Valve repair device and valve repair system

Abstract

To provide a valve repair device for repairing the native valve of a patient.SOLUTION: A 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 is movable between an open position and a closed position and configured to attach the valve repair device to the native valve of a patient. The at least one leak control extension extends from the spacer and is configured to block a neighboring, adjacent and / or surrounding retrograde blood flow along sides of a device, e.g., the spacer or coaptation element.SELECTED DRAWING: Figure 34

Description

[Technical field]

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

[0002] Native heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform important functions in ensuring forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be damaged and therefore less effective, for example, by congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such damage to the valves can lead to serious cardiovascular disorders or death. Damaged valves 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 manner than open-heart surgery. As an example, a transvascular technique that can be used to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., inserting the catheter into the right femoral vein, the inferior vena cava, and the right atrium). The septum is then punctured and the catheter is threaded into the left atrium. A similar transvascular technique can be used to implant a prosthetic device within the tricuspid valve, starting similarly to the transseptal technique but stopping before puncturing the septum and instead directing the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart is generally cone-shaped tapering to a lower apex. 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 separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than other native heart valves. The mitral valve includes an annular portion, which is a circular portion of native valve tissue that surrounds the mitral orifice, and a pair of cusps or leaflets 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 leaflet may be larger than the posterior leaflet, forming a generally "C"-shaped boundary between adjacent sides of the leaflets when the leaflets are closed.

[0004] During normal operation, the anterior and posterior leaflets 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 left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the elevated blood pressure in the left ventricle presses the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot return to the left atrium and instead is expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0005] Valve regurgitation involves the valve inappropriately allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve does not close properly during the systole phase of heart contraction, causing blood to flow from the left ventricle into the left atrium. 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, insufficient papillary muscles, stretching of the mitral annulus resulting from dilation of the left ventricle, or two or more of these. Mitral regurgitation in the central portion of the leaflets may be referred to as central jet mitral regurgitation, and mitral regurgitation close to the commissure of one of the leaflets (i.e., where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. Central jet mitral regurgitation occurs when the ends of the leaflets do not meet in the middle, and thus the valve does not close and regurgitation is present. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Provisional Patent Application No. 62 / 744,031 [Patent Document 2] PCT / US2019 / 012707 [Patent Document 3] PCT / US2018 / 028189 [Patent Document 4] U.S. Patent No. 8,449,599 [Patent Document 5] US Patent Application Publication No. 2014 / 0222136 [Patent Document 6] US Patent Application Publication No. 2014 / 0067052 [Patent Document 7] US Patent Application Publication No. 2016 / 0331523 [Patent Document 8] PCT / US2019 / 062391 Summary of the Invention [Means for solving the problem]

[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 in this summary is not required by the claims unless the claims explicitly recite the feature. Also, 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 may be repaired by placing a spacer between the leaflets of the patient's native valve such that retrograde blood flow through the gap between the spacer and the leaflets is blocked or inhibited.

[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.) may be coupled to the spacer. The pair of anchors (e.g., a 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 a 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 by the delivery sheath into the patient's native valve. 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 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 a side of the spacer.

[0011] In some implementations, a valve repair device for repairing a patient's native valve includes 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 leak control extension extending from the spacer.

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

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

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

[0015] In some implementations, the valve repair device further comprises a pair of fasteners, where the pair of anchors (eg, 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 implementations, the spacer is configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve.

[0017] In some implementations, the at least one leak 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 implementations, the flexible wire frame is configured to deform when placed against a wall within the patient's heart.

[0019] In some implementations, 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 implementations, the opening of the at least one leak control extension is configured to be positioned under one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some implementations, the opening of the at least one leak control extension is configured to be positioned 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 implementations, at least a portion of the leak control extension is configured to be positioned under 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 implementations, the entire leak control extension is configured to be positioned above the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some implementations, the entire leak control extension is configured to be positioned below the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0022] In some implementations, the at least one leak control extension comprises one or more deflector paddles and a barrier element. In some implementations, each of the one or more deflector paddles has a flexible wire frame covered by a fabric barrier material. In some implementations, 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 implementations, a valve repair device for repairing a native valve includes at least one anchor (e.g., a 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 implementations, the at least one anchor is movable between an open position and a closed position.

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

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

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

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

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

[0030] In some implementations, the valve repair device further comprises at least one fastener, wherein the at least one anchor and the at least one fastener are configured to attach the valve repair device to the patient's native valve.

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

[0032] In some implementations, the at least one leak control extension comprises a deflector paddle having a flexible wire frame covered by a fabric 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 placed against a wall within the patient's native valve.

[0033] In some implementations, 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 implementations, the opening of the at least one leak control extension is configured to be positioned under one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some implementations, the opening of the at least one leak control extension is configured to be positioned over the 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 implementations, at least a portion of the leak control extension is configured to be positioned under the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some implementations, the entire leak control extension is configured to be positioned over the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some implementations, the entire leak control extension is configured to be positioned under the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0035] In some implementations, the at least one leak control extension comprises one or more deflector paddles and a barrier element. In some implementations, the one or more deflector paddles have a flexible wire frame covered by a fabric barrier material. In some implementations, 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 implementations, a valve repair system for repairing a patient's native valve comprises a delivery sheath and a valve repair device deployable into the patient's native valve by the delivery sheath.

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

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

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

[0041] In some implementations, the system (e.g., a valve repair device of the system) further comprises a pair of fasteners, wherein 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 / coaptation element is configured to close a gap in the patient's native valve when the valve repair device is attached to the native valve.

[0043] In some implementations, the at least one leak control extension comprises a deflector paddle having a flexible wire frame covered by a fabric 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 placed against a wall within the patient's heart.

[0044] In some implementations, 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 implementations, the opening of the at least one leak control extension is configured to be positioned under one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some implementations, the opening of the at least one leak control extension is configured to be positioned 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 implementations, at least a portion of the leak control extension is configured to be positioned 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 implementations, the entire leak control extension is configured to be positioned above the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some implementations, the entire leak control extension is configured to be positioned below the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0047] In some implementations, the at least one leak control extension comprises one or more deflector paddles and a barrier element. In some implementations, each of the one or more deflector paddles has a flexible wire frame covered by a fabric barrier material. In some implementations, 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 implementations, a valve repair system for repairing a patient's native valve comprises a delivery sheath and a valve repair device deployable into the patient's native valve by the delivery sheath.

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

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

[0051] In some implementations, the system (eg, a valve repair device of the system) further comprises a coaptation element (eg, a spacer, a coaptation element, etc.).

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

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

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

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

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

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

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

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

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

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

[0062] In some implementations, 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.

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

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

[0066] In some implementations, the entire leak control extension is configured to be positioned above the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve. In some implementations, the entire leak control extension is configured to be positioned below the ventricular end of one or more leaflets of the native valve when the valve repair device is attached to the native valve.

[0067] In some implementations, the at least one leak control extension comprises one or more deflector paddles and a barrier element. In some implementations, each of the one or more deflector paddles has a flexible wire frame covered by a fabric barrier material. In some implementations, 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 implementations, a method of repairing a patient's native valve includes attaching a spacer or coaptation element between the leaflets of the patient's native valve and blocking retrograde blood flow through a gap between the spacer and the leaflets.

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

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

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

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

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

[0074] The above methods may be performed on a living animal or on a simulation such as a cadaver, cadaver heart, simulator (eg, in which body parts, hearts, tissues, etc. are simulated).

[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 bear like reference numerals and in which:

