Cardiac valve encapsulation device and delivery device thereof

Abstract

To provide a cardiac valve encapsulation device and a delivery device thereof.SOLUTION: An exemplary system and a valve repair device for repairing a natural valve of a patient include a plurality of paddle sections. Each of the paddle sections may include a stretchable portion stretchable from a still state to a stretched state. These paddle sections can move between an open position and a close position and is configured to be attached to the natural valve of the patient.SELECTED DRAWING: Figure 308

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 912,828, filed Oct. 9, 2019, entitled "Heart Valve Sealing Devices and Delivery Devices Therefor", which is hereby incorporated by reference in its entirety.

Background Art

[0002] Natural heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play an important role in ensuring the proper forward flow of blood supply through the cardiovascular system. These heart valves can be damaged by congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus their effectiveness may be reduced. Such valve damage can pose serious cardiovascular risks and even death. A damaged valve can be surgically repaired or replaced in open - heart surgery. However, open - heart surgery is highly invasive and can cause complications. A less invasive approach for introducing and implanting a prosthetic device can use a transvascular technique. As an example, a transseptal technique may be used, which can include inserting a catheter into the right femoral vein, advancing it upward through the inferior vena cava, and delivering it into the right atrium, puncturing the septum, and passing the catheter into the left atrium.

[0003] A healthy heart has a generally conical shape that tapers towards the inferior apex. The heart is provided with four chambers, including the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical form from other native heart valves. The mitral valve comprises an annulus portion, which is an annular portion of native valve tissue surrounding the mitral valve orifice, and a pair of cardiac valve leaflets, i.e., leaflets, that extend downward from the annulus into the left ventricle. The mitral valve annulus can form a cross-sectional shape that is "D"-shaped, oval, or another non-circular shape with a major axis and a minor axis. The anterior leaflet is larger than the posterior leaflet, and when they are both closed, they can generally form a "C"-shaped boundary between the abutting side surfaces of each leaflet.

[0004] When operating properly, both the anterior and posterior leaflets function as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also called the "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also called the "ventricular systole" or "systole"), the elevated blood pressure in the left ventricle biases the side surfaces of the two leaflets together, thereby closing the one-way mitral valve. As a result, blood cannot flow back into the left atrium and is instead discharged from the left ventricle via the aortic valve. To prevent the two leaflets from deviating under pressure and folding back from the mitral valve annulus towards the left atrium, a plurality of fibrous cords called chordae tendineae anchor the leaflets to the papillary muscles of the left ventricle.

[0005] Mitral regurgitation occurs when the natural mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during systole of the cardiac contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have multiple different causes, such as leaflet prolapse, papillary muscle insufficiency, mitral annulus elongation, or a combination of these, which result from the dilation of the left ventricle. Mitral regurgitation at the central part of the leaflet is called central jet mitral regurgitation, and mitral regurgitation closer to one commissure of the leaflet (i.e., the position where the leaflets contact) can be called eccentric jet mitral regurgitation. Central jet mitral regurgitation occurs when the edges of the leaflets do not contact in the middle and thus there is regurgitation without the valve closing.

[0006] Techniques for treating a patient's mitral valve and other valvular regurgitation may include directly fixing the edges of the natural leaflets to each other. For example, a catheter-delivered clip may be used to attempt to hold the sides of the leaflets together at the ends of the leaflets. However, significant problems exist. For example, multiple clips may be required to remove or reduce the regurgitation to an acceptable level, but in some situations, the surgical time may be prolonged, the flow may be overly restricted, or unwanted stress may be applied to the natural anatomical structure.

[0007] Despite these conventional techniques, there continues to be a need for improvements in devices and methods for treating valvular regurgitation.

Prior Art Documents

Patent Documents

[0008]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Summary of the Invention

Means for Solving the Problems

[0009] In this summary of the invention, several examples are presented, and it is not intended to limit the scope of the present invention in any way. For example, none of the features included in the examples of this summary of the invention are claimed in the claims unless explicitly stated in the claims. Also, the features, components, steps, concepts, etc. described in the examples in this summary of the invention and elsewhere in this disclosure can be combined in various ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

[0010] Exemplary systems and valve repair devices for repairing a patient's native valve include a junction and a plurality of paddle portions. Each paddle portion may include an extendable portion that is extendable from a rest state to an extended state. These paddle portions are movable between an open position and a closed position and are configured to be attached to the patient's native valve.

[0011] An exemplary valve repair device for repairing a patient's native valve includes a plurality of paddle portions. Each paddle portion includes an extendable portion that is extendable from a rest state to an extended state. These paddle portions are movable between an open position and a closed position based on the movement of the cap towards the collar and away from the collar and are configured to be attached to the patient's native valve.

[0012] Exemplary valve repair devices for repairing a patient's native valve include a plurality of paddle portions. Each paddle portion is extendable from a rest state to an extended state and includes two extendable portions surrounding a paddle extension space. The paddle portion is movable between an open position and a closed position and is configured to be attached to the patient's native valve.

[0013] An exemplary system for repairing a patient's native valve includes a catheter and a valve repair device. The valve repair device comprises a plurality of paddle portions. Each paddle portion comprises two extendable portions surrounding a paddle extension space. Each extendable portion is transitionable between a narrow state and a wide state. The paddle portion is movable between an open position and a closed position and is configured to be attached to the patient's native valve.

[0014] An exemplary system for repairing a patient's native valve includes a catheter and a valve repair device. The valve repair device comprises a plurality of paddle portions. Each paddle portion includes an extendable portion that is extendable from a rest state to an extended state. The paddle portion is movable between an open position and a closed position and is configured to be attached to the patient's native valve.

[0015] An exemplary method for repairing a patient's native valve includes inserting a valve repair device into the patient's heart. A plurality of paddle portions are moved between a rest state and an extended state. The paddle portion is moved from an open position to a closed position to attach the valve repair device to the patient's native valve.

[0016] In some embodiments, a valve repair device for repairing a patient's native valve comprises a junction, a collar, a cap movable away from the collar, and some or all of a plurality of paddle portions.

[0017] Each of the plurality of paddle portions may include an extendable portion that is extendable from a rest state to an extended state.

[0018] The paddle part can be configured to be movable between an open position and a closed position by moving the cap with respect to the color.

[0019] In some embodiments, the width of the extensible portion is inversely proportional to the length of the extensible portion.

[0020] In some embodiments, the extensible portion is formed from at least one of a braided material tube, a shape memory alloy, and an elastomeric material.

[0021] In some embodiments, the extensible portion is formed integrally with the paddle part.

[0022] In some embodiments, the paddle frame is connected to the cap and the paddle part. In some embodiments, the width of the paddle frame decreases as the extended portion extends from the stationary state to the extended state. The paddle frame can be ring-shaped in some implementations.

[0023] The joining element can be configured to close the gap of the patient's native valve when the valve repair device is attached to the native valve.

[0024] In some embodiments, a valve repair device for repairing a patient's native valve comprises a joint, a collar attached to the joint, a cap movable away from the collar, and some or all of a plurality of paddle parts each comprising two extensible portions surrounding a paddle extension space.

[0025] Each extensible portion can be configured to be extensible from a stationary state to an extended state.

[0026] In some embodiments, when the cap moves towards the collar, the paddle part moves to the closed position, and when the cap moves away from the collar, the paddle part moves to the open position.

[0027] In some embodiments, the width of the paddle extension space is inversely proportional to the length of the extendable portion.

[0028] In some embodiments, the extendable portion is formed from at least one of a braided material tube, a shape memory alloy, and an elastomer material. In some embodiments, the extendable portion is formed integrally with the paddle portion.

[0029] In some embodiments, the device further comprises a paddle frame coupled to the cap and the paddle portion.

[0030] In some embodiments, the paddle frame is configured such that its width decreases as the extendable portion extends from a stationary state to an extended state. The paddle frame can be ring-shaped in some implementations.

[0031] In some embodiments, a system (e.g., a valve treatment system or a valve repair system, etc.) comprises a delivery catheter and a valve repair device. The valve repair device can be coupled to the delivery catheter.

[0032] In some embodiments, the valve repair device comprises a plurality of paddle portions, and each paddle portion includes an extendable portion that is extendable from a stationary state to an extended state. The paddle portions can be configured to be movable between an open position and a closed position by moving the cap with respect to the collar.

[0033] In some embodiments, the width of the extendable portion is inversely proportional to the length of the extendable portion.

[0034] In some embodiments, the extendable portion is formed from at least one of a braided material tube, a shape memory alloy, and an elastomer material.

[0035] In some embodiments, the extendable portion is formed integrally with the paddle portion.

[0036] In some embodiments, the valve repair device further comprises a paddle frame coupled to the cap and the paddle portion.

[0037] In some embodiments, the paddle frame decreases in width as the extended portion extends from a stationary state to an extended state.

[0038] In some embodiments, the valve repair device further comprises a joining element configured to close the gap of the patient's native valve when the valve repair device is attached to the native valve.

[0039] In some embodiments, a system (e.g., a valve treatment system, a valve repair system, etc.) comprises a delivery catheter and a valve repair device. The valve repair device may be coupled to or may be couplable to the delivery catheter.

[0040] In some embodiments, the valve repair device comprises a plurality of paddle portions each including two extensible portions surrounding a paddle extension space, and each extensible portion is transitionable between a narrow state and a wide state.

[0041] The paddle portion may be configured to be movable between an open position and a closed position and is configured to be attached to the patient's native valve.

[0042] In some embodiments, the system further comprises one, some, or all of a shaft, a junction, and a collar through which the shaft extends. The collar may be attached to the junction. The system may also comprise a cap attached to the shaft such that the shaft can move the cap away from the collar.

[0043] In some embodiments, the system is configured such that when the cap moves towards the collar, the paddle portion moves to the closed position, and when the cap moves away from the collar, the paddle portion moves to the open position.

[0044] In some embodiments, the paddle portion is hingedly coupled to the cap at a plurality of outer hinge regions.

[0045] In some embodiments, at least one fastener is attached to at least one of the plurality of paddle portions. In some embodiments, at least one fastener is attached to each of the plurality of paddle portions.

[0046] In some embodiments, the width of the paddle extension space is inversely proportional to the length of the extendable portion.

[0047] In some embodiments, the extendable portion is formed from at least one of a braided material tube, a shape memory alloy, and an elastomeric material.

[0048] In some embodiments, the extendable portion is formed integrally with the paddle portion.

[0049] In some embodiments, the paddle frame is coupled to the paddle portion. The paddle frame can be configured to decrease in width as the extendable portion transitions from a wide state to a narrow state.

[0050] In some embodiments, the engagement element is configured to close the gap of the native valve when attached to the native valve.

[0051] In some embodiments, the delivery catheter is configured to facilitate delivery to the native valve and attachment of the plurality of paddles to the native valve.

[0052] In some embodiments, a method for repairing a patient's native valve includes inserting a valve repair device into the patient's heart and extending a plurality of paddle portions from a rest state to an extended state, each paddle portion comprising an extendable portion, and moving the paddle portions from an open position to a closed position to attach the valve repair device to the patient's native valve. The valve repair device may be the same as or similar to any of the valve repair devices described above or elsewhere in this specification.

[0053] In some embodiments, the method includes reducing the width of the paddle frame as the extended portion extends from the rest state to the extended state.

[0054] The method may further include closing a gap in the patient's native valve with a joining element when the valve repair device is attached to the native valve.

[0055] In some embodiments, an exemplary method for repairing a patient's native valve includes inserting a valve repair device into the patient's heart and extending a plurality of paddle portions from a rest state to an extended state, each paddle portion comprising two extendable portions surrounding a paddle extension space, and moving the paddle portions from an open position to a closed position to attach the valve repair device to the patient's native valve. The valve repair device may be the same as or similar to any of the valve repair devices described above or elsewhere in this specification.

[0056] In some embodiments, the method includes reducing the width of the paddle frame as the extendable portion extends from the rest state to the extended state.

[0057] The method may further include closing a gap in the patient's native valve with a joining element when the valve repair device is attached to the native valve.

[0058] In some embodiments, a system (e.g., a valve treatment system, a valve repair system, etc.) comprises a plurality of paddle portions each including two extensible portions that each surround a paddle extension space, each extensible portion being transitionable between a narrow state and a wide state, the paddle portions being movable between an open position and a closed position and configured to be attached to a patient's native valve.

[0059] In some embodiments, the system comprises a plurality of hinge regions where the paddle portions are hingedly coupled to other parts of the system, such as joints, etc.

[0060] In some embodiments, the system comprises a shaft, a collar through which the shaft extends and is attached to a joint, and a cap attached to the shaft such that the shaft can move the cap away from the collar.

[0061] In some embodiments, the system is configured such that when the cap moves towards the collar, the paddle portions move to the closed position, and when the cap moves away from the collar, the paddle portions move to the open position.

[0062] In some embodiments, the paddle portions are hingedly coupled to the cap at a plurality of outer hinge regions.

[0063] In some embodiments, at least one fastener is attached to at least one of the plurality of paddle portions. In some embodiments, at least one fastener is attached to each of the plurality of paddle portions.

[0064] In some embodiments, the width of the paddle extension space is inversely proportional to the length of the extensible portion.

[0065] In some embodiments, the extensible portion is formed from at least one of a braided material tube, a shape memory alloy, and an elastomer material.

[0066] In some embodiments, the extensible portion is formed integrally with the paddle portion.

[0067] In some embodiments, the paddle frame is connected to the paddle portion. In some embodiments, the paddle frame decreases in width as the extensible portion transitions from the wide state to the narrow state. The paddle frame can be ring-shaped.

[0068] The system can include a joining element configured to close the gap of the natural valve when attached to the natural valve.

[0069] In some embodiments, the system further includes a delivery catheter configured to facilitate delivery to the natural valve and attachment of the plurality of paddles to the natural valve.

[0070] A further understanding of the nature and advantages of the present invention will become apparent from the following description and claims, particularly when considered in conjunction with the accompanying drawings. In the drawings, like reference numerals are assigned to the same parts.

[0071] To further clarify various aspects of the embodiments of the present invention, a more specific description of some embodiments will be made with reference to various aspects of the accompanying drawings. It should be understood that these drawings show only typical embodiments of the present disclosure and are not to be considered as limiting the scope of the present disclosure. Further, the figures may be drawn to scale in some embodiments, but not all embodiments are drawn to scale. The embodiments, features, and advantages of the present disclosure will be described and explained more specifically and in detail with reference to the accompanying drawings. [Appended Claim 1] A valve repair device for repairing a patient's natural valve, a joint, a collar attached to the joint, a cap that can be moved in a direction away from the collar, A plurality of paddle parts, including extendable parts where each paddle part can extend from a stationary state to an extended state, comprising: A valve repair device, wherein the paddle part is movable between an open position and a closed position by moving the cap relative to the collar. [Additional Claim 2] The valve repair device according to claim 1, wherein the width of the extendable part is inversely proportional to the length of the extendable part. [Additional Claim 3] The valve repair device according to claim 1 or 2, wherein the extendable part is formed from a braided material tube. [Additional Claim 4] The valve repair device according to any one of claims 1 to 3, wherein the extendable part is formed from a shape memory alloy. [Additional Claim 5] The valve repair device according to any one of claims 1 to 3, wherein the extendable part is formed from an elastomer material. [Additional Claim 6] The valve repair device according to any one of claims 1 to 5, wherein the extendable part is integrally formed with the paddle part. [Additional Claim 7] The valve repair device according to any one of claims 1 to 6, further comprising a paddle frame connected to the cap and the paddle part. [Additional Claim 8] The valve repair device according to claim 7, wherein the paddle frame decreases in width as the extended part extends from the stationary state to the extended state. [Additional Claim 9] The valve repair device according to claim 7, wherein the paddle frame has an annular shape. [Additional Claim 10] The valve repair device according to any one of appended claims 1 to 9, characterized in that when the valve repair device is attached to a native valve, the joining element is configured to close the gap of the patient's native valve. [Appended claim 11] A valve repair device for repairing a patient's native valve, comprising: a joint portion, a collar attached to the joint portion, a cap movable in a direction away from the collar, a plurality of paddle portions, each paddle portion having two extendable portions surrounding a paddle extension space, and wherein: each extendable portion is extendable from a stationary state to an extended state, the paddle portion moves to a closed position when the cap moves towards the collar, and the paddle portion moves to an open position when the cap moves in a direction away from the collar. [Appended claim 12] The valve repair device according to appended claim 11, characterized in that the width of the paddle extension space is inversely proportional to the length of the extendable portion. [Appended claim 13] The valve repair device according to appended claim 11 or 12, characterized in that the extendable portion is formed from a braided material tube. [Appended claim 14] The valve repair device according to any one of appended claims 11 to 13, characterized in that the extendable portion is formed from a shape memory alloy. [Appended claim 15] The valve repair device according to any one of appended claims 11 to 13, characterized in that the extendable portion is formed from an elastomeric material. [Appended claim 16] The valve repair device according to any one of appended claims 11 to 15, characterized in that the extendable portion is integrally formed with the paddle portion. [Appended claim 17] The valve repair device according to any one of claims 11 to 16, further comprising a paddle frame connected to the cap and the paddle part. [Additional claim 18] The valve repair device according to claim 17, wherein the width of the paddle frame decreases as the extendable part extends from the stationary state to the extended state. [Additional claim 19] The valve repair device according to claim 17, wherein the paddle frame has an annular shape. [Additional claim 20] The valve repair device according to any one of claims 11 to 19, wherein when the valve repair device is attached to a native valve, the joining element is configured to close the gap of the patient's native valve. [Additional claim 21] A delivery catheter, A valve repair device coupled to the delivery catheter, A system comprising: The valve repair device, Comprises a plurality of paddle parts including an extendable part where each paddle part is extendable from a stationary state to an extended state, The system is characterized in that the paddle part is movable between an open position and a closed position by moving the cap relative to the collar. [Additional claim 22] The system according to claim 21, wherein the width of the extendable part is inversely proportional to the length of the extendable part. [Additional claim 23] The system according to claim 21 or 22, wherein the extendable part is formed from a braided material tube. [Additional claim 24] The system according to any one of claims 21 to 23, wherein the extendable part is formed from a shape memory alloy. [Additional claim 25] The system according to any one of appended claims 21 to 23, wherein the extendable portion is formed of an elastomer material. [Appended claim 26] The system according to any one of appended claims 21 to 25, wherein the extendable portion is integrally formed with the paddle portion. [Appended claim 27] The system according to any one of appended claims 21 to 26, further comprising a paddle frame connected to the cap and the paddle portion. [Appended claim 28] The system according to appended claim 27, wherein the paddle frame has a width that decreases as the extended portion extends from a stationary state to an extended state. [Appended claim 29] The system according to appended claim 27, wherein the paddle frame has an annular shape. [Appended claim 30] The system according to any one of appended claims 21 to 29, further comprising a joining element configured to close a gap of a patient's native valve when the valve repair device is attached to the native valve. [Appended claim 31] A delivery catheter, A valve repair device coupled to the delivery catheter, A system comprising: The valve repair device, Comprises a plurality of paddle portions including an extendable portion where each paddle portion is extendable from a stationary state to an extended state, Each extendable portion is transitionable between a narrow state and a wide state, The system, wherein the paddle portion is movable between an open position and a closed position and is configured to be attached to a patient's native valve. [Appended claim 32] A shaft, A joint, A collar through which the shaft extends and is attached to the joint. A cap attached to the shaft, the cap being movable away from the collar by the shaft, and The system according to claim 31, further comprising. [Claim 33] The system according to claim 32, wherein the paddle portion moves to the closed position when the cap moves toward the collar, and the paddle portion moves to the open position when the cap moves away from the collar. [Claim 34] The system according to claim 32 or 33, wherein the paddle portion is hingedly connected to the cap in a plurality of outer hinge regions. [Claim 35] The system according to any one of claims 31 to 34, wherein at least one fastener is attached to at least one of the plurality of paddle portions. [Claim 36] The system according to any one of claims 31 to 34, wherein at least one fastener is attached to each of the plurality of paddle portions. [Claim 37] The system according to any one of claims 31 to 36, wherein the width of the paddle extension space is inversely proportional to the length of the extensible portion. [Claim 38] The system according to any one of claims 31 to 37, wherein the extensible portion is formed from a braided material tube. [Claim 39] The system according to any one of claims 31 to 38, wherein the extensible portion is formed from a shape memory alloy. [Claim 40] The system according to any one of claims 31 to 38, wherein the extensible portion is formed from an elastomeric material. [Claim 41] The system according to any one of claims 31 to 40, wherein the extendable portion is integrally formed with the paddle portion. [Claim 42] The system according to any one of claims 31 to 41, further comprising a paddle frame connected to the paddle portion. [Claim 43] The system according to claim 42, wherein the paddle frame decreases in width when the extendable portion transitions from a wide state to a narrow state. [Claim 44] The system according to claim 42, wherein the paddle frame has an annular shape. [Claim 45] The system according to any one of claims 32 to 44, wherein the joining element is configured to close the gap of the native valve when attached to the native valve. [Claim 46] The system according to any one of claims 31 to 45, wherein the delivery catheter is configured to facilitate delivery to the native valve and attachment of the plurality of paddles to the native valve. [Claim 47] A method for repairing a patient's native valve, comprising: placing a valve repair device into the patient's heart; extending a plurality of paddle portions from a rest state to an extended state, each paddle portion comprising an extendable portion; moving the paddle portions from an open position to a closed position and attaching the valve repair device to the patient's native valve. A method, characterized by comprising the above steps. [Claim 48] The method according to claim 47, wherein the width of the extendable portion is inversely proportional to the length of the extendable portion. [Claim 49] The method according to claim 47 or 48, wherein the extendable portion is formed from a braided material tube. [Additional Item 50] The method according to any one of Additional Items 47 to 49, wherein the extendable portion is formed of a shape memory alloy. [Additional Item 51] The method according to any one of Additional Items 47 to 49, wherein the extendable portion is formed of an elastomer material. [Additional Item 52] The method according to any one of Additional Items 47 to 51, wherein the extendable portion is integrally formed with the paddle portion. [Additional Item 53] The method according to any one of Additional Items 47 to 52, further comprising connecting the paddle frame to the cap and the paddle portion. [Additional Item 54] The method according to Additional Item 53, wherein the paddle frame has a width that decreases as the extended portion extends from the stationary state to the extended state. [Additional Item 55] The method according to Additional Item 53, wherein the paddle frame has an annular shape. [Additional Item 56] The method according to any one of Additional Items 47 to 55, further comprising closing a gap in the patient's native valve with a joining element when the valve repair device is attached to the native valve. [Additional Item 57] A method for repairing a patient's native valve, comprising: placing a valve repair device into the patient's heart; extending a plurality of paddle portions from a stationary state to an extended state, each paddle portion comprising two extendable portions surrounding a paddle extension space; moving the paddle portion from an open position to a closed position and attaching the valve repair device to the patient's native valve; characterized by comprising. [Additional Item 58] The method according to appended claim 57, characterized in that the width of the paddle extension space is inversely proportional to the length of the extendable part. [Appended claim 59] The method according to appended claim 57 or 58, characterized in that the extendable part is formed from a braided material tube. [Appended claim 60] The method according to any one of appended claims 57 to 59, characterized in that the extendable part is formed from a shape memory alloy. [Appended claim 61] The method according to any one of appended claims 57 to 59, characterized in that the extendable part is formed from an elastomer material. [Appended claim 62] The method according to any one of appended claims 57 to 61, characterized in that the extendable part is integrally formed with the paddle part. [Appended claim 63] The method according to any one of appended claims 57 to 62, further comprising the step of connecting the paddle frame to the cap and the paddle part. [Appended claim 64] The method according to appended claim 63, characterized in that the width of the paddle frame decreases as the extendable part extends from the stationary state to the extended state. [Appended claim 65] The method according to appended claim 63, characterized in that the paddle frame has an annular shape. [Appended claim 66] The method according to any one of appended claims 57 to 65, further comprising the step of closing the gap of the patient's natural valve with a joining element when the valve repair device is attached to the natural valve. [Appended claim 67] A system comprising a plurality of paddle portions, each paddle portion having two extensible portions surrounding a paddle extension space, each extensible portion being capable of transitioning between a narrow state and a wide state, the paddle portion being movable between an open position and a closed position and configured to be attached to a patient's native valve. [Appendix Item 68] The system according to Appendix Item 67, wherein the paddle portion further comprises a plurality of hinge regions that are hingeably connected to another part of the system. [Appendix Item 69] A shaft, A collar through which the shaft extends and is attached to a joint, A cap attached to the shaft and movable away from the collar by the shaft, The system according to Appendix Item 67, further comprising the above. [Appendix Item 70] The system according to Appendix Item 68, wherein the paddle portion moves to the closed position when the cap moves towards the collar, and the paddle portion moves to the open position when the cap moves away from the collar. [Appendix Item 71] The system according to any one of Appendix Items 67 to 69, wherein the paddle portion is hingeably connected to the cap at a plurality of outer hinge regions. [Appendix Item 72] The system according to any one of Appendix Items 67 to 70, wherein at least one fastener is attached to at least one of the plurality of paddle portions. [Appendix Item 73] The system according to any one of Appendix Items 67 to 70, wherein at least one fastener is attached to each of the plurality of paddle portions. [Appendix Item 74] The system according to any one of appendices 67 to 72, characterized in that the width of the paddle extension space is inversely proportional to the length of the extendable part. [Appendix 75] The system according to any one of appendices 67 to 73, characterized in that the extendable part is formed from a tube of braided material. [Appendix 76] The system according to any one of appendices 67 to 74, characterized in that the extendable part is formed from a shape memory alloy. [Appendix 77] The system according to any one of appendices 67 to 74, characterized in that the extendable part is formed from an elastomer material. [Appendix 78] The system according to any one of appendices 67 to 76, characterized in that the extendable part is integrally formed with the paddle part. [Appendix 79] The system according to any one of appendices 67 to 77, further comprising a paddle frame connected to the paddle part. [Appendix 80] The system according to appendix 78, characterized in that the paddle frame has a smaller width when the extendable part transitions from a wide state to a narrow state. [Appendix 81] The system according to appendix 78, characterized in that the paddle frame has an annular shape. [Appendix 82] The system according to any one of appendices 67 to 80, characterized in that when attached to the native valve, the joining element is configured to close the gap of the native valve. [Appendix 83] The system according to any one of appendices 67 to 81, further comprising a delivery catheter configured to facilitate delivery to the native valve and attachment of the plurality of paddles to the native valve.

