Heart valve sealing device and associated feeding devices

Abstract

Implantable prosthetic device (100) that helps to seal native heart valves and prevent or reduce regurgitation through them, the prosthetic device (100) comprising: a coaptation element (110); several paddles (120, 122) that are movable between a closed position and an open position to accommodate native mitral or tricuspid valve leaflets (42, 44) between the paddles (120, 122) and the coaptation element (110); and a double-ended prong clamp (3000) having a base (3010) with joint sections (3020) located near the coaptation element (110) and movable arms (3030) extending from both ends of the base (3010); wherein each of the movable arms (3030) can be moved from an open position to a closed position in order to press the native mitral or tricuspid valve tissue (42, 44) against one of the several paddles (120, 122) respectively.

Description

CROSS-REFERENCE TO RELATED REGISTRATIONS

[0001] The present application relates to and claims the benefits of the following patent applications: US Patent Application No. 15 / 884,193, filed on January 30, 2018; US Patent Application No. 15 / 909,803, filed on March 1, 2018; US Patent Application No. 15 / 910,951, filed on March 2, 2018; US Patent Application No. 15 / 914,143, filed on March 7, 2018; US Patent Application No. 15 / 927,814, filed on March 21, 2018; US Patent Application No. 15 / 946,604, filed on April 5, 2018; US Patent Application No. 15 / 953,220, filed on April 13, 2018; US Patent Application No. 15 / 953,263, filed on April 13, 2018, US Patent Application No. 15 / 953,283, filed on April 13, 2018, Preliminary US Application Serial No. 62 / 486,835, filed on April 18, 2017, entitled HEART VALVE SEALING DEVICES AND DELIVERY DEVICES THEREFOR, the full disclosure of which is included here by reference. TECHNICAL AREA

[0002] The present invention relates generally to prosthetic devices and associated methods for assisting in the sealing of the body's own (native) heart valves or for preventing or reducing blood backflow or regurgitation through them, as well as devices and associated methods for implanting such prosthetic devices. BACKGROUND OF THE INVENTION

[0003] The native (body's own) heart valves (i.e., the aortic, pulmonary, tricuspid, and mitral valves) perform vital functions by ensuring the forward flow of an adequate amount of blood through the cardiovascular system. These heart valves can be damaged by congenital malformations, inflammatory processes, infectious conditions, or diseases, and thus function less efficiently. Such valve damage can lead to serious cardiovascular impairment or death. For many years, the primary treatment for such damaged valves was surgical repair or replacement during open-heart surgery. However, open-heart surgery is highly invasive and prone to numerous complications. Therefore, such a procedure was often avoided in elderly and frail patients with defective heart valves.Recently, transvascular techniques have been developed that allow prosthetic devices to be inserted and implanted in a way that is far less invasive than open-heart surgery. One specific transvascular technique used to access the body's own mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein and advancing it up the inferior vena cava into the left atrium. The septum is then punctured, and the catheter is advanced into the left atrium.

[0004] A healthy heart generally has a conical shape, tapering towards a lower apex. The heart has four chambers: the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The mitral valve connects the left atrium to the left ventricle. The mitral valve has an anatomy that differs significantly from other heart valves. It contains an annulus, a ring-shaped section of the body's own valve tissue surrounding the mitral valve orifice, and a pair of cusps or leaflets that extend downward from the annulus into the left ventricle.The mitral valve annulus can have a D-shaped, oval, or otherwise non-circular cross-sectional shape with a major and a minor axis. The anterior leaflet may be larger than the posterior leaflet, generally forming a C-shaped boundary between the adjacent free edges of the leaflets when they close.

[0005] When functioning correctly, the anterior and posterior leaflets work together as a one-way valve, allowing blood to flow exclusively from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle relaxes (also known as ventricular diastole or diastole), the oxygen-rich blood that has accumulated 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 compresses the two leaflets, closing the one-way mitral valve. This prevents blood from flowing back into the left atrium and instead forces it out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing due to pressure and snapping back through the mitral annulus into the left atrium, they are held in place by a multitude of tendinous cords called chordae tendineae, which attach them to the papillary muscles in the left ventricle.

[0006] Mitral regurgitation, or mitral insufficiency, occurs when the mitral valve does not close properly, allowing blood to flow from the left ventricle into the left atrium during the systolic phase of heart contraction. Mitral regurgitation is the most common form of valvular heart disease. It has various causes, such as leaflet prolapse, dysfunctional papillary muscles, and / or stretching of the mitral valve annulus due to left ventricular dilation. Mitral regurgitation in the mid-section of the leaflets is called mid-ray mitral regurgitation, while regurgitation closer to a leaflet commissure (i.e., where the leaflets meet) is called lateral-ray mitral regurgitation.A midstream regurgitation occurs when the edges of the sails do not meet in the middle and thus the flap does not close, resulting in regurgitation.

[0007] Some known techniques for treating mitral regurgitation in patients involve directly stapling the edges of the patient's mitral valve leaflets together. Attempts have been made to staple the leaflet edges together using a clip delivered via a catheter, similar to a surgical stapling procedure. However, this clip has limitations, as it can only be used to staple the mid-margins of the leaflets, specifically where they overlap by approximately 2 mm or more. Alternatively, attempts have been made to use multiple clips at the mitral valve commissures, where there may be a greater overlap of the leaflets. This technique is more time-consuming and also involves stapling the patient's leaflets laterally, which restricts blood flow.Furthermore, it can be assumed that both surgical treatment and clip treatment place a strain on the patient's sails.

[0008] Despite these available techniques, there remains a need for improved devices and procedures for the treatment of mitral valve regurgitation. OVERVIEW

[0009] An implantable prosthetic device comprises a coaptation portion, paddles, and clasps. The paddles are movable from a closed to an open position. The clasps are also movable from an open to a closed position. The implantable prosthetic device can be used to repair a native valve, such as a native mitral valve.

[0010] A better understanding of the features and advantages of the present invention is set out in the following description and the claims, in particular in conjunction with the accompanying drawings, in which identical parts are provided with the same reference numerals. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] These and other features and advantages of the present invention will now be better illustrated by reference to the following description in conjunction with the accompanying drawings, in which: Fig. Figures 1-6 show an implantable prosthetic device according to a first embodiment at various stages of insertion; Fig. 7-12 the implantable prosthetic device made of Fig. 16 during insertion and implantation into the body's own mitral valve; Fig. 13-13A show another implantable prosthetic device according to a second embodiment; Fig. Figures 14-25 show another implantable prosthetic device according to a third embodiment during insertion and implantation into the body's own mitral valve; Fig. 23A shows a section of mitral valve tissue captured by a barbed clamp or barbed clamp; Fig. 26 shows a spiked clamp for an implantable prosthetic device according to one embodiment; Fig. 27 shows a spiked clamp for an implantable prosthetic device according to a second embodiment; Fig. 28 shows a spiked clamp for an implantable prosthetic device according to a third embodiment; Fig. 29-31 show a side view of a spiked clamp for an implantable prosthetic device in various bending stages; Fig. 32 shows a spiked clamp for an implantable prosthetic device according to a fourth embodiment; Fig. 33 shows a spiked clamp for an implantable prosthetic device according to a fifth embodiment; Fig. 34 shows a spiked clamp for an implantable prosthetic device according to a sixth embodiment; Fig. 35 shows a spiked clamp for an implantable prosthetic device according to a seventh embodiment; Fig. 36 shows a spiked clamp for an implantable prosthetic device according to an eighth embodiment; Fig. 37-52 show a spiked clamp for an implantable prosthetic device according to a ninth embodiment; Fig. 53-55 show a spiked clamp for an implantable prosthetic device according to a tenth embodiment; Fig. 56 shows a spiked clamp for an implantable prosthetic device according to an eleventh embodiment; Fig. 56A-56B alternative embodiments of joint sections of the spike clamp made of Fig. 56 show; Fig. 57-58 show a spiked clamp for an implantable prosthetic device according to a twelfth embodiment; Fig. 57A shows a flat stamped article used to manufacture the items described in the Fig. 57 and Fig. The spiked clamp shown in section 58 is used; Fig. 59-63 show a spiked clamp for an implantable prosthetic device according to a thirteenth embodiment; Fig. 64-68 show a spiked clamp for an implantable prosthetic device according to a fourteenth embodiment; Fig. 69-73B show exemplary arrangements for attaching actuating cords to an exemplary prosthetic clamp for an implantable prosthetic device; Fig. Figures 74A-74B show an exemplary barbed clamp which is opened using actuating cords; Fig. Figure 75 shows an exemplary spiked clamp according to the ninth or tenth embodiment with actuating cords; Fig. 76 shows a spiked clamp for an implantable prosthetic device according to a fifteenth embodiment; Fig. 77 shows a spiked clamp for an implantable prosthetic device according to a sixteenth embodiment; Fig. 78-79 show a spiked clamp for an implantable device according to a seventeenth embodiment; Fig. 80A-80E show a spiked clamp for an implantable device according to an eighteenth embodiment; Fig. 81A-81C show a spiked clamp for an implantable device according to a nineteenth embodiment; Fig. Figure 82 shows an exemplary actuation mechanism for use with the implantable devices described herein. DETAILED DESCRIPTION

[0012] If, in the following description, one or more components are described as connected, joined, fixed, coupled, attached, or otherwise connected to one another, such a connection can be either directly between the components in question or indirectly, for example, through the use of one or more intermediate components. Furthermore, any reference here to an "element," a "component," or a "section" is not to be understood as limited to a single structural element, component, or element, but can also refer to an arrangement of components, links, or elements. Moreover, the terms "essentially" and "approximately" used here are defined as being at least close to (and containing) a given value or state (preferably within a range of 10%, more preferably within 1%, and most preferably within 0.1% thereof).

[0013] A prosthetic device comprises a coaptation device or element and at least one anchoring device or anchor. The coaptation element is designed to be positioned within the body's natural heart valve orifice to assist in the formation of a more efficient seal between the body's natural leaflets, thereby reducing or preventing regurgitation. The coaptation element may have a blood-impermeable structure that allows the body's natural leaflets to close against each other on either side of the coaptation element during ventricular systole, thus preventing backflow of blood from the left or right ventricle into the left or right atrium, respectively.The prosthetic device can be designed to seal against two or three natural valve leaflets; that is, the device can be used with both a natural mitral (bicuspid) and a natural tricuspid valve. The coaptation element is sometimes also referred to as a spacer, since it can bridge a gap between malfunctioning, natural mitral or tricuspid leaflets that no longer close completely.

[0014] The coaptation element can have various shapes. According to some embodiments, the coaptation element can have an elongated, cylindrical shape with a round cross-sectional shape. According to other embodiments, the coaptation element can have an oval cross-sectional shape, a crescent-shaped cross-sectional shape, or various other non-cylindrical shapes. The coaptation element can have an atrial or superior end positioned in or adjacent to the left atrium, a ventricular or inferior end positioned in or adjacent to the left ventricle, and a lateral surface extending between the mitral valve leaflets.In embodiments designed for use in the tricuspid valve, the atrial or upper end is positioned in or adjacent to the right atrium, the ventricular or lower end is positioned in or adjacent to the right ventricle, and the lateral surface extends between the body's own tricuspid leaflets.

[0015] The anchor can be designed to attach the device to one or both of the mitral valve leaflets such that the coaptation element is positioned between the two leaflets. In embodiments designed for use in the tricuspid valve, the anchor is designed to attach the device to one, two, or three of the tricuspid valve leaflets such that the coaptation element is positioned between the three leaflets. According to some embodiments, the anchor can be attached to the coaptation element at a location adjacent to the ventricular end of the coaptation element. According to some embodiments, the anchor can be attached to an actuating device, such as a shaft or actuating wire, to which the coaptation element is also attached.According to some embodiments, the anchor and the coaptation element can be positioned independently of each other by moving them separately along the longitudinal axis of the shaft or actuating wire. According to other embodiments, the anchor and the coaptation element can be positioned simultaneously by moving them together along the longitudinal axis of the shaft or actuating wire. The anchor can be designed to be positioned behind a body sail during implantation in such a way that the sail is captured by the anchor.

[0016] The prosthetic device can be designed for implantation via a delivery system, such as a delivery sleeve. The coaptation element and the anchor can be compressible into a radially compressed state and self-expanding into a radially expanded state when compression pressure is removed. The device can be designed such that the anchor initially expands radially away from the still-compressed coaptation element to create a gap between the coaptation element and the anchor. Subsequently, an autologous sail can be positioned within this gap. The coaptation element can then expand radially, closing the gap between the coaptation element and the anchor and trapping the sail between them.According to some embodiments, the anchor and coaptation element are optionally designed to be self-expanding. The implantation procedures may differ for various embodiments of the prosthetic device and are discussed in more detail below with respect to each embodiment. Additional information regarding these and other insertion and delivery procedures can be found in U.S. Patent No. 8,449,599 and U.S. Patent Application Publications Nos. 2014 / 0222136 and 2014 / 0067052, 2016 / 0331523.

[0017] In the disclosed prosthetic devices, atrial embolization is avoided by hooking the anchor to a sail, utilizing the tension of the body's own chordae tendineae, which is capable of withstanding the high systolic pressure that tends to push the device toward the left atrium. During diastole, the devices benefit from the compression and retention forces exerted by the sail, which is captured by the anchor, to prevent embolization into the left ventricle.

[0018] In the Fig. Figures 1-6, to which reference is now made, show an implantable prosthetic device 100 in various stages of insertion. The device 100 is inserted from a delivery sleeve 102 and comprises a coaptation section 104 and an anchor section 106. The coaptation section 104 of the device 100 contains a coaptation element 110, which is adapted for implantation between the leaflets of the patient's own mitral valve and is slidably attached to an actuating wire or shaft 112. The anchor section 106 is actuated between an open and a closed state and can assume a wide range of shapes, such as paddles, grasping elements, or the like. Actuation of the actuating wire 112 opens and closes the anchor section 106 of the device 100 to capture the mitral valve leaflets during implantation.The actuating wire or shaft 112 can take on a wide range of different forms. For example, the actuating wire or shaft can be threaded so that turning the actuating wire or shaft moves the armature section 106 relative to the coaptation section 104. Alternatively, the actuating wire or shaft can also be unthreaded so that pushing or pulling the actuating wire or shaft 112 moves the armature section 106 relative to the coaptation section 104.

[0019] The anchor section 106 of the device 100 contains outer paddles or gripping elements 120 and inner paddles or gripping elements 122, which are connected between a cap 114 and the coaptation element 110 by sections 124, 126, and 128. Sections 124, 126, and 128 can be hinged and / or flexible to allow movement between all the positions described below. The actuating wire 112 extends through the feed sleeve and the coaptation element 110 to the cap 114 at the distal end of the anchor section 106. Extending and retracting the actuating wire 112 increases or decreases the distance between the coaptation element 110 and the cap 114, respectively.The coaptation element 110 is detachably attached to the feed sleeve 102 by means of an attachment means or a collar (not shown), so that the coaptation element 110 slides along the actuating wire 112 during actuation to open and close the paddles 120, 122 of the anchor section 106.

[0020] In Fig. In Figure 3, to which reference is now made, the spiked clamps 130 comprise a base or a fixed arm 132, a movable arm 134, spikes 136, and a joint section 138. The fixed arms 132 are attached to the inner paddles 122, with the joint section 138 being located near the coaptation element 110. The joint section 138 provides a spring force between the fixed arm and the movable arm 132, 134 of the spiked clamp 130. The joint section 138 can be any suitable joint, such as a flexible joint, a spring joint, a hinge, or the like. According to certain embodiments, the joint section 138 is a flexible piece of material formed integrally with the fixed arm and the movable arm 132, 134.The fixed arms 132 are attached to the inner paddles 122 and remain stationary relative to the inner paddles 122 when the movable arms 134 are opened to open the spine clamps 130 and expose the spines 136. The spine clamps 130 are opened by applying a tensile force to the actuating cords 116 attached to the ends of the movable arms 134, causing the movable arms 134 to pivot at the joint sections 138.

[0021] During implantation, the paddles 120, 122 are opened and closed to capture the patient's own mitral valve leaflets between the paddles 120, 122 and the coaptation element 110. The spine clamps 130 further secure the patient's own leaflets by engaging them with spines 136 and clamping them between the movable arms and the fixed arms 134, 132. The spines 136 of the spine clamps 130 increase friction with the leaflets or can also partially or completely pierce them. The actuating cables 116 can be operated independently of each other, so that each spine clamp 130 can be opened and closed independently. This independent actuation allows only one leaflet to be captured at a time, or a clamp 130 to be repositioned on an insufficiently captured leaflet without altering a successfully established grip on the other leaflet.The spiked clamps 130 can not only be opened and closed independently of each other, but can also be fully opened and closed independently of the position of the inner paddle 122, making it possible to capture the sails in many different positions depending on the requirements of a specific situation.

[0022] The spiked clamps 130 can be opened independently by pulling on an associated actuating device or actuating cord 116, which extends through the feed sleeve 102 to the end of the spiked clamp 130. The actuating cord 116 can take many different forms, such as a cord, a thread, a wire, a rod, a catheter, or the like. The spiked clamps 130 can be spring-loaded so that they continue to exert a clamping force (squeezing force) on the captured body sails even in the closed position. This clamping force remains constant regardless of the position of the inner paddles 122. The spikes 136 of the spiked clamps 130 can pierce the body sails to further secure them.

[0023] In Fig. Figure 1, to which reference is now made, shows the device 100 in an elongated or fully open state, ready to be inserted from a delivery sheath. The device 100 is loaded into the delivery sheath in the fully open position because the fully open position occupies the least space and thus allows the use of the smallest catheter (or the largest device 100 that can be used for a given catheter size). In the elongated state, the cap 114 is spaced apart from the coaptation element 110, so that the paddles 120, 122 of the anchor section 106 are reversed or fully open. According to some embodiments, the angle between the inner surfaces of the outer paddle and the inner paddle 120, 122 is approximately 180 degrees. The barb clips 130 are held in a closed position by the delivery sheath 102 during insertion, so that the barbs 136 ( Fig. 3) not become trapped in or damage the patient's sheath or heart tissue.

[0024] In Fig. Figure 1A, to which reference is now made, shows the device 100 in an elongated untangling state, similar to that in Fig. 1, however, with the prong clamps 130 in a fully open position, with a range of approximately 140 degrees to approximately 200 degrees, to approximately 170 degrees, to approximately 190 degrees, or approximately 180 degrees between the fixed and movable sections of the prong clamps 130. By fully opening the device 100 and the clamps 130, it has been proven that the ease of disentangling from the patient's anatomy during implantation of the device 100 has been improved.

[0025] In Fig. Figure 2, to which reference is now made, shows the device 100 in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier maneuvering and placement inside the heart. To move the device 100 from the extended state to the shortened state, the actuating wire 112 is retracted, so that the cap 114 is drawn toward the coaptation element 110. The joints or flexible connections 126 between the outer paddle 120 and the inner paddle 122 are restricted in their movement such that compressive pressures acting on the outer paddle 120 when the cap 114 is retracted toward the coaptation element 110 cause the paddles or grasping elements 120, 122 to move radially outward.During the movement from the open to the closed position, the outer paddles 120 maintain an acute angle with respect to the actuating wire 112. The outer paddles 120 may optionally be biased towards the closed position. The inner paddles 122 move over a considerably larger angle during the same movement, as they are oriented away from the coaptation element 110 in the open position and are folded along the sides of the coaptation element 110 in the closed position. According to certain embodiments, the inner paddles 122 are thinner and / or narrower than the outer paddles 120, and the hinge or flex sections 126, 128 connected to the inner paddles 122 are thinner and / or more flexible to allow a greater degree of movement than the hinge or flex section 124 that connects the outer paddles 124 to the cap 114.

[0026] In the Fig. Figures 3-5, to which reference is now made, show the device 100 in a partially open, ready-to-catch state. To effect a transition from the fully closed state to the partially open state, the actuating wire 112 is extended to push the cap 114 away from the coaptation element 110, thereby pulling on the outer paddles 120, which in turn pulls on the inner paddles 122, causing the anchor section 106 to partially unfold. The actuating cords 116 are also retracted to open the clamps 130, allowing the sails to be caught.

[0027] In Fig. 4, to which reference is now made, one of the actuating strands 116 is extended to allow the closing of one of the clamps 130. In Fig. 5, to which reference is now made, the other actuating strand 116 is extended to allow the closing of the other clamp 130. One or the other actuating strand 116, or both, can be actuated repeatedly to repeatedly open and close the barbed clamps 130.

[0028] In Fig. Figure 6, to which reference is now made, shows the device 100 in a fully closed and installed state. The feed sleeve 102 and the actuating wire 112 are retracted, and the paddles 120, 122, and the clamps 130 remain in a fully closed position. The fully installed device 100 can then be held in the fully closed position by means of a mechanical lock, or it can be pre-tensioned and thus held closed by means of spring materials such as steel, other metals, plastics, composites, etc., or shape memory alloys such as Nitinol. For example, the hinge or flex sections 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or an additional pre-tensioning component (see component 224 in Figure 6) can be pre-tensioned. Fig. 13) made of metals such as steel or a shape-memory alloy such as Nitinol – manufactured in the form of a wire, sheet, tube, or laser-sintered powder – and prestressed such that they hold the outer paddles 120 closed around the coaptation element 110 and hold the spine clamps 130 clamped around the body's own sails. Similarly, the fixed arm and the movable arm 132, 134 of the spine clamps 130 are also prestressed to clamp the sails. According to certain embodiments, the joint sections 124, 126, 128, 138 and / or the inner and outer paddles 122 and / or an additional prestressing component (see component 224 in Fig. 13) be made of any other suitable elastic material, such as a metal or polymer material, to keep the device closed after implantation.