[0076] In order to further clarify various aspects of the embodiments of the present disclosure, a more particular description of the exemplary embodiments will be made by referring to various aspects of the accompanying drawings. It is understood that these drawings depict only typical embodiments of the present disclosure and therefore should not be considered as limiting the scope of the present disclosure. Furthermore, while the figures may be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. The embodiments of the present disclosure, as well as other features and advantages, will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0077] [Figure 1] FIG. 1 is a cross-sectional view of a human heart during diastole. [Diagram 2] FIG. 1 is a cross-sectional view of a human heart during systole. [Diagram 3] FIG. 1 is a cross-sectional view of a human heart during diastole, showing the chordae tendineae that attach the mitral and tricuspid valve leaflets to the ventricular wall. [Figure 4]FIG. 1 illustrates a healthy mitral valve with closed leaflets as viewed from the atrial side of the mitral valve. [Diagram 5] FIG. 1 shows a dysfunctional mitral valve with visible gaps between the leaflets as viewed from the atrial side of the mitral valve. [Figure 6] FIG. 1 illustrates a mitral valve with a wide gap between the posterior and anterior leaflets. [Figure 7] FIG. 2 shows the tricuspid valve as viewed from the atrial side of the tricuspid valve. [Figure 8] 1A-1D illustrate examples of implantable prosthetic devices at various stages of deployment. [Figure 9] 1A-1D illustrate examples of implantable prosthetic devices at various stages of deployment. [Figure 10] 1A-1D illustrate examples of implantable prosthetic devices at various stages of deployment. [Figure 11] 1A-1D illustrate examples of implantable prosthetic devices at various stages of deployment. [Figure 12] 1A-1D illustrate examples of implantable prosthetic devices at various stages of deployment. [Figure 13] 1A-1D illustrate examples of implantable prosthetic devices at various stages of deployment. [Figure 14] 1A-1D illustrate examples of implantable prosthetic devices at various stages of deployment. [Figure 15] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 16] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 17] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 18] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 19] FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 20]FIG. 15 illustrates the implantable prosthetic device of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 21] FIG. 15 shows the implantable prosthetic device of FIGS. 8-14 implanted within a native valve. [Figure 22] FIG. 1 illustrates an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 23] 23 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 22, the cross-section being taken along the plane indicated by line 23-23 in FIG. 22. [Figure 24] 23 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 22, viewed from the ventricular side of the native valve. [Diagram 25] 23 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 22, viewed from the atrial side of the native valve. [Figure 26] 23 shows the implantable prosthetic device of FIG. 22 implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 27] 27 shows the implantable prosthetic device of FIG. 22 implanted in a second exemplary location within the native valve shown in FIG. 26, viewed from the atrial side of the native valve. [Figure 28] 1A-1C show an example of an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 29] 29 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 28, the cross-section being taken along the plane indicated by line 29-29 in FIG. 28. [Diagram 30] FIG. 29 illustrates an implantable prosthetic device implanted in a first position within the valve shown in FIG. 28 as viewed when the heart is in diastole. [Diagram 31] 31 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 30, the cross-section being taken along the plane indicated by line 31-31 shown in FIG. 30. [Diagram 32] FIG. 29 illustrates an implantable prosthetic device implanted in a first position within the valve shown in FIG. 28 as viewed when the heart is in systole. [Diagram 33] 33 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 32, the cross-section being taken along the plane indicated by line 33-33 shown in FIG. 32. [Diagram 34] 29 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 28, viewed from the ventricular side of the native valve. [Diagram 35] 29 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 28, viewed from the atrial side of the native valve. [Diagram 36] 29 shows the implantable prosthetic device of FIG. 28 implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 37] 37 shows the implantable prosthetic device of FIG. 28 implanted in a second exemplary location within the native valve shown in FIG. 36, viewed from the atrial side of the native valve. [Figure 38A] 1A-1C show an example of an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 38B] 1A-1C show an example of an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 39A] 39A is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38A, the cross-section being taken along the plane indicated by line 39A-39B shown in FIG. 38A. [Figure 39B] 39B is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38B, the cross-section being taken along the plane indicated by line 39B-39B shown in FIG. 38B. [Figure 40A] FIG. 38B illustrates an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38A as viewed when the heart is in diastole. [Figure 40B]FIG. 38C shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38B as viewed when the heart is in diastole. [Figure 41A] 41A is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 40A, the cross-section being taken along the plane indicated by line 41A-41A shown in FIG. 40A. [Figure 41B] 41B is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 40B, the cross-section being taken along the plane indicated by line 41B-41B shown in FIG. 40B. [Figure 42A] FIG. 38B illustrates an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38A as viewed when the heart is in systole. [Figure 42B] FIG. 38C shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38B as viewed when the heart is in systole. [Figure 43A] 43A is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 42A, the cross-section being taken along the plane indicated by line 43A-43A shown in FIG. 42A. [Figure 43B] 43B is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 42B, the cross-section being taken along the plane indicated by line 43B-43B shown in FIG. 42B. [Figure 44A] FIG. 38B shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38A, viewed from the ventricular side of the native valve. [Figure 44B] FIG. 38C shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38B, viewed from the ventricular side of the native valve. [Figure 45A] FIG. 38B shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38A, viewed from the atrial side of the native valve. [Figure 45B]FIG. 38C shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 38B, viewed from the atrial side of the native valve. [Figure 46A] FIG. 38B shows the implantable prosthetic device of FIG. 38A implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 46B] FIG. 38C shows the implantable prosthetic device of FIG. 38B implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 47A] FIG. 46B shows the implantable prosthetic device of FIG. 38A implanted in a second exemplary location within the mitral valve shown in FIG. 46A, viewed from the atrial side of the native valve. [Figure 47B] FIG. 46B shows the implantable prosthetic device of FIG. 38B implanted in a second exemplary location within the mitral valve shown in FIG. 46B, viewed from the atrial side of the native valve. [Figure 48A] 1A-1C show an example of an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 48B] 1A-1C show an example of an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 49A] 49A is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48A, the cross-section being taken along the plane indicated by line 49A-49A shown in FIG. 48A. [Figure 49B] 49B is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48B, the cross-section being taken along the plane indicated by line 49B-49B shown in FIG. 48B. [Figure 50A] FIG. 48B illustrates an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48A as viewed when the heart is in diastole. [Figure 50B] FIG. 48C shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48B as viewed when the heart is in diastole. [Figure 51A]51A is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 50A, the cross-section being taken along the plane indicated by line 51A-51A shown in FIG. 50A. [Figure 51B] 51B is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 50B, the cross-section being taken along the plane indicated by line 51B-51B shown in FIG. 50B. [Figure 52A] FIG. 48B illustrates an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48A as viewed when the heart is in systole. [Figure 52B] FIG. 48C shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48B as viewed when the heart is in systole. [Figure 53A] 53A is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 52A, the cross-section being taken along the plane indicated by line 53A-53A shown in FIG. 52A. [Figure 53B] 53B is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 52B, the cross-section being taken along the plane indicated by line 53B-53B shown in FIG. 52B. [Figure 54A] FIG. 48B shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48A, viewed from the ventricular side of the native valve. [Figure 54B] FIG. 48C shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48B, viewed from the ventricular side of the native valve. [Figure 55A] FIG. 48B shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48A, viewed from the atrial side of the native valve. [Figure 55B] FIG. 48C shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 48B, viewed from the atrial side of the native valve. [Figure 56A]FIG. 48B shows the implantable prosthetic device of FIG. 48A implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 56B] FIG. 48C shows the implantable prosthetic device of FIG. 48B implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 57A] 56A shows the implantable prosthetic device of FIG. 48A implanted in a second exemplary location within the native valve shown in FIG. 56A, viewed from the atrial side of the native valve. [Figure 57B] 56B shows the implantable prosthetic device of FIG. 48B implanted in a second exemplary location within the native valve shown in FIG. 56B, viewed from the atrial side of the native valve. [Figure 58] 1A-1C show an example of an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 59] 59 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 58, the cross-section being taken along the plane indicated by line 59-59 in FIG. 58. [Figure 60] FIG. 59 illustrates an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 58 as viewed when the heart is in diastole. [Figure 61] 61 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 60, the cross-section being taken along the plane indicated by line 61-61 shown in FIG. 60. [Figure 62] FIG. 59 illustrates an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 58 as viewed when the heart is in systole. [Figure 63] 63 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 62 taken along line 63-63 shown in FIG. 62. [Figure 64] FIG. 59 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 58, viewed from the ventricular side of the native valve. [Figure 65]FIG. 59 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 58, viewed from the atrial side of the native valve. [Figure 66] FIG. 59 shows the implantable prosthetic device of FIG. 58 implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 67] 67 shows the implantable prosthetic device of FIG. 58 implanted in a second exemplary location within the native valve shown in FIG. 66, viewed from the atrial side of the native valve. [Figure 68] 1A-1C show an example of an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 69] 69 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 68, the cross-section being taken along the plane indicated by line 69-69 in FIG. 68. [Figure 70] FIG. 69 illustrates an implantable prosthetic device implanted in a first position within the valve shown in FIG. 68 as viewed when the heart is in diastole. [Figure 71] 71 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 70, the cross-section being taken along the plane indicated by line 71-71 in FIG. [Figure 72] FIG. 69 illustrates an implantable prosthetic device implanted in a first position within the valve shown in FIG. 68 as viewed when the heart is in systole. [Figure 73] 73 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 72, the cross-section being taken along the plane indicated by line 73-73 in FIG. 72. [Figure 74] 69 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 68, viewed from the ventricular side of the native valve. [Figure 75] 69 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 68, viewed from the atrial side of the native valve. [Figure 76]FIG. 69 shows the implantable prosthetic device of FIG. 68 implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 77] 77 shows the implantable prosthetic device of FIG. 68 implanted in a second exemplary location within the native valve shown in FIG. 76, viewed from the atrial side of the native valve. [Figure 78] FIG. 47B is a bottom view of a more specific example of an implantable prosthetic device shown in FIGS. 38A-47A. [Figure 79] FIG. 47B is a bottom view of a more specific example of an implantable prosthetic device shown in FIGS. 38A-47A. [Figure 80] FIG. 57B is a front view of a more specific example of an implantable prosthetic device shown in FIGS. 48A-57A. [Figure 81] FIG. 81 is a bottom view of the implantable prosthetic device shown in FIG. 80. [Figure 82] 1A-1C show an example of an implantable prosthetic device implanted in a first exemplary location within a native valve. [Figure 83] 83 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 82, the cross-section being taken along the plane indicated by line 83-83 in FIG. 82. [Figure 84] FIG. 83 illustrates an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 82 as viewed when the heart is in diastole. [Figure 85] 85 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 84, the cross-section being taken along the plane indicated by line 85-85 shown in FIG. 84. [Figure 86] FIG. 83 illustrates an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 82 as viewed when the heart is in systole. [Figure 87] 87 is a cross-sectional view of an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 86, the cross-section being taken along the plane indicated by line 87-87 shown in FIG. 86. [Figure 88]FIG. 83 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 82, viewed from the ventricular side of the native valve. [Figure 89] FIG. 83 shows an implantable prosthetic device implanted in a first position within the native valve shown in FIG. 82, viewed from the atrial side of the native valve. [Figure 90] FIG. 83 shows the implantable prosthetic device of FIG. 82 implanted in a second exemplary location within the native valve, viewed from the ventricular side of the native valve. [Figure 91] 90 shows the implantable prosthetic device of FIG. 82 implanted in a second exemplary location within the native valve shown in FIG. 90, viewed from the atrial side of the native valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0078] The following description refers to the accompanying drawings which illustrate specific embodiments of the present disclosure. Other embodiments having different structure and operation 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 native valve repair devices, systems for delivery of native valve repair devices, and systems for removal of implanted native valve repair devices are disclosed herein, and it should be noted that any combination of these options may be performed unless specifically excluded. In other words, individual components of the disclosed devices and systems may be combined unless mutually exclusive or otherwise physically impossible. Furthermore, the techniques and methods may 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 interconnection may be direct between the components, or may be indirect, such as through the use of one or more intermediate components. Also, as described herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but may include a collection of components, members, or elements. Also, as described herein, the terms "substantially" and "about" are defined as at least close to (and including) a given value or condition (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0081] 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, i.e., atrioventricular valves, respectively. 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 has flexible leaflets (e.g., leaflets 20, 22 shown in Figs. 4 and 5) that extend inwardly across their respective openings, which come together or "coapt" in flow to form a one-way fluid occlusion surface. The native valve repair system of the present application is described primarily with respect to the mitral valve MV. Accordingly, the anatomical structures of the left atrium LA and the left ventricle LV will be described in more detail. However, the devices described herein may also be used in repairing other native valves, for example, the devices may be used in repairing the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0082] The left atrium LA receives oxygenated blood from the lungs. During the diastolic phase or diastole seen in FIG. 1, blood previously collected in the left atrium LA (during systole) moves through the mitral valve MV to the left ventricle LV due to the expansion of the left ventricle LV. During the systolic phase or systole seen in FIG. 2, the left ventricle LV contracts to pump blood into the body via 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 to the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In one exemplary implementation, the device described in the present application is used to restore the function of a defective mitral valve MV. That is, the device is configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV to the left atrium LA.

