Valve repair device and valve repair system

Abstract

The valve repair device includes a pair of paddles and at least one leak control extension. The device can also include a spacer or coaptation element. The pair of paddles can be coupled to the spacer or coaptation element. The pair of paddles are movable between an open position and a closed position and are configured to attach the valve repair device to the patient's native valve. The at least one leak control extension extends from the spacer and is configured to block retrograde blood flow along, adjacent to, proximal to, and / or surrounding the device, e.g., the spacer or coaptation element.

Description

Technical Field

[0001] Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 953,098, filed on December 23, 2019, which is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) play an important role in ensuring the forward flow of the appropriate supply of blood through the cardiovascular system. These heart valves can be damaged, for example, by congenital malformations, inflammatory processes, infectious conditions, diseases, etc., and thus their effectiveness may be reduced. Such damage to the valve can lead to serious cardiovascular disorders or death. A damaged valve can be surgically repaired or replaced during open-heart surgery. However, open-heart surgery is highly invasive and complications can occur. Transvascular techniques can be used to introduce and implant prosthetic devices in a much less invasive way than open-heart surgery. As an example, a transseptal technique is a transvascular technique that can be used to access the native mitral and aortic valves. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, inferior vena cava, and right atrium). The septum is then punctured and the catheter is passed into the left atrium. A similar transvascular technique that starts the same as the transseptal technique but stops before puncturing the septum and instead directs the delivery catheter towards the tricuspid valve within the right atrium can be used to implant a prosthetic device within the tricuspid valve.

[0003] A healthy heart is generally conical, tapering towards the apex at the lower side. The heart has four chambers, including the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are generally separated by a wall called 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 structure from other native heart valves. The mitral valve includes an annulus portion, which is an annular part of the native valve tissue surrounding the mitral valve orifice, and a pair of leaflets or cusps that extend downward from the annulus into the left ventricle. The mitral annulus can form a "D"-shaped, elliptical, or other non-circular cross-sectional shape with a long axis and a short axis. The anterior cusp may be larger than the posterior cusp, and when the cusps are closed, they generally form a "C"-shaped boundary between the adjacent sides of the cusps.

[0004] When functioning properly, the anterior and posterior cusps function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle dilates (also called "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 "ventricular systole" or "systole"), the increased blood pressure within the left ventricle presses the sides of the two cusps together, thereby closing the one-way mitral valve so that blood cannot return to the left atrium and instead is ejected out of the left ventricle through the aortic valve. To prevent the two cusps from prolapsing under pressure and folding back towards the left atrium through the mitral annulus, a plurality of fibrous cords called chordae tendineae anchor the cusps to the papillary muscles within the left ventricle.

[0005] Mitral regurgitation involves the valve inappropriately allowing some blood to flow through the valve in the wrong direction. For example, during systole of cardiac contraction, if the native mitral valve does not close properly and blood flows from the left ventricle into the left atrium, mitral regurgitation occurs. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as prolapse of the valve leaflets, dysfunction of the papillary muscles, dilation of the left ventricle resulting in stretching of the mitral annulus, or two or more of these. Mitral regurgitation at the central part of the valve leaflets may be called central jet mitral regurgitation, and mitral regurgitation near one of the commissures (i.e., the place where the valve leaflets meet) of the valve leaflets may be called eccentric jet mitral regurgitation. Central jet mitral regurgitation occurs when the tips of the valve leaflets do not meet centrally, and thus the valve does not close and there is regurgitation.

Prior Art Documents

Patent Documents

[0006]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Summary of the Invention

Means for Solving the Problems

[0007] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of this summary is not required by the claims unless the claims explicitly recite the feature. Also, the features, components, steps, concepts, etc. described in the examples in this summary or elsewhere in this disclosure may be combined in various ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0008] A patient's native valve can be repaired by attaching a spacer between the leaflets of the patient's native valve. Retrograde blood flow through the gap between the spacer and the leaflets is blocked or suppressed.

[0009] An exemplary valve repair device includes a spacer, a pair of paddles, and at least one leak control extension. A pair of anchors (e.g., paddles, latches, clamps, grippers, fasteners, etc.) can be coupled to the spacer. The pair of anchors (e.g., a pair of paddles) is movable between an open position and a closed position and is configured to attach the valve repair device to a patient's native valve. At least one leak control extension extends from the spacer and is configured to block retrograde blood flow along the side of the spacer.

[0010] An exemplary valve repair system includes a delivery sheath and a valve repair device. The valve repair device is deployable to a patient's native valve by the delivery sheath. The valve repair device includes a spacer, a pair of paddles, and at least one leak control extension. The pair of paddles is coupled to the spacer. The pair of paddles is movable between an open position and a closed position and is configured to attach the valve repair device to a patient's native valve. At least one leak control extension extends from the spacer and is configured to block retrograde blood flow along the side of the spacer.

[0011] In some embodiments, a valve repair device for repairing a patient's native valve comprises a spacer, a pair of anchors (e.g., paddles, latches, clamps, grippers, fasteners, etc.) configured to attach the valve repair device to the patient's native valve, and at least one leakage control extension extending from the spacer.

[0012] In some embodiments, the pair of anchors are a pair of paddles coupled to the spacer. In some embodiments, the pair of paddles are movable between an open position and a closed position.

[0013] In some embodiments, at least one leakage control extension extends from the spacer. The leakage control extension is configured to block retrograde blood flow along the side surface of the spacer.

[0014] In some embodiments, the valve repair device further comprises a cap connected to the spacer. In some embodiments, at least one leakage control extension is connected to a cap connected to the spacer. In some embodiments, at least one leakage control extension is pivotally attached to the cap. In some embodiments, at least one leakage control extension is directly connected to the spacer.

[0015] In some embodiments, the valve repair device further comprises a pair of fasteners, and the pair of anchors (e.g., a pair of paddles) and the pair of fasteners are configured to attach the valve repair device to the patient's native valve.

[0016] In some embodiments, the spacer is configured to close a gap within the patient's native valve when the valve repair device is attached to the native valve.

[0017] In some embodiments, at least one leakage control extension comprises a deflector paddle having a flexible wire frame covered by a fabric barrier material. The deflector paddle may be connected to the spacer by one or more arms.

[0018] In some embodiments, the flexible wire frame is configured to deform when disposed against the walls within a patient's heart.

[0019] In some embodiments, at least one leak control extension comprises a pocket that includes a flexible wire frame defining an opening of the pocket and a fabric barrier material defining at least a portion of the interior of the pocket. In some embodiments, the opening of the at least one leak control extension is configured to be disposed beneath one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some embodiments, the opening of the at least one leak control extension is configured to be disposed over the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0020] In some embodiments, at least a portion of the leak control extension is configured to be disposed beneath the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0021] In some embodiments, when the valve repair device is attached to the native valve, the entire leak control extension is configured to be disposed over the ventricular end of one or more leaflets of the native valve. In some embodiments, when the valve repair device is attached to the native valve, the entire leak control extension is configured to be disposed beneath the ventricular end of one or more leaflets of the native valve.

[0022] In some embodiments, at least one leak control extension comprises one or more deflector paddles and a barrier element. In some embodiments, each of the one or more deflector paddles has a flexible wire frame covered by a fabric barrier material. In some embodiments, the barrier element comprises at least one of a fabric material, a biocompatible material, bovine or porcine heart tissue, and a plastic membrane.

[0023] In some embodiments, a valve repair device for repairing a native valve comprises at least one anchor (e.g., paddle, latch, clamp, gripper, fastener, etc.) configured to attach the valve repair device to the patient's native valve, and at least one leak control extension extending from a portion of the valve repair device.

[0024] In some embodiments, the at least one anchor is movable between an open position and a closed position.

[0025] In some embodiments, the at least one leak control extension is configured to block retrograde blood flow adjacent to or proximate to the device.

[0026] In some embodiments, the valve repair device further comprises a coaption element (e.g., a coaptation element, a spacer, etc.). The coaption element is configured to close a gap within the patient's native valve when the valve repair device is attached to the native valve. In some embodiments, the at least one leak control extension extends from the coaption element and is configured to block retrograde blood flow along the side of the coaption element.

[0027] In some embodiments, the valve repair device further comprises a cap connected to the coaption element. In some embodiments, the at least one leak control extension is directly connected to the coaption element. In some embodiments, the at least one leak control extension is connected to a cap connected to the coaption element. In some embodiments, the at least one leak control extension is pivotally attached to the cap.

[0028] In some embodiments, the at least one anchor is coupled to the coaption element. In some embodiments, the at least one anchor comprises a pair of paddles coupled to the coaption element.

[0029] In some embodiments, at least one anchor comprises a pair of paddles.

[0030] In some embodiments, the valve repair device further comprises at least one fastener, and the at least one anchor and the at least one fastener are configured to attach the valve repair device to a native valve of a patient.

[0031] In some embodiments, the at least one fastener is coupled to a cap of the device.

[0032] In some embodiments, the at least one leak control extension comprises a deflector paddle having a flexible wire frame covered by a fabric barrier material. In some embodiments, the deflector paddle is connected to a spacer by one or more arms. In some embodiments, the flexible wire frame is configured to deform when disposed against a wall within a native valve of a patient.

[0033] In some embodiments, the at least one leak control extension comprises a pocket including a flexible wire frame defining an opening of the pocket and a fabric barrier material defining at least a portion of an interior of the pocket. In some embodiments, the opening of the at least one leak control extension is configured to be disposed under one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some embodiments, the opening of the at least one leak control extension is configured to be disposed over a ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0034] In some embodiments, at least a portion of the leak control extension is configured to be disposed beneath the ventricular ends of one or more leaflet tips of the native valve when the valve repair device is attached to the native valve. In some embodiments, when the valve repair device is attached to the native valve, the entire leak control extension is configured to be disposed above the ventricular ends of one or more leaflet tips of the native valve. In some embodiments, when the valve repair device is attached to the native valve, the entire leak control extension is configured to be disposed beneath the ventricular ends of one or more leaflet tips of the native valve.

[0035] In some embodiments, at least one leak control extension comprises one or more deflector paddles and a barrier element. In some embodiments, the one or more deflector paddles have a flexible wire frame covered by a fabric barrier material. In some embodiments, the barrier element comprises at least one of a fabric material, a biocompatible material, bovine or porcine heart tissue, and a plastic membrane.

[0036] In some embodiments, a valve repair system for repairing a patient's native valve comprises a delivery sheath and a valve repair device deployable by the delivery sheath to the patient's native valve.

[0037] In some embodiments, the valve repair device comprises a joining element or spacer, a pair of paddles (or other anchors) coupled to the spacer / joining element, and at least one leak control extension extending from the spacer / joining element, the leak control extension being configured to block retrograde blood flow along the side of the spacer / joining element.

[0038] In some embodiments, the pair of paddles (or other anchors) is movable between an open position and a closed position and is configured to attach the valve repair device to the patient's native valve.

[0039] In some implementations, the system (e.g., the valve repair device of the system) further comprises a cap connected to the spacer / junction element. In some implementations, at least one leak control extension is connected to a cap connected to the spacer / junction element. In some implementations, at least one leak control extension is pivotally attached to the cap.

[0040] In some implementations, at least one leak control extension is directly connected to the spacer / junction element.

[0041] In some implementations, the system (e.g., the valve repair device of the system) further comprises a pair of fasteners, and the pair of paddles (or other anchors) and the pair of fasteners are configured to attach the valve repair device to the patient's native valve.

[0042] In some implementations, the spacer / junction element is configured to close the gap within the patient's native valve when the valve repair device is attached to the native valve.

[0043] In some implementations, at least one leak control extension comprises a deflector paddle having a flexible wire frame covered by a cloth barrier material. In some implementations, the deflector paddle is connected to the spacer by one or more arms. In some implementations, the flexible wire frame is configured to deform when disposed against the wall within the patient's heart.

