Abstract: An anchor for a prosthetic heart valve includes a core, a first cover layer, and a second cover layer. The core includes a plurality of helical turns. One or more outflow turns of the plurality of helical turns has a diameter configured to be disposed on an outflow side of a native valve, and one or more inflow turns of the plurality of helical turns has a diameter configured to be disposed on an inflow side of a native valve. The first cover layer is disposed over and contacts the helical core, and the first cover layer includes a first material. The second cover layer is disposed over and contacts the first cover layer, and the second cover layer includes a second material, which is different than the first material.

Abstract: Prosthetic heart valves and anchors for use with such valves are provided that allow for an improved implantation procedure. In various embodiments, an anchoring device is formed as a coiled or twisted anchor that includes one or more turns that twist or curve around a central axis. One or more arms attached to the frame of the valve guide the anchoring device into position at the native valve as it exits the delivery catheter, and the expandable prosthetic valve is held within the coil of the anchoring device. The anchoring device and the valve can be delivered together, simplifying the valve replacement procedure.

Abstract: An implant and method for repairing and/or replacing functionality of a native mitral valve are in various embodiments configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor can be used to implant a prosthetic valve in a native mitral valve of a heart. The coiled anchor can include a plurality of ventricular turns and one or more atrial turns. The coiled anchor is configured to be implanted at the native mitral valve with the plurality of ventricular turns positioned in a left ventricle of the heart and around valve leaflets of the native mitral valve. The plurality of ventricular turns are configured such that when a radially outward pressure is applied to at least one of the plurality of ventricular turns, the coiled anchor is biased such that a first diameter of a first turn of the plurality of ventricular turns is expanded and a second diameter of a second turn of the plurality of ventricular turns is reduced.

Abstract: Various systems, devices and methods associated with the placement of a dock or anchor for a prosthetic valve. The anchor can comprise a plurality of coils adapted to support a valve prosthesis, the plurality of coils including an upper coil, one or more middle coils, and a lower coil. The upper coil can have a larger diameter than the one or more middle coils and the lower coil, and the upper coil is configured to engage a wall of an atrium of the heart at a position superior to and spaced axially from the mitral valve annulus after the plurality of coils have been fully delivered from the coil guide catheter.

Abstract: Anchors and systems for docking a prosthetic heart valve at a native heart valve are disclosed. An anchor can include at least three coils and a seal positioned between at least two adjacent coils of the at least three coils. The seal circumscribes at least a portion of the at least two adjacent coils and has opposite ends that are spaced away from corresponding opposite ends of the at least three coils.

Abstract: A coiled anchor is positioned at a mitral valve by extending and deflecting a catheter such that a distal end portion of the catheter has a curved shape that is disposed in a left atrium and a distal end of the catheter is positioned near a commissure of the mitral valve. A ventricular portion of the coiled anchor is advanced from the catheter under the mitral valve at the commissure and into a left ventricle. An atrial portion of the coiled anchor is deployed in the left atrium by retracting the catheter off the atrial portion of the coiled anchor while maintaining the position of the ventricular portion of the coiled anchor in the left ventricle.

Abstract: An implant and method for repairing and/or replacing functionality of a native mitral valve are in various embodiments configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor can be used to implant a prosthetic valve in a native mitral valve of a heart. The coiled anchor can include a first turn, a second turn, and a third turn. The coiled anchor is configured to be implanted at the native mitral valve with the second turn and the third turn positioned in a left ventricle of the heart and around the valve leaflets of the native mitral valve. The first turn is positioned in a left atrium of the heart such that the first turn is spaced apart from the native mitral valve. The coiled anchor is configured for positioning such that the first turn is the sole turn of the coiled anchor positioned in the left atrium.

Abstract: Various systems, devices and methods associated with the placement of a dock or anchor (72) for a prosthetic valve (120). The anchor (72) may take the form of a helical anchor having multiple coils (104, 108) and/or a stent-like structure. Various methods include different levels of minimal invasive procedures for delivering the prosthetic valve anchor (72) and prosthetic valve (120), as well as tissue anchors for plication or other purposes to the native valve position in the heart (14).

Abstract: Methods for replacing a native heart valve. An anchor comprises coils adapted to support a heart valve prosthesis. The anchor is positioned at a native heart valve. An expansible heart valve prosthesis is delivered into the anchor and expanded inside the coils. This moves at least one coil from a first diameter to a second, larger diameter while securing the anchor and the heart valve prosthesis relative to each other. The heart valve prosthesis comprises a seal on the expansible heart valve prosthesis. Additional apparatus and methods are disclosed.

Abstract: Systems and methods for replacing a native heart valve. An anchor comprises multiple coils adapted to support a heart valve prosthesis. At least one of the coils is normally at a first diameter, and is expandable to a second, larger diameter upon application of radial outward force from within the anchor. An expansible heart valve prosthesis is provided and is configured to be delivered into the anchor and expanded inside the multiple coils. This moves at least one coil from the first diameter to the second diameter while securing the anchor and the heart valve prosthesis relative to each other. The system further includes a seal on the anchor that can prevent at least some blood leakage after implantation of the heart valve prosthesis in the helical anchor. Additional apparatus and methods are disclosed.