[0083] Now, referring to Figures 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 Figure 3, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae 10. The chordae tendineae 10 are string-like tendons that connect the papillary muscles 12 (i.e., the base 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 serve to limit the movement of the mitral valve MV and prevent the mitral valve from recoiling. The mitral valve MV opens and closes in response to pressure changes in the left atrium LA and left ventricle LV. The papillary muscles do not open or close the mitral valve MV. Rather, the papillary muscles support the mitral valve MV against the high pressures required to circulate blood throughout the body. The papillary muscles and chordae tendineae are collectively known as the subvalvular apparatus, which functions to prevent the mitral valve MV from herniating into the left atrium LA when the mitral valve is closed.

[0084] Various disease processes can impair the proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (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 from a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can distort the geometry of the native valve, which can cause the native valve to malfunction. However, the majority of patients who undergo valvular surgery, such as surgery on the mitral valve MV, suffer from degenerative diseases that cause malfunction in the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve MV) resulting in prolapse and regurgitation.

[0085] In general, 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 completely, thereby causing an obstruction of blood flow. Typically, valvular stenosis results from the accumulation of calcified material on the leaflets of the valve, which thickens the leaflets and impairs the ability of the valve to open completely to allow forward blood flow.

[0086] The second type of valve insufficiency, valve regurgitation, occurs when the leaflets of the valve do not close completely, thereby leaking blood into the previous chamber (e.g., leaking blood from the left ventricle into the left atrium). There are three mechanisms by which native valves can regurgitate or become insufficient, including Carpentier's types I, II, and III insufficiencies. Carpentier's type I insufficiency involves dilation of the valve annulus such that normally functioning leaflets are pulled apart from one another and fail to form a seal (i.e., the leaflets do not coapt properly). Insufficiency of the type I mechanism includes leaflet perforation, such as present in endocarditis. Carpentier's type II insufficiency involves prolapse of one or more leaflets of the native valve above the plane of coaptation. Carpentier's 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 annulus. The restriction of the leaflets can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0087] With reference to FIG. 4, when a healthy mitral valve MV is in a closed position, the anterior leaflets 20 and posterior leaflets 22 coapt, which prevents blood from leaking from the left ventricle LV into the left atrium LA. With reference to FIG. 5, regurgitation occurs when the anterior leaflets 20 and / or posterior leaflets 22 of the mitral valve MV move into the left atrium LA during systole. This failure of coaptation creates a gap 26 between the anterior leaflets 20 and posterior leaflets 22, which allows blood to flow back from the left ventricle LV into the left atrium LA during systole. As noted above, there are several different ways that the leaflets (leaflets 20, 22 of the mitral valve MV) can become incompetent, thereby leading to regurgitation.

[0088] 6, in certain circumstances, a 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 a 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, e.g., between about 5 mm and about 15 mm, e.g., between about 7.5 mm and about 12.5 mm, e.g., between about 10 mm. In some circumstances, the gap 26 may have a width W greater than 15 mm. In any of the above circumstances, a valve repair device is designed that is desirably capable of engaging 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] Although stenosis or regurgitation can affect any valve, stenosis is found to primarily affect either the aortic valve AV or the pulmonary valve PV, and regurgitation is found to primarily 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, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating blood flow throughout the body, insufficiency of the mitral valve MV or the aortic valve AV is particularly problematic and often life-threatening. Therefore, due to the substantially higher pressures in the left side of the heart, insufficiency of the mitral valve MV or the aortic valve AV is much more problematic.

[0090] Dysfunctional native heart valves may be repaired or replaced. Repair typically involves preserving and modifying 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 stenotic damage sustained by the valve leaflets is irreversible, the most common treatment for a stenotic aortic valve or 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 deformation of the valve leaflets, which, as explained above, prevents the mitral valve or tricuspid valve from closing properly and allows regurgitation or back flow of blood from the ventricle to the atrium (e.g., a deformed mitral valve MV allows regurgitation or back flow from the left ventricle LV to the left atrium LA). Regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or tricuspid valve TV may be repairable. In addition, the chordae tendineae 10 may become incompetent (e.g., the chordae tendineae may stretch or rupture), allowing the anterior leaflets 20 and posterior leaflets 22 to revert so that blood flows back into the left atrium LA, causing regurgitation. Problems caused by incompetent chordae tendineae may be repaired by repairing the structure of the chordae tendineae or the mitral valve (e.g., by fixing the leaflets 20, 22 in the affected portion of the mitral valve).

[0091] The devices and procedures disclosed herein refer to repairing the structure of the mitral valve or removing an implanted repair device from the mitral valve. However, it should be understood that the devices and concepts provided herein can be used to repair any native valve or any component of a native valve. Now referring 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, the septal leaflet 32, and the posterior leaflet 34 to prevent 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 on all three of the leaflets 30, 32, 34 to prevent backflow of blood from the right ventricle to the right atrium. That is, the valve repair device provided herein can be centered between the three leaflets 30, 32, 34.

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

[0093] 8-14 show examples of valve repair devices. An exemplary implantable prosthetic device can have a coaptation or coaptation element (e.g., a spacer, etc.) and at least one anchor. The coaptation element is configured to be placed within the opening of the native heart valve to help fill the space and form a more effective seal, thereby reducing or preventing regurgitation as described above. The coaptation element can have a structure that is impermeable to blood and allows the native valve leaflets to close around the coaptation element during ventricular systole and block blood from flowing from the left or right ventricle to the left or right atrium, respectively. The prosthetic device can be configured to seal against two or three native valve leaflets, i.e., the device can be used in native mitral (bicuspid) and tricuspid valves. Because the coaptation element can fill the space between the leaflets of an improperly functioning native mitral or tricuspid valve that does not close completely, the coaptation element is sometimes referred to herein as a spacer.

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

[0095] The anchors may be configured to secure the device to one or both of the native mitral valve leaflets such that the coaptation element is positioned between two native leaflets. In embodiments configured for use in a tricuspid valve, the anchors are configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the coaptation element is positioned between three native leaflets. In some embodiments, the anchors may attach the coaptation element at a location adjacent to the ventricular portion of the coaptation element. In some embodiments, the anchors may attach to a shaft, actuation wire, or other actuation element to which the coaptation element is also attached. In some embodiments, the anchors and coaptation element may be independently positioned. In some embodiments, the anchors and coaptation element may be positioned simultaneously. The anchors may be configured to grasp the leaflets.

[0096] The prosthetic device may be configured to be implanted via a delivery sheath. Additional information regarding examples of delivery devices may 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. Additionally, these methods may be performed mutatis mutandis on live animals or on simulations such as cadavers, cadaver hearts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated), etc.

[0097] 8-14, an example of a schematic implantable prosthetic device 100 is shown at various stages of deployment. However, the implantable prosthetic device can take a wide variety of different forms as described above. For example, 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. The device 100 can include any other features related to implantable prosthetic devices discussed in the present application, and the device 100 can be positioned 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] The device 100 may be deployed from a delivery sheath 102 and may include a coaptation portion 104 and / or an anchor portion 106. The coaptation portion 104 of the 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 coaptation element or spacer 110 slidably attached to an actuation member or element 112 (e.g., a wire, shaft, rod, line, suture, tether, etc.). The anchor portion 106 is actuable between an open state and a closed state and may take a wide variety of forms, such as, for example, a paddle, latch, catch, fastener, gripping element, etc. Differential movement of the actuation element 112 (e.g., actuation of an actuation wire, etc.) opens and closes the anchor portion 106 of the device 100 to grip the mitral valve leaflets during implantation. The actuation element 112 may take a wide variety of forms. For example, the actuation element may be threaded such that rotation of the actuation element moves the anchor portion 106 relative to the coaptation portion 104. Alternatively, the actuation element may be non-threaded such that pushing or pulling on the actuation element 112 moves the anchor portion 106 relative to the interface portion 104 .

