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 on December 23, 2019, which is hereby incorporated by reference in its entirety for all purposes.

Background Art

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

[0003] A healthy heart is generally cone-shaped, tapering towards its lower apex. The heart has four chambers: the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly called the septum. The natural mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure from other natural heart valves. The mitral valve includes an annular portion, which is the ring-shaped part of the natural valve tissue surrounding the mitral valve orifice, and a pair of 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 and, when the leaflets are closed, generally form a "C"-shaped boundary between the adjacent sides of the leaflets.

[0004] When functioning normally, the anterior and posterior leaflets work together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract (also called "ventricular systole" or "systole"), the increased blood pressure 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 is instead drained out of the left ventricle through the aortic valve. To prevent the two leaflets from escaping under pressure and folding back towards the left atrium through the mitral annulus, several fibrous cords called chordae tendineae tether the leaflets to the papillary muscles inside the left ventricle.

[0005] Valve regurgitation involves a valve improperly allowing some blood to flow through the valve in the wrong direction. For example, mitral regurgitation occurs when the spontaneous mitral valve does not close properly during systole, allowing 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, including leaflet prolapse, papillary muscle dysfunction, stretching of the mitral annulus resulting from left ventricular dilation, or two or more of these. Mitral regurgitation in the central part of the leaflets may be called central jet mitral regurgitation, and mitral regurgitation near one of the leaflets' commissures (i.e., where the leaflets meet) may be called eccentric jet mitral regurgitation. Central jet mitral regurgitation occurs when the ends of the leaflets do not meet in the middle, and therefore the valve does not close, resulting in regurgitation. [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] U.S. Patent Application Publication No. 2014 / 0222136 [Patent Document 6] U.S. Patent Application Publication No. 2014 / 0067052 [Patent Document 7] U.S. Patent Application Publication No. 2016 / 0331523 [Patent Document 8] PCT / US2019 / 062391 [Overview of the project] [Means for solving the problem]

[0007] This abstract is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, no feature included in the examples in this abstract is required by the claims unless the claims expressly describe such a feature. Also, the features, components, steps, concepts, etc., in the examples in this abstract or elsewhere in the disclosure may be combined in various ways. Various features and steps, such as those described elsewhere in the disclosure, may be included in the examples summarized herein.

[0008] A patient's natural valve can be repaired by inserting a spacer between the leaflets of the valve. 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 and closed position and are configured to attach the valve repair device to the patient's natural valve. At least one leak control extension extends from the spacer and is configured to block retrograde blood flow along the sides of the spacer.

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

[0011] In some implementations, a valve repair device for repairing a patient's natural valve comprises a spacer, a pair of anchors (e.g., paddles, latches, clamps, grippers, fasteners, etc.) configured to attach the valve repair device to the patient's natural 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 a 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 the side of the spacer.

[0014] In some implementations, the valve repair device further comprises a cap connected to a spacer. In some implementations, at least one leak control extension is connected to the cap connected to the spacer. In some implementations, at least one leak control extension is pivotably mounted to the cap. In some implementations, 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, the pair of anchors (e.g., a pair of paddles) and the pair of fasteners configured to attach the valve repair device to the patient's natural valve.

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

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

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

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

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

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

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

[0025] [[ID=⑨]]In some embodiments, the at least one leak control extension is configured to block retrograde blood flow adjacent to or proximate the device.

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

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

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

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

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

[0031] In some implementations, at least one fastener is attached to the device's cap.

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

[0033] In some implementations, at least one leak control extension comprises a pocket including a flexible wire frame defining an opening in the pocket and a fabric barrier material defining at least a portion of the interior of the pocket. In some implementations, the opening of at least one leak control extension is configured to be positioned below one or more leaflets of the natural valve when the valve repair device is attached to the natural valve. In some implementations, the opening of at least one leak control extension is configured to be positioned above the ventricular ends of one or more leaflets of the natural valve when the valve repair device is attached to the natural valve.

[0034] In some implementations, at least a portion of the leak control extension is configured to be positioned below the ventricular end of one or more leaflets of the natural valve when the valve repair device is attached to the natural valve. In some implementations, the entire leak control extension is configured to be positioned above the ventricular end of one or more leaflets of the natural valve when the valve repair device is attached to the natural 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 natural valve when the valve repair device is attached to the natural valve.

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

[0036] In several implementations, a valve repair system for repairing a patient's natural valve comprises a delivery sheath and a valve repair device that can be deployed onto the patient's natural valve by the delivery sheath.

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

[0038] In some implementations, a 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 natural valve.

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

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

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

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

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

[0044] In some implementations, at least one leak control extension comprises a pocket including a flexible wire frame defining an opening in the pocket and a fabric barrier material defining at least a portion of the interior of the pocket. In some implementations, the opening of at least one leak control extension is configured to be positioned below one or more leaflets of the natural valve when the valve repair device is attached to the natural valve. In some implementations, the opening of at least one leak control extension is configured to be positioned above the ventricular ends of one or more leaflets of the natural valve when the valve repair device is attached to the natural valve.

[0045] In some implementations, at least a portion of the leak control extension is configured to be positioned below the ventricular end of one or more leaflets of the natural valve when the valve repair device is attached to the natural valve.

[0046] In some implementations, when the valve repair device is attached to a natural valve, the entire leak control extension is configured to be positioned above the ventricular end of one or more leaflets of the natural valve. In some implementations, when the valve repair device is attached to a natural valve, the entire leak control extension is configured to be positioned below the ventricular end of one or more leaflets of the natural valve.

[0047] In some implementations, 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 with a cloth barrier material. In some implementations, the barrier element comprises at least one of cloth material, biocompatible material, bovine or porcine heart tissue, and a plastic membrane.

[0048] In several implementations, a valve repair system for repairing a patient's natural valve comprises a delivery sheath and a valve repair device that can be deployed onto the patient's natural valve by the delivery sheath.

[0049] In some implementations, the valve repair device comprises 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 being configured to block retrograde blood flow adjacent to or near the device.

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

[0051] In some implementations, the system (for example, a valve repair device for the system) further comprises bonding elements (for example, spacers, coaptation elements, etc.).

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

[0053] The system (for example, a valve repair device in the system) further comprises a cap connected to the joint element.

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

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

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

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

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

[0059] In some implementations, the connecting element is configured to close the gap within the patient's natural valve when the valve repair device is attached to the natural valve.

[0060] In some implementations, the system further comprises at least one 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 natural valve. In some implementations, the at least one fastener is coupled to the cap of the device.

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

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

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

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

[0065] In some implementations, at least a portion of the leak control extension is configured to be positioned below the ventricular end of one or more leaflets of the natural valve when the valve repair device is attached to the natural valve.

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

[0067] In some implementations, 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 with a cloth barrier material. In some implementations, the barrier element comprises at least one of cloth material, biocompatible material, bovine or porcine heart tissue, and a plastic membrane.

[0068] In some implementations, a method for repairing a patient's natural valve includes the steps of: inserting a spacer or connecting element between the leaflets of the patient's natural valve; and blocking retrograde blood flow through the gap between the spacer and the leaflets.

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

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

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

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

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

[0074] The above methods can be performed on living animals or on corpses, corpse hearts, or simulations such as simulators (in which body parts, hearts, tissues, etc., are simulated).

[0075] A further understanding of the nature and advantages of the present invention is provided in the following description and claims, in particular when similar parts are considered in conjunction with the accompanying drawings bearing the same reference numbers.

[0076] To further clarify the various aspects of the embodiments of this disclosure, a more specific description of exemplary embodiments is provided by reference to various aspects of the accompanying drawings. It is understood that these drawings show only typical embodiments of this disclosure and should therefore not be considered limitations of the scope of this disclosure. Furthermore, while the drawings may be drawn to a certain scale for some embodiments, they are not necessarily drawn to a certain scale for all embodiments. Embodiments of this disclosure, as well as other features and advantages, are described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawing]

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

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

[0079] The exemplary implementations of this disclosure are directed toward systems, devices, methods, etc., for repairing defective heart valves. Various embodiments of spontaneous valve repair devices, systems for the delivery of spontaneous valve repair devices, and systems for the removal of implanted spontaneous valve repair devices are disclosed herein, and it should be noted that any combination of these options may be made unless specifically excluded. In other words, the individual components of the disclosed devices and systems may be combined unless they are mutually exclusive or otherwise physically impossible. Furthermore, the techniques and methods may be performed on living animals or on simulations such as cadavers, cadaveric hearts, or simulators (in which body parts, hearts, tissues, etc., are simulated).

