A side gap 2508 is shown formed between the actuation suture 2504 and the side of the barbed portion 1240 of the fastener 1200. In certain situations, the gap 2508 can become a grasping point—that is, a location with the potential to grasp or catch native tissue or other parts of the implantable device during deployment and installation and / or during retraction on the catheter wall. In particular, sharp angles and edges can become grasping points. Figure 71 As shown in , rounding the corners of fastener 1200 reduces the chance that fastener 1200 will grab onto native tissue or other parts of the device.

[0154] Now refer to Figure 72-73B , an exemplary suture arrangement 2600 is shown attached to the aforementioned barbed fastener 1200. Suture arrangement 2600 includes a central suture loop 2602 that is inserted through an eyelet 1242 near the side of fastener 1200 and around the end of barbed portion 1240. An actuation suture 2604 is passed from a delivery sheath through central suture loop 2602 and back into the delivery sheath. When the spring force holding fastener 1200 closed is overcome, the tension applied to actuation suture 2604 opens fastener 1200. The release of tension on actuation suture 2604 allows fastener 1200 to spring open and close.

[0155] Suture placement 2600 reduces or eliminates Figures 70A-71 The gap shown in the figure can be turned into a gripping point. The formation of an intermediate suture loop 2602 around the end of the barbed portion 1240 eliminates the need for Figure 70A The gap 2406 shown in FIG may form between the fastener 1200 and the actuation suture 2604. Suture arrangement 2600 also reduces or eliminates the side gaps between the actuation suture 2604 and the sides of the fastener 1200, as shown in FIG. Figure 70B and 71 Side gap 2508 shown in .

[0156] Now refer to Figures 74A-75 , shows an exemplary barbed fastener and implantable device. As described above, a grip point is a location on an implantable device that has the potential to grip or hold onto native tissue, other parts of the implantable device, and / or a delivery catheter during deployment and installation and / or during recapture or retraction. In addition to grip points that can be formed on separate components of an implantable device (such as the grip points described above), grip points can also be formed by assembling two or more components.

[0157] Now refer to Figures 74A-74B, an exemplary implantable device 2700 is shown assembled with two barbed fasteners 400. The barbed fastener 400 is attached to an inner paddle 2720 of the implantable device 2700 that extends from the mate 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 condition, the offset of the hinge portion 420 creates a gap 2740 between the fastener 400 and the mate element 2710 that becomes a gripping point. As shown Figure 74B As shown in , although the gap 2740 is reduced or eliminated when the clasp 400 is partially opened, the overall width of the device 2700 is increased by the opening of the clasp 400. Figure 74B As shown in FIG, the catch point can be eliminated during recapture or retraction by partially opening the fastener 400. Partially opening the fastener has the additional benefit of allowing the actuation wire or suture to engage the opening 2703 of the delivery sheath 2702 when the device is retracted into the sheath, thereby opening the opening 2703 and providing a larger opening through which the device 2700 can be withdrawn. When the suture is extended from the fastener in two positions, as shown in FIG. Figure 70B and 71 Those sutures shown in FIG. 27 are configured to engage opening 2703 in two locations, thereby widening opening 2703 in a substantially diamond-shaped shape. Figure 72 Those sutures shown in FIG4 engage the opening 2703 in four locations because the sutures extend from the fasteners in four locations, thereby widening the opening 2703 in a substantially rectangular shape. After the hinge portion 420 is in the catheter, the actuation sutures 2734 can be relaxed.

[0158] Now refer to Figure 75 , an exemplary implantable device 2800 is shown assembled with two barbed fasteners 1200. The barbed fastener 1200 is attached to an inner paddle 2820 of the implantable device 2800 that extends from the mating 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 the formation of a grab point at the intersection 2840 between the hinge portion 1220 and the mating element 2810. Thus, the shape of the fastener 1200 reduces or eliminates gaps that can become grab points, such as Figure 74B 2740 shown in the embodiment of the present invention, without having to partially open the clasp 1200 during retraction or recapture.