[0099] In some implementations, the anchor portion 106 of the device 100 includes an outer paddle 120 and an inner paddle 122 connected between the cap 114 and the interface element 110 by portions 124, 126, and 128. The portions 124, 126, and 128 may 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, interface element 110, and cap 114 by portions 124, 126, and 128 may constrain the device to the positions and movements shown herein. In some implementations, the device includes only one outer paddle 120 and one inner paddle 122, which may be configured in different ways.

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

[0101] 11, the anchor portion 106 includes an attachment portion or gripping member. The illustrated gripping member is shown as a barbed fastener 130 including a base or fixed arm 132, a movable arm 134, barbs 136, and a flex, hinge, or joint portion 138. However, other friction enhancing elements may be used in place of the barbs. The fixed arm 132 is attached to the inner paddle 122, and the flex, hinge, or joint portion 138 is located proximate to the mating element 110. The barbed fastener has a flat surface and does not fit into a recess in the paddle. Rather, the flat portion of the barbed fastener 130 is located 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 barbed 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, etc. 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 barbed fastener 130 and expose the barbs 136. The barbed fastener 130 is opened by applying tension to the actuation line 116 attached to the movable arm 134, thereby causing the flex, hinge, or joint portion 138 to move, bend, and / or pivot.

[0102] During implantation, the paddles 120, 122 are opened and closed to capture or grasp the native mitral valve leaflets between the paddles 120, 122 and the coaptation element 110. The barbed fasteners 130 further secure the native leaflets by engaging the leaflets with the barbs 136 and sandwiching the leaflets between the movable arm 134 and the fixed arm 132. The barbs 136 of the barbed fasteners 130 may increase friction with the leaflets or partially or completely puncture the leaflets. The actuation lines 116 may be independently or separately actuated such that each barbed fastener 130 may be opened and closed independently or separately. Separate / independent actuation allows one leaflet to be grasped at a time or allows repositioning of the fasteners 130 against a poorly grasped leaflet without altering the normal grip against the other leaflets. The barbed fasteners 130 can not only open and close independently of one another, but can also open and close completely independent of the position of the inner paddle 122, thereby allowing the leaflets to be captured in a variety of positions as a particular situation requires.

[0103] The barbed fasteners 130 may 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 barbed fasteners 130. The actuation line 116 may take a wide variety of forms, such as, for example, a line, a suture, a rod, a catheter, etc. The barbed fasteners 130 are spring loaded or otherwise biased such that in the closed position, the barbed fasteners 130 continue to provide a clamping force against the captured or grasped native leaflet. This clamping force may remain constant or positive regardless of the position of the inner paddle 122. The barbs 136 of the barbed fasteners 130 may pierce the native leaflet to further secure the native leaflet.

[0104] Referring now to FIG. 8, the device 100 is shown in an extended or fully open state for deployment from the delivery sheath 102. The device 100 is loaded into the delivery sheath 102 in the fully open position because it takes up the least space and allows the smallest catheter to be used (or the largest implantable device 100 for a given catheter size). In the extended state, the cap 114 is spaced away from the coaptation element 110 such that the paddles 120, 122 of the anchor portion 106 are fully open or fully extended. In some embodiments, the angle formed between the interior of the outer and inner paddles 120, 122 is about 180 degrees. The barbed fasteners 130 are kept closed during deployment through the delivery sheath 102 so that the barbs 136 (FIG. 11) do not snag or damage tissue within the sheath or the patient's heart.

[0105] 9, device 100 is shown in an elongated detangled condition similar to that of FIG. 8, but with barbed fasteners 130 in a fully open position at 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 fasteners 130. Fully opening the paddles 120, 122 and fasteners 130 has been found to improve ease of detanglement from the patient's anatomy during implantation of device 100.

[0106] Referring now to FIG. 10, the device 100 is shown in a shortened or fully closed state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To move the device 100 from the extended state to the shortened state, the actuating element 112 is retracted to pull the cap 114 toward the coaptation element 110. The joint, hinge, or flexible connection 126 between the outer paddle 120 and the inner paddle 122 is limited or constrained from movement such that a compressive force acting on the outer paddle 120 from the cap 114 being retracted toward the coaptation element 110 moves the paddles 120, 122 or gripping elements radially outward. During movement from the open position to the closed position, the outer paddle 120 maintains an acute angle with the actuating element 112. The outer paddle 120 may optionally be biased toward the closed position. The inner paddle 122 during the same movement moves through a much larger angle as it points away from the interface element 110 in the open state and collapses along the side of the interface element 110 in the closed position. In some embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the joints, hinges, or flexible portions 126, 128 connected to the inner paddle 122 may be thinner and / or more flexible. For example, this increased flexibility may allow for more movement than the joints, hinges, or flexible portions 124 connecting the outer paddle 120 to the cap 114. In some embodiments, the outer paddle 120 is narrower than the inner paddle 122. The joints or flexible portions 126, 128 connected to the inner paddle 122 may be more flexible to allow for more movement than the joints or flexible portions 124 connecting the outer paddle 120 to the cap 114, for example. In some embodiments, the inner paddle 122 can be the same width, or substantially the same width, as the outer paddle.

[0107] 11-13, the device 100 is shown in a partially open, ready to capture, or ready to grasp state. To move from a fully closed state to a partially open state, the actuation element 112 (e.g., and actuation wire, actuation shaft, etc.) is expanded to push the cap 114 away from the coaptation element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, partially deploying the anchor portion 106. The actuation line 116 is also retracted to open the catch 130 so that the leaflets may be captured or grasped. In some embodiments, such as the example shown by FIG. 11, the pair of inner and outer paddles 122, 120 are moved in unison, rather than independently, by a single actuation element 112. Also, the position of the catch 130 may depend on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 may also close the catch. In some embodiments, the paddles 122, 120 may be independently controllable. For example, the device 100 may have two actuation elements and two independent caps, such that one independent wire and cap is used to control one paddle and another independent wire and cap is used to control the other paddle.

[0108] 12, one of the actuation lines 116 is expanded to allow one of the fasteners 130 to close. Now referring to FIGURE 13, the other actuation line 116 is expanded to allow the other fastener 130 to close. Either or both of the actuation lines 116 may be repeatedly actuated to repeatedly open and close the barbed fasteners 130.

[0109] 14, the device 100 is shown in a fully closed and deployed state. The delivery sheath 102 and actuation element 112 are retracted and the paddles 120, 122 and catches 130 remain in the fully closed position. Once deployed, the device 100 may be maintained in the fully closed position using a mechanical latch or may be biased to remain closed by the use of spring materials such as steel, other metals, plastics, composites, or shape memory alloys such as Nitinol. For example, the jointed, hinged, or flexible portions 124, 126, 128, 138, and / or additional biasing components may be formed of metals such as steel or shape memory alloys such as Nitinol manufactured in wire, sheet, tube, or laser sintered powder and biased to hold the outer paddle 120 closed around the coaptation element or spacer 110 and the barbed catches 130 pinched around the native leaflets. In some embodiments, the pads 120, 122 can be configured to open and close with the beating of the heart and the corresponding opening and closing of the native valve.

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

[0111] 21, the device 100 of FIGS. 8-14 is shown implanted in a native valve, e.g., 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 coaptation element 110 (e.g., a spacer, etc.), and a cap 114. The outer paddle 120 and the inner paddle 122 are connected between the cap 114 and the coaptation element 110 by portions 124, 126, 128 (which may be jointed and / or flexible to move between various positions). The coaptation element 110 is adapted to be implanted between the leaflets 20, 22 of the native valve. The fastener 130 is configured to connect the device 100 to the 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 friction-enhancing elements (e.g., barbs, ridges, rough surfaces, adhesives, etc.) for engaging the native valve leaflets 20, 22. In some embodiments, the device 100 has only one outer paddle 120, only one inner paddle 122, and only one fastener (e.g., a barbed fastener, etc.), which may be configured in different ways.

[0112] 22-27, an implantable prosthetic device 100 is attached to the leaflets 20, 22 of a native valve (e.g., shown as a mitral valve MV, but may be used for another valve, such as a tricuspid valve, as well) in a fully closed position. In the embodiment shown in FIGS. 22-25, the implantable prosthetic device 100 is attached to the native valve at a substantially central location within the annulus 24. However, the implantable prosthetic device 100 may be attached to the leaflets 20, 22 at any location within the native valve (e.g., the locations shown in FIGS. 26-27). The device 100 is shown as having a pair of paddles 120, a pair of fasteners 130, a coaptation element 110, and a cap 114. However, the implantable prosthetic device 100 may take any suitable form, such as, for example, any of the forms described in this application.

[0113] 24 and 25, during systole, the leaflets 20, 22 coapt around the implantable prosthetic device 100 to prevent the backflow of blood from the left ventricle into the left atrium. However, in certain circumstances, they may not fully coapt around the device 100, which may result in the formation of 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 where both leaflets 20, 22 and the device 100 meet. However, the openings 2400 may be formed at any point where the device 100 and a single leaflet 20, 22 meet. These openings 2400 allow blood to flow back into the left atrium during systole.