[0029] In the Fig. 7-12, to which reference is now made, is the implantable device 100 from the Fig. Figures 1-6 show that it is inserted and implanted inside the body's own mitral valve 40 of a heart 10. In Fig. 7, to which reference is now made, the feed sleeve is inserted through the septum into the left atrium 20 and the device 100 is inserted from the feed sleeve in the fully open state. The actuating wire 112 is then withdrawn to move the device 100 into the Fig. to move to the fully closed state shown in section 8. As in Fig. As can be seen in Figure 9, the device 100 is positioned inside the mitral valve 40 in the ventricle 30 and partially opened so that the leaflets 42, 44 can be captured. Fig. 10, to which reference is now made, an actuating cord 116 is extended to close one of the clamps 130 and thereby capture a sail 42. Fig. Figure 11 shows the other actuating strand 116, which is then extended to close the other clamp 130 and thus capture the remaining sail 44. Finally, as in Fig. 12 can be seen, whereupon the feed sleeve 102 and the actuating wire 112 are withdrawn and the device 100 is now completely closed and inserted into the body's own mitral valve 400.

[0030] In Fig. Figure 13, to which reference is now made, shows an implantable prosthetic device 200. The implantable device 200 is one of the many different configurations described in the Fig. The device 200 can be assumed as shown schematically in Figure 1-12. The device 200 is inserted from a delivery sheath (not shown) and contains a coaptation section 204 and an anchor section 206. The device 200 is loaded into the delivery sheath in the fully open position because the fully open position occupies the least space and thus allows the use of the smallest catheter (or the largest device 200 that can be used for a given catheter size). The coaptation section 204 of the device contains a coaptation element 210 for implantation between the leaflets of the patient's own mitral valve, which is slidably attached to an actuating wire or shaft 212. Actuation of the actuating wire 212 opens and closes the anchor section 206 of the device 200 to capture the mitral valve leaflets during implantation.

[0031] The anchor section 206 of the device 200 contains outer paddles 220 and inner paddles 222, which are pivotably connected to the cap 214 and the coaptation element 210. The actuating wire 212 extends through the feed sleeve (not shown), a collar 211, and the coaptation element 210 to the cap 214 at the distal end of the anchor section 206. By extending and retracting the actuating wire 212, the distance between the coaptation element 210 and the cap 214 is increased or decreased, respectively. The collar 211 optionally includes a collar seal 213 which, during implantation of the device 200, forms a seal around the actuating wire or shaft 212 and forms a tight seal when the actuating wire 212 is removed, in order to substantially seal the device 200 against blood flow through the interior of the coaptation element 210 after implantation.In some embodiments, the coaptation element 200 is detachably engaged by the collar 2011 and attached to the feed sleeve, such that during actuation, the coaptation element 210 slides along the actuating wire 212 to open and close the paddles 220, 222 of the anchor section 206. In some embodiments, the collar 2011 is held closed around the coaptation element 210 by the actuating wire 212, so that removing the actuating wire 212 allows the fingers (not shown) of the collar to open, thereby releasing the coaptation element 210. In some embodiments, the cap 2014 optionally includes a seal 216 and / or an insert 218 that fit into an opening 215 of the coaptation element 210, the coaptation element 210 having an internal cavity.The seal 216 and / or the insert 218 keep the coaptation element 210 substantially closed to blood flow when the actuating wire 212 is removed and the device 200 is implanted.

[0032] The coaptation element 210 and the paddles 220, 222 are formed from a cover, which may be a net, woven, braided, or formed in any other suitable manner. The cover may be made of a fabric, a wire of a shape-memory alloy—such as Nitinol—to provide shape-adjusting capability, or another flexible material suitable for implantation into the human body. Paddle frames 224 provide additional clamping force between the outer paddles 222 and the coaptation element 210 and assist in wrapping the sails around the sides of the coaptation element 210 to achieve a better seal between the coaptation elements 210 and the sails. In some embodiments, the cover extends around the paddle frames 224.

[0033] The spine clamps 230 comprise a base or fixed arm 232, a movable arm 234, spines 236, and an articulated section 238. The fixed arms 232 are attached to the inner paddles 222, with the articulated section 238 located near the coaptation element 210. The fixed arms 232 are attached to the inner paddles 222 by threads (not shown) through holes or slots 233. The fixed arms 232 can be attached to the inner paddles 222 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical locks or snaps, welds, adhesives, or the like. The fixed arms 232 remain stationary relative to the inner paddles 222 when the movable arms 234 are opened to open the spine clamps 230 and expose the spines 236.The spiked clamps 230 are opened by applying a tensile force to actuating cords (not shown) which are attached to holes 235 located at the ends of the movable arms 234, causing the movable arms 234 to pivot at the joint sections 238.

[0034] During implantation, the paddles 220, 222 are opened and closed to capture the patient's own mitral valve leaflets between the paddles 220, 222 and the coaptation element 210. The prong clamps 230 further secure the patient's own leaflets by engaging them with prongs 236 and clamping them between the movable arms and the fixed arms 234, 232. The prongs 236 of the prong clamps 230 increase friction with the leaflets or can also partially or completely pierce them. The actuating cables can be operated independently of each other, so that each prong clamp 230 can be opened and closed independently. This independent actuation allows only one leaflet to be captured at a time, or a clamp 230 to be repositioned on an insufficiently captured leaflet without altering a successfully established grip on the other leaflet.The spiked clamps 230 can not only be opened and closed independently of each other, but can also be fully opened and closed independently of the position of the inner paddle 222, making it possible to capture the sails in many different positions depending on the requirements of a specific situation.

[0035] In the Fig. Figures 14-25, to which reference is now made, show an implantable device 300 that is inserted and implanted inside the body's own mitral valve 40 of the heart 10. The device 300 is similar to the implantable device 200 from Figure 14-25. Fig. 13, although the device 300 has a cover over the coaptation element 310, the clamps 330, the inner paddles 322, and / or the outer paddles 320. The device 300 is inserted from a delivery sleeve 302 and includes a coaptation section 304 and an anchor section 306. The coaptation section 304 of the device contains a coaptation element 310 for implantation between the leaflets of the patient's own mitral valve, which is slidably attached to an actuating wire or shaft 312. Actuation of the actuating wire or shaft 312 opens and closes the anchor section 306 of the device 300 to capture the mitral valve leaflets during implantation.

[0036] The anchor section 306 of the device 300 contains outer paddles 320 and inner paddles 322, which are flexibly connected to the cap 314 and the coaptation element 310. The actuating wire 312 extends through a collar 303 (see Fig. 20), through the feed sleeve 302 and through the coaptation element 310 to the cap 314 at the distal end of the anchor section 306. By extending and retracting the actuating wire 312, the distance between the coaptation element 310 and the cap 314 is increased or decreased, respectively. The coaptation element 310 is detachably attached to the feed sleeve 302 by the fingers of a collar 303, so that during actuation the coaptation element 310 slides along the actuating wire 312 to open and close the paddles 320, 322 of the anchor section 306. According to some embodiments, the collar 303 is held closed around the coaptation element 310 by the actuating wire 312, so that removing the actuating wire 312 allows the fingers of the collar 303 to open, thereby releasing the coaptation element 310.

[0037] The coaptation element 310 and the paddles 320, 322 are formed from a flexible material, which may be a mesh that is woven, braided, or formed in any other suitable manner. The flexible material may consist of a fabric, a wire made of a shape-memory alloy—such as nitinol—to provide a shape-adjusting capability, or any other flexible material suitable for implantation into the human body.

[0038] The barbed clamps 330 contain a base or a fixed arm 332, a movable arm 334, barbs 336 (see Fig. 20) and a joint section 338. The fixed arms 332 are attached to the inner paddles 322, with the joint section 338 located near the coaptation element 310. The fixed arms 332 are attached to the inner paddles 322 by sutures (not shown). The fixed arms 332 can be attached to the inner paddles 322 by any suitable means, such as screws or other fasteners, crimp sleeves, mechanical locks or snap elements, welds, adhesives, or the like. The fixed arms 332 remain stationary when the movable arms 334 are opened to open the spine clamps 330 and expose the spines 336.The spiked clamps 330 are opened by applying a tensile force to the actuating cords 316 attached to the ends of the movable arms 334, causing the movable arms 334 to pivot at the joint sections 338.

[0039] During implantation, the paddles 320, 322 are opened and closed to capture the patient's own mitral valve leaflets between the paddles 320, 322 and the coaptation element 310. The outer paddles 320 have a wide, curved shape that wraps around and is adapted to the curved shape of the coaptation element 310 to more reliably grasp the leaflets. The curved shape and rounded edges of the outer paddle 320 also prevent tearing of the leaflet tissue. The spine clamps 330 further secure the patient's own leaflets by engaging them with spines 336 and clamping them between the movable arms and the fixed arms 334, 332. The spines 336 of the spine clamps 330 increase friction with the leaflets or can also partially or completely pierce them.The actuating cables can be operated independently of each other, allowing each spiked clamp 330 to be opened and closed independently. This independent operation makes it possible to capture only one sail at a time or to reposition a clamp 330 on a sail that is insufficiently captured, without altering a successfully set grip on the other sail. The spiked clamps 330 can not only be opened and closed independently of each other, but can also be fully opened and closed independently of the position of the inner paddle 322, thus making it possible to capture the sails in a variety of positions depending on the requirements of a specific situation.

[0040] 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 thus allows the use of the smallest catheter (or the largest device 300 that can be used for a given catheter size). Fig. 14, to which reference is now made, the feed sleeve is inserted through the septum into the left atrium 20, thereby setting the device 300 in the fully open state from the feed sleeve 302. Subsequently, the actuating wire 312 is retracted to move the device 300 into the Fig. to move to the fully closed state shown in 15-16, and then this will be, as in Fig. 17 shown, maneuvered towards the mitral valve 40. In Fig. 18, to which reference is now made, the actuating wire 312 is extended when the device 300 is aligned with the mitral valve 40 to move the paddles 320, 322 into the partially open position, and then the actuating cables 316 are retracted to open the spike clamps 330 in preparation for catching the sails. Next, as in the Fig. As shown in Figures 19-20, the partially open device 300 is inserted through the mitral valve 40 until the sails are correctly positioned between the inner paddles 322 and the coaptation element 310 inside the spine clamps 330. Fig. Figure 21 shows the device 300 with both clamps 330 in the closed position, although the prongs 336 of one of the clamps 330 have missed one of the sails 44. As shown in the Fig. As can be seen in Figures 22-23, the mispositioned clamp 330 is reopened and closed again to catch the missed sail 44. When both sails 42 and 44 are correctly caught, the actuating wire 312 is retracted to return the device 300 to the position shown in Figures 22-23. Fig. to move the device 300 to the fully closed position shown in Figure 24. After the device 300 has been fully implanted into the patient's own mitral valve 40, the actuating wire 312 is removed to release the collar 303 from an upper end or upper plate 311 of the coaptation element 310. The fully implanted device 300 can then be held in the fully closed position by means of a mechanical device such as a locking mechanism, or it can be pre-tensioned and thus held closed by means of a spring material such as steel and / or shape memory alloys such as nitinol.For example, the paddles 320, 322 can be made of steel or a nitinol shape memory alloy - manufactured in the form of a wire, a sheet, a tube or a laser-sintered powder - and be pre-stressed such that they keep the outer paddles 320 closed around the coaptation element 310 and hold the spine clamps 330 clamped around the body's own sails.

[0041] In Fig. Figure 23A, to which reference is now made, shows a close-up view of one of the sails 42, 44, which is captured by one of the clamps 330. The sail 42, 44 is captured between the movable and the fixed arms 334, 332 of the clamp 330. As in Fig. As shown in Figure 23A, the tissue of the sail 42, 44 is not pierced by the spines 336, although in some embodiments the spines 336 may partially or completely pierce the sail 42, 44. The angle and height of the spines 336 relative to the movable arm 334 contribute to securing the sail 42, 44 within the clamp 330. In particular, a force aimed at pulling the implant away from the body's own sail presses the spines 336 deeper into the tissue, thus ensuring a better hold. The hold of the sail 42, 44 in the clamp 330 is further improved by the position of the fixed arm 332 close to the spines 336 when the clamp 330 is closed. In this arrangement, the tissue is formed into an S-shaped, winding path by the fixed and movable arms 332, 334 and by the spines 336.Thus, forces aimed at pulling the sail away from the clamp 330 tend to cause the tissue to engage further with the spines 336 before the sail can escape.

[0042] Fig. Figure 26, which is now referred to, shows an exemplary prong clasp 400 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The prong clasp 400 is formed from an upper layer (or layer) 402 and a lower layer (or layer) 404. The two-layer construction of the clasp 400 allows the use of thinner material sheets, thereby improving the flexibility of the clasp 400 compared to a clasp formed from a single, thicker sheet, while still maintaining the strength of the clasp 400 required for successful retention of an autologous valve leaflet.

[0043] The prong clamp 400 comprises a fixed arm 410, a joint section 420, and a movable arm 430 with a prong section 440 (prong-equipped section). The upper and lower layers 402, 404 have a similar shape and, in certain embodiments, are joined at the prong-equipped end 440. The joint section 420 is spring-loaded, so that the fixed arm and the movable arm 410, 430 are biased against each other when the prong clamp 400 is in a closed position. When mounted on an implantable prosthetic device, the fixed arm 410 is attached to a section of the prosthetic device. The clamp 400 is opened by pulling on an actuating cord attached to the movable arm 430 until the spring force of the joint section 420 is overcome.

[0044] The stationary arm 410 is formed by a material tongue 411, which extends from the joint section 420 between two side supports 431 of the movable arm 430. The tongue 411 is pre-tensioned between the side supports 431 by the joint section 420 such that a force must be applied to move the tongue 411 from a neutral position, in which it extends beyond the side supports 431, to a pre-tensioned position, in which it runs essentially parallel to the side supports 431. The tongue 411 is held in the pre-tensioned position by a T-shaped cross member (transverse element) 414, which is attached to the tongue 411 and extends outwards from it to engage with the side supports 431.When the tongue is in the neutral position, according to certain embodiments the angle between the fixed and the movable arm 410, 430 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.

[0045] The tongue 411 contains holes 412 for receiving sutures (not shown) by which the fixed arm 410 is attached to an implantable device. The fixed arm 410 can be attached to an implantable device by various means, such as screws or other fasteners, crimp sleeves, mechanical locks or snaps, welding, adhesives, or the like. According to certain embodiments, the holes 412 can be elongated slots or oval holes to allow displacement of the layers 402, 404 without damaging the sutures by which the clamp 400 is attached to an implantable device.

[0046] The joint section 420 is formed by two support loops 422 extending from the tongue 411 of the fixed arm 410 to the side supports 431 of the movable arm 430. In certain embodiments, the support loops 422 are narrower than the tongue 411 and the side supports 431 to provide additional flexibility. Each support loop 422 comprises a central section 424 extending from the tongue 411 and an outer section 426 extending towards the side supports 431. The support loops 422 are formed to a certain degree into a spiral or helical shape by bending the central and outer sections 424, 426 in opposite directions, thereby forming an offset or step 428 between the tongue 411 and the side supports 431.The step spacing 428 creates a space between arms 410 and 430 to receive the mitral valve leaflets after they have been captured. According to certain embodiments, the step spacing 428 is approximately 0.5 millimeters to approximately 1 millimeter, or approximately 0.75 millimeters.

[0047] Viewed from above, the support loops have an "omega-shaped" form. This shape of the support loops 422 allows a considerable degree of movement of the fixed and movable arms 410, 430 relative to each other without plastic deformation of the clamping material. In some embodiments, for example, the tongue 411 can be pivoted from a neutral position, which projects approximately 45 degrees beyond the movable arm 430, into a fully open position, which lies within a range of approximately 140 degrees to approximately 200 degrees, to approximately 170 degrees, to approximately 190 degrees, or at approximately 180 degrees with respect to the movable arm 430, without plastic deformation of the clamping material.According to certain embodiments, the clamping material is plastically deformed during opening without reducing or significantly reducing the clamping force acting between the fixed and movable arms in the closed position.

[0048] Pre-tensioning the tongue 411 allows the clip 400 to maintain a clamping force on the sail in the closed position, while still being able to open wide for easier catching of the sail. This pre-tensioning of the tongue 411 offers a significant advantage over comparable clips of the prior art, which exhibit little or no clamping force when closed. Furthermore, the spring-assisted closing mechanism of the clip 400 represents a significant improvement over clips using a one-time locking mechanism, as the clip 400 can be repeatedly opened and closed for repositioning on the sail and still maintains sufficient clamping force when closed.

[0049] The spiked section 440 of the movable arm 430 includes an eyelet 442, spikes 444, and spike supports 446. By positioning the spiked section of the clamp 400 at one end of the movable arm 430, the space between the spikes 444 and the fixed arm 410 is increased when the clamp 400 is opened, thereby improving the clamp 400's ability to successfully capture the sail during implantation. This distance also allows the spikes 444 to be more reliably disengaged from the sail for repositioning. According to certain embodiments, the clamp's spikes can be arranged offset lengthwise to better distribute the clamping forces and thus the local load on the sail.

[0050] The prongs 444 are spaced transversely at the same distance from the joint section 420, resulting in a better distribution of clamping forces on the sail fabric and a more reliable capture of the sail by the clamp than is the case with a prong arrangement in a longitudinal row. According to some embodiments, the prongs 444 can be arranged offset to better distribute the clamping forces and thus the local load on the sail.

[0051] The spines 444 are formed from the lower layer 404, and the spine supports 446 are formed from the upper layer. In certain embodiments, the spines are also formed from the upper layer 402, and the spine supports are formed from the lower layer 404. Forming the spines 444 from only one of the two layers 402, 404 makes it possible to design the spines thinner and thus, in effect, sharper than would be possible with a spine of the same material twice as thick. The spine supports 446 extend along a lower section of the spines 444 to stiffen them, thereby further improving penetration of and adhesion to the sailcloth. In certain embodiments, the ends of the spines 444 are further sharpened by any suitable sharpening agent.

[0052] The spines 444 are angled away from the movable arm 430 so that they can penetrate the tissue of the body's own sails with minimal clamping force. The spines 444 extend from the movable arm at an angle of approximately 45 degrees to approximately 75 degrees, or from approximately 45 degrees to approximately 60 degrees, or from approximately 48 degrees to approximately 56 degrees, or from approximately 52 degrees. The angle of the spines 444 provides additional advantages in that a force aimed at pulling the implant away from the body's own sail forces the spines 444 deeper into the tissue, thus ensuring better retention. The retention of the sail in the clamp 400 is further enhanced by the position of the T-shaped crossbar 414 close to the spines 444 when the clamp 400 is closed.In this arrangement, the tissue pierced by the spines 444 is clamped against the movable arm 430 at the location of the crossbeam 414, thereby forming the tissue into an S-shaped, winding path as it passes over the spines 444. Thus, forces aimed at pulling the sail away from the clamp 400 cause the tissue to engage further with the spines 444 before the sail can escape.

[0053] Each layer 402, 404 of the clamp 400 is laser-cut from a sheet of a shape-memory alloy such as Nitinol. The upper layer 402 is aligned with and attached to the lower layer 404. According to certain embodiments, the layers 402, 404 are attached to one another at the spiked end 440 of the movable arm 430. For example, the layers 402, 404 may be attached only at the spiked end 440 to allow free movement relative to each other for the remaining layers. Sections of the combined layers 402, 404, such as the fixed arm 410, the spikes 444 and spike supports 446, as well as the support loops 422, are bent into a desired position. Layers 402 and 404 can be bent and shaped together, or they can be bent and shaped separately and then joined together.The clip 400 is then subjected to a form-setting process, such that internal forces of the material tend to return to the set shape after being deformed by external forces. After form-setting, the tongue 411 is moved into its pre-tensioned position, allowing the crossbar 414 to be attached. Consequently, the clip 400 can be completely flat for insertion through a delivery sheath and expandable once it has been placed inside the heart.

[0054] The clamp 400 is opened and closed by applying or releasing a tensile tension on an actuating device, such as an actuating cord, suture thread, wire, rod, catheter, or the like (not shown), which is attached to the movable arm 430. The suture thread is inserted through an eyelet 442 near the prong section 440 of the movable arm 430 and wound around the end of the movable arm 430 before being returned to the feed sleeve. According to certain embodiments, an intermediate loop of suture thread is formed through the eyelet, and the suture thread is threaded through this intermediate loop. Such an intermediate loop of suture material (thread, suture thread) reduces the friction acting on the actuating thread relative to the friction between the actuating thread and the clamp material.When the sewing thread is threaded through the eyelet 442 or through the intermediate loop, both ends of the actuating thread extend back into and through the feed sleeve 102 (see . Fig. 1) The suture thread can be removed by pulling proximal on one end of the suture thread until the other end of the suture thread is pulled through the eyelet or intermediate loop and into the feed sleeve.

[0055] Fig. Figure 27, which is now referred to, shows an exemplary prong clip 500 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The prong clip 500 is essentially identical to the prong clip 400, except that the prong clip 500 contains a suture pin 543 instead of the hole 442, which is positioned over an opening 542. The prong clip 500 is formed from an upper layer 502 and a lower layer 504. The two-layer construction of the clip 500 allows the use of thinner material sheets, thereby improving the flexibility of the clip 500 compared to a clip formed from a single, thicker sheet, while still maintaining the strength of the clip 500 required for successful retention of an autologous valve leaflet.