[0159] In certain embodiments, rather than a central suture loop, the actuation wire or suture is attached to a portion of a covering surrounding a fastener of the implantable device. For example, the actuation wire or suture may be threaded through a loop or opening in the covering. The covering may be formed of a flexible material, which may be a mesh that is woven, braided, or formed in any other suitable manner. The flexible material may be cloth, a shape memory alloy wire, such as Nitinol, to provide shape-holding capabilities, or any other flexible material suitable for implantation in the human body.

[0160] Now refer to Figure 76 , shows a side view of an exemplary barbed fastener 2900. Although shown in the shape of fastener 1200 described above, fastener 2900 can have any shape suitable for use as a barbed fastener formed from layers of laminated 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 material layer 2902 and a second material layer 2904. Layers 2902, 2904 can be formed from similar or different materials and can have the same or different thicknesses. In certain embodiments, additional layers of material can also be provided.

[0161] Now refer to Figure 77 , shows a side view of an exemplary double-ended barbed fastener 3000. Double-ended fastener 3000 has a fixed arm 3010 with a hinge portion 3020 and movable arms 3030 extending from both ends. Each movable arm 3030 includes a barbed portion 3040 containing at least one barb 3042. Although barbs 3042 are shown facing outward, in other embodiments, barbs 3042 face inward. Although fastener 3000 is formed from first and second layers of material 3002, 3004, in some embodiments, the fastener is formed from a single layer, and in certain other embodiments, from more than two layers. The hinge portion 3020, movable arm 3030, and barbed portion 3040 can be formed in the shape of any of the fasteners described above.

[0162] Now refer to Figures 78-79, shows an exemplary barbed fastener 3102 for an implantable prosthetic device, such as devices 100, 200, and 300 described above. Barbed fastener 3102 includes elements of fastener 1200 described above. Barbed fastener 3102 includes a fixed arm 3110 that attaches to the implantable device, and a hinge portion 3120 that allows fastener 3102 to open and close. Hinge portion 3120 is formed by a repeating pattern of spring segments 3122 and cutouts 3124, as in fastener 1200. Barbed fastener 3102 also includes a pair of independent first and second movable arms 3130, 3132 that extend from hinge portion 3120 to a barbed portion 3140 having barbs 3144.

[0163] The securing arm 3110 is formed by a tongue 3111 extending from the hinge portion 3120 to a distal end 3114. The tongue 3111 includes a hole 3112 for securing the tongue 3111 to the implantable device. In some embodiments, the tongue 3111 is formed from a wide sheet of material to provide a larger lateral area for clamping. In some embodiments, the distal end 3114 of the tongue 3111 includes a T-shaped transverse element, similar to that of the fastener 3102.

[0164] The movable arms 3130, 3132 of the clasp 3102 individually clamp the tissue of the native leaflet, which allows 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 the movable arm 1230 of the clasp 1200, which is divided into first and second movable arms 3130, 3132 by a cut 3148, allowing the first and second movable arms 3130, 3132 to open and close independently of each other. In some embodiments, the hinge portion 3120 is also divided into first and second hinge portions (not shown).

[0165] Now refer to Figure 79, an exemplary implantable device 3100 is shown assembled with two barbed fasteners 3102. The barbed fasteners 3102 are attached to an inner paddle 3108 of the implantable device 3100 that extends from an apposition element 3106. An actuation arrangement 3150 includes a middle suture loop 3152 attached to an aperture 3146 in the barbed portions 3140 of the first and second movable arms 3130, 3132, and first and second actuation sutures 3154, 3156. The first and second actuation sutures 3154, 3156 extend from the delivery sheath 3104 through the middle suture loop 3152 and back into the delivery sheath 3104. Each of the movable arms 3130, 3132 can be individually opened by applying tension to the first and second actuation sutures 3154, 3156, respectively. Individually opening the first and second movable arms 3130 , 3132 allows the clamping 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 .