[0044] In some embodiments, at least one leak control extension comprises a pocket that includes a flexible wireframe defining an opening of the pocket and a fabric barrier material defining at least a portion of the interior of the pocket. In some embodiments, the opening of the at least one leak control extension is configured to be disposed under one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some embodiments, the opening of the at least one leak control extension is configured to be disposed over the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0045] In some embodiments, at least a portion of the leak control extension is configured to be disposed under the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0046] In some embodiments, when the valve repair device is attached to the native valve, the entire leak control extension is configured to be disposed over the ventricular end of one or more leaflets of the native valve. In some embodiments, when the valve repair device is attached to the native valve, the entire leak control extension is configured to be disposed under the ventricular end of one or more leaflets of the native valve.

[0047] In some embodiments, at least one leak control extension comprises one or more deflector paddles and a barrier element. In some embodiments, each of the one or more deflector paddles has a flexible wireframe covered by a fabric barrier material. In some embodiments, the barrier element comprises at least one of a fabric material, a biocompatible material, bovine or porcine heart tissue, and a plastic membrane.

[0048] In some embodiments, a valve repair system for repairing a patient's native valve comprises a delivery sheath and a valve repair device deployable by the delivery sheath to the patient's native valve.

[0049] In some embodiments, the valve repair device comprises at least one anchor (e.g., paddle, latch, clamp, gripper, fastener, etc.) and at least one leak control extension extending from a portion of the device, the leak control extension being configured to block retrograde blood flow adjacent to or proximate to the device.

[0050] In some embodiments, at least one anchor is movable between an open position and a closed position, and a pair of paddles are configured to attach the valve repair device to a natural valve of a patient.

[0051] In some embodiments, the system (e.g., the valve repair device of the system) further comprises a joining element (e.g., spacer, coaptation element, etc.).

[0052] In some embodiments, at least one leak control extension extends from the joining element and is configured to block retrograde blood flow along a side surface of the joining element.

[0053] The system (e.g., the valve repair device of the system) further comprises a cap connected to the joining element.

[0054] In some embodiments, at least one leak control extension is directly connected to the joining element.

[0055] In some embodiments, at least one leak control extension is connected to a cap connected to the joining element.

[0056] In some embodiments, at least one leak control extension is pivotally attached to the cap.

[0057] In some embodiments, at least one anchor is coupled to the joining element. In some embodiments, at least one anchor comprises a pair of paddles coupled to the joining element.

[0058] In some embodiments, at least one anchor comprises a pair of paddles.

[0059] In some embodiments, the engagement element is configured to close a gap within the patient's native valve when the valve repair device is attached to the native valve.

[0060] In some embodiments, the system further comprises at least a pair of fasteners, and at least one anchor and at least one fastener are configured to attach the valve repair device to the patient's native valve. In some embodiments, at least one fastener is coupled to a cap of the device.

[0061] In some embodiments, at least one leak control extension comprises a deflector paddle having a flexible wire frame covered by a fabric barrier material. In some embodiments, the deflector paddle is connected to the engagement element by one or more arms. In some embodiments, the flexible wire frame is configured to deform when disposed against a wall within the patient's native valve.

[0062] In some embodiments, at least one leak control extension comprises a pocket including a flexible wire frame defining an opening of the pocket and a fabric barrier material defining at least a portion of an interior of the pocket.

[0063] In some embodiments, an opening of at least one leak control extension is configured to be disposed under one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0064] In some embodiments, an opening of at least one leak control extension is configured to be disposed over a ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0065] In some embodiments, at least a portion of the leakage control extension is configured to be disposed beneath the ventricular ends of one or more leaflet tips of the native valve when the valve repair device is attached to the native valve.

[0066] In some embodiments, when the valve repair device is attached to the native valve, the entire leakage control extension is configured to be disposed above the ventricular ends of one or more leaflet tips of the native valve. In some embodiments, when the valve repair device is attached to the native valve, the entire leakage control extension is configured to be disposed beneath the ventricular ends of one or more leaflet tips of the native valve.

[0067] In some embodiments, at least one leakage control extension comprises one or more deflector paddles and a barrier element. In some embodiments, each of the one or more deflector paddles has a flexible wire frame covered by a fabric barrier material. In some embodiments, the barrier element comprises at least one of a fabric material, a biocompatible material, bovine or porcine heart tissue, and a plastic membrane.

[0068] In some embodiments, a method of repairing a patient's native valve includes attaching a spacer or joining element between the leaflets of the patient's native valve and blocking retrograde blood flow through the gap between the spacer and the leaflets.

[0069] In some embodiments, the retrograde blood flow through the gap is blocked without filling the gap.

[0070] In some embodiments, the retrograde blood flow through the gap is blocked without filling any portion of the gap.

[0071] In some embodiments, the retrograde blood flow is blocked by an extension disposed at least partially on the ventricular side of the leaflets.

[0072] In some embodiments, the retrograde blood flow is blocked by an extension that is disposed entirely on the ventricular side of the valve leaflet.

[0073] In some embodiments, the method further includes positioning a spacer to deform one or more of the extensions against a wall within the patient's heart.

[0074] The above method can be performed on a living animal or on a simulation such as a simulator (e.g., a body part, heart, tissue, etc. are simulated) of a cadaver, cadaver heart.

[0075] A further understanding of the nature and advantages of the present invention is set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts are labeled with like reference numerals.

[0076] To further clarify various aspects of the embodiments of the present disclosure, a more specific description of exemplary embodiments is made by referring to various aspects of the accompanying drawings. It is understood that these drawings show only typical embodiments of the present disclosure and should not be considered as limiting the scope of the present disclosure. Further, although the figures may be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments of the present disclosure, as well as other features and advantages, are described and explained with additional specificity and detail through the use of the accompanying drawings.

Brief Description of the Drawings

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[0078] The following description refers to the accompanying drawings that illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operations do not depart from the scope of the present disclosure.

[0079] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing defective heart valves. Various embodiments of a native valve repair device, a system for delivering the native valve repair device, and a system for removing the implanted native valve repair device are disclosed herein, and it should be noted that any combination of these options may be made, unless specifically excluded. In other words, the individual components of the disclosed devices and systems can be combined as long as they are not mutually exclusive or physically impossible in other respects. Further, the techniques and methods can be performed on live animals or on simulations such as cadavers, cadaver hearts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated).

[0080] As described herein, when one or more components are described as being connected, joined, fixed, coupled, attached, or otherwise interconnected, such interconnections can be direct between the components or can be indirect, such as by use of one or more intermediate components. Also, as described herein, references to "member", "component", or "portion" are not limited to a single structural member, component, or element, but can include an assembly of components, members, or elements. Also, as described herein, the terms "substantially" and "about" are defined as being at least nearly the given value or state (and including that), preferably within 10% thereof, more preferably within 1% thereof, and most preferably within 0.1% thereof.

[0081] Figures 1 and 2 are cross-sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and 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 PA. Each of these valves comes together or "coapts" in the flow to form a one-way fluid occluding surface and has flexible valve leaflets (e.g., leaflets 20, 22 shown in FIGS. 4 and 5) that extend inwardly across their respective openings. The native valve repair system of the present application is mainly described with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and left ventricle LV are described in more detail. However, the devices described herein can also be used in repairing other native valves, e.g., the devices can be used in repairing the tricuspid valve TV, aortic valve AV, and pulmonary valve PV.

[0082] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase or diastole, as seen in Figure 1, the blood previously collected in the left atrium LA during systole is moved through the mitral valve MV into the left ventricle LV by the expansion of the left ventricle LV. During the systolic phase or systole, as seen in Figure 2, the left ventricle LV contracts to pump blood into the body through the aortic valve AV and the ascending aorta AA. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected into the left atrium from the pulmonary veins. In one exemplary implementation, the device described in this application is used to repair the function of a defective mitral valve MV. That is, the device is configured to assist in closing the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV into the left atrium LA.

[0083] Referring now to FIGS. 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variably dense fibrous ring of tissue surrounding the leaflets 20, 22. Referring to FIG. 3, the mitral valve MV is secured 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 bases of the chordae tendineae and the muscles located within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 limit the movement of the mitral valve MV and help prevent the mitral valve from prolapsing. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and the left ventricle LV. The papillary muscles do not open and close the mitral valve MV. Rather, the papillary muscles support the mitral valve MV against the high pressures necessary to circulate blood throughout the body. The papillary muscles and chordae tendineae together are known as the subvalvular apparatus, and the subvalvular apparatus functions to prevent the mitral valve MV from prolapsing into the left atrium LA when the mitral valve is closed.

[0084] Various disease processes can impair the proper functioning of one or more of the native valves of the heart H. 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, damage to the left ventricle LV or right ventricle RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can deform the geometric shape of the native valve, which can render the native valve dysfunctional. However, the majority of patients undergoing valve surgery, such as mitral valve MV surgery, suffer from degenerative diseases that cause dysfunction at the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) resulting in prolapse and regurgitation.

[0085] Generally, native valves can become dysfunctional in two different ways: (1) valvular stenosis, and (2) valvular regurgitation. Valvular stenosis occurs when the native valve does not open fully, thereby causing an obstruction to 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.

[0086] The second type of valve insufficiency, valvular regurgitation, occurs when the valve leaflets do not close completely, thereby allowing blood to leak back into the previous chamber (e.g., allowing blood to leak from the left ventricle into the left atrium). There are three mechanisms by which native valves regurgitate or become insufficient, including Carpentier type I, type II, and type III insufficiency. Carpentier type I insufficiency involves dilation of the valve annulus such that normally functioning leaflets are pulled apart from each other and fail to form a seal (i.e., the leaflets do not appose properly). Perforation of the leaflets, such as that which occurs in endocarditis, is included in the malfunction of the type I mechanism. Carpentier type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier type III insufficiency involves restriction of the movement of one or more leaflets of the native valve such that the leaflets are abnormally constrained below the plane of the valve annulus. Restriction of the leaflets can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0087] Referring to FIG. 4, when a healthy mitral valve MV is in the closed position, the anterior leaflet 20 and posterior leaflet 22 appose, which prevents 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 posterior leaflet 22 of the mitral valve MV move into the left atrium LA during systole. This failure of apposition creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which allows blood to regurgitate from the left ventricle LV into the left atrium LA during systole. As described above, there are several different ways in which the leaflets (leaflets 20, 22 of the mitral valve MV) can become insufficient, which can lead to regurgitation.

[0088] Referring to FIG. 6, in certain situations, the patient's mitral valve MV may have a wide gap 26 between the anterior leaflet 20 and the posterior leaflet 22 when the mitral valve is in the closed position (i.e., during systole). For example, the gap 26 may have a width W between about 2.5 mm and about 17.5 mm, for example, between about 5 mm and about 15 mm, for example, between about 7.5 mm and about 12.5 mm, for example, between about 10 mm. In some situations, the gap 26 may have a width W greater than 15 mm. In any of the above situations, a valve repair device is designed that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV.

[0089] Stenosis or regurgitation can affect any valve, but stenosis has been found to mainly affect either the aortic valve AV or the pulmonary valve PV, and regurgitation has been found to mainly 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 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, left ventricle LV, mitral valve MV, and aortic valve AV) is mainly responsible for circulating blood flow throughout the body, dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening. Therefore, due to the substantially higher pressure on the left side of the heart, dysfunction of the mitral valve MV or the aortic valve AV is much more of a problem.

[0090] A dysfunctional native heart valve can be repaired or replaced. Repair typically involves preservation and modification of the patient's native valve. Replacement typically involves replacing the patient's native valve with a biological or mechanical substitute. Typically, the aortic valve AV and pulmonary valve PV are more prone to stenosis. Since the stenosis damage sustained by the valve leaflets is irreversible, the most common treatment for a stenotic aortic valve or stenotic pulmonary valve is removal of the valve and replacement with a surgically implanted heart valve, or replacement of the valve with a transcatheter heart valve. The mitral valve MV and tricuspid valve TV are more prone to leaflet deformation, which, as explained above, prevents the mitral or tricuspid valve from closing properly and allows backflow or regurgitation of blood from the ventricle to the atrium (e.g., a deformed mitral valve MV allows backflow or regurgitation from the left ventricle LV to the left atrium LA). Backflow or regurgitation of blood from the ventricle to the atrium results in valvular insufficiency. Deformation of the structure or shape of the mitral valve MV or tricuspid valve TV may be repairable. In addition, the chordae tendineae 10 may malfunction (e.g., the chordae tendineae can stretch or rupture), allowing blood to flow back into the left atrium LA and causing backflow to occur. The problems caused by malfunctioning chordae tendineae may be repaired by repairing the chordae tendineae or the structure of the mitral valve (e.g., by fixing the valve leaflets 20, 22 at the affected part of the mitral valve).