[0056] The prong clasp 500 comprises a fixed arm 510, a joint section 520, and a movable arm 530 with a prong section 540. The upper and lower layers 502, 504 have a similar shape and, in certain embodiments, are joined to one another at the prong-equipped end 540. The joint section 520 is spring-loaded, so that the fixed arm and the movable arm 510, 530 are biased against each other when the prong clasp 500 is in a closed position. When mounted on an implantable prosthetic device, the fixed arm 510 is attached to a section of the prosthetic device. The clasp 500 is opened by pulling on an actuating device or actuating cable attached to the movable arm 530 until the spring force of the joint section 520 is overcome.

[0057] The stationary arm 510 is formed by a material tongue 511 extending from the joint section 520 between two side supports 531 of the movable arm 530. The tongue 511 is pre-tensioned between the side supports 531 by the joint section 520 such that a force must be applied to move the tongue 511 from a neutral position, in which it extends beyond the side supports 531, to a pre-tensioned position, in which it runs substantially parallel to the side supports 531. The tongue 511 is held in the pre-tensioned position by a T-shaped cross member 514, which is attached to the tongue 511 and extends outwards from it to engage with the side supports 531.When the tongue is in the neutral position, according to certain embodiments the angle between the fixed and the movable arm 510, 530 is approximately 30 to approximately 100 degrees, approximately 30 to approximately 90 degrees, or approximately 30 to approximately 60 degrees, or approximately 40 to approximately 50 degrees, or approximately 45 degrees.

[0058] The tongue 511 contains holes 512 for receiving sutures (not shown) by which the fixed arm 510 is attached to an implantable device. The fixed arm 510 can be attached to an implantable device by various means, such as screws or other fasteners, crimp sleeves, mechanical locks or snap elements, welding, adhesives, or the like. According to certain embodiments, the holes 512 can be elongated slots or oval holes to allow displacement of the layers 502, 504 without damaging the sutures by which the clamp 500 is attached to an implantable device.

[0059] The joint section 520 is formed by two support loops 522 extending from the tongue 511 of the fixed arm 510 to the side supports 531 of the movable arm 530. In certain embodiments, the support loops 522 are narrower than the tongue 511 and the side supports 531 to provide additional flexibility. Each support loop 522 comprises a central section 524 extending from the tongue 511 and an outer section 526 extending towards the side supports 531. The support loops 522 are formed to a certain degree into a spiral or helical shape by bending the central and outer sections 524, 526 in opposite directions, thereby forming a step gap 528 between the tongue 511 and the side supports 531.The step spacing 528 creates a space between the arms 510 and 530 to receive the mitral valve leaflet after it has been captured. According to certain embodiments, the step spacing 528 is approximately 0.5 millimeters to approximately 1 millimeter, or approximately 0.75 millimeters.

[0060] Viewed from above, the support loops have an "omega-shaped" form. This shape of the support loops 522 allows a considerable degree of movement of the fixed and movable arms 510, 530 relative to each other without plastic deformation of the clamping material. In some embodiments, for example, the tongue 511 can be pivoted from a neutral position, which projects approximately 45 degrees beyond the movable arm 530, into a fully open position, which lies within a range of approximately 140 degrees to approximately 200 degrees, to approximately 170 degrees, to approximately 190 degrees, or at approximately 180 degrees with respect to the movable arm 530, without plastic deformation of the clamping material.According to certain embodiments, the clamping material is plastically deformed during opening without reducing the clamping force acting between the fixed and movable arms in the closed position.

[0061] Pre-tensioning the tongue 511 allows the clip 500 to maintain a clamping force on the sail in the closed position, while still being able to open wide for easier catching of the sail. This pre-tensioning of the tongue 511 offers a significant advantage over comparable clips of the prior art, which exhibit little or no clamping force when closed. Furthermore, the spring-assisted closing mechanism of the clip 500 represents a significant improvement over clips using a one-time locking mechanism, as the clip 500 can be repeatedly opened and closed for repositioning on the sail and still maintains sufficient clamping force when closed.

[0062] The prong section 540 of the movable arm 530 includes an eyelet 542, prongs 544, and prong supports 546. By positioning the prong section of the clamp 500 at one end of the movable arm 530, the space between the prongs 544 and the fixed arm 510 is increased when the clamp 500 is opened, thereby improving the clamp 500's ability to successfully capture the sail during implantation. This distance also allows the prongs 544 to be more reliably disengaged from the sail for repositioning. According to certain embodiments, the prongs of the clamp can be arranged offset lengthwise to better distribute the clamping forces and thus the local load on the sail.

[0063] The spines 544 are spaced transversely at the same distance from the joint section 520, resulting in a better distribution of clamping forces on the sail fabric and a more reliable capture of the sail by the clamp than is the case with a spine arrangement in a longitudinal row.

[0064] The spines 544 are formed from the lower layer 504, and the spine supports 546 are formed from the upper layer. Forming the spines 544 from only one of the two layers 502, 504 makes it possible to design the spines thinner and thus, in effect, sharper than would be possible with a spine of the same material twice as thick. The spine supports 546 extend along a lower section of the spines 544 to stiffen them, thereby further improving penetration of and adhesion to the sailcloth. According to certain embodiments, the ends of the spines 544 are further sharpened by any suitable sharpening agent.

[0065] The spines 544 are angled away from the movable arm 530 so that they can penetrate the tissue of the body's own sails with minimal clamping force. The spines 544 extend from the movable arm at an angle of approximately 45 to approximately 75 degrees, or approximately 45 to approximately 60 degrees, or approximately 48 to approximately 56 degrees, or approximately 52 degrees. The angle of the spines 544 provides additional advantages in that a force aimed at pulling the implant away from the body's own sail forces the spines 544 deeper into the tissue, thus ensuring better retention. The retention of the sail in the clamp 500 is further enhanced by the position of the T-shaped crossbar 514 close to the spines 544 when the clamp 500 is closed.In this arrangement, the tissue pierced by the spines 544 is clamped against the movable arm 530 at the location of the crossbeam 514, thereby forming the tissue into an S-shaped, winding path as it passes over the spines 544. Thus, forces aimed at pulling the sail away from the clamp 500 cause the tissue to engage further with the spines 544 before the sail can escape.

[0066] Each layer 502, 504 of the clamp 500 is laser-cut from a sheet of a shape-memory alloy such as Nitinol. The upper layer 502 is aligned with and attached to the lower layer 504. According to certain embodiments, the layers 502, 504 are attached to one another at the spiked end 540 of the movable arm 530. For example, the layers 402, 404 may be attached only at the spiked end 440 to allow free movement relative to each other for the remaining layers. Sections of the combined layers 502, 504, such as the fixed arm 510, the spikes 544 and spike supports 546, as well as the support loops 522, are bent into a desired position.The clip 500 is then subjected to a form-setting process, such that internal forces of the material tend to return to the set shape after being deformed by external forces. After form-setting, the tongue 511 is moved into its pre-tensioned position, allowing the crossbar 514 to be attached. Consequently, the clip 500 can be completely flat for insertion through a delivery sheath and expandable once it has been placed inside the heart.

[0067] The clamp 500 is opened and closed by applying or releasing a tensile force to an actuating device, such as an actuating cord, suture thread, wire, rod, catheter, or the like (not shown), which is attached to the movable arm 530. The suture thread is inserted through an opening 542 in the movable arm 530 and wound around a pin 543 located in the opening 542. The smooth, round shape of the pin 543 allows tensile force to be applied to the movable arm 530 from many directions without causing wear to the suture thread. According to certain embodiments, an intermediate loop of suture thread is created through the opening and around the pin, and the suture thread is inserted through this intermediate loop.Such an intermediate loop of thread material reduces the friction acting on the actuating thread relative to the friction between the actuating thread and the staple material. When the actuating thread is wound around the pin 543, both ends of the actuating thread extend back into and through the feed sleeve 102 (see ). Fig. 1) The suture thread can be removed by pulling on one end of the suture thread in a proximal direction until the other end of the suture thread is pulled around the pin 543 and into the feed sleeve.

[0068] In the Fig. Figures 28-31, to which reference is now made, show an exemplary spine clamp 600, similar to spine clamps 400 and 500, in various curved positions to illustrate the independent movement of the layers that form spine clamps 400, 500, and 600. Spine clamp 600 is formed from an upper layer 602 and a lower layer 604. Spine clamp 600 includes a movable arm 620, a fixed arm 622, and a hinged section 624. The movable arm 620 includes a spine section 626 with spines 628. Spine clamp 600 does not include a crossbeam to prevent the movable arm 620 from moving past the fixed arm 622. Instead of a crossbeam, the movable arm 620 is held in a closed position with the fixed arm 622 by the inner paddle (not shown). To better illustrate the pre-tensioning of the clamp 600, the following is shown in the Fig. Figures 28-31 show how the stationary arm 622 moves relative to the movable arm 620, which is shown here in a stationary position. However, when mounted on an implantable device, the movable arm 620 would move relative to the stationary arm 622 attached to the device.

[0069] In Fig. Figures 28-29, to which reference is now made, show the clamp 600 in a pre-tensioned or forming-adjustment state. The fixed arm 622 is bent past the movable arm 620 to an angle 610 below it before the forming-adjustment process is carried out. A force must be applied to return the fixed arm 622 to a parallel position with the movable arm 620. Increasing the pre-tension angle 610 also increases the force required to move the fixed arm 622, thereby also increasing the pre-tension spring force with which the arms 620, 622 are clamped together in the closed state of the clamp 600. In other words, the larger the angle 610, the greater the spring force exerted by the arms 620, 622 on the captured tissue.

[0070] In Fig. Figures 30-31, to which reference is now made, show the clamp 600 in a state opened to an opening angle of 612. As in the Fig. 30 and Fig. As can be seen in Figure 31, the support loops of the joint section 624 tend to separate during the opening of the clamp 600. By allowing the layers 602, 604 to separate, the elongation of the material is reduced, thereby further increasing the maximum opening angle 612 that can be achieved before plastic deformation of the clamp material occurs. As mentioned above, the joint section 624 is shaped to form spiral or helical support loops to a certain degree, creating a gap or step spacing 614 between the arms 620, 622 ( Fig. 29) is formed, in which the sailcloth can be trapped.

[0071] When the clamp 600 is opened, the layers 602 and 604 in the fixed arm 622 are displaced relative to each other. According to some embodiments, the holes passing through the fixed arm 622 are elongated so that the sutures with which the fixed arm 622 is attached to the implantable device are not pinched by the sliding movement of the layers, and the layers 602 and 604 are not prevented from shifting, thereby reducing tensile stress on the clamp material.

[0072] In the Fig. Figures 32-35, to which reference is now made, show exemplary barbed staples 700, 800, 900, and 1000. These staples, similar to staples 400, 500, and 600, can be used in the implantable devices 100, 200, and 300 mentioned above. However, unlike staples 400, 500, and 600, staples 700, 800, 900, and 1000 are formed by laser cutting material from the side of the staple rather than from the tip. Laser cutting from the side reduces the number of operations required to manufacture the staple and allows the thickness of the staples to be varied to modify the bending properties of sections of the staple based on the specific function of that section. For example, joint sections can be made thinner to provide more flexibility, while arms can be made thicker to provide more stiffness.

[0073] In Fig. Figure 32, to which reference is now made, shows a laminated barbed clamp 700. The barbed clamp 700 has thick and thin sections 702, 704 and is formed by alternating spacer layers 706 and barbed layers 708 to create a laminate structure. The clamp 700 includes a movable arm 720, a fixed arm 722, and an articulated section 724. The movable arm 720 contains a barbed section 726 with barbs 728 formed in the barbed layers 708. The formation of the layers 706, 708 by laser cutting from a side profile makes it possible to shape the barbs 728 conically, thus providing a rigid barb with a sharp tip. The fixed arm 722 contains holes for attaching the clamp 700 to an implantable device.When mounted on an implantable device, the fixed arm 722 is extended by the attached inner paddle, thereby clamping the body tissue between the movable arm 720 and the device's inner paddle. The movable and fixed arms 720, 722 are positioned at an angle relative to each other such that any extension of the fixed arm 722 would collide with the movable arm 720. By attaching the fixed arm 722 to the inner paddle, the end of the fixed arm 722 is extended in such a way that the inner paddle would engage with the movable arm 720.This interaction of the components causes the movable arm 720 to move relative to the fixed arm 722 in such a way that the clamp 700 opens, thereby pre-tensioning the movable arm 722 to exert a clamping force against the inner paddle when the clamp 700 is in the closed position. Thus, a clamping force is generated between the movable and fixed arms 720, 722 without requiring any shaping of the movable and fixed arms 720, 722 of the clamp 700. Alternatively, the individual layers are shaped so that the movable and fixed arms 720, 722 are parallel to each other, and then bent and shaped so that the movable arm 720 is pre-tensioned towards the fixed arm 722 when the clamp 700 is attached to the inner paddle.

[0074] In the Fig. Figures 33-35, to which reference is now made, show exemplary barbed staples 800, 900, and 1000. These staples are similar in their overall shape but illustrate the different possible thicknesses when laser-cut from the side. Each staple has a thin section (804, 904, 1004) and a thick section (802, 902, 1002). Clamps 800, 900, 1000 contain a movable arm 820, 920, 1020, a fixed arm 822, 922, 1022, and an articulated section 824, 924, 1024. The movable arm 820, 920, 1020 contains a prong section 826, 926, 1026 with prongs (not shown) similar to the prongs 728 of prong section 726 of clamp 700. As in the Fig. As shown in Figures 33-35, holes may be provided in the fixed arm 822, 922, 1022 to attach the clamp 800, 900, 1000 to an implantable device. When mounted on an implantable device, the fixed arm 822, 922, 1022 is extended by the inner paddle attached to it, thereby clamping the body tissue between the movable arm 820, 920, 1020 and the inner paddle of the device.

[0075] In Fig. Figure 36, to which reference is now made, shows an exemplary barbed clamp 1100 similar to barbed clamps 400, 500, and 600. However, unlike barbed clamps 400, 500, and 600, barbed clamp 1100 is formed from a single layer of material, which differs in thickness between a thick section 1102 and a thin section 1104. Barbed clamp 1100 comprises a fixed arm 1110, a hinged section 1120, and a movable arm 1130. The fixed arm 1110 includes mounting holes 1112 and an optional integrated cross member 1114. The hinged section 1120 includes an arc-shaped joint 1122 formed from the thin section 1104. The movable arm 1130 contains a spiked section 1140 with spikes 1144. A thread (not shown) can be attached to an eyelet 1142 near the spiked section 1140 to open and close the clamp 1100.

[0076] To form the prong clamp 1100, a material sheet is thinned to create the thin section 1104. The shape of the clamp 1100 is then laser-cut from the material sheet such that the joint section 1120 is aligned with the thin section 1104. The prongs 1144 and the fixed arm 1110 are then inserted into the die before the die is set. Fig. The optional T-shaped crossbeam 1114 of the fixed arm 1110 must be rotated to allow it to pass through the slot in the movable arm 1130 for mold setting and to move the movable arms 1110, 1130 from the pre-tensioned position to a closed position. According to certain embodiments, the optional T-shaped crossbeam 1114 can be omitted, made smaller, or alternatively replaced by a recess in the movable arm 1130 to improve ease of assembly and facilitate mold setting. After mold setting, the crossbeam is bent, moved back through the slot, and positioned on the thick section 1102. The crossbeam 1114 is generally positioned in the same manner as the crossbeam 414 (see Figure 36). Fig. 26).

[0077] Like the clamps 400 and 500 described above, the clamp 1100 can also be fully opened without plastically deforming the clamp material, while still providing a clamping force in the closed position. Compared to the clamps mentioned above, however, the clamp 1100 requires fewer steps to manufacture, as it is cut from a single sheet of material and no welding process is required to join layers of material.

[0078] The Fig. References 37-52, which are hereby incorporated by reference, show an exemplary prong clasp 1200 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The prong clasp 1200 is formed from a single layer of material 1202. The prong clasp 1200 comprises a fixed arm 1210, a joint section 1220, and a movable arm 1230 with a prong section 1240. The joint section 1220 is spring-loaded, so that the fixed arm and the movable arm 1210, 1230 are biased against each other when the prong clasp 1200 is in a closed position. When mounted on an implantable prosthetic device, the fixed arm 1210 is attached to a section of the prosthetic device.The clamp 1200 is opened by pulling on an actuating device, such as an actuating cord or an actuating thread, which is attached to the movable arm 1230, until the spring force of the joint section 1220 is overcome.

[0079] The stationary arm 1210 is formed by a material tongue 1211 extending from the joint section 1220 between two side supports 1231 of the movable arm 1230 to an end 1214. According to some embodiments, the movable arm is formed by a material tongue extending between two side supports of the stationary arm. The tongue 1211 is pre-tensioned between the side supports 1231 by the joint section 1220 such that a force must be applied to move the tongue 1211 from a neutral position, in which it extends beyond the side supports 1231, to a pre-tensioned position, in which it runs almost parallel to or parallel to the side supports 1231, as described in the Fig. Figures 39-40E show that the tongue 1211 is held in the pre-tensioned position when attached to a paddle of an implantable prosthetic device. The end 1214 of the tongue 1211 may optionally have a T-shaped cross member that engages with the side members 1231 to hold the tongue 1211 in the pre-tensioned position.

[0080] When the tongue 1211 is in the neutral position, according to certain embodiments the angle between the fixed and the movable arm 1210, 1230 is approximately 30 to approximately 120 degrees, 40 to approximately 110 degrees, or approximately 50 to approximately 100 degrees, or approximately 60 to approximately 90 degrees, or approximately 90 degrees. The tongue 1211 contains holes 1212 for receiving sutures (not shown) by which the fixed arm 1210 is attached to an implantable device.

[0081] The joint section 1220 is formed by a plurality (or multiple) torsion spring segments 1222 (twisted sections) arranged in a repeating pattern and extending from the tongue 1211 of the fixed arm 1210 to the side supports 1231 of the movable arm 1230. Each spring segment 1222 is connected to other spring segments 1222 in a repeating pattern. By connecting multiple segments 1222 together, the joint section 1220 is allowed to bend to a considerable degree without plastic deformation of the material, as the individual torsion spring segments 1222 are twisted.In some embodiments, the tongue 1211 can be pivoted from the neutral position, which projects approximately 90 degrees beyond the movable arm 1230, into a fully open position located in a range of approximately 140 degrees to approximately 200 degrees, to approximately 170 degrees, to approximately 190 degrees, or at approximately 180 degrees with respect to the movable arm 1230, without plastic deformation of the clamping material. According to certain embodiments, the clamping material can be plastically deformed during opening without reducing or significantly reducing the clamping force acting between the fixed and movable arms in the closed position. The spring segments 1222 of the prototype are formed from open-edged and closed-edged cutouts 1224 in the joint section 1220. Exemplary spring segments and their arrangement in a prototype are shown below. Fig. 51A-52 described and shown.

[0082] Pre-tensioning the tongue 1211 allows the clip 1200 to maintain a clamping force on the sail in the closed position, while still being able to open wide for easier catching of the sail. This pre-tensioning of the tongue 1211 offers a significant advantage over comparable clips of the state of the art, which have little or no clamping force when closed. Furthermore, the spring-assisted closing mechanism of the clip 1200 represents a significant improvement over clips that use a one-time locking mechanism, as the clip 1200 can be repeatedly opened and closed for repositioning on the sail and still maintains sufficient clamping force when closed.

[0083] The prong section 1240 of the movable arm 1230 contains eyelets 1242 and prongs 1244. By positioning the prong section of the clamp 1200 at one end of the movable arm 1230, the space between the prongs 1244 and the fixed arm 1210 is increased when the clamp 1200 is opened, thereby improving the clamp 1200's ability to successfully capture the sail during implantation. This spacing also allows the prongs 1244 to be more reliably disengaged from the sail for repositioning. In certain embodiments, the prongs of the clamp can be arranged offset lengthwise to better distribute the clamping forces and thus the local stress on the sail. In certain embodiments, the ends of the prongs 1244 are further sharpened by any suitable sharpening agent.

[0084] The prongs 1244 are spaced transversely at the same distance from the joint section 1220, resulting in a better distribution of clamping forces on the sail fabric and a more reliable capture of the sail by the clamp than would be the case with a prong arrangement in a longitudinal row. According to some embodiments, the prongs 1244 can be arranged in an offset pattern to better distribute the clamping forces and thus the local load on the sail.

[0085] The spines 1244 are away from the movable arm 1230 at an angle 1246 ( Fig. 38A) angled so that they can engage with the tissue of the body's own sails with minimal clamping or clasping force. During use, the prongs 1244 may penetrate the body's own sail tissue, although tissue penetration is not strictly necessary for the clamp 1200 to securely grasp the sails. The prongs 1244 extend from the movable arm at an angle 1246 of approximately 20 degrees to approximately 90 degrees, or of approximately 40 degrees to approximately 70 degrees, or of approximately 50 degrees to approximately 60 degrees, or of approximately 53 degrees. The angle of the prongs 1244 provides additional advantages in that a force aimed at pulling the implant away from the body's own sail will press the prongs 1244 deeper into the tissue, thus ensuring a better hold.The retention of the sail in the clamp 1200 is further improved by the position of the end 1214 of the fixed arm 1210 when the clamp 1200 is closed. In this arrangement, the tissue engaged by the prongs 1244 is clamped against the movable arm 1230 at the point of end 1214, forming the tissue into an S-shaped, winding path as it passes over the prongs 1244. Thus, forces aimed at pulling the sail away from the clamp 1200 cause the tissue to engage more deeply with the prongs 1244 before the sail can escape. The end 1214 can optionally be shaped with a slight bend towards the movable arm 1230 to reinforce the S-shape of the winding path of the captured tissue between the fixed and the movable arm 1210, 1230.