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

[0115] 28-91 illustrate various embodiments of the implantable prosthetic device 100 including one or more leak control mechanisms or leak control extensions 2800 that allow blood to flow through or over the leak control extension 2800 when the heart is in diastole (i.e., blood flows from the atrium to the ventricle) and block or deflect at least a portion of blood that would otherwise flow back through the opening 2400 when the heart is in systole (i.e., blood flows from the ventricle to the atrium). The leak control extension 2800 can take a wide variety of different forms. For example, the leak control extension 2800 can have configurations such as a substantially flat deflection paddle, a curved deflection paddle, a bag or sack that opens into a cap, a deflection paddle and fabric assembly, and the like. The leak control extension 2800 can be made from a wide variety of different materials. For example, the leak control extension can be made from a thin plastic, a wire frame covered in fabric, fabric without a frame, fabric with a plastic frame, any combination thereof, and the like. The leak control extension 2800 may be positioned in a variety of different ways, for example, the leak control extension may be positioned underneath the native valve leaflets, below the underneath of the native valve leaflets, between the underneath of the native valve leaflets and the native valve annulus, or such that a portion of the leak control extension is underneath the native valve leaflets and a portion of the leak control extension is between the underneath of the native valve leaflets and the native valve annulus.

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

[0117] In the example shown by Figs. 28 and 29, the leak control extension 2800 includes a deflection paddle 2801 connected to the top surface of the cap and positioned under the native valve leaflets. The leak control extension 2800 is configured to block 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 migrating through any jets or openings between the leaflets 20, 22 of the native valve during systole. In the illustrated embodiment, the leak control extension 2800 is positioned within the left ventricle LV when the device 100 is attached to the leaflets 20, 22. In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to the top 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] 30 and 31, 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. The device 100 is connected to the leaflets 20, 22 so that when the leaflets 20, 22 are in the open position, a portion 3003 of the mitral valve MV is substantially blocked by the device 100 and another portion 3005 of the mitral valve is open to allow blood to move to the left ventricle LV. 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 against the deflection paddle 2801, which causes the deflection paddle 2801 to pivot around the cap 114 or bend relative to the cap 114 such that blood moves around the leak control extension 2800 in direction X.

[0119] 32-35, during systole, the leaflets 20, 22 of the mitral valve MV coapt to prevent blood from flowing back into the left atrium LA as blood is pushed from the left ventricle into the aorta, and the device 100 is connected to the leaflets 20, 22 to help coapt or facilitate coaptation of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not fully coapt around the device 100, which may form 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 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 leak control extension 2800 is positioned to prevent blood from flowing back into the left atrium through the one or more openings 2400.

[0120] 32 and 33, contraction of the left ventricle LV pushes blood in direction Y towards the mitral valve MV, engaging the deflecting paddle 2801 of the leak 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 deflecting paddle 2801, which causes the deflecting paddle 2801 to pivot about the cap 114 or bend relative to the cap such that the blood is directed away from the opening 2400 around the leak control extension 2800 in direction Z.

[0121] 36 and 37, the device 100 shown in FIGS. 28-35 may be placed in the native valve at a location near the annulus 24. As with the device 100 placed in a more central location in the native valve (as shown in FIGS. 28-35), an opening 2400 may be formed where both leaflets 20, 22 and the device 100 meet. When the device 100 is placed near the annulus 24, as shown in the illustrated embodiment, the force of the device 100 on the native valve may cause the opening 2400 adjacent the 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 causes the leak control extension to compress. For example, as shown in FIGS. 36 and 37, the leak control extension 2800 adjacent the annulus 24 presses against the annulus 24 (or the side wall of the ventricle), which compresses the leak control extension 2800 into a deformed shape. This compression of the leak control extension 2800 allows the leak control extension to cover the deformed opening 2400 adjacent the valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be positioned within the native valve in a variety of locations without causing irritation to the valve annulus 24 or the ventricular or atrial side walls. 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] 38A-47A show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a native valve (e.g., shown as a mitral valve MV, but may be used similarly for another valve, such as a tricuspid valve) in a fully closed position, with the device 100 including one or more leak control extensions 2800. In the embodiment shown in FIGS. 38A-45A, the implantable prosthetic device 100 is attached to the native valve at a substantially central location within the annulus 24. However, it should be understood that the implantable prosthetic device 100 may be attached to the leaflets 20, 22 at any location within the native valve (e.g., the locations shown in FIGS. 46A-47A). The device 100 has a pair of paddles 120, a pair of fasteners 130, a coaptation element 110 (e.g., a spacer, etc.), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 may take any suitable form, such as, for example, any of the forms described herein in combination with 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 extends from the device (e.g., from the end of the cap 114 of the device 100) such that the leak control extension is positioned to prevent blood from moving through any jets or openings between the leaflets 20, 22 of the mitral valve MV during systole. In the illustrated embodiment, the leak control extension 2800 includes a deflection paddle 2801 that is positioned 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. Although the illustrated embodiment is shown as having two leak control extensions 2800, the device 100 may have any suitable number of leak control extensions.

[0124] 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. The device 100 is connected to the leaflets 20, 22 so that when the leaflets 20, 22 are in the open position, a portion 3003 of the mitral valve MV is substantially blocked by the device 100 and another portion 3005 of the mitral valve is open to allow blood to move to the left ventricle LV. Blood moves in direction D through the open portion 3005 and engages the leak control extension 2800. In some embodiments, the blood provides a force against the leak control extension 2800 that causes the leak control extension 2800 to pivot around the cap 114 or bend relative to the cap such that blood moves around the leak control extension 2800 in direction X.

[0125] 42A-45A, during systole, the leaflets 20, 22 of the mitral valve MV coapt to prevent blood from flowing back into the left atrium LA as blood is pushed from the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help coapt or facilitate coaptation of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not fully coapt around the device 100, which may form 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 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 leak control extension 2800 may be positioned to prevent blood from flowing back into the left atrium through the one or more openings 2400.

[0126] 42A and 43A, contraction of the left ventricle LV pushes blood in direction Y towards the mitral valve MV, engaging the deflecting paddle 2801 of the leak 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 deflecting paddle 2801, which causes the deflecting paddle 2801 to pivot around or bend relative to the cap 114 such that the blood moves around the leak control extension 2800 in direction Z.

[0127] 46A and 47A, the device 100 shown in FIGS. 38A-45A may be placed in the mitral valve MV at a location near the annulus 24. Similar to the device 100 being placed in a more central location in the mitral valve MV (as shown in FIGS. 38A-45A), an opening 2400 may be formed where both leaflets 20, 22 and the device 100 meet. When the device 100 is placed near the annulus 24, as shown in the illustrated embodiment, the force of the device 100 on the mitral valve MV may cause the opening 2400 adjacent the 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 causes the leak control extension to compress. For example, as shown in Figures 46A and 47A, the leak control extension 2800 adjacent to the annulus 24 is pressed against the annulus 24 (or the sidewall of the left ventricle LV), which compresses the leak control extension 2800 into a deformed shape. This compression of the leak control extension 2800 allows the leak control extension to cover the deformed opening 2400 adjacent to the annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be placed in the native valve in a variety of positions. In addition, the flexible leak control extension 2800 is advantageous because it can assume the necessary shape to block blood flow through any deformed opening caused by the connection between the device 100 and the leaflets 20, 22.

[0128] FIG. 78 illustrates a more specific example of the implantable prosthetic device 100 shown in FIGS. 38A-47A. The device 100 includes a pair of paddles 120, a pair of fasteners (not shown), a joint element (e.g., spacer, etc.), a cap 114, and a pair of leak control extensions 2800. The leak control extensions 2800 have a deflection 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 fabric material, a biocompatible material, bovine or porcine heart tissue, a plastic membrane, etc. In the illustrated embodiment, the flexible frame 7801 of each leak control extension 2800 is attached to a leading edge 7810 and a trailing edge 7812 of the cap 114, and the barrier material 7803 is optionally attached to 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 about the side edges 7811, 7813 of the cap.

[0129] FIG. 79 illustrates a more specific example of the implantable prosthetic device 100 shown in FIGS. 38A-47A, where 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 example shapes are shown, various different shapes are possible, e.g., triangular, circular, rectangular, oval, elliptical, etc. In one example implementation, the shape of the leak control extension 2800 can be changed by bending before the device 100 is implanted. The device 100 includes a pair of paddles 120, a pair of fasteners (not shown), a joint element (e.g., spacer, etc.), a cap 114, and a pair of leak control extensions 2800. The leak control extensions 2800 have a deflection paddle 2801 including 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 from a plastically deformable material to allow the shape of the flexible frame 7901 to be altered prior to implantation. The barrier material 7903 can take a wide variety of forms. For example, the barrier material can be a fabric material, a biocompatible material, bovine or porcine heart tissue, a plastic film, and the like. In the illustrated embodiment, the flexible frame 7901 of each leak control extension 2800 is attached to a leading edge 7910 and a 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 about the side edges 7911, 7913 of the cap.

[0130] 38B-47B show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a native valve (e.g., shown as a mitral valve MV, but could be used for another valve, such as a tricuspid valve, as well) in a fully closed position, where the device 100 includes one or more leak control extensions 2800. In the embodiment shown in FIGS. 38B-45B, the implantable prosthetic device 100 is attached to the native valve at a substantially central location within the annulus 24. However, it should be understood that the implantable prosthetic device 100 may be attached to the leaflets 20, 22 at any location within the native valve (e.g., the positions shown in FIGS. 46B-47B).

[0131] In some implementations, the device 100 has a pair of paddles 120, a pair of fasteners 130, a joint 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, for example, any of the forms described herein in combination with at least one leak control extension 2800.