[0166] Now refer to Figures 80A-80E , shows an exemplary barbed fastener 3200 that can be used with an implantable prosthetic device such as devices 100, 200, 300 described above. The fastener 3200 is configured to place tension on the natural tissue when the implantable prosthetic device, e.g., any of the devices described herein, is attached to natural tissue. Like the barbed fasteners described above, the barbed fastener 3200 includes a fixed arm 3210, a hinge portion 3220, and a movable arm 3230 having a barbed portion 3240. The fixed arm 3210 of the fastener 3200 is slidably connected to the paddle 3202 of the implantable device such that the fastener 3200 can be moved along the paddle 3202 in a direction 3204. For example, an actuation wire 3250 can be used to move the fastener 3200 along the paddle 3202 in a direction 3204. The actuation wire 3250 can also be used to move the fastener 3200 in a closed position (e.g., Figure 80A ) and the open position (as shown in Figure 80B ). The actuator wire 3250 can take any form described herein. In some embodiments, the clasp 3200 includes a device configured to hold the clasp 3200 in a desired position (e.g., Figure 80A and 80E , and any biasing element 3260 (e.g., a spring) in the position shown in FIG.

[0167] refer to Figure 80A , the fastener 3200 is shown in a first position on the paddle 3202 and in a closed position. Figure 80B , the buckle 3200 is shown after the movable arm 3230 has been moved to the open position in direction 3203 by the actuation line 3250. Figure 80C, buckle 3200 is shown after being moved in direction 3205 along paddle 3202 to a second position. In some embodiments, buckle 3200 is moved in direction 3205 along paddle 3202 by actuation wire 3250 or a separate mechanism. In embodiments including biasing element 3260, sufficient force is applied to buckle 3200 to move buckle 3200 in direction 3205, causing biasing element 3260 to expand and create tension on buckle 3200 in direction 3206, which is opposite to direction 3205. Although buckle 3200 is moved in direction 3205 along paddle 3202 to a second position (e.g., Figure 80C ), the exemplary embodiment shows that the fastener 3200 is moved to the open position (as shown in FIG. Figure 80B ), but it should be understood that the clasp 3200 may be moved in direction 3205 to the second position before the movable arm 3230 of the clasp 3200 is moved in direction 3203 to the open position, or the movements may be simultaneous. Figure 80D , the movable arm 3230 is moved to a closed position in direction 3207 by the actuation line 3250 to secure the barbed portion 3240 of the fastener 3200 to the valve tissue (not shown). Figure 80D , the biasing element 3260 is held in the extended position (e.g., due to a force applied to the buckle 3200 by the actuation wire 3250 or another mechanism to hold the buckle 3200 in the second position), meaning that the biasing element 3260 places tension on the buckle 3200 in the direction 3206. Figure 80E After barbed portion 3240 of fastener 3200 is secured to the native tissue, the force holding fastener 3200 in the second position is released, causing the tension applied by biasing element 3260 to move fastener 3200 along paddle 3202 in direction 3208. Movement of fastener 3200 in direction 3208 causes barbed portion 3240 to generate 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.

[0168] Now refer to Figures 81A-81C, shows an exemplary barbed fastener 3300 for an implantable prosthetic device, such as devices 100, 200, and 300 described above. When the implantable prosthetic device, such as any of the devices described herein, is attached to natural tissue, the fastener 3300 is configured to place tension on the natural tissue. Like 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 include, for example, a cutout in the movable arm 3330, a different material than the rest of the movable arm 3330, or may take any other suitable form that allows the flexible portion 3332 to be more flexible than the rest of the movable arm 3330. In some embodiments, the flexible portion 3332 is omitted, and the actuation mechanism 3350 is still capable of causing the barbed portion 3340 of the movable arm 3330 to move as shown in FIG. Figures 81A-81C deflection as shown in .