[0086] The material layer 1202 of the clip 1200 is laser-cut from a sheet of a shape-memory alloy such as nitinol. Sections of layer 1202, such as the fixed arm 1210, the joint section 1220, and the prongs 1244, are bent into a predetermined position. The clip 1200 then undergoes a shape-setting process, such that internal forces within the material tend to return to the set shape after being deformed by external forces. Following shape-setting, the tongue 1211 is moved into its pre-tensioned, closed, or open position for attachment to the implantable device. Consequently, the clip 1200 can be essentially flat in the closed position for insertion through a delivery sheath and expandable once inside the heart.

[0087] The clamp 1200 is opened and closed by applying a tensile tension to an actuating strand or thread (e.g. the seam thread 2504 made of Fig. 71), which is attached to the movable arm 1230, is exerted or such tensile tension is released. The sewing thread is inserted through at least one of the eyelets 1242, which are located near the prong section 1240 of the movable arm 1230, before it is guided back into the feed sleeve. According to certain embodiments, an intermediate loop of the sewing thread is formed through one or more of the eyelets 1242, and the actuating thread is threaded through one or more of the intermediate loops. Such an intermediate loop of sewing material reduces the friction acting on the actuating thread relative to the friction between the actuating thread and the staple material. When the sewing thread is threaded through the eyelet 1242 or through the intermediate loop, both ends of the actuating thread extend back into and through the feed sleeve 102 (see, for example, Fig. 1) The suture thread can be removed by pulling proximal on one end of the suture thread until the other end of the suture thread is pulled through the eyelet or intermediate loop and into the feed sleeve.

[0088] Like the clamps 400 and 500 described above, the clamp 1200 can also be fully opened without plastically deforming the clamp material, while still providing a clamping force in the closed position. Compared to the clamps mentioned above, however, fewer steps are required to manufacture the clamp 1100, since the clamp 1200 is cut from a single sheet of material and no welding process is required to join layers of material.

[0089] In the Fig. 37-48E, to which reference is now made, is the bracket 1200 in various bending positions from a neutral position ( Fig. 37-38E) to a fully open position ( Fig. 47-48E). Although in the Fig. Figures 37-48E show the fixed arm 1210 in different positions. After assembly on an implantable device, the movable arm 1230 is actuated by the surgeon so that it moves relative to the device, while the fixed arm 1210 remains stationary relative to the device.

[0090] The Fig. Figures 37-38E show the clamp 1200 in the neutral position with respect to the mold setting. During mold setting, the tongue 1211 of the fixed arm 1210 is bent to a tongue angle 1216 that lies at approximately 60 degrees to approximately 120 degrees, or at approximately 90 degrees below the side supports 1231 of the movable arm 1230. After mold setting, the tongue 1211 remains in the mold setting position or normal position until forces act upon it that cause the tongue 1211 to move into other positions. Thus, when the tongue 1211 is moved into a preloaded or closed position ( Fig. 39-40E), internal forces of the stapler material are exerted in the closing direction, generating a clamping force when the stapler 1200 is in the closed or pre-tensioned position. During the implantation of a medical device with the stapler 1200, the movable arm 1230 is actuated with a suture (not shown) to change the angle 1216 between the fixed and the movable arms 1210, 1230. The stapler 1200 is in the Fig. 41-42E in a quarter-open state, in the Fig. 43-44E in a half-open state, in the Fig. 45-46Ea in a three-quarters open state and in the Fig. Figures 47-48E are shown in a fully open state. The angle 1216 between the fixed and the movable arm 1210, 1230 can be approximately 140 degrees to approximately 200 degrees, approximately 170 degrees to approximately 190 degrees, or approximately 180 degrees in the fully open position. That is, the clamp 1200 can be opened essentially completely flat without any plastic deformation of the clamp material occurring.

[0091] In the Fig. Figures 49-50, to which reference is now made, show the material layer 1202 for forming the clamp 1200 in a state before the mold setting, that is, in a substantially flat state, after it has been cut out of a material sheet by laser cutting. In particular Fig. Figure 50 clearly shows the repeating nature of the pattern of the spring segments 1222 and the cutouts 1224 that form the joint section 1220.

[0092] In the Fig. References 51A-51D show exemplary torsion spring segments 1300, 1400, 1500, 1600 for a patterned joint section (e.g., the joint section 1220 of the clamp 1200). The spring segments 1300, 1400, 1500, 1600 can be arranged according to a repeating pattern punched from a single piece, so that there are no physical seams between the individual segments. Thus, the shape of the spring segments 1300, 1400, 1500, 1600 is defined by the cutouts in the joint section and by imaginary boundaries at the "joints" between the segments.

[0093] In Fig. In Figure 51A, to which reference is now made, the spring segment 1300 is formed by cutouts 1301 made in a layer of material 1302, resulting in a substantially rotationally symmetrical S-shaped form. 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 joining point 1312 (first end joining point, first end joining point) is located at the first end 1310 adjacent to the first side 1330. A first side joining point 1332 (first side joining point, first side joining point) is located at the first side 1330 adjacent to the first end 1310. A second end joining point 1322 (second end joining point, second end joining point) is located at the second end 1320 adjacent to the second side 1340.A second side joining point 1342 (second side joining point, joining point of the second side) is located on the second side 1340 adjacent to the second end 1320. The side surface 1304 extends between the first end joining point 1312 and the second side joining point 1342, as well as between the second end joining point 1322 and the first side joining point 1332. An inside corner 1306 is formed near each side joining point 1332, 1342.

[0094] In the Fig. The spring segments 1400, 1500, and 1600 are shown in 51B-51D, which are now being referred to. These spring segments 1400, 1500, 1600 are similar in construction to the spring segment 1300 described above; however, spring segments 1400, 1500, 1600 contain an external corner 1408, 1508, 1608 opposite the corresponding side joint near each end joint. The shapes of the spring segments 1300, 1400, 1500, 1600 differ in the size and shape of the side surfaces 1304, 1404, 1504, 1604, the rounded internal corners 1306, 1406, 1506, 1606, and the rounded external corners 1408, 1508, 1608. For example, the side surfaces 1304, 1404 are essentially straight, while the side surfaces 1504, 1604 They are concave in shape. These differences in shape alter the load distribution in the joint sections, which are formed from a pattern of differently shaped spring segments.

[0095] In Fig. Figure 52, to which reference is now made, shows an exemplary spring grouping of 1700 spring segments (1300). As in Fig. As can be seen in Figure 52, the side joining points 1332, 1342 are joined to other side joining points 1332, 1342, and the end joining points 1312, 1322 are joined to other end joining points 1312, 1322. The essentially rotationally symmetrical shape of the spring segments 1300 makes it possible to join any end 1310, 1320 or any side 1330, 1340 of one segment to any end 1310, 1320 or any side 1330, 1340 of another segment. Thus, various patterns can be formed, such as the one created by the grouping 1700 in Fig. 52 H-patterns were formed. Although segments 1300, 1400, 1500, and 1600 are essentially rotationally symmetrical, individual segments within a segment pattern can be modified to form rounded outer edges of a joint section or to adapt to the fixed or movable arm of a clamp.

[0096] When the spring assembly 1700 is subjected to a bending force 1710, each of the segments 1300 is twisted in the direction indicated by the arrows 1720. Consequently, the individual spring segments 1300 are subjected to a torsional load and not a bending load. Furthermore, it is evident that the deformation of the material 1302 is less than that of a flat material plate bent in a similar manner, while maintaining the spring force of the joint section of the clamp. As a result, a joint section formed from a pattern of torsional spring segments is both robust and flexible.

[0097] To form a patterned joint section, such as the joint section 1220 described above, a pattern of numerous spring segments is arranged in rows and columns. The spring segments are arranged with their longitudinal and transverse axes in the same orientation as shown in the Fig. Figures 49-50 and 52 show that, according to certain embodiments, the spring segments can be twisted relative to one another to form other spring patterns. The spring segments are organized into columns and rows. Columns are defined along the longitudinal axis of the bracket, while rows are defined along the transverse axis of the bracket. Thus, a column is as wide as the longest dimension of a single spring segment, whereas a row of spring segments has a height equal to the shortest dimension of a single spring segment. For example, the one in Fig. The clamp shown in Figure 50 comprises three columns and seven rows of spring segments (partial rows connecting the joint section to the fixed and movable arms are not included). At points where segment ends abut an edge of the clamp, two segments in adjacent rows are joined at a single point to form a U-shaped grouping. Individual spring segments or groupings of spring segments may be modified in their rotational symmetry to increase the smoothness and / or robustness of the edges of the joint section. At points where segment ends are located at a junction of two columns, the segments may be joined to up to three other segments to form an X-shaped grouping, as shown in Figure 50. Fig. Grouping 1700 shown in Figure 52. The patterned joint can contain any suitable number of rows and columns of spring segments. The size and shape of each segment can be adjusted to adapt the spring parameters of the patterned joint. The size and shape of the spring segments can be uniform throughout the patterned joint, or they can vary based on the location of the spring element within the pattern.

[0098] In the Fig. Figures 53-55, to which reference is now made, show an exemplary barbed clamp 1800 cut from a material tube 1802 using four-axis laser cutting (X, Y, Z, and rotation axes) and five-axis laser cutting (X, Y, Z, and two tilt axes for the laser head). The tube can first be cut into segments, and each segment is subsequently cut in a generally similar manner to how a flat piece of a starting or blank material is cut; that is, the tube represents a curved blank rather than a flat one. The additional degrees of freedom of the laser cutting device make it possible to rotate the tube or tilt the head of the laser cutting device during the laser cutting process. By rotating the tube or tilting the laser cutting head, the cutting of the barbs in the Fig. The sharper prong configuration shown in Figure 55 is possible without requiring a separate sharpening step. The clamp 1800 is similar in construction to the clamp 1200 described in detail above. The material tube 802 has an inner radius 1804, an inner surface 1801, and an outer surface 1803. Cutting the clamp 1800 out of a material tube 1802 results in a front view, as shown in Figure 55. Fig. Figure 54 shows a bowl-shaped or concave profile. One effect of the concave profile is that the elongated sections of the fixed and movable arms 1810, 1830 acquire increased stiffness without significantly impairing the flexibility of the joint section 1820. Furthermore, the concave profile allows spines 1844 with sharper points or teeth 1846 to be produced without the need for a separate sharpening process—that is, the spines are formed with beveled edges without a separate sharpening process. The sharp points 1846 enable improved engagement with the body's own sail tissue. Fig. 55, to which reference is now made, the sharp points 1846 are formed during the laser cutting process by the cutting planes forming the first and second sides 1847, 1848 of the spikes 1844 intersecting at the tip 1846, thus forming the shape of a triangular pyramid ending in a point. This shape cannot be achieved if the cutting planes forming the sides of the spikes are parallel and do not intersect. Therefore, the spikes 1844 of the clamp 1800 have a robust base 1845 and a sharp tip 1846 formed in a single layer of material and do not require a secondary sharpening process.

[0099] In Fig. Figure 56, to which reference is now made, shows an exemplary clamp 1900. Clamp 1900 is similar in structure to clamp 1200, which is described in detail above, but has a differently structured joint section 1920. The joint section 1920 contains a multitude of supports 1922, which are formed by a series of elongated cutouts 1924. In the Fig. Reference is made to figures 56A-56B, which show alternative embodiments of the support 1922 of the joint section 1920. Fig. Figure 56A shows the rectangular support from 1922 with a curved section from 1926. Fig. Figure 56B shows the rectangular beam 1922 with a curved section 1926, which is also rotated by approximately 90 degrees such that the cross-section of the beam in the curved section 1926 is perpendicular to the sections of the beam 1922 at its ends. The rotation of the beam 1922, as shown in Fig. As shown in Figure 56B, the tensile stress in the support 1922 is reduced, thereby increasing its flexibility.

[0100] The Fig. Figures 57-58, which are now referred to, show an exemplary prong clamp 2000 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The prong clamp 2000 includes a fixed arm 210 attached to the implantable device. The prong clamp 2000 differs from other clamps in that it includes multiple movable arms 2030, each having a joint section 2020 and a prong section 2040 with a single prong 2042. The independent arms 2030 of the clamp 2000 each individually clamp the tissue of the body's own leaflet, thus enabling improved intervention with tissue of uneven thickness.The arms 2030 can also be pre-formed in a wide or splayed arrangement and crimped together for insertion into a narrow configuration, allowing the spikes 2042 to be spaced further apart in the transverse direction than would be possible if the arms were rigidly connected. According to certain embodiments, the arms 2030 include an optional hole or groove (not shown) into which an actuating thread can engage to hold the arms 2030 together during insertion.

[0101] The fixed arm 2010 is formed from a tongue 2011, from which supports 2031 extend, forming the movable arm 2030. The joint sections 2020 are formed by bending each of the supports 2031 to create a curved section 2022. The joint sections 2020 are spring-loaded, so that the fixed arm and the movable arm 2010, 2030 are biased against each other when the prong clamp 2000 is in a closed position. In certain embodiments, the tongue 2011 is formed from a wide sheet of material to provide a wider lateral area as a clamping point for the independent arms 2030.

[0102] The barbed clamp 2000 is laser-cut from a layer 2002 of a shape-memory alloy such as nitinol. As in Fig. As shown in Figure 57A, the spines 2042 lie flat in the same plane as the rest of the clamp 2000 when they are cut out of the material layer 2002. The movable arms 2030 and the spines 2040 are then bent over and inserted into the Fig. The form shown in Figure 57 was rotated and then subjected to a form-setting process. As mentioned above, the independent arms 2030 of the clamp 2000 can be formed to be as wide or as narrow as desired. According to certain embodiments, individual arms 2030 can be longer or shorter than others, and the spacing between the arms 2030 can be different or uniform.

[0103] Cutting the spines 2042 out of the material sheet and subsequently rotating them into position also makes it possible to form larger spines with a variety of shapes. According to certain embodiments, the spine sections 2040 can contain several smaller spines arranged in rows, which may point in the same direction or not in the same direction. According to certain embodiments, the ends of the spines 2042 are further pointed by any suitable sharpening agent. According to certain embodiments, the joint sections 2020 of the carriers 2031 contain twisted sections 2024. The twisted sections 2024 can act as torsion springs that resist lateral forces applied to the ends of the spines 2042 and thereby assist in maintaining the orientation of the spines 2042 when they engage with the tissue of the body's own sails.

[0104] The Fig. Figures 59-63, which are now referred to, show an exemplary clasp 2100 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The clasp 2100 is expandable between a contracted and an expanded state and is pre-shaped in the expanded state so that the clasp 2100 automatically expands from the contracted state to the expanded state. As shown in the figures below, the clasp 2100 is expandable between a contracted and an expanded state. Fig. As can be seen in Figure 61A, the clamp 2100 can be inserted from a feed sleeve 2150 in the contracted state and then transition to the expanded state by self-expansion.

[0105] The clamp 2100 has numerous features similar to the clamp 1200 described in detail above, such as a patterned joint section 2120 formed by a plurality of spring segments 2122 and cutouts 2124, a fixed arm 2110 incorporating a tongue 2111 with holes 2112 for attaching the fixed arm 2110 to an implantable device, and a T-shaped end 2114 to hold the fixed arm 2110 in a pre-tensioned position. The clamp 2100 also has a movable arm 2130 incorporating a spike section 2140 with a plurality of spikes 2142.

[0106] The bow-like shape of the movable arm 2130 provides a wider spike section 2140, which can contain more spikes 2142 with the same or a greater lateral spacing from each other than in other clamps. The wider spacing of the spikes 2142 allows for better capture of the body's own sails. According to certain embodiments, the bow shape of the movable arm 2130 resembles the shape of broad outer paddles of an implantable device, so that clamping forces of the paddles are distributed evenly across the spikes, further improving the hold on the body's own sails. Some of the spikes 2142 may also be arranged longitudinally offset due to their position on the bow-like shape of the movable arm 2130. According to certain embodiments, the ends of the spikes 2142 are further sharpened by any suitable sharpening agent.According to certain embodiments, the tongue 2111 is formed from a wide material plate to provide a wider side area as a clamping point.

[0107] The movable arm 2130 is provided in the form of a bracket or ring. The movable arm 2130 includes side supports 2131, which are thinner and more flexible, particularly in the transverse direction, than the side supports 1231 of the clamp 1200 described above. The side supports 2131 include a first joint section 2132, which is arranged towards the proximal end of the movable arm 2130, and a second joint section 2136, which is arranged at the distal end of the movable arm 2130. The first joint section 2132 is formed by one or more bends in the side supports 2131. According to certain embodiments, the second joint section 2136 includes a thinner—and therefore more flexible—section in order to reduce the force required to tighten the clamp 2100.The movable arm 2130 contains holes 2134 arranged between the first and second joint sections 2132, 2136 to receive the actuating threads 2152, which are used to retract the movable arm 2130. The holes 2134 are arranged further away from the center of the clamp 2130 in the transverse direction than the joint sections 2132, 2136, in order to provide a mechanical advantage when applying force via the threads 2152. According to certain embodiments, the holes 2134 are located at the outermost transverse point of the side supports 2131.

[0108] The rounded shape of the clamp 2100 allows it to be retracted simply by pulling it back into the feed sleeve. According to certain embodiments, the expansion and contraction of the clamp 2100 is controlled by the actuating threads 2152. The threads 2152 can be guided through an opening 2156 in a guide 2154 to the holes 2134 in the movable arm 2130 to control the direction in which the force applied along the thread 2152 is used to tighten the movable arm 2130 into a retracted position. For example, by positioning the guide 2154 closer to the connection point of the seam threads 2152 with the clamp 2100, the forces exerted on the clamp 2100 by the seam threads 2152 can be directed more in a transverse direction than in a longitudinal direction. Alternatively, as shown in Fig. As can be seen in Figure 61B, a single thread loop 2153 is passed through the opening 2156 in the guide 2154, through each of the holes 2134 in the movable arm 2130 and then back through the guide 2154, so that by actuating the single loop 2153 the movable arm 2130 can be tightened into a closed position.

[0109] The Fig. Figures 64-68, which are hereby referenced, show an exemplary prong clamp 2200 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The prong clamp 2200 incorporates elements of the clamps 1200 and 2000 described above. The prong clamp 2200 includes a fixed arm 2210, which is attached to the implantable device, and an articulated section 2220, which allows the clamp 2200 to open and close. The articulated section 2220, like that of the flap 1200, is formed from a repeating pattern of spring segments 2222 and cutouts 2224.

[0110] The barbed clamp 2200 also incorporates features similar to those of the clamp 2000, such as a plurality of independent, movable arms 2230, each having a barbed section 2240 with a single barb 2244. The independent arms 2230 of the clamp 2200 each individually clamp the tissue of the body's own sail, thus enabling improved intervention with tissue of uneven thickness. The arms 2230 can also be pre-formed in a wide or splayed configuration and crimped together for insertion into a narrow configuration, allowing the barbs 2244 to be spaced further apart laterally than would be possible if the arms were rigidly connected. The barbed section 2240 of each arm 2230 contains a hole 2242 for receiving an actuating thread 2252 ( Fig. 65A).

[0111] The bracket 2200 is expandable between a contracted state and an expanded state and is set to the expanded state, so that the bracket 2200 automatically expands from the contracted state to the expanded state. As shown in Fig. As shown in Figure 65A, the clamp 2200 can be inserted from a feed sleeve 2250 in its contracted state and subsequently expand to its expanded state by self-expansion. The expansion and contraction of the clamp 2200 is controlled by the actuating thread 2252, which pulls the independent arms 2230 together to retract the clamp 2200 so that it fits into the feed sleeve 2250. According to some embodiments, the independent arms can be retracted by simply pulling the clamp 2200 back into the feed sleeve.

[0112] The fixed arm 2210 is formed by a tongue 2211 extending from the joint section 2220 to an end 2214. The tongue 2211 has holes 2212 for attaching it to the implantable device. In certain embodiments, the tongue 2211 is formed from a wide sheet of material to provide a wider lateral area for clamping. In certain embodiments, the end 2214 of the tongue 2211 includes a T-shaped cross member similar to that of the clamp 2100.

[0113] The 2200 barbed clip is laser-cut from a layer 2202 of a shape memory alloy such as nitinol. Similar to the one in Fig. In the clamp 2100 shown in Figure 57A, the spikes 2242 lie flat in the same plane as the rest of the clamp 2200 when they are cut out of the material layer 2202. The movable arms 2230 and the spike sections 2240 are then bent over and inserted into the Fig. The shape shown in Figures 64-68 is rotated and then subjected to a shape-setting process. According to some embodiments, the prongs of the independent arms are cut such that the prongs are bent upwards similarly to the prongs of the clamp 1200, in which case twisting of the independent arms is not necessary. As mentioned above, the independent arms 2230 of the clamp 2200 can be shaped as wide or as narrow as desired. According to certain embodiments, individual arms 2230 can be longer or shorter than others, and the spacing between the arms 2230 can be different or uniform.

[0114] Cutting the spines 2244 out of the material sheet and subsequently rotating them into position also makes it possible to form larger spines with a variety of shapes. According to certain embodiments, the spine sections 2240 can contain several smaller spines arranged in rows, which may point in the same direction or not. According to certain embodiments, the ends of the spines 2244 are further sharpened by any suitable sharpening agent. According to certain embodiments, the carriers 2231 contain twisted sections 2232. The twisted sections 2232 can act as torsion springs that resist lateral forces applied to the ends of the spines 2244 and thereby assist in maintaining the orientation of the spines 2244 when they engage with the tissue of the body's own sails.