[0080] Where it is stated that one or more components are connected, joined, fixed, coupled, attached or otherwise interconnected as described herein, such interconnections may be direct between components or indirect, such as through the use of one or more intermediate components. Also, as described herein, references to “member,” “component,” or “part” 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 state (preferably within 10%, more preferably within 1%, and most preferably within 0.1%).

[0081] Figures 1 and 2 are cross-sectional views of a human heart H in diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., the atrioventricular valves. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA. Each of these valves has flexible valve leaflets (e.g., leaflets 20, 22 shown in Figures 4 and 5) that extend medially across their respective openings, joining together or "coapting" in the flow to form a unidirectional fluid occlusion surface. The spontaneous valve repair system of this application is described primarily with respect to the mitral valve MV. Therefore, the anatomical structures of the left atrium LA and left ventricle LV are described in more detail. However, the devices described herein may also be used to repair other natural valves, for example, the devices may be used to repair 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 diastolic phase (or diastole), as shown in Figure 1, the blood previously collected in the left atrium (LA) is moved into the left ventricular LV through the mitral valve (MV) by the expansion of the left ventricle (LV). During systolic phase (or systole), as shown in Figure 2, the left ventricle (LV) contracts to pump blood into the body via the aortic valve (AV) and ascending aorta (AA). During systolic phase, 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 in the left atrium from the pulmonary veins. In one exemplary implementation, the device described in this application is used to repair the function of a defective mitral valve (MV). Specifically, 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] Referring to Figures 1-7, the mitral valve MV includes two leaflets, anterior leaflet 20 and posterior leaflet 22. The mitral valve MV also includes an annulus 24, which is a variablely 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. Chordae tendineae 10 are cord-like tendons that connect the papillary muscles 12 (i.e., the base of the chordae tendineae and muscles located within the wall of the left ventricle) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles 12 help restrict the movement of the mitral valve MV and prevent the mitral valve from returning to its original position. 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 together are known as the subvalvular apparatus, which functions to prevent the mitral valve (MV) from protruding 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 heart's natural valves. These disease processes include degenerative processes (Barlow's disease, fibroelasticity deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). In addition, damage to the left ventricular LV or right ventricular RV due to a previous heart attack (i.e., myocardial infarction secondary to coronary artery disease) or other heart disease (e.g., cardiomyopathy) can deform the geometric shape of the natural valve, which can lead to valve dysfunction. However, the majority of patients undergoing valve surgery, such as surgery on the mitral valve MV, suffer from degenerative diseases that cause dysfunction in the leaflets (e.g., leaflets 20, 22) of the natural valve (e.g., mitral valve MV), resulting in prolapse and regurgitation.

[0085] Generally, the natural valve can malfunction in two different ways: (1) stenosis and (2) regurgitation. Stenosis occurs when the natural valve does not open completely, thereby causing obstruction of blood flow. Typically, stenosis results from the accumulation of calcified material on the valve leaflets, which thickens the leaflets and impairs their ability to fully open the valve to allow forward blood flow.

[0086] The second type of valvular dysfunction, valvular regurgitation, occurs when the valve leaflets do not close completely, thereby allowing blood to leak into the anterior chamber (for example, from the left ventricle to the left atrium). There are three mechanisms by which a spontaneous valve can regurgitate or malfunction, including Carpentier type I, type II, and type III dysfunction. Carpentier type I dysfunction involves dilation of the annulus such that normally functioning leaflets are pulled apart from each other and fail to form a seal (i.e., the leaflets do not properly join). Leaflet perforation, such as that found in endocarditis, is included in the dysfunction of the type I mechanism. Carpentier type II dysfunction involves prolapse of one or more leaflets of the spontaneous valve on the plane of joining. Carpentier type III dysfunction involves restricted movement of one or more leaflets of the spontaneous valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0087] Referring to Figure 4, when a healthy mitral valve (MV) is in the closed position, the anterior leaflet 20 and posterior leaflet 22 are joined, which prevents blood from leaking from the left ventricle (LV) to the left atrium (LA). Referring to Figure 5, regurgitation occurs when the anterior leaflet 20 and / or posterior leaflet 22 of the mitral valve (MV) move to the left atrium (LA) during systole. This failure of joining creates a gap 26 between the anterior leaflet 20 and posterior leaflet 22, which allows blood to flow back from the left ventricle (LV) to the left atrium (LA) during systole. As described above, there are several different ways in which the valve leaflets (leaflets 20, 22 of the mitral valve (MV)) can become dysfunctional, which can thereby lead to regurgitation.

[0088] Referring to Figure 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 the closed position (i.e., during systole). For example, the gap 26 may have a width W between approximately 2.5 mm and approximately 17.5 mm, for example between approximately 5 mm and approximately 15 mm, for example between approximately 7.5 mm and approximately 12.5 mm, for example between approximately 10 mm. In some circumstances, the gap 26 may have a width W greater than 15 mm. In any of the above circumstances, it is desirable to design a valve repair device that can engage the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV.

[0089] Valve stenosis or regurgitation can affect any valve, but stenosis is known to primarily affect either the aortic valve (AV) or the pulmonary valve (PV), while regurgitation is known to primarily affect the mitral valve (MV) or the tricuspid valve (TV). Both valve stenosis and regurgitation increase the workload on the heart and, if left untreated, can lead to very serious conditions such as endocarditis, congestive heart failure, permanent cardiac damage, cardiac arrest, and ultimately death. Dysfunction of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening because the left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV) are primarily responsible for circulating blood throughout the body. Thus, mitral valve (MV) or aortic valve (AV) dysfunction is far more problematic due to the substantially higher pressure on the left side of the heart.

[0090] Dysfunctional spontaneous heart valves can be repaired or replaced. Repair typically involves preserving and modifying the patient's spontaneous valve. Replacement typically involves replacing the patient's spontaneous valve with a biological or mechanical substitute. Typically, the aortic valve (AV) and pulmonary valve (PV) are more prone to stenosis. Since stenotic damage sustained by the valve leaflets is irreversible, the most common treatments for a stenotic aortic or pulmonary valve are valve removal and replacement with a surgically implanted heart valve, or valve replacement with a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to leaflet deformation, which, as described above, prevents the mitral or tricuspid valve from closing properly, allowing for regurgitation or backflow of blood from the ventricles to the atria (for example, a deformed mitral valve (MV) allows for regurgitation or backflow from the left ventricle (LV) to the left atrium (LA)). Regurgitation or backflow of blood from the ventricles to the atria results in valve regurgitation. Structural or morphological deformities of the mitral valve MV or tricuspid valve TV may be repairable. In addition, regurgitation may occur when the chordae tendineae 10 become dysfunctional (for example, the chordae tendineae may stretch or rupture), allowing the anterior leaflet 20 and posterior leaflet 22 to return to their original position, causing blood to flow back into the left atrium LA. Problems caused by dysfunctional chordae tendineae may be repaired by repairing the structure of the chordae tendineae or the mitral valve (for example, by fixing the leaflets 20, 22 in the affected area of ​​the mitral valve).

[0091] The devices and procedures disclosed herein refer to repairing the structure of the mitral valve or removing a repair device implanted from the mitral valve. However, it should be understood that the devices and concepts provided herein may be used to repair any natural valve or any component of a natural valve. Referring here to Figure 7, any of the devices and concepts provided herein may be used to repair the tricuspid valve TV. For example, the devices and concepts provided herein may be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent regurgitation of blood from the right ventricle to the right atrium. In addition, any of the devices and concepts provided herein may be used together for all three leaflets 30, 32, and 34 to prevent regurgitation of blood from the right ventricle to the right atrium. That is, the valve repair device provided herein may be positioned in the center between the three leaflets 30, 32, and 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 on 10 October 2018, Patent Cooperation Treaty Application No. PCT / US2019 / 012707 filed on 8 January 2019, and Patent Cooperation Treaty Application No. PCT / US2018 / 028189, which are incorporated herein by reference in their entirety.