[0169] The actuation mechanism 3350 includes an actuation wire 3352 (e.g., a suture) and a push-pull link 3354 configured to receive the wire 3352. The push-pull link 3354 can be a catheter, a wire with a loop (e.g., a Figure 82 ), or any other linkage capable of receiving the wire 3352 and pushing or pulling the movable arm 3330 of the buckle 3300. The actuation wire 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 disposed proximate the barbed portion 3340. The actuation wire 3352 also extends from the first connection point 3356 and is removably attached to the movable arm 3330 at a second connection point 3358 disposed between the flexible portion 3332 and the hinge portion 3320. The actuation wire 3352 then extends from the second connection point 3358 and passes through a push-pull linkage 3354 at a second end 3353.

[0170] refer to Figure 81A , the fastener 3300 is shown in an open position, wherein the natural tissue 3302 is disposed in 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 wire 3352. Figure 81B, the link 3354 and the wire 3352 of the actuating mechanism 3350 are used to move the movable arm 3330 to the closed position in the closing direction 3306 and to flex the barbed portion 3340 in the opening direction 3308. To do so, the first end 3351 of the wire 3352 is pulled in the opening direction 3308 and the link 3354 is pushed in the closing direction 3306, causing the barbed portion 3340 of the movable arm 3330 to pivot or flex at the flexible portion 3332 in the upward direction 3303 (as it opens). Still referring to Figure 81B , the link 3354 and wire 3352 are moved so that the barbed portion 3340 engages or pierces the natural tissue 3302 when the movable arm 3330 is moved to the closed position and the barbed portion 3340 is in the flexed position.

[0171] Now refer to Figure 81C , the first end 3351 of the wire 3352 is released, allowing the barbed portion 3340 of the movable arm 3330 to pivot about the flexible portion 3332. When the barbed portion 3340 pivots, the natural tissue 3302 is retracted in the downward or inward direction 3305, thereby generating tension on the natural tissue in the inward direction 3305. After the movable arm 3330 is fixed to the natural tissue 3302 (as shown in FIG. Figure 81C ), the link 3354 and wire 3352 are removed from the buckle 3300.

[0172] Now refer to Figure 82, shows an actuation mechanism 3400 for an implantable prosthetic device, such as devices 100, 200, and 300 described above. Mechanism 3400 includes first and second control members 3410, 3420 extending from a delivery device 3402. Delivery device 3402 can be any suitable device, such as a sheath or catheter. First and second control members 3410, 3420 include first and second sutures 3412, 3422, and first and second flexible filaments 3414, 3424. First and second flexible filaments 3414, 3424 extend from delivery device 3402 and each include a loop 3416, 3426 for receiving first and second sutures 3412, 3422 and for engaging a fastener (e.g., fastener 1200 described above). Each of first and second sutures 3412, 3422 extends from delivery device 3402, passes through one of first and second loops 3416, 3426, respectively, and returns to delivery device 3402. In some embodiments, the first and second control members 3412, 3422 extend through a separate delivery device 3402. The sutures 3412, 3422 are removably attached to the movable arms of the exemplary barbed fasteners described above. The first and second loops 3416, 3426 of each wire 3414, 3424 are movable along the corresponding suture 3412, 3422, allowing the loops 3416, 3426 to engage the corresponding barbed fasteners, thereby engaging the movable arms. That is, the sutures 3412, 3422 are used to pull the movable arms in an opening direction, while the wires 3414, 3424 are used to push the movable arms in a closing direction. The wires 3414, 3424 can be made of, for example, a steel alloy, a nickel-titanium alloy, or any other metal or plastic material. In certain embodiments, the diameter of the filaments 3414, 3424 can be between approximately 0.10 mm and approximately 0.35 mm, between approximately 0.15 mm and approximately 0.30 mm, and between approximately 0.20 mm and approximately 0.25 mm.