[0091] The devices and procedures disclosed herein refer to repairing the structure of the mitral valve or removing a repair device implanted from the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any natural valve or any component of a natural valve. Referring now to FIG. 7, any of the devices and concepts provided herein can be used to repair the tricuspid valve TV. For example, the devices and concepts provided herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and 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 provided herein can be used together for all three of the valve leaflets 30, 32, 34 to prevent the backflow of blood from the right ventricle to the right atrium. That is, the valve repair device provided herein can be disposed centrally between the three valve leaflets 30, 32, 34.

[0092] The concepts disclosed in this patent application can be applied to a variety of different valve repair devices. Some examples of valve repair devices to which the concepts disclosed herein can be applied are disclosed in U.S. Provisional Patent Application No. 62 / 744,031, filed Oct. 10, 2018, Patent Cooperation Treaty Application No. PCT / US2019 / 012707, filed Jan. 8, 2019, and Patent Cooperation Treaty No. PCT / US2018 / 028189, which are hereby incorporated by reference in their entirety.

[0093] Figures 8-14 illustrate examples of valve repair devices. An exemplary implantable prosthetic device can have a core adaptation or joining element (e.g., a spacer, etc.) and at least one anchor. The joining element is configured to be disposed within the opening of the native heart valve to help fill the space and form a more effective seal, thereby reducing or preventing the backflow described above. The joining element can have a structure that does not allow blood to pass through and enables the native valve leaflets to close around the joining element during ventricular systole, blocking the blood flow from the left or right ventricle to the left or right atrium, respectively. The prosthetic device can be configured to seal against the leaflets of two or three native valves, i.e., the device can be used in the native mitral (bicuspid) and tricuspid valves. Since the joining element can fill the space between the leaflets of a native mitral or tricuspid valve that functions inappropriately and does not close completely, the joining element is sometimes referred to herein as a spacer.

[0094] The joining element (e.g., a spacer, etc.) can have various shapes. In some embodiments, the joining element can have an elongated cylindrical shape with a circular cross-sectional shape. In some embodiments, the joining element can have an elliptical cross-sectional shape, a crescent-shaped cross-sectional shape, or various other non-cylindrical shapes. The joining element can have an atrial portion disposed within or adjacent to the left atrium, a ventricular portion or lower part disposed within or adjacent to the left ventricle, and a side surface extending between the native mitral valve leaflets. In embodiments configured for use in the tricuspid valve, the atrial portion or upper part is disposed within or adjacent to the right atrium, the ventricular portion or lower part is disposed within or adjacent to the right ventricle, and the side surface extends between the native tricuspid valve leaflets.

[0095] The anchor can be configured to secure the device to one or both of the natural mitral valve leaflets such that the engagement element is disposed between the two natural valve leaflets. In embodiments configured for use in the tricuspid valve, the anchor is configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the engagement element is disposed between the three natural valve leaflets. In some embodiments, the anchor can attach the engagement element at a location adjacent to the ventricular portion of the engagement element. In some embodiments, the anchor can attach to a shaft, an actuating wire, or other actuating element to which the engagement element is also attached. In some embodiments, the anchor and the engagement element can be disposed independently. In some embodiments, the anchor and the engagement element can be disposed simultaneously. The anchor can be configured to grip the valve leaflet.

[0096] The prosthetic device can be configured to be implanted via a delivery sheath. Additional information regarding examples of delivery devices can be found in U.S. Patent No. 8,449,599, as well as U.S. Patent Application Publication Nos. 2014 / 0222136, 2014 / 0067052, and 2016 / 0331523, each of which is incorporated herein by reference in its entirety. Further, these methods can be performed, with the necessary modifications, on a living animal or on a simulation such as a simulator (e.g., a body part, a heart, a tissue, etc. is simulated) of a cadaver, a cadaver heart.

[0097] Referring now to FIGS. 8-14, an example of an implantable prosthetic device 100 that is schematically shown is presented at various stages of deployment. However, implantable prosthetic devices can take a wide variety of different forms as described above. For example, the features of the present application can be included in any of the implantable prosthetic devices disclosed in U.S. Patent Application No. 62 / 744,031, Patent Cooperation Treaty Application No. PCT / US2019 / 012707, and / or Patent Cooperation Treaty Application No. PCT / US2018 / 028189. Device 100 can include any other features related to the implantable prosthetic devices discussed in the present application, and device 100 can be arranged to engage valve tissue (e.g., valve leaflets 20, 22) as part of any suitable valve repair device (e.g., any valve repair device disclosed in the present application).

[0098] Device 100 can be deployed from delivery sheath 102 and can include a junction portion 104 and / or an anchor portion 106. The junction portion 104 of device 100 is adapted to be implanted between the leaflets of a native valve (e.g., native mitral valve, native tricuspid valve, etc.) and includes a junction element or spacer 110 that is slidably attached to an actuating member or element 112 (e.g., wire, shaft, rod, line, suture, tether, etc.). The anchor portion 106 is operable between an open state and a closed state and can take a wide variety of forms, such as paddles, latches, fasteners, clasps, gripping elements, etc. Differential actuation of the actuating element 112 (e.g., actuation of an actuating wire) opens and closes the anchor portion 106 of device 100 to grip the mitral valve leaflets during implantation. The actuating element 112 can take a wide variety of forms. For example, the actuating element can be threaded such that rotation of the actuating element moves the anchor portion 106 relative to the junction portion 104. Alternatively, the actuating element need not be threaded such that pushing or pulling on the actuating element 112 moves the anchor portion 106 relative to the junction portion 104.

[0099] In some embodiments, the anchor portion 106 of device 100 includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the joining element 110 by portions 124, 126, and 128. Portions 124, 126, 128 can be jointed, hinged, and / or flexible to move between all of the portions described below. The interconnection of the outer paddle 120, inner paddle 122, joining element 110, and cap 114 by portions 124, 126, and 128 can constrain the device to the positions and movements shown herein. In some embodiments, the device includes only one outer paddle 120 and one inner paddle 122, which can be configured in different ways.

[0100] The actuating member or element extends through the delivery sheath and / or pusher tube / rod and / or joining element or spacer 110 to the cap 114 at the distal connection of the anchor portion 106. Extending and contracting the actuating element 112 increases and decreases the spacing between the joining element 110 and the cap 104, respectively. Optional attachment means or collar (not shown) removably attaches the joining element 110 to the pusher tube or rod and / or delivery sheath 102 such that the collar slides along the actuating element 112 during actuation so that the actuating element 112 opens and closes the paddles 120, 122 of the anchor portion 106. After the device 100 is connected to the valve tissue, if the device 100 needs to be removed from the valve tissue, a retrieval device can be used to connect to the collar 115 such that the actuating element extends through the collar 115 and the joining element 110 to engage the anchor portion 106 to open the paddles 120, 122 so that the device 100 can be removed from the valve tissue. An example of a retrieval device that can be used is shown in PCT Application No. PCT / US2019 / 062391, filed November 20, 2019, which is hereby incorporated by reference in its entirety.

[0101] Referring now to FIG. 11, the anchor portion 106 includes an attachment portion or gripping member. The gripping member shown includes a base or fixed arm 132, a movable arm 134, a ratchet 136, and a flex, hinge, or joint portion 138 shown as a ratchet fastener 130. However, other elements that increase friction may be used instead of the ratchet. The fixed arm 132 is attached to the inner paddle 122, and the flex, hinge, or joint portion 138 is disposed proximate the joining element 110. The ratchet fastener has a flat surface and does not fit within the recess of the paddle. Rather, the flat portion of the ratchet fastener 130 is disposed against the surface of the inner paddle 122. The flex, hinge, or joint portion 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the ratchet fastener 130. The joint portion 138 can be any suitable flexible portion, hinge, or joint, such as a flexible joint or hinge, a spring joint or hinge, a pivot joint or hinge. In some embodiments, the flex, hinge, or joint portion 138 is a flexible piece of material integrally formed with the fixed and movable arms 132, 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary relative to the inner paddle 122 when the movable arm 134 is opened to open the ratchet fastener 130 and expose the ratchet 136. The ratchet fastener 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby moving, flexing, and / or pivoting the flex, hinge, or joint portion 138.

[0102] During implantation, paddles 120, 122 are opened and closed to capture or grip the native mitral valve leaflet between the paddles 120, 122 and the engagement element 110. The spiked fastener 130 further secures the native leaflet by engaging the leaflet with the spike 136 and sandwiching the leaflet between the movable arm 134 and the fixed arm 132. The spike 136 of the spiked fastener 130 can increase friction with the leaflet or partially or completely penetrate the leaflet. The actuation line 116 can be actuated independently or separately so that each spiked fastener 130 can be opened and closed independently or separately. The separate / independent movement allows one leaflet to be gripped at a time or allows repositioning of the fastener 130 for a poorly gripped leaflet without changing the normal grip on other leaflets. The spiked fasteners 130 can not only open and close independently of each other, but can also open and close fully regardless of the position of the inner paddle 122, thereby allowing the leaflet to be captured at various positions required by a particular situation.

[0103] The spiked fastener 130 can be opened independently or separately by pulling on an attached actuation line 116 (or other actuation means) that extends through the delivery sheath 102 to the spiked fastener 130. The actuation line 116 can take a variety of forms such as, for example, a line, suture, rod, catheter, etc. The spiked fastener 130 is spring-loaded or otherwise biased to continue to provide a clamping force against the native leaflet captured or gripped by the spiked fastener 130 in the closed position. This clamping force can remain constant or positive regardless of the position of the inner paddle 122. The spike 136 of the spiked fastener 130 can penetrate the native leaflet to further secure it.

[0104] Referring now to FIG. 8, device 100 is shown in an extended or fully open state for deployment from delivery sheath 102. The fully open position occupies the least space and allows for the use of the smallest catheter (or the use of the largest implantable device 100 for a given catheter size), so device 100 is loaded into delivery sheath 102 in the fully open position. In the extended state, cap 114 is spaced from engagement element 110 such that paddles 120, 122 of anchor portion 106 are fully open or fully expanded. In some embodiments, the angle formed between the inside of outer and inner paddles 120, 122 is about 180 degrees. Barbed fastener 130 is kept in a closed state while being deployed through delivery sheath 102 so that barbs 136 (FIG. 11) do not catch or damage the sheath or tissue within the patient's heart.

[0105] Referring now to FIG. 9, device 100 is shown in a state of releasing a similar elongated entanglement as in FIG. 8, but barbed fastener 130 is in a fully open position of about 140 degrees to about 200 degrees, about 170 degrees to about 190 degrees, or about 180 degrees between the fixed and movable portions of barbed fastener 130. It has been found that fully opening paddles 120, 122 and fastener 130 improves the ease of detangling from the patient's anatomical structure during implantation of device 100.