[0093] Figures 8–14 show examples of valve repair devices. Exemplary implantable prosthetic devices may have a coaptation or joint element (e.g., a spacer) and at least one anchor. The joint element is configured to be positioned within the opening of a natural heart valve to help fill a space and form a more effective seal, thereby reducing or preventing the regurgitation described above. The joint element may have a structure that is impermeable to blood and allows the natural valve leaflets to close around the joint element during ventricular systole, thereby blocking blood flow from the left or right ventricle to the left or right atrium, respectively. The prosthetic device may be configured to seal to two or three natural valve leaflets; i.e., the device may be used in natural mitral valves (bicuspid valves) and tricuspid valves. Since the joint element can fill the space between improperly functioning natural mitral or tricuspid valve leaflets that do not close completely, the joint element is sometimes referred to herein as a spacer.

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

[0095] The anchor may be configured to secure the device to one or both of the natural mitral valve leaflets so that the connecting element is positioned between two natural valve leaflets. In embodiments configured for use in a tricuspid valve, the anchor may be configured to secure the device to one, two, or three of the tricuspid valve leaflets so that the connecting element is positioned between three natural valve leaflets. In some embodiments, the anchor may be mounted on the connecting element at a position adjacent to the ventricular portion of the connecting element. In some embodiments, the anchor may be mounted on a shaft, actuating wire, or other actuating element to which the connecting element is also mounted. In some embodiments, the anchor and the connecting element may be positioned independently. In some embodiments, the anchor and the connecting element may be positioned simultaneously. The anchor may be configured to grip the valve leaflets.

[0096] The prosthetic device may be configured to be implanted via a delivery sheath. Additional information regarding examples of delivery devices can be found in U.S. Patent No. 8,449,599, and U.S. Patent Application Publications 2014 / 0222136, 2014 / 0067052, and 2016 / 0331523, each of which is incorporated herein by reference in whole. Furthermore, these methods may be performed on living animals or on simulations such as cadavers, cadaveric hearts, or simulators (in which body parts, hearts, tissues, etc., are simulated).

[0097] Referring here to Figures 8 to 14, an example of the implantable prosthetic device 100, schematically shown, is illustrated at various stages of development. However, as described above, the implantable prosthetic device can take on a wide variety of different forms. For example, the features of this application may be included in any of the implantable prosthetic devices disclosed in U.S. Patent Application No. 62 / 744,031, Patent Cooperation Treaty Application No. PCT / US2019 / 012707, and / or Patent Cooperation Treaty Application No. PCT / US2018 / 028189. Device 100 may include any other features relating to the implantable prosthetic device discussed in this application, and device 100 may be positioned to engage with valve tissue (e.g., valve leaflets 20, 22) as part of any suitable valve restoration device (e.g., any valve restoration device disclosed in this application).

[0098] Device 100 may be deployed from a delivery sheath 102 and may include a joint portion 104 and / or an anchor portion 106. The joint portion 104 of device 100 is adapted to be implanted between the leaflets of a natural valve (e.g., a natural mitral valve, a natural tricuspid valve, etc.) and includes a joint element or spacer 110 that is slidably attached to an actuator or actuating element 112 (e.g., a wire, shaft, rod, line, suture, tether, etc.). The anchor portion 106 is actuated between an open and closed position and can take a wide variety of forms, such as a paddle, latch, fastener, crimping element. Differential operation of the actuating element 112 (e.g., operation of an actuating wire) opens and closes the anchor portion 106 of device 100 to grasp the mitral valve leaflets during implantation. The actuating element 112 can take a wide variety of forms. For example, the actuating element may be threaded so that rotation of the actuating element moves the anchor portion 106 relative to the joint portion 104. Alternatively, the actuation element does not need to be threaded so that pushing or pulling the actuation element 112 moves the anchor portion 106 relative to the joint portion 104.

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

[0100] The actuating member or actuating element extends through the delivery sheath and / or pusher tube / rod and / or connecting element or spacer 110 to the cap 114 at the distal connection of the anchor portion 106. Extending and contracting the actuating element 112 increases or decreases the distance between the connecting element 110 and the cap 104, respectively. Optional mounting means or collar (not shown) detachably attach the connecting element 110 to the pusher tube or rod and / or delivery sheath 102 so that the actuating element 112 slides along the actuating element 112 during operation to open and close the paddles 120, 122 of the anchor portion 106. If the device 100 needs to be removed from the valve tissue after it has been connected, a retrieval device may be used to connect to the collar 115 so that the actuating element extends through the collar 115 and connecting element 110 to engage with the anchor portion 106 to open the paddles 120, 122, allowing the device 100 to be removed from the valve tissue. Examples of recovery devices that may be used are shown in PCT application number PCT / US2019 / 062391, filed on November 20, 2019, which is incorporated herein by reference in its entirety.

[0101] Referring here to Figure 11, the anchor portion 106 includes a mounting portion or gripping member. The illustrated gripping member is shown as a spiked fastener 130, which includes a base or fixed arm 132, a movable arm 134, spikes 136, and a flex, hinge, or joint portion 138. However, other friction-enhancing elements may be used instead of spikes. The fixed arm 132 is attached to the inner paddle 122, and the flex, hinge, or joint portion 138 is positioned close to the joining element 110. The spiked fastener has a flat surface and does not fit into a recess in the paddle. Rather, the flat portion of the spiked fastener 130 is positioned 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 spiked fastener 130. The joint portion 138 may be any suitable flexible portion, hinge, or joint, such as a flexible joint or hinge, a spring joint or hinge, or a pivot joint or hinge. In some embodiments, the flex, hinge, or joint portion 138 is a flexible piece of material formed integrally 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 a spiked fastener 130 and expose the spikes 136. The spiked fastener 130 is opened by applying tension to an actuation line 116 attached to the movable arm 134, thereby moving, bending, and / or pivoting the flex, hinge, or joint portion 138.

[0102] During implantation, paddles 120 and 122 open and close to capture or grasp the natural mitral valve leaflet between the paddles 120 and 122 and the connecting element 110. The spiked fastener 130 further secures the natural valve leaflet by engaging it with the spike 136 and pinching it between the movable arm 134 and the fixed arm 132. The spike 136 of the spiked fastener 130 can increase friction with the valve leaflet or partially or completely puncture it. The actuation line 116 can be actuated independently or separately so that each spiked fastener 130 can be opened and closed independently or separately. Separate / independent action allows one valve leaflet to be grasped at a time, or allows repositioning of the fastener 130 for an inadequately grasped valve leaflet without altering the normal grasp for other valve leaflets. The spiked fasteners 130 can not only open and close independently of each other, but can also open and close completely regardless of the position of the inner paddles 122, thereby allowing the valve leaflets to be captured in various positions as required by specific circumstances.

[0103] The barbed fastener 130 can be opened independently or separately by pulling an attached actuation line 116 (or other actuation means) that extends from the delivery sheath 102 to the barbed fastener 130. The actuation line 116 can take a wide variety of forms, such as a line, suture, rod, or catheter. In the closed position, the barbed fastener 130 is spring-loaded or otherwise biased so that it continues to provide a clamping force to the captured or grasped natural valve leaflet. This clamping force may remain constant or positive regardless of the position of the internal paddle 122. The barbs 136 of the barbed fastener 130 can penetrate the natural valve leaflet to further secure it.

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

[0105] Referring here to Figure 9, device 100 is shown in a state of detanglement similar to that in Figure 8, but the spiked fastener 130 is in a fully open position with a range of approximately 140 to 200 degrees, 170 to 190 degrees, or 180 degrees between the fixed and movable parts of the spiked fastener 130. Fully opening the paddles 120, 122 and the fastener 130 has been found to improve the ease of detanglement from the patient's anatomical structure during implantation of device 100.