[0115] In the Fig. References 69-73B show various arrangements for attaching an actuating thread to exemplary barbed staples. According to these embodiments, an intermediate loop of thread is formed through one or more of the eyelets in the barbed staple, and the actuating thread is threaded through one or more of these intermediate loops. Such a connection to the staple via an intermediate loop of thread material reduces the friction acting on the actuating thread relative to the friction between the actuating thread and the staple material. Both ends of the actuating thread extend back into and through the feed sleeve (not shown).The suture thread can be removed by pulling on one end of the suture thread in a proximal direction until the other end of the suture thread is pulled through the eyelet or intermediate loop and into the feed sleeve.

[0116] In Fig. Figure 69, to which reference is now made, shows an exemplary thread assembly 2300 attached to the prong clamp 400 described above. The thread assembly 2300 includes a thread intermediate loop 2302, which has been passed through the eyelet 442 and around the end of the prong section 440. Alternatively, the thread intermediate loop 2302 can be passed through the eyelet 442 and between the side supports of the movable arm. An actuating thread 2304 is threaded from the feed sleeve through the thread intermediate loop 2302 and back into the feed sleeve. A tensile force exerted on the actuating thread 2304 opens the clamp 400 when the spring forces holding the clamp 400 closed are overcome. When no tension is exerted on the actuating thread 2304, the clamp 400 can spring into its closed position.The rounded shape of the prong section 440 of the clamp 400 prevents the clamp 400 from becoming entangled in body tissue or in other sections of the implantable device.

[0117] In the Fig. Figures 70A-70B, to which reference is now made, show an exemplary thread assembly 2400 attached to the prong clamp 1200 described above. The thread assembly 2400 includes a thread intermediate loop 2402, which has been passed through the central eyelet 1242 and between the side supports 1231 of the movable arm 1230. An actuating thread 2404 is threaded from the feed sleeve through the thread intermediate loop 2402 and back into the feed sleeve. By applying tension to the actuating thread 2404, the clamp 1200 is opened when the spring forces that hold the clamp 1200 closed are overcome. When no tension is applied to the actuating thread 2404, the clamp 1200 can spring back into its closed position.

[0118] Fig. Figure 70A is a side view of the suture thread assembly 2400, showing that a gap or offset 2406 can form between the end of the clamp and the actuating thread 2404 of the suture thread assembly 2400 described above. Such a gap 2406 can form, in particular, when the actuating thread 2404 is arranged at an angle with respect to the prong section of the clamp 1200. Fig. Figure 70B is a front view of the suture assembly 2400, showing that lateral gaps or offsets 2408 occur between the actuating thread 2404 and the sides of the prong section 1240 of the clamp 1200. Under certain circumstances, such gaps or offsets 2406, 2408 can become entanglement points—that is, locations that pose a risk of snagging on the body tissue or other sections of the implantable device during insertion and installation, and / or on a catheter wall during retrieval. In particular, acute angles or sharp edges can represent such entanglement points. By rounding the corners of the clamp 1200, as shown in Figure 70B, the risk of entanglement is reduced. Fig. As can be seen in Figure 70B, the risk of the clamp 1200 becoming entangled can be reduced. According to some embodiments, the device does not exhibit any offset formations with a depth greater than one-third of the device's width.

[0119] In the Fig. Figure 71, to which reference is now made, shows a front view of an exemplary thread assembly 2500 attached to the prong clamp 1200 described above. The thread assembly 2500 includes a thread intermediate loop 2502, which has been passed through the central eyelet 1242 and around the end of the prong section 1240. An actuating thread 2504 is threaded from the feed sleeve through the thread intermediate loop 2502 and back into the feed sleeve. By applying tension to the actuating thread 2504, the clamp 1200 is opened when the spring forces holding the clamp 1200 closed are overcome. When no tension is applied to the actuating thread 2504, the clamp 1200 can spring back into its closed position.

[0120] By forming the intermediate loop of the seam thread 2502 around the end of the spike section 1240, it is possible to avoid a gap (e.g., the one in Fig. The gap shown in 70A (2406) forms between the actuating thread and the clamp. Similar to the one described above and in Fig. The suture arrangement shown in 70B, 2400, is shown. Fig. 71, that lateral gaps 2508 are formed between the actuating thread 2504 and the sides of the prong section 1240 of the clamp 1200. Under certain circumstances, such gaps 2508 can become entanglement points – that is, a location that poses a risk of becoming caught on the body's own tissue or on other sections of the implantable device during insertion and installation and / or on the catheter during retrieval. In particular, acute angles or sharp edges can constitute such entanglement points. By rounding the corners of the clamp 1200, as in Fig. As can be seen in Figure 71, the risk of the clamp 1200 becoming caught on body tissue or on other parts of the device can be reduced.

[0121] In the Fig. Figures 72-73B, to which reference is now made, show an exemplary thread assembly 2600 attached to the prong stapler 1200 described above. The thread assembly 2600 includes thread intermediate loops 2602, which have been passed through the eyelets 1242 near the sides of the stapler 1200 and around the end of the prong section 1240. An actuating thread 2604 is threaded from the feed sleeve through the thread intermediate loops 2602 and back into the feed sleeve. By applying tension to the actuating thread 2604, the stapler 1200 is opened when the spring forces holding the stapler 1200 closed are overcome. When no tension is applied to the actuating thread 2604, the stapler 1200 can spring back into its closed position.

[0122] The 2600 thread arrangement allows for the creation of the Fig. The gap shown in 70A-71, which can represent snagging points, can be reduced or eliminated. By forming the intermediate thread loops 2602 around the end of the spike section 1240, it can be avoided that a gap, such as the one shown in Fig. The gap 2406 shown in Figure 70A forms between the clamp 1200 and the actuating thread 2604. The seam thread arrangement 2600 also reduces or eliminates lateral gaps, such as those found in the Fig. 70B and Fig. 71 shown side column 2508, between the actuating thread 2604 and the sides of the clamp 1200.

[0123] In the Fig. Figures 74A-75, which are now referenced, show examples of barbed clips and implantable devices. As noted above, capture points are locations on the implantable device that pose a risk of becoming entangled in the body's own tissue, other parts of the implantable device, and / or the introducing catheter during insertion and installation, and / or during recapture or withdrawal. In addition to capture points that may be formed on individual components of the implantable device, such as those described above, such capture points may also be formed during the assembly of two or more components.

[0124] In the Fig. Reference is made to Figures 74A-74B, which show an exemplary implantable device 2700 with two spiked clamps 400 mounted thereon. The spiked clamps 400 are attached to inner paddles 2720 of the implantable device 2700, which extend from a coaptation element 2710. A suture assembly 2730 includes suture intermediate loops 2732, which are attached to the spiked section 440 of the clamps 400, and actuating sutures 2734, which extend from a feed sheath 2702 through the suture intermediate loops 2732 and back into the sheath 2702. When the clamps 400 are in a closed state, the offset of the hinge sections 420 forms a gap 2740 between the clamps 400 and the coaptation element 2710, which can represent a snap point. As in Fig. As can be seen in Figure 74B, this gap 2740 is reduced or eliminated when the clamps 400 are partially opened, whereby the overall width of the device 2700 also increases due to the opening of the clamps 400. Thus, the catch point during recapture or retraction can be eliminated by partially opening the clamps 400, as shown in Figure 74B. Fig. Figure 74B shows that the partial opening of the clamps when the device is retracted into the casing also advantageously causes the actuating cords or the actuating seam threads to engage with an opening 2703 in the feed casing 2702, thereby widening the opening 2703 and providing a larger opening through which the device 2700 can be removed. Seam thread configurations such as those shown in the Fig. 70B and Fig. As shown in Figure 71, the suture threads engage with the opening 2703 at two points, as they extend from the staples at two locations, thereby widening the opening 2703 into an essentially rhombic shape. Suture configurations such as those shown in the Fig. As shown in Figure 72, the sutures engage with the opening 2703 at four points, as they extend from the staples at four locations, thereby widening the opening 2703 into a substantially rectangular shape. The actuating sutures 2734 can be loosened after the joint sections 420 are inside the catheter.

[0125] In Fig. Reference 75 shows an exemplary implantable device 2800 with two spiked clamps 1200 mounted thereon. The spiked clamps 1200 are attached to inner paddles 2820 of the implantable device 2800, which extend from a coaptation element 2810. A suture assembly 2830 includes suture intermediate loops 2832, which are attached to the spiked section 1240 of the clamps 1200, and actuating sutures 2834, which extend from a feed sheath 2802 through the suture intermediate loops 2832 and back into the sheath 2802. The round shape of the joint section 1220 of the clamp 1200 prevents a snap point from forming at the contact point 2840 between the joint section 1220 and the coaptation element 2810. Thus, the shape of the clamp 1200 prevents gaps, such as the one shown in Fig. The gap 2740 shown in Figure 74B, which can represent snap points, is reduced or eliminated without the need to partially open the brackets 1200 during retrieval or repositioning.

[0126] In certain embodiments, the actuating cord or thread is not attached to an intermediate suture loop but to a section of a cover surrounding a clasp of an implantable device. For example, the actuating cord or thread may be threaded through a loop or opening in the cover. The cover may be formed from a flexible material, which may be a mesh woven, braided, or formed in any other suitable manner. The flexible material may consist of a fabric, a wire made of a shape-memory alloy—such as Nitinol—to provide shape-adjusting capability, or any other flexible material suitable for implantation in the human body.

[0127] In Fig. Reference 76, to which reference is now made, shows a side view of an exemplary barbed clamp 2900. Although the clamp 2900 is shown here in the form of the clamp 1200 described above, the clamp 2900 can have any shape suitable for a barbed clamp formed from laminated material layers, such as any of the clamps described above. The clamp 2900 has a fixed arm 2910, a hinged section 2920, a movable arm 2930, and a barbed section 2940. The clamp 2900 is formed from a first material layer 2902 and a second material layer 2904. The layers 2902 and 2904 can be formed from similar or different materials and can have the same or different thicknesses. According to certain embodiments, additional material layers may also be provided.

[0128] In Fig. Reference 77 to which we now refer, shows a side view of an exemplary double-ended prong clamp 3000. The double-ended clamp 3000 has a fixed arm 3010 with hinge sections 3020 and movable arms 3030 extending from both ends. Each movable arm 3030 contains a prong section 3040 with at least one prong 3042. Although the prongs 3042 are shown here pointing outwards, in other embodiments the prongs 3042 point inwards. The clamp 3000 is formed from a first and a second layer of material 3002, 3004; however, in certain embodiments the clamp is formed from only one layer, and in certain further embodiments it is formed from more than two layers. The hinge sections 3020, the movable arms 3030, and the prong sections 3040 can be formed according to the shape of any of the clamps described above.

[0129] The Fig. Figures 78-79, which are hereby referenced, show an exemplary prong clamp 3102 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The prong clamp 3102 incorporates elements of the clamp 1200 described above. The prong clamp 3102 includes a fixed arm 3110, which is attached to the implantable device, and an articulated section 3120, which allows the clamp 3102 to open and close. The articulated section 3120, like that of the flap 1200, is formed from a repeating pattern of spring segments 3122 and cutouts 3124. The barbed clamp 3102 also contains a pair of independent, first and second movable arms 3130, 3132, each extending from the joint section 3120 to a barbed section 3140 with barbs 3144.

[0130] The fixed arm 3110 is formed by a tongue 3111 extending from the joint section 3120 to an end 3114. The tongue 3111 has holes 3112 for attaching it to the implantable device. In certain embodiments, the tongue 3111 is formed from a wide sheet of material to provide a wider lateral area for clamping. In certain embodiments, the end 3114 of the tongue 3111 includes a T-shaped cross member similar to that of the clamp 3102.

[0131] The movable arms 3130, 3132 of the clamp 3102 each individually clamp the tissue of the body's own sail, thereby enabling improved intervention with tissue of uneven thickness. According to some embodiments, the movable arms 3130, 3132 are formed from a single movable arm, similar to the movable arm 1230 of the flap 1200, which is divided by a cut 3148 into a first and a second movable arm 3130, 3132 such that the first and the second movable arm 3130, 3132 can be opened and closed independently of each other. According to some embodiments, the joint section 3120 is also divided into a first and a second joint section (not shown).

[0132] In Fig. Reference 79 shows an exemplary implantable device 3100 with two spiked clamps 3102 mounted thereon. The spiked clamps 3102 are attached to inner paddles 3108 of the implantable device 3100, which extend from a coaptation element 3106. An actuating arrangement 3150 includes suture loops 3152, which are attached to holes 3146 in the spiked section 3140 of the first and second movable arms 3130, 3132 and to the first and second actuating threads 3154, 3156. The first and second actuating threads 3154, 3156 extend from the feed sheath 3104 through the suture loops 3152 and back into the feed sheath 3104. Each of the movable arms 3130, 3132 can be opened separately by applying a tension force to the first and second actuating threads 3154, 3156 respectively.By separately opening the first and second movable arms 3130, 3132, it becomes possible to adapt the handle of the clamp 3102 to the body's own tissue based on the thickness of the tissue and on the orientation of the clamp 3100.

[0133] The Fig. References 80A-80E, to which reference is now made, show an exemplary prong clamp 3200 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The clamp 3200 is designed to exert a clamping force on the body's own tissue when the implantable prosthetic device—e.g., any device described in the present application—is attached to the body's own tissue. Similar to the prong clamps described above, the prong clamp 3200 comprises a fixed arm 3210, an articulated section 3220, and a movable arm 3230 with a prong section 3240. The fixed arm 3210 of the clamp 3200 is slidably connected to a paddle 3202 of an implantable device such that the clamp 3200 can be moved along the paddle 3202 in the direction 3204.For example, an actuating cable 3250 can be used to move the clamp 3200 along the paddle 3202 in the direction 3204. Furthermore, the actuating cable 3250 can also be used to move the movable arm 3230 between the closed position (in . Fig. 80A shown) and the open position (in Fig. to move. The actuating string 3250 can take any form described in the present application. According to some embodiments, the clamp 3200 includes an optional preload element 3260 (e.g., a spring) designed to move the clamp 3200 in a desired position along the paddle 3202 (e.g., in the position shown in the Fig. 80A and Fig. to keep in position (position shown at 80E).

[0134] With reference to Fig. Figure 80A shows the clamp 3200 in a first position on the paddle 3202 in a closed position. Referring to Fig. Figure 80B shows the clamp 3200 after the movable arm 3230 has been moved by the actuating string 3250 in a direction 3203 into an open position. With reference to Fig. Figure 80C shows the clamp 3200 after it has been moved along the paddle 3202 in a direction 3205 into a second position. According to some embodiments, the clamp 3200 is moved along the paddle 3202 in the direction 3205 by the actuating string 3250 or by a separate mechanism. In embodiments that include the preload element 3260, sufficient force is applied to the clamp 3200 to move it in the direction 3205, causing the preload element 3260 to extend and exert a clamping force on the clamp 3200 in a direction 3206 opposite to the direction 3205. Although the illustrated embodiment shows how the clamp 3200 moves into an open position (in Fig. (shown on 80B) is moved before the clamp 3200 is moved along the paddle 3202 in the direction of 3205 into the second position (in Fig. (shown in Figure 80C) is moved; however, it is understood that the clamp 3200 can just as easily be moved in the direction 3205 into the second position before the movable arm 3230 of the clamp 3200 is moved in the direction 3203 into an open position, or these movements can also occur simultaneously. With reference to Fig. At 80D, the movable arm 3230 is moved by the actuating cord 3250 in the direction 3207 into a closed position in order to attach the prong section 3240 of the clamp 3200 to the flap fabric (not shown). In the Fig. In the position shown in Figure 80D, the preloading element 3260 is held in an extended position (e.g., as a result of the force exerted on the clamp 3200 by the actuating string 3250 or by another mechanism to hold the clamp 3200 in the second position), which means that the preloading element 3260 exerts a clamping force on the clamp 3200 acting in the direction 3206. With reference to Fig. 80E, after the prong section 3240 of the clamp 3200 has been attached to the body tissue, the force holding the clamp 3200 in the second position is released, causing the tension applied by the pre-tensioning element 3260 to move the clamp 3200 along the paddle 3202 in direction 3208. The movement of the clamp 3200 in direction 3208 causes the prong section 3240 to generate a tension force acting in direction 3209 on the body tissue. This tension force exerted on the body tissue ensures a secure connection between the implantable device and the body tissue.

[0135] The Fig. References 81A-81C, to which reference is now made, show an exemplary prong clamp 3300 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The clamp 3300 is designed to exert a clamping force on the body's own tissue when the implantable prosthetic device—e.g., any device described in the present application—is attached to the body's own tissue. Similar to the prong clamps described above, the prong clamp 3300 comprises a fixed arm 3310, an articulated section 3320, and a movable arm 3330 with a prong section 3340. The movable arm 3330 includes a flexible section 3332 arranged between the articulated section 3320 and the prong section 3340.The flexible section 3332 can, for example, comprise a cutout in the movable arm 3330, a material different from the rest of the movable arm 3330, or can assume any other shape that allows the flexible section 3332 to be more flexible than the rest of the movable arm 3330. According to some embodiments, the flexible section 3332 is omitted, and the actuating mechanism 3350 is nevertheless able to bend the spike section 3340 of the movable arm 3330, as described in the... Fig. 81A-81C is illustrated.

[0136] The actuating mechanism 3350 includes an actuating strand 3352 (e.g., a suture thread) and a push-and-pull element 3354 designed to accommodate the strand 3352. For example, the push-and-pull element 3354 could be a catheter, a wire with a loop (as in Fig. (82 shown) or any other link capable of receiving the cord 3352 and pushing or pulling the movable arm 3330 of the clamp 3300. The actuating cord 3352 extends at a first end 3351 from a feed sleeve (not shown) and is detachably attached to the movable arm 3330 at a first connection point 3356 located near the spike section 3340. The actuating cord 3352 also extends from the first connection point 3356 and is detachably attached to the movable arm 3330 at a second connection point 3358 located between the flexible section 3332 and the joint section 3320. The actuating string 3352 then extends from the second connection point 3358 through the push and pull member 3354 to a second end 3353.

[0137] With reference to Fig. Figure 81A shows the clamp 3300 in an open position, with autologous tissue 3302 arranged in an opening 3304 between the movable arm 3330 and the fixed arm 3310. The clamp 3300 can be moved into the open position by pulling on the cord 3352. With reference to Fig. In 81B, the link 3354 and the strand 3352 of the actuating mechanism 3350 are used to move the movable arm 3330 into the closed position in the closing direction 3306 and to bend the spike section 3340 in the opening direction 3308. The first end 3351 of the strand 3352 is pulled in the opening direction 3308, while the link 3354 is pushed in the closing direction 3306, so that the spike section 3340 of the movable arm 3330 is pivoted or bent at the flexible section 3332 during opening in the upward direction 3303. With further reference to Fig. 81B the member 3354 and the strand 3352 are moved such that the spine section 3340 engages or pierces the body's own tissue 3302, while the movable arm 3330 is moved into the closed position and the spine section 3340 is in the bent position.

[0138] In Fig. 81C, to which reference is now made, the first end 3351 of the strand 3352 is released, thereby enabling the spine section 3340 of the movable arm 3330 to pivot around the flexible section 3332. While the spine section 3340 is pivoting, the body tissue 3302 is retracted in the downward or inward direction 3305, thereby generating a tension force acting on the body tissue in the inward direction 3305. After the movable arm 3330 has returned to the body tissue 3302 (as in Fig. (as shown in 81C) has been attached, the link 3354 and the strand 3352 are removed from the clamp 3300.

[0139] Fig.Figure 82, which is now referred to, shows an actuating mechanism 3400 for use with implantable prosthetic devices, such as the devices 100, 200, and 300 described above. The mechanism 3400 includes a first and a second control element 3410 and 3420, which extend from a feeder 3402. The feeder 3402 can be any suitable device, such as a sheath or a catheter. The first and second control elements 3410, 3420 contain a first and a second suture thread 3412, 3422 and a first and a second flexible wire 3414, 3424. The first and the second flexible wire 3414, 3424 extend from the feeder 3402 and each contain a loop 3416, 3426 to receive the first and the second suture thread 3412, 3422 and to engage with a clamp (e.g., with the clamp 1200 described above).The first and second threads 3412, 3422 each extend from the feeder 3402 through one of the first and second loops 3416, 3426, respectively, and back into the feeder 3402. According to some embodiments, the first and second control elements 3412, 3422 extend through separate feeders 3402. The threads 3412, 3422 are detachably attached to movable arms of exemplary barbed staples as described above. The first and second loops 3416, 3426 of the wires 3414, 3424 are able to move along the corresponding suture threads 3412, 3422 in such a way that the loops 3416, 3426 can engage with the corresponding barbed clamps in order to engage with the movable arms.This means that the threads 3412, 3422 are used to pull the movable arms in an opening direction, and the wires 3414, 3424 are used to push the movable arms in a closing direction. The wires 3414, 3424 can be made, for example, of a steel alloy, a nickel-titanium alloy, or any other metal or plastic material. According to certain embodiments, the wires 3414, 3424 can have a diameter of 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.

[0140] While various inventive aspects, concepts, and features of the disclosures can be described and illustrated here as they are embodied in combination in the exemplary embodiments, these various aspects, concepts, and features can be used in many alternative embodiments, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations fall within the scope of the present application. Even if various alternative embodiments relating to the various aspects, concepts, and features of the disclosures—such as, for example,Alternative materials, structures, configurations, processes, devices and components, alternatives relating to shape, fit and function, and the like are described; however, these descriptions are not intended to constitute a complete or exhaustive list of available alternative embodiments, whether currently known or subsequently developed. A person skilled in the art may readily incorporate one or more of the inventive aspects, concepts, or features into additional embodiments and uses within the scope of this application, even if such embodiments are not expressly disclosed herein.