Brief Description of the Drawings

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BRIEF DESCRIPTION OF THE DRAWINGS

[0073] In the following description, reference is made to the accompanying drawings that show certain embodiments of the present disclosure. Other embodiments, in which the structures and operations are different, are not outside the scope of the present disclosure.

[0074] Exemplary embodiments of the present disclosure are directed to devices and methods for repairing defective heart valves. Various embodiments of a native valve repair device and system for delivery are disclosed herein, and it should be noted that any combination of these options can be obtained, unless specifically excluded. In other words, the individual components of the disclosed devices and systems can be combined, provided they are not mutually incompatible or physically impossible.

[0075] As described herein, when one or more components are described as being connected, joined, attached, coupled, mounted, or interconnected in another way, such interconnection can be direct between the components or indirect, such as by using one or more intermediate components. Also, as described herein, reference to a “member,” “component,” or “portion” is not limited to a single structural member, component, or element, but can include an assembly of components, members, or elements. Further, as described herein, the terms “substantially” and “about” are defined as being at least nearly (and including the value or state) of a given value or state (preferably within 10% thereof, more preferably within 1% thereof, and most preferably within 0.1% thereof).

[0076] Figures 1 and 2 are cross-sectional views of the human heart H during diastole and systole, respectively. The right ventricle RV and the left ventricle LV are separated from the right atrium RA and the left atrium LA by the tricuspid valve TV and the mitral valve MV, respectively, i.e., the atrioventricular valves. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery. Each of these valves has flexible valve leaflets (e.g., valve leaflets 20, 22 shown in FIGS. 4 and 5) that extend inwardly across their respective openings, and these valve leaflets come together in the flow stream, i.e., "join," to form a one-way fluid barrier surface. The native valve repair system of the present application is described primarily with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and the left ventricle LV are described in great detail. It should be understood that the devices described herein can also be used to repair other native valves, e.g., this device can be used to repair the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0077] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase (or diastole) as seen in Figure 1, the blood that was previously collected in the left atrium LA during the systolic phase enters the left ventricle LV through the mitral valve MV as the left ventricle LV expands. During the systolic phase (or systole) as seen in Figure 2, the left ventricle LV contracts, forcing blood through the aortic valve AV and into the ascending aorta and out into the body. During contraction, the leaflets of the mitral valve MV close, preventing blood from flowing back from the left ventricle LV into the original left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In one exemplary embodiment, the device described by this application is used to repair the function of a defective mitral valve MV. That is, the device is configured to help the leaflets of the mitral valve close and prevent blood from flowing back from the left ventricle LV into the original left atrium LA. Unlike prior art that describes using sutures or clips, which often require numerous sutures or clips and additional supports to treat large regurgitations, the device described in this application is designed to easily grip and hold the natural leaflets around a joining element that functions as a filler for the regurgitation opening. In this application, the terms joining element, spacer, spacer element, and coaptation element refer to components that fill a portion of the space within a natural heart valve such as the mitral valve or tricuspid valve.

[0078] Next, referring to FIGS. 1-7, the mitral valve MV includes two valve leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24A, which is a fibrous ring of tissue of variable density surrounding the leaflets 20, 22. Referring to FIG. 3, the mitral valve MV is tethered to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are cord-like tendons that connect the papillary muscles 12 (i.e., the muscles within the base of the chordae tendineae and the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 function to limit the movement of the mitral valve MV and prevent the mitral valve from prolapsing. The mitral valve MV opens and closes in response to pressure changes within the left atrium LA and the left ventricle LV. The papillary muscles do not open or close the mitral valve MV. Rather, the papillary muscles fix the mitral valve MV against the high pressures required to circulate blood throughout the body. The papillary muscles and chordae tendineae together are known as the subvalvular apparatus and function to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0079] In various disease processes, one or more of the proper functions of the native valves of the heart H may be impaired. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, in left ventricular LV or right ventricular RV damage due to a previous heart attack (i.e., myocardial infarction following coronary artery disease) or other heart diseases (e.g., cardiomyopathy), the geometry of the native valve may be deformed, and this deformation can cause the native valve to malfunction. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that cause insufficiency of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV), and as a result of this insufficiency, prolapse and regurgitation occur.

[0080] Generally, a native valve can cease to function properly in two different states, namely (1) valvular stenosis, and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not open fully, thereby causing a disruption in blood flow. Typically, valvular stenosis results from the accumulation of calcific material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open fully to allow forward blood flow.

[0081] Valve regurgitation, the second type of valve dysfunction, occurs when the valve leaflets do not close completely, allowing blood to leak back into the atrium (e.g., blood leaks from the left ventricle into the left atrium). There are three main mechanisms by which native valves become regurgitant, or incompetent, including Carpentier type I, II, and III dysfunction. Carpentier type I dysfunction involves dilation of the valve annulus such that normally functioning leaflets are separated from each other and cannot form a seal (i.e., the leaflets do not appose properly). Type I dysfunction includes perforation of the leaflets, such as in endocarditis. Carpentier type II dysfunction involves prolapse of one or more leaflets of the native valve onto the coaptation surface. Carpentier type III dysfunction involves restriction of movement of one or more leaflets of the native valve such that the leaflets are abnormally constrained below the plane of the valve annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0082] Referring to FIG. 4, when the healthy mitral valve MV is in the closed state, the anterior leaflet 20 and the posterior leaflet 22 appose, preventing blood from leaking from the left ventricle LV into the left atrium LA. Referring to FIG. 5, regurgitation occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV displaces into the left atrium LA during systole. This disruption of coaptation creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, through which blood flows backward from the left ventricle LV into the left atrium LA during systole. As previously discussed, there are a variety of different ways in which leaflets (e.g., leaflets 20, 22 of the mitral valve MV) can fail to function properly, thereby causing regurgitation.

[0083] Referring to FIG. 6, in some situations, in the mitral valve MV of a patient, there may be a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in the closed state (i.e., during systole). For example, the gap 26 may have a width W between about 2.5 mm and about 17.5 mm, such as between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some situations, the gap may have a width W greater than 15 mm. In any of the above situations, a valve repair device that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent the backflow of blood through the mitral valve MV is desired.

[0084] Stenosis or regurgitation can affect any valve, but stenosis has been mainly found to affect the aortic valve AV or the pulmonary valve PV, and regurgitation has been mainly found to affect the mitral valve MV or the tricuspid valve TV. Both valve stenosis and valve regurgitation increase the workload of the heart H, and if left untreated, can lead to very serious medical conditions such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. Since the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) is mainly responsible for circulating the blood flow throughout the body, the malfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening. Accordingly, due to the relatively high pressure on the left side of the heart, the malfunction of the mitral valve MV or the aortic valve AV often becomes even more problematic.

[0085] A natural heart valve that does not function properly can be repaired or replaced. Repair usually involves preserving and correcting the patient's natural valve. Replacement usually involves replacing the patient's natural valve with a biological or mechanical substitute. Usually, the aortic valve AV and the pulmonary valve PV are more prone to stenosis. Since the stenosis damage received by the valve leaflets is irreversible, the most common treatment for a stenotic aortic valve or a stenotic pulmonary valve is to remove the valve and replace it with a surgically implanted heart valve or to replace it with a transcatheter heart valve. The mitral valve MV and the tricuspid valve TV are more prone to leaflet deformation, which, as described above, prevents the mitral valve or the tricuspid valve from closing properly and causes blood to flow backward, i.e., regurgitate, from the ventricle to the atrium (for example, a deformed mitral valve MV causes regurgitation from the left ventricle LV to the left atrium LA). The backward flow of blood from the ventricle to the atrium, i.e., regurgitation, leads to valvular insufficiency. Deformation of the structure or shape of the mitral valve MV or the tricuspid valve TV is often repairable. In addition, regurgitation may be caused by dysfunctional chordae tendineae 10 (for example, the chordae tendineae may stretch or rupture), which cause the anterior leaflet 20 and the posterior leaflet 22 to flip back so as to cause blood to regurgitate into the left atrium LA. These problems caused by dysfunctional chordae tendineae 10 can be repaired by repairing the chordae tendineae or the structure of the mitral valve (for example, by fixing the leaflets 20, 22 in the affected part of the mitral valve).

[0086] In the devices and procedures disclosed herein, the mitral valve is often mentioned for purposes of illustration in repairing it. However, it should be understood that the devices and concepts presented herein can be used to repair any natural valve, as well as any component of a natural valve. For example, referring next to FIG. 7, any of the devices and concepts presented herein can be used to repair the tricuspid valve TV. For example, any of the devices and concepts presented herein can be used between any two of the anterior leaflet 30, the septal leaflet 32, and the posterior leaflet 34 to prevent the backflow of blood from the right ventricle to the right atrium. In addition, any of the devices and concepts presented herein can be used together on all three of the leaflets 30, 32, 34 to prevent the backflow of blood from the right ventricle to the right atrium. That is, the valve repair device presented herein can be placed at the center between the three leaflets 30, 32, 34.

[0087] An exemplary implantable prosthetic device has a joining element and at least one anchor. The joining element is disposed within the natural heart valve orifice to fill the space and help form a more effective seal, thereby being configured to reduce or prevent the backflow described above. The joining element can have a blood-impermeable structure that also enables the natural leaflets to close around the joining element during ventricular contraction to prevent or resist blood from flowing back from the left or right ventricle into the left or right atrium, respectively. The prosthetic device can be configured to seal two or three natural leaflets. That is, this device can be used for natural mitral (bicuspid) and tricuspid valves. The joining element is sometimes referred to herein as a spacer. This is because the joining element can fill the space between a natural mitral or tricuspid valve that does not close completely and is functioning improperly.

[0088] The joining element (e.g., spacer, joining formation element, etc.) can have various shapes. In some embodiments, the joining element can have an elongated cylindrical shape with a circular cross-section. In some embodiments, the joining element can have an elliptical cross-sectional shape, a crescent-shaped cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. The joining element can have an atrial portion disposed within or near the left atrium, a ventricular portion or lower portion disposed within or near the left ventricle, and a side surface extending between the natural mitral valve leaflets. In embodiments configured for use with the tricuspid valve, the atrial portion or upper portion is disposed within or near the right atrium, the ventricular portion or lower portion is disposed within or near the right ventricle, and the side surface extends between the natural tricuspid valve leaflets.

[0089] The anchor can be configured to secure the device to one or both of the natural mitral valve leaflets such that the joining element is disposed between the two natural leaflets. In embodiments configured for use with the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the joining element is disposed between the three natural leaflets. In some embodiments, the anchor can be attached to the joining element at a position adjacent to the ventricular portion of the joining element. In some embodiments, the anchor can be attached to a drive element, such as a shaft or drive wire to which the joining element is also attached. In some embodiments, the anchor and the joining element can be separately positioned relative to each other by moving each of the anchor and the joining element separately along the longitudinal axis of the shaft or the drive wire. In some embodiments, the anchor and the joining element can be simultaneously positioned by moving the anchor and the joining element together along the longitudinal axis of the shaft or the drive wire. The anchor can be configured to be positioned behind the natural leaflet when the leaflet is implanted such that the leaflet is gripped by the anchor.

[0090] The prosthetic device can be configured to be implanted through a delivery sheath. The engagement element and the anchor can be compressible into a radially compressed state and self-expandable into a radially expanded state when the compressive pressure is released. The device can be configured such that the anchor radially expands from the initially statically compressed engagement element to create a gap between the engagement element and the anchor. Next, the native valve cusp is positioned in the gap. The engagement element radially expands to close the gap between the engagement element and the anchor and can capture the valve cusp between the engagement element and the anchor. In some embodiments, the anchor and the engagement element are optionally configured to self-expand. The implantation methods of the various embodiments may vary and will be discussed more fully below for each embodiment. Further information regarding the above and other delivery methods can be found in U.S. Patent No. 8,449,599, U.S. Patent Application Publication No. 2014 / 0222136, U.S. Patent Application Publication No. 2014 / 0067052, and U.S. Patent Application Publication No. 2016 / 0331523, each of which is hereby incorporated by reference in its entirety. These methods can be performed in a live animal or in a simulation experiment such as an anatomical cadaver, an anatomical cadaver heart, a mock-up device (e.g., a body part, tissue, etc. is simulated).

[0091] The disclosed prosthetic device can be configured such that the anchor is coupled to the valve cusp and utilizes the tension from the native chordae to withstand the high systolic pressures that bias the device towards the left atrium. During diastole, the device can rely on the compressive and retaining forces exerted on the valve cusp held by the anchor.

[0092] Next, referring to FIGS. 8 - 14, a transplantable prosthetic device 100 (e.g., a prosthetic spacer device, etc.) shown schematically is shown at various stages of deployment. The device 100 can include any other features of the transplantable prosthetic devices discussed in this application, and the device 100 can be arranged to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any repair system disclosed in this application).

[0093] The device 100 is deployed from a delivery sheath or means 102 for delivery and includes a junction or junction forming portion 104 and an anchor portion 106. The junction forming portion 104 of the device 100 is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, tricuspid valve, etc.) and includes a junction element or means 110 for engagement that is slidably attached to a drive element 112 (e.g., a drive wire, drive shaft, drive tube, etc.). The anchor portion 106 is drivable between an open position and a closed position and can take a variety of forms such as, for example, paddles, gripping elements, etc. Driving of the drive element or means 112 for driving opens and closes the anchor portion 106 of the device 100 to grip the native valve leaflets during implantation. The drive element 112 (e.g., a wire, shaft, tube, screw, line, etc.) can take a wide variety of different forms. For example, the drive element can be threaded such that when the drive element (e.g., a wire, shaft, tube, screw, etc.) rotates, the anchor portion 106 moves relative to the junction portion 104. Alternatively, the drive element may not be threaded such that when the drive element 112 is pushed or pulled, the anchor portion 106 moves relative to the junction portion 104.

[0094] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 that are connected by portions 124, 126, 128 between the cap 114 and the joining element or means 110 for joining. The portions 124, 126, 128 can be joined and / or made flexible to move between all of the positions described below. By interconnecting the outer paddle 120, the inner paddle 122, the joining element or means 110 for joining, and the cap 114 by the portions 124, 126, and 128, the device can be restricted to the positions and movements shown herein.

[0095] In some implementations, a drive element or means 112 for driving (e.g., a drive wire, a drive shaft, etc.) extends through the delivery sheath and the joining element or means 110 for joining to the cap 114 at the distal connection of the anchor portion 106. When the drive element or means 112 for driving is extended and retracted, the spacing between the joining element or means 110 for joining and the cap 114 increases and decreases, respectively. The joining element or means 110 for joining is removably attached to the delivery sheath or means 102 for delivery by a collar or other attachment element, whereby the drive element or means 112 slides through the collar or other attachment element and the joining element or means 110 for joining during driving to open and close the paddles 120, 122 of the anchor portion 106.

[0096] Next, referring to FIG. 11, the anchor portion 106 includes an attachment portion, i.e., a gripping member. The illustrated gripping member includes a return clip 130 including a base or fixed arm 132, a movable arm 134, other means 136 for returning or fixing, and a coupling portion 138. The fixed arm 132 is attached to the inner paddle 122, and the coupling portion 138 is disposed adjacent to a joining element or means 110 for joining. The return clip has a flat surface and does not fit into the recess of the paddle. Rather, the flat surface of the return clip is disposed opposite to the surface of the inner paddle 122. The coupling portion 138 applies a spring force between the fixed arm 132 and the movable arm 134 of the return clip 130. The coupling portion 138 can be any suitable coupling such as a flexible coupling, a spring coupling, a pivot coupling, etc. In some embodiments, the coupling portion 138 is a flexible piece made of a material formed integrally with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary with respect to the inner paddle 122 when the movable arm 134 is opened and the return clip 130 opens and the means 136 for returning or fixing is exposed. In some implementations, the return clip 130 is opened by applying tension to a drive line 116 attached to the movable arm 134, whereby the movable arm 134 articulates, bends, or pivots about the coupling portion 138 as a fulcrum. Other drive mechanisms are possible.

[0097] During implantation, paddles 120, 122 can be opened and closed, for example, to grip a native valve tip or native mitral valve tip between the paddles 120, 122 and a joining element or means 110 for joining. The reversible fastener 130 can be used to grip and / or further secure the native valve tip by engaging a means 136 for returning or fixing the valve tip and by sandwiching the valve tip between a movable arm 134 and a fixed arm 132. The means 136 for returning or fixing the reversible fastener 130 can increase friction with the valve tip or can partially or completely pierce the valve tip. The drive lines 116 can be driven separately, whereby each reversible fastener 130 can be opened and closed separately. By operating separately, it becomes possible to grip the valve tips one by one at a time, or to reposition the return 130 of an insufficiently gripped valve tip without changing the successful gripping of the other valve tip. The reversible fastener 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in the open position), whereby the valve tip can be gripped in various states required in a particular situation.

[0098] The reversible fasteners 130 can be opened separately by pulling on an attached drive line 116 that extends through a delivery sheath or means 102 for delivery to the reversible fastener 130. The drive line 116 can take a wide variety of forms, such as, for example, a line, thread, wire, rod, catheter, etc. A spring load can be applied to the reversible fastener 130, whereby in the closed position the reversible fastener 130 continuously applies a pinch force to the gripped native valve tip. This pinch force remains constant regardless of the position of the inner paddle 122. The means 136 for returning or fixing the reversible fastener 130 can pierce the native valve tip to further secure the native valve tip.

[0099] Next, referring to FIG. 8, the device 100 is shown in an elongated, i.e., fully open state for deployment from a delivery sheath. The device 100 is loaded into the delivery sheath in a fully open state. The reason is that in the fully open state, the space occupied is minimized, enabling the use of the smallest catheter (or the largest device 100 for a given catheter size). In the elongated state, the cap 114 is spaced from the joining element or means 110 for joining such that the paddles 120, 122 of the anchor portion 106 are fully extended. In some embodiments, the angle formed between the inside of the outer paddle 120 and the inside of the inner paddle 122 is about 180 degrees. The detachable fastener 130 is held in a closed state during deployment by the delivery sheath or means 102 for delivery, whereby the means 136 for returning or fixing (FIG. 11) does not catch or damage the sheath or the patient's heart tissue.

[0100] Next, referring to FIG. 9, the device 100 is shown in an elongated and intertwined state as in FIG. 8, but the detachable fastener 130 is in a fully open position, in a range from about 140 degrees to about 200 degrees, to about 170 degrees, to about 190 degrees, or about 180 degrees between the fixed and movable positions of the detachable fastener 130. It has been found that fully opening the paddles 120, 122 and the fastener 130 improves the ease of removal or detachment of the entanglement from the patient's anatomical structure during implantation of the device 100.

[0101] Next, referring to FIG. 10, device 100 is shown in a shortened, i.e., fully closed state. The compact size of device 100 in the shortened state allows for easier manipulation and placement within the heart. To move device 100 from the elongated state to the shortened state, drive element or means 112 for driving is retracted and cap 114 is pulled towards joining element or means 110 for joining. Joint or flexible connection 126 between outer paddle 120 and inner paddle 122 restricts movement such that the compressive force acting on paddle 120 from cap 114, which is retracted towards joining element or means 110 for joining, moves paddles 120, 122 or gripping elements radially outwards. During movement from the open position to the closed position, outer paddle 120 maintains an acute angle with drive element or means 112 for driving. Outer paddle 120 can optionally be biased towards the closed position. During the same movement, inner paddle 122 moves through a fairly large angle as it moves away from joining element or means 110 in the open position and is folded along the side of joining element or means 110 in the closed position. In some embodiments, inner paddle 122 is thinner and / or narrower than outer paddle 120, and joints or flexible portions 126, 128 connected to inner paddle 122 can be made thinner and / or more flexible. For example, this increased flexibility allows for a greater movement than flexible portion 124, which connects outer paddle 120 to cap 114. In some embodiments, outer paddle 120 is narrower than inner paddle 122. Joints or flexible portions 126, 128 connected to inner paddle 122 can be made more flexible, for example, to allow for a greater movement than flexible portion 124, which connects outer paddle 120 to cap 114. In one embodiment, inner paddle 122 can be the same width as, or substantially the same width as, the outer paddle (see, e.g., FIG. 65A).

[0102] Next, referring to FIGS. 11 - 13, device 100 is shown in an incompletely open, gripping - ready state. To move from the fully - closed state to the incompletely open state, the drive element or means 112 for driving is extended to push the cap 114 away from the joining element or means 110 for joining, thereby pulling the outer paddle 120, and then the outer paddle pulls the inner paddle 122, causing the anchor portion 106 to spread incompletely. The drive line 116 is also pulled to open the fastener 130, thereby enabling the gripping of the valve tip. In the example shown in FIG. 11, the pair of the inner paddle 122 and the outer paddle 120 move in unison rather than separately by a single drive element or means 112 for driving. Also, the position of the fastener 130 depends on the positions of the paddles 122, 120. For example, referring to FIG. 10, when the paddles 122, 120 are closed, the fastener also closes.

[0103] FIG. 11A shows an exemplary embodiment in which the paddles 120, 122 are independently controllable. Device 100A shown in FIG. 11A is similar to the device shown in FIG. 11, except that device 100A includes a drive element configured as two independent drive elements 112A, 112B coupled to two separate caps 114A, 114B. To move the first inner paddle and the first outer paddle from the fully - closed state to the incompletely open state, the drive element or means 112A for driving is extended to push the cap 114A away from the joining element or means 110 for joining, thereby pulling the outer paddle 120, and then the outer paddle pulls the inner paddle 122, causing the first anchor portion 106 to spread incompletely. To move the second inner paddle and the second outer paddle from the fully - closed state to the incompletely open state, the drive element or means 112B for driving is extended to push the cap 114 away from the joining element or means 110 for joining, thereby pulling the outer paddle 120, and then the outer paddle pulls the inner paddle 122, causing the second anchor portion 106 to spread incompletely. The independent paddle control shown in FIG. 11A can be implemented in any of the devices disclosed by this application.

[0104] Referring next to FIG. 12, one of the drive lines 116 is extended to enable one of the fasteners 130 to close. Referring next to FIG. 13, the other drive line 116 is extended to enable the other fastener 130 to close. Either or both of the drive lines 116 can be repeatedly driven to repeatedly open and close the reversible fastener 130.