[0106] Referring here to Figure 10, the device 100 is shown in a retracted or fully closed state. The compact size of the device 100 in the retracted state allows for easier handling and placement within the heart. To move the device 100 from the extended to the retracted state, the actuating element 112 is retracted to pull the cap 114 toward the connecting element 110. The joint, hinge, or flexible connection 126 between the outer paddle 120 and the inner paddle 122 is restricted or constrained in its movement so that the compressive force acting on the outer paddle 120 from the cap 114 as it retracts toward the connecting element 110 causes the paddles 120, 122, or the gripping element to move radially outward. During movement from the open to the closed position, the outer paddle 120 maintains an acute angle with the actuating element 112. The outer paddle 120 can optionally be biased toward the closed position. During the same motion, the inner paddle 122 is oriented away from the joint element 110 in the open position and collapses along the side of the joint element 110 in the closed position, thus moving through a considerably larger angle. In some embodiments, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the joints, hinges, or flexible parts 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 parts 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 parts 126, 128 connected to the inner paddle 122 may be more flexible to allow for more movement than, for example, the joints or flexible parts 124 connecting the outer paddle 120 to the cap 114. In some embodiments, the inner paddle 122 may have the same width as, or substantially the same width as, the outer paddle.

[0107] Referring here to Figures 11-13, the device 100 is shown in a partially open, capture-ready, or grip-ready state. To transition from a fully closed state to a partially open state, the actuating element 112 (e.g., actuating wire, actuating shaft, etc.) expands to push the cap 114 away from the coupling element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor portion 106 to partially unfold. The actuating line 116 is also retracted to open the fastener 130 so that the valve leaflet can be captured or gripped. In some embodiments, such as the example shown in Figure 11, the pair of inner and outer paddles 122, 120 are moved simultaneously, rather than independently, by a single actuating element 112. Also, the position of the fastener 130 may depend on the position of the paddles 122, 120. Referring to Figure 10, for example, closing the paddles 122, 120 may also close the fastener. In some embodiments, the paddles 122, 120 may be independently controllable. For example, 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 the other independent wire and cap is used to control the other paddle.

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

[0109] Referring here to Figure 14, 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 fasteners 130 remain in the fully closed position. When deployed, device 100 can be maintained in the fully closed position using a mechanical latch, or it can be biased to remain closed by the use of spring material such as steel, other metals, plastics, composite materials, or shape memory alloys such as Nitinol. For example, jointed, hinged, or flexible parts 124, 126, 128, 138 and / or additional biasing components may be formed from a metal such as steel or a shape memory alloy such as Nitinol, manufactured in wire, sheet, tube, or laser-sintered powder, and can be biased to hold the closed outer paddles 120 around the joint element or spacer 110 and the spiked fasteners 130 sandwiched around the natural valve leaflets. In some embodiments, the pads 120, 122 may be configured to open and close in conjunction with the heartbeat and the corresponding opening and closing of the natural valves.

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

[0111] Referring here to Figure 21, the device 100 in Figures 8 to 14 is shown implanted in a natural valve, for example, a natural 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 connecting element 110 (for example, a spacer), and a cap 114. The outer paddle 120 and the inner paddle 122 are connected between the cap 114 and the connecting element 110 by parts 124, 126, 128 (which may be jointed and / or flexible to move between various positions). The connecting element 110 is adapted to be implanted between the leaflets 20, 22 of the natural 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 a friction-enhancing element (e.g., spikes, bumps, rough surfaces, adhesive, etc.) for engaging with the valve leaflets 20, 22 of the natural valve. In some embodiments, the device 100 has only one outer paddle 120, only one inner paddle 122, and only one fastener (e.g., a spiked fastener, etc.), which may be configured in different ways.

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

[0113] Referring to Figures 24 and 25, during systole, the valve leaflets 20, 22 fuse around an implantable prosthetic device 100 to prevent the backflow of blood from the left ventricle to the left atrium. However, in certain circumstances, they may not fuse 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 valve leaflets 20, 22. The openings 2400 may form where both valve leaflets 20, 22 and the device 100 intersect. However, the openings 2400 may form at any point where the device 100 and a single valve leaflet 20, 22 intersect. These openings 2400 allow blood to flow back into the left atrium during systole.

[0114] Referring to Figures 26 and 27, the device 100 may be positioned within the natural valve or mitral valve MV near the valve annulus 24. Similar to the case where the device 100 is positioned in a more central location within the mitral valve MV (as shown in Figures 24 and 25), the opening 2400 may be formed where both leaflets 20, 22 and the device 100 intersect. When the device 100 is positioned near the valve annulus 24, as shown in the illustrated embodiments, the force exerted by the device 100 on the mitral valve MV may cause some of the leaflets to bundle or wrinkle, resulting in the opening 2400 having a deformed shape. For example, when the device 100 is positioned near the valve annulus, it is more difficult to align the leaflets within the device. If the leaflets are offset from each other within the device 100, the portion of the leaflets adjacent to the valve annulus 24 may bundle or wrinkle, resulting in an opening 2400 with a deformed shape on one or both sides of the device.

[0115] Figures 28 to 91 illustrate various embodiments of an implantable prosthetic device 100 including one or more leak control mechanisms or leak control extensions 2800, the leak control extensions 2800 which allow blood to flow through or over the leak control extensions 2800 when the heart is in diastole (i.e., blood to flow from the atria to the ventricles) and block or deflect at least a portion of the blood that would otherwise flow backward through the openings 2400 when the heart is in systole (i.e., blood to flow from the ventricles to the atria). The leak control extensions 2800 can take on a wide variety of different forms. For example, the leak control extensions 2800 may have configurations such as substantially flat deflection paddles, curved deflection paddles, bags or sacks that open toward a cap, deflection paddles and cloth assemblies. The leak control extensions 2800 can be made from a wide variety of different materials. For example, the leak control extensions may be made from thin plastic, cloth-covered wire frames, frameless cloth, cloth with plastic frames, or any combination thereof. The leak control extension 2800 can be positioned in a wide variety of different ways. For example, the leak control extension may be positioned below the natural valve leaflet, below the lower part of the natural valve leaflet, between the lower part of the natural valve leaflet and the natural valve ring, or a portion of the leak control extension may be below the natural valve leaflet and a portion of the leak control extension may be between the lower part of the natural valve leaflet and the natural valve ring.

[0116] Figures 28–37 show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a natural valve in a fully closed position (for example, shown as a mitral valve MV, but can be similarly used for other valves such as a tricuspid valve), the device 100 including one or more leak control extensions 2800. In the embodiments shown in Figures 28–35, the implantable prosthetic device 100 is attached to the natural valve in a substantially central position relative to the annulus 24. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any position within the natural valve (for example, the positions shown in Figures 36–37). The device 100 comprises a pair of paddles 120, a pair of fasteners 130, a joining element 110 (e.g., a spacer), a cap 114, and a leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described in this application, or 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, combined with the leak control extension 2800.

[0117] In the example shown by Figures 28 and 29, the leak control extension 2800 includes deflection paddles 2801 connected to the upper surface of the cap and positioned below the natural valve leaflets. The leak control extension 2800 is configured to prevent blood from the ventricle from reaching the opening 2400 during systole. That is, the leak control extension 2800 extends from the device (for example, from the cap 114 of device 100) so that the leak control extension prevents blood from moving through any jet or opening between the natural valve leaflets 20, 22 during systole. In the illustrated embodiment, the leak control extension 2800 is positioned within the left ventricular LV when device 100 is attached to the valve leaflets 20, 22. In the illustrated embodiment, device 100 has two leak control extensions 2800 attached to the upper surface of the cap 114. Although the illustrated embodiment is shown as having two leak control extensions, it should be understood that device 100 may have any appropriate number of leak control extensions.

[0118] Referring to Figures 30 and 31, during diastole, the leaflets 20, 22 of the mitral valve MV open, allowing blood to move from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20, 22, when the leaflets 20, 22 are in the open position, portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open, allowing blood to move to the left ventricle LV. The blood moves through the open portion 3005 in direction D and engages with 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 against the cap 114, so that the blood moves around the leak control extension 2800 in direction X.