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

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

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

[0135] With reference to the example shown in FIG. 40B and FIG. 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. The device 100 is connected to the leaflets 20, 22 so that when the leaflets 20, 22 are in the open position, a portion 3003 of the mitral valve MV is substantially blocked by the device 100 and another portion 3005 of the mitral valve is open to allow blood to move to the left ventricle LV. Blood moves in direction D through the open portion 3005 and engages the leak control extension 2800. In some embodiments, the blood provides a force against the leak control extension 2800 that causes the leak control extension 2800 to pivot around the cap 114 or bend relative to the cap such that blood moves around the leak control extension 2800 in direction X.

[0136] 42B-45B, during systole, the leaflets 20, 22 of the mitral valve MV coapt to prevent blood from flowing back into the left atrium LA as blood is pushed from the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help coapt or facilitate coaptation of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not coapt completely around the device 100, which may form 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 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 leak control extension 2800 may be positioned to prevent blood from flowing back into the left atrium through the one or more openings 2400.

[0137] 42B and 43B, contraction of the left ventricle LV pushes blood in direction Y towards the mitral valve MV, engaging the deflecting paddle 2801 of the leak 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 deflecting paddle 2801, which causes the deflecting paddle 2801 to pivot around or bend relative to the cap 114 such that the blood moves around the leak control extension 2800 in direction Z.

[0138] 46B and 47B, the device 100 shown in FIGS. 38B-45B may be placed in the native valve at a position near the annulus 24. Similar to the device 100 placed in a more central position in the native valve (as shown in FIGS. 38B-45B), an opening 2400 may be formed where both leaflets 20, 22 and the device 100 meet. When the device 100 is placed near the annulus 24, as shown in the illustrated embodiment, the force of the device 100 on the native valve may cause the opening 2400 adjacent the 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 causes the leak control extension to compress. For example, as shown in FIGS. 46B and 47B, the leak control extension 2800 adjacent the annulus 24 presses against the annulus 24 (or the side wall of the ventricle), which compresses the leak control extension 2800 into a deformed shape. This compression of the leak control extension 2800 allows the leak control extension to cover the deformed opening 2400 adjacent the valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be placed within the native valve in a variety of positions. In addition, the flexible leak control extension 2800 is advantageous because it can assume the necessary configuration to block blood flow through any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0139] 48A-57A show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a native valve (e.g., shown as a mitral valve MV, but may be used similarly for another valve, such as a tricuspid valve) in a fully closed position, with the device 100 including one or more leak control extensions 2800. In the embodiment shown in FIGS. 48A-55A, the implantable prosthetic device 100 is attached to the native valve in a substantially central position and has the leak control extension 2800 between the base of the native valve leaflets and the native valve annulus. However, it should be understood that the implantable prosthetic device 100 may be attached to the leaflets 20, 22 in any position (e.g., the positions shown in FIGS. 56A-57A). The device 100 includes a pair of paddles 120, a pair of fasteners 130, a coaptation element 110 (e.g., a spacer, etc.), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 may take any suitable form, such as, for example, any of the forms described herein in combination with at least one leak control extension 2800.

[0140] 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 extends from the device such that the leak control extension is positioned to block blood moving through the opening between the leaflets 20, 22 of the native valve during systole. In the illustrated embodiment, the leak control extension 2800 includes a pocket configured to receive blood to prevent blood from moving into the atrium. In some implementations, the leak control extension 2800 can have a flexible frame or loop 4801 that defines an opening of the pocket and a barrier material 4803 that defines an interior of the pocket. The flexible frame 4801 can have any suitable shape for defining the opening of the pocket, such as, for example, a circular shape (as shown in FIGS. 54A-57A), an elliptical shape, a triangular shape, a polygonal shape, etc. The flexible frame 4801 can be made, for example, from 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 migrate through the leak control extension 2800. The barrier material 4803 may be made from, for example, a fabric material, a biocompatible material, bovine or porcine heart tissue, a plastic membrane, or the like.

[0141] In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to the coaptation element or spacer 110. In some embodiments, the opening of the leak control extension 2800 is located within the atrium when the device 100 is attached to the leaflets 20, 22 (see FIG. 55A). However, the leak control extension 2800 may be attached to any other portion 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 may be in either the atrium or the ventricle. For example, the leak control extension 2800 may be attached to a pair of paddles 120, a pair of catches 130, a coaptation element 110, a cap 114, or any combination thereof. Although the illustrated embodiment is shown as having two leak control extensions 2800, it should be understood that the device 100 may have any suitable number of leak control extensions.

[0142] 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. The device 100 is connected to the leaflets 20, 22 so that when the leaflets 20, 22 are in the open position, a portion 3003 of the mitral valve MV is substantially blocked by the device 100 and another portion 3005 of the mitral valve is open to allow blood to move to the left ventricle LV. Blood moves in 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, which compresses the barrier material 4803 and moves blood around the leak control extension 2800 in the X direction.

[0143] 52A-55A, during systole, the leaflets 20, 22 of the mitral valve MV coapt to prevent blood from flowing back into the left atrium LA as blood is pushed from the left ventricle into the aorta, and the device 100 is connected to the leaflets 20, 22 to help coapt or facilitate coaptation of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not coapt completely around the device 100, which may form 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 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 leak control extension 2800 may be positioned to prevent blood from flowing back into the left atrium through the one or more openings 2400.

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

[0145] 56A and 57A, the device 100 shown in FIGS. 48A-55A may be placed in the mitral valve MV at a location near the annulus 24. Similar to the device 100 being placed in a more central location in the mitral valve MV (as shown in FIGS. 48A-55A), an opening 2400 may be formed where both leaflets 20, 22 and the device 100 meet. When the device 100 is placed near the annulus 24, as shown in the illustrated embodiment, the force of the device 100 on the mitral valve MV may cause the opening 2400 adjacent the 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 causes the flexible frame 4801 to compress. For example, as shown in Figures 56A and 57A, the leak control extension 2800 adjacent to the annulus 24 is pressed against the annulus 24 (or the sidewall of the left ventricle LV), which compresses the flexible frame 4801 into a deformed shape. This compression of the flexible frame 4801 allows the leak control extension to cover the deformed opening 2400 adjacent to the annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be placed in the mitral valve MV in a variety of positions. 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 leaflets 20, 22.

[0146] 80 and 81 show a more specific example 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 extensions 2800 have a flexible frame 4801 that defines a pocket opening 8005, and a barrier material 4803 that defines an 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 migrate through the leak control extensions 2800.

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

[0148] 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 extends from the device such that the leak control extension is positioned to block blood moving 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 to prevent blood from moving into the atrium. In some implementations, the leak control extension 2800 can have a flexible frame or loop 4801 that defines an opening of the pocket and a barrier material 4803 that defines an interior of the pocket. The flexible frame 4801 can have any suitable shape for defining the opening of the pocket, such as, for example, a circular shape (as shown in FIGS. 54B-57B), an elliptical shape, a triangular shape, a polygonal shape, etc. The flexible frame 4801 can be made, for example, from 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 migrate through the leak control extension 2800. The barrier material 4803 may be made from, for example, a fabric material, a biocompatible material, bovine or porcine heart tissue, a plastic membrane, or the like.

[0149] In the illustrated embodiment, the device 100 has two leak control mechanisms or leak control extensions 2800 attached to the coaptation element or spacer 100 (see FIG. 55B). In the illustrated embodiment, when the device 100 is attached to the leaflets 20, 22, a portion of the leak control extension 2800 is in the atrium and another portion of the leak control extension 2800 is in the ventricle such that an opening of the leak control extension 2800 is located in the ventricle. However, the leak control extension 2800 may be attached to any other portion 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 may be in either the atrium or the ventricle. For example, the leak control extension 2800 may be attached to a pair of paddles 120, a pair of catches 130, a coaptation element 110, a cap 114, or any combination thereof. 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.

[0150] 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. The device 100 is connected to the leaflets 20, 22 so that when the leaflets 20, 22 are in the open position, a portion 3003 of the mitral valve MV is substantially blocked by the device 100 and another portion 3005 of the mitral valve is open to allow blood to move to the left ventricle LV. Blood moves in 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, which compresses the barrier material 4803 and moves blood around the leak control extension 2800 in the X direction.

[0151] 52B-55B, during systole, the leaflets 20, 22 of the mitral valve MV coapt to prevent blood from flowing back into the left atrium LA as blood is pushed from the left ventricle LV into the aorta, and the device 100 is connected to the leaflets 20, 22 to help coapt or facilitate coaptation of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not fully coapt around the device 100, which may form 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 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 leak control extension 2800 is positioned to prevent blood from flowing back into the left atrium through the one or more openings 2400.

[0152] 52B and 53B, contraction of the left ventricle LV pushes blood in direction Y towards the mitral valve MV, engaging the leak control extension 2800 in the mitral valve, which prevents additional blood from moving through the opening 2400 into the left atrium LA. In some embodiments, such as the one shown, blood enters the leak control extension 2800 and provides a force to the barrier material 4803 that causes it to expand.

[0153] 56B and 57B, the device 100 shown in FIGS. 48B-55B may be placed in the native valve at a location near the annulus 24. Similar to the device 100 placed in a more central location in the native valve (as shown in FIGS. 54B-55B), an opening 2400 may be formed where both leaflets 20, 22 and the device 100 meet. When the device 100 is placed near the annulus 24, as shown in the illustrated embodiment, the force of the device 100 against the native valve may cause the opening 2400 adjacent the 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 causes the flexible frame 4801 to compress. For example, as shown in FIG. 56B and FIG. 57B, the leak control extension 2800 adjacent to the annulus 24 is pressed against the annulus 24 (or the side wall of the ventricle), which compresses the flexible frame 4801 into a deformed shape. This compression of the flexible frame 4801 allows the leak control extension to cover the deformed opening 2400 adjacent to the annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be placed in the native valve in a variety of positions. 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 native valve leaflets.