[0105] Referring next to FIG. 14, the device 100 is shown in a fully closed and deployed state. The delivery sheath or means for delivery 102 and the drive element or means for drive 112 are retracted, and the paddles 120, 122 and the fasteners 130 remain in their fully closed positions. After deployment, the device 100 can be maintained in its fully closed position by mechanical latching, or can be biased to remain closed by using a spring material such as steel, other metals, plastics, composites, or a shape memory alloy such as nitinol. For example, the jointed or flexible portions 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or additional biasing components (see component or frame 524 of FIG. 28) can be formed of a metal such as steel, or a shape memory alloy such as nitinol (produced as wire, sheet, tube, or laser sintered powder), and are biased to keep the outer paddle 120 closed around the joining element or means for joining 110, and to clamp the reversible fastener 130 around the natural valve tip. Similarly, the fixed arm 132 and the movable arm 134 of the reversible fastener 130 are biased to clamp the valve tip. In some embodiments, the attachments or joints 124, 126, 128, 138, and / or the inner and outer paddles 122, and / or additional biasing components (see component or frame 524 of FIG. 28) can be formed of any other suitable elastic material such as a metal or polymer material to maintain the device in a closed state after implantation.

[0106] Next, referring to FIGS. 226 to 231, the implantable device 100 is illustrated with the cover 140 provided. The cover 140 may be a cloth material such as a fine mesh polyethylene cloth. The cloth cover can seal blood on the surface of the spacer and / or promote rapid tissue ingrowth. The cover 140 includes a first cover portion 142 and a second cover portion 144 that each cover different portions of the device 100. In some embodiments, a part of one of the first cover portion 142 and the second cover portion 144 overlaps a part of the other of the first cover portion 142 and the second cover portion 144. The first cover portion 142 and the second cover portion 144 may include an overlapping portion 146 that overlaps one of the first cover portion 142 and the second cover portion 144 in some embodiments.

[0107] Next, referring to FIGS. 226 to 229, various arrangements of the first cover portion 142 and the second cover portion 144 are illustrated without the overlapping portion 146. Referring to FIG. 226 next, the first cover portion 142 (represented by thin cross-hatching), which can be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixing arm 132 of the fastener 130. The second cover 144 (represented by thin cross-hatching), which may be a single piece of material, covers the joining element or means 110 for joining.

[0108] Referring to FIG. 227 next, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, the fixing arm 132 and the movable arm 134 of the fastener 130. Similar to the cover 140 of FIG. 226, the second cover 144 covers the joining element or means 110 for joining.

[0109] Next, referring to FIG. 228, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the fastener 130. The second cover 144, which can be made from a single piece of material, covers the joining element or means 110 for joining and extends from the joining element or means 110 for joining to cover the movable arm 134 of the fastener 130.

[0110] Next, referring to FIG. 229, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 and covers the cap 114 and the outer paddle 120. The second cover 144, which can be made from a single piece of material, covers the joining element or means 110 for joining and extends from the joining element or means 110 for joining to cover the inner paddle, as well as the fixed arm 132 and the movable arm 134 of the fastener 130.

[0111] Next, referring to FIGS. 230 - 231, the arrangement of the first cover portion 142 and the second cover portion 144 is shown to include an overlapping portion 146. Next, referring to FIG. 230, the first cover portion 142, which can be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, as well as the fixed arm 132 and the movable arm 134 of the fastener 130. The second cover 144, which can be made from a single piece of material, covers the joining element or means 110 for joining and extends from the joining element or means 110 for joining to include an overlapping portion 146 that overlaps a portion of the movable arm 134 covered by the first cover 142.

[0112] Next, referring to FIG. 231, a first cover portion 142, which can be made from a single piece of material, extends from the cap 114 and covers the cap 114, the outer paddle 120, the inner paddle 122, and the fixed arm 132 of the fastener 130. A second cover 144, which can be made from a single piece of material, covers the joining element or means 110 for joining and the movable arm 134 of the fastener 130. The first cover 142 also includes an overlapping portion 146 that extends from the fixed arm 132 and the inner paddle 122 and overlaps a part of the movable arm 134 and the joining element or means 110 for joining that is covered by the second cover 144.

[0113] Next, referring to FIGS. 15 - 20, the implantable device 100 of FIGS. 8 - 14 is shown being delivered and implanted into the native mitral valve MV of the heart H. The methods and steps shown and / or described can be performed in live animals, or in mock experiments such as on cadavers, cadaver hearts, mock experimental devices (e.g., where parts of the body, heart, tissue, etc. are simulated).

[0114] Next, referring to FIG. 15, the delivery sheath is inserted through the septum into the left atrium LA, and the device 100 is deployed from the delivery sheath in a fully open state. Then, the drive element or means 112 for driving is retracted, thereby moving the device 100 to the fully closed state shown in FIG. 16. As can be seen in FIG. 17, the device 100 is placed at a predetermined position within the mitral valve MV into the ventricle LV and opens incompletely, thereby being able to grip the valve leaflets 20, 22. Next, referring to FIG. 18, the drive line 116 is extended and one of the fasteners 130 is closed, thereby capturing the valve leaflet 20. FIG. 19 shows the other drive line 116, which is then extended to close the other fastener 130, thereby capturing the remaining valve leaflet 22. As can be seen in FIG. 20, next the delivery sheath or means 102 for delivery and the drive element or means 112 for driving and the drive line 116 are retracted, the device 100 is fully closed, and is deployed within the native mitral valve MV.

[0115] Next, referring to FIG. 21, an exemplary implantable prosthetic device 200 (e.g., a prosthetic spacer device, etc.) or its frame is shown. In some embodiments, the device 200 includes an annular spacer member 202, a fabric cover (not shown), and anchors 204 extending from the optional spacer member 202. The end of each anchor 204 can be coupled to the respective strut of the spacer member 202 by respective sleeves 206, and these sleeves can be crimped or welded around the connection of the anchor 204 and the strut of the spacer member 202. In one exemplary embodiment, a latching mechanism can couple the spacer member 202 to the anchor 204 within the sleeve 206. For example, the sleeve can be machined to have an inner shape that conforms to or is slightly smaller than the outer shape formed by the ends of the spacer member 202 and the anchor 204, such that the sleeve can frictionally fit into the connection. One or more returns or protrusions 208 can be attached to the frame of the spacer member 202. The free ends of the returns or protrusions 208 can have various shapes, such as round, pointed, hooked, etc. The protrusions 208 can exert a holding force on the natural valve cusp by the anchor 204, which is shaped to force the natural valve cusp inwardly into the spacer member 202.

[0116] Next, referring to FIG. 22, an exemplary implantable prosthetic device 300 (e.g., a prosthetic spacer device, etc.) or its frame is shown. In some embodiments, the prosthetic device or prosthetic spacer device 300 includes a spacer member 302, a fabric cover (not shown), and an anchor 304 extending from the spacer member 302, and can be configured similarly to the prosthetic device or prosthetic spacer member 200. One or more returns or protrusions 306 can be attached to the frame of the spacer member 302. The end of the protrusion 306 can include a stopper 308. The stopper 308 of the protrusion can be configured in a variety of different ways. For example, the stopper 308 can be configured to limit the extent to which the protrusion 306 can engage and / or pierce the natural valve tip, and / or the stopper can be configured to prevent the protrusion 306 from detaching from the tissue after the protrusion 306 has pierced the tissue.

[0117] The anchor 304 of the prosthetic device or prosthetic spacer device 300 can be configured similarly to the anchor 204 of the prosthetic device or prosthetic spacer device 200, except that the curve of each anchor 304 includes a larger radius than the anchor 204. Thus, the anchor 304 covers a relatively larger portion of the spacer member 302 than the anchor 204. Thereby, for example, to further protect the natural valve tip tissue, the clamping force of the anchor 304 on the natural valve tip can be dispersed over a relatively large surface of the natural valve tip.

[0118] Further details regarding the prosthetic device or prosthetic spacer device can be found, for example, in U.S. Patent Application Publication No. 2016 / 0331523 and U.S. Provisional Patent Application No. 62 / 161,688, which are incorporated herein by reference. Devices 200, 300 can include any other features of the implantable prosthetic device discussed in this application, and devices 200, 300 can be arranged to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0119] Referring now to FIGS. 23-27, an exemplary embodiment of an implantable prosthetic device 400 (e.g., a prosthetic spacer device, etc.) and its components is shown. Device 400 can include any other features of the implantable prosthetic device discussed in this application, and device 400 can be arranged to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0120] Referring now to FIG. 23, prosthetic device or prosthetic spacer / attachment device 400 can include a junction 404 and an anchor portion 406, and anchor portion 406 can include a plurality of anchors 408. Junction 404 includes a junction member or spacer member 410. Anchor portion 406 includes a plurality of paddles 420 (e.g., two in the illustrated embodiment) and a plurality of fasteners 430 (e.g., two in the illustrated embodiment). A first or proximal collar 411 and a second collar or cap 414 are used to move junction 404 and anchor portion 406 relative to each other.

[0121] As shown in FIG. 25, a first connection portion 425 of anchor 408 can be coupled to a first portion 417 of junction element or spacer member 410 and can extend therefrom, and a second connection portion 421 of anchor 408 can be coupled to first collar 414. Proximal collar 411 can be coupled to a second portion 419 of junction element / member 410.

[0122] The joining element / member 410 and the anchor 408 can be joined in a variety of ways. For example, as shown in the illustrated embodiment, the joining element / member 410 and the anchor 408 can be joined by integrating the joining element / member 410 and the anchor 408 as a single integral component. This can be achieved, for example, by forming the joining element / member 410 and the anchor 408 from a braided or woven material such as braided or woven nitinol wire. In some embodiments, the joining element / member 410 and the anchor 408 can be joined by welding, fasteners, adhesives, coupling joints, threads, friction fits, caulking, and / or other means of joining.

[0123] Referring now to FIG. 24, the anchor 408 can comprise a first portion, namely an outer paddle 420, and a second portion, namely an inner paddle 422, separated by a junction 423. In this aspect, the anchor 408 is configured similarly to a leg in that the inner paddle 422 resembles the upper part of the leg, the outer paddle 420 resembles the lower part of the leg, and the junction 423 resembles the knee of the leg. In some embodiments, the inner paddle portion 422, the outer paddle portion 420, and the junction 423 are formed from a continuous strip of fabric such as a metal fabric. In some embodiments, the strip of fabric is a composite strip of fabric.

[0124] The anchor 408 can be configured to move between various configurations by axially moving the cap 414 relative to the proximal collar 411, i.e., by axially moving the anchor 408 relative to the engagement element / member 410 along the longitudinal axis extending between the first or distal portion 417 and the second or proximal portion 419 of the engagement element / member 410. For example, the anchor 408 can be positioned in a straight configuration by moving the cap 414 away from the engagement element / member 410. In the straight configuration, the paddle portions are aligned in the direction of the longitudinal axis of the device, i.e., are straight, and the coupling portion 423 of the anchor 408 is adjacent to the longitudinal axis of the engagement element / member 410 (e.g., similar to the configuration shown in FIG. 59). From the straight configuration, the anchor 408 can move to a fully folded configuration (e.g., FIG. 23) by moving towards the engagement element / member 410. Initially as the cap 414 moves towards the engagement element / member 410, the anchor 408 bends at the coupling portions 423, 425, 421, and the coupling portion 423 moves radially outward relative to the longitudinal axis of the engagement element / member 410 and axially towards the first portion 414 of the engagement element / member 410 as shown in FIGS. 24-25. As the cap 414 continues to move towards the engagement element / member 410, the coupling portion 423 moves radially inward relative to the longitudinal axis of the engagement element / member 410 and axially towards the proximal portion 419 of the engagement element / member 410 as shown in FIG. 23.

[0125] In some embodiments, when the anchor 408 is in the straight configuration (see, e.g., FIG. 59), the angle between the inner paddle 422 of the anchor 408 and the engagement element / member 410 can be about 180 degrees, and when the anchor 408 is in the fully folded configuration (see FIG. 23), the angle between the inner paddle 422 of the anchor 408 and the engagement element / member 410 can be about 0 degrees. The anchor 408 can be positioned in various partially folded configurations such that the angle between the inner paddle 422 of the anchor 408 and the engagement element / member 410 can be about 10-170 degrees, or about 45-135 degrees.

[0126] Configuring the prosthetic device or prosthetic spacer device 400 such that the anchor 408 can extend into a straight or substantially straight configuration (e.g., about 120 - 180 degrees relative to the joining element / member 410) can provide several advantages. For example, this can reduce the radial fold profile of the prosthetic device or prosthetic spacer device 400. Also, by providing a larger opening for gripping the natural valve tip, it can be easier to grip the natural valve tip. Additionally, the relatively thin, straight configuration can prevent or reduce the likelihood of the prosthetic device / spacer device 400 becoming entangled with natural anatomical structures (e.g., chordae tendineae) when positioning and / or retrieving the prosthetic device / spacer device 400 within a delivery device.

[0127] Referring again to FIG. 24, the fastener 430 can include an attachment or fixing portion 432 and an arm or movable portion 434. The attachment or fixing portion 432 can be coupled to the inner paddle 422 of the anchor 408 in various ways, such as using thread, adhesive, fasteners, welding, suturing, crimping, friction fitting, and / or other means of bonding or fastening.

[0128] In some embodiments, the movable portion 434 can articulate, flex, or pivot relative to the fixing portion 432 between an open configuration (e.g., FIG. 24) and a closed configuration (FIGS. 23 and 25). In some embodiments, the fastener 430 can be biased towards the closed configuration. In some embodiments, in the open configuration, the fixing portion 432 and the movable portion 434 flex or pivot away from each other such that a natural valve tip can be positioned between the fixing portion 432 and the movable portion 434. In some embodiments, in the closed configuration, the fixing portion 432 and the movable portion 434 flex or pivot towards each other, thereby securing the natural valve tip between the fixing portion 432 and the movable portion 434.

[0129] Referring to FIGS. 26 - 27, the fastener 430 is shown in a top perspective view. The fixing part 432 (only one is shown in FIGS. 26 - 27) can include one or more openings 433 (for example, three in the illustrated embodiment). At least some of the openings 433 can be used to couple the fixing part 432 to the anchor 408. For example, a thread and / or a fastener can extend through the opening 433 to couple the fixing part 432 to the anchor 408, or other attachments such as welding, adhesives, etc. can be used.

[0130] The movable part 434 can include one or more side beams 431. When two side beams are included as shown, the side beams can be spaced apart to form a slot 431A. The slot 431A can be configured to receive the fixing part 432. The movable part 434 can also include a spring part 434A, which is coupled to the fixing part 432 and a return support part 434A disposed on the opposite side of the spring part 434A.

[0131] The return support part 434B can include a gripper element or an attachment element such as a suture 436 and / or other means for frictionally engaging the natural valve tip tissue. The gripper element can be configured to engage and / or perforate the natural valve tip tissue to help hold the valve tip between the fixing part 432 and the movable part 434 of the fastener 430.

[0132] The return support part 434B can also include a rivet 435, which can be used to couple the return support part 434B to a drive mechanism configured to bend or pivot the movable part 434 relative to the fixing part 432. Further details regarding coupling the fastener 430 to the drive mechanism are presented below.

[0133] In some embodiments, the fastener 430 can be formed from a shape memory material such as Nitinol, stainless steel, and / or a shape memory polymer. In some embodiments, the fastener 430 can be formed by laser cutting a single piece of flat sheet material (e.g., Nitinol) or a tube into the form shown in FIG. 26, or a similar or different form, and then setting the shape of the fastener 430 into the form shown in FIG. 27.

[0134] By setting the shape of the fastener 430 in this way, several advantages can be achieved. For example, the fastener 430 can be optionally compressed from the set shape (e.g., FIG. 27) to a flat shape (e.g., FIG. 26), or to another shape that reduces the radial fold contour of the fastener 430. For example, the return can be optionally compressed to a flat shape. By reducing the radial fold contour, the followability and retrievability of the prosthesis device or prosthesis spacer device 400 with respect to the catheter shaft of the delivery device can be improved. The reason is that when the prosthesis device or prosthesis spacer device 400 is fed through the catheter shaft or retrieved into the catheter shaft, the return 440 is directed radially inwardly towards the anchor 408 (see, for example, FIG. 33). This can prevent, or reduce the likelihood of, the return 430 catching or scraping the catheter shaft.

[0135] In addition, by configuring the fastener 430 in the form shown in FIG. 27, the clamping force of the fastener 430 when the fastener 430 is in the closed form can be increased. This is because the anchor 408 prevents the movable part 434 from moving further towards the configured form, so that when the fastener 430 is attached to the anchor 408 (for example, in FIG. 25), the movable part 434 is configured with respect to the fixed part 432 to a first position (for example, in FIG. 27) beyond the position that the movable part 434 can reach. As a result, when the fastener 430 is attached to the anchor 408 and in the closed form, the movable part 434 will have a preload (that is, the clamping force is greater than zero). Therefore, by configuring the fastener 430 in the form of FIG. 27, the clamping force of the fastener 430 can be increased compared to the fastener configured in the closed form.

[0136] The magnitude of the preload of the fastener 430 can be changed by adjusting the angle when the movable part 434 is configured with respect to the fixed part 432. For example, increasing the relative angle between the movable part 434 and the fixed part 432 increases the preload, and reducing the relative angle between the movable part 434 and the fixed part 432 reduces the preload. This can also be adjusted by other methods, such as based on the form of the joint, hinge, material, etc.

[0137] In some embodiments, the proximal collar 411 and / or the joining element / member 410 can include a hemostatic seal 413 configured to reduce or prevent blood from flowing out of the proximal collar 411 and / or the joining element / member 410. For example, in some embodiments, the hemostatic seal 413 can include a plurality of flexible flaps 413A as shown in FIG. 23. In some embodiments, the flaps 413A can be configured to pivot from a sealed configuration to an open configuration to allow the shaft of the delivery device to extend through the second collar 411. In one exemplary embodiment, the flaps 413A form a seal around the shaft of the delivery device. When the shaft of the delivery device is removed, the flaps 413A can be configured to return from the open configuration to the sealed configuration.

[0138] Referring now to FIG. 23A, an exemplary embodiment of an implantable prosthetic device or an implantable prosthetic spacer device 400A is shown. The device 400A can include any other features of the implantable prosthetic devices discussed in this application, and the device 400A can be arranged to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0139] The prosthetic device (e.g., a prosthetic spacer or a joining device) 400A can include a joining portion 404A and an anchor portion 406A, and the anchor portion 406A can include a plurality of anchors 408A. The joining portion 404A can include a joining element, a joining member, or a spacer member 410A. The anchor portion 406A can include a plurality of paddles 420A (e.g., two in the illustrated embodiment), and a plurality of fasteners 430A (e.g., two in the illustrated embodiment). A first or proximal collar 411A and a second collar or cap 414A are used to move the joining portion 404A and the anchor portion 406A relative to each other.

[0140] The engagement element / member 410A extends from a proximal portion 419B assembled to the collar 411A to a distal portion 417A that couples to the anchor 408A. The engagement element / member 410A and the anchor 408A can be joined together in various ways. For example, as shown in the illustrated embodiment, the engagement element / member 410A and the anchor 408A can be joined together by forming the engagement element / member 410 and the anchor 408A as a single integral component. This can be accomplished, for example, by forming the engagement element / member 410A and the anchor 408A from a continuous strip 401A of braided or woven material, such as braided or woven nitinol wire.

[0141] The anchor 408A is attached to the engagement element / member 410A by a hinge portion 425A and to the cap 414A by a hinge portion 421A. The anchor 408A can include a first portion, an outer paddle 420A, and a second portion, an inner paddle 422A, separated by a junction 423A. The junction 423A is attached to a paddle frame 424A that is hingedly attached to the cap 414A. In this aspect, the anchor 408A is configured similarly to a leg in that the inner paddle 422A resembles the upper part of the leg, the outer paddle 420A resembles the lower part of the leg, and the junction 423A resembles the knee of the leg. In the illustrated example, the inner paddle portion 422A, the outer paddle portion 420A, and the junction 423A are formed from a continuous strip 410A of fabric, such as a metal fabric.

[0142] The anchor 408 can be configured to move between various configurations by axially moving the cap 414A relative to the proximal collar 411A, and thus the anchor 408A, along the longitudinal axis extending between the cap 414A and the proximal collar 411A with respect to the joining element / member 410A. For example, the anchor 408 can be positioned in a straight configuration (see FIG. 60A) by moving the cap 414A away from the joining element / member 410A. In the straight configuration, the paddle portions 420A, 422A are aligned or straight in the direction of the longitudinal axis of the device, and the coupling portion 423A of the anchor 408A is adjacent to the longitudinal axis of the joining element / member 410A (e.g., similar to the configuration shown in FIG. 60A). From the straight configuration, the anchor 408 can move to a fully folded configuration (e.g., FIG. 23A) by moving towards the joining element / member 410A. Initially, as the cap 414A moves towards the joining element / member 410A, the anchor 408A bends at the coupling portions 421A, 423A, 425A, and the coupling portion 423A moves radially outward with respect to the longitudinal axis of the device 400A and axially towards the distal portion 417A of the joining element / member 410A, as shown in FIGS. 53A and 54A. As the cap 414A continues to move towards the joining element / member 410A, the coupling portion 423A moves radially inward with respect to the longitudinal axis of the device 400A and axially towards the proximal portion 419B of the joining element / member 410A, as shown in FIG. 23A.

[0143] In some embodiments, when the anchor 408A is in a straight configuration (see, e.g., FIG. 60A), the angle between the inner paddle 422A of the anchor 408A and the engagement element / member 410A can be about 180 degrees, and when the anchor 408A is in a fully folded configuration (see FIG. 23A), the angle between the inner paddle 422A of the anchor 408A and the engagement element / member 410A can be about 0 degrees. The anchor 408A can be arranged in various incompletely folded configurations such that the angle between the inner paddle 422A of the anchor 408A and the engagement element / member 410A can be about 10-170 degrees, or about 45-135 degrees.

[0144] Constructing the prosthesis or spacer device 400A such that the anchor 408A can extend to a straight or substantially straight configuration (e.g., about 120-180 degrees relative to the engagement element / member 410A) can provide several advantages. For example, this can reduce the radial fold profile of the prosthesis or prosthetic spacer device 400A. Also, by providing a larger opening for gripping the natural valve cusp, it can be easier to grip the natural valve cusp. Additionally, the relatively thin, straight configuration can prevent or reduce the likelihood of the prosthesis or prosthetic spacer device 400A becoming entangled with natural anatomical structures (e.g., chordae tendineae) when positioning and / or retrieving the prosthesis / prosthetic spacer device 400A within a delivery device.

[0145] The fastener 430A can include an attachment or fixed portion 432C and an arm or movable portion 434C. The attachment or fixed portion 432C can be coupled to the inner paddle 422A of the anchor 408A in a variety of ways, such as using suture, adhesive, fasteners, welding, suturing, crimping, friction fitting, and / or other means of attachment. The fastener 430A is similar to the fastener 430.

[0146] In some embodiments, the movable portion 434C can articulate, bend, or pivot relative to the fixed portion 432C between an open configuration (e.g., FIG. 54A) and a closed configuration (FIG. 53A). In some embodiments, the fastener 430A can be biased toward the closed configuration. In the open configuration, the fixed portion 432C and the movable portion 434C can articulate, pivot, or bend away from each other so that a natural valve tip can be disposed between the fixed portion 432C and the movable portion 434C. In the closed configuration, the fixed portion 432C and the movable portion 434C can articulate, pivot, or bend toward each other, thereby securing the natural valve tip between the fixed portion 432C and the movable portion 434C.

[0147] The strip 401A is attached to the collar 411A, the cap 414A, the paddle frame 424A, and the fastener 430A to form both the joint portion 404A and the anchor portion 406A of the device 400A. In the illustrated embodiment, the joint element / member 410A, the hinge portions 421A, 423A, 425A, the outer paddle 420A, and the inner paddle 422A are formed from a continuous strip 401A. The continuous strip 401A can be a single layer of material or can include two or more layers. In some embodiments, a portion of the device 400A has a single layer of the strip 401A of material and another portion is formed from multiple overlapping or overlying layers of the strip 401A of material. For example, FIG. 23A shows the joint element / member 410A and the inner paddle 422A formed from multiple overlapping layers of the strip 401A of material. The single continuous strip 401A of material can begin and end in various arrangements of the device 400A. The ends of the strip 401A of material can be in the same or different arrangements of the device 400A. For example, in the illustrated embodiment of FIG. 23A, the strip of material begins and ends in the arrangement of the inner paddle 422A.

[0148] Next, referring to FIG. 30A, an exemplary implantable device 400A is illustrated as being covered by a cover 440A. The cover 440A is disposed over a bonding element / member 410A, a collar 411A, a cap 414A, paddles 420A, 422A, a paddle frame 424A, and a fastener 430A. The cover 440A can be configured to prevent or reduce blood flow through the patch device / spacer device 400A and / or to promote ingrowth of native tissue. In some embodiments, the cover 440A can be a cloth or fabric, such as PET, velour, or other suitable fabric. In some embodiments, instead of or in addition to the fabric, the cover 440A can include a coating (e.g., a polymeric material, silicone, etc.) applied to the patch device / spacer device 400A.