[0119] Referring to Figures 32-35, during systole, the mitral valve leaflets 20, 22 join to prevent blood from flowing back into the left atrium (LA) as blood is pushed from the left ventricle into the aorta, and device 100 connects to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not join completely around device 100, which may form one or more openings or jets 2400 between device 100 and one or more of the leaflets 20, 22. The openings 2400 may be formed where both leaflets 20, 22 and device 100 intersect. However, the openings 2400 may also be formed at any point where device 100 and a single leaflet 20, 22 intersect. The leak control extension 2800 is positioned to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0120] Referring to Figures 32 and 33, the contraction of the left ventricular LV pushes blood toward the mitral valve MV in direction Y, engaging with the deflection paddle 2801 of the leak control extension 2800, which prevents blood from moving through the opening 2400 to 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 the cap 114 or bend relative to the cap so that the blood is directed away from the opening 2400 around the leak control extension 2800 in direction Z.

[0121] Referring to Figures 36 and 37, the device 100 shown in Figures 28-35 may be positioned within the natural valve near the annulus 24. Similar to the device 100 positioned in a more central location within the natural valve (as shown in Figures 28-35), an opening 2400 may be formed where both valve leaflets 20, 22 and the device 100 intersect. When the device 100 is positioned near the annulus 24, as shown in the illustrated embodiments, the force exerted by the device 100 on the natural valve may cause the opening 2400 adjacent to the annulus 24 to have a deformed shape. In some embodiments, the leak control extension 2800 is flexible so that a force applied to the leak control extension compresses it. For example, as shown in Figures 36 and 37, 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 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 valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be positioned within the natural valve at various locations without causing irritation to the valve annulus 24 or the side walls of the 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 valve leaflets 20, 22.

[0122] Figures 38A to 47A show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a natural valve in a fully closed position (for example, shown as a mitral valve MV, but can be similarly used for other valves such as a tricuspid valve), the device 100 including one or more leak control extensions 2800. In the embodiments shown in Figures 38A to 45A, the implantable prosthetic device 100 is attached to the natural valve in a substantially central position within the annulus 24. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any position within the natural valve (for example, the positions shown in Figures 46A to 47A). The device 100 comprises a pair of paddles 120, a pair of fasteners 130, a joining element 110 (for example, a spacer), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described 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 (for example, from the end of the cap 114 of device 100) so that the leak control extension is positioned to prevent blood from moving through any jet or opening between the leaflets 20, 22 of the mitral valve MV during systole. In the illustrated embodiment, the leak control extension 2800 includes deflection paddles 2801 that are positioned in the left ventricular LV when the device is attached to the leaflets 20, 22. In the illustrated embodiment, device 100 has two leak control extensions 2800 attached to the bottom surface of the cap 114. The leak control extensions 2800 may be connected to each other (as shown in the illustrated embodiment), or the leak control extensions 2800 may be separate extensions. Although the illustrated embodiment is shown having two leak control extensions 2800, the device 100 may have any suitable number of leak control extensions.

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

[0125] Referring to Figures 42A to 45A, during systole, the mitral valve leaflets 20, 22 join 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 connects to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not join 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 intersect. However, the openings 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 intersect. Leak control extensions 2800 may be positioned to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0126] Referring to Figures 42A and 43A, the contraction of the left ventricular LV pushes blood toward the mitral valve MV in direction Y, engaging with the deflection paddle 2801 of the leak control extension 2800, which prevents blood from moving through the opening 2400 to 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 the cap 114 or bend relative to the cap, so that the blood moves around the leak control extension 2800 in direction Z.

[0127] Referring to Figures 46A and 47A, the device 100 shown in Figures 38A to 45A may be positioned within the mitral valve MV near the valve ring 24. Similar to the device 100 positioned in a more central location within the mitral valve MV (as shown in Figures 38A to 45A), an opening 2400 may be formed where both valve leaflets 20, 22 and the device 100 intersect. When the device 100 is positioned near the valve ring 24, as shown in the illustrated embodiments, the force exerted by the device 100 on the mitral valve MV may cause the opening 2400 adjacent to the valve ring 24 to have a deformed shape. In some embodiments, the leak control extension 2800 is flexible so that a force applied to the leak control extension compresses the leak control extension. For example, as shown in Figures 46A and 47A, the leak control extension 2800 adjacent to the valve annulus 24 is pressed against the valve annulus 24 (or the side wall of the left ventricular 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 valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be positioned within the natural valve at various locations. In addition, the flexible leak control extension 2800 is advantageous because it can take the shape necessary to block blood flow through any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0128] Figure 78 shows a more specific example of the implantable prosthetic device 100 shown in Figures 38A to 47A. The device 100 includes a pair of paddles 120, a pair of fasteners (not shown), a bonding element (e.g., a spacer), a cap 114, and a pair of leak control extensions 2800. The leak control extensions 2800 have deflection paddles 2801 including a flexible frame 7801 and a barrier material 7803. The flexible frame 7801 can be made of 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 may be a cloth material, a biocompatible material, bovine or porcine heart tissue, and a plastic membrane, etc. In the illustrated embodiment, the flexible frame 7801 of each leak control extension 2800 is attached to the front edge 7810 and rear edge 7812 of the cap 114, and the barrier material 7803 is optionally attached to the side edges 7811, 7813 of the cap 114. This connection between the leak control extension 2800 and the cap 114 allows the leak control extension 2800 to pivot or bend around the side edges 7811, 7813 of the cap.

[0129] Figure 79 shows a more specific example of the implantable prosthetic device 100 shown in Figures 38A to 47A, where the leak control extension 2800 has a different shape from the example in Figure 78. For example, the leak control extension has a narrower shape. Various exemplary shapes are shown, but various different shapes are possible, such as triangular, circular, rectangular, oval, elliptical, etc. In one exemplary implementation, the shape of the leak control extension 2800 can be modified by bending it before the device 100 is implanted. The device 100 includes a pair of paddles 120, a pair of fasteners (not shown), a joining element (e.g., a spacer), a cap 114, and a pair of leak control extensions 2800. The leak control extension 2800 has deflection paddles 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 before implantation. The barrier material 7903 can take a wide variety of forms. For example, the barrier material may be a cloth material, a biocompatible material, bovine or porcine heart tissue, and a plastic membrane. In the illustrated embodiment, the flexible frame 7901 of each leak control extension 2800 is attached to the front edge 7910 and rear edge 7912 of the cap 114, and the barrier material 7903 is optionally attached to the side edges 7911, 7913 of the cap 114. This connection between the leak control extension 2800 and the cap 114 allows the leak control extension 2800 to pivot or bend around the side edges 7911, 7913 of the cap.

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

[0131] In some implementations, the device 100 comprises a pair of paddles 120, a pair of fasteners 130, a bonding element 110 (e.g., a spacer), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described 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 the backflow of blood from the ventricle to the atrium during systole. That is, the leak control extension 2800 extends from the device (for example, from the end of the cap 114 of device 100) so that the leak control extension is positioned to prevent blood from moving through any jet or opening between the leaflets 20, 22 of the natural valve during systole. In the illustrated embodiment, the leak control extension 2800 includes a deflection paddle 2801 positioned inside the ventricle when the device is attached to the leaflets 20, 22, 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 would prevent it from preventing backflow of blood during systole. The arm 3803 may be made of, for example, cloth, sutures, wire, any combination thereof, or any other suitable material or component that can secure the deflection paddle to the spacer 110. While 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 part of the device 100 that prevents undesirable movement of the deflection paddle.

[0134] In the illustrated example, device 100 has two leak control extensions 2800, each leak control extension 2800 including a deflection paddle 2801 attached to the bottom surface of the cap 114. The deflection paddles 2801 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 having two leak control extensions 2800, it should be understood that device 100 may have any appropriate number of leak control extensions.

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

[0136] Referring to Figures 42B to 45B, during systole, the mitral valve leaflets 20, 22 join 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 connects to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not join 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 intersect. However, the openings 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 intersect. Leak control extensions 2800 may be positioned to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0137] Referring to Figures 42B and 43B, the contraction of the left ventricular LV pushes blood toward the mitral valve MV in direction Y, engaging with the deflection paddle 2801 of the leak control extension 2800, which prevents blood from moving through the opening 2400 to 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 the cap 114 or bend relative to the cap, so that the blood moves around the leak control extension 2800 in direction Z.