[0154] 58-67 show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a native valve (e.g., shown as a mitral valve MV, but may be used for another valve, such as a tricuspid valve, as well). In the embodiment shown in Figs. 58-65, the implantable prosthetic device 100 is attached to the native valve at a location substantially in the center of the leaflets. However, it should be understood that the implantable prosthetic device 100 may be attached to the leaflets 20, 22 at any location (e.g., the locations shown in Figs. 56A-57A). In the example shown by Figs. 58-67, the leak control extension 2800 is positioned between the end of the native valve leaflets and the native valve annulus. The device 100 has a pair of paddles 120, a pair of fasteners 130, a coaptation element 110 (e.g., a spacer, etc.), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 may take any suitable form, such as, for example, any of the forms described herein in combination with 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 example illustrated by Figures 58-67, the leak control extension 2800 extends from the device such that the leak control extension is positioned 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 to block blood in the native valve moving toward the atrium.

[0156] In some implementations, 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, a circular shape (as shown in FIGS. 64-67), an oval shape, a triangular shape, a polygonal shape, etc. The flexible frame 4801 can be made, for example, from 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 migrate through the leak control extension 2800. The barrier material 4803 can be made, for example, from a fabric material, a biocompatible material, bovine or porcine heart tissue, a plastic film, etc.

[0157] In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to the coaptation element or spacer 100 at the top of the device 100. In some embodiments, the openings of the leak control extensions 2800 are positioned approximately midway between the native valve annulus and the ends of the native valve leaflets when the device 100 is attached to the leaflets 20, 22. The leak control extensions 2800 may be attached to any other part of the device 100 that allows the leak control extensions 2800 to be positioned to prevent all or a portion of blood from backflowing into the atrium, and the openings of the leak control extensions 2800 may be in either the atrium or the ventricle. For example, the leak control extensions 2800 may be attached to a pair of paddles 120, a pair of catches 130, a coaptation element 110, a cap 114, or any combination thereof. In addition, the leak control extensions 2800 may 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.

[0158] 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. The device 100 is connected to the leaflets 20, 22 so that when the leaflets 20, 22 are in the open position, a portion 3003 of the mitral valve MV is substantially blocked by the device 100 and another portion 3005 of the mitral valve is open to allow blood to move to the left ventricle LV. Blood moves in 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, which compresses the barrier material 4803 and moves blood around the leak control extension 2800 in the X direction.

[0159] 62-65, during systole, the leaflets 20, 22 of the mitral valve MV coapt to prevent blood from flowing back into the left atrium LA as blood is pushed from the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help coapt or facilitate coaptation of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not fully coapt around the device 100, which may create 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 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 leak control extension 2800 is positioned to block blood flowing back through the one or more openings 2400 from entering the left atrium.

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

[0161] 66 and 67, the device 100 shown in FIGS. 58-65 may be placed in the native valve at a location near the annulus 24. Similar to the device 100 being placed in a more central location in the native valve (as shown in FIGS. 58-65), an opening 2400 may be formed where both leaflets 20, 22 and the device 100 meet. When the device 100 is placed near the annulus 24, as shown in the illustrated embodiment, the force of the device 100 against the native valve may cause the opening 2400 adjacent the 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 causes the flexible frame 4801 to compress. For example, as shown in Figs. 66 and 67, the leak control extension 2800 adjacent to the annulus 24 is pressed against the annulus 24 (or the sidewall of the ventricle), which compresses the flexible frame 4801 into a deformed shape. This compression of the flexible frame 4801 allows the leak control extension to cover the deformed opening 2400 adjacent to the annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be placed in the native valve in various positions without causing irritation to the annulus 24 or the sidewall of the ventricle or atrium. In addition, the flexible leak control extension 2800 is advantageous because it can assume a form that can block flow in any deformed opening caused by the connection between the device 100 and the leaflets 20, 22.

[0162] 68-77 show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a native valve (e.g., shown as a mitral valve MV, but may be used for another valve, such as a tricuspid valve, as well) in a fully closed position. In the embodiment shown in FIGS. 68-75, the implantable prosthetic device 100 is attached to the native valve at a substantially central location within the annulus 24. However, it should be understood that the implantable prosthetic device 100 may be attached to the leaflets 20, 22 at any location within the native valve (e.g., the locations shown in FIGS. 66-67). The device 100 has a pair of paddles 120, a pair of fasteners 130, a coaptation element 110 (e.g., a spacer, etc.), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 may take any suitable form, such as, for example, any of the forms described herein in combination with at least one leak control extension 2800.

[0163] 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 extends from the device such that the leak control extension is positioned to prevent blood from migrating through any jets or openings 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 to prevent blood from migrating to the atrium. In some implementations, the leak control extension 2800 has a flexible frame 4801 that defines an opening of the pocket and a barrier material 4803 that defines an interior of the pocket.

[0164] The flexible frame 4801 can have any suitable shape for defining the opening of the pocket, such as, for example, a circular shape (as shown in FIGS. 74-77), an oval shape, a triangular shape, a polygonal shape, etc. The flexible frame 4801 can be made, for example, from 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 migrate through the leak control extension 2800. The barrier material 4803 can be made, for example, from a fabric 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 disposed within the ventricle when the device 100 is attached to the leaflets 20, 22. The leak control extension 2800 may be attached to any other location 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 may be in either the atrium or the ventricle. For example, the leak control extension 2800 may be attached to a pair of paddles 120, a pair of catches 130, a coaptation element 110, a cap 114, or any combination thereof. In addition, the leak control extension 2800 may be disposed 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 may have any suitable number of leak control extensions.

[0166] 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. The device 100 is connected to the leaflets 20, 22 so that when the leaflets 20, 22 are in the open position, a portion 3003 of the mitral valve MV is substantially blocked by the device 100 and another portion 3005 of the mitral valve is open to allow blood to move to the left ventricle LV. Blood moves in 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, which compresses the barrier material 4803 and moves blood around the leak control extension 2800 in the X direction.

[0167] 72-75, during systole, the leaflets 20, 22 of the mitral valve MV coapt to prevent blood from flowing back into the left atrium LA as blood is pushed from the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help coapt or facilitate coaptation of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not coapt completely around the device 100, which may create 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 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 leak control extension 2800 is positioned to prevent blood from flowing back into the left atrium through the one or more openings 2400.

[0168] 72 and 73, contraction of the left ventricle LV pushes blood in direction Y towards the mitral valve MV, engaging the leak control extension 2800, which prevents blood from moving through the opening 2400 into the left atrium LA. In some embodiments, such as the one shown, blood enters the leak control extension 2800 and provides a force to the barrier material 4803 that causes it to expand.

[0169] 66 and 77, the device 100 shown in FIGS. 68-75 may be placed within the native valve at a location near the annulus 24. As with the device 100 placed at a more central location within the native valve (as shown in FIGS. 68-75), an opening 2400 may be formed where both leaflets 20, 22 and the device 100 meet. When the device 100 is placed near the annulus 24, as shown in the illustrated embodiment, the force of the device 100 against the native valve may cause the opening 2400 adjacent the annulus 24 to have a deformed shape.

[0170] 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 or deforms the flexible frame 4801. For example, as shown in FIG. 76 and FIG. 77, the leak control extension 2800 adjacent to the annulus 24 is pressed against the annulus 24 (or the sidewall of the ventricle), which compresses the flexible frame 4801 into a deformed shape. This compression of the flexible frame 4801 allows the leak control extension to cover the deformed opening 2400 adjacent to the annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be placed in the native valve in various positions without causing irritation to the annulus 24 or the sidewall of the left ventricle or atrium. 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 leaflets 20, 22.

[0171] 82-91 show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a native valve (e.g., shown as a mitral valve MV, but may be used similarly for another valve, such as a tricuspid valve) in a fully closed position, with the device 100 including one or more leak control extensions 2800. In the embodiment shown in FIGS. 82-89, the implantable prosthetic device 100 is attached to the native valve at a substantially central location within the annulus 24. However, it should be understood that the implantable prosthetic device 100 may be attached to the leaflets 20, 22 at any location within the native valve (e.g., the locations shown in FIGS. 90-91). The device 100 has a pair of paddles 120, a pair of fasteners 130, a coaptation element 110 (e.g., a spacer, etc.), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 may take any suitable form, such as, for example, any of the forms described herein in combination with at least one leak control extension 2800.

[0172] The leak control extensions 2800 are configured to prevent blood from flowing back from the ventricle to the atrium during systole. That is, the leak control extensions 2800 extend from the device (e.g., from the end of the cap 114 of the device 100) such that the leak control extensions are positioned to prevent blood from moving through any jets or openings between the leaflets 20, 22 of the native valve during systole. Each of the leak 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 extending from the first paddle 120 of the device 100 to the second paddle of the device 100, which prevents blood from flowing back during diastole. In the illustrated embodiment, the leak control extensions 2800 each include two deflection paddles 2801 attached to the cap 114 and a barrier element 8203 connecting to and extending from the first paddle 120, the second deflection paddle 2801, and the other paddle 120. The barrier element 8203 may include one or more pieces of material, such as, for example, one or more pieces of fabric material, biocompatible material, bovine or porcine heart tissue, plastic film, and the like. In the illustrated embodiment, the device 100 has two leak control extensions 2800, each leak control extension 2800 including one or more deflection paddles 2801 and a barrier material 8203. Although the illustrated embodiment is shown as having two leak control extensions 2800, it should be understood that the device 100 may have any suitable number of leak control extensions.