[0149] Next, referring to FIGS. 28 - 30, an exemplary embodiment of an implantable patch device 500 (e.g., a patch spacer device, etc.) is shown. The implantable device 500 is one of many different forms that the device 100 schematically shown in FIGS. 8 - 20 can take. The device 500 can include any of the other features of the implantable patch devices discussed in this application, and the device 500 can be arranged to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0150] The patch device or patch spacer device 500 can include a plurality of anchors 508 including a bonding element, a bonding member, or a spacer 510, outer paddles 520, inner paddles 522, a fastener 530, a first collar or proximal collar 511, and a second collar or cap 514. These components of the patch device or patch spacer device 500 can be configured similarly or substantially similarly to the corresponding components of the patch device or patch spacer device 400.

[0151] The patch device or patch spacer device 500 can also include a plurality of paddle extension members, i.e., paddle frames 524. The paddle frames 524 can be configured in a round three-dimensional shape, with a first connection portion 526 coupled to and extending from the cap 514, and a second connection portion 528 disposed on the opposite side of the first connection portion 526. The paddle frames 524 can be configured to extend circumferentially wider than the outer paddles 520 around the joining element / member 510. For example, in some embodiments, each of the paddle frames 524 extends to surround approximately half of the circumference around the joining element / member 510 (as shown in FIG. 29), and the outer paddles 520 extend to surround less than half of the circumference around the joining element / member 510 (as shown in FIG. 28). The paddle frames 524 can also be configured to extend laterally (i.e., perpendicular to the longitudinal axis of the joining element / member 510) beyond the outer diameter of the joining element / member 510. In the illustrated example, the inner paddles 522 and the outer paddles 520 can be formed from a continuous strip of fabric connected to the paddle frames 524. For example, the inner paddle portion and the outer paddle portion can be connected at the connection portion of the paddle frame at a flexible connection between the inner paddle portion and the outer paddle portion.

[0152] The paddle frame 524 can further be configured such that the connecting portion 528 of the paddle frame 524 is connected to or axially adjacent to the connecting portion 523. The connecting portion of the paddle frame 524 can be disposed between the outer paddle 520 and the inner paddle 522, outside the paddle portion 520, inside the inner paddle portion, or above the connecting portion 523 when the patch device or patch spacer device 500 is in the folded configuration (see, e.g., FIGS. 28-30). The connecting portions between each paddle frame 524, the single strip forming the outer paddle 520 and the inner paddle 522, the cap 514, and the joining elements can constrain each of these portions to the movements and positions described herein. In particular, the connecting portion 523 is constrained by its connection between the outer paddle 520 and the inner paddle 522 and by its connection to the paddle frame. Similarly, the paddle frame 524 is constrained by its attachment to the connecting portion 523 (and thus the inner and outer paddles) and the cap.

[0153] By configuring the paddle frame 524 in this manner, an increase in surface area is achieved as compared to the outer paddle 520 alone. This increase in surface area makes it easier to grip and hold the native valve leaflet. The increase in surface area also allows the clamping force of the paddles 520 and paddle frame 524 against the native valve leaflet to be distributed over a relatively large surface of the native valve leaflet to further protect the native valve leaflet tissue.

[0154] The increase in surface area of the paddle frame 524 also enables the native valve leaflet to be secured to the patch device or patch spacer device 500 such that the native valve leaflet joins generally around the joining element / member 510. By doing so, for example, the sealing of the native valve leaflet can be improved and thus mitral valve regurgitation can be prevented or further reduced.

[0155] Referring to FIG. 30, the prosthetic device or prosthetic spacer device 500 can also include a cover 540. In some embodiments, the cover 540 can be disposed on the joining element / member 510, paddles 520, 522, and / or paddle frame 524. The cover 540 can be configured to prevent or reduce blood flow through the prosthetic device or prosthetic spacer device 500 and / or to promote ingrowth of natural tissue. In some embodiments, the cover 540 can be a cloth or fabric such as PET, velour, or other suitable fabric. In some embodiments, instead of or in addition to the fabric, the cover 540 can include a coating (e.g., polymer, silicone, etc.) applied to the prosthetic device 500.

[0156] FIGS. 31-32 show the implantable prosthetic device 500 of FIGS. 28 and 29 with the anchor 508 and fastener 530 of the anchor portion 506 in the open position. The device 500 is deployed from a delivery sheath (not shown) and includes a junction 504 and an anchor portion 506. The device 500 is loaded into the delivery sheath in a fully extended or everted state. The reason for this is that in the fully extended or everted state, the space occupied is minimized and the smallest catheter can be used (see FIG. 35). Alternatively, in the fully extended state, it becomes possible to use the largest device 500 for a given catheter size. The junction 504 of the device includes a joining element 510 for implanting between the natural valve leaflets of a natural valve (e.g., mitral valve, tricuspid valve, etc.). An insert 516B is disposed inside the joining element 510. The insert 516B and the joining element 510 are slidably attached to a drive element 512 (e.g., drive wire, rod, shaft, tube, screw, suture, line, etc.). The anchor 508 of the device 500 includes outer paddles 520 and inner paddles 522 that are flexibly connected to the cap 514 and the joining element 510. Driving the drive element or driving means 512 opens and closes the anchor 508 of the device 500 to grip the valve leaflets of the natural valve during implantation.

[0157] The drive element 512 extends through a delivery sheath (not shown), a proximal collar 511, a coupling element 510, an insert 516B to the cap 514. When the drive element 512 is extended and retracted, the spaces between the coupling element 510 and the cap 514 increase and decrease respectively. This change in the space between the coupling element 510 and the cap 514 causes the anchor portion 506 of the device to move between different positions.

[0158] The proximal collar 511 optionally includes a color seal 513 which forms a seal around the drive element or drive means 512 during implantation of the device 500 and also seals when the drive element 512 is removed to close or substantially close the proximal end of the device 500 against blood flow through the interior of the coupling element 510 after implantation. In some embodiments, means 2214 (see FIG. 145) for coupling or connection removably engages and attaches the proximal collar 511 and the coupling element 510 to the delivery sheath. In some embodiments, the means 2214 for coupling or connection is closed around the proximal collar 511 by the drive element 512 such that when the drive element 512 is removed, the fingers (see FIG. 145) of the means 2214 for coupling or connection can open to release the proximal collar 511.

[0159] The inserts 516B within the proximal collar 511 and the coupling element 510 slide along the drive element 512 during actuation to open and close the paddles 520, 522 of the anchor 508. Referring to FIGS. 32A and 32B, in some embodiments the cap 514 optionally includes a sealing projection 516 that seals into a sealing opening 517 of the insert 516B. In one exemplary embodiment, the cap 514 includes a sealing opening and the insert 516B includes a sealing projection. The insert 516B can seal fit inside the distal opening 515 (FIG. 31) of the coupling element 510 which is hollow inside. Referring to FIG. 32A, the sealing projection 516 of the cap 514 seals engage the opening 517B of the insert 516B to close or substantially close the distal end of the coupling element 510 against blood flow when the device 500 is implanted and / or when in the closed position.

[0160] In one exemplary embodiment, instead of a sealing engagement between the cap 514 and the insert 516B, the insert 516B can optionally include a seal such as the color seal 513 of the proximal collar, which forms a seal around the drive element or drive means 512 during implantation of the device 500 and closes tightly when the drive element 512 is removed. Such a seal can close or substantially close the distal end of the joining element 510 against the blood flow after implantation.

[0161] The joining element 510 and the paddles 520, 522 can be formed from a flexible material such as a metal fabric, a woven, knitted, or otherwise suitably formed mesh, or a flexible material such as a laser cut or otherwise cut flexible material. This material may also be a cloth, a shape memory alloy wire (such as nitinol) to obtain a shape setting function, or any other flexible material suitable for implantation in the human body. The paddle frame 524 applies an additional pinching force between the inner paddle 522 and the joining element 510 and helps to enclose the valve tip around the side of the joining element 510 for a more suitable seal between the joining element 510 and the valve tip. In some embodiments, the cover 540 shown in FIG. 30 extends around the paddle frame 524.

[0162] The fastener 530 includes a base, i.e., a fixed arm 532, a movable arm 534, a return 536, and a coupling portion 538. The fixed arm 532 is attached to the inner paddle 522, and the coupling portion 538 is disposed adjacent to the joining element 510. The return fastener has a flat surface and does not fit into the recess of the paddle. Rather, the closed end of the return fastener is placed against the surface of the paddle 522. For example, the fixed arm 532 is attached to the inner paddle 522 by a thread (not shown) through a hole, i.e., a slot 533. The fixed arm 532 can be attached to the inner paddle 522 or another part of the device by any suitable means, such as a screw or other fastener, a fixed sleeve, a mechanical latch or clip, welding, an adhesive, etc. The fixed arm 532 remains fixed or substantially fixed relative to the inner paddle 522 when the movable arm 534 is opened and the return fastener 530 is opened and the return 536 is exposed. The return fastener 530 is opened by applying tension to a drive line (not shown) attached to the hole 535 of the movable arm 534, whereby the movable arm 534 pivots or bends about the coupling portion 538 as a fulcrum.

[0163] During implantation, the anchor 508 is opened and closed so that the valve tip of the native valve is gripped between the paddles 520, 522 and the joining element 510. The return fastener 530 further secures the native valve tip by engaging the valve tip with the return 536 and by sandwiching the valve tip between the movable arm 534 and the fixed arm 532. The return 536 of the return fastener 530 can increase the friction with the valve tip or can partially or completely perforate the valve tip. The drive lines can be driven separately, whereby each return fastener 530 can be opened and closed separately. By operating separately, it becomes possible to grip the valve tips one by one at a time, or to reposition the return 530 of an insufficiently gripped valve tip without changing the successful gripping of the other valve tip. The return fastener 530 can be opened and closed when the inner paddle 522 is not closed, whereby the valve tip can be gripped in various states required in a particular situation.

[0164] Next, referring to FIG. 33, an exemplary return fastener 600 for use in an implantable prosthetic device such as the device described above is shown. However, a wide variety of different return fasteners can be used. Examples of return fasteners that can be used include, but are not limited to, any of the return fasteners disclosed in this application, and any application incorporated herein by reference, and / or any application for which this application claims priority. In the illustrated example, the return fastener 600 is formed from an upper layer 602 and a lower layer 604. The two-layer design of the fastener 600 allows for the use of a thin sheet of material, thereby improving the flexibility of the fastener 600 compared to a fastener formed from a single thick sheet while maintaining the strength of the fastener 600 necessary to successfully hold the natural valve tip.

[0165] The return fastener 600 includes a fixed arm 610, a coupling portion 620, and a movable arm 630 having a return portion 640. The upper layer 602 and the lower layer 604 have similar shapes and, in some embodiments, are attached to each other at the return portion 640. However, the upper layer 602 and the lower layer 604 can also be attached to each other at other locations or additional locations. A spring load is applied to the coupling portion 620 such that the fixed arm 610 and the movable arm 630 are biased towards each other when the return fastener 600 is in the closed state. When combined with an implantable prosthetic device, the fixed arm 610 is attached to a portion of the prosthetic device. The fastener 600 is opened by pulling on a drive line attached to the movable arm 630 until the spring force of the coupling portion 620 is overcome.

[0166] The fixed arm 610 is formed from a tongue 611 of material extending from a junction 620 between two side beams 631 of the movable arm 630. The tongue 611 is biased between the side beams 631 by the junction 620 such that a force must be applied to move the tongue 611 from a neutral position beyond the side beams 631 to a preloaded position parallel or substantially parallel to the side beams 631. The tongue 611 is held in the preloaded position by an optional T-shaped crossbar 614 that extends outwardly from the tongue 611 and engages the side beams 631. In one exemplary embodiment, the crossbar is omitted and the tongue 611 is attached to the inner paddle 522, which maintains the fastener in the preloaded position. In a two-layer fastener application, either the upper layer 602 and the lower layer 604, or just the upper layer, can be attached to the inner paddle. In some embodiments, the angle between the fixed arm 610 and the movable arm 630 when the tongue is in the neutral position is from about 30 degrees to about 100 degrees, from 30 degrees to about 90 degrees, or from about 30 degrees to about 60 degrees, or from about 40 degrees to about 50 degrees, or about 45 degrees.

[0167] The tongue 611 includes a hole 612 for receiving a thread (not shown) that attaches the fixed arm 610 to the implantable device. The fixed arm 610 can be attached to the implantable device using screws or other fasteners, a fixing sleeve, a mechanical latch or clip, welding, adhesives, etc. In some embodiments, the hole 612 is an elongated slot or an oval hole to accommodate sliding of the layers 602, 604 without damaging the thread that attaches the fastener 600 to the implantable device.

[0168] The joint portion 620 is formed by two beam loops 622 that extend from the tongue 611 of the fixed arm 610 to the side beam 631 of the movable arm 630. In some embodiments, the beam loops 622 are thinner than the tongue 611 and the side beam 631 to obtain additional flexibility. Each of the beam loops 622 includes a central portion 624 that extends from the tongue 611 and an outer portion 626 that extends to the side beam 631. The beam loops 622 are bent into somewhat of a spiral or helical shape by bending the central portion 624 and the outer portion 626, thereby forming an offset or step 628 between the tongue 611 and the side beam 631. The step 628 provides a space between the arms 610, 630 for accommodating the natural valve leaflet after it has been grasped. In some embodiments, the step 628 is from about 0.5 millimeter to about 1 millimeter, or about 0.75 millimeter.

[0169] When viewed in a top view, the beam loops have an "Ω-like" shape. This shape of the beam loops 622 allows the fixed arm 610 and the movable arm 630 to move relative to each other quite a bit without plastically deforming the fastener material. For example, in some embodiments, the tongue 611 can be bent or pivoted from a neutral position beyond about 45 degrees of the movable arm 630 to a fully open position reaching up to about 140 degrees, up to about 200 degrees, up to about 170 degrees, up to about 190 degrees, or up to about 180 degrees from the movable arm 630 without plastically deforming the fastener material. In some embodiments, the fastener material plastically deforms while open without reducing, or substantially reducing, the pinch force between the fixed and movable arms in the closed position.

[0170] Applying a preload to the tongue 611 enables the fastener 600 to maintain the pinch or clip force applied to the natural valve tip when closed. By applying a preload to the tongue 611, significant advantages are obtained compared to prior art clips where little or no pinch force is applied when closed. Additionally, closing the fastener 600 using spring force allows the fastener 600 to be repeatedly opened and closed for repositioning to the valve tip while still maintaining sufficient pinch force when closed, which is a significant improvement compared to clips using a one-time lock closure mechanism. Additionally, the spring-loaded fastener also enables easy removal of the device over a period of time compared to devices that lock in the closed position (after in-tissue growth). In one exemplary embodiment, both the fastener and the paddle are spring-biased towards their closed position (as opposed to being locked in the closed position), thereby enabling easy removal of the device after in-tissue growth.

[0171] The return portion 640 of the movable arm 630 includes a barb 642, a return 644, and a return support 646. Positioning the return portion of the fastener 600 towards the end of the movable arm 630 increases the space between the return 644 and the fixed arm 630 when the fastener 600 is opened, thereby improving the ability of the fastener 600 to successfully grip the valve tip during implantation. This spacing also allows the return 644 to more reliably disengage from the valve tip for repositioning. In some embodiments, the returns of the fastener can be staggered along the longitudinal axis to further disperse the pinch force and local valve tip stress.

[0172] The returns 644 are laterally spaced at the same distance from the coupling portion 620 to make the fastener more robust against valve tip gripping than returns arranged in a longitudinal row while still achieving better dispersion of the pinch force applied to the valve tip tissue. In some embodiments, the returns 644 can be staggered to further disperse the pinch force and local valve tip stress.

[0173] The barb 644 is formed from the lower layer 604, and the barb support 646 is formed from the upper layer. In some embodiments, the barb is formed from the upper layer 602 and the barb support is formed from the lower layer 604. Forming the barb 644 from only one of the two layers 602, 604 can thin the barb, and thus be practically sharper than a barb formed from the same material that is twice as thick. The barb support 646 extends along the lower part of the barb 644 to stiffen the barb 644, further improving the piercing and holding of the valve tip tissue. In some embodiments, the end of the barb 644 is further sharpened using any suitable means of sharpening.

[0174] The barb 644 is angled from the movable arm 630 so as to easily pierce the natural valve tip tissue with a minimum pinch or clip force. The barb 644 extends from the movable arm at an angle of from about 45 degrees to about 75 degrees, or from about 45 degrees to about 60 degrees, or from about 48 degrees to about 56 degrees, or about 52 degrees. The angle of the barb 644 provides an additional advantage in that the force to pull the implant away from the natural valve tip encourages the barb 644 to engage more with the tissue, thereby ensuring more proper retention. Holding the valve tip on the barb 600 can be further improved by the T-shaped crossbar being located near the barb 644 when the fastener 600 is closed. In this arrangement, the tissue pierced by the barb 644 is clamped between the movable arms 630 at the location of the crossbar 614, whereby the tissue is shaped into an S-shaped winding path as it passes over the barb 644. Thus, the force to pull the valve tip away from the fastener 600 will encourage the tissue to engage more with the barb 644 before the valve tip can escape. For example, the valve tip tension during diastole can encourage the barb to be pulled towards the end portion of the valve tip. The valve tip tension during diastole can be utilized in the S-shaped path to engage the valve tip more tightly with the barb.

[0175] Each layer 602, 604 of the fastener 600 is laser cut from a sheet of shape memory alloy such as Nitinol. The upper layer 602 is aligned and attached to the lower layer 604. In some embodiments, the layers 602, 604 are attached at the return portion 640 of the movable arm 630. For example, the layers 602, 604 can be attached only at the return portion 640 so that the remaining portions of the layers can slide relative to each other. Each portion of the combined layers 602, 604, such as the fixed arm 610, the return 644 and return support 646, and the beam loop 622, is bent into a desired state. The layers 602, 604 may be bent and shaped together or may be bent and shaped separately and then joined together. The fastener 600 is then subjected to a shaping process, whereby the internal forces of the material tend to return to the set shape after being deformed by an external force. After shaping, the tongue 611 moves to its preloaded position, whereby the crossbar 614 can be attached. In one exemplary embodiment, the fastener 600 can optionally be flattened completely for delivery by a delivery sheath and expanded after being deployed in the heart. The fastener 600 is opened and closed by applying and releasing tension to a drive line, thread, wire, rod, catheter, etc. (not shown) attached to the movable arm 630. In some embodiments, the drive line or suture is inserted through the grommet 642 near the return portion 640 of the movable arm 630 and wrapped around the movable arm 630 before returning to the delivery sheath. In some embodiments, an intermediate thread loop is created through the grommet and the thread is inserted into the intermediate loop. An alternative to the intermediate loop can be constructed from a fabric or another material attached to the movable arm instead of a thread loop.

[0176] The intermediate loop of the thread material reduces the friction experienced by the drive line / thread in correlation with the friction between the drive line / thread and the fastener material. As the thread loops through the grommet 642 or the intermediate loop, both ends of the drive line / thread return into the delivery sheath (e.g., FIG. 8). The thread can be removed by pulling one end of the thread proximally until the other end of the thread is pulled and returns into the delivery sheath through the grommet or intermediate loop.

[0177] Next, referring to FIG. 34, an enlarged view of one of the valve tips 20, 22 held by a snap-fastener such as fasteners 430, 530 is shown. The valve tips 20, 22 are held between the movable arms and the fixed arms 434, 534 of the fasteners 430, 530. As shown in FIG. 34, the tissue of the valve tips 20, 22 is not perforated by the returns 436, 536, but in some embodiments, the returns 436, 536 can perforate the valve tips 20, 22 either incompletely or completely. The angles and heights of the returns 436, 536 relative to the movable arms 434, 534 assist in fixing the valve tips 20, 22 within the fasteners 430, 530. In particular, the force to pull the implant away from the natural valve tip promotes further engagement of the returns 436, 536 with the tissue, thereby ensuring more appropriate retention. Holding the valve tips 20, 22 in the returns 430, 530 is further improved by the fact that when the fasteners 430, 530 are closed, the fixed arms 432, 532 are located near the returns 436, 536. In this arrangement, the tissue is formed into an S-shaped winding path by the fixed arms 432, 532, the movable arms 434, 534, and the returns 436, 536. Thus, the force to pull the valve tip away from the fasteners 430, 530 will promote further engagement of the tissue with the returns 436, 536 before the valve tip can escape. For example, as described above, the valve tip tension during diastole can promote pulling the return towards the end portion of the valve tip. The valve tip tension during diastole in the S-shaped path can be utilized to engage the valve tip more tightly with the return.

[0178] Next, referring to FIGS. 35 - 46, an implantable device 500 is shown that has been delivered and implanted into the native mitral valve MV of the heart H. The methods and steps shown and / or described can be performed in live animals, or in mock experiments such as on cadavers, cadaver hearts, mock experimental devices (e.g., where a part of the body, heart, tissue, etc. is simulated).

[0179] As described above, the device 500 has a cover 540 (see FIG. 30) covering the joining element 510, a fastener 530, an inner paddle 522 and / or an outer paddle 520. The device 500 is deployed from a delivery sheath 502 and includes a junction 504 and an anchor portion 506 including a plurality of anchors 508 (i.e., two in the illustrated embodiment). The junction 504 of the device includes a joining element 510 slidably attached to a driving element or driving means 512 for implantation between the valve tips 20, 22 of the native mitral valve MV. When the driving element or driving means 512 is driven, the anchors 508 of the device 500 open and close to grip the mitral valve tips 20, 22 during implantation.

[0180] The anchors 508 of the device 500 include an outer paddle 520 and an inner paddle 522 that are flexibly connected to a cap 514 and a joining element 510. The driving element 512 extends through a capture mechanism 503 (see FIG. 41), a delivery sheath 502, and a joining element 510 to a cap 514 connected to the anchor portion 506. When the driving element 512 is extended and retracted, the distance between the joining element 510 and the cap 514 increases and decreases. In the examples shown in FIGS. 35-46, the pair of inner paddle 522 and outer paddle 520 move in unison rather than separately by a single driving element 512. Also, the position of the fastener 530 depends on the position of the paddles 522, 520. For example, referring to FIG. 45, when the paddles 522, 520 are closed, the fastener also closes. In one exemplary embodiment, the device 500 can be fabricated such that the paddles 520, 522 can be independently controlled in the same manner as in the embodiment of FIG. 11A.

[0181] The fingers of the capture mechanism 503 removably attach a collar 511 to the delivery sheath 502. The collar 511 and the joining element 510 slide along the driving element 512 during driving to open and close the anchor 508 of the anchor portion 506. In some embodiments, the capture mechanism 503 is closed around the collar 511 by the driving element 512 such that when the driving element 512 is removed, the fingers of the capture mechanism 503 open to release the collar 511 and thus the joining element 510.

[0182] In some embodiments, the engagement element 510 and paddles 520, 522 can be formed from a flexible material such as a metal fabric, a woven, knitted, or otherwise suitably formed mesh, or a flexible material cut by laser cutting or other means. This flexible material can also be a cloth, a shape memory alloy wire (such as nitinol) for obtaining a shape setting function, or any other flexible material suitable for implantation in the human body. Other configurations are possible.

[0183] The return fastener 530 includes a base or fixed arm 532, a movable arm 534, a return 536 (see FIG. 41), and a joint 538. The fixed arm 532 is attached to the inner paddle 522, and the joint 538 is disposed adjacent to the engagement element 510. A thread (not shown) attaches the fixed arm 532 to the inner paddle 522. The fixed arm 532 can be attached to the inner paddle 522 and / or another part of the device by any suitable means such as screws or other fasteners, a fixing sleeve, a mechanical latch or clip, welding, an adhesive, etc. The fixed arm 532 remains fixed or substantially fixed when the movable arm 534 is opened and the return fastener 530 is opened and the return 536 is exposed. The return fastener 530 is opened by applying tension to a fastener control member or drive line 537 attached to the movable arm 534, thereby causing the movable arm 534 to pivot or bend about the joint 538.