[0106] Referring now to FIG. 10, device 100 is shown in a shortened or 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 extended state to the shortened state, actuation element 112 is retracted to pull cap 114 toward engagement element 110. A joint, hinge, or flexible connection 126 between outer paddle 120 and inner paddle 122 restricts or constrains movement such that a compressive force acting on outer paddle 120 from cap 114 being retracted toward engagement element 110 moves paddles 120, 122 or gripping elements radially outward. During movement from the open position to the closed position, outer paddle 120 maintains an acute angle with actuation element 112. Outer paddle 120 may optionally be biased toward the closed position. Inner paddle 122 during the same movement is oriented in a direction away from engagement element 110 in the open state and collapses along the side of engagement element 110 in the closed position, thus moving through a much larger angle. In some embodiments, inner paddle 122 is thinner and / or narrower than outer paddle 120, and joints, hinges, or flexible portions 126, 128 connected to inner paddle 122 may be thinner and / or more flexible. For example, this increased flexibility can allow for more movement than joint, hinge, or flexible portion 124 connecting 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 may be more flexible, for example, to allow for more movement than joint or flexible portion 124 connecting outer paddle 120 to cap 114. In some embodiments, inner paddle 122 may be the same width as, or substantially the same width as, the outer paddle.

[0107] Referring now to FIGS. 11 - 13, device 100 is shown in a partially open, capture - ready, or gripping - ready state. To transition from a fully closed state to a partially open state, the actuating element 112 (e.g., and actuating wire, actuating shaft, etc.) is extended to push the cap 114 away from the joining element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122 and partially deploys the anchor portion 106. The actuating line 116 is also retracted to open the fastener 130 so that the valve tip can be captured or gripped. In some embodiments, such as the example shown by FIG. 11, the pair of inner and outer paddles 122, 120 are moved together by a single actuating element 112, rather than independently. Also, the position of the fastener 130 may depend on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 can also close the fastener. In some embodiments, the paddles 122, 120 may be controllable independently. For example, device 100 can have two actuating elements and two independent caps such that one independent wire and cap are used to control one paddle and the other independent wire and cap are used to control the other paddle.

[0108] Referring now to FIG. 12, one of the actuating lines 116 is extended to enable closing of one of the fasteners 130. Referring now to FIG. 13, the other actuating line 116 is extended to enable closing of the other fastener 130. Either or both of the actuating lines 116 can be actuated repeatedly to repeatedly open and close the ratchet fastener 130.

[0109] Referring now to FIG. 14, device 100 is shown in a fully closed and deployed state. Delivery sheath 102 and actuating element 112 are retracted, and paddles 120, 122 and fastener 130 remain in a fully closed position. When deployed, device 100 can be maintained in a fully closed position using a mechanical latch or biased to remain closed by the use of a spring material such as steel, other metals, plastics, composite materials, or a shape memory alloy such as nitinol. For example, jointed, hinged, or flexible portions 124, 126, 128, 138, and / or additional biasing components can be formed of a metal such as steel or a shape memory alloy such as nitinol, manufactured in wire, sheet, tube, or laser sintered powder, and biased to hold outer paddle 120 closed around joint element or spacer 110 and spiked fastener 130 sandwiched around the natural valve tip. In some embodiments, pads 120, 122 can be configured to open and close in accordance with the heartbeat of the heart and the corresponding opening and closing of the natural valve.

[0110] Referring now to FIGS. 15-20, the implantable device 100 of FIGS. 8-14 is shown being delivered and implanted within the native mitral valve MV of the heart H. Referring now to FIG. 15, the delivery sheath is inserted into the left atrium LA through the septum, and the device 100 is deployed from the delivery sheath in a fully open state. The actuating element 112 is then retracted to move the device 100 to the fully closed state shown in FIG. 16. As seen in FIG. 17, the device 100 is moved to a predetermined position within the mitral valve MV toward the ventricle LV and is partially opened so that the valve leaflets 20, 22 can be captured or grasped. Referring now to FIG. 18, the actuating line 116 is extended to close one of the fasteners 130 and capture the valve leaflet 20. FIG. 19 shows that the other actuating line 116 is then extended to close the other fastener 130 and capture the remaining valve leaflet 22. Finally, as seen in FIG. 20, the delivery sheath 102 as well as the actuating element 112 and the actuating lines 116 are then retracted, and the device 100 is fully closed and deployed within the native mitral valve MV.

[0111] Referring now to FIG. 21, the device 100 of FIGS. 8 - 14 is shown implanted within a native valve, such as a native mitral valve MV, in a fully closed position. The implanted device 100 has an outer paddle 120, an inner paddle 122, a fastener 130, a joining element 110 (such as a spacer, etc.), and a cap 114. The outer paddle 120 and the inner paddle 122 are connected between the cap 114 and the joining element 110 by portions 124, 126, 128 (which may be jointed and / or flexible to move between various positions). The joining element 110 is adapted to be implanted between the valve leaflets 20, 22 of the native valve. The fastener 130 is configured to connect the device 100 to the valve leaflets 20, 22. In some embodiments, the fastener 130 includes a fixed arm attached to the inner paddle 122 and a movable arm 134 having a friction - enhancing element (such as a spine, a ridge, a rough surface, an adhesive, etc.) for engaging the valve leaflets 20, 22 of the native valve. In some embodiments, the device 100 has only one outer paddle 120, only one inner paddle 122, and only one fastener (such as a spined fastener, etc.), which may be configured in different ways.

[0112] Referring to FIGS. 22 - 27, the implantable prosthetic device 100 is attached to the valve leaflets 20, 22 of a native valve (shown as the mitral valve MV, but can be used similarly for other valves such as the tricuspid valve) in a fully closed position. In the embodiments shown in FIGS. 22 - 25, the implantable prosthetic device 100 is attached to the native valve at a substantially central position within the valve annulus 24. However, the implantable prosthetic device 100 can be attached to the valve leaflets 20, 22 at any position within the native valve (such as the positions shown in FIGS. 26 - 27). The device 100 is shown as having a pair of paddles 120, a pair of fasteners 130, a joining element 110, and a cap 114. However, the implantable prosthetic device 100 can take any suitable form, such as any of the forms described in this application, for example.

[0113] Referring to FIGS. 24 and 25, during systole, the valve leaflets 20, 22 join around the implantable patch device 100 to prevent backflow of blood from the left ventricle to the left atrium. However, in certain situations, they may not join completely around the device 100, thereby creating one or more openings or jets 2400 between the device 100 and one or more of the valve leaflets 20, 22. The opening 2400 can be formed where both valve leaflets 20, 22 and the device 100 meet. However, the opening 2400 can be formed at any point where the device 100 and a single valve leaflet 20, 22 meet. These openings 2400 allow blood to flow back into the left atrium during systole.

[0114] Referring to FIGS. 26 and 27, the device 100 can be positioned within the native valve or mitral valve MV near the valve annulus 24. Similar to the device 100 positioned at a more central location within the mitral valve MV (as shown in FIGS. 24 and 25), the opening 2400 can be formed where both valve leaflets 20, 22 and the device 100 meet. As shown in the illustrated embodiment, when the device 100 is positioned near the valve annulus 24, the force exerted by the device 100 on the mitral valve MV may cause a portion of the valve leaflets to bunch up or wrinkle, and the opening 2400 may have a deformed shape. For example, when the device 100 is positioned near the valve annulus, it is more difficult to align the valve leaflets within the device. If the valve leaflets are offset from each other within the device 100, the portion of the valve leaflet adjacent to the valve annulus 24 may bunch up or wrinkle, creating an opening 2400 with a deformed shape on one or both sides of the device.

[0115] Figures 28-91 show various embodiments of an implantable prosthetic device 100 that includes one or more leak control mechanisms or leak control extensions 2800, the leak control extensions 2800 being configured to allow blood to flow through or over the leak control extensions 2800 when the heart is in diastole (i.e., blood flows from the atrium to the ventricle), and to block or deflect at least a portion of the blood that would otherwise flow backward through the opening 2400 when the heart is in systole (i.e., blood flows from the ventricle to the atrium). The leak control extensions 2800 can take a wide variety of different forms. For example, the leak control extensions 2800 can have configurations such as substantially flat deflection paddles, curved deflection paddles, bags or sacks that open towards a cap, deflection paddle and fabric assemblies, and the like. The leak control extensions 2800 can be made from a wide variety of different materials. For example, the leak control extensions can be made from thin plastics, wire frames covered with fabric, fabric without a frame, fabric with a plastic frame, any combination thereof, and the like. The leak control extensions 2800 can be arranged in a wide variety of different ways. For example, the leak control extensions can be arranged below the natural valve leaflet tip, below the lower part of the natural valve leaflet tip, between the lower part of the natural valve leaflet tip and the natural valve annulus, or such that a portion of the leak control extension is below the natural valve leaflet tip and a portion of the leak control extension is between the lower part of the natural valve leaflet tip and the natural valve annulus.

[0116] Figures 28-37 show examples of implantable prosthetic devices 100 attached to the leaflets 20, 22 of a native valve in a fully closed position (e.g., shown as a mitral valve MV, but can be used similarly for other valves such as a tricuspid valve). The device 100 includes one or more leak control extensions 2800. In the embodiments shown in Figures 28-35, the implantable prosthetic device 100 is attached to the native valve at a position substantially centered with respect to the valve annulus 24. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any position within the native valve (e.g., the positions shown in Figures 36-37). The device 100 has a pair of paddles 120, a pair of fasteners 130, a joining element 110 (e.g., a spacer, etc.), a cap 114, and a leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any of the forms described in this application, in combination with the leak control extension 2800, of an implantable prosthetic device disclosed in U.S. Provisional Patent Application No. 62 / 744,031, Patent Cooperation Treaty Application No. PCT / US2019 / 012707, and / or Patent Cooperation Treaty No. PCT / US2018 / 028189.

[0117] In the example shown by FIGS. 28 and 29, the leak control extension 2800 is connected to the upper surface of the cap and includes a deflection paddle 2801 disposed below the natural valve tip. The leak control extension 2800 is configured to prevent blood from the ventricle from reaching the opening 2400 during systole. That is, the leak control extension 2800 extends from the device (e.g., from the cap 114 of the device 100) such that the leak control extension prevents blood from moving through any jet or opening between the valve tips 20, 22 of the natural valve during systole. In the illustrated embodiment, the leak control extension 2800 is disposed within the left ventricle LV when the device 100 is attached to the valve tips 20, 22. In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to the upper surface of the cap 114. Although the illustrated embodiment is shown as having two leak control extensions, it should be understood that the device 100 can have any suitable number of leak control extensions.

[0118] Referring to FIGS. 30 and 31, during diastole, the valve tips 20, 22 of the mitral valve MV open and blood moves from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the valve tips 20, 22, when the valve tips 20, 22 are in the open position, the portion 3003 of the mitral valve MV is substantially blocked by the device 100 and the other portion 3005 of the mitral valve is open to allow blood to move into the left ventricle LV. The blood moves in direction D through the open portion 3005 and engages the deflection paddle 2801 of the leak control extension 2800. In some embodiments, the blood provides a force to the deflection paddle 2801 that pivots the deflection paddle 2801 around the cap 114 or flexes the deflection paddle 2801 relative to the cap 114 such that the blood moves around the leak control extension 2800 in direction X.

[0119] Referring to FIGS. 32-35, during systole, the leaflets 20, 22 of the mitral valve MV are joined to prevent blood from flowing back into the left atrium LA as blood is being pushed out of the left ventricle into the aorta, and the device 100 is connected to the leaflets 20, 22 to assist in joining or facilitating the joining of the leaflets. However, in certain situations, the leaflets 20, 22 may not fully join around the device 100, thereby creating one or more openings or jets 2400 between the device 100 and one or more of the leaflets 20, 22. The opening 2400 may be formed at the location where both leaflets 20, 22 and the device 100 meet. However, the opening 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 meet. The leak control extension 2800 is arranged to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0120] Referring to FIGS. 32 and 33, contraction of the left ventricle LV pushes blood towards the mitral valve MV in direction Y and engages the deflection paddle 2801 of the leak control extension 2800, which prevents blood from moving through the opening 2400 into the left atrium LA. In some embodiments, the blood provides a force against the deflection paddle 2801 that pivots the deflection paddle 2801 around the cap 114 or bends it relative to the cap such that the force is directed away from the opening 2400 around the leak control extension 2800 in direction Z.