[0138] Referring to Figures 46B and 47B, the device 100 shown in Figures 38B–45B may be positioned within the natural valve near the annulus 24. Similar to the device 100 positioned in a more central location within the natural valve (as shown in Figures 38B–45B), an opening 2400 may be formed where both valve leaflets 20, 22 and the device 100 intersect. When the device 100 is positioned near the annulus 24, as shown in the illustrated embodiments, the force exerted by the device 100 on the natural valve may cause the opening 2400 adjacent to the annulus 24 to have a deformed shape. In some embodiments, the leak control extension 2800 is flexible so that a force applied to the leak control extension compresses it. For example, as shown in Figures 46B and 47B, 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 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 valve ring 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be positioned within the natural valve at various locations. In addition, the flexible leak control extension 2800 is advantageous because it can take the shape necessary to block blood flow through any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0139] Figures 48A to 57A show an example of an implantable prosthetic device 100 attached to the leaflets 20, 22 of a natural valve in a fully closed position (for example, shown as a mitral valve MV, but can be similarly used for other valves such as a tricuspid valve), the device 100 including one or more leak control extensions 2800. In the embodiments shown in Figures 48A to 55A, the implantable prosthetic device 100 is attached to the natural valve in a substantially central position and has a leak control extension 2800 between the base of the natural valve leaflets and the natural valve annulus. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 in any position (for example, the position shown in Figures 56A to 57A). The device 100 includes a pair of paddles 120, a pair of fasteners 130, a joining element 110 (for example, a spacer), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described 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 it is positioned to block blood moving through the opening between the leaflets 20, 22 of the natural valve during systole. In the illustrated embodiment, the leak control extension 2800 includes a pocket configured to receive blood in order to prevent blood from moving into the atrium. In some implementations, the leak control extension 2800 may have a flexible frame or loop 4801 defining the opening of the pocket and a barrier material 4803 defining the interior of the pocket. The flexible frame 4801 may have any suitable shape for defining the opening of the pocket, such as circular, elliptical, triangular, polygonal, etc. (as shown in Figures 54A to 57A). The flexible frame 4801 may be made from, for example, a metal wire such as steel or nitinol wire, plastic, etc. The barrier material 4803 is configured to trap blood so that it does not move through the leak control extension 2800. The barrier material 4803 may be made from, for example, cloth material, biocompatible material, bovine or porcine heart tissue, or a plastic membrane.

[0141] In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to a connecting element or spacer 110. In some embodiments, the openings of the leak control extensions 2800 are positioned within the atrium when the device 100 is attached to the valve leaflets 20, 22 (see Figure 55A). However, 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 blood from flowing back 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 fasteners 130, a connecting element 110, a cap 114, or any combination thereof. Although the illustrated embodiment is shown having two leak control extensions 2800, it should be understood that the device 100 may have any appropriate number of leak control extensions.

[0142] Referring to Figures 50A and 51A, during diastole, the leaflets 20 and 22 of the mitral valve MV open, allowing blood to move from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20 and 22, when the leaflets 20 and 22 are in the open position, portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open, allowing blood to move to the left ventricle LV. The blood moves through the open portion 3005 in direction D and engages with 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 the blood around the leak control extension 2800 in direction X.

[0143] Referring to Figures 52A to 55A, during systole, the mitral valve leaflets 20, 22 join to prevent blood from flowing back into the left atrium (LA) as blood is pushed out of the left ventricle into the aorta, and the device 100 connects to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not join 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 intersect. However, the openings 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 intersect. Leak control extensions 2800 may be positioned to prevent blood from flowing back into the left atrium through one or more openings 2400.

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

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

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

[0147] Figures 48B to 57B show an exemplary implantable prosthesis device 100 attached to the leaflets 20, 22 of a natural valve in a fully closed position (for example, shown as a mitral valve MV, but can be similarly used for other valves such as a tricuspid valve), the device 100 including one or more leak control extensions 2800. In the embodiments shown in Figures 48B to 55B, the implantable prosthesis device 100 is attached to the natural valve in a substantially central position and has a leak control extension 2800 between the base of the natural valve leaflets and the natural valve annulus. However, it should be understood that the implantable prosthesis device 100 can be attached to the leaflets 20, 22 in any position (for example, the position shown in Figures 56B to 57B). The device 100 includes a pair of paddles 120, a pair of fasteners 130, a joining element 110 (for example, a spacer), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described 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 so that it is positioned to block blood moving through the opening between the leaflets 20, 22 of the natural valve during systole. In the illustrated embodiment, the leak control extension 2800 is a pocket configured to receive blood in order to prevent blood from moving into the atrium. In some implementations, the leak control extension 2800 may have a flexible frame or loop 4801 defining the opening of the pocket and a barrier material 4803 defining the interior of the pocket. The flexible frame 4801 may have any suitable shape for defining the opening of the pocket, such as circular, elliptical, triangular, polygonal, etc. (as shown in Figures 54B to 57B). The flexible frame 4801 may be made from, for example, a metal wire such as steel or nitinol wire, plastic, etc. The barrier material 4803 is configured to trap blood so that it does not move through the leak control extension 2800. The barrier material 4803 may be made from, for example, cloth material, biocompatible material, bovine or porcine heart tissue, or a plastic membrane.

[0149] In the illustrated embodiment, the device 100 has two leak control mechanisms or leak control extensions 2800 attached to a connecting element or spacer 100 (see Figure 55B). In the illustrated embodiment, when the device 100 is attached to the valve leaflets 20, 22, part of the leak control extension 2800 is in the atrium, and the other part of the leak control extension 2800 is in the ventricle such that the opening of the leak control extension 2800 is located in the ventricle. However, the leak control extension 2800 may be attached to any other part 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 fasteners 130, a connecting element 110, a cap 114, or any combination thereof. Although the illustrated embodiment is shown having two leak control extensions 2800, it should be understood that the device 100 may have any appropriate number of leak control extensions.

[0150] Referring to Figures 50B and 51B, during diastole, the leaflets 20 and 22 of the mitral valve MV open, allowing blood to move from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20 and 22, when the leaflets 20 and 22 are in the open position, portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open, allowing blood to move to the left ventricle LV. The blood moves through the open portion 3005 in direction D and engages with 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 the blood around the leak control extension 2800 in direction X.

[0151] Referring to Figures 52B to 55B, during systole, the mitral valve leaflets 20, 22 join 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 connects to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not join 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 intersect. However, the openings 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 intersect. The leak control extension 2800 is positioned to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0152] Referring to Figures 52B and 53B, the contraction of the left ventricular LV pushes blood toward the mitral valve MV in direction Y, engaging with the leak control extension 2800 within the mitral valve, which prevents additional blood from moving through the opening 2400 to the left atrium LA. In some embodiments, such as the illustrated embodiment, the blood enters the leak control extension 2800 and provides a force to the barrier material 4803 that expands the barrier material 4803.

[0153] Referring to Figures 56B and 57B, the device 100 shown in Figures 48B to 55B may be positioned within the natural valve near the valve ring 24. Similar to the device 100 positioned more centrally within the natural valve (as shown in Figures 54B to 55B), an opening 2400 may be formed where both valve leaflets 20, 22 and the device 100 intersect. When the device 100 is positioned near the valve ring 24, as shown in the illustrated embodiments, the force exerted by the device 100 on the natural valve may cause the opening 2400 adjacent to the valve ring 24 to have a deformed shape. In some embodiments, the flexible frame 4801 of the leak control extension 2800 is flexible such that a force applied to the leak control extension 2800 compresses the flexible frame 4801. For example, as shown in Figures 56B and 57B, the leak control extension 2800 adjacent to the valve annulus 24 is pressed against the valve 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 valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be positioned within the natural valve at various locations. In addition, the flexible leak control extension 2800 is advantageous because it can take the form of any deformed opening caused by the connection between the device 100 and the natural valve leaflet.

[0154] Figures 58–67 show examples of implantable prosthetic devices 100 attached to the leaflets 20, 22 of a natural valve (shown, for example, as a mitral valve MV, but which can be similarly used for other valves such as a tricuspid valve). In the embodiments shown in Figures 58–65, the implantable prosthetic device 100 is attached to the natural valve at a substantially central position on the leaflets. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any position (for example, the positions shown in Figures 56A–57A). In the examples shown by Figures 58–67, the leak control extension 2800 is positioned between the ends of the natural valve leaflets and the natural valve annulus. The device 100 comprises a pair of paddles 120, a pair of fasteners 130, a joining element 110 (e.g., a spacer), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described herein, in combination with at least one leak control extension 2800.