[0184] During implantation, the anchor 508 is opened and the cusp of the native valve is gripped between the paddles 520, 522 and the engagement element 510. The outer paddle 520 has a wide, curved shape that conforms to the curved engagement element 510 to more securely grip the cusps 20, 22. The curved shape and rounded edges of the outer paddle 520 also prevent tearing of the cusp tissue. The return fastener 530 further secures the native cusp by engaging the cusp with the return 536 and by sandwiching the cusp between the movable arm 534 and the fixed arm 532. The return 536 of the return fastener 530 can increase friction with the cusp or can partially or fully penetrate the cusp. The drive lines can be driven separately, such that each return fastener 530 can be opened and closed separately. By operating separately, it becomes possible to grip the cusps one at a time, or to reposition a return 530 of an inadequately gripped cusp without altering the successful gripping of the other cusp. The return fastener 530 can be fully opened and closed when the inner paddle 522 is not closed, thereby enabling the cusp to be gripped in various states required in a particular situation.

[0185] Device 500 is loaded into the delivery sheath in a fully open or fully extended state. The reason is that in the fully open or fully extended state, the occupied space is minimized and the smallest catheter (or the largest device 500 for a given catheter size) can be used. Referring to FIG. 35 next, the delivery sheath is inserted through the septum into the left atrium LA, and device 500 is deployed from delivery sheath 502 in a fully open state. Next, drive element 512 is retracted, and device 500 moves to the fully closed state shown in FIGS. 36-37, and then, as shown in FIG. 38, is moved toward the mitral valve MV. Referring to FIG. 39 next, when device 500 is aligned with the mitral valve MV (or another native valve if implanted in another valve), drive element 512 is extended and paddles 520, 522 open to an incomplete open position, and the fastener control member or drive line 537 is retracted and the return fastener 530 opens to prepare for cusp grasping. Next, as shown in FIGS. 40-41, the incompletely open device 500 is inserted into the mitral valve MV until the valve cusps 20, 22 are properly positioned between the inner paddle 522 and the inside of the engagement element 510 and the open return fastener 530. FIG. 42 shows device 500 with both fasteners 530 closed, but the return 536 of one fastener 530 has slipped past one valve cusp 22. As can be seen in FIGS. 42-44, the mislocated fastener 530 is opened and closed again to properly grasp the escaped valve cusp 22. When both valve cusps 20, 22 are properly grasped, drive element 512 is retracted and device 500 moves to the fully closed position shown in FIG. 45. With device 500 fully implanted in the native mitral valve MV, drive element 512 is withdrawn and the capture mechanism 503 is released from the proximal collar 511. After deployment, device 500 can be maintained in the fully closed position using mechanical means such as latching, or can be biased to remain closed by using a spring material such as steel and / or a shape memory alloy such as nitinol.For example, paddles 520, 522 can be formed of steel or nitinol shape memory alloy (produced as wire, sheet, tube, or laser sintered powder), and the paddles are also biased to close the outer paddle 520 around the inner paddle 522 and joint element 510, and to clamp the return fastener 530 around the natural valve leaflets 20, 22.

[0186] Device 500 can have a wide variety of different shapes and sizes. Referring to FIGS. 6 and 6A-6E, in an exemplary embodiment, joint element 510 functions as a gap filler for a valve backflow opening, such as the natural valve gap 26 shown in FIG. 6. Referring to FIG. 6A, since joint element 510 is disposed between two opposing valve leaflets 20, 22, the valve leaflets do not join to each other within the region of joint element 510, but instead join to joint element 510. This joining reduces the distance that the valve leaflets 20, 22 need to approach each other. As a result of the reduced valve leaflet approach distance, several advantages can be provided. For example, the joint element and the resulting approach can facilitate the repair of severe mitral valve anatomical structures, such as large gaps in functional valve disease (see, e.g., FIG. 6). Since joint element 510 reduces the distance that the natural valve has to approach, the stress on the natural valve can be reduced or minimized. When the approach distance of valve leaflets 20, 22 is short, the force required to bring them closer can be reduced, and as a result, the tension of the valve leaflets can be reduced and the reduction in the diameter of the valve annulus can be less. With less reduction (or no reduction) in the valve annulus, the reduction in the valve opening area can be less compared to a device without a spacer. As a result, joint element 510 can reduce the gradient across the valve.

[0187] In one exemplary embodiment, the paddle frame 524 conforms to the shape of the engagement element 510. In one example, if the engagement element 510 is wider than the paddle frame 524, a space (gap) can be created by the device 500 between the opposing valve leaflets 20, 22. Referring to FIGS. 6A-6E, in one exemplary embodiment the paddle is configured to conform to the shape, i.e., the geometry, of the engagement element 510. As a result, the paddle can fit onto both the engagement element 510 and the native valve. Referring to FIGS. 6D and 6E, in one exemplary embodiment the paddle frame 524 surrounds the engagement element 510. Thus, when the valve leaflets 20, 22 are joined or pressed against the engagement element 510, the valve leaflets 20, 22 completely surround, i.e., "envelop," the engagement element 510 in its entirety, thereby preventing a small amount of leakage in the central and lateral planes of the engagement member 510. FIGS. 6B and 6C show the valve repair device 500 attached to the valve leaflets 20, 22 of the native valve from the ventricular side of the mitral valve. FIG. 6A shows the valve repair device 500 attached to the mitral valve leaflets 20, 22 from the atrial side of the mitral valve. Referring to FIGS. 6A and 6B, when the paddle has a geometry that conforms to the geometry of the engagement element 510, the valve leaflets 20, 22 can join around the engagement element and / or along the entire length of the spacer. Referring to FIG. 6E, a schematic atrial / surgical view shows a paddle frame (not actually visible from the true atrial view) that conforms to the spacer geometry. The opposing valve leaflets 20, 22 brought together by the paddle (the ends of which are also not actually visible in the true atrial view) surround, i.e., "envelop," the engagement element 510.

[0188] Referring to FIGS. 6B - 6E, since the paddle frame 524 conforms to the shape of the joining element 510, the valve tips 20, 22 can be fully joined by the paddle frame 524 around the joining element, including the lateral surface 601 and the central surface 603 of the joining element 510. Joining the valve tips 20, 22 to the lateral and central surfaces of the joining element 510 in this way may seem to conflict with what was stated above, namely that the distance the valve tips need to approach is minimized by the presence of the joining element 510. However, the distance the valve tips 20, 22 need to approach is still minimized when the joining element 510 is accurately positioned in the backflow gap and the backflow gap is smaller than the width (central - lateral) of the joining element 510.

[0189] Referring to FIGS. 6A and 6E, the joining element 510 can take a wide variety of different forms. In one exemplary embodiment, when viewed from above (and / or a cross - sectional view from above - see FIGS. 95 - 102), the joining element has an oval or elliptical shape. In an oval or elliptical shape, the paddle frame 524 can be made to conform to the shape of the joining element and / or lateral leakage can be reduced (see FIGS. 65 - 83).

[0190] As described above, the joining element 510 can reduce the tension of the opposing valve tips by reducing the distance the valve tips need to approach the joining element 510 at positions 601, 603. By reducing the valve tip approach distance at positions 601, 603, the stress and gradient of the valve tips can be reduced. Additionally, as also explained above, the valve tips 20, 22 of the native valve can surround, i.e., "embrace", the joining element to prevent lateral leakage. In one exemplary embodiment, the geometric characteristics of the joining element can be designed to preserve and increase these two characteristics of the device 500. Referring to FIG. 2A, as can be seen from the left ventricular outflow tract (LVOT) view, the anatomical structure of the valve tips 20, 22 is such that the inside of the valve tips joins at the free - end portion and the valve tips 20, 22 begin to recede or spread apart from each other. The valve tips 20, 22 spread in the atrial direction until each valve tip meets the mitral annulus.

[0191] In one exemplary embodiment, the valve repair device 500 and its engagement element 510 are designed to conform to the geometric anatomy of the valve leaflets 20, 22. To achieve valve sealing, the valve repair device 500 can be designed to completely surround the engagement element, including the central position 601 and the lateral position 603 of the engagement element 510, and join the natural valve leaflets to the engagement element. Additionally, by reducing the forces required to contact the valve leaflets with the engagement element 510 at positions 601, 603, the stress and gradient of the valve leaflets can be minimized. FIG. 2B shows how the tapered or triangular shape of the engagement element 510 naturally conforms to the geometry of the natural valve and the nature of its valve leaflets that expand (towards the valve annulus).

[0192] FIG. 6D shows the geometry of the engagement element 510 and the paddle frame 524 from the LVOT perspective. As can be seen in this figure, the engagement element 510 has a tapered shape where the dimensions are smaller in the region where the inner surfaces of the valve leaflets 20, 22 need to be joined and where the dimensions increase as the engagement element extends towards the atrium. The illustrated geometry of the natural valve is accommodated by the tapered engagement element geometry. Referring further to FIG. 6D, the tapered engagement element geometry, together with the shape of the paddle frame 524 that expands (towards the valve annulus) as illustrated, can help achieve the joining of the valve leaflets to the lower ends, reduce stress, and minimize the gradient across the valve.

[0193] Referring to FIG. 6C, in one exemplary embodiment, the shapes of the joining element 510 and the remainder of the paddle frame 524 can be defined based on the natural valve and the cross-linked internal view of the device 500. The two elements of these shapes are the cusp joint with the joining element 510 and the reduction of the stress applied to the cusp by the joint. Referring to FIGS. 6C and 67, in order to join both of the cusps 20, 22 to the joining element 510 and also to reduce the stress applied to the cusps 20, 22 by the joining element 510 and / or the paddle frame 524, the joining element 510 can have a round or rounded shape, and the paddle frame 524 can have an overall radius range extending from one leg of the paddle to the other leg of the paddle. The round shape of the joining element and / or the overall rounded shape of the illustrated paddle frame disperse the stress applied to the cusps 20, 22 over the entire wide curved engagement region 607. For example, in FIG. 6C, when the cusp 20 attempts to open during the expansion period, the force applied to the cusps 20, 22 by the paddle frame is distributed along the rounded overall length of the paddle frame 524.

[0194] Referring to FIG. 67, in one exemplary embodiment, in order to cooperate with the overall rounded shape of the paddle frame 524 and / or to maximize the cusp joint with the joining element 510 and the cusp-to-cusp joint at the intermediate portion or sides 601, 603 of the joining element 510, the shape of the joining element in the cross-linked internal view follows a round shape. Referring to FIG. 67, the round shape of the joining element in this figure substantially follows or is close to the shape of the paddle frame 524.

[0195] In one exemplary embodiment, the overall shape of the joining element 510 has an oval or elliptical cross-section when viewed from the surgical view (top view - see FIG. 70), a tapered shape or cross-section when viewed from the LVOT view (side view - see FIG. 69), and a substantially round or rounded shape when viewed from the cross-linked internal view (see FIG. 68). In one exemplary embodiment, the combination of these three geometries results in the three-dimensional shape of the illustrated joining element 510 that achieves the above-described benefits.

[0196] In one exemplary embodiment, the dimensions of the engagement element are selected to minimize the number of implants (preferably one) required by a patient while simultaneously maintaining a low valve inside-outside gradient. In one exemplary embodiment, the anterior-posterior distance X at the top of the spacer 47B is about 5 mm, and the central lateral distance X of the spacer 67D is about 10 mm at its widest point. In one exemplary embodiment, the overall geometry of the device 500 can be based on these two dimensions and the overall shape strategy described above. As a starting point for the device, another anterior-posterior distance X 47B and central lateral distance X 67D It should soon become apparent that different-sized devices can be obtained by using. Additionally, different-sized devices can also be obtained by using other dimensions and the shape strategy described above.

[0197] Table A (Table 1), Table B (Table 2), and Table C (Table 3) present examples of the dimensions and ranges of values of the devices and components of the devices for several exemplary embodiments. However, the devices can have a wide variety of different shapes and sizes and do not need to have all or any of the dimensional values or ranges of dimensions presented in Table A (Table 1), Table B (Table 2), and Table C (Table 3). Table A (Table 1) presents each example of the length dimension X in millimeters and the range of length dimensions in millimeters of the device and the components of the device. Table B (Table 2) presents each example of the radius dimension R in millimeters and the range of radius dimensions in millimeters of the device and the components of the device. Table C (Table 3) presents each example of the angular dimension α in degrees and the range of angular dimensions in degrees of the device and the components of the device. Each subscript of the dimension indicates the drawing in which that dimension first appears.

[0198] [Table 1]

[0199]

Table 2

[0200]

Table 3

[0201] Next, referring to FIGS. 47 - 61, implantable device 500 is shown in various states and configurations. Implantable device 500 can include any other features of the implantable prosthetic devices discussed in this application, and device 500 can be arranged to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0202] The implantable device 500 has a proximal or attachment portion 505, a joining element 510 (e.g., a spacer, etc.), an inner anchor portion or inner paddle 522, an outer anchor portion or outer paddle 520, an anchor extension member or paddle frame 524, and a distal portion 507. The inner paddle 522 is attached (e.g., attachable in a butt-joint manner, etc.) between the joining element 510 and the outer paddle 520. The outer paddle 520 is attached (e.g., attachable in a butt-joint manner, etc.) between the inner paddle 522 and the distal portion 507. The paddle frame 524 is attached to the cap 514 at the distal portion 507 and extends to the junction 523 between the inner paddle 522 and the outer paddle 520. In some embodiments, the paddle frame 524 is formed of a material that is more rigid and stiffer than the material forming the paddles 522, 520, whereby the paddle frame 524 serves as a support for the paddles 522, 520. In one exemplary embodiment, the inner paddle 522 is firm, relatively firm, rigid, has a rigid portion, and / or is stiffened by a fixing portion of a stiffening member or fastener 530. By stiffening the inner paddle, the device is enabled to move to various different positions illustrated and described herein. The inner paddle 522, the outer paddle 520, and the junctions can all be interconnected as described herein so that the device 500 is constrained to the movements and positions illustrated and described herein.

[0203] Referring now to FIGS. 47-48, the device 500 is shown in a closed configuration. When closed, the inner paddle 522 is disposed between the outer paddle 520 and the joining element 510. In some embodiments, the device 500 includes a fastener or gripping member 530 (FIG. 48) that can be opened and closed to grip the natural valve leaflets 20, 22 of the mitral valve MV. The fastener 530 is attached to the inner paddle 522, moves with the inner paddle, and is disposed between the inner paddle 522 and the joining element 510.

[0204] Next, referring to FIGS. 49 - 51, device 500 is shown in an incompletely open state. Device 500 is moved to an incompletely open position by drive element or drive means 512, which can removably engage the distal portion 507 through attachment portion 505 and engagement element 510. Drive element 512 extends through attachment portion 505 such that the distance D between attachment portion 505 and distal portion 507 increases as drive element 512 extends. In the example shown in FIGS. 49 - 51, the pair of inner paddle 522 and outer paddle 520 move in unison rather than separately by a single drive element 512. Also, the position of fastener 530 depends on the position of paddles 522, 520. For example, referring to FIG. 48, when paddles 522, 520 are closed, the fastener also closes. In one exemplary embodiment, device 500 can be fabricated such that paddles 520, 522 can be independently controlled in the same manner as in FIG. 11A.

[0205] By extending drive element 512, the lower portions of outer paddle 520 and paddle frame 524 are pulled down. Outer paddle 520 and paddle frame 524 pull down inner paddle 522. However, inner paddle 522 is connected to outer paddle 520 and paddle frame 524. Since attachment portion 505 and engagement element 510 are held in place, inner paddle 522 will bend or pivot in the opening direction. Inner paddle 522, outer paddle 520, and paddle frame all bend to the state shown in FIG. 49. When paddles 522, 520 and frame 524 are opened, a gap 520D is formed between engagement element 510 and inner paddle 522 to receive and grip natural valve tip 20.

[0206] As described above, some embodiments of the device 500 include a fastener or gripping member 530. When the device 500 is slightly opened, the fastener 530 is exposed. In some embodiments, the closed fastener 530 (FIG. 50) can be opened (FIG. 51), thereby creating a second opening or gap 530A for receiving and capturing the natural valve tips 20, 22. The spread of the gap 530A of the fastener 530 is limited to the extent that the inner paddle 522 is open from the joining element 510.

[0207] Referring now to FIGS. 52 - 54, the device 500 is shown in a laterally extended or open state. The device 500 is laterally extended or moved to an open state by continuing to extend the drive element 512 described above, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. By continuing to extend the drive element 512, the outer paddle 520 and the paddle frame 524 are pulled down, thereby causing the inner paddle 522 to move away from the joining element 510 and open further. In the laterally extended or open state, the inner paddle 522 extends more horizontally and at a greater extent than in other states of the device 500, forming an angle of approximately 90 degrees with respect to the joining element 510. Similarly, the paddle frame 524 is in its maximally extended state when the device 500 is in the laterally extended or open state. The enlarged gap 520D formed in the laterally extended or open state allows the fastener 530 to open further (FIG. 54) before engaging the joining element 510, thereby increasing the size of the gap 530A.

[0208] Next, referring to FIGS. 55 - 57, the device 500 is shown in a three - quarters extended state. The device 500 moves to the three - quarters extended state by continuously extending the drive element 512 described above, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. By continuously extending the drive element 512, the outer paddle 520 and the paddle frame 524 are pulled down, whereby the inner paddle 522 moves away from the engagement element 510 and further opens. In the three - quarters extended state, the inner paddle 522 is open to about 135 degrees beyond 90 degrees with respect to the engagement element 510. The paddle frame 524 is laterally extended, that is, less spread than in the open state, and begins to move inwardly toward the drive element 512 as the drive element 512 is further extended. The outer paddle 520 also bends oppositely toward the drive element 512. Due to the laterally extended, that is, an enlarged gap 520D formed in the same lateral - extension as in the open state, the fastener 530 can open further (FIG. 57), thereby increasing the size of the gap 530A.

[0209] Next, referring to FIG. 58, the device 500 is shown in an almost fully extended state. The device 500 moves to the almost fully extended state by continuously extending the drive element 512 described above, thereby increasing the distance D between the attachment portion 505 and the distal portion 507. By continuously extending the drive element 512, the outer paddle 520 and the paddle frame 524 are pulled down, whereby the inner paddle 522 moves away from the engagement element 510 and further opens. In the almost fully extended state, the inner paddle 522 begins to approach approximately 180 degrees with respect to the engagement element 510. The inner paddle moves to this state, but the outer paddle 520 and the paddle frame 524 never move or bend more than 90 degrees with respect to the engagement element 510. In the almost fully extended state, the inner paddle 522 and the outer paddle 520 may have a somewhat curved shape.

[0210] Next, referring to FIGS. 59 - 61, the device 500 is shown in a fully extended state. The device 500 moves to a nearly fully extended state by continuously extending the drive element 512 described above, whereby the distance D between the attachment portion 505 and the distal portion 507 increases to an acceptable distance for the device 500. By continuously extending the drive element 512, the outer paddle 520 and the paddle frame 524 are pulled down, whereby the inner paddle 522 moves away from the engagement element 510 and further opens. The outer paddle 520 and the paddle frame 524 move to a position close to the drive element. In the fully extended state, the inner paddle 522 is open approximately 180 degrees relative to the engagement element 510. The inner paddle 522 and the outer paddle 520 are straightly stretched to the fully extended state, forming an angle of approximately 180 degrees between the paddles 522, 520. In the fully extended state of the device 500, the size of the gap 520D between the paddles is maximized, and in some embodiments, the fastener 530 can also be fully opened up to approximately 180 degrees (FIG. 61) between the portions of the fastener 530. The state of the device 500 is in its thinnest form. That is, the fully extended state of the device 500 can be a desirable state for removing the device 500 from a failed implantation or for inserting the device into a delivery catheter.

[0211] Next, referring to FIGS. 47A, 48A - 48H, 53A - 53C, 54A - 54D, 60A - 60D, and 61A - 61D, the implantable device 500A is shown in various states and configurations. The implantable device 500A can include any other features of the implantable prosthetic devices discussed in this application, and the device 500A can be arranged to engage the valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0212] The implantable device 500A has a proximal or attachment portion 505A, a joining element 510A, an inner anchor portion or inner paddle 522A, an outer anchor portion or outer paddle 520A, an anchor extension member or paddle frame 524A, and a distal portion 507A. The inner paddle 522A is attached (e.g., removably attached) between the joining element 510A, for example by a coupling portion 525A, and the outer paddle 520A, for example by a coupling portion 523A. The outer paddle 520A is attached (e.g., removably attached) between the inner paddle 522A, for example by a coupling portion 523A, and the distal portion 507A, for example by a coupling portion 521A. The paddle frame 524A is attached at the distal portion 507A to a cap 514A (FIG. 48A) and extends to a coupling portion 523A between the inner paddle 522A and the outer paddle 520A. In some embodiments, the paddle frame 524A is formed from a material that is more rigid and stiffer than the material forming the paddles 522A, 520A, such that the paddle frame 524A serves as a support for the paddles 522A, 520A. The paddle frame 524A includes a connection portion such as an opening or slot 524B (FIG. 70A) for receiving the coupling portion 523A (FIG. 65A). In some embodiments, the inner paddle 522A is firm, relatively firm, rigid, has rigid portions, and / or is stiffened by a securing portion of a member or fastener 530C that stiffens it. By stiffening the inner paddle, the device is enabled to move to various different positions illustrated and described herein. The inner paddle 522A, the outer paddle 520A, and the joining element can all be interconnected as described herein such that the device 500A is constrained to the movements and positions illustrated and described herein.

[0213] The engaging element 510A, the inner paddle 522A, and the outer paddle 520A can be attached by forming the engaging element 510A and the paddles 520A, 522A as a single integral component. This can be accomplished, for example, by forming the joining member 510A and the paddles 520A, 522A from a continuous strip 501A of a braided or woven material, such as a braided or woven Nitinol wire.

[0214] The continuous strip 501A is attached to the collar 511D, the cap 514A, the paddle frame 524A, and the fastener 530C. In the illustrated embodiment, the engaging element 510A, the hinge portions 521A, 523A, 525A, the outer paddle 520A, and the inner paddle 522A are formed from the continuous strip 501A. The continuous strip 501A can be a single layer of material or can include two or more layers. In some embodiments, a portion of the device 500A has a single layer of the strip 501A of material and another portion is formed from multiple overlapping or overlying layers of the strip 501A of material. For example, FIG. 47A shows the engaging element 510A and the inner paddle 522A formed from multiple overlapping or overlying layers of the strip 501A of material. As a result, the engaging element 510A and the inner paddle 522A are more rigid than the outer paddle 520A formed from a single layer of the material 501A. The single continuous strip 501A of material may begin and end in various arrangements of the device 500A. The ends of the strip 501A of material may be in the same or different arrangements of the device 500A. For example, in the illustrated embodiment of FIG. 47A, the strip of material begins and ends in the arrangement of the inner paddle 522.

[0215] The fastener 530C can include an attachment or fixed portion 532C, an arm or movable portion 534C, a return 536C, and a coupling portion 538C. The attachment or fixed portion 532C can be coupled to the inner paddle 522A in a variety of ways such as by stitching, adhesive, fasteners, welding, suturing, crimping, friction fitting, and / or other means for coupling to a coupling portion 538C disposed near the joining element 510A. The fastener 530C may be similar to the fastener 430.

[0216] The movable portion 534C can pivot or bend relative to the fixed portion 532C between an open configuration (e.g., FIG. 54A) and a closed configuration (FIG. 48A). In some embodiments, the fastener 530C can be biased to the closed configuration. In the open configuration, the fixed portion 532C and the movable portion 534C pivot or bend away from each other such that a natural valve tip can be disposed between the fixed portion 532C and the movable portion 534C. In the closed configuration, the fixed portion 532C and the movable portion 534C pivot or bend towards each other, thereby clamping the natural valve tip between the fixed portion 532C and the movable portion 534C. The fixed arm 532C remains fixed or substantially fixed when the movable arm 534C is opened and the return fastener 530C is opened and the return 536C is exposed. The return fastener 530C is opened by applying tension to a drive line 516A attached to the movable arm 534C, thereby causing the movable arm 534C to pivot or bend about the coupling portion 538C as a fulcrum.

[0217] Next, referring to FIGS. 47A and 48A - 48H, device 500A is shown in a closed configuration. Side views of device 500A are shown in FIGS. 48B, 48C, and 48F, front views in FIGS. 48D, 48E, and 48G, and a bottom view in FIG. 48H. Device 500A is narrower when viewed from the front than from the side. When viewed from the side, device 500A has a generally upside - down trapezoidal shape that tapers towards the distal portion 507A of device 500A and is rounded. When viewed from the front, device 500A has a generally rounded and somewhat tapered rectangular shape that tapers towards the distal portion 507A. As can be seen in the bottom view of device 500A shown in FIG. 48H, device 500A has a generally rounded rectangular shape when viewed from below (and also, for example, when viewed from above as can be seen in FIG. 70A).