[0121] Referring to FIGS. 36 and 37, the device 100 shown in FIGS. 28 - 35 can be disposed within the native valve at a location near the valve annulus 24. Similar to the device 100 disposed at a more central location within the native valve (as shown in FIGS. 28 - 35), an opening 2400 can be formed at the location where both valve leaflets 20, 22 and the device 100 intersect. As shown in the illustrated embodiment, when the device 100 is disposed near the valve annulus 24, the force of the device 100 on the native valve can cause the opening 2400 adjacent to the valve annulus 24 to have a deformed shape. In some embodiments, the leak control extension 2800 is flexible such that a force applied to the leak control extension compresses the leak control extension. For example, as shown in FIGS. 36 and 37, the leak control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the ventricular sidewall), which compresses the leak control extension 2800 into a deformed shape. This compression of the leak control extension 2800 enables the leak control extension to cover the deformed opening 2400 adjacent to the valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be disposed within the native valve at various locations without causing irritation to the valve annulus 24 or the ventricular or atrial sidewalls. Additionally, the flexible leak control extension 2800 is advantageous because it can take the form of any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0122] Figures 38A-47A show examples of implantable patch devices 100 attached to the leaflets 20, 22 of a native valve in a fully closed position (e.g., shown as a mitral valve MV, but can be used similarly for other valves such as a tricuspid valve), and the device 100 includes one or more leak control extensions 2800. In the embodiments shown in Figures 38A-45A, the implantable patch device 100 is attached to the native valve at a substantially central position within the valve annulus 24. However, it should be understood that the implantable patch device 100 can be attached to the leaflets 20, 22 at any position within the native valve (e.g., the positions shown in Figures 46A-47A). The device 100 has a pair of paddles 120, a pair of fasteners 130, a joining element 110 (e.g., a spacer, etc.), a cap 114, and at least one leak control extension 2800. However, the implantable patch device 100 can take any suitable form, such as any form described in this application in combination with, for example, at least one leak control extension 2800.

[0123] The leak control extension 2800 is configured to prevent blood from flowing back from the ventricle to the atrium during systole. That is, the leak control extension 2800 is arranged such that the leak control extension prevents blood from moving through any jets or openings between the leaflets 20, 22 of the mitral valve MV during systole, and extends from the device (e.g., from the end of the cap 114 of the device 100). In the illustrated embodiment, the leak control extension 2800 includes a deflecting paddle 2801 that is disposed within the left ventricle LV when the device is attached to the leaflets 20, 22. In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to the bottom surface of the cap 114. The leak control extensions 2800 can be connected to each other (as shown in the illustrated embodiment), or the leak control extensions 2800 can be separate extensions. The illustrated embodiment is shown as having two leak control extensions 2800, but the device 100 can have any suitable number of leak control extensions.

[0124] Referring to FIGS. 40A and 41A, during diastole, the leaflets 20, 22 of the mitral valve MV open and blood moves from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20, 22, when the leaflets 20, 22 are in the open position, the portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open so that blood can move into the left ventricle LV. The blood moves in direction D through the open portion 3005 and engages the leakage control extension 2800. In some embodiments, the blood provides a force on the leakage control extension 2800 that pivots the leakage control extension 2800 around the cap 114 or flexes it relative to the cap so that the blood moves around the leakage control extension 2800 in direction X.

[0125] Referring to FIGS. 42A-45A, during systole, the leaflets 20, 22 of the mitral valve MV join to prevent blood from flowing back into the left atrium LA when blood is being ejected from the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to assist in joining or facilitating the joining of the leaflets. However, in certain situations, the leaflets 20, 22 may not join completely around the device 100, thereby forming one or more openings or jets 2400 between the device 100 and one or more of the leaflets 20, 22. The openings 2400 may be formed at the location where both leaflets 20, 22 and the device 100 meet. However, the openings 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 meet. The leakage control extension 2800 may be arranged to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0126] Referring to FIGS. 42A and 43A, the contraction of the left ventricle LV pushes the blood towards the mitral valve MV in direction Y, engaging the deflection paddle 2801 of the leakage control extension 2800, which prevents the blood from moving through the opening 2400 into the left atrium LA. In some embodiments, the blood provides a force against the deflection paddle 2801 that pivots the deflection paddle 2801 around the cap 114 or flexes it relative to the cap so that the blood moves around the leakage control extension 2800 in direction Z.

[0127] Referring to FIGS. 46A and 47A, the device 100 shown in FIGS. 38A-45A can be disposed within the mitral valve MV at a location near the valve annulus 24. Similar to the device 100 disposed at a more central location within the mitral valve MV (as shown in FIGS. 38A-45A), an opening 2400 can be formed at the location where both valve leaflets 20, 22 and the device 100 intersect. As shown in the illustrated embodiment, when the device 100 is disposed near the valve annulus 24, the force exerted by the device 100 on the mitral valve MV can cause the opening 2400 adjacent to the valve annulus 24 to have a deformed shape. In some embodiments, the leakage control extension 2800 is flexible such that a force applied to the leakage control extension compresses the leakage control extension. For example, as shown in FIGS. 46A and 47A, the leakage control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the side wall of the left ventricle LV), which compresses the leakage control extension 2800 into a deformed shape. This compression of the leakage control extension 2800 enables the leakage control extension to cover the deformed opening 2400 adjacent to the valve annulus 24. The flexible leakage control extension 2800 is advantageous because it allows the device 100 to be disposed within the native valve at various locations. In addition, the flexible leakage control extension 2800 is advantageous because it can take the form necessary to block blood flow through any deformed openings caused by the connection between the device 100 and the valve leaflets 20, 22.

[0128] FIG. 78 shows a more specific example of the implantable prosthesis device 100 shown in FIGS. 38A-47A. The device 100 includes a pair of paddles 120, a pair of fasteners (not shown), a joining element (e.g., a spacer, etc.), a cap 114, and a pair of leak control extensions 2800. The leak control extensions 2800 have a deflectable paddle 2801 that includes a flexible frame 7801 and a barrier material 7803. The flexible frame 7801 can be made of, for example, a metal wire such as steel or nitinol wire, plastic, etc. The barrier material 7803 can take a wide variety of forms. For example, the barrier material can be a cloth material, a biocompatible material, bovine or porcine heart tissue, and a plastic film, etc. In the illustrated embodiment, the flexible frame 7801 of each leak control extension 2800 is attached to the leading edge 7810 and the trailing edge 7812 of the cap 114, and the barrier material 7803 is optionally attached to the side edges 7811, 7813 of the cap 114. This connection between the leak control extension 2800 and the cap 114 allows the leak control extension 2800 to pivot or bend around the side edges 7811, 7813 of the cap.

[0129] FIG. 79 shows a more specific example of the implantable prosthesis device 100 shown in FIGS. 38A-47A, and the leak control extension 2800 has a different shape than the example of FIG. 78. For example, the leak control extension has a narrower shape. Although various exemplary shapes are shown, various different shapes are possible, such as triangular, circular, rectangular, oval, elliptical, etc. In one exemplary implementation, the shape of the leak control extension 2800 can be changed by bending it before the device 100 is implanted. The device 100 includes a pair of paddles 120, a pair of fasteners (not shown), a joining element (such as a spacer, etc.), a cap 114, and a pair of leak control extensions 2800. The leak control extension 2800 has a deflecting paddle 2801 that includes a flexible frame 7901 and a barrier material 7903. The flexible frame 7901 can be made of, for example, a metal wire such as steel or nitinol wire, plastic, etc. In one exemplary implementation, the flexible frame is made of a plastically deformable material to allow the shape of the flexible frame 7901 to be changed before implantation. The barrier material 7903 can take a wide variety of forms. For example, the barrier material can be a cloth material, a biocompatible material, bovine or porcine heart tissue, and a plastic film, etc. In the illustrated embodiment, the flexible frame 7901 of each leak control extension 2800 is attached to the leading edge 7910 and the trailing edge 7912 of the cap 114, and the barrier material 7903 is optionally attached to the side edges 7911, 7913 of the cap 114. This connection between the leak control extension 2800 and the cap 114 allows the leak control extension 2800 to pivot or bend around the side edges 7911, 7913 of the cap.

[0130] Figures 38B - 47B show examples of implantable prosthetic devices 100 attached to the leaflets 20, 22 of a native valve in a fully closed position (e.g., shown as a mitral valve MV, but can be used similarly for other valves such as a tricuspid valve), and the device 100 includes one or more leakage control extensions 2800. In the embodiments shown in Figures 38B - 45B, the implantable prosthetic device 100 is attached to the native valve at a substantially central position within the valve annulus 24. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any position within the native valve (e.g., the positions shown in Figures 46B - 47B).

[0131] In some implementations, the device 100 has a pair of paddles 120, a pair of fasteners 130, a joining element 110 (e.g., a spacer, etc.), a cap 114, and at least one leakage control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described in this application in combination with, for example, at least one leakage control extension 2800.

[0132] In some implementations, the leakage control extension 2800 is configured to prevent or inhibit blood from flowing back from the ventricle to the atrium during systole. That is, the leakage control extension 2800 extends from the device (e.g., from the end of the cap 114 of the device 100) such that the leakage control extension is positioned to prevent blood from moving through any jets or openings between the leaflets 20, 22 of the native valve during systole. In the illustrated embodiment, the leakage control extension 2800 includes a deflector paddle 2801 that is disposed within the ventricle when the device is attached to the leaflets 20, 22, and the deflector paddle 2801 is attached to the spacer 110 by one or more arms 3803.

[0133] In some embodiments, the arm 3803 secures the deflection paddle 2801 to the spacer 110 to prevent the deflection paddle 2801 from moving to a position where it cannot prevent backflow of blood during systole. The arm 3803 can be made of, for example, a fabric material, a suture, a wire, any combination thereof, or any other suitable material or component capable of securing the deflection paddle to the spacer 110. The illustrated embodiment shows an arm 3803 connecting the deflection paddle 2801 to the spacer 110, but it should be understood that the arm 3803 can connect the deflection paddle 2801 to any other part of the device 100 that prevents undesired movement of the deflection paddle.

[0134] In the example shown, the device 100 has two leak control extensions 2800, each leak control extension 2800 including a deflection paddle 2801 attached to the bottom surface of the cap 114. The deflection paddles 2801 can be connected to each other (as shown in the illustrated embodiment), or the deflection paddles 2801 can be separate extensions. The illustrated embodiment is shown as having two leak control extensions 2800, but it should be understood that the device 100 can have any suitable number of leak control extensions.

[0135] Referring to the examples shown in FIGS. 40B and 41B, during diastole, the leaflets 20, 22 of the mitral valve MV open and blood moves from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20, 22, when the leaflets 20, 22 are in the open position, the portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open so that blood can move into the left ventricle LV. The blood moves in direction D through the open portion 3005 and engages the leakage control extension 2800. In some embodiments, the blood provides a force against the leakage control extension 2800 that pivots the leakage control extension 2800 around the cap 114 or flexes it relative to the cap so that the blood moves around the leakage control extension 2800 in direction X.

[0136] Referring to FIGS. 42B - 45B, during systole, the leaflets 20, 22 of the mitral valve MV join to prevent blood from flowing back into the left atrium LA when the blood is pushed out of the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain situations, the leaflets 20, 22 may not fully join around the device 100, thereby forming one or more openings or jets 2400 between the device 100 and one or more of the leaflets 20, 22. The opening 2400 can be formed where both leaflets 20, 22 and the device 100 meet. However, the opening 2400 can also be formed at any point where the device 100 and a single leaflet 20, 22 meet. The leakage control extension 2800 can be arranged to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0137] Referring to FIGS. 42B and 43B, the contraction of the left ventricle LV pushes blood towards the mitral valve MV in direction Y, engaging the deflection paddle 2801 of the leakage control extension 2800, which prevents blood from moving through the opening 2400 into the left atrium LA. In some embodiments, the blood provides a force against the deflection paddle 2801 that pivots the deflection paddle 2801 around the cap 114 or flexes it relative to the cap so that the blood moves around the leakage control extension 2800 in direction Z.