Abstract: Systems and methods comprising an anchor adapted to be positioned at a native heart valve annulus. The anchor comprises multiple coils adapted to support a heart valve prosthesis. A flexible outer tube adapted to hold the multiple coils of the anchor can combine with the anchor to form an assembly. A delivery tool adapted to deliver the assembly into position at a native heart valve can be provided and used. The outer tube is adapted to be removed from the multiple coils of the anchor after the coil portions of the anchor are positioned above and/or below the heart valve annulus. Additional apparatus and methods are disclosed.

Abstract: Anchors and systems for docking a prosthetic heart valve at a native heart valve are disclosed. An anchor can include at least three coils and a seal positioned between at least two adjacent coils of the at least three coils. The seal circumscribes at least a portion of the at least two adjacent coils and has opposite ends that are spaced away from corresponding opposite ends of the at least three coils.

Abstract: Systems and methods for docking a heart valve prosthesis. A system can include an anchor formed as multiple coils adapted to support a heart valve prosthesis with coil portions positioned above and below the heart valve annulus. At least one of the coil portions can normally be at a first diameter and be expandable to a second, larger diameter upon application of radial outward force from within the helical anchor. Methods can include delivering an anchor, positioning and implanting a heart valve prosthesis, and expanding the heart valve prosthesis inside the anchor.

Abstract: Prosthetic heart valves and anchors for use with such valves are provided that allow for an improved implantation procedure. In various embodiments, an anchoring device is formed as a coiled or twisted anchor that includes one or more turns that twist or curve around a central axis. One or more arms attached to the frame of the valve guide the anchoring device into position at the native valve as it exits the delivery catheter, and the expandable prosthetic valve is held within the coil of the anchoring device. The anchoring device and the valve can be delivered together, simplifying the valve replacement procedure.

Abstract: An implant and method for repairing and/or replacing functionality of a native mitral valve are in various embodiments configured to reduce or eliminate mitral regurgitation and residual mitral valve leakage. A coiled anchor with a central turn that reduces in size upon implantation is used to approximate the amount of reduction in the size and the reshaping of the native mitral annulus to reduce valve leakage. A clip can be further applied to the native valve leaflets to reduce the size of the native mitral annulus and leakage therethrough. A prosthetic heart valve can be implanted in the coiled anchor to replace and further improve functionality of the valve. In some cases, the prosthetic valve can be implanted in a clipped valve, where the clip is detached from one of the native valve leaflets to provide space for the prosthetic valve to expand.

Abstract: A system including an anchor for docking a prosthetic valve at a native valve of a heart can have a first end, a second end, and a central axis extending between the first and second ends, and defines an inner space coaxial with the central axis. The valve prosthesis can include a protective layer or annular ring that surrounds a bottom edge of the second frame end. The protective layer or annular ring can include two layers, and the two layers can be different materials.

Abstract: Systems and methods for replacing a heart valve. An expansible helical anchor is formed as multiple coils to support a valve prosthesis. At least one of the coils is expandable to a second, larger diameter upon application force from within the anchor. A gap is defined between adjacent coils sufficient to prevent engagement by at least one of the adjacent coils with the native heart valve. An expansible heart valve prosthesis is provided and is configured to be delivered into the anchor and expanded inside the coils into engagement. This moves the coil from the first diameter to the second diameter while securing the anchor and prosthesis together. The system further includes a seal on the expansible heart valve prosthesis configured to engage the helical anchor and prevent blood leakage past the heart valve prosthesis after implantation of the heart valve prosthesis in the helical anchor.

Abstract: Various systems, devices and methods associated with the placement of a dock or anchor (72) for a prosthetic mitral valve (120). The anchor (72) may take the form of a helical anchor having multiple coils (104, 108) and/or a stent-like structure. Various methods include different levels of minimal invasive procedures for delivering the prosthetic valve anchor (72) and prosthetic valve (120), as well as tissue anchors for plication or other purposes to the mitral valve position in the heart (14).

Abstract: Prosthetic mitral heart valves and anchors for use with such valves are provided that allow for an improved implantation procedure. In various embodiments, a helical anchoring device is formed as a coiled or twisted anchor that includes one or more turns that twist or curve around a central axis. Curved arms attached to the frame of the valve guide the helical anchoring device into position beneath the valve leaflets and around the mitral valve annulus as it exits the delivery catheter, and the expandable prosthetic mitral valve is held within the coil of the anchoring device. The anchoring device and the valve can be delivered together, simplifying the valve replacement procedure.

Abstract: A coiled anchor for docking a mitral valve prosthesis at a native mitral valve of a heart has a first end, a second end, and a central axis extending between the first and second ends, and defines an inner space coaxial with the central axis. The coiled anchor includes a coiled core including a bio-compatible metal or metal alloy and having a plurality of turns extending around the central axis in a first position, and a cover layer around the core, the cover layer including a bio-compatible material that is less rigid than the metal or metal alloy of the coiled core.