[0218] In the closed configuration of device 500A, the inner paddle 522A is disposed between the outer paddle 520A and the joining element 510A. In some embodiments, device 500A includes a fastener or gripping member 530C (FIG. 48) that can be opened and closed to grip the natural valve leaflets 20, 22 of the mitral valve MV. The fastener 530C is attached to the inner paddle 522A, moves with the inner paddle 522A, and is disposed between the inner paddle 522A and the joining element 510A.

[0219] Next, referring to FIGS. 48B - 48D, device 500A is shown in a state attached to delivery device 502A. Delivery device 502A has a drivable member or finger 503A that releasably engages attachment portion 505A. Drive element 512A extends from delivery device 502A through attachment portion 505A and joining element 510A of patch device 500A to cap 514A. When drive element 512A is extended and retracted, device 500A opens and closes as described below. Drive line / suture 516A extends from delivery device 502A and attaches to fastener 530C. Tension can be applied to suture 516A to open fastener 530C and the fastener 530C can be released to close. Device 500A is shown separated from delivery device 502A in the deployed state in FIGS. 48F - 48G.

[0220] Next, referring to FIGS. 48C and 48E, device 500A is shown with cover 540A. Cover 540A can be formed from a single piece of material or from multiple segments that abut or are joined to each other. In the illustrated embodiment, cover 540A has outer or lower cover 541A and inner or upper cover 543A. Outer cover 541A covers cap 514A, outer paddle 520A, inner paddle 522A, and fastener 530C. Inner cover 543A covers joining element 510A and the proximal ends of inner paddle 522A and fastener 530C, and joining element 510A contacts inner paddle 522A and fastener 530C. Cover 540A can be a cloth material such as a fine mesh polyethylene cloth. The cloth cover can seal blood on the surface of the spacer and / or promote rapid in - tissue growth.

[0221] Next, referring to FIGS. 53A-53D and FIGS. 54A-54D, device 500A is shown in a laterally extended, i.e., open state. Device 500A moves to an open position by a drive element or means 512A for driving that can removably engage the distal portion 507A through the attachment portion 505A and the joining element 510A. The drive element 512A extends through the attachment portion 505A such that the distance D2 between the attachment portion 505A and the distal portion 507A increases as the drive element 512A extends. In the example shown in FIGS. 53A-53D and FIGS. 54A-54D, the pair of the inner paddle 520A and the outer paddle 522A move in unison rather than separately by a single drive element 512A. Also, the position of the fastener 530C depends on the positions of the paddles 520A, 522A. For example, referring to FIG. 48A, when the paddles 520A, 522A are closed, the fastener 530C also closes. In one exemplary embodiment, device 500A can be fabricated such that the paddles 520A, 522A can be independently controlled in the same manner as in the embodiment of FIG. 11A.

[0222] By extending the drive element 512, the bottom of the outer paddle 520A and the paddle frame 524A are pulled down, and device 500A moves from a closed position to a partially open position. The outer paddle 520A and the paddle frame 524A pull down the inner paddle 522A. However, the inner paddle 522A is connected to the outer paddle 520A and the paddle frame 524A. Since the attachment portion 505A and the joining element 510A are held in place, the inner paddle 522A will pivot or bend in the opening direction. The inner paddle 522A, the outer paddle 520A, and the paddle frame all bend to the state shown in FIG. 53A. When the paddles 522A, 520A and the frame 524 are opened, a gap 520D is formed between the joining element 510A and the inner paddle 522A that can receive and grip the natural valve tip 20.

[0223] By continuing to extend the drive element 512A, the outer paddle 520A and the paddle frame 524A are pulled down, thereby causing the inner paddle 522A to move away from the engagement element 510A and further open. When extended laterally, i.e., in the open state, the inner paddle 522A extends more horizontally and at an angle of approximately 90 degrees with respect to the engagement element 510A than in other states of the device 500A. Similarly, the paddle frame 524A is in its most expanded state when the device 500A is extended laterally, i.e., in the open state. The enlarged gap 520D formed when extended laterally, i.e., in the open state, allows the fastener 530C to open further before engaging the engagement element 510A (FIG. 54A), thereby increasing the size of the gap 530D compared to the incompletely open state.

[0224] As described above, some embodiments of the device 500A include a fastener or gripping member 530C. When the device 500A is opened, the fastener 530C is exposed. In some embodiments, the closed fastener 530C (FIGS. 53A - 53D) can be opened (FIGS. 54A - 54D), thereby creating a second opening or gap 530D for receiving and capturing the natural valve tips 20, 22. The spread of the gap 530D of the fastener 530C is limited to the extent that the inner paddle 522A has opened away from the engagement element 510A.

[0225] Next, referring to FIGS. 60A-60D and FIGS. 61A-61D, device 500A is shown in a fully extended state. Device 500A moves to a fully extended state by continuing to extend drive element 512A described above, whereby the distance D2 between attachment portion 505A and distal portion 507A increases to an acceptable distance for device 500A. By continuing to extend drive element 512A, outer paddle 520A and paddle frame 524A are pulled down, whereby inner paddle 522A extends further away from engagement element 510A. Outer paddle 520A and paddle frame 524A move to a position close to the drive element. In the fully extended state, inner paddle 522A is open approximately 180 degrees relative to engagement element 510A. Inner paddle 522A and outer paddle 520A are pulled straight or substantially straight to a fully extended state to form an angle of approximately 180 degrees between paddles 522A, 520A. In the fully extended state of device 500A, the size of gap 520D between the paddles is maximized, and in some embodiments, fastener 530C can also fully open to approximately 180 degrees (FIG. 61A) between portions of fastener 530C. The state of device 500A is in its thinnest form. Thus, the fully extended state of device 500A may be a desirable state for removing device 500A from a failed implantation or for inserting the device into a delivery catheter.

[0226] Next, referring to FIGS. 197 - 198, an enlarged view of a portion of FIG. 60C is shown. Referring to FIG. 197 next, it can be seen that the inner cover 543A covers the joining element 510A from the proximal portion 519B to the distal portion 517A. In some embodiments, the inner cover 543A is formed from a flat sheet of a fabric material such as a fine mesh polyethylene fabric (see FIG. 201), folded around the joining element 510A, and held in place by stitches 545A. Referring to FIG. 198 next, it can be seen that the outer cover 541A covers the fastener 530C and the inner paddle 522A. The collar portion 548A of the inner cover 543A covers a portion of the fastener 530C and the inner paddle 522A that is closest to the joining element 510A. The transition portion 547A of the inner cover 543A extends from the joining element 510A to the collar portion 548A, providing a smooth transition between the joining element 510A and the fastener 530C and the inner paddle 522A, such that natural tissue is not trapped on the device 500A during implantation.

[0227] Next, referring to FIG. 199, an exploded view of the device 500A is shown. The joining element 510A, the outer paddle 520A, and the inner paddle 522A are formed from a strip 501A of a single material as described above. The collar 511D, the cap 514A, the paddle frame 524A, and the fastener 530C are assembled to the strip 501A of material to form the device 500A. The cap 514A includes a retaining body portion 560A with a locking aperture 561A for receiving a retaining nut 562A having a threaded bore 564A that engages the threaded portion 568A of the retaining bolt 566A. The threaded portion 568A of the retaining bolt 566A is inserted into the aperture 527B to engage the retaining body portion 560A and the nut 562A and attach the cap 514A to the strip 501A of material.

[0228] In some embodiments, the stiffening member 539C is attached to the inner paddle 522A to stiffen the inner paddle 522A and maintain the inner paddle in a straight or substantially straight configuration as the inner paddle moves between various positions. The notch 539D in the stiffening member 539C has a shape that receives the fixed arm 532C of the fastener 530C so that the stiffening member 539C can fit around the fixed arm 532C when both the stiffening member 539C and the fastener 530C are attached to the inner paddle 522A. Similar to the fixed arm 532C, the stiffening member 539C can be coupled to the inner paddle 522A in a variety of ways, such as using sutures, adhesives, fasteners, welding, stitching, crimping, friction fitting, and / or other means of attachment.

[0229] Next, referring to FIG. 200, an enlarged view of the collar 511A attached to the proximal portion 519B of the joining element 510A is shown. The collar 511A includes a protrusion 511E for releasably engaging the finger 503A of the delivery device 502A. The aperture 515A in the collar 511A receives the drive element 512A. The proximal portion 519B of the joining element 510A flares outwardly and forms two loops 519D that are inserted into an arcuate opening 513A of the collar 511D for attaching the collar 511D to the proximal portion 519B of the joining element 510A. The loops 519D are formed by folding a strip 501A of material, thereby forming a first layer 581A and a second layer 582A. In some embodiments, the arcuate opening 513A includes an opening (not shown) that is similar to __.

[0230] Next, referring to FIGS. 201 - 202, an enlarged view and an exploded assembly view of the cap 514A are shown respectively. FIG. 201 shows an enlarged view of the cap 514A attached to the distal portion 527A of the strip 501A of material. The retaining body portion 560A, the retaining nut 562A, and the retaining bolt 566A cooperate to attach the paddle frame 524A to the distal portion 527A of the strip 501A of material. In particular, the retaining bolt 566A is inserted into the aperture 527B of the distal portion 527A (FIG. 202) to prevent the cap 514A from moving along the strip 501A of material. The channel 560B of the retaining body portion 560A and the flange 567A of the bolt 566A form a passage 514B through the cap 514A for the distal portion 527A.

[0231] Next, referring to FIG. 202, the components of the cap 514A are shown in an exploded assembly view so that the features of the components of the cap 514A and the paddle frame 524A are clear and to show how those features interact during the assembly of the cap 514A to the distal portion 527A. By forming the cap 514A from a plurality of components that can be assembled around the strip 501A of material, the strip 501A of material can be folded and joined to form the joining element 510A and the paddles 520A, 522A, and the cap 514A can be attached after being woven through the collar 511D and the paddle frame 524A.

[0232] The retaining body portion 560A includes a lock aperture 561A for receiving the retaining nut 562A. The lock aperture 561A generally has a rectangular shape and includes two opposing lock channels 561B for receiving the attachment portion 524C of the paddle frame 524A. The lateral lock channel 561C formed at the bottom of the retaining body portion 560A has the same width as the lock channels 561B. The paddle frame 524A includes a cut 524D within the attachment portion 524C that forms a hook portion 524E that engages the lateral lock channel 561A to fix the paddle frame 524A to the cap 514A.

[0233] The retaining nut 562A includes a rectangular lock body portion 563A that extends distally from the flange 563B. The lock body portion 563A is configured to slidably engage with the lock aperture 561A of the retaining body portion 560A while leaving the lock channel 561B unobstructed. Thus, the lock body portion 563A can be inserted into the lock aperture 561A to lock the attachment portion 524C of the paddle frame 524A within the lock channel 561B. The notch 563C within the flange 563B accommodates the attachment portion 524C of the paddle frame 524A. The threaded bore 564A is formed through the retaining nut 562A to receive the retaining bolt 566A.

[0234] The retaining bolt 566A includes a threaded portion 568A that extends from the flange 567A. The threaded portion 568A is inserted into the aperture 527B of the distal portion 527A and threaded into the threaded bore 564A of the retaining nut 562A. The flange 567A has a rounded shape that provides a rounded end to the distal portion 507A of the device 500A. The flange 567A includes an opening 567B for receiving a tool (not shown) that engages the bolt 566A so that the bolt 566A can be turned during assembly to join the components of the cap 514A together.

[0235] To assemble the paddle frame 524A and the cap 514A to the distal portion 527A, the paddle frame 524A is strongly tightened to narrow the width of the attachment portion 524C so that the attachment portion 524C can be inserted into the locking channel 561B of the lock aperture 561A. When the paddle frame 524A is allowed to expand, the attachment portion 524C expands outwardly, the notch 524D engages with the holding body portion 560A, and the hook portion 524E engages with the lateral locking channel 561C. Then, the retaining nut 562A is inserted into the lock aperture 561A with the locking portion 563A disposed between the two attachment portions 524C of each paddle frame 524A, thereby engaging and locking the paddle frame 524A with the holding body portion 560A. The assembled paddle frame 524A, the holding body portion 560A, and the retaining nut 562A are disposed on the distal portion 527A such that the threaded bore 564A is aligned with the aperture 527B, and the threaded portion 568A of the bolt 566A is inserted into the aperture 527B and threaded into the threaded bore 564A. The bolt 566A is then tightened until the flange 567A engages the holder 560A, and the cap 514A is firmly assembled to the distal portion 527A.

[0236] Referring now to FIGS. 203 and 204, a portion of the cover 540A is shown cut away from a sheet of flat material. The cover 540A includes an outer cover 541A and an inner cover 543A. Each of the covers 541A, 543A includes segments or portions of different shapes for attachment to different parts of the device 500A. In particular, the covers 541A, 543A are formed to smooth the transition between parts of the device 500A, reduce catch points, and provide a smooth appearance to the device 500.

[0237] The various segments of covers 541A and 543A extend from an intermediate portion shaped to be attached to the ends of device 500A. In some embodiments, the portions of covers 541A and 543A that attach to the ends of device 500A can be located at the ends of covers 541A and 543A, or at any location between the intermediate and end portions of covers 541A and 543A. The various portions of covers 541A and 543A can be shaped to enclose those portions of device 500A. Cover 540A can be made from any suitable material such as a fine mesh polyethylene fabric. In some embodiments, the cover is formed from a single piece of material. In some embodiments, the cover can be formed from any number of pieces of material that are attached to and / or joined together to the device by any suitable means such as sewing, adhesives, welding, or similar means.

[0238] Referring to FIGS. 60C and 204, outer cover 541A extends outwardly from intermediate portion 580 to end portion 588. Intermediate portion 580 is shaped to be attached to cap 514A of device 500A. Outer paddle portion 582 extends from intermediate portion 580 to inner paddle and inner fastener portion 584. Inner paddle and inner fastener portion 584 extends from outer paddle portion 582 to outer movable fastener portion 586. Outer movable fastener portion 586 extends from fastener and / or inner paddle portion 584 to end portion 588.

[0239] The outer paddle portion 582 includes a wing portion 583 that extends laterally by an amount wider than other portions of the outer cover 541A so that the outer paddle portion 582 can be attached to the outer paddle 520A and the paddle frame 524A of the device 500A. The fastener and / or the inner paddle portion 584 is attached to the inner surfaces (the side with the return) of the inner paddle 522A, the fixed arm 532C, and the movable arm 534C. The outer fastener portion 586 is attached to the outer surface (the side without the return) of the movable arm 534C of the fastener 530C. The end 588 of the outer cover 541A terminates near the coupling portion 538C of the fastener 530C that is on the outside of the fastener 530C. The inner paddle and the inner fastener portion 584 include an opening 585 that allows the return 536C of the fastener 530C to protrude through the outer cover 541A and engage with the tissue of the natural heart valve.

[0240] Referring to FIGS. 60C and 203, the inner cover 543A extends outwardly from an intermediate portion 590 to an end 598. The intermediate portion 590 is configured to be attached to the collar 511D of the device 500A. The opening 591 within the intermediate portion 590 exposes the protrusion 511E from the collar 511D such that the protrusion 511E can be engaged by the delivery device 502A when the intermediate portion 590 is attached to the collar 511D. The junction portion 592 extends from the intermediate portion 590 to the flexible hinge portion 594. The holes 593 along the edge of the junction portion 592 allow each of the junction portions 592 to be joined together after being folded around the joining element 510A, for example, by stitches 545A or the like. The flexible hinge portion 594 extends from the junction portion 592 to the transition portion 596. The transition portion 596 extends from the flexible hinge portion 594 to the end 598. The holes 597 along the edge of the transition portion 596 allow each of the transition portions 596 to be wrapped around the ends of the inner paddle 522A and the fastener 530C and secured to itself by stitches or other suitable securing means. The flexible hinge portion 594 bridges the gap between the joining element 510A and the fastener 530C when the device 500A is opened as can be seen in FIG. 198.

[0241] Next, referring to FIGS. 62A - 64C, an implantable device 700 is shown. The implantable device 700 has paddles 702 that open and close to engage and hold the valve leaflets 20, 22 against a clip or gripping device 704. The paddles 702 move to create an opening 706 between the paddles 702 and the gripping device 704 that can hold the valve leaflets 20, 22. The device 700 can be configured to close the large gaps 26 (FIG. 6) of the native heart valves MV, TV. Additionally, the implantable device 700 can include any other features of the devices discussed in this application, and the device 700 can be arranged to engage the valve leaflets 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application). The device 700 can include any other features of the implantable prosthetic devices discussed in this application, and the device 700 can be arranged to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0242] Referring to FIG. 62A, the paddles 702 of the device 700 move, rotate, or pivot in an outward direction X to create an opening 706 of width W between the paddles 702 and the gripping member 704. The width W can be, for example, between about 5 mm and about 15 mm, such as about 10 mm, such as between about 7.5 mm and about 12.5 mm. In alternative embodiments, the width W can be less than 5 mm or greater than 15 mm.

[0243] Referring to FIG. 62B, the paddle 702 of device 700 moves in the outward direction Z such that the width of the opening 706 is H. The width H can be, for example, between about 10 mm and about 20 mm, between about 12.5 mm and about 17.5 mm, about 15 mm, between about 10 mm and about 25 mm. In some embodiments, the width H can be less than 10 mm or greater than 25 mm. In some embodiments, the ratio of the width H to the width W can be, for example, about 4 to 1 or less, about 3 to 1 or less, about 2 to 1 or less, about 1.5 to 1 or less, about 1.25 to 1 or less, about 1 to 1, about 5 to 1 or less. The device 700 can be configured such that the paddle 702 moves, rotates, or pivots in the outward direction X and then moves in the outward direction Z to create an opening 706 of width H between the paddle 702 and the gripping member 704. Optionally, the device 700 can be configured such that the paddle moves in the outward direction Z and then moves or pivots in the outward direction X to create a width H between the paddle 702 and the gripping member 704. Additionally, the device 700 can be configured such that the paddle 702 moves or pivots in the outward direction X and simultaneously moves in the outward direction Z to create a width H between the paddle 702 and the gripping member 704.

[0244] Figures 63A - 63C illustrate an implantable device 700 in which paddle 702 moves, rotates, or pivots in an outward direction X and subsequently moves in an outward direction Z to create a wider opening 706. FIG. 63A shows the implantable device 700 in a closed state with paddle 702 engaged with gripping member 704. Referring to FIG. 63B, paddle 702 has moved or pivoted in the outward direction X to create an opening 706 of width W for receiving valve tissue. Referring to FIG. 63C, after paddle 702 has moved or pivoted in the outward direction X, paddle 702 is moving in the outward direction Z such that the width of opening 706 is H. After valve tissue has been received in opening 706 between paddle 702 and gripping member 704, the valve repair device is returned to a closed state (shown in FIG. 63A) to secure implantable device 700 to the valve tissue. The implantable device 700 can include any other features of the implantable devices discussed in this application, and the implantable device 700 can be arranged to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0245] Figures 64A-64C show a transplantable device 700 in which paddle 702 moves in an outward direction Z and then moves, rotates, or pivots in an outward direction X to create a wider opening 706. FIG. 64A shows the transplantable device 700 in a closed state with paddle 702 engaged with gripping member 704. Referring to FIG. 64B, paddle 702 has moved in an outward direction Z to create an opening 706 of width W for receiving valve tissue. Referring to FIG. 64C, after paddle 702 has moved in an outward direction Z, paddle 702 has moved or pivoted in an outward direction X such that the width of opening 706 is H. After the valve tissue has been received in opening 706 between paddle 702 and gripping member 704, the transplantable device 700 is returned to a closed state (shown in FIG. 64A) to secure the transplantable device 700 to the valve tissue. The transplantable device 700 can include any other features of the transplantable devices discussed in this application, and the transplantable device 700 can be arranged to engage valve tissues 20, 22 as part of any suitable valve repair system (e.g., any valve repair system disclosed in this application).

[0246] Figures 63A-63C show device 700 in which paddle 702 moves or pivots and then spreads apart, and FIGS. 64A-64C show device 700 in which paddle 702 spreads apart and then moves or pivots, but in alternative embodiments, device 700 can include paddles 702 that can spread, move, or pivot simultaneously. Additionally, in some embodiments, paddles 702 can spread, move, or pivot independently of each other. That is, in the embodiments of valve repair device 700 shown in FIGS. 63A-63C and FIGS. 64A-64C, and in embodiments in which each paddle 702 spreads and moves or pivots simultaneously, paddles 702 can be controlled independently of each other.

[0247] Next, referring to FIGS. 65 - 83, an exemplary implantable device 500 is shown in a closed state. Next, referring to FIGS. 65 - 66, the device 500 extends from a proximal portion 505 to a distal portion 507 and includes a junction 510, inner paddles 522, outer paddles 520, and a paddle frame 524. In some embodiments, the outer paddles 520 can extend to and / or around the paddle frame 524 and can have multiple layers for surrounding the paddle frame 524. The proximal portion 505 can include a collar 11 (not shown) for attaching a delivery device. The distal portion 507 can include a cap 514, which is attached to the outer paddles 520 (e.g., attachable in a butt - joint manner, etc.) and is also engaged with a drive element (not shown) to open and close the device 500, making it easier to implant into a native valve as described in this application.

[0248] Next, referring to FIGS. 67 - 68, a front view of the device 500 is shown. The device 500 is shaped symmetrically or substantially symmetrically about a vertical anteroposterior plane 550, and the distal portion 507 is generally thinner than the proximal portion 505. The junction element 510 and the paddle frame 524 are shaped rounded or generally rounded so that the device 500 does not catch or snag heart structures such as chordae tendineae during implantation. For this reason, the proximal collar 511 (FIG. 68) and the cap 514 (FIG. 68) also have rounded edges. When viewed from the front or back, the paddle frame 524 extends upwardly and outwardly from the distal end 507 and is seen to be rounded or generally rounded, substantially matching the shape of the junction element 510 when viewed from the front and back. Thus, the junction element 510 and the paddle frame 524 generally define the shape of the device 500 when viewed from the front or back. Additionally, the rounded shape of the paddle frame 524 and the corresponding rounded shape of the junction element allow the valve tip stress to be distributed over a wider surface area. In some exemplary embodiments, the paddle frame 524 and / or the junction element 510 can have a different shape.

[0249] Next, referring to FIG. 69, a side view of device 500 is shown. Similar to the front and rear views (FIGS. 67 - 68), device 500 has a shape that is symmetric or substantially symmetric about a plane between the vertical sides 552 when viewed from the side. The distal portion 507 is also generally thinner than the proximal portion 505 when device 500 is viewed from the side. The joining element 510 is also optionally shaped to be tapered or overall tapered towards the distal portion 507 of device 500. However, in some exemplary embodiments, the joining element is not tapered as it extends from the proximal portion of the device to the distal portion of the device.

[0250] The rounded appearance of device 500 is further revealed by the rounded shapes of paddles 520, 522 where the inner paddle 522 and outer paddle 520 are joined, and the rounded shape of paddle frame 524. However, paddles 520, 522 and paddle frame 524 can take a wide variety of different shapes. For example, paddles 520, 522 and paddle frame 524 may be rounded along the upper ends, but the sides of paddles 520, 522 and / or paddle frame may be flat or substantially flat. By making paddles 520, 522 flat or substantially flat, two devices can be implanted side - by - side at the tip of a natural valve, and these two devices are in the same plane or substantially in the same plane as each other.

[0251] The closed paddles 520, 522 form a gap 542 between the inner paddle 522 configured to receive natural tissue and the joining element 510. As can be seen from FIG. 69, as the joining element 510 narrows, gap 542 is given a somewhat teardrop shape where the width of the gap 542 expands as it approaches the distal portion 507 of the device. As the width of gap 542 widens towards the distal portion 507, paddles 520, 522 are able to contact the tissue gripped in gap 542 closer to the proximal portion 505.

[0252] The paddle frame 524 extends vertically from the distal portion 507 towards the proximal portion 505 up to approximately the middle third of the device 500 before bending or spreading outwards, such that the connecting portion of the frame 524 passes through the gap 544 formed by the inner paddle 522 folded inside the outer paddle 520. However, in some embodiments, the connecting portion of the frame is disposed inside the inner paddle 522 or outside the outer paddle 520. The outer paddle 520 has a rounded shape similar to that of the joining element 510 when viewed from the front or the rear (Figs. 67 - 68). That is, the device 500 has a round or substantially round shape. The round shape of the device 500 is particularly visible when the device 500 is viewed from above (Figs. 70 - 71) or from below (Figs. 72 - 73).