[0141] Even if some features, concepts, or aspects of the disclosures are described here as preferred arrangements or methods, such a description should not suggest that such a feature is required or necessary unless expressly stated. Furthermore, exemplary or representative values ​​and ranges may be given to facilitate understanding of the present application. However, such values ​​and ranges are not to be understood in a restrictive sense and should only be considered critical values ​​or ranges if expressly stated.

[0142] Even if various aspects, features, and concepts are expressly designated herein as inventive or as part of a disclosure, such designation is not to be understood as exclusive; rather, there may be inventive aspects, concepts, and features that are fully described herein without being expressly designated as such or as part of a particular disclosure; the disclosures are instead set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to the inclusion of all steps required in all cases, nor is the order in which the steps are presented to be construed as required or necessary unless expressly stated. The words used in the claims have their full ordinary meaning and are in no way limited by the description of embodiments in the description.

[0143] Further embodiments are disclosed below: 1. Implantable prosthetic device, comprising: a coaptation section; an anchor comprising several paddles, the paddles having an outer and an inner section and being extendable from a folded closed position to an open position; and a clamp attached to each of the multiple paddles, the clamp comprising: a fixed arm attached to the inner section of the paddle; a movable arm having a section covered with spikes; and a joint section that connects the fixed arm to the movable arm; wherein the movable arm is essentially parallel to the fixed arm when the clamp is in a closed position. 2. Implantable prosthetic device according to embodiment 1, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from a shape memory material. 3. Implantable prosthetic device according to embodiment 2, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clasp is opened. 4. Implantable prosthetic device according to embodiment 3, wherein the upper layer and the lower layer are connected to each other at one end of the movable arm. 5. Implantable prosthetic device according to embodiments 2 to 4, wherein the spiked section comprises spikes and spike supports, and wherein the spikes are formed from the lower layer and the spike supports from the upper layer. 6. Implantable prosthetic device according to embodiments 2 to 4, wherein the spiked section comprises spikes and spike supports, and wherein the spikes are formed from the upper layer and the spike supports from the lower layer. 7. Implantable prosthetic device according to one of the above-mentioned embodiments, wherein: the movable arm comprises two side supports; and the joint section comprises two support loops, each supporting loop comprising: a central section extending from the fixed arm; and an outer section extending from the middle section to one of the two side supports of the movable arm. 8. Implantable prosthetic device according to one of the above-mentioned embodiments, wherein the ends of the fixed and movable arms adjacent to the joint section are adjacent to each other by an offset distance. 9. Implantable prosthetic device according to one of the above embodiments, wherein the clasp is formed from a shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 10. Implantable prosthetic device according to one of embodiments 8 to 9, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 11. Implantable prosthetic device according to embodiment 9, wherein the fixed arm is bent in the closing direction by approximately 45 degrees beyond the closed position into the preload position. 12. Implantable prosthetic device according to embodiment 9, wherein the fixed arm is bent in the closing direction by approximately 90 degrees beyond the closed position into the preload position. 13. Implantable prosthetic device according to embodiment 9, wherein, after the shape has been adjusted, the fixed arm is prevented from returning to the preloaded position by a transverse element. 14. Implantable prosthetic device according to embodiment 13, wherein the transverse element is a one-piece transverse element. 15. Implantable prosthetic device according to one of the above-mentioned embodiments, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened to a fully open position of approximately 140 degrees relative to the fixed arm. 16. Implantable prosthetic device according to embodiment 1, wherein the clasp is formed from a shape memory material having a thick section and a thin section. 17. Implantable prosthetic device according to embodiment 16, wherein the clasp is formed from several layers having thick and thin sections. 18. Implantable prosthetic device according to embodiment 17, wherein the multiple layers are laminated over the width of the clasp. 19. Implantable prosthetic device according to one of embodiments 16 to 18, wherein at least two of the multiple layers are provided with spikes. 20. Implantable prosthetic device according to one of the above-mentioned embodiments, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clasp. 21. Implantable prosthetic device according to one of the above embodiments, wherein the joint section is formed from a section of a generally circular loop. 22. Implantable prosthetic device according to one of the above embodiments, wherein the holes in the clasp extend over the width of the clasp. 23. Implantable prosthetic device, comprising: a coaptation section; an anchor comprising several paddles, the paddles having an outer section and an inner section and being able to extend from a folded closed position to an open position; and a clamp attached to each of the multiple paddles, the clamp comprising: a fixed arm attached to the inner section of the paddle; a movable arm having a section covered with spikes; and a joint section that connects the fixed arm to the movable arm in a jointed manner, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 24. Implantable prosthetic device according to embodiment 23, wherein the spring segments are torsion spring segments. 25. Implantable prosthetic device according to one of embodiments 23 to 24, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 26. Implantable prosthetic device according to one of embodiments 23 to 25, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and A second terminal connection point is adjacent to the second side. 27. Implantable prosthetic device according to embodiment 26, wherein: the spring segments are arranged in several rows and at least one column; the first or second ends of the spring segments are connected to another spring segment near a side edge of the clamp; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 28. Implantable prosthetic device according to one of embodiments 23 to 27, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 29. Implantable prosthetic device according to one of embodiments 23 to 28, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from a shape memory material. 30. Implantable prosthetic device according to embodiment 29, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clasp is opened. 31. Implantable prosthetic device according to one of embodiments 23 to 30, wherein the clasp is formed from a shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 32. Implantable prosthetic device according to embodiment 31, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 33. Implantable prosthetic device according to embodiment 32, wherein the fixed arm is bent in the closing direction by approximately 45 degrees beyond the closed position into the preload position. 34. Implantable prosthetic device according to embodiment 32, wherein the fixed arm is bent in the closing direction by approximately 90 degrees beyond the closed position into the preload position. 35. Implantable prosthetic device according to embodiment 32, wherein, after the shape has been adjusted, the fixed arm is prevented from returning to the preload position by a transverse element. 36. Implantable prosthetic device according to embodiment 35, wherein the transverse element is a one-piece transverse element. 37. Implantable prosthetic device according to one of embodiments 23 to 36, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened to a fully open position of approximately 140 degrees relative to the fixed arm. 38. Implantable prosthetic device according to one of embodiments 23 to 37, wherein the clasp is formed from a shape memory material having a thick section and a thin section. 39. Implantable prosthetic device according to embodiment 29, wherein spikes are formed in both the upper and lower positions. 40. Implantable prosthetic device according to one of embodiments 23 to 39, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clasp. 41. Implantable prosthetic device according to one of embodiments 23 to 40, wherein the spikes of the spiked section terminate in a point. 42. Clamp for an implantable prosthetic device, comprising: a fixed arm; a movable arm having a section covered with spikes; and a joint section that connects the fixed arm to the movable arm in a jointed manner, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 43. Clamp according to embodiment 42, wherein the spring segments are torsion spring segments. 44. Bracket according to one of embodiments 42 to 43, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 45. Bracket according to one of embodiments 42 to 44, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and A second terminal connection point is adjacent to the second side. 46. ​​Clamp according to embodiment 44, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 47. Bracket according to one of embodiments 42 to 46, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 48. Clamp according to one of embodiments 42 to 47, wherein the clamp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 49. Clamp according to embodiment 48, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 50. Clamp according to one of embodiments 42 to 49, wherein the clamp is formed from a shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 51. Clamp according to embodiment 50, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 52. Clamp according to embodiment 51, wherein the fixed arm is bent in the closing direction by approximately 45 degrees beyond the closed position into the preload position. 53. Clamp according to embodiment 51, wherein the fixed arm is bent in the closing direction by approximately 90 degrees beyond the closed position into the preload position. 54. Clamp according to embodiment 51, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 55. Clamp according to embodiment 54, wherein the transverse element is a one-piece transverse element. 56. Clamp according to embodiments 42 to 55, wherein a plastic limit of the clamp material is not exceeded when the movable arm is opened to a fully open position of about 140 degrees from the fixed arm. 57. Clamp according to embodiment 42, wherein the clamp consists of a shape memory material having a thick section and a thin section. 58. Clamp according to embodiment 48, wherein at least two of the multiple layers are provided with the spikes. 59. Clamp according to one of embodiments 42 to 58, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clamp. 60. Clamp according to one of embodiments 42 to 59, wherein the spikes of the spiked section terminate in a point. 61. Implantable prosthetic device, comprising: a coaptation section; an anchor section comprising several paddles, the paddles having an outer section and an inner section and extending from a folded closed position to an open position; and a clamp attachable to each of the multiple paddles, the clamp having a concave top and a convex bottom, comprising the following: a fixed arm attached to the inner section of the paddle; a movable arm having a section covered with spikes; and A joint section that connects the fixed arm to the movable arm. 62. Implantable prosthetic device according to embodiment 61, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 63. Implantable prosthetic device according to embodiment 62, wherein the spring segments are torsion spring segments. 64. Implantable prosthetic device according to one of embodiments 62 to 63, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 65. Implantable prosthetic device according to one of embodiments 62 to 64, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second connection point is adjacent to the second side; and a second connection point is located on the second side. 66. Implantable prosthetic device according to embodiment 64, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 67. Implantable prosthetic device according to one of embodiments 62 to 66, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 68. Implantable prosthetic device according to one of the above-mentioned embodiments, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from a shape memory material. 69. Implantable prosthetic device according to embodiment 68, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clasp is opened. 70. Implantable prosthetic device according to one of embodiments 61 to 69, wherein the clasp is formed from shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 71. Implantable prosthetic device according to embodiment 70, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 72. Implantable prosthetic device according to embodiment 71, wherein the fixed arm is bent in the closing direction by approximately 45 degrees beyond the closed position into the preload position. 73. Implantable prosthetic device according to embodiment 71, wherein the fixed arm is bent in the closing direction by approximately 90 degrees beyond the closed position into the preload position. 74. Implantable prosthetic device according to embodiment 71, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 75. Implantable prosthetic device according to embodiment 74, wherein the transverse element is a one-piece transverse element. 76. Implantable prosthetic device according to one of embodiments 61 to 75, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the fixed arm. 77. Implantable prosthetic device according to embodiment 61, wherein the clasp has a thick and a thin section formed from shape memory material. 78. Implantable prosthetic device according to embodiment 68, wherein at least two of the multiple layers of spikes are formed. 79. Implantable prosthetic device according to one of embodiments 61 to 78, wherein the spikes of the spiked section are tapered in the direction of the length of the clasp. 80. Implantable prosthetic device according to one of embodiments 61 to 69, wherein the spikes of the spiked section terminate in a point. 81. Implantable prosthetic device according to one of embodiments 61 to 80, wherein the clasp is cut from a tubular piece of material. 82. Implantable prosthetic device according to embodiment 81, wherein the clasp is cut with a 4-axis laser cutter. 83. Implantable prosthetic device according to one of embodiments 61 to 82, wherein the clasp is cut with a 5-axis laser cutter. 84. Implantable prosthetic device according to one of embodiments 61 to 69, wherein the spikes of the spiked section have a beveled edge. 85. Clamp for an implantable prosthetic device, comprising: a fixed arm that has a concave surface along the length of the fixed arm; a movable arm having a concave surface along the length of the movable arm and a section equipped with spikes; wherein the concave surface of the fixed arm faces the concave surface of the movable arm when the clamp is in a closed position; a joint section that connects the fixed arm to the movable arm and pre-tensions the clamp into the closed position. 86. Clamp according to embodiment 82, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 87. Clamp according to embodiment 83, wherein the spring segments are torsion spring segments. 88. Bracket according to one of embodiments 83 to 84, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 89. Bracket according to one of embodiments 83 to 85, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second connection point is adjacent to the second side; and a second terminal connection adjacent to the second side. 90. Clamp according to embodiment 85, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 91. Bracket according to one of embodiments 83 to 87, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 92. Clamp according to one of embodiments 82 to 88, wherein the clamp is formed from an upper layer and a lower layer, the upper and lower layers being formed from a shape memory material. 93. Clamp according to embodiment 89, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 94. Clamp according to one of embodiments 82 to 90, wherein the clamp is formed from shape memory material and the fixed and movable arms are pre-positioned in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 95. Clamp according to embodiment 91, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 96. Clamp according to embodiment 92, wherein the fixed arm is bent in the closing direction by approximately 45 degrees beyond the closed position into the preload position. 97. Clamp according to embodiment 92, wherein the fixed arm is bent in the closing direction by approximately 90 degrees beyond the closed position into the preload position. 98. Clamp according to embodiment 92, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 99. Clamp according to embodiment 74, wherein the transverse element is a one-piece transverse element. 100. Clamp according to one of embodiments 82 to 96, wherein a plastic limit of the material of the clamp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees from the fixed arm. 101. Clamp according to embodiment 92, wherein the clamp is formed from a shape memory material having a thick section and a thin section. 102. Clamp according to embodiment 98, wherein spikes are formed in at least two of the multiple layers. 103. Clamp according to one of embodiments 82 to 99, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clamp. 104. Clamp according to one of embodiments 82 to 100, wherein the spikes of the spiked section terminate in a point. 105. Clamp according to one of embodiments 82 to 101, wherein the clamp is cut from a tubular piece of material. 106. Implantable prosthetic device, comprising: a coaptation section; an anchor section comprising several paddles, the paddles having an outer section and an inner section and being extendable from a folded closed position to an open position; and a clamp that can be attached to each of the multiple paddles, the clamp comprising: a fixed arm attached to the inner section of the paddle; a movable, ring-shaped arm extending from a first end to a second end and having a section equipped with spikes; and a joint section that connects the fixed arm to the movable arm. 107. Implantable prosthetic device according to embodiment 106, wherein the retraction of the clasp into a feed sleeve causes the collapse of the ring-shaped movable arm. 108. Implantable prosthetic device according to one of embodiments 106 to 107, wherein actuation of a suture material causes the ring-shaped movable arm to collapse laterally. 109. Implantable prosthetic device according to embodiment 106, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 110. Implantable prosthetic device according to embodiment 109, wherein the spring segments are torsion spring segments. 111. Implantable prosthetic device according to one of embodiments 109 to 110, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 112. Implantable prosthetic device according to one of embodiments 109 to 111, wherein: the spring segments comprise a first end, a second end, a first side and a second side; A first lateral connection point is adjacent to the first end; a first terminal connection point is adjacent to the first side; A second lateral connection point is adjacent at the second end; and a second terminal connection adjacent to the second side. 113. Implantable prosthetic device according to embodiment 112, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 114. Implantable prosthetic device according to one of embodiments 109 to 113, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 115. Implantable prosthetic device according to one of embodiments 106 to 115, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 116. Implantable prosthetic device according to embodiment 115, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clasp is opened. 117. Implantable prosthetic device according to one of embodiments 106 to 116, wherein the clasp is formed from a shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 118. Implantable prosthetic device according to embodiment 117, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 119. Implantable prosthetic device according to embodiment 118, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 120. Implantable prosthetic device according to embodiment 118, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 121. Implantable prosthetic device according to embodiment 118, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 122. Implantable prosthetic device according to embodiment 121, wherein the transverse element is a one-piece transverse element. 123. Implantable prosthetic device according to one of embodiments 106 to 122, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the fixed arm. 124. Implantable prosthetic device according to embodiment 106, wherein the clasp is formed from a shape memory material having a thick section and a thin section. 125. Implantable prosthetic device according to embodiment 115, wherein spikes are formed in at least two of the multiple layers. 126. Implantable prosthetic device according to one of embodiments 111 to 112, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clasp. 127. Implantable prosthetic device according to one of embodiments 106 to 126, wherein the spikes of the spiked section terminate in a point. 128. Implantable prosthetic device according to one of embodiments 106 to 127, wherein the clasp is cut from a tubular piece of material. 129. Parenthesis, encompassing: a fixed arm; a bow-shaped movable arm extending from a first end to a second end and having a section equipped with spikes; a joint section that connects the fixed arm to the movable arm. 130. Clamp according to embodiment 129, wherein the retraction of the clamp into a feed sleeve causes the ring-shaped movable arm to collapse. 131. Clamp according to one of embodiments 129 to 130, wherein actuation of a suture material causes the ring-shaped movable arm to collapse laterally. 132. Clamp according to embodiment 129, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 133. Clamp according to embodiment 132, wherein the spring segments are torsion spring segments. 134. Bracket according to one of embodiments 132 to 133, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 135. Bracket according to one of embodiments 132 to 134, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second connection point is adjacent to the second side; and a second connection point is located on the second side. 136. Clamp according to embodiment 135, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 137. Bracket according to one of embodiments 132 to 136, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 138. Clamp according to one of embodiments 139 to 137, wherein the clamp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 139. Clamp according to embodiment 138, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 140. Clamp according to one of embodiments 129 to 139, wherein the clamp is formed from shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 141. Clamp according to embodiment 140, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 142. Clamp according to embodiment 132, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 143. Clamp according to embodiment 132, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 144. Clamp according to embodiment 132, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 145. Clamp according to embodiment 144, wherein the transverse element is a one-piece transverse element. 146. Clamp according to one of embodiments 129 to 145, wherein a plastic limit of the material of the clamp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the fixed arm. 147. Clamp according to embodiment 129, wherein the clamp has a thick section and a thin section. 148. Clamp according to embodiment 138, wherein spikes are formed in at least two of the several layers. 149. Clamp according to one of embodiments 129 to 148, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clamp. 150. Clamp according to one of embodiments 129 to 149, wherein the spikes of the spiked section terminate in a point. 151. Clamp according to one of embodiments 129 to 150, wherein the clamp is cut from a tubular piece of material. 152. Implantable prosthetic device, comprising: a coaptation section; an anchor comprising several paddles, the paddles having an outer and an inner section and being extendable from a folded closed position to an open position; and a clamp attached to each of the multiple paddles, the clamp comprising: a fixed arm attached to the inner section of the paddle; several movable arms, each having a section equipped with spikes; and several joint sections that connect the fixed arm to the multitude of movable arms. 153. Implantable prosthetic device according to embodiment 152, wherein the movable arms are bent to form the joint sections. 154. Implantable prosthetic device according to one of embodiments 152 to 153, wherein the movable arms have a twisted section. 155. Implantable prosthetic device according to one of embodiments 152 to 154, wherein the clasp is cut from a flat piece of material and the movable arms are bent and twisted before molding so that the prongs are substantially perpendicular to the fixed arm. 156. Implantable prosthetic device according to one of embodiments 152 to 155, wherein the clamp comprises four movable arms, each movable arm having a joint section. 157. Implantable prosthetic device according to one of embodiments 152 to 156, wherein actuation of a suture material causes the movable arms to collapse laterally and be brought together. 158. Implantable prosthetic device according to embodiment 152, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 159. Implantable prosthetic device according to embodiment 158, wherein the spring segments are torsion spring segments. 160. Implantable prosthetic device according to one of embodiments 158 to 159, wherein: the spring segments comprise a first end and a second end; and The first end of one spring segment is connected to at least one of the first and second ends of another spring segment. 161. Implantable prosthetic device according to one of embodiments 158 to 160, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and A second terminal connection point is adjacent to the second side. 162. Implantable prosthetic device according to embodiment 160, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments are connected to another spring segment near a side edge of the clamp; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 163. Implantable prosthetic device according to one of embodiments 158 to 162, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 164. Implantable prosthetic device according to one of embodiments 152 to 1163, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 165. Implantable prosthetic device according to embodiment 164, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clasp is opened. 166. Implantable prosthetic device according to one of embodiments 152 to 153, wherein the clasp is formed from a shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 167. Implantable prosthetic device according to embodiment 166, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 168. Implantable prosthetic device according to embodiment 167, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 169. Implantable prosthetic device according to embodiment 167, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 170. Implantable prosthetic device according to embodiment 167, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 171. Implantable prosthetic device according to embodiment 170, wherein the transverse element is a one-piece transverse element. 172. Implantable prosthetic device according to one of embodiments 152 to 171, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened into a fully open position of about 140 degrees relative to the fixed arm. 173. Implantable prosthetic device according to embodiment 152, wherein the clasp is formed from a shape memory material having a thick section and a thin section. 174. Implantable prosthetic device according to embodiment 164, wherein spikes are formed in at least two of the multiple layers. 175. Implantable prosthetic device according to one of embodiments 152 to 174, wherein the spikes of the spiked section are tapered in the direction of the length of the clasp. 176. Implantable prosthetic device according to one of embodiments 152 to 175, wherein the spikes of the spiked section terminate in a point. 177. Implantable prosthetic device according to one of embodiments 152 to 176, wherein the clasp is cut from a tubular piece of material. 178. Parenthesis, encompassing: a fixed arm; several movable arms, each having a section equipped with spikes; and several joint sections that connect the fixed arm to the multitude of movable arms. 179. Clamp according to embodiment 178, wherein the movable arms are bent to form the joint sections. 180. Clamp according to one of embodiments 178 to 179, wherein the movable arms each have a twisted section. 181. Clamp according to one of embodiments 178 to 179, wherein the clamp is cut from a flat piece of material and the movable arms are bent and twisted before shaping so that the prongs are substantially perpendicular to the fixed arm. 182. Clamp according to one of embodiments 178 to 181, wherein the clamp comprises four movable arms, each movable arm having a joint section. 183. Clamp according to one of embodiments 178 to 182, wherein actuation of a suture material causes the movable arms to collapse laterally and be brought together. 184. Clamp according to embodiment 178, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 185. Clamp according to embodiment 184, wherein the spring segments are torsion spring segments. 186. Bracket according to one of embodiments 184 to 185, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 187. Bracket according to one of embodiments 184 to 186, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and a second terminal connection point adjacent to the second side. 188. Clamp according to embodiment 186, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 189. Bracket according to one of embodiments 186 to 188, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 190. Clamp according to one of embodiments 188 to 189, wherein the clamp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 191. Clamp according to embodiment 188, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 192. Clamp according to one of embodiments 188 to 191, wherein the clamp is formed from shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 193. Clamp according to embodiment 192, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 194. Clamp according to embodiment 193, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 195. Clamp according to embodiment 193, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 196. Clamp according to embodiment 193, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 197. Clamp according to embodiment 196, wherein the transverse element is a one-piece transverse element. 198. Clamp according to one of embodiments 178 to 197, wherein a plastic limit of the material of the clamp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the fixed arm. 199. Clamp according to embodiment 178, wherein the clamp is formed from a shape memory material having a thick section and a thin section. 200. Clamp according to embodiment 190, wherein spikes are formed in at least two of the multiple layers. 201. Clamp according to one of embodiments 178 to 200, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clamp. 202. Clamp according to one of embodiments 178 to 201, wherein the spikes of the spiked section terminate in a point. 203. Clamp according to one of embodiments 178 to 202, wherein the clamp is cut from a tubular piece of material. 204. Implantable prosthetic device, comprising: a coaptation section; an anchor comprising several paddles, the paddles having an outer section and an inner section and being extendable from a folded closed position to an open position; a clamp that can be attached to each of the multiple paddles, the clamp comprising: a fixed arm attached to the inner section of the paddle; a movable arm having a spiked section, a first eyelet and a second eyelet; and a joint section that connects the fixed arm to the movable arm; a first intermediate seam material loop attached to the first eyelet; a second intermediate seam material attached to the second eyelet; and at least one actuating seam attached to the first and second intermediate seam material loop. 205. Implantable prosthetic device according to embodiment 204, wherein the first eyelet is located near a first side of the clasp and the second eyelet is located near a second side of the clasp. 206. Implantable prosthetic device according to embodiment 204, further comprising a first lateral gap between a first side of the clasp and the first eyelet and a second lateral gap between the second side of the clasp and the second eyelet; wherein the first and the second lateral gaps are less than one third of the width of the clasp. 207. Implantable prosthetic device according to one of embodiments 204 to 206, wherein the first and second intermediate suture loop wraps around one end of the movable arm. 208. Implantable prosthetic device according to one of embodiments 204 to 207, wherein the first and second intermediate suture material loops extend through an opening in the movable arm. 209. Implantable prosthetic device according to embodiment 204, wherein one end of the movable arm is rounded. 210. Implantable prosthetic device according to embodiment 204, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 211. Implantable prosthetic device according to embodiment 210, wherein the spring segments are torsion spring segments. 