[0173] Although each creative aspect, conception and feature of the disclosure can be described in this article and be illustrated as embodied in conjunction with exemplary embodiments, these various aspects, conception and feature can be used individually or in the mode of its various combinations or sub-combinations in many optional embodiments.Unless clearly excluded herein, all such combinations and sub-combinations are intended to be within the scope of the application.In addition, although the optional embodiments (such as optional materials, structures, configurations, methods, devices and parts, about the alternative selection of form, coordination and function etc.) of each aspect, conception and feature of the disclosure can be described in this article, such description is not intended to be a sufficient or detailed list of obtainable optional embodiments (no matter currently known or later developed).Those skilled in the art can easily adopt one or more of creative aspect, conception and feature to other embodiments and purposes within the scope of the application, even if such embodiments are not clearly disclosed in this article.

[0174] In addition, even though some features, concepts or aspects of the disclosure may be described herein as being preferred arrangements or methods, such description is not intended to imply that such features are required or essential unless expressly set forth as such. Furthermore, exemplary or representative values ​​and ranges may be included to aid understanding of the present application, however, such values ​​and ranges are not to be interpreted in a limiting sense and are intended to be critical values ​​or ranges unless expressly set forth as such.

[0175] Furthermore, while various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the disclosure, such identification is not intended to be exclusive, and there may be inventive aspects, concepts, and features that are fully described herein without being so expressly identified or being part of a particular disclosure, which disclosure is instead set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps as required in all instances, nor is the order in which the steps are presented to be construed as required or necessary unless expressly so set forth. Terms used in the claims have their full ordinary meaning and are not limited in any way by the description of embodiments in the specification.

Claims

1. An implantable prosthetic device for helping to seal a native heart valve and prevent or reduce regurgitation therethrough, the prosthetic device comprising: Integral components; a plurality of paddles movable from an open position to a closed position to capture native mitral or tricuspid valve leaflets between the paddles and the apposition element; and a double-ended barbed fastener having a base and movable arms extending from opposite ends of the base, the base having a hinge portion disposed adjacent the engaging element; wherein each of said movable arms is movable from an open position to a closed position to clamp said native mitral or tricuspid valve leaflet to a respective one of said plurality of paddles; The barbed fastener is spring loaded such that in the closed position, the barbed fastener is configured to continue to provide a clamping force on the captured native mitral or tricuspid valve leaflet.

2. The device of claim 1 , wherein the apposition element has an upper end configured to be positioned in or near the atrium, a lower end configured to be positioned in or near the ventricle, and a side surface extending between the leaflets of the native mitral or tricuspid valve.

3. The device of claim 1 , wherein the coaptation element is configured to be positioned within the native heart valve orifice to help form a more effective seal between the native mitral or tricuspid valve leaflets.

4. The device of claim 1 , wherein the apposition element has a blood-impermeable structure, and wherein the structure allows the native mitral or tricuspid valve leaflets to close together on either side of the apposition element during ventricular systole to prevent blood from flowing back from the ventricle into the atrium. The device of claim 1 , wherein the apposing element has a non-cylindrical shape. The device according to claim 5 , wherein the involute element has an elliptical cross-sectional shape or a crescent cross-sectional shape.

7. The device of claim 1 configured to seal against two or three native valve leaflets.

8. The device of claim 1, wherein the apposition elements are configured to self-expand from a radially compressed state to a radially expanded state.

9. The device of claim 8, wherein the apposition element is formed of a flexible material which may be mesh, woven, or braided, preferably wherein the flexible material is a shape memory alloy wire, such as Nitinol.

10. The device of claim 1, further comprising an actuation device attached to a distal end of each of the movable arms.

11. The device of claim 10, wherein applying tension to the actuation device causes the movable arm to pivot on the hinge portion.

12. A device according to any one of claims 10 or 11, wherein the actuation means is independently actuatable so that each barbed fastener can be opened and closed independently.

13. The device of claim 12, wherein the barbed fastener is capable of opening and closing independently of the position of the paddle.

14. The device of any one of claims 1-11 configured to be retained in a deployed condition by means of a mechanical latch or biased through the use of a spring material, wherein the deployed condition is a condition in which the paddle and barbed fastener are maintained in their respective closed positions.

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