[0253] Referring now to Figs. 70 - 71, a top view of the device 500 is shown. The device 500 is shaped symmetrically or substantially symmetrically about the plane 550 between the front and the rear and also symmetrically or substantially symmetrically about the plane 552 between the sides when viewed from above. The opening 519A of the joining element 510 can be seen at the proximal portion 505 of the device 500. As can be seen in Fig. 70, the joining element 510 can be hollow inside. The proximal collar 511 shown in Fig. 71 can be fixed to the joining element 510 to close the joining element 510.

[0254] In one exemplary embodiment, the engagement element is not flat and all surfaces are curved. For example, the engagement element 510 described herein can be formed from a series of hybrid surfaces having a variety of different radii of curvature. The engagement element 510 has an elliptical or generally elliptical shape when viewed from above. However, in some exemplary embodiments, the engagement element 510 can have a different shape when viewed from above. For example, the engagement element can have a rectangular, square, diamond, oval, or any other shape. Each of the paddle frames 524 has an arcuate shape with a radius smaller than that of the engagement element 510, such that the gap 542 formed between the inner paddle 522 and the paddle frame 524 and the engagement element 510 becomes narrower as it approaches the left side surface 551 and the right side surface 553 of the device 500. Thus, natural tissue such as the valve leaflets 20, 22 tends to be pinched between the paddle frame 524 and the engagement element 510 toward the left side surface 551 and the right side surface 553 of the device 500.

[0255] Referring now to FIGS. 72-73, a bottom view of the device 500 is shown. Similar to the top view (FIGS. 70-71), the device 500 is symmetric or substantially symmetric about the anterior-posterior plane 550 and also symmetric or substantially symmetric about the inter-lateral plane 552 when viewed from the bottom. A cap 514 is shown in FIG. 73 and can be attachable to the outer paddles 520 and the paddle frames 524 in a butt-joint manner.

[0256] The paddle frames 524 extend outwardly from the distal portion 507 of the device 500 to the left side surface 551 and the right side surface 553 at a narrow or minute angle from the inter-lateral plane 552. The paddle frames 524 flare further from the inter-lateral plane 552 as the paddle frames 524 extend toward the proximal portion of the device 500 (FIG. 69), ultimately forming the arcuate shape seen in FIGS. 70-71.

[0257] Next, referring to FIGS. 74-83, perspective and cross-sectional views of the device 500 are shown. Next, referring to FIG. 74, the device 500 is shown cut along a cross-section 75 near the proximal portion of the joining element 510. Next, referring to FIG. 75, a cross-section of the device 500 as seen from the cross-section 75 of FIG. 74 is shown. At the position of the plane 75, the joining element 510 has a round or generally round shape, and lobes are arranged along the front and rear surfaces 550. The gap 542 between the paddle frame 524 and the joining element 510 forms a shape similar to a crescent of a central width 543. As described above, the gap 542 becomes narrower as the gap 542 approaches the left side surface 551 and the right side surface 553.

[0258] Next, referring to FIG. 76, the device 500 is shown cut along a cross-section 77 located at approximately three-quarters of the travel between the distal portion 507 and the proximal portion 505 of the joining element 510. Next, referring to FIG. 77, a cross-section of the device 500 as seen from the cross-section 77 of FIG. 76 is shown. At the position of the plane 75, the joining element 510 has an elliptical or generally elliptical shape with an orientation along the plane between the side surfaces 552. The gap 542 between the paddle frame 524 and the joining element 510 forms a crescent shape or a shape similar to a crescent with a central width 543 smaller than the central width 543 seen in FIG. 75. At the position of the plane 77, the width 543 of the gap 542 narrows towards the center of the device, widens somewhat as the gap 542 approaches the left side surface 551 and the right side surface 553, and then narrows again. Thus, the natural tissue is clamped at the center of the gap 542 at approximately three-quarters of the travel of the joining element 510 upwards.

[0259] Next, referring to FIG. 78, device 500 is shown cut along a cross-section 79 that is located at approximately half of the travel between the distal portion 507 and the proximal portion 505 of the joining element 510. Next, referring to FIG. 79, a cross-section of device 500 as seen from cross-section 79 of FIG. 78 is shown. At the position of plane 79, the joining element 510 has an elliptical shape, or generally an elliptical shape, with its orientation along the plane between the side surfaces 552. It can be seen that the paddle frame 524 is very close to or in contact with the joining element 510 near the left side surface 551 and the right side surface 553. The gap 542 is crescent-shaped, or generally crescent-shaped, and is wider than the gap 542 (FIG. 77) as seen along plane 77.

[0260] Next, referring to FIG. 80, device 500 is shown cut along a cross-section 81 that is located at approximately one-fourth of the travel between the distal portion 507 and the proximal portion 505 of the joining element 510. Next, referring to FIG. 81, a cross-section of device 500 as seen from cross-section 81 of FIG. 80 is shown. At the position of plane 81, the joining element 510 has an elliptical shape, or generally an elliptical shape, with its orientation along the plane between the side surfaces 552, and is narrower than the elliptical shape seen in FIG. 77. It can be seen that the paddle frame 524 is very close to or in contact with the joining element 510 near the left side surface 551 and the right side surface 553. The gap 542 is crescent-shaped, or generally crescent-shaped, and is wider than the gap 542 (FIG. 79) as seen along plane 79.

[0261] Next, referring to FIG. 82, the device 500 is shown cut along a cross-section 83 located near the distal portion 507 of the joining element 510. Next, referring to FIG. 83, a cross-section of the device 500 as seen from the cross-section 83 of FIG. 82 is shown. At the position of the plane 83, the joining element 510 has an elliptical shape or generally an elliptical shape with its orientation along the plane between the side surfaces 552, and this elliptical shape becomes narrower than the elliptical shape seen in FIG. 79 as the joining element 510 tapers towards the distal portion 507 of the device 500. It can be seen that the paddle frame 524 is very close to or in contact with the joining element 510 near the left side surface 551 and the right side surface 553. Although the inner paddle 522 is not visible in FIG. 81, the gap 542 is crescent-shaped or generally crescent-shaped and is wider than the gap 542 (FIG. 81) seen along the plane 81.

[0262] Next, referring to FIGS. 65A, 66A, 67A, 68A, 70A, 71A, 72A, 73A, 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, an exemplary implantable device 500A is shown in a closed state. Next, referring to FIGS. 65A and 66A, the device 500A extends from the proximal portion 505A to the distal portion 507A and includes a joining portion 510A, an inner paddle 522A, an outer paddle 520A, and a paddle frame 524A. The proximal portion 505A may include a collar 511D (not shown) for attaching a delivery device. The distal portion 507A can include a cap 514A, which is attached to the outer paddle 520 (e.g., attachable in a butt-joint manner, etc.) and is also engaged with a drive element (not shown) to open and close the device 500A, facilitating smooth implantation into the mitral valve as described in the present application.

[0263] Next, referring to FIGS. 67A and 68A, a front view of device 500A is shown. Device 500A is symmetric or substantially symmetric about a vertical anteroposterior plane 550A and has a generally narrower shape at distal portion 507A than along paddle frame 524A. The shapes of engagement element 510A and paddle frame 524A are generally rounded rectangular shapes so that device 500A does not catch or snag heart structures such as chordae tendineae during implantation. For this reason, proximal collar 511D (FIG. 68A) and cap 514A (FIG. 68A) can also have rounded edges. When viewed from the front or back, paddle frame 524A has a generally rounded rectangular shape that extends upwardly and outwardly to a shape having sides that are wider than engagement element 510A from distal end 507A and generally parallel when viewed from the front and back. Thus, paddle frame 524A generally defines the shape of device 500A when viewed from the front or back. In addition, the rounded rectangular shape of paddle frame 524 can distribute cusp stress over a wider surface area. In some exemplary embodiments, paddle frame 524A and / or engagement element 510A can have another shape.

[0264] Similar to the front and rear views (FIGS. 67A and 68A), device 500A has a shape that is symmetric or substantially symmetric about a vertical lateral plane 552A (FIG. 70A) when viewed from the side (e.g., FIG. 47A). Distal portion 507A is also generally thinner than proximal portion 505A when device 500A is viewed from the side. In the embodiment illustrated in FIG. 48B, engagement element 510A is not tapered as it extends from proximal portion 505A of device 500A to distal portion 507A of device 500A. However, in some exemplary embodiments, the engagement element is tapered as it extends from the proximal portion of the device to the distal portion of the device (e.g., FIG. 47).

[0265] The generally rounded features of device 500A are further accentuated by the rounded shape of paddles 520A and 522A, where the inner paddle 520A and outer paddle 522A are joined together. However, paddles 520A, 522A, and paddle frame 524A can take on a wide variety of different shapes. For example, paddles 520A, 522A, and paddle frame 524A can be rounded along the upper edge and flat or substantially flat on the sides (e.g., the sides of paddle frame 524A disposed on the front and rear sides of device 500A). By making paddles 520A, 522A flat or substantially flat, two devices can be implanted side by side at the natural valve leaflets, and these two devices are in the same plane or substantially in the same plane as each other.

[0266] The closed paddles 520A, 522A form a gap 542A between the inner paddle 522A configured to receive natural tissue and the joining element 510A. As can be seen in FIGS. 48B and 48F, the proximal end of the joining element 510A has an approximately dogbone shape such that the gap 542A narrows towards the proximal portion 505A as the gap 542A approaches the distal portion 507A of the device. By the width of the gap 542A narrowing towards the proximal portion 505A, the paddles 520A, 522A are able to contact the tissue gripped in the gap 542 closer to the proximal portion 505A.

[0267] The paddle frame 524A extends vertically from the distal portion 507A to approximately one-third of the way into the device 500A toward the proximal portion 505A before bending or spreading outwardly, such that the connection or slot 524B of the frame 524A passes through the gap 544A formed by the inner paddle 522A folded inside the outer paddle 520A. However, in some embodiments, the connection of the frame is disposed inside the inner paddle 522A or outside the outer paddle 520A. The outer paddle 520A has a rounded rectangular shape similar to that of the joining element 510A when viewed from the front or the back (Figs. 67A and 68A). Thus, the device 500A has a rounded rectangular shape. The rounded rectangular shape of the device 500A is particularly visible when the device 500A is viewed from the top (Figs. 70A and 71A) or from the bottom (Figs. 72A and 73A).

[0268] Next, referring to FIGS. 70A and 71A, a top view of device 500A is shown. Device 500A is shaped symmetrically or substantially symmetrically about a plane 550A between front and back when viewed from above, and also symmetrically or substantially symmetrically about a plane 552A between sides. The proximal opening 519C of the joining element 510A can be seen at the proximal portion 505A of device 500A. The drive element 512A is received through the opening 519C such that the joining element 510A wraps around the drive element 512A. In some embodiments, the opening 519C is formed by inserting the drive element 512A between folded and overlapping layers of a strip of material 501A (described in detail below). In some embodiments, the opening 519C is formed by shaping a folded layer of the strip of material 501A that forms the joining element 510A around a blank or fixture such that the joining element 510A is round or generally round in shape. The proximal collar 511D shown in FIG. 71A can be fixed to the joining element 510A to close the joining element 510A. The proximal collar 511D includes an attachment portion 513A that engages an opening 546A formed by a folded layer of the strip of material 501A that forms the joining element 510A. In some embodiments, the attachment portion 513A is a hole within the collar 511D and the strip of material 501A must be inserted into the collar 511D before folding the strip of material 501A during the assembly of device 500A. In some embodiments, the attachment portion 513A is an open slot (e.g., the attachment portion or slot 524B of the paddle frame 524A) that receives the strip of material 501A either before or after folding the strip of material 501A.

[0269] As described above, the engagement element 510A generally has a rectangular shape when viewed from the top. In some exemplary embodiments, the engagement element 510A may have a different shape when viewed from the top. For example, the engagement element may have a round shape, a square, a diamond, an oval, or any other shape. The paddle frames 524A each have a rounded rectangular shape when viewed from the top such that the paddle frame 224A surrounds the rectangular engagement element 510A. Thus, natural tissue, such as the valve leaflets 20, 22, tends to be evenly sandwiched or compressed within the gap 542A formed between the inner paddle 522A and the paddle frame 524A and the engagement element 510A.

[0270] Next, referring to FIGS. 72A and 73A, a bottom view of the device 500A is shown. Similar to the top views (FIGS. 70A and 71A), the device 500A is symmetric or substantially symmetric about the anteroposterior plane 550A when viewed from the bottom and is also symmetric or substantially symmetric about the interlateral plane 552A. The distal portion 527A of the strip of material 501A includes an aperture 527B for receiving the cap 514A shown in FIG. 73A.

[0271] The paddle frame 524A extends outwardly from the distal portion 507A of the device 500A to the left side surface 551A and the right side surface 553A at a narrow angle, i.e., a small angle, from the interlateral plane 552A. The paddle frame 524A extends further away from the interlateral plane 552A while maintaining a generally constant distance from the anteroposterior plane 550A as the paddle frame 524A extends toward the proximal portion 505A of the device 500A (FIG. 65A) and ultimately forms the rounded rectangular shape shown in FIGS. 70A and 71A.

[0272] In one exemplary embodiment, the dimensions of device 500A are selected to minimize the number of implants (preferably one) required by a single patient while simultaneously maintaining a low valve inside-outside gradient. In one exemplary embodiment, the anterior-posterior distance Y47I of device 500A is less than 10 mm, and the central lateral distance Y67C of the spacer is less than 6 mm at its widest point. In one exemplary embodiment, the overall geometry of device 500A can be based on these two dimensions and the overall shape strategy described above. It should be immediately apparent that different devices can be obtained by using a different anterior-posterior distance Y47I and central lateral distance Y67C as the starting point for device 500A. Additionally, different devices can also be obtained by using other dimensions and the shape strategy described above.

[0273] Table D (Table 4) and Table E (Table 5) present examples of the dimensions and ranges of values of device 500A and the components of device 500A in some exemplary embodiments. However, device 500A can have a wide variety of different shapes and sizes and does not need to have all or any of the dimension values or dimension ranges presented in Table D (Table 4) and Table E (Table 5). Table D (Table 4) presents examples of the length dimension Y in millimeters and the ranges of length dimensions in millimeters of device 500A and the components of device 500A. Table B (Table 2) presents examples of the radius dimension S in millimeters and the ranges of radius dimensions in millimeters of device 500A and the components of device 500A. Each subscript of the dimension indicates the drawing in which that dimension first appears.

[0274] [Table 4]

[0275] [Table 5]

[0276] Next, referring to FIGS. 74A, 75A, 76A, 77A, 78A, 79A, 80A, 81A, 82A, and 83A, perspective and cross-sectional views of device 500A are shown. Next, referring to FIG. 74A, device 500A is shown cut along cross-section 75A near the proximal portion of joining element 510A. Next, referring to FIG. 75A, a cross-section of device 500A as seen from cross-section 75A of FIG. 74A is shown. At the position of plane 75A, joining element 510A generally has a rounded rectangular shape. Gap 542A between inner paddle 522A and joining element 510A has width 542B. As described above, gap 542A has a consistent or generally consistent width.

[0277] Next, referring to FIG. 76A, device 500A is shown cut along cross-section 77A located approximately three-quarters of the way between distal portion 507A and proximal portion 505A of joining element 510A. Next, referring to FIG. 77A, a cross-section of device 500A as seen from cross-section 77A of FIG. 76A is shown. As can be seen in FIGS. 76A and 77A, strip 501A of the material forming device 500A is stacked to form four layers within the region of joining element 510A. A single layer of strip 501A of material forms each of inner paddle 522A and outer paddle 520A. At the position of plane 75A, joining element 510A has a generally rectangular shape with its orientation along side-plane 552A. Gap 542A between inner paddle 522A and joining element 510A is visible. Gap 542A between inner paddle 522A and joining element 510A has a width 542B that is greater than width 542B shown in FIG. 75A. Gap 544A between outer paddle 520A and inner paddle 522A has a consistent or generally consistent width 544B for receiving attachment portion or slot 524B of paddle frame 524A.

[0278] Next, referring to FIG. 78A, device 500A is shown cut along a cross-section 79A located at approximately one-half of the travel between the distal portion 507A and the proximal portion 505A of device 500A. Next, referring to FIG. 79A, a cross-section of device 500A as seen from cross-section 79A of FIG. 78A is shown. As can be seen in FIGS. 78A and 79A, the strip 501A of material forming device 500A is layered such that four layers are formed within the region of the bonding element 510A, two layers are formed within the region of the inner paddle 522A, and one layer is formed within the region of the outer paddle 520A. At the location of plane 79A, the bonding element 510A has a generally rectangular shape with its orientation along the inter-side plane 552A. The gap 542A between the inner paddle 522A and the bonding element 510A has a width 542B that is the same as, or approximately the same as, the width 542B shown in FIG. 77A.

[0279] Next, referring to FIG. 80A, device 500A is shown cut along a cross-section 81A located at approximately one-quarter of the travel between the distal portion 507A and the proximal portion 505A of device 500A. Next, referring to FIG. 81A, a cross-section of device 500A as seen from cross-section 81A of FIG. 80A is shown. As can be seen in FIGS. 80A and 81A, the strip 501A of material forming device 500A is layered such that four layers are formed within the region of the bonding element 510A and two layers are formed within the region of the inner paddle 522A, and the outer paddle 520A is formed by a single layer. At the location of plane 81A, the bonding element 510A has a generally rectangular shape with its orientation along the inter-side plane 552A. The gap 542A between the inner paddle 522A and the bonding element 510A has a width 542B that is approximately the same as the central width 542B shown in FIG. 79A.

[0280] Next, referring to FIG. 82A, device 500A is shown cut along a cross-section 83A located approximately one-quarter of the way between the distal portion 507A and the proximal portion 505A of device 500A. Next, referring to FIG. 83A, a cross-section of device 500A as seen from cross-section 83A of FIG. 82A is shown. As can be seen in FIGS. 82A and 83A, the strip 501A of material forming device 500A is overlapped to form four layers within the region of the joining element 510A, two layers within the region of the inner paddle 522A, and a single layer forms the outer paddle 520A. At the position of plane 83A, the joining element 510A has a generally rectangular shape with its orientation along the inter-side plane 552A. The gap 542A between the inner paddle 522A and the joining element 510A forms an arch-shaped with a width 542B that is approximately the same as the central width 542B shown in FIG. 81A.

[0281] Next, referring to FIGS. 84 - 88, 86A, 87A, and 88A, exemplary implantable devices 100, 500, 500A are shown without fasteners or engagable gripping members. Rather, the exemplary devices 100, 500, 500A shown in FIGS. 84 - 88, 86A, 87A, and 88A have returns or gripping members 800 / 800A and / or 802 / 802A integrated into the joining element or paddle portions of the anchor portions of the devices to facilitate gripping of the tissue of the native heart valve.

[0282] Next, referring to FIG. 84, an exemplary implantable device 100 is shown without a fastener or engaging element that can be joined. As described above, device 100 is deployed from a delivery sheath or means 102 for delivery and includes a junction 104 and an anchor portion 106. The junction 104 of device 100 includes a joining element or means 110 for joining, which is adapted to be implanted between the valve leaflets 20, 22 of a native valve (e.g., mitral valve MV, etc.) and is slidably attached to a drive element or drive shaft 112 that extends through the joining element or means 110 for joining to a distal cap 114.

[0283] The anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 that are connected between the distal cap 114 and a joining element or means 110 for joining. The anchor portion 106 is driven between an open state and a closed state and can take a variety of forms, such as paddles, gripping elements, etc. The driving of the driving element or means 112 for driving opens and closes the anchor portion 106 of the device 100 to grip the natural valve leaflets 20, 22 during implantation.

[0284] The device 100 shown in FIG. 84 includes a return portion 800 disposed on the joining element or means 110 for joining rather than a joinable fastener or gripping element, with at least one return portion 800 on each side of the joining element or means 110 for joining. When the anchor portion 106 of the device 100 is closed, the tissue gripped between the inner paddle 122 and the joining element or means 110 for joining is pressed against the return portion 800. The return portion 800 can be sharpened, thereby engaging the natural tissue, piercing the natural tissue in some embodiments, and preventing the tissue from moving backward from the device 100. In some embodiments, the return portion 800 is angled downward to improve engagement with the natural tissue.

[0285] Referring now to FIG. 85, an exemplary device 100 without a separate joinable fastener is shown. As described above, the device 100 is deployed from a delivery sheath or means 102 for delivery and includes a junction 104 and an anchor portion 106. The junction 104 of the device 100 includes a joining element or means 110 that is adapted to be implanted between the valve leaflets 20, 22 of a natural valve or mitral valve MV and is slidably attached to a driving element 112 (such as a drive wire, shaft, rod, suture, line, etc.) that extends through the joining element or means 110 to the distal cap 114.

[0286] The anchor portion 106 of device 100 includes an outer paddle 120 and an inner paddle 122 that are connected between a distal cap 114 and a joining element or means 110 for joining. The anchor portion 106 is driven between an open state and a closed state and can take a variety of forms, such as paddles, gripping elements, etc. The driving of a driving element or means 112 for driving opens and closes the anchor portion 106 of device 100 to grip the natural valve tips 20, 22 during implantation.

[0287] The device 100 shown in FIG. 85 includes a return portion 800 disposed on the inner paddle 122 rather than a separate joinable fastener or gripping element, with at least one return portion 800 on each side of the inner paddle 122. When the anchor portion 106 of device 100 is closed, the tissue gripped between the inner paddle 122 and the joining element or means 110 for joining is pressed against the return portion 800. The return portion 800 is sharp, thereby engaging the natural tissue and, in some embodiments, piercing the natural tissue to prevent the tissue from moving back out of device 100. In some embodiments, the return portion 800 is angled downward to improve engagement with the natural tissue.

[0288] Referring now to FIG. 86, an exemplary implantable device 500 is shown that does not include a joinable fastener or gripping element. As described above, device 500 includes a junction 504 and an anchor portion 506. The junction 504 of device 500 includes a joining element 510 that is adapted to be implanted between the valve tips 20, 22 of a natural valve or natural mitral valve MV and is slidably attached to a driving element or means 512 that extends through the joining element 510 to a distal cap 514.

[0289] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 that are connected between a distal cap 514 and a joining element 510. The anchor portion 506 is driven between an open state and a closed state and can take a variety of forms, such as paddles, gripping elements, etc. When the drive element 512 is driven, the anchor portion 506 of the device 500 opens and closes to grip the valve tips 20, 22 of the natural valve during implantation.

[0290] The device 500 includes a return portion 800 disposed on the inner paddle 522 rather than a joinable fastener or gripping element, and there are optionally a plurality of return portions 800 on each side of the inner paddle 522. When the anchor portion 506 of the device 500 is closed, the tissue gripped between the inner paddle 522 and the joining element 550 is pressed against the return portion 800. The return portion 800 is sharp, thereby engaging the natural tissue, and in some embodiments piercing the natural tissue to prevent the tissue from moving back from the device 500. In some embodiments, the return portion 800 is angled downward to improve engagement with the natural tissue.

[0291] Referring now to FIG. 86A, an exemplary implantable device 500A is shown that does not include a separate joinable fastener or gripping element. As described above, the device 500A includes a joining element 510A that is adapted to be implanted between the valve tips 20, 22 of a natural valve or a natural mitral valve MV and is slidably attached to a drive element or means for driving (not shown) that extends through the joining element 510A to a distal cap 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A that are connected between the distal cap 514A and the joining element 510A. The device 500A is driven between an open state and a closed state and can take a variety of forms, such as paddles, gripping elements, etc. When the drive element is driven, the paddles 520A, 522A of the device 500A open and close to grip the valve tips 20, 22 of the natural valve during implantation.

[0292] Device 500A includes a return portion 800A disposed on the inner paddle 522A, rather than a joinable fastener or gripping element, and optionally a plurality of return portions 800A on each side of the inner paddle 522A. When device 500A is closed, tissue gripped between the inner paddle 522A and the joining element 510A is pressed against the return portion 800A. The return portion 800A is sharp, thereby engaging natural tissue and in some embodiments piercing the natural tissue to prevent the tissue from backing out of device 500A. In some embodiments, the return portion 800A is angled downward to improve engagement with natural tissue.

[0293] Referring now to FIG. 87, an exemplary implantable device 500 is shown without a separate joinable fastener or gripping element. As described above, device 500 includes a junction 504 and an anchor portion 506. The junction 504 of device 500 includes a joining element 510 that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to a drive element or means 512 for driving that extends through the joining element 510 to a distal cap 514.