[0138] Referring to FIGS. 46B and 47B, the device 100 shown in FIGS. 38B - 45B can be disposed within the native valve at a location near the valve annulus 24. Similar to the device 100 disposed at a more central location within the native valve (as shown in FIGS. 38B - 45B), an opening 2400 can be formed at the location where both valve leaflets 20, 22 and the device 100 intersect. As shown in the illustrated embodiment, when the device 100 is disposed near the valve annulus 24, the force of the device 100 on the native valve can cause the opening 2400 adjacent to the valve annulus 24 to have a deformed shape. In some embodiments, the leakage control extension 2800 is flexible such that a force applied to the leakage control extension compresses the leakage control extension. For example, as shown in FIGS. 46B and 47B, the leakage control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the ventricular side wall), which compresses the leakage control extension 2800 into a deformed shape. This compression of the leakage control extension 2800 allows the leakage control extension to cover the deformed opening 2400 adjacent to the valve annulus 24. The flexible leakage control extension 2800 is advantageous because it allows the device 100 to be disposed within the native valve at various locations. In addition, the flexible leakage control extension 2800 is advantageous because it can take the form necessary to block blood flow through any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0139] Figures 48A - 57A show examples of implantable prosthetic devices 100 attached to the leaflets 20, 22 of a native valve (shown, for example, as a mitral valve MV, but can be used similarly for other valves such as a tricuspid valve) in a fully closed position. The device 100 includes one or more leakage control extensions 2800. In the embodiments shown in Figures 48A - 55A, the implantable prosthetic device 100 is attached to the native valve at a substantially central location and has a leakage control extension 2800 between the bottom of the native valve leaflet and the native valve annulus. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any location (for example, the locations shown in Figures 56A - 57A). The device 100 has a pair of paddles 120, a pair of fasteners 130, a joining element 110 (such as a spacer, etc.), a cap 114, and at least one leakage control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any of the forms described in this application in combination with, for example, at least one leakage control extension 2800.

[0140] The leakage control extension 2800 is configured to prevent blood from flowing back from the ventricle to the atrium during systole. That is, the leakage control extension 2800 extends from the device such that the leakage control extension is positioned to block blood moving through the opening between the valve leaflets 20, 22 of the native valve during systole. In the illustrated embodiment, the leakage control extension 2800 includes a pocket configured to receive blood to prevent blood from moving into the atrium. In some implementations, the leakage control extension 2800 can have a flexible frame or loop 4801 that defines the opening of the pocket and a barrier material 4803 that defines the interior of the pocket. The flexible frame 4801 can have any suitable shape for defining the opening of the pocket, such as, for example, circular, elliptical, triangular, polygonal, etc. (as shown in FIGS. 54A - 57A). The flexible frame 4801 can be made from, for example, a metal wire such as steel or nitinol wire, plastic, etc. The barrier material 4803 is configured to trap blood so that blood does not move through the leakage control extension 2800. The barrier material 4803 can be made from, for example, a cloth material, a biocompatible material, bovine or porcine heart tissue, a plastic film, etc.

[0141] In the illustrated embodiment, device 100 has two leak control extensions 2800 attached to a joining element or spacer 110. In some embodiments, the openings of the leak control extensions 2800 are positioned within the atrium when device 100 is attached to valve leaflets 20, 22 (see FIG. 55A). However, leak control extensions 2800 can be attached to any other part of device 100 that allows the leak control extensions 2800 to be positioned to prevent blood from flowing back into the atrium, and the openings of the leak control extensions 2800 can be within either the atrium or ventricle. For example, leak control extensions 2800 can be attached to a pair of paddles 120, a pair of fasteners 130, joining element 110, cap 114, or any combination thereof. Although the illustrated embodiment is shown as having two leak control extensions 2800, it should be understood that device 100 can have any suitable number of leak control extensions.

[0142] Referring to FIGS. 50A and 51A, during diastole, the leaflets 20, 22 of the mitral valve MV open and blood moves from the left atrium LA to the left ventricle LV. Since device 100 is connected to leaflets 20, 22, when leaflets 20, 22 are in the open position, portion 3003 of the mitral valve MV is substantially blocked by device 100 and the other portion 3005 of the mitral valve is open to allow blood to move into the left ventricle LV. Blood moves in direction D through the open portion 3005 and engages the leak control extensions 2800. In some embodiments, the blood provides a force against the barrier material 4803 of the leak control extensions 2800, which compresses the barrier material 4803 and moves the blood around the leak control extensions 2800 in the X direction.

[0143] Referring to FIGS. 52A-55A, during systole, the leaflets 20, 22 of the mitral valve MV are joined to prevent blood from flowing back into the left atrium LA as blood is ejected from the left ventricle into the aorta, and the device 100 is connected to the leaflets 20, 22 to assist in joining or facilitating the joining of the leaflets. However, in certain situations, the leaflets 20, 22 may not fully join around the device 100, thereby creating one or more openings or jets 2400 between the device 100 and one or more of the leaflets 20, 22. The opening 2400 may be formed at the location where both leaflets 20, 22 and the device 100 meet. However, the opening 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 meet. The leak control extension 2800 may be arranged to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0144] Referring to FIGS. 52A and 53A, contraction of the left ventricle LV pushes blood towards the mitral valve MV in direction Y, engaging the leak control extension 2800 within the mitral valve, which prevents additional blood from moving through the opening 2400 into the left atrium LA. In some embodiments, such as the illustrated embodiment, the blood enters the leak control extension 2800 and provides a force to expand the barrier material 4803 against the barrier material 4803.

[0145] Referring to FIGS. 56A and 57A, the device 100 shown in FIGS. 48A-55A can be disposed within the mitral valve MV at a location near the valve annulus 24. Similar to the device 100 disposed at a more central location within the mitral valve MV (as shown in FIGS. 48A-55A), an opening 2400 can be formed at the location where both valve leaflets 20, 22 and the device 100 intersect. As shown in the illustrated embodiment, when the device 100 is disposed near the valve annulus 24, the force exerted by the device 100 on the mitral valve MV can cause the opening 2400 adjacent to the valve annulus 24 to have a deformed shape. In some embodiments, the flexible frame 4801 of the leak control extension 2800 is flexible such that a force applied to the leak control extension 2800 compresses the flexible frame 4801. For example, as shown in FIGS. 56A and 57A, the leak control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the side wall of the left ventricle LV), which compresses the flexible frame 4801 into a deformed shape. This compression of the flexible frame 4801 enables the leak control extension to cover the deformed opening 2400 adjacent to the valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be disposed within the mitral valve MV at various locations. In addition, the flexible leak control extension 2800 is advantageous because it can take the form of any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0146] Figures 80 and 81 show more specific examples of the implantable prosthetic device 100 shown in FIGS. 48A - 57A. The device 100 includes a pair of paddles 120, a pair of fasteners (not shown), a joining element (e.g., a spacer, etc.), a cap 114, and a pair of leak control extensions 2800. The leak control extension 2800 has a flexible frame 4801 that defines the opening 8005 of the pocket and a barrier material 4803 that defines the interior of the pocket. In the illustrated embodiment, the flexible frame 4801 is formed to give the opening 8005 a circular shape. The barrier material 4803 is configured to capture blood so that blood does not move through the leak control extension 2800.

[0147] Figs. 48B - 57B show an exemplary implantable prosthetic device 100 attached to the leaflets 20, 22 of a native valve in a fully closed position (e.g., shown as the mitral valve MV, but can be used similarly for other valves such as the tricuspid valve). The device 100 includes one or more leak control extensions 2800. In the embodiments shown in Figs. 48B - 55B, the implantable prosthetic device 100 is attached to the native valve at a substantially central location and has the leak control extension 2800 between the bottom of the native valve leaflet and the native valve annulus. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any location (e.g., the locations shown in Figs. 56B - 57B). The device 100 has a pair of paddles 120, a pair of fasteners 130, a joining element 110 (e.g., a spacer, etc.), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described in this application in combination with, for example, at least one leak control extension 2800.

[0148] The leakage control extension 2800 is configured to prevent blood from flowing back from the ventricle to the atrium during systole. That is, the leakage control extension 2800 extends from the device such that the leakage control extension is positioned to block blood moving through the opening between the valve leaflets 20, 22 of the native valve during systole. In the illustrated embodiment, the leakage control extension 2800 is a pocket configured to receive blood to prevent blood from moving into the atrium. In some implementations, the leakage control extension 2800 can have a flexible frame or loop 4801 that defines the opening of the pocket and a barrier material 4803 that defines the interior of the pocket. The flexible frame 4801 can have any suitable shape for defining the opening of the pocket, such as, for example, circular, elliptical, triangular, polygonal, etc. (as shown in FIGS. 54B - 57B). The flexible frame 4801 can be made from, for example, a metal wire such as steel or nitinol wire, plastic, etc. The barrier material 4803 is configured to capture blood so that blood does not move through the leakage control extension 2800. The barrier material 4803 can be made from, for example, a cloth material, a biocompatible material, bovine or porcine heart tissue, a plastic film, etc.

[0149] In the illustrated embodiment, device 100 has two leak control mechanisms or leak control extensions 2800 attached to a junction element or spacer 100 (see FIG. 55B). In the illustrated embodiment, when device 100 is attached to valve leaflets 20, 22, a portion of leak control extension 2800 is within the atrium and another portion of leak control extension 2800 is within the ventricle such that the opening of leak control extension 2800 is disposed within the ventricle. However, leak control extension 2800 can be attached to any other portion of device 100 that allows leak control extension 2800 to be positioned to prevent blood from flowing back into the atrium, and the opening of leak control extension 2800 can be within either the atrium or the ventricle. For example, leak control extension 2800 can be attached to a pair of paddles 120, a pair of fasteners 130, junction element 110, cap 114, or any combination thereof. The illustrated embodiment is shown as having two leak control extensions 2800, but it should be understood that device 100 can have any suitable number of leak control extensions.

[0150] Referring to FIGS. 50B and 51B, during diastole, the leaflets 20, 22 of the mitral valve MV open and blood moves from the left atrium LA to the left ventricle LV. Since device 100 is connected to leaflets 20, 22, when leaflets 20, 22 are in the open position, portion 3003 of the mitral valve MV is substantially blocked by device 100 and the other portion 3005 of the mitral valve is open to allow blood to move into the left ventricle LV. Blood moves in direction D through the open portion 3005 and engages leak control extension 2800. In some embodiments, the blood provides a force against barrier material 4803 of leak control extension 2800, which compresses barrier material 4803 and moves the blood around leak control extension 2800 in the X direction.

[0151] Referring to FIGS. 52B - 55B, during systole, the leaflets 20, 22 of the mitral valve MV are joined to prevent blood from flowing back into the left atrium LA as blood is ejected from the left ventricle LV into the aorta, and the device 100 is connected to the leaflets 20, 22 to assist in joining or facilitating the joining of the leaflets. However, in certain situations, the leaflets 20, 22 may not join completely around the device 100, thereby forming one or more openings or jets 2400 between the device 100 and one or more of the leaflets 20, 22. The openings 2400 can be formed at the location where both leaflets 20, 22 and the device 100 intersect. However, the openings 2400 can also be formed at any point where the device 100 and a single leaflet 20, 22 intersect. The leakage control extension 2800 is arranged to prevent blood from flowing back into the left atrium through one or more of the openings 2400.

[0152] Referring to FIGS. 52B and 53B, contraction of the left ventricle LV pushes blood towards the mitral valve MV in direction Y, engaging the leakage control extension 2800 within the mitral valve, which prevents additional blood from moving through the openings 2400 into the left atrium LA. In some embodiments, such as the illustrated embodiment, blood enters the leakage control extension 2800 and provides a force to expand the barrier material 4803 against the barrier material 4803.