[0155] The leak control extension 2800 is configured to prevent blood from flowing backward from the ventricle to the atrium during systole. In the examples shown by Figures 58–67, the leak control extension 2800 extends from the device so that it is positioned to block blood flowing through the opening between the leaflets 20, 22 of the natural valve during systole. In the illustrated embodiment, the leak control extension 2800 is a pocket configured to receive blood in order to block blood moving into the natural valve toward the atrium.

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

[0157] In the illustrated embodiment, the device 100 has two leak control extensions 2800 attached to a connecting 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 valve leaflets 20, 22. The leak control extensions 2800 may be attached to any other part of the device 100, allowing them to be positioned to prevent all or part of the blood from flowing back into the atrium, and the openings of the leak control extensions 2800 may be located 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 fasteners 130, a connecting element 110, a cap 114, or any combination thereof. In addition, the leak control extensions 2800 may be positioned at any position along the height of the device 100. Although the illustrated embodiment is shown having two leak control extensions 2800, it should be understood that the device 100 may have any appropriate number of leak control extensions.

[0158] Referring to Figures 60 and 61, during diastole, the leaflets 20, 22 of the natural valve (shown as the mitral valve MV) open, allowing blood to move from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20, 22, when the leaflets 20, 22 are in the open position, portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open, allowing blood to move to the left ventricle LV. The blood moves through the open portion 3005 in direction D and engages with 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 the blood around the leak control extension 2800 in direction X.

[0159] Referring to Figures 62-65, during systole, the mitral valve leaflets 20, 22 join 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 connects to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not join 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 intersect. However, the openings 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 intersect. The leak control extension 2800 is positioned to prevent blood flowing back through one or more openings 2400 from entering the left atrium.

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

[0161] Referring to Figures 66 and 67, the device 100 shown in Figures 58 to 65 may be positioned within the natural valve near the valve ring 24. Similar to the device 100 positioned in a more central location within the natural valve (as shown in Figures 58 to 65), an opening 2400 may be formed where both valve leaflets 20, 22 and the device 100 intersect. When the device 100 is positioned near the valve ring 24, as shown in the illustrated embodiments, the force exerted by the device 100 on the natural valve may cause the opening 2400 adjacent to the valve ring 24 to have a deformed shape. In some embodiments, the flexible frame 4801 of the leak control extension 2800 is flexible such that a force applied to the leak control extension 2800 compresses the flexible frame 4801. For example, as shown in Figures 66 and 67, the leak control extension 2800 adjacent to the valve annulus 24 is pressed against the valve 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 valve annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be positioned within the natural valve at various locations without causing irritation to the valve annulus 24 or the side wall of the ventricle or atrium. In addition, the flexible leak control extension 2800 is advantageous because it can take a form that can block the flow of any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0162] Figures 68–77 show examples of implantable prosthetic devices 100 attached to the leaflets 20, 22 of a natural valve in a fully closed position (for example, shown as a mitral valve MV, but can be similarly used for other valves such as a tricuspid valve). In the embodiments shown in Figures 68–75, the implantable prosthetic device 100 is attached to the natural valve in a substantially central position within the annulus 24. However, it should be understood that the implantable prosthetic device 100 can be attached to the leaflets 20, 22 at any position within the natural valve (for example, the position shown in Figures 66–67). The device 100 comprises a pair of paddles 120, a pair of fasteners 130, a connecting element 110 (for example, a spacer), a cap 114, and at least one leak control extension 2800. However, the implantable prosthetic device 100 can take any suitable form, such as any form described 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 it is positioned to prevent blood from moving through any jet or opening between the leaflets 20, 22 of the natural valve during systole. In the illustrated embodiment, the leak control extension 2800 is a pocket configured to receive blood in order to prevent blood from moving into the atrium. In some implementations, the leak control extension 2800 has a flexible frame 4801 defining the opening of the pocket and a barrier material 4803 defining the interior of the pocket.

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

[0165] In some embodiments, the opening of the leak control extension 2800 is located inside the ventricle when the device 100 is attached to the valve leaflets 20, 22. The leak control extension 2800 may be attached to any other location on the device 100 that allows it to be positioned to prevent blood from flowing back into the atrium, and the opening of the leak control extension 2800 may be inside 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 fasteners 130, a connecting element 110, a cap 114, or any combination thereof. In addition, the leak control extension 2800 may be positioned at any location along the height of the device 100. Although the illustrated embodiment is shown having two leak control extensions 2800, it should be understood that the device 100 may have any appropriate number of leak control extensions.

[0166] Referring to Figures 70 and 71, during diastole, the leaflets 20, 22 of the natural valve (shown as the mitral valve MV) open, allowing blood to move from the left atrium LA to the left ventricle LV. Since the device 100 is connected to the leaflets 20, 22, when the leaflets 20, 22 are in the open position, portion 3003 of the mitral valve MV is substantially blocked by the device 100, and the other portion 3005 of the mitral valve is open, allowing blood to move to the left ventricle LV. The blood moves through the open portion 3005 in direction D and engages with 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 the blood around the leak control extension 2800 in direction X.

[0167] Referring to Figures 72-75, during systole, the mitral valve leaflets 20, 22 join 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 connects to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not join 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 intersect. However, the openings 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 intersect. The leak control extension 2800 is positioned to prevent blood from flowing back into the left atrium through one or more openings 2400.

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

[0169] Referring to Figures 66 and 77, the device 100 shown in Figures 68-75 may be positioned within the natural valve near the valve ring 24. Similar to the device 100 positioned in a more central location within the natural valve (as shown in Figures 68-75), an opening 2400 may be formed where both valve leaflets 20, 22 and the device 100 intersect. When the device 100 is positioned near the valve ring 24, as shown in the illustrated embodiments, the force exerted by the device 100 on the natural valve may cause the opening 2400 adjacent to the valve ring 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 Figures 76 and 77, a 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 a deformed opening 2400 adjacent to the annulus 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be positioned within the natural valve at various locations without causing irritation to the annulus 24 or the side wall 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 valve leaflets 20, 22.

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

[0172] The leak control extension 2800 is configured to prevent blood from flowing back from the ventricles to the atria during systole. That is, the leak control extension 2800 extends from the device (for example, from the end of the cap 114 of device 100) so that the leak control extension is positioned to prevent blood from moving through any jet or opening between the leaflets 20, 22 of the natural valve during systole. Each of the leak control extensions 2800 may include one or more deflection paddles 2801 (or other extension members) and a barrier element 8203. One or more deflection paddles 2801 may be attached to the cap 114 of device 100 (or any other part of the device), and the barrier element 8203 may be attached to paddle 120 and deflection paddle 2801 to create a barrier extending from a first paddle 120 of device 100 to a second paddle of device 100, the barrier preventing backflow of blood during diastole. In the illustrated embodiment, each leak control extension 2800 includes two deflection paddles 2801 attached to the cap 114, and a barrier element 8203 connected to and extending from a first paddle 120, the two deflection paddles 2801, and the other paddle 120. The barrier element 8203 may include one or more pieces of material, such as one or more pieces of cloth material, biocompatible material, bovine or porcine heart tissue, or a plastic membrane. 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 the barrier material 8203. Although the illustrated embodiment is shown having two leak control extensions 2800, it should be understood that the device 100 may have any appropriate number of leak control extensions.

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

[0174] Referring to Figures 86-89, during systole, the mitral valve leaflets 20, 22 join 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 connects to the leaflets 20, 22 to help join or facilitate the joining of the leaflets. However, in certain circumstances, the leaflets 20, 22 may not join 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 intersect. However, the openings 2400 may also be formed at any point where the device 100 and a single leaflet 20, 22 intersect. The leak control extension 2800 is positioned to prevent blood from flowing back into the left atrium through one or more openings 2400.