[0294] The anchor portion 506 of device 500 includes an outer paddle 520 and an inner paddle 522 that are connected between the distal cap 514 and the joining element 510. The anchor portion 506 is driven between an open state and a closed state and can take a wide variety of forms, such as paddles, gripping elements, etc. Driving the drive element 512 causes the anchor portion 506 of device 500 to open and close to grip the native leaflets 20, 22 during implantation.

[0295] Device 500 includes a return portion 800 disposed on the joining element 510, rather than a separate attachable fastener or gripping element, with a plurality of return portions 800 on each side of the joining element 510. When the anchor portion 506 of the device 500 is closed, the tissue gripped between the inner paddle 522 and the joining element 550 is pressed against the return portion 800. The return portion 800 is sharp, thereby engaging the native tissue and, in some embodiments, piercing the native tissue to prevent the tissue from moving backward from the device 500. In some embodiments, the return portion 800 is angled downward to improve engagement with the native tissue.

[0296] Next, referring to FIG. 87A, an exemplary implantable device 500A is shown without an attachable fastener or gripping element. As described above, the device 500A can have a joining element 510A that is adapted to be implanted between the leaflets 20, 22 of a native valve or native mitral valve MV and is slidably attached to a drive element or means for driving (not shown) that extends through the joining element 510A to the distal cap 514A. The device 500A also includes an outer paddle 520A and an inner paddle 522A that are connected between the distal cap 514A and the joining element 510A. The device 500A is driven between an open state and a closed state and can take a variety of forms, such as paddles, gripping elements, etc. Driving the drive element causes the paddles 520A, 522A of the device 500A to open and close to grip the native leaflets 20, 22 during implantation.

[0297] Device 500A includes a return portion 800A disposed on the engagement element 510A, rather than a separate attachable fastener or gripping element, and there are a plurality of return portions 800A on each side of the engagement element 510A. When the device 500A is closed, the tissue gripped between the inner paddle 522A and the engagement element 510A is pressed against the return portion 800A. The return portion 800A is sharp, thereby engaging the natural tissue, piercing the natural tissue in some embodiments, and preventing the tissue from moving backward from the device 500A. In some embodiments, the return portion 800A is angled downward to improve engagement with the natural tissue.

[0298] Referring now to FIG. 88, an exemplary implantable device 500 is shown that does not include a separate attachable fastener or gripping element. As described above, the device 500 includes a junction 504 and an anchor portion 506. The junction 504 of the device 500 includes an engagement element 510 that is adapted to be implanted between the cusps 20, 22 of a native valve or a native mitral valve MV and is slidably attached to a drive element or drive means 512 that extends through the engagement element 510 to the distal cap 514.

[0299] The anchor portion 506 of the device 500 includes an outer paddle 520 and an inner paddle 522 that are connected between the distal cap 514 and the engagement element 510. The anchor portion 506 is driven between an open state and a closed state and can take a variety of forms, such as paddles, gripping elements, etc. When the drive element 512 is driven, the anchor portion 506 of the device 500 opens and closes to grip the cusps 20, 22 of the native valve during implantation.

[0300] Device 500 includes a return portion 800 disposed on the engagement element 510, rather than a joinable fastener or gripping element, and at least one return portion 800 is included on each side of the engagement element 510. Similar to the device shown in FIG. 85, device 500 also includes a return portion 802 disposed on the inner paddle 522, and there is at least one return portion 802 on each inner paddle 522.

[0301] When the anchor portion 506 of the device 500 is closed, the tissue gripped between the inner paddle 522 and the engagement element 550 is pressed against the return portions 800, 802. The return portions 800, 802 are sharp, thereby engaging the native tissue and, in some embodiments, piercing the native tissue to prevent the tissue from moving backward from the device 500. In some embodiments, the return portions 800, 802 are angled downward to improve engagement with the native tissue. The combination of the return portion 800 of the engagement element 510 and the return portion 802 of the inner paddle 522 causes the gripped tissue to be formed into an S-shaped serpentine path as it passes over the return portions 800, 802. Thus, the force to pull the tissue away from the device 500 will encourage further engagement of the tissue with the return portions 800, 802 before the tissue can escape.

[0302] Referring now to FIG. 88A, an exemplary implantable device 500A is shown without a connectable fastener or gripping element. As described above, the device 500A can have an engagement element 510A that is adapted to be implanted between the leaflets 20, 22 of a native valve or a native mitral valve MV and is slidably attached to a drive element or means for driving (not shown) that extends through the engagement element 510A to a distal cap 514A. The device 500 also includes an outer paddle 520A and an inner paddle 522A that are connected between the distal cap 514A and the engagement element 510A. The device 500A is driven between an open state and a closed state and can take a wide variety of forms, such as paddles, gripping elements, and the like. Driving the drive element causes the paddles 520A, 522A of the device 500A to open and close to grip the native leaflets 20, 22 during implantation.

[0303] Device 500A includes a return portion 800A disposed on the engaging element 510A, rather than a joinable fastener or gripping element, and each side of the engaging element 510A is provided with at least one return portion 800A. Device 500A also includes a return portion 802A disposed on the inner paddle 522A, and each inner paddle 522A has at least one return portion 802A.

[0304] When device 500A is closed, the tissue gripped between the inner paddle 522A and the engaging element 510A is pressed against the return portions 800A, 802A. The return portions 800A, 802A are sharp, thereby engaging the natural tissue and, in some embodiments, piercing the natural tissue to prevent the tissue from backing out of device 500A. In some embodiments, the return portions 800A, 802A are angled downward to improve engagement with the natural tissue. The combination of the return portion 800A of the engaging element 510A and the return portion 802A of the inner paddle 522A causes the gripped tissue to be formed in an S-shaped, serpentine path as it passes over the return portions 800A, 802A. Thus, the force to pull the tissue away from device 500A will encourage the tissue to engage further with the return portions 800A, 802A before the tissue can escape.

[0305] Referring now to FIGS. 89 - 102, the engaging element 510 and paddles 520, 522 of an exemplary device 500 are shown. The engaging element 510 and paddles can be made from a wide variety of different materials. The engaging element 510 and paddles 520, 522 can be formed from one or more of a metal fabric, such as a mesh that is woven, knitted, electrospun, or deposited or formed by any other suitable method, or a material or flexible material that is cut by laser cutting or some other means. This material can also be a cloth, a shape memory alloy wire (such as nitinol) to obtain a shape setting function, or any other flexible material suitable for implantation in the human body.

[0306] In one exemplary embodiment, the joining element is made from a woven mesh of metal wires, such as a mesh of nitinol wires. In one exemplary embodiment, the joining element 510 can be made of a mesh woven with between 25 and 100 wires, such as between 40 and 85 wires, such as between 45 and 60 wires, such as about 48 or 48 nitinol wires.

[0307] The joining element can be covered with a cloth, such as a polyethylene cloth. The joining element 510 can be surrounded entirely by a cloth cover, such as a fine mesh polyethylene cloth. The cloth cover can seal blood from the surface of the spacer and / or facilitate rapid in-growth of tissue.

[0308] Using a shape memory material, such as a woven nitinol wire mesh, to construct the joining element 510 can result in a joining element that is self-expandable and flexible in all directions, and / or has reduced stress when the joining element is crimped and / or bent. This material can be a single piece, a joined bisected piece, or multiple parts or pieces that are fixedly or joined together in any suitable manner, such as by welding, adhesives, etc.

[0309] Next, referring to FIGS. 89 - 90, device 500 extends from a proximal portion 505 to a distal portion 507 and includes a junction element 510, an inner paddle 522, and an outer paddle 520. The junction element 510 includes a proximal opening 519A and a distal opening 515 (FIGS. 92 and 94). The proximal opening 519A of the junction element 510 is formed in the proximal portion 519 of the junction element 510. The junction element 510 is connectably coupled to the inner paddle 522 by a coupling portion 525. The inner paddle 522 is connectably coupled to the outer paddle 520 by a coupling portion 523. The outer paddle 520 is attached (e.g., connectably attached, etc.) to the distal portion 527 by a coupling portion 521. A junction gap 542 is formed between the inner paddle 522 and the junction element 510. A paddle gap 544 is formed between the inner paddle 522 and the outer paddle 520 when the paddles 520, 522 are folded, as shown, for example, in FIG. 90.

[0310] Next, referring to FIG. 91, a front view of the device 500 is shown (the rear view is the same). The junction element 510 includes a proximal portion 519, an intermediate portion 518, and a distal portion 517. The proximal portion 519 includes a proximal opening 519A. The distal portion 517 includes a distal opening 515 and is coupled to the coupling portion 525. The shape of the junction element 510 is rounded or generally rounded so that the device 500 does not catch or snag heart structures such as chordae tendineae during implantation.

[0311] Next, referring to FIG. 92, a side view of the device 500 is shown. Similar to the device 500 as viewed from the front, the distal portion 507 of the device 500 is generally thinner than the proximal portion 505 of the device 500 when the device 500 is viewed from the side. The joining element 510 flares outwardly at the proximal portion 519 from the proximal opening 519A to the intermediate portion 518. The joining element 510 then tapers, i.e., becomes thinner, from the proximal portion 519 to the distal portion 517 at the intermediate portion 518. The distal portion 517 remains thin and then bifurcates into two coupling portions 525. The generally rounded appearance of the device 500 is further enhanced by the rounded shape of the coupling portion 523 that connects the inner paddle 522 and the outer paddle 520 in a joinable manner, and the outwardly curved shape of the outer paddle 520.

[0312] The joining gap 542 formed between the inner paddle 522 and the joining element 510 is configured to receive the natural valve tip. As the joining element 510 narrows, the gap 542 is given a somewhat tear-drop shape where the width of the gap 542 increases as the gap 542 approaches the distal portion 507 of the device 500. The widening of the gap 542 towards the distal portion 507 allows the inner paddle 522 to contact the tissue held in the gap 542 closer to the proximal portion 505, and the pinch force increases as a result of the mechanical advantage obtained by the lengths of the paddles 520, 522, and other securing elements, i.e., anchor elements, such as those described in the present application.

[0313] Next, referring to FIG. 93, a top view of the device 500 is shown. The proximal opening 519A of the joining element 510 can be seen at the proximal portion 505 of the device 500, and it can be seen that the joining element 510 is hollow inside. The joining element 510 has an elliptical or generally elliptical shape when viewed from above. The paddles 520, 522 appear to be in a protruding rectangular shape, but the paddles 520, 522 can extend laterally and have an arcuate, i.e., crescent-like, shape.

[0314] Next, referring to FIG. 94, a bottom view of the device 500 is shown. The distal opening 515 of the joining element 510 can be seen at the distal portion 507 of the device 500, and it can be seen that the joining element 510 is hollow inside. The joining element 510 has an elliptical or generally elliptical shape when viewed from above. The paddles 520, 522 appear to be in a protruding rectangular shape, but the paddles 520, 522 can extend laterally and have an arcuate, i.e., crescent-like shape. The distal portion 517 of the joining element 510 can be seen to be divided into two to join with the joint 525.

[0315] Next, referring to FIGS. 89A, 90A, 91A, 92A, 93A, 94A, 95A, 96A, 97A, 98A, 99A, 100A, 101A, and 102A, a portion of the device 500A formed by a strip of material 501A (e.g., a single continuous strip of material, a composite strip of material, etc.), namely, the joining element 510A and the paddles 520A, 522A, is shown. The joining element 510A and the paddles can be made of a wide variety of different materials. The joining element 510A and the paddles 520A, 522A can be formed from materials such as woven, knitted, electrospun, or deposited or formed in any other suitable manner, or a network, or a metal fabric such as a material cut by laser cutting or any other means or a flexible material. This material may also be a cloth, a shape memory alloy wire (such as nitinol) for obtaining a shape setting function, or any other flexible material suitable for implantation in the human body.

[0316] In one exemplary embodiment, the joining element 510A, the inner paddle 522A, and the outer paddle 520A are made from a single continuous strip 501A of material. The strip 501A of material can be a woven, knitted, electrospun, or otherwise suitably deposited or formed web, or a metal fabric such as a material cut by laser cutting or some other means, or a flexible material. This material may also be a cloth, a shape memory alloy wire (such as nitinol) to obtain a shape setting function, or any other flexible material suitable for implantation into the human body. In one exemplary embodiment, the strip 501A of material is made of a web in which strings between 25 and 100, such as strings between 40 and 85, such as strings between 45 and 60, or about 48 or 48 nitinol wires are knitted.

[0317] Next, referring to FIGS. 205 - 207, an exemplary woven or braided material 4000 that can be used for the strip 501A of material is shown. Referring now to FIG. 205, an enlarged plan view of the material 4000 is shown. The material 4000 extends from a first edge 4002 to a second edge 4004. The edges 4002, 4004 surround a central portion or area 4006. The material 4000 is formed by braiding or weaving together a central string 4020, such as a nitinol wire. Edge strings 4010 extend longitudinally through the material 4000 along the edges 4002, 4004. The central string 4020 is woven or braided such that the central string 4020 wraps around the edge strings 4010. By wrapping the central string 4020 around the edge strings 4010, the material 4000 near the edges 4002, 4004 is thicker than the material of the central portion 4006, forming a split or dog - bone - like shape when the material 4000 is viewed from the end, as shown in FIG. 206. Thus, the edges 4002, 4004 of the material 4000 are less flexible than the central portion 4006. The edge strings 4010 and the central string 4020 may be of similar diameter and can have a diameter in the range from about 0.06 millimeters to about 0.18 millimeters. In some embodiments, the edge strings 4010 are larger in diameter than the central string 4020, thereby making the edges 4002, 4004 stiffer or more rigid than the central portion 4006. For example, the edge strings 4010 can have a diameter in the range from 0.07 millimeters to about 0.27 millimeters, or about 0.17 millimeters, and the central string 4020 can have a diameter in the range from about 0.04 millimeters to about 0.15 millimeters, or about 0.009 millimeters. In some embodiments, the edges 4002, 4004 are made less flexible than the central portion 4006 by using different materials for the edge strings 4010 and the central string 4020, such as a metal material, e.g., nitinol, for the edge strings 4010 and a cloth or plastic material, e.g., polyethylene, for the central string 4020.Alternatively, the edge string 4010 and the central string 4020 can be made from the same material that undergoes different chemical and / or thermal processes that vary the flexibility of the material such that the flexibility of the central string 4020 is higher than that of the edge string 4010.

[0318] Referring now to FIG. 207, the folded portions of the material 4000 are stacked on top of each other to form a section having four layers 4000A, 4000B, 4000C, 4000D. The cleavage shape of the individual layers, having edges 4002, 4004 that are thicker than the central portion 4006, forms three gaps 4001A, 4001B, 4001C between the layers 4000A, 4000B, 4000C, 4000D of the material 4000 in the arrangement of the central portion 4006. The outer gaps 4001A, 4001C are formed between the outer layers 4000A, 4000D and the adjacent intermediate layers 4000B, 4000C.

[0319] As described in the present disclosure, the joining element 510A of the device 500A can be formed from four layers of material, such as the material 4000. When the layers of the material 4000 are used to form the joining element 510A, the driving element 512A of the device 500A may be inserted as being formed in the central gap 4001B formed in the center of the four layers of the material 4000. The driving element 512A can have a diameter larger than the width of the gap 4001B, and thus when the driving element 512A is inserted, the central gap 4001B opens and stretches the adjacent outer gaps 4001A, 4001C to reduce their size. In some embodiments, inserting the driving element 512A causes the central body portion 4006 on either side to bulge outwardly until it has a thickness greater than the thickness of the four stacked edge portions 4002, 4004.

[0320] The joining element 510A and paddles 520A, 522A can be covered with a cloth such as a polyethylene cloth. The joining element 510A and paddles 520A, 522A can be surrounded entirely by a cloth cover (e.g., cover 540A) such as a fine mesh polyethylene cloth. The cloth cover can seal blood on the surface of the spacer and / or promote rapid in-growth of tissue.

[0321] To construct the joining element 510A and paddles 520A, 522A, using a shape memory material such as a braided nitinol wire mesh results in a joining element and paddles that can be self-expanding and flexible in all directions and / or have less strain when crimped and / or bent. This material can be a single piece, a joined bisected piece, or multiple parts or pieces that are fixedly or joined together in any suitable manner such as by welding, adhesives, etc.

[0322] Referring now to FIGS. 89A and 90A, device 500A extends from proximal portion 505A to distal portion 507A and includes joining element 510A, inner paddle 522A, and outer paddle 520A. A single continuous strip 501A of material extends between two ends 501B and is folded to form joining element 510A, inner paddle 522A, and outer paddle 520A. Some portions of device 500A are formed from multiple layers of strip 501A of material. For example, strip 501A of material is overlapped to form four layers within the region of joining element 510A and two layers within the region of inner paddle 522A.

[0323] The engaging element 510A and the paddles 520A, 522A are connectable to be joined together by a joint of the strip of material 501A. The engaging element 510A is connectable to be joined to the inner paddle 522A by a joint 525A. The inner paddle 522A is connectable to be joined to the outer paddle 520A by a joint 523A. The outer paddle 520A is attached (e.g., connectable to be joined) to the distal portion 527A by a joint 521A. An aperture 527B within the distal portion 527A engages with the cap 514A.

[0324] Various gaps are formed between portions of the device 500A when the strip of material 501A is folded into the desired shape. A joint gap 542A is formed between the inner paddle 522A and the engaging element 510A. A paddle gap 544A is formed between the inner paddle 520A and the outer paddle 522A when the paddles 520A, 522A are folded, as shown for example in FIG. 90A. A collar gap 546A is formed when the strip of material 501A is folded to form the proximal portion 519B of the engaging element 510A.

[0325] Referring now to FIG. 91A, a front view of the device 500A is shown (the rear view is the same). The engaging element 510A includes a proximal portion 519B that extends above the joint 523A of the paddles 520A, 522A. The distal portion 517A of the engaging element 510A is hidden by the paddles 520A, 522A when viewed from the front or rear, giving the device 500A a long, narrow, rounded rectangular shape. The shape of the engaging element 510A helps prevent the device 500A from catching or snagging heart structures such as chordae tendineae during implantation.

[0326] Next, referring to FIG. 92A, a side view of device 500A is shown. The distal end 507A of device 500A forms a generally rounded shape that is generally narrower and less sharp than the proximal end 505A of device 500A when viewed from the side. The engagement element 510A includes a proximal portion 519B, an intermediate portion 518A, and a distal portion 517A. The proximal portion 519B extends outwardly from the intermediate portion 518A and engages with the collar 511D (FIG. 48A). The intermediate portion 518A of the engagement element 510A is straight or generally straight when viewed from the side. The distal portion 517A is attached to the inner paddle 522A by a coupling portion 525A (e.g., attachable in a butt-joint manner, etc.). The generally rounded features of device 500A are further clarified by the rounded shape of the coupling portion 523A that butt-jointly connects the paddles 520A, 522A. The coupling portion 521A that connects the outer paddle 520A to the distal portion 527A is also rounded and facilitates the transition in shape to the cap 514A (FIG. 48A) that is assembled from the strip of material 501A to the flat or generally flat distal portion 527A.

[0327] An engagement gap 542A formed between the inner paddle 522A and the engagement element 510A is configured to receive natural tissue. Due to the intermediate portion 518A of the engagement element 510A and the inner paddle 522A being generally straight, the gap 542A is consistent or generally consistent with a narrow upper end that extends outwardly such that the proximal portion 519B engages with the collar 511D (FIG. 48A). Thus, the inner paddle 522A contacts the tissue gripped within the gap 542A closer to the proximal end 505A, where the pinching force is greater as a result of the mechanical advantage obtained by the length of the paddles 520A, 522A and other securing elements or anchor elements such as those described in the present application.

[0328] As described above, the joining element 510A and paddles 520A, 522A of the device 500A are formed by folding a strip 501A of material. The folded strip 501A of material is then unfolded and assembled with other components such as the color 511D, the cap 514A, and the paddle frame 524A. The strip 501A of material is shaped after being formed into a desired shape, whereby the strip 501A of material returns to the desired shape after assembly with other components. In some embodiments, a jig is used when the strip 501A of material is folded and shaped to ensure that the strip 501A of material is folded at the appropriate location with the desired radius.

[0329] Referring again to FIG. 92A, a portion of a jig 570A for assisting in folding and shaping the device 500A is shown. The strip 501A of material is shown wrapped around the jig 570A such that the strip 501A of material forms a desired shape. To fold the strip 501A of material into the shape of the device 500A using the jig 570A, the strip 501A of material is disposed with one end 501B at the location of the inner paddle 522A. The strip 501A extends distally 507B from the end 501B to form the first layer 581A of the inner paddle 522A, extends around the first jig portion 572A to form the first layer 581A of the hinge portion 525A, and then extends proximally 505B to form the first layer 581A of the bonding element 510A. The first layer 581A of material forms the sides of the inner paddle 522A and the bonding element 510A surrounding the bonding gap 542A. The strip 501A is then wrapped around the second jig portion 574A to form one of the proximal portion 519B of the bonding element 510A and the opening 546A. The strip 501A then extends distally 507B along the first layer 581A to form the second layer 582A of the bonding element 510A. The strip 501A is then wound back around the first jig portion 572A to form the second layer 582A of the hinge portion 525A and back proximally 505B to form the second layer 582A of the inner paddle 522A. The strip 501A is then wrapped around the third jig portion 576A to form the joint 523A. The strip 501A then extends distally 507B along the inner paddle 522A to form the outer paddle 520A and is then folded around the fourth jig portion 578A to form the joint 521. The strip 501A then extends laterally to form the distal portion 527. The routing operation of the strip 501A through the jig 570A is then performed in the reverse order on the opposite side of the jig 570A to form the second half of the device 500A.That is, the strip 501A is then wrapped around the fourth, third, first, second, and first (second time) jig portions 578A, 576A, 572A, 574A, 572A to form the second half of the device 500A. After the strip 501A is wrapped around the jig portions as described above, a shaping operation is performed. The illustrated jig portions have a rounded or generally round shape, but those portions can have any shape to assist in folding and shaping the material 501A. The jig 570A can have more or fewer portions for engaging the strip of material 501A.

[0330] Next, referring to FIG. 93A, a top view of the device 500A is shown. The first layer 581A and the second layer 582A of each half of the device 500A form four layers of the bonding element 510A. The proximal opening 519C of the bonding element 510A is formed between the two second layers 582A. In some embodiments, the opening 519C is formed by inserting a drive element 512A (not shown) between the folded and overlapping layers of the strip of material 501A after shaping the strip of material 501A. In some embodiments, the opening 519C is formed by shaping the folded layers 581A, 582A of the strip of material 501A around an additional jig portion (not shown) such that the bonding element 510A has a round or generally round shape when viewed from above.

[0331] Next, referring to FIG. 94A, a bottom view of the device 500A is shown. The distal portion 527A of the strip of material 501A is shown as an aperture 527B for receiving the cap 514A. The bonding element 510A and the outer paddle 520A have a generally rounded rectangular shape when viewed from below.

[0332] Next, referring to FIGS. 95 to 102, a perspective view and cross-sectional views of the device 500 are shown. Next, referring to FIG. 95, the device 500 is shown cut along a cross-section 96 near the proximal portion of the joining element 510. Next, referring to FIG. 96, a cross-section of the device 500 as seen from the cross-section 96 of FIG. 95 is shown. At the position of the plane 96, the joining element 510 has an elliptical or generally elliptical shape with a thick portion along the side surface of the joining element 510. The distal opening 515 can be seen from the proximal portion, and the joining element 510 is hollow inside.

[0333] Next, referring to FIG. 97, the device 500 is shown cut along a cross-section 98 located approximately halfway along the travel between the distal portion 507 and the proximal portion 505 of the joining element 510. Next, referring to FIG. 98, a cross-section of the device 500 as seen from the cross-section 98 of FIG. 97 is shown. At the position of the plane 98, the joining element 510 has an elliptical or generally elliptical shape that is larger than the elliptical shape in FIG. 96.

[0334] Next, referring to FIG. 99, the device 500 is shown cut along a cross-section 100 located approximately one-fourth along the travel between the distal portion 507 and the proximal portion 505 of the joining element 510. Next, referring to FIG. 100, a cross-section of the device 500 as seen from the cross-section 100 of FIG. 99 is shown. At the position of the plane 100, the joining element 510 has an elliptical or generally elliptical shape that is narrower than the elliptical shape visible in FIG. 98.

[0335] N...

Claims

Claim 1 A valve repair device for repairing a patient's native valve, a junction, a collar attached to the junction, a cap that can be moved in a direction away from the collar, a plurality of paddle portions including extendable portions where each paddle portion can extend from a stationary state to an extended state, comprising, wherein the paddle portions are movable between an open position and a closed position by moving the cap relative to the collar, a valve repair device.

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