[0153] Referring to FIGS. 56B and 57B, the device 100 shown in FIGS. 48B - 55B can be disposed within the native valve at a location near the valve annulus 24. Similar to the device 100 disposed at a more central location within the native valve (as shown in FIGS. 54B - 55B), an opening 2400 can be formed at the location where both valve leaflets 20, 22 and the device 100 intersect. As shown in the illustrated embodiment, when the device 100 is disposed near the valve annulus 24, the force exerted by the device 100 on the native valve can cause the opening 2400 adjacent to the valve annulus 24 to have a deformed shape. In some embodiments, the flexible frame 4801 of the leak control extension 2800 is flexible such that a force applied to the leak control extension 2800 compresses the flexible frame 4801. For example, as shown in FIGS. 56B and 57B, the leak control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the ventricular side wall), which compresses the flexible frame 4801 into a deformed shape. This compression of the flexible frame 4801 enables the leak control extension to cover the deformed opening 2400 adjacent to the valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be disposed within the native valve at various locations. Additionally, the flexible leak control extension 2800 is advantageous because it can conform to any deformed opening configuration caused by the connection between the device 100 and the native valve leaflets.

[0154] Figures 58-67 illustrate examples of implantable patch devices 100 attached to the leaflets 20, 22 of a native valve (shown, for example, as a mitral valve MV, but which can be used similarly for other valves such as a tricuspid valve). In the embodiments shown in Figures 58-65, the implantable patch device 100 is attached to the native valve at a substantially central location of the leaflet. However, it should be understood that the implantable patch device 100 can be attached to the leaflets 20, 22 at any location (such as the locations shown in Figures 56A-57A). In the examples shown by Figures 58-67, the leak control extension 2800 is disposed between the end of the native valve leaflet and the native valve annulus. The device 100 includes a pair of paddles 120, a pair of fasteners 130, a joining element 110 (such as a spacer, etc.), a cap 114, and at least one leak control extension 2800. However, the implantable patch device 100 can take any suitable form, such as any form described in this application in combination with, for example, at least one leak control extension 2800.

[0155] The leak control extension 2800 is configured to prevent blood from flowing back from the ventricle to the atrium during systole. In the examples shown by Figures 58-67, the leak control extension 2800 extends from the device such that the leak control extension is disposed to block blood flowing through the opening between the leaflets 20, 22 of the native valve during systole. In the illustrated embodiment, the leak control extension 2800 is a pocket configured to receive blood in order to block the blood within the native valve that is moving towards the atrium.

[0156] In some embodiments, the leak control extension 2800 can have a flexible frame or loop 4801 that defines the opening of the pocket and a barrier material 4803 that defines the interior of the pocket. The flexible frame 4801 can have any suitable shape for defining the opening of the pocket, such as, for example, circular, elliptical, triangular, polygonal, etc. (as shown in FIGS. 64-67). The flexible frame 4801 can be made from, for example, a metal wire such as steel or nitinol wire, plastic, or the like. The barrier material 4803 is configured to capture blood so that blood does not move through the leak control extension 2800. The barrier material 4803 can be made from, for example, a cloth material, a biocompatible material, bovine or porcine heart tissue, a plastic film, or the like.

[0157] In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to the device 100 at a junction element or spacer 100 at the top of the device 100. In some embodiments, the opening of the leak control extension 2800 is disposed approximately midway between the natural valve annulus and the end of the natural valve leaflets when the device 100 is attached to the valve leaflets 20, 22. The leak control extension 2800 can be attached to any other part of the device 100 that allows the leak control extension 2800 to be positioned to prevent all or a portion of the blood from flowing back into the atrium, and the opening of the leak control extension 2800 can be in either the atrium or the ventricle. For example, the leak control extension 2800 can be attached to a pair of paddles 120, a pair of fasteners 130, a junction element 110, a cap 114, or any combination thereof. Additionally, the leak control extension 2800 can be disposed at any position along the height of the device 100. The illustrated embodiment is shown as having two leak control extensions 2800, but it should be understood that the device 100 can have any suitable number of leak control extensions.

[0158] Referring to FIGS. 60 and 61, during diastole, the leaflets 20, 22 of the native valve (shown as the mitral valve MV) open and blood moves from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20, 22, when the leaflets 20, 22 are in the open position, the portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open so that blood can move into the left ventricle LV. The blood moves in direction D through the open portion 3005 and engages the leakage control extension 2800. In some embodiments, the blood provides a force against the barrier material 4803 of the leakage control extension 2800, and this force compresses the barrier material 4803 and moves the blood around the leakage control extension 2800 in the X direction.

[0159] Referring to FIGS. 62-65, during systole, the leaflets 20, 22 of the mitral valve MV join to prevent blood from flowing back into the left atrium LA when the blood is being pushed out of the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain situations, the leaflets 20, 22 may not join completely around the device 100, thereby forming one or more openings or jets 2400 between the device 100 and one or more of the leaflets 20, 22. The openings 2400 can be formed at the location where both leaflets 20, 22 and the device 100 meet. However, the openings 2400 can also be formed at any point where the device 100 and a single leaflet 20, 22 meet. The leakage control extension 2800 is arranged to prevent blood flowing back through one or more of the openings 2400 from flowing into the left atrium.

[0160] Referring to FIGS. 62 and 63, the contraction of the left ventricle LV pushes the blood towards the mitral valve MV in the direction Y, through the opening 2400, and engages with the leakage control extension 2800. This engagement with the leakage control extension 2800 prevents the blood flowing through the opening 2400 from flowing into the left atrium LA. In some embodiments, such as the illustrated embodiment, the blood enters the leakage control extension 2800 and provides the barrier material 4803 with a force to expand the barrier material 4803.

[0161] Referring to FIGS. 66 and 67, the device 100 shown in FIGS. 58 - 65 can be disposed within the native valve at a location near the valve annulus 24. Similar to the device 100 disposed at a more central location within the native valve (as shown in FIGS. 58 - 65), an opening 2400 can be formed at the location where both valve leaflets 20, 22 and the device 100 intersect. As shown in the illustrated embodiment, when the device 100 is disposed near the valve annulus 24, the force exerted by the device 100 on the native valve can cause the opening 2400 adjacent to the valve annulus 24 to have a deformed shape. In some embodiments, the flexible frame 4801 of the leakage control extension 2800 is flexible such that a force applied to the leakage control extension 2800 compresses the flexible frame 4801. For example, as shown in FIGS. 66 and 67, the leakage control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the ventricular side wall), which compresses the flexible frame 4801 into a deformed shape. This compression of the flexible frame 4801 enables the leakage control extension to cover the deformed opening 2400 adjacent to the valve annulus 24. The flexible leakage control extension 2800 is advantageous because it allows the device 100 to be disposed within the native valve at various locations without causing irritation to the valve annulus 24 or the ventricular or atrial side walls. In addition, the flexible leakage control extension 2800 is advantageous because it can be configured to block the flow through any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0162] Figures 68-77 show examples of implantable prosthetic devices 100 attached to the leaflets 20, 22 of a native valve in a fully closed position (e.g., shown as a mitral valve MV, but can be used similarly for other valves such as a tricuspid valve). In the embodiments shown in Figures 68-75, the implantable prosthetic device 100 is attached to the native valve at a substantially central position within the valve annulus 24. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any position within the native valve (e.g., the positions shown in Figures 66-67). The device 100 includes a pair of paddles 120, a pair of fasteners 130, a joining element 110 (e.g., a spacer, etc.), a cap 114, and at least one leakage control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described in this application in combination with, for example, at least one leakage control extension 2800.

[0163] The leakage control extension 2800 is configured to prevent blood from flowing back from the ventricle to the atrium during systole. That is, the leakage control extension 2800 extends from the device such that the leakage control extension is positioned to prevent blood from moving through any jets or openings between the leaflets 20, 22 of the native valve during systole. In the illustrated embodiment, the leakage control extension 2800 is a pocket configured to receive blood to prevent blood from moving into the atrium. In some implementations, the leakage control extension 2800 includes a flexible frame 4801 that defines an opening of the pocket and a barrier material 4803 that defines the interior of the pocket.

[0164] The flexible frame 4801 can have any suitable shape for defining the opening of the pocket, such as circular, elliptical, triangular, polygonal, etc. (as shown in FIGS. 74-77). The flexible frame 4801 can be made of, for example, a metal wire such as steel or nitinol wire, plastic, etc. The barrier material 4803 is configured to capture blood so that blood does not move through the leak control extension 2800. The barrier material 4803 can be made of, for example, a cloth material, a biocompatible material, bovine or porcine heart tissue, a plastic film, etc. In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to the cap 114.

[0165] In some embodiments, the opening of the leak control extension 2800 is positioned within the ventricle when the device 100 is attached to the valve leaflets 20, 22. The leak control extension 2800 can be attached to any other position of the device 100 that allows the leak control extension 2800 to be positioned to prevent blood from flowing back into the atrium, and the opening of the leak control extension 2800 can be within either the atrium or the ventricle. For example, the leak control extension 2800 can be attached to a pair of paddles 120, a pair of fasteners 130, the joining element 110, the cap 114, or any combination thereof. In addition, the leak control extension 2800 can be positioned at any location along the height of the device 100. Although the illustrated embodiment is shown as having two leak control extensions 2800, it should be understood that the device 100 can have any suitable number of leak control extensions.

[0166] Referring to FIGS. 70 and 71, during diastole, the leaflets 20, 22 of the native valve (shown as the mitral valve MV) open and blood moves from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20, 22, when the leaflets 20, 22 are in the open position, the portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open so that blood can move into the left ventricle LV. The blood moves in the direction D through the open portion 3005 and engages the leak control extension 2800. In some embodiments, the blood provides a force against the barrier material 4803 of the leak control extension 2800, and this force compresses the barrier material 4803 and moves the blood around the leak control extension 2800 in the X direction.

[0167] Referring to FIGS. 72-75, during systole, the leaflets 20, 22 of the mitral valve MV join to prevent blood from flowing back into the left atrium LA when the blood is pushed out of the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain situations, the leaflets 20, 22 may not fully join around the device 100, thereby forming one or more openings or jets 2400 between the device 100 and one or more of the leaflets 20, 22. The openings 2400 can be formed at the location where both leaflets 20, 22 and the device 100 meet. However, the openings 2400 can also be formed at any point where the device 100 and a single leaflet 20, 22 meet. The leak control extension 2800 is arranged to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0168] Referring to FIGS. 72 and 73, the contraction of the left ventricle LV pushes blood towards the mitral valve MV in direction Y and engages the leakage control extension 2800, which prevents blood from moving through the opening 2400 into the left atrium LA. In some embodiments, such as the illustrated embodiment, blood enters the leakage control extension 2800 and provides a force to the barrier material 4803 that expands the barrier material 4803.

[0169] Referring to FIGS. 66 and 77, the device 100 shown in FIGS. 68 - 75 can be disposed within the native valve at a location near the valve annulus 24. Similar to the device 100 disposed at a more central location within the native valve (as shown in FIGS. 68 - 75), an opening 2400 can be formed at the location where both valve leaflets 20, 22 and the device 100 intersect. As shown in the illustrated embodiment, when the device 100 is disposed near the valve annulus 24, the force exerted by the device 100 on the native valve can cause the opening 2400 adjacent to the valve annulus 24 to have a deformed shape.

[0170] In some embodiments, the flexible frame 4801 of the leakage control extension 2800 is flexible such that a force applied to the leakage control extension 2800 compresses or deforms the flexible frame 4801. For example, as shown in FIGS. 76 and 77, the leakage control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the ventricular side wall), which compresses the flexible frame 4801 into a deformed shape. This compression of the flexible frame 4801 enables the leakage control extension to cover the deformed opening 2400 adjacent to the valve annulus 24. The flexible leakage control extension 2800 is advantageous because it allows the device 100 to be disposed within the native valve at various locations without causing irritation to the valve annulus 24 or the side walls of the left ventricle or atrium. Additionally, the flexible leakage control extension 2800 is advantageous because it can take the form of any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0171] Figures 82-91 show examples of implantable prosthetic devices 100 attached to the leaflets 20, 22 of a native valve in a fully closed position (e.g., shown as a mitral valve MV, but can be used similarly for other valves such as a tricuspid valve), and the device 100 includes one or more leakage control extensions 2800. In the embodiments shown in Figures 82-89, the implantable prosthetic device 100 is attached to the native valve at a substantially central position within the valve annulus 24. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any position within the native valve (e.g., the positions shown in Figures 90-91). The device 100 has a pair of paddles 120, a pair of fasteners 130, a joining element 110 (e.g., a spacer, etc.), a cap 114, and at least one leakage control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described in this application in combination with, for example, at least one leakage control extension 2800.