[0173] 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. The device 100 is connected to the leaflets 20, 22 so that when the leaflets 20, 22 are in the open position, a portion 3003 of the mitral valve MV is substantially blocked by the device 100 and another portion 3005 of the mitral valve is open to allow blood to move to the left ventricle LV. Blood moves in direction D through the open portion 3005 and engages the leak control extension 2800. In some embodiments, the blood provides a force against the leak control extension 2800 that causes the deflection paddle 2801 to pivot about the cap 114 or bend relative to the cap such that blood moves around the leak control extension 2800 in direction X.

[0174] 86-89, during systole, the leaflets 20, 22 of the mitral valve MV coapt to prevent blood from flowing back into the left atrium LA as blood is pushed from the left ventricle into the pulmonary artery PA, and the device 100 is connected to the leaflets 20, 22 to help coapt or facilitate coaptation of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not coapt completely around the device 100, which may form 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 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 leak control extension 2800 is positioned to prevent blood from flowing back into the left atrium through the one or more openings 2400.

[0175] 86 and 87, contraction of the left ventricle LV pushes blood in direction Y towards the mitral valve MV, engaging the deflection paddle 2801 and barrier element 8203 of the leak 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, which causes the deflection paddle 2801 to pivot around or bend relative to the cap 114 such that the blood moves around the leak control extension 2800 in direction Z. In some embodiments, the blood provides a force against the barrier element 8203, which causes a portion of the barrier element 8203 disposed between the two deflection paddles 2801 to move upward.

[0176] 90 and 91, the device 100 shown in FIGS. 82-89 may be placed in the native valve at a location near the annulus 24. As with the device 100 placed in a more central location in the native valve (as shown in FIGS. 82-89), an opening 2400 may be formed where both leaflets 20, 22 and the device 100 meet. When the device 100 is placed near the annulus 24, as shown in the illustrated embodiment, the force of the device 100 on the native valve may cause the opening 2400 adjacent the 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 causes the leak control extension to compress. For example, as shown in FIGS. 90 and 91, the leak control extension 2800 adjacent the annulus 24 presses against the annulus 24 (or the side wall of the ventricle), which compresses the leak control extension 2800 into a deformed shape. This compression of the leak control extension 2800 allows the leak control extension to cover the deformed opening 2400 adjacent the valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be placed within the native valve in a variety of positions. In addition, the flexible leak control extension 2800 is advantageous because it can assume the necessary configuration to block blood flow through any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0177] Although various inventive aspects, concepts, and features of the present disclosure may be described and illustrated herein as embodied in combination in exemplary embodiments, these various aspects, concepts, and features may be used in many alternative embodiments, either individually or in various combinations and subcombinations thereof. Unless expressly excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Furthermore, although various alternative embodiments of various aspects, concepts, and features of the present disclosure may be described herein, such as alternative materials, structures, configurations, methods, devices, and components, form, fit, and function, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether currently known or later developed. Those skilled in the art may readily adopt one or more of the aspects, concepts, or features of the present invention into additional embodiments and applications within the scope of the present application, even if such embodiments are not expressly disclosed herein.

[0178] In addition, although some features, concepts, or aspects of the present disclosure may be described herein as being preferred arrangements or methods, such description is not intended to imply that such features are required or essential, unless expressly so stated. Furthermore, while example or typical values ​​and ranges may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and are intended to be significant values ​​or ranges only if so expressly stated.

[0179] Furthermore, although various aspects, features, and concepts may be expressly identified herein as being inventive or forming part of the present disclosure, such identification is not intended to be exclusive; rather, there may be aspects, concepts, and features of the invention that are fully described herein without being expressly 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 necessary in all cases, nor should the order in which the steps are presented be construed as necessary or essential unless expressly so described. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein may be performed on live animals or on non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., where body parts, hearts, tissues, etc. are simulated). The words used in the claims have their full ordinary meaning and are not limited in any way by the description of the embodiments herein. [Explanation of symbols]

[0180] 10 Chordae tendineae 12 Papillary muscles 20 Valve leaflet, anterior leaflet 22 Valve leaflet, posterior leaflet 24 Valve Annulus 30 Anterior leaflet, leaflet 32 Septal leaflet, valve leaflet 34 Posterior leaflet, leaflet 100 Implantable prosthetic devices, devices, implantable devices 102 Delivery sheath 104 Joint part 106 Anchor part 110 Joint element or spacer, Joint element, spacer 112 Working part or working element, working element, working member or working element 114 Cap 115 Color 116 Operating Line 120 Outer paddle, paddle 122 Inner paddle, paddle 124 Part, joint, hinge, or flexible part, jointed, hinged, or flexible part 126 Part, joint, hinge, or flexible connection, joint or flexible part, jointed, hinged, or flexible part 128 Part, joint or flexible part, jointed, hinged or flexible part 130 Barbed fasteners, fasteners 132 Base or Fixed Arm 134 Movable Arm 136 Thorns 138 flex, hinge, or joint part, joint part, jointed, hinged, or flexible part 2400 opening or jet, opening 2800 Leak control mechanism or leak control extension, leak control extension, flexible leak control extension 2801 Deflection Paddle 3003 part 3005 part, open part 3803 Arm 4801 Flexible frame or loop, flexible frame 4803 Barrier materials 7801 Flexible Frame 7803 Barrier materials 7810 Leading edge 7812 Trailing edge 7811 Side edge 7813 Side edge 7901 Flexible Frame 7903 Barrier materials 8005 Opening 8203 Barrier elements, barrier materials

Claims

1. 1. A valve repair device for repairing a native valve in a patient, the valve repair device comprising: an anchor portion comprising a first anchor and a second anchor configured to move from an open position to a closed position to secure an implantable device to leaflets of the native valve; one or more leak control extensions configured to inhibit backflow of blood through one or more openings between the leaflets of the native valve during systole, the leak control extensions comprising a barrier element attached to first and second anchors; 13. A valve repair device comprising:

2. The valve repair device of claim 1 , wherein the barrier element comprises one or more pieces of a fabric material.

3. The valve repair device of claim 1 , wherein the barrier element comprises one or more strips of a biocompatible material.

4. The valve repair device of claim 1 , wherein the barrier element extends from the first anchor to the second anchor forming a barrier extending between the first anchor and the second anchor.

5. The valve repair device of claim 1 , wherein the first and second anchors each include a paddle frame, and the barrier element is attached to the paddle frames of both the first and second anchors.

6. A valve restoration device, wherein each of the leak control extensions comprises one or more deflection paddles.

7. The valve repair apparatus of claim 6 , wherein the barrier element connects to and extends from the first anchor, two of the one or more deflection paddles, and a second anchor.

8. The valve repair device of claim 6 , wherein the deflection paddle comprises a fabric covered wire frame.

9. The valve repair device of claim 1 , further comprising a spacer disposed between the first anchor and the second anchor.

10. 1. A valve repair device for repairing a native valve in a patient, the valve repair device comprising: an anchor portion comprising a first anchor and a second anchor, the first anchor and the second anchor configured to move from an open position to a closed position to secure the implantable device to the leaflets of a native valve; a barrier element attached to the first anchor and the second anchor, the barrier element extending between the first anchor and the second anchor to inhibit backflow of blood through one or more openings between the leaflets of the native valve during systole; and 13. A valve repair device comprising:

11. The valve repair device of claim 10 , wherein the barrier element is a component of a leak control extension.

12. The valve repair device of claim 11 , wherein the leak control extension further comprises one or more deflection paddles.

13. The valve repair device of claim 10 , wherein the barrier element comprises one or more pieces of a fabric material.

14. The valve repair device of claim 10 , wherein the barrier element comprises one or more strips of a biocompatible material.

15. The valve repair device of claim 10 , wherein the barrier element extends from the first anchor to the second anchor forming a barrier extending between the first anchor and the second anchor.

16. The valve repair device of claim 10 , wherein the first and second anchors each include a paddle frame, and the barrier element is attached to the paddle frames of both the first and second anchors.

17. The valve repair device of claim 10 , further comprising a spacer disposed between the first anchor and the second anchor.

18. 1. A valve repair device for repairing a native valve in a patient, the valve repair device comprising: an anchor portion comprising a first anchor and a second anchor configured to move from an open position to a closed position to secure an implantable device to the leaflets of the native valve; one or more pieces of fabric material attached to a first anchor and a second anchor, whereby a barrier extends between the first anchor and the second anchor to inhibit backflow of blood through one or more openings between the leaflets of the native valve during systole; and 13. A valve repair device comprising:

19. The valve repair device of claim 18 , wherein the barrier element is a component of a leak control extension.

20. The valve repair device of claim 19 , wherein the leak control extension further comprises one or more deflection paddles.

21. The valve repair device of claim 18 , wherein the fabric material is a biocompatible material.

22. 20. The valve repair device of claim 18, wherein the first and second anchors each include a paddle frame, and the one or more pieces of fabric material are attached to the paddle frames of both the first and second anchors.

23. The valve repair device of claim 18 , further comprising a spacer disposed between the first anchor and the second anchor.

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