212. Implantable prosthetic device according to one of embodiments 210 to 211, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 213. Implantable prosthetic device according to one of embodiments 210 to 212, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and a second terminal connection point adjacent to the second side. 214. Implantable prosthetic device according to embodiment 212, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments are connected to another spring segment near a side edge of the clamp; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 215. Implantable prosthetic device according to one of embodiments 210 to 214, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 216. Implantable prosthetic device according to one of embodiments 204 to 215, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 217. Implantable prosthetic device according to embodiment 216, wherein the upper and lower layers are connected to each other only at one point so that the upper and lower layers can slide relative to each other when the clasp is opened. 218. Implantable prosthetic device according to one of embodiments 204 to 217, wherein the clasp is formed from a shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 219. Implantable prosthetic device according to embodiment 218, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 220. Implantable prosthetic device according to embodiment 219, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 221. Implantable prosthetic device according to embodiment 219, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 222. Implantable prosthetic device according to embodiment 219, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 223. Implantable prosthetic device according to embodiment 222, wherein the transverse element is a one-piece transverse element. 224. Implantable prosthetic device according to one of embodiments 204 to 223, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the fixed arm. 225. Implantable prosthetic device according to embodiment 204, wherein the clasp is formed from a shape memory material having a thick section and a thin section. 226. Implantable prosthetic device according to embodiment 216, wherein the spikes are formed in at least two of the several layers. 227. Implantable prosthetic device according to one of embodiments 204 to 226, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clasp. 228. Implantable prosthetic device according to one of embodiments 204 to 227, wherein the spikes of the spiked section terminate in a point. 229. Implantable prosthetic device according to one of inventions 204 to 223, wherein the clasp is cut from a tubular piece of material. 230. Parenthesis, encompassing: a fixed arm; a movable arm having a spiked section, a first eyelet and a second eyelet; and a joint section that connects the fixed arm to the movable arm; a first loop of the suture material attached to the first eyelet; a second loop of suture material attached to the second eyelet; and at least one actuating seam attached to the first and second intermediate seam material loop. 231. Clamp according to embodiment 230, wherein the first eyelet is located near a first side of the clamp and the second eyelet is located near a second side of the clamp. 232. Clamp according to embodiment 230, further comprising a first side gap between a first side of the clamp and the first eyelet and a second side gap between the second side of the clamp and the second eyelet; wherein the first and the second side gaps are less than one third of the width of the clamp. 233. Clamp according to one of embodiments 230 to 232, wherein the first and the second intermediate suture loop wrap around one end of the movable arm. 234. Clamp according to one of embodiments 230 to 233, wherein the first and second intermediate seam loop extend through an opening in the movable arm. 235. Clamp according to embodiment 230, wherein one end of the movable arm is rounded. 236. Clamp according to embodiment 230, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 237. Clamp according to embodiment 236, wherein the spring segments are torsion spring segments. 238. Bracket according to one of embodiments 236 to 237, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 239. Bracket according to one of embodiments 236 to 238, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and A second terminal connection point is adjacent to the second side. 240. Clamp according to embodiment 238, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 241. Bracket according to one of embodiments 236 to 240, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 242. Clamp according to one of embodiments 240 to 241, wherein the clamp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 243. Clamp according to embodiment 242, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 244. Clamp according to one of embodiments 230 to 243, wherein the clamp is formed from shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 245. Clamp according to embodiment 244, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 246. Clamp according to embodiment 245, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 247. Clamp according to embodiment 245, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 248. Clamp according to embodiment 245, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 249. Clamp according to embodiment 248, wherein the transverse element is a one-piece transverse element. 250. Clamp according to one of embodiments 230 to 249, wherein a plastic limit of the material of the clamp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the stationary arm. 251. Clamp according to embodiment 230, wherein the clamp is formed from a shape memory material having a thick section and a thin section. 252. Clamp according to embodiment 242, wherein spikes are formed in at least two of the multiple layers. 253. Clamp according to one of embodiments 230 to 252, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clamp. 254. Clamp according to one of embodiments 230 to 253, wherein the spikes of the spiked sections terminate in a point. 255. Clamp according to one of embodiments 230 to 254, wherein the clamp is cut from a tubular piece of material. 256. Clamp according to embodiment 232, wherein the first and second lateral gaps are less than a quarter of the width of the clamp. 257. Implantable prosthetic device, comprising: a coaptation section; an anchor comprising several paddles, the paddles having an outer and an inner section and extending from a folded closed position to an open position; and a clamp attached to each of the multiple paddles, the clamp comprising: a fixed arm attached to the inner section of the paddle; a movable arm having a spiked section and a rounded end; and a joint section that connects the fixed arm to the movable arm. 258. Implantable prosthetic device according to embodiment 257, wherein the edges of the movable arm are rounded. 259. Implantable prosthetic device according to embodiment 257, wherein the end of the movable arm has a convex curved shape formed from a single radius. 260. Implantable prosthetic device according to embodiment 257, wherein the end of the movable arm has a semicircular shape. 261. Implantable prosthetic device according to embodiment 257, wherein the end of the movable arm has a semi-elliptical shape. 262. Implantable prosthetic device according to embodiment 257, wherein the end of the movable arm has a rounded triangular shape. 263. Implantable prosthetic device according to embodiment 257, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 264. Implantable prosthetic device according to embodiment 263, wherein the spring segments are torsion spring segments. 265. Implantable prosthetic device according to one of embodiments 263 to 264, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 266. Implantable prosthetic device according to one of embodiments 263 to 265, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and a second terminal connection point adjacent to the second side. 267. Implantable prosthetic device according to embodiment 265, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 268. Implantable prosthetic device according to one of embodiments 263 to 267, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 269. Implantable prosthetic device according to one of embodiments 257 to 268, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 270. Implantable prosthetic device according to embodiment 269, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clasp is opened. 271. Implantable prosthetic device according to one of embodiments 257 to 270, wherein the clasp is formed from shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 272. Implantable prosthetic device according to embodiment 271, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 273. Implantable prosthetic device according to embodiment 272, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 274. Implantable prosthetic device according to embodiment 272, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 275. Implantable prosthetic device according to embodiment 272, wherein, after setting the shape, the fixed arm is prevented from returning to the preload position by a transverse element. 276. Implantable prosthetic device according to embodiment 275, wherein the transverse element is a one-piece transverse element. 277. Implantable prosthetic device according to one of embodiments 257 to 276, wherein a plasticity limit of the material of the clasp is not exceeded when the movable arm is opened into a fully open position of about 140 degrees relative to the fixed arm. 278. Implantable prosthetic device according to embodiment 257, wherein the clasp is formed from a shape memory material having a thick section and a thin section. 279. Implantable prosthetic device according to embodiment 269, wherein spikes are formed in at least two of the multiple layers. 280. Implantable prosthetic device according to one of embodiments 257 to 279, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clasp. 281. Implantable prosthetic device according to one of embodiments 257 to 280, wherein the spikes of the spiked section terminate in a point. 282. Implantable prosthetic device according to one of embodiments 257 to 281, wherein the clasp is cut from a tubular piece of material. 283. Parenthesis, encompassing: a fixed arm; a movable arm having a spiked section and a rounded end; and a joint section that connects the fixed arm with the movable arm. 284. Clamp according to embodiment 283, wherein the edges of the movable arm are rounded. 285. Clamp according to embodiment 283, wherein the end of the movable arm has a convexly curved shape formed from a single radius. 286. Clamp according to embodiment 283, wherein the end of the movable arm has a semicircular shape. 287. Clamp according to embodiment 283, wherein the end of the movable arm has a semi-elliptical shape. 288. Clamp according to embodiment 283, wherein the end of the movable arm has a rounded triangular shape. 289. Clamp according to embodiment 283, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 290. Clamp according to embodiment 289, wherein the spring segments are torsion spring segments. 291. Bracket according to one of embodiments 289 to 290, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 292. Bracket according to one of embodiments 289 to 291, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and a second terminal connection point adjacent to the second side. 293. Clamp according to embodiment 291, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 294. Bracket according to one of embodiments 289 to 293, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 295. Clamp according to one of embodiments 289 to 294, wherein the clamp is formed from an upper layer and a lower layer, wherein the upper layer and the lower layer are formed from shape memory material. 296. Clamp according to embodiment 295, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 297. Clamp according to one of embodiments 293 to 295, wherein the clamp is formed from shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 298. Clamp according to embodiment 297, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 299. Clamp according to embodiment 298, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 300. Clamp according to embodiment 298, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 301. Clamp according to embodiment 298, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 302. Clamp according to embodiment 301, wherein the transverse element is a one-piece transverse element. 303. Clamp according to one of embodiments 283 to 302, wherein a plastic limit of the material of the clamp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees from the fixed arm. 304. Clamp according to embodiment 283, wherein the clamp consists of a shape memory material having a thick section and a thin section. 305. Clamp according to embodiment 295, wherein spikes are formed in at least two of the multiple layers. 306. Clamp according to one of embodiments 283 to 305, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clamp. 307. Clamp according to one of embodiments 283 to 306, wherein the spikes of the spiked section terminate in a point. 308. Clamp according to one of embodiments 283 to 307, wherein the clamp is cut from a tubular piece of material. 309. Implantable prosthetic device, comprising: a coaptation section; an anchor section comprising several paddles, the paddles having an outer section and an inner section and being extendable from a folded closed position to an open position; and a clamp that can be attached to each of the multiple paddles, the clamp comprising: a fixed arm attached to the inner section of the paddle; a movable arm having a section equipped with spikes; and a joint section that connects the fixed arm to the movable arm; the device has no catch points when the section is in the open position and the clamps are in a closed state. 310. Implantable prosthetic device according to embodiment 309, wherein the device does not have any recesses with a depth of more than one third of the width of the device. 311. Implantable prosthetic device according to embodiment 309, wherein the joint section is rounded when the clasp is in the closed state. 312. Implantable prosthetic device according to embodiment 309, wherein the device does not have a spike-shaped projection. 313. Implantable prosthetic device according to embodiment 309, wherein the device does not have any hook-shaped projections. 314. Implantable prosthetic device according to embodiment 309, wherein the device does not have needle-shaped projections. 315. Implantable prosthetic device according to embodiment 309, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 316. Implantable prosthetic device according to embodiment 315, wherein the spring segments are torsion spring segments. 317. Implantable prosthetic device according to one of embodiments 315 to 316, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 318. Implantable prosthetic device according to one of embodiments 315 to 317, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and a second terminal connection point adjacent to the second side. 319. Implantable prosthetic device according to embodiment 317, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments are connected to another spring segment near a side edge of the clamp; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 320. Implantable prosthetic device according to one of embodiments 315 to 319, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 321. Implantable prosthetic device according to one of embodiments 309 to 320, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 322. Implantable prosthetic device according to embodiment 321, wherein the upper and lower layers are connected to each other only at one point so that the upper and lower layers can slide relative to each other when the clasp is opened. 323. Implantable prosthetic device according to one of embodiments 309 to 322, wherein the clasp is formed from a shape memory material and the fixed and movable arms are preset in a preload position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 324. Implantable prosthetic device according to embodiment 323, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 325. Implantable prosthetic device according to embodiment 324, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 326. Implantable prosthetic device according to embodiment 324, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 327. Implantable prosthetic device according to embodiment 324, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 328. Implantable prosthetic device according to embodiment 327, wherein the transverse element is a one-piece transverse element. 329. Implantable prosthetic device according to one of embodiments 309 to 328, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees from the fixed arm. 330. Implantable prosthetic device according to embodiment 309, wherein the clasp is formed from a shape memory material having a thick section and a thin section, which has a thick section and a thin section. 331. Implantable prosthetic device according to embodiment 321, wherein at least two of the multiple layers of spikes are formed. 332. Implantable prosthetic device according to one of embodiments 309 to 331, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clasp. 333. Implantable prosthetic device according to one of embodiments 309 to 332, wherein the spikes of the spiked sections terminate in a point. 334. Implantable prosthetic device according to one of embodiments 309 to 333, wherein the clasp is cut from a tubular piece of material. 335. Implantable prosthetic device, comprising: a coaptation section; an anchor section comprising several paddles, the paddles having an outer section and an inner section and extending from a folded closed position to an open position; and a bracket that includes: a fixed arm; several movable arms, each having a section equipped with spikes; and several joint sections that connect the movable arms to the stationary arm. 336. Implantable prosthetic device according to embodiment 335, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from a shape memory material. 337. Implantable prosthetic device according to embodiment 336, wherein the upper and lower layers are connected to each other only at one point so that the upper and lower layers can slide relative to each other when the clasp is opened. 338. Implantable prosthetic device according to embodiments 336 to 337, wherein the spiked section comprises spikes and spike supports, and wherein the spikes are formed from the lower layer and the spike supports are formed from the upper layer. 339. Implantable prosthetic device according to embodiments 336 to 337, wherein the spiked section comprises spikes and spike supports, and wherein the spikes are formed from the upper layer and the spike supports are formed from the lower layer. 340. Implantable prosthetic device according to embodiment 335, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 341. Implantable prosthetic device according to embodiment 340, wherein the spring segments are torsion spring segments. 342. Implantable prosthetic device according to one of embodiments 340 to 341, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 343. Implantable prosthetic device according to one of embodiments 340 to 342, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and A second terminal connection point is adjacent to the second side. 344. Implantable prosthetic device according to embodiment 342, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments are connected to another spring segment near a side edge of the clamp; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 345. Implantable prosthetic device according to one of embodiments 340 to 344, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 346. Implantable prosthetic device according to one of embodiments 335 to 345, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from a shape memory material. 347. Implantable prosthetic device according to embodiment 346, wherein the upper and lower layers are connected to each other only at one point so that the upper and lower layers can slide relative to each other when the clasp is opened. 348. Implantable prosthetic device according to one of embodiments 335 to 347, wherein the clasp is formed from a shape memory material and the fixed and movable arms are pre-molded in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 349. Implantable prosthetic device according to embodiment 348, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 350. Implantable prosthetic device according to embodiment 349, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 351. Implantable prosthetic device according to embodiment 349, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 352. Implantable prosthetic device according to embodiment 349, wherein, after setting the shape, the fixed arm is prevented by a transverse element from returning to the preload position. 353. Implantable prosthetic device according to embodiment 352, wherein the transverse element is a one-piece transverse element. 354. The implantable prosthetic device according to one of embodiments 335 to 353, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees from the fixed arm. 355. Implantable prosthetic device according to embodiment 335, wherein the clasp is formed from a shape memory material having a thick section and a thin section. 356. Implantable prosthetic device according to one of embodiments 335 to 355, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clasp. 357. Implantable prosthetic device according to one of embodiments 335 to 356, wherein the spikes of the spiked section terminate in a point. 358. Implantable prosthetic device according to one of embodiments 335 to 357, wherein the clasp is cut from a tubular piece of material. 359. Parenthesis, encompassing: a fixed arm; several movable arms, each having a section equipped with spikes; and several joint sections that connect the movable arms to the stationary arm. 360. Clamp according to embodiment 359, wherein the clamp is formed from an upper layer and a lower layer, wherein the upper layer and the lower layer are formed from shape memory material. 361. Clamp according to embodiment 360, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 362. Clamp according to embodiments 360 to 361, wherein the spiked section comprises spikes and spike supports, and wherein the spikes are formed from the lower layer and the spike supports are formed from the upper layer. 363. Clamp according to embodiments 360 to 361, wherein the spiked section comprises spikes and spike supports, and wherein the spikes are formed from the upper layer and the spike supports are formed from the lower layer. 364. Clamp according to embodiment 359, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 365. Clamp according to embodiment 364, wherein the spring segments are torsion spring segments. 366. Bracket according to one of embodiments 364 to 365, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 367. Bracket according to one of embodiments 364 to 366, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and a second terminal connection point adjacent to the second side. 368. Clamp according to embodiment 366, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 369. Bracket according to one of embodiments 364 to 368, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 370. Clamp according to one of embodiments 359 to 369, wherein the clamp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 371. Clamp according to embodiment 370, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 372. Clamp according to one of embodiments 359 to 371, wherein the clamp is formed from a shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 373. Clamp according to embodiment 372, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 374. Clamp according to embodiment 373, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 375. Clamp according to embodiment 373, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 376. Clamp according to embodiment 373, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 377. Clamp according to embodiment 376, wherein the transverse element is a one-piece transverse element. 378. Clamp according to one of embodiments 359 to 377, wherein a plastic limit of the material of the clamp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the fixed arm. 379. Clamp according to embodiment 359, wherein the clamp is formed from a shape memory material having a thick section and a thin section. 380. Clamp according to one of embodiments 359 to 379, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clamp. 381. Clamp according to one of embodiments 359 to 380, wherein the spikes of the spiked section terminate in a point. 382. Clamp according to one of embodiments 359 to 381, wherein the clamp is cut from a tubular piece of material. 383. Implantable prosthetic device, comprising: a coaptation section; an anchor comprising several paddles, the paddles having an outer and an inner section and extending from a folded closed position to an open position; a clamp that can be attached to each of the multiple paddles, the clamp comprising: a fixed arm attached to the inner section of the paddle; a movable arm having a section covered with spikes; and a joint section that connects the fixed arm to the movable arm; a cover that wraps around at least a section of the movable arm of the clamp; and at least one suture material attached to the cover. 384. Implantable prosthetic device according to embodiment 383, wherein the cover comprises a flexible mesh. 385. Implantable prosthetic device according to embodiment 383, further comprising a first lateral gap between a first side of the clasp and a first attachment point of the cover and a second lateral gap between a second side of the clasp and a second attachment point of the cover; wherein the first and the second lateral gaps are less than one third of the width of the clasp. 386. Implantable prosthetic device according to embodiment 385, wherein the first and second lateral gaps are less than a quarter of the width of the clasp. 387. Implantable prosthetic device according to one of embodiments 383 to 386, wherein the cover wraps around one end of the movable arm. 388. Implantable prosthetic device according to one of embodiments 383 to 387, wherein at least one section of the cover forms at least one section of the coaptation section. 389. Implantable prosthetic device according to embodiment 383, wherein one end of the movable arm is rounded. 390. Implantable prosthetic device according to embodiment 383, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 391. Implantable prosthetic device according to embodiment 390, wherein the spring segments are torsion spring segments. 392. Implantable prosthetic device according to one of embodiments 390 to 391, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 393. Implantable prosthetic device according to one of embodiments 390 to 392, wherein: the spring segments comprise a first end, a second end, a first side and a second side; A first lateral connection point is adjacent to the first end; a first terminal connection point is adjacent to the first side; A second lateral connection point is adjacent at the second end; and a second terminal connection adjacent to the second side. 394. Implantable prosthetic device according to embodiment 392, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments are connected to another spring segment near a side edge of the clamp; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 395. Implantable prosthetic device according to one of embodiments 390 to 394, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 396. Implantable prosthetic device according to one of embodiments 383 to 395, wherein the clasp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 397. Implantable prosthetic device according to embodiment 396, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clasp is opened. 398. Implantable prosthetic device according to one of embodiments 383 to 397, wherein the clasp is formed from shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 399. Implantable prosthetic device according to embodiment 398, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 400. Implantable prosthetic device according to embodiment 399, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 401. Implantable prosthetic device according to embodiment 399, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 402. Implantable prosthetic device according to embodiment 399, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 403. Implantable prosthetic device according to embodiment 402, wherein the transverse element is a one-piece transverse element. 404. Implantable prosthetic device according to one of embodiments 383 to 403, wherein a plastic limit of the material of the clasp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the fixed arm. 405. Implantable prosthetic device according to embodiment 383, wherein the clasp is formed from a shape memory material having a thick section and a thin section. 406. Implantable prosthetic device according to embodiment 396, wherein spikes are formed in at least two of the several layers. 407. Implantable prosthetic device according to one of embodiments 383 to 406, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clasp. 408. Implantable prosthetic device according to one of embodiments 383 to 407, wherein the spikes of the spiked section terminate in a point. 409. Implantable prosthetic device according to one of embodiments 383 to 408, wherein the clasp is cut from a tubular piece of material. 410. Parenthesis, encompassing: a fixed arm; a movable arm having a section covered with spikes; and a joint section that connects the fixed arm to the movable arm; a cover that surrounds at least a section of the movable arm; and at least one seam material attached to the cover. 411. Clamp according to embodiment 410, wherein the first eyelet is arranged near a first side of the clamp and the second eyelet is arranged near a second side of the clamp. 412. Clamp according to embodiment 410, further comprising a first side gap between a first side of the clamp and the first eyelet and a second side gap between the second side of the clamp and the second eyelet; wherein the first and the second side gaps are less than one third of the width of the clamp. 413. Clamp according to one of embodiments 410 to 412, wherein the first and the second intermediate seam loop wrap around one end of the movable arm. 414. Clamp according to one of embodiments 410 to 413, wherein the first and second intermediate seam loop extend through an opening in the movable arm. 415. Clamp according to embodiment 410, wherein one end of the movable arm is rounded. 416. Clamp according to embodiment 410, wherein the joint section comprises several spring segments, each spring segment being connected to several spring segments. 417. Clamp according to embodiment 416, wherein the spring segments are torsion spring segments. 418. Bracket according to one of embodiments 416 to 417, wherein: the spring segments comprise a first end and a second end; and the first end of a spring segment is connected to at least one of the first and second ends of another spring segment. 419. Bracket according to one of embodiments 416 to 418, wherein: the spring segments comprise a first end, a second end, a first side and a second side; a first lateral connection point adjacent to the first end; a first terminal connection point adjacent to the first side; a second lateral connection point adjacent to the second end; and A second terminal connection point is adjacent to the second side. 420. Clamp according to embodiment 418, wherein: the spring segments are arranged in several rows and columns; the first or second ends of the spring segments located near a side edge of the clamp are connected to another spring segment; and the first or second ends of the spring segments are connected to at least one other spring segment in the vicinity of an adjacent slit. 421. Bracket according to one of embodiments 416 to 420, wherein: the spring segments are arranged in a pattern that has three columns and seven rows of spring segments. 422. Clamp according to one of embodiments 410 to 421, wherein the clamp is formed from an upper layer and a lower layer, the upper layer and the lower layer being formed from shape memory material. 423. Clamp according to embodiment 422, wherein the upper and lower layers are connected to each other only at one point, so that the upper and lower layers can slide relative to each other when the clamp is opened. 424. Clamp according to one of embodiments 422 to 423, wherein the clamp is formed from a shape memory material and the fixed and movable arms are pre-set in a pre-tensioned position such that a clamping force exists between the fixed and movable arms when the fixed arm is approximately parallel to the movable arm. 425. Clamp according to embodiment 424, wherein the fixed arm is bent in the closing direction beyond the closed position into the preload position. 426. Clamp according to embodiment 425, wherein the fixed arm is bent in the closing direction by about 45 degrees beyond the closed position into the preload position. 427. Clamp according to embodiment 425, wherein the fixed arm is bent in the closing direction by about 90 degrees beyond the closed position into the preload position. 428. Clamp according to embodiment 425, wherein, after the shape has been set, the fixed arm is prevented from returning to the preload position by a transverse element. 429. Clamp according to embodiment 428, wherein the transverse element is a one-piece transverse element. 430. Clamp according to one of embodiments 410 to 429, wherein a plastic limit of the material of the clamp is not exceeded when the movable arm is opened to a fully open position of about 140 degrees relative to the fixed arm. 431. Clamp according to embodiment 410, wherein the clamp has a thick section and a thin section. 432. Clamp according to embodiment 422, wherein spikes are formed in at least two of the multiple layers. 433. Clamp according to one of embodiments 410 to 432, wherein the spikes of the spiked section are tapered in the longitudinal direction of the clamp. 434. Clamp according to one of embodiments 410 to 433, wherein the spikes of the spiked section terminate in a point. 435. Clamp according to one of embodiments 410 to 434, wherein the clamp is cut from a tubular piece of material. 436. Bracket comprising any combination of the features of the preceding embodiments. 437. Method for repairing a mitral valve, comprising any combination of any features and steps of any of the preceding embodiments. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] US 15 / 884,193