[0172] The leakage control extension 2800 is configured to prevent blood from flowing back from the ventricle to the atrium during systole. That is, the leakage control extension 2800 is arranged such that the leakage control extension prevents blood from moving through any jets or openings between the valve leaflets 20, 22 of the native valve during systole. The leakage control extension 2800 extends from the device (e.g., from the end of the cap 114 of the device 100) such that the leakage control extension is arranged to prevent blood from moving through any jets or openings between the valve leaflets 20, 22 of the native valve during systole. Each of the leakage control extensions 2800 can include one or more deflection paddles 2801 (or other extension members) and a barrier element 8203. The one or more deflection paddles 2801 can be attached to the cap 114 of the device 100 (or any other part of the device), and the barrier element 8203 can be attached to the paddle 120 and the deflection paddle 2801 to create a barrier that extends from the first paddle 120 of the device 100 to the second paddle of the device 100, and the barrier prevents backflow of blood during diastole. In the illustrated embodiment, each of the leakage control extensions 2800 includes two deflection paddles 2801 attached to the cap 114 and a barrier element 8203 that is connected to and extends from the first paddle 120, the two deflection paddles 2801, and the other paddle 120. The barrier element 8203 can include one or more pieces of material, such as one or more pieces of a cloth material, a biocompatible material, bovine or porcine heart tissue, a plastic film, etc. In the illustrated embodiment, the device 100 has two leakage control extensions 2800, and each leakage control extension 2800 includes one or more deflection paddles 2801 and a barrier material 8203. Although the illustrated embodiment is shown as having two leakage control extensions 2800, it should be understood that the device 100 can have any suitable number of leakage control extensions.

[0173] Referring to FIGS. 84 and 85, during diastole, the leaflets 20, 22 of the mitral valve MV open and blood moves from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20, 22, when the leaflets 20, 22 are in the open position, the portion 3003 of the mitral valve MV is substantially blocked by the device 100 and the other portion 3005 of the mitral valve is open so that blood can move into the left ventricle LV. The blood moves in direction D through the open portion 3005 and engages the leakage control extension 2800. In some embodiments, the blood provides a force to the leakage control extension 2800 that pivots the deflection paddle 2801 around the cap 114 or bends it relative to the cap so that the blood moves around the leakage control extension 2800 in direction X.

[0174] Referring to FIGS. 86 - 89, during systole, the leaflets 20, 22 of the mitral valve MV join to prevent blood from flowing back into the left atrium LA when blood is being ejected from the left ventricle to the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain situations, the leaflets 20, 22 may not join completely around the device 100, thereby forming one or more openings or jets 2400 between the device 100 and one or more of the leaflets 20, 22. The opening 2400 can be formed where both leaflets 20, 22 and the device 100 meet. However, the opening 2400 can also be formed at any point where the device 100 and a single leaflet 20, 22 meet. The leakage control extension 2800 is arranged to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0175] Referring to FIGS. 86 and 87, the contraction of the left ventricle LV pushes blood towards the mitral valve MV in direction Y, engaging the deflection paddles 2801 of the leakage control extension 2800 and the barrier element 8203, which prevents blood from moving through the opening 2400 into the left atrium LA. In some embodiments, the blood provides a force against the deflection paddle 2801 that pivots the deflection paddle 2801 around the cap 114 or flexes it relative to the cap so that the blood moves around the leakage control extension 2800 in direction Z. In some embodiments, the blood provides a force against the barrier element 8203 that moves a portion of the barrier element 8203 disposed between the two deflection paddles 2801 upward.

[0176] Referring to FIGS. 90 and 91, the device 100 shown in FIGS. 82-89 can be disposed within the native valve at a location near the valve annulus 24. Similar to the device 100 disposed at a more central location within the native valve (as shown in FIGS. 82-89), an opening 2400 can be formed at the location where both valve leaflets 20, 22 and the device 100 intersect. As shown in the illustrated embodiment, when the device 100 is disposed near the valve annulus 24, the force of the device 100 on the native valve can cause the opening 2400 adjacent to the valve annulus 24 to have a deformed shape. In some embodiments, the leak control extension 2800 is flexible such that a force applied to the leak control extension compresses the leak control extension. For example, as shown in FIGS. 90 and 91, the leak control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the ventricular sidewall), which compresses the leak control extension 2800 into a deformed shape. This compression of the leak control extension 2800 enables the leak control extension to cover the deformed opening 2400 adjacent to the valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be disposed within the native valve at various locations. Additionally, the flexible leak control extension 2800 is advantageous because it can take the form necessary to block blood flow through any deformed openings caused by the connection between the device 100 and the valve leaflets 20, 22.

[0177] Although various aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in exemplary embodiments in combination, these various aspects, concepts, and features may be used in many alternative embodiments individually or in their various combinations and sub - combinations. All such combinations and sub - combinations are intended to be within the scope of this application unless explicitly excluded herein. Further, various alternative embodiments regarding the present disclosure's various aspects, concepts, and features, such as alternative materials, structures, configurations, methods, devices, and components, forms, fits, and functions, may be described herein, but such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether currently known or later developed. One of ordinary skill in the art may readily adopt one or more of the aspects, concepts, or features of the present invention into additional embodiments and uses within the scope of this application even if such embodiments are not explicitly disclosed herein.

[0178] In addition, although some features, concepts, or aspects of the present disclosure may be described herein as a preferred arrangement or method, such descriptions are not intended to suggest that such features are required or essential unless explicitly so stated. Further, exemplary or typical values and ranges may be included to assist in understanding this application, but such values and ranges should not be construed in a limiting sense and are intended to be important values or ranges only if explicitly so described.

[0179] Furthermore, although various aspects, features, and concepts may be explicitly identified herein as being inventive or as forming part of the present disclosure, such identification is not intended to be exclusive, and rather, aspects, concepts, and features of the invention may exist that are fully described herein without being so identified as such or as part of a particular disclosure, and the present disclosure is instead set forth in the appended claims. The description of an exemplary method or process is not limited to including all steps as being necessary in all cases, nor should the order in which steps are presented be construed as necessary or essential unless explicitly stated otherwise. Further, techniques, methods, operations, steps, etc. described or suggested herein may be performed on a living animal or on a non-living simulation such as a simulator (e.g., where body parts, hearts, tissues, etc. are simulated) of a cadaver, cadaver heart. The words used in the claims have their full ordinary meaning and are not limited in any way by the description of embodiments herein.

Explanation of Signs

[0180] 10 Chordae tendineae 12 Papillary muscle 20 Valve leaflet, anterior leaflet 22 Valve leaflet, posterior leaflet 24 Valve annulus 30 Anterior leaflet, valve leaflet 32 Septal leaflet, valve leaflet 34 Posterior leaflet, valve leaflet 100 Implantable prosthetic device, device, implantable device 102 Delivery sheath 104 Junction portion 106 Anchor portion 110 Joining element or spacer, joining element, spacer 112 Actuating portion or actuating element, actuating element, actuating member or actuating element 114 Cap 115 Collar 116 Actuating line 120 Outer paddle, paddle 122 Inner paddle, paddle 124 Portion, joint, hinge, or flexible portion, joint type, hinge type, or flexible portion 126 Portion, joint, hinge, or flexible connection, joint or flexible portion, joint type, hinge type, or flexible portion 128 Portion, joint or flexible portion, joint type, hinge type, or flexible portion 130 Fastener with ratchet, fastener 132 Base or fixed arm 134 Movable arm 136 Ratchet 138 Flex, hinge, or joint portion, joint portion, joint type, hinge type, or flexible portion 2400 Opening or jet, opening 2800 Leakage control mechanism or leakage control extension, leakage control extension, flexible leakage control extension 2801 Deflecting paddle 3003 Portion 3005 Portion, open portion 3803 Arm 4801 Flexible frame or loop, flexible frame 4803 Barrier material 7801 Flexible frame 7803 Barrier material 7810 Leading edge 7812 Trailing edge 7811 Side edge 7813 Side edge 7901 Flexible frame 7903 Barrier material 8005 Opening 8203 Barrier element, barrier material

Claims

**Claim 1** A valve repair device for repairing a patient's native valve, comprising: a first paddle; a second paddle; a pair of fasteners disposed between the first paddle and the second paddle; wherein the first paddle, the second paddle, and the pair of fasteners are configured to attach the valve repair device to the patient's native valve; the valve repair device further comprising: a barrier material extending from the first paddle to the second paddle; a pair of extension members attached to the barrier material; a valve repair device. **Claim 2** The valve repair device according to claim 1, wherein the barrier material is configured to prevent backflow of blood during systole. **Claim 3** The valve repair device according to claim 1 or 2, further comprising a spacer disposed between the first paddle and the second paddle. **Claim 4** The valve repair device according to any one of claims 1 to 3, wherein the first paddle is attached to a cap, the second paddle is attached to the cap, and the barrier material is attached to the cap. **Claim 5** The valve repair device according to any one of claims 1 to 4, wherein the barrier material comprises one or more pieces of cloth material, biocompatible material, bovine heart tissue, porcine heart tissue, or plastic film. **Claim 6** The valve repair device according to any one of claims 1 to 5, wherein the first paddle, the second paddle, and the pair of fasteners are configured to attach the valve repair device to the native mitral valve. **Claim 7** A valve repair system for repairing a patient's native valve, comprising: a delivery sheath; a valve repair device deployable to the patient's native valve by the delivery sheath; wherein the valve repair device comprises: a first paddle; a second paddle; a pair of fasteners disposed between the first paddle and the second paddle; wherein the first paddle, the second paddle, and the pair of fasteners are configured to attach the valve repair device to the patient's native valve; the valve repair device further comprising: a barrier material extending from the first paddle to the second paddle; a pair of extension members attached to the barrier material; a valve repair system. **Claim 8** The valve repair system according to claim 7, wherein the barrier material is configured to prevent backflow of blood during systole. **Claim 9** ​ The valve repair system according to claim 7 or 8, further comprising a spacer disposed between the first paddle and the second paddle.

10. The valve repair system according to any one of claims 7 to 9, wherein the first paddle is attached to a cap, the second paddle is attached to the cap, and the barrier material is attached to the cap.

11. The valve repair system according to any one of claims 7 to 10, wherein the barrier material comprises one or more pieces of a cloth material, a biocompatible material, bovine heart tissue, porcine heart tissue, or a plastic film.

12. The valve repair system according to any one of claims 7 to 11, wherein the first paddle, the second paddle, and the pair of fasteners are configured to attach the valve repair device to a native mitral valve.

13. A valve repair device for repairing a patient's native valve, comprising a spacer and a pair of paddles coupled to the spacer, the pair of paddles being movable between an open position and a closed position and configured to attach the valve repair device to the patient's native valve, at least one leak control extension extending from the spacer and configured to block retrograde blood flow along a side surface of the spacer, comprising The valve repair device, wherein the at least one leak control extension comprises a pocket defining an opening of the pocket with a flexible wire frame and a cloth barrier material defining at least a portion of an interior of the pocket.

14. The valve repair device according to claim 13, further comprising a cap connected to the spacer, wherein the at least one leak control extension is connected to the cap connected to the spacer.

15. The valve repair device according to claim 13 or 14, wherein at least a portion of the leak control extension is configured to be disposed under a ventricular end of one or more valve leaflets of the native valve when the valve repair device is attached to the native valve.

16. The valve repair device according to any one of claims 13 to 15, wherein the at least one leak control extension comprises one or more deflector paddles and a barrier element.

17. The valve repair device according to claim 16, wherein each of the one or more deflector paddles has a flexible wire frame covered by a fabric barrier material.

Images