[0175] Referring to Figures 86 and 87, the contraction of the left ventricular LV pushes blood toward the mitral valve MV in direction Y, engaging the deflection paddles 2801 and barrier element 8203 of the leak control extension 2800, which prevents blood from moving through the opening 2400 to the left atrium LA. In some embodiments, the blood provides a force to the deflection paddles 2801, which causes the deflection paddles 2801 to pivot around the cap 114 or bend relative to the cap, so that the blood moves around the leak control extension 2800 in direction Z. In some embodiments, the blood provides a force to the barrier element 8203, which causes a portion of the barrier element 8203 positioned between the two deflection paddles 2801 to move upward.

[0176] Referring to Figures 90 and 91, the device 100 shown in Figures 82–89 may be positioned within the natural valve near the annulus 24. Similar to the device 100 positioned in a more central location within the natural valve (as shown in Figures 82–89), an opening 2400 may be formed where both valve leaflets 20, 22 and the device 100 intersect. When the device 100 is positioned near the annulus 24, as shown in the illustrated embodiments, the force exerted by the device 100 on the natural valve may cause the opening 2400 adjacent to the annulus 24 to have a deformed shape. In some embodiments, the leak control extension 2800 is flexible so that a force applied to the leak control extension compresses it. For example, as shown in Figures 90 and 91, 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 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 valve ring 24. The flexible leak control extension 2800 is advantageous because it allows the device 100 to be positioned within the natural valve at various locations. In addition, the flexible leak control extension 2800 is advantageous because it can take the shape necessary to block blood flow through any deformed opening caused by the connection between the device 100 and the valve leaflets 20, 22.

[0177] While various aspects, concepts, and features of the inventions of this disclosure may be described and illustrated herein as being embodied in combination in exemplary embodiments, these various aspects, concepts, and features may be used individually or in various combinations and partial combinations thereof in many alternative embodiments. Unless expressly excluded herein, all such combinations and partial combinations are intended to be within the scope of this application. Furthermore, various alternative embodiments relating to various aspects, concepts, and features of the disclosure may be described herein, such as alternatives relating to alternative materials, structures, configurations, methods, devices, and components, forms, fits, and functions, but such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether currently known or to be developed later. Those skilled in the art will readily be able to adopt one or more aspects, concepts, or features of the invention in additional embodiments and uses within the scope of this application, even if such embodiments are not expressly disclosed herein.

[0178] In addition, some features, concepts, or aspects of this disclosure may be described herein as preferred arrangements or methods, but such descriptions are not intended to imply that such features are required or essential unless expressly stated so. Furthermore, illustrative or typical values ​​and ranges may be included to aid in understanding this application, but such values ​​and ranges are not to be constrained and are intended to be significant values ​​or ranges only if expressly stated so.

[0179] Furthermore, various aspects, features, and concepts may be expressly identified herein as inventive or forming part of the disclosure, but such identification is not intended to be exclusive. Rather, there may be aspects, concepts, and features of the invention fully described herein that are not expressly identified as such or as part of a particular disclosure, and which are instead described in the appended claims. Descriptions of exemplary methods or processes are not limited to including all steps as necessary in all cases, and the order in which the steps are presented should not be construed as necessary or essential unless expressly stated otherwise. Furthermore, techniques, methods, actions, steps, etc., described or suggested herein may be performed on living animals or on non-living simulations such as cadavers, cadaveric hearts, or simulators (in which, for example, body parts, hearts, tissues, etc., are simulated). The words used in the claims have their full, ordinary meanings and are not limited in any way by the descriptions of embodiments herein. [Explanation of Symbols]

[0180] 10 Chordae tendineae 12 Papillary muscles 20 Valve leaflet, anterior leaflet 22 Valve leaflet, posterior leaflet 24 valve rings 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 section 110 Joint element or spacer, joint element, spacer 112 Operating part or operating element, operating element, operating member or operating element 114 Cap 115 Colors 116 Operating Line 120 outside paddle, paddle 122 Inside paddle, paddle 124 Parts, joints, hinges, or flexible parts, jointed, hinged, or flexible parts 126 Parts, joints, hinges, or flexible connections, joints or flexible parts, jointed, hinged, or flexible parts 128. Parts, joints or flexible parts, jointed, hinged, or flexible parts 130 Thorn fasteners, fasteners 132 Base or fixed arm 134 Movable Arm 136 Thorns 138 Flex, hinge, or joint portion, jointed portion, hinged portion, or flexible portion 2400 opening or jet, opening 2800 Leak control mechanism or leak control extension, leak control extension, flexible leak control extension 2801 Polarized 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. A valve repair device for repairing a patient's natural valve, wherein the valve repair device is An anchor portion comprising a first anchor and a second anchor, wherein the first anchor and the second anchor are configured to move from an open position to a closed position to secure a portable device to the leaflet of the natural valve, One or more leak control extensions configured to suppress the backflow of blood through one or more openings between the leaflets of the natural valve during systole, wherein the leak control extension comprises barrier elements attached to first and second anchors, Equipped with, Each of the aforementioned leak control extensions is equipped with one or more deflection paddles, The one or more deflection paddles are configured to bend toward the ventricle of the heart during diastole, with the implantable device fixed to the leaflet of the natural valve, A valve repair device characterized in that one or more deflection paddles are configured to bend toward the atrium of the heart during systole, with the implantable device fixed to the leaflet of the natural valve.

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

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

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

6. The valve repair device according to claim 1, wherein the barrier element is connected to and extends from the first anchor, two of the one or more deflection paddles, and the second anchor.

7. The valve repair device according to claim 1, wherein the deflection paddle includes a wire frame covered with cloth.

8. The valve repair device according to claim 1, further comprising a spacer disposed between the first anchor and the second anchor.

9. A valve repair device for repairing a patient's natural valve, wherein the valve repair device is An anchor portion comprising a first anchor and a second anchor, wherein the first anchor and the second anchor are configured to move from an open position to a closed position in order to secure a portable device to the leaflet of a natural valve, A barrier element attached to the first anchor and the second anchor, wherein the barrier element extends between the first anchor and the second anchor to suppress the backflow of blood through one or more openings between the leaflets of the natural valve during systole, Equipped with, The barrier element is a component of a leak control extension, further comprising one or more deflection paddles. The one or more deflection paddles are configured to bend toward the ventricle of the heart during diastole, with the implantable device fixed to the leaflet of the natural valve, A valve repair device characterized in that one or more deflection paddles are configured to bend toward the atrium of the heart during systole, with the implantable device fixed to the leaflet of the natural valve.

10. The valve repair device according to claim 9, wherein the barrier element includes one or more pieces of fabric material.

11. The valve repair device according to claim 9, wherein the barrier element comprises one or more pieces of biocompatible material.

12. The valve repair device according to claim 9, 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.

13. The valve repair device according to claim 9, wherein each of the first and second anchors comprises a paddle frame, and the barrier element is attached to the paddle frames of both the first and second anchors.

14. The valve repair device according to claim 9, further comprising a spacer disposed between the first anchor and the second anchor.

15. A valve repair device for repairing a patient's natural valve, wherein the valve repair device is An anchor portion comprising a first anchor and a second anchor, wherein the first anchor and the second anchor are configured to move from an open position to a closed position in order to secure a transplantable device to the leaflet of the natural valve, One or more pieces of fabric material attached to the first anchor and the second anchor, wherein the barrier element extends between the first anchor and the second anchor to suppress the backflow of blood through one or more openings between the leaflets of the natural valve during systole, Equipped with, The barrier element is a component of the leak control extension, The aforementioned leak control extension further comprises one or more deflection paddles, The one or more deflection paddles are configured to bend toward the ventricle of the heart during diastole, with the implantable device fixed to the leaflet of the natural valve, A valve repair device characterized in that one or more deflection paddles are configured to bend toward the atrium of the heart during systole, with the implantable device fixed to the leaflet of the natural valve.

16. The valve repair device according to claim 15, wherein the fabric material is a biocompatible material.

17. The valve repair device according to claim 15, wherein each of the first and second anchors comprises a paddle frame, and one or more pieces of the fabric material are attached to the paddle frames of both the first and second anchors.

18. The valve repair device according to claim 15, further comprising a spacer disposed between the first anchor and the second anchor.

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