[0001] US 15 / 909,803

[0001] US 15 / 910,951

[0001] US 15 / 914,143

[0001] US 15 / 927,814

[0001] US 15 / 946,604

[0001] US 15 / 953,220

[0001] US 15 / 953,263

[0001] US 15 / 953,283

[0001] US 62 / 486,835

[0001] US 8,449,599

[0016] US 2014 / 0222136

[0016] US 2014 / 0067052

[0016] US 2016 / 0331523

[0016]

Claims

[1] Implantable prosthetic device (100) that helps to seal native heart valves and prevent or reduce regurgitation through them, the prosthetic device (100) comprising: a coaptation element (110); several paddles (120, 122) that are movable between a closed position and an open position to accommodate native mitral or tricuspid valve leaflets (42, 44) between the paddles (120, 122) and the coaptation element (110); and a double-ended prong clamp (3000) having a base (3010) with joint sections (3020) located near the coaptation element (110) and movable arms (3030) extending from both ends of the base (3010); wherein each of the movable arms (3030) can be moved from an open position to a closed position in order to press the native mitral or tricuspid valve tissue (42, 44) against one of the several paddles (120, 122) respectively. [2] Device according to claim 1, wherein the coaptation element (110) has an upper end configured to be positioned in or adjacent to the atrium, a lower end configured to be positioned in or adjacent to the ventricle, and a side surface extending between the native leaflets. [3] Device according to any of the preceding claims, wherein the coaptation element (110) has a blood-impermeable structure which allows the native leaflets to close together on each side of the coaptation element (110) during ventricular systole in order to prevent blood from flowing back from the ventricle into the atrium. [4] Device according to one of the preceding claims, wherein the coaptation element (110) has a non-cylindrical shape. [5] Device according to one of the preceding claims, wherein the coaptation element (110) has an oval cross-sectional shape or a crescent-shaped cross-sectional shape. [6] Device according to one of the preceding claims, configured to seal against two or three native flap sails. [7] Device according to one of the preceding claims, wherein the coaptation element (110) is configured to expand independently from a radially compressed state to a radially expanded state. [8] Device according to claim 7, wherein the coaptation element (110) is formed from a flexible material which may be a mesh, woven or braided, wherein the flexible material is preferably a wire made of a shape memory alloy such as Nitinol. [9] Device according to one of the preceding claims, further comprising an actuating device (116) attached to the ends of each of the movable arms (3030). [10] Device according to claim 9, wherein the application of a tensile stress to the actuating means (116) causes the movable arms (3030) to pivot about the joint sections (3020). [11] Device according to one of claims 9 or 10, wherein the actuating means (116) can be actuated independently so that each spiked clamp (3000) can be opened and closed independently. [12] Device according to claim 11, wherein the spiked clamp (3000) can be opened and closed independently of the position of the paddles (120, 122). [13] Device according to one of the preceding claims, wherein the spiked clamp (3000) is spring-loaded so that in the closed position the spiked clamp (3000) is configured to continue to exert a clamping force on the received native sails. [14] Device according to one of the preceding claims, configured to be held in a deployed state by a mechanical locking mechanism or by preloading using spring materials, wherein the deployed state is a state in which the paddles (120, 122) and the spiked clamp (3000) remain in their respective closed positions. [15] Implantable prosthetic device (100) that helps to seal native heart valves and prevent or reduce regurgitation through them, the prosthetic device (100) comprising: a coaptation element (110); several paddles (120, 122) that are movable between a closed position and an open position to accommodate native mitral or tricuspid valve leaflets (42, 44) between the paddles (120, 122) and the coaptation element (110); several brackets (130) that are movable between an open position and a closed position; and a cover over the coaptation element (110) and the paddles (120, 122). [16] Device according to claim 15, wherein the cover consists of a flexible material which may be a mesh, woven or braided fabric, wherein the flexible material is preferably a fabric. [17] Device according to one of claims 15 or 16, wherein the multiple clamps (130) are formed by a spiked clamp (3000) having two ends, comprising a base (3010) with joint sections (3020) arranged near the coaptation element (110), and movable arms (3030) extending from both ends of the base (3010); wherein each of the movable arms (3030) is movable from an open position to a closed position in order to press the native mitral or tricuspid valve tissue (42, 44) against one of the multiple paddles (120, 122) respectively. [18] Device according to any one of claims 15 to 17, wherein the coaptation element (110) has an upper end configured to be positioned in or adjacent to the atrium, a lower end configured to be positioned in or adjacent to the ventricle, and a side surface extending between the native leaflets. [19] Device according to any one of claims 15 to 18, wherein the coaptation element (110) has a blood-impermeable structure which allows the native leaflets to close together on each side of the coaptation element (110) during ventricular systole to prevent blood from flowing back from the ventricle into the atrium. [20] Device according to one of claims 15 to 19, wherein the coaptation element (110) has a non-cylindrical shape. [21] Device according to one of claims 15 to 20, wherein the coaptation element (110) has an oval cross-sectional shape or a crescent-shaped cross-sectional shape. [22] Device according to any one of claims 15 to 21, configured to seal on two or three native flap sails. [23] Device according to one of claims 15 to 22, wherein the coaptation element (110) is configured to expand autonomously from a radially compressed state to a radially expanded state. [24] Device according to one of claims 17 to 23, further comprising an actuating device (116) attached to the ends of each of the movable arms (3030). [25] Device according to claim 24, wherein the application of a tensile stress to the actuating means (116) causes the movable arms (3030) to pivot about the joint sections (3020). [26] Device according to one of claims 24 or 25, wherein the actuating means (116) can be actuated independently, so that each spiked clamp (3000) can be opened and closed independently. [27] Device according to claim 26, wherein the spiked clamp (3000) can be opened and closed independently of the position of the paddles (120, 122). [28] Device according to any one of claims 15 to 27, wherein the spiked clamp (3000) is spring-loaded so that the clamp (3000) in the closed position is configured to continue to exert a clamping force on the received native sails. [29] Implantable prosthetic device (100) that helps to seal native heart valves and prevent or reduce regurgitation through them, the prosthetic device (100) comprising: a coaptation element (110) having a non-cylindrical shape; several paddles (120, 122) that are movable between a closed position and an open position to accommodate native mitral or tricuspid valve leaflets (42, 44) between the paddles (120, 122) and the coaptation element (110); several brackets (130) that can be moved from an open position to a closed position. [30] Device according to claim 29, wherein the coaptation element (110) has an upper end configured to be positioned in or adjacent to the atrium, a lower end configured to be positioned in or adjacent to the ventricle, and a side surface extending between the native leaflets. [31] Device according to one of claims 29 to 30, which further comprises a cover over the coaptation element (110) and the paddles (120, 122). [32] Device according to any one of claims 29 to 31, wherein the multiple clamps (130) are formed by a spiked clamp (3000) having two ends, comprising a base (3010) with joint sections (3020) arranged near the coaptation element (110), and movable arms (3030) extending from both ends of the base (3010); wherein each of the movable arms (3030) is movable from an open position to a closed position in order to press the native mitral or tricuspid valve tissue (42, 44) against one of the multiple paddles (120, 122) respectively. [33] Device according to one of claims 29 to 32, wherein the coaptation element (110) has an oval cross-sectional shape or a crescent-shaped cross-sectional shape. [34] Device according to one of claims 29 to 33, configured to seal against two or three native flap sails. [35] Device according to one of claims 29 to 34, wherein the coaptation element (110) is configured to expand independently from a radially compressed state to a radially expanded state. [36] Device according to claim 35, wherein the coaptation element (110) is formed from a flexible material which may be a mesh, woven or braided, wherein the flexible material is preferably a wire made of a shape memory alloy such as Nitinol. [37] Device according to one of claims 32 to 36, further comprising an actuating device (116) attached to the ends of each of the movable arms (3030). [38] Device according to claim 37, wherein the application of a tensile stress to the actuating means (116) causes the movable arms (3030) to pivot about the joint sections (3020). [39] Device according to one of claims 37 or 38, wherein the actuating means (116) can be actuated independently, so that each spiked clamp (3000) can be opened and closed independently. [40] Device according to claim 39, wherein the spiked clamp (3000) can be opened and closed independently of the position of the paddles (120, 122). [41] Device according to any one of claims 32 to 40, wherein the spiked clamp (3000) is spring-loaded, so that in the closed position the spiked clamp (3000) is configured to continue to exert a clamping force on the received native sails. [42] Device according to any one of claims 32 to 41, which is configured to be held in a deployed state by a mechanical locking mechanism or by the use of spring materials, wherein the deployed state is a state in which the paddles (120, 122) and the spiked clamp (3000) remain in their respective closed positions. [43] Implantable prosthetic device (100) for repairing a native mitral or tricuspid valve, the device comprising: a coaptation section (104) comprising a spacer (110) having an oval cross-sectional shape and configured to be positioned within the native heart valve orifice to help form a more effective seal between the native leaflets (42, 44), thereby reducing or preventing regurgitation; an anchor section (106) comprising several paddles (120, 122), the paddles (120, 122) being movable between a closed position and an open position to accommodate native mitral or tricuspid valve sails (42, 44) between the paddles (120, 122) and the spacer (110); and a bracket (3000), comprising: a base (3010); several movable arms (3030), each having a spiked section (3040); and several joint sections (3020) that connect the movable arms (3030) to the base (3010) in a joint manner. [44] Implantable prosthetic device (100) according to claim 43, wherein the anchor section (106) is attached to an actuating means such as a shaft or an actuating wire (112), to which the spacer (110) is also attached. [45] Implantable prosthetic device (100) according to claim 44, wherein the anchor section (106) and the coaptation element (110) can be positioned simultaneously by moving the anchor and the coaptation element together along the longitudinal axis of the shaft or the actuating wire (112). [46] Implantable prosthetic device (100) according to any one of claims 43 to 45, wherein the clamp (3000) is a spiked clamp (3000) with two ends, wherein the joint sections (3020) and the movable arms (3030) extend from both ends of the base (3010). [47] Implantable prosthetic device (100) according to any one of claims 43 to 46, wherein each of the movable arms (3030) is movable from an open position to a closed position in order to press the native mitral or tricuspid valve tissue against a corresponding one of the multiple paddles (120, 122). [48] ​​Device according to any one of claims 43 to 47, wherein the spacer (110) is configured to expand independently from a radially compressed state to a radially expanded state. [49] Device according to claim 48, wherein the spacer (110) is formed from a flexible material which may be a mesh, woven or braided, wherein the flexible material is preferably a wire made of a shape memory alloy such as Nitinol. [50] Device according to one of claims 43 to 49, further comprising an actuating device (116) attached to the ends of each of the movable arms (3030). [51] Device according to claim 50, wherein the application of a tensile stress to the actuating means (116) causes the movable arms (3030) to pivot at the joint sections (3020). [52] Device according to one of claims 50 or 51, wherein the actuating means (116) can be actuated independently of each other, so that each movable arm can be opened and closed independently. [53] Device according to claim 52, wherein the movable arms can be opened and closed independently of the position of the paddles (120, 122). [54] Device according to any one of claims 43 to 53, further comprising: a cover that is wrapped around at least one section of the movable arm of the clamp (3000); and at least one actuating thread attached to the cover (116). [55] Device according to claim 54, wherein the cover is wrapped around one end of the movable arm. [56] Device according to one of claims 54 or 55, wherein at least one section of the cover forms at least a part of the coaptation section (104). [57] Device according to any one of claims 54 to 56, wherein the cover is made of a flexible material. [58] Implantable prosthetic device (100), comprising: a coapulation section (104); an anchor section (106) comprising several paddles (120, 122), wherein the paddles (120, 122) have an outer and an inner section and are extendable from a folded closed position to an open position; and a bracket (3000), comprising: a fixed arm (310); several movable arms (3030), each having a section equipped with spikes; and several joint sections (3020) that connect the movable arms (3030) to the fixed arm (310) in a joint manner. [59] Device according to claim 58, wherein the device is configured to repair a native valve, such as a native mitral valve. [60] Device according to one of claims 58 or 59, wherein the coaptation section (104) comprises a coaptation element (110) configured to be positioned within a native heart valve orifice to help form a more effective seal between the native leaflets (42, 44), thereby reducing or preventing regurgitation. [61] Device according to claim 60, wherein the coaptation element (110) has an oval cross-sectional shape. [62] Device according to one of claims 60 or 61, wherein the coaptation element (110) has an atrial or upper end configured to be positioned in or adjacent to an atrium, a ventricular or lower end configured to be positioned in or adjacent to a ventricle, and a side surface extending between the native leaflets. [63] Device according to claim 62, wherein the anchor section (106) is attached to the coaptation element (110) at a location near the ventricular end of the coaptation element (110). [64] Device according to one of claims 60 to 63, wherein the anchor section (106) is attached to an actuating means (116), such as a shaft or actuating wire, to which the coaptation element (110) is also attached. [65] Device according to claim 64, wherein the anchor section (106) and the coaptation element (110) can be positioned simultaneously by moving the anchor section (106) and the coaptation element (110) together along the longitudinal axis of the shaft or actuating wire. [66] Device according to one of claims 64 or 65, wherein the actuation of the shaft or the actuating wire opens and closes the anchor section (106) of the device to accommodate the valve leaflets (42, 44) during implantation. [67] Device according to any one of claims 60 to 66, wherein the device has a cover over the coaptation element (110), the clamp (3000), the inner paddles (120, 122) and / or the outer paddles (120, 122). [68] Device according to one of claims 60 to 67, wherein the coaptation element (110) and the paddles (120, 122) are made of nitinol. [69] Device according to one of claims 60 to 68, wherein the coaptation element (110) has a hollow interior. [70] Device according to any one of claims 58 to 69, wherein the clamp (3000) is a spiked clamp (3000) having two ends, the movable arms (3030) of which extend from both ends; and wherein each movable arm has a spiked section with at least one spike. [71] Device according to claim 70, wherein the clamp (3000) is formed from a single layer of material. [72] Device according to any one of claims 58 to 69, wherein the movable arms (3030) comprise a pair of independent first and second movable arms extending from the joint section to a spiked section. [73] Implantable prosthetic device comprising a coaptation section, paddles and clasps, wherein: the paddles can be moved from a closed position to an open position; the brackets are movable from an open position to a closed position; and the implantable prosthetic device can be used to repair a native valve, such as a native mitral valve. [74] Implantable prosthetic device according to claim 73, wherein the coaptation section includes a coaptation element configured to be positioned within the native heart valve orifice to help form a more effective seal between the native leaflets, thereby reducing or preventing regurgitation. [75] An implantable prosthetic device comprising a coaptation device or coaptation element and at least one anchoring device or anchor, 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 leaflets, thereby reducing or preventing regurgitation. [76] Implantable prosthetic device according to one of claims 74 or 75, wherein the coaptation element has an oval cross-sectional shape. [77] Implantable prosthetic device according to one of claims 75 or 76, wherein the coaptation element has an atrial or upper end positioned in or adjacent to the atrium, a ventricular or lower end positioned in or adjacent to the ventricle, and a side surface extending between the native mitral or tricuspid leaflets. [78] Implantable prosthetic device according to claim 77, wherein the anchor is configured to attach the device to one or both native mitral valves, such that the coaptation element is arranged between the two native valves. [79] Implantable prosthetic device according to claim 77, wherein the anchor is configured to attach the device to one, two or three of the tricuspid leaflets, such that the coaptation element is arranged between the three native leaflets. [80] Implantable prosthetic device according to any one of claims 77 to 79, wherein the anchor is attached to the coaptation element at a location adjacent to the ventricular end of the coaptation element. [81] Implantable prosthetic device according to claim 80, wherein the anchor is attached to an actuating means, such as a shaft or an actuating wire, to which the coaptation element is also attached. [82] Implantable prosthetic device according to any one of claims 75 to 81, wherein the anchor is configured to be positioned behind a native sail during implantation, so that the sail is captured by the anchor. [83] Implantable prosthetic device according to any one of claims 75 to 82, wherein the anchor comprises outer gripping elements and inner gripping elements connected by articulated and / or flexible sections between a cap and the coaptation element. [84] Implantable prosthetic device according to claim 83, wherein a fastening means or a collar detachably attaches the coaptation element to a feed sleeve, so that the coaptation element slides along the actuating wire during actuation to open and close the paddles of the anchor. [85] An implantable prosthetic device according to any one of claims 73 to 84, comprising a spiked clamp with two ends. [86] Implantable prosthetic device according to claim 85, wherein the clamp has two ends comprising a fixed arm with joint sections and movable arms extending from both ends. [87] Implantable prosthetic device according to claim 86, wherein each movable arm has a spiked section with at least one spike.

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