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: Methods and systems for replacing a native heart valve are disclosed. A system comprises a delivery catheter having a deflectable distal tip configured to bend in one or more directions relative to a native annulus of a native heart valve when the distal tip is positioned within an atrium of a heart and a helical anchor configured to be carried within the delivery catheter in a delivery configuration and to be axially movable relative to the deflectable distal tip. The helical anchor has a coiled configuration comprising a plurality of turns after being delivered from the deflectable distal tip into the heart, where the coiled configuration is configured to support a heart valve prosthesis.

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: A prosthetic heart valve assembly includes a self-expandable stent having an inlet end and an outlet end and a passageway extending therethrough. The stent includes a plurality of rows of prongs on the outer surface of the stent. A valve portion comprising a plurality of leaflets is positioned within the passageway for permitting blood to flow through the passageway from the inlet end to the outlet end while blocking flow in the opposite direction. The stent further includes a flared upper portion shaped for placement along a supra-annular surface of an annulus for preventing downward migration of the prosthetic valve assembly into a ventricle. Each of the prongs has a tip pointing toward the inlet end for penetrating surrounding tissue and preventing upward migration of the prosthetic heart valve assembly toward an atrium.

Abstract: A deficient native mitral valve is treated by implanting a prosthetic mitral valve assembly valve in a patient's heart. The prosthetic mitral valve assembly includes a stent having a flared upper portion, an intermediate portion, and a lower portion. The diameter at the inflow end of the stent is larger than at the outflow end. The prosthetic mitral valve assembly also includes a valve portion formed with pericardial tissue leaflets. A tether has a first end attached to the stent and a second end attached to an anchor. The tether extends through a wall of the left ventricle and the tissue anchor is placed outside the left ventricle. After implantation, the flared upper portion resists movement in the downstream direction and the tether resists movement in the upstream direction for securing the prosthetic mitral valve assembly in the native mitral valve.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Abstract: A method for heart valve replacement comprises forming an incision in a wall of a ventricle of a heart and inserting a delivery apparatus and a prosthetic heart valve through the incision and into the ventricle of the heart. The prosthetic valve comprises a self-expanding frame having an annular main body and a valve member disposed within the annular main body. The prosthetic valve further comprises an atrial sealing member formed by an annular metal ring and a fabric, wherein only the fabric of the atrial sealing member is connected to the main body for enhancing the flexibility and conformability of the atrial sealing member. The method further comprises deploying the prosthetic valve from the delivery apparatus such that the atrial sealing member extends radially outwardly from the main body within an atrium of the heart and the main body self-expands to a deployed state within a native heart valve.

Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body. When inside a delivery sheath, the first anchor and the second anchor can extend distally from the spacer body.

Abstract: A prosthetic apparatus for implantation in a native heart valve includes a main body for placement within the native annulus. The main body is compressible to a radially compressed state for delivery into the heart and is self-expandable from the compressed state to a radially expanded state for implantation. A valve structure is mounted within a lumen of the main body and preferably forms three leaflets made of pericardium. Ventricular anchors are coupled to a ventricular end portion of the main body. The ventricular anchors are adapted to be straightened for delivery to the native heart valve and are biased to spring back to a pre-formed bent shape for capturing the native heart valve leaflets between the main body and the ventricular anchors. An atrial sealing member may be provided along an atrial portion of the main body for impeding the flow of blood between the main body and the native annulus.

Abstract: An exemplary two-stage prosthetic heart valve system has a radially expandable base stent implanted within a native valve annulus. The base stent desirably has three position markers projecting in the axial direction from the outflow end of the base stent to assist in aligning the stent with respect to the commissures of the native valve. The two-stage heart valve system also has a valve component that is delivered to and mounted within the base stent in a separate or sequential operation after the base stent has been anchored within the annulus. The valve component in certain embodiments comprises a hybrid valve component that includes a conventional, non-expandable surgical valve that is modified to include an expandable coupling stent that can be expanded to engage the inner surface of the base stent, thereby anchoring the valve component to the base stent.

Abstract: A heart valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve has a base stent that is deployed at a treatment site, and a valve component configured to quickly connect to the base stent. The base stent may take the form of a self- or balloon-expandable stent that expands outward against the native valve with or without leaflet excision. The valve component has a non-expandable prosthetic valve and a self- or balloon-expandable coupling stent for attachment to the base stent, thereby fixing the position of the valve component relative to the base stent. The prosthetic valve may be a commercially available to valve with a sewing ring and the coupling stent attaches to the sewing ring. The system is particularly suited for rapid deployment of heart valves in a conventional open-heart surgical environment. A catheter-based system and method for deployment is provided.

Abstract: An implantable prosthetic valve includes a radially collapsible and radially expandable annular frame. The frame includes an annular main body sized to be implanted within a native mitral valve annulus. The frame also includes an atrial sealing member coupled to and extending radially away from the main body. The atrial sealing member is sized to extend over tissue of the native mitral annulus within a left atrium to reduce paravalvular leakage. The atrial sealing member includes an inner zig-zag portion and an outer zig-zag portion. The inner zig-zag portion and the outer zig-zag portion are connected to the main body portion only via a fabric to enhance flexibility of the atrial sealing member relative to the main body. The prosthetic valve also includes a valve member disposed within an interior of the frame.

Abstract: An implantable prosthetic valve includes a radially collapsible and radially expandable annular frame. The frame includes an annular main body sized to be implanted within a native mitral valve annulus. The frame also includes an atrial sealing member coupled to and extending radially away from the main body. The atrial sealing member is sized to extend over tissue of the native mitral annulus within a left atrium to reduce paravalvular leakage. The atrial sealing member includes an inner zig-zag portion and an outer zig-zag portion. The inner zig-zag portion and the outer zig-zag portion are connected to the main body portion only via a fabric to enhance flexibility of the atrial sealing member relative to the main body. The prosthetic valve also includes a valve member disposed within an interior of the frame.

Abstract: A prosthetic mitral valve can include an outer frame, an inner frame, a valve structure, and a sealing member. The outer frame comprises a plurality of first struts arranged in a lattice pattern and defining a first lumen. The outer frame is self-expandable from a compressed state to an expanded state. The inner frame comprises a plurality of second struts arranged in a lattice pattern and defining a second lumen. The inner frame is disposed within the first lumen of the outer frame, is self-expandable from a compressed state to an expanded state. The valve structure comprises three leaflets made from pericardium and is mounted within the second lumen of the inner frame. The sealing member is coupled to and extends radially outwardly from an atrial end of the outer frame and is configured to engage native tissue of the heart on an atrial side of the native mitral valve.

Abstract: A prosthetic device includes a main body, a first anchor, a second anchor, a first anchor spreader, and a second anchor spreader. The first anchor is coupled to the main body such that a spring force of the first anchor biases the first anchor toward the main body. The second anchor is coupled to the main body such that a spring force of the second anchor biases the second anchor against the main body. The first anchor spreader is coupled to the first anchor such that applying a force to the first anchor spreader moves the first anchor away from the main body against the spring force of the first anchor. The second anchor spreader is coupled to the second anchor such that applying a force to the second anchor spreader moves the second anchor away from the main body against the spring force of the second anchor.

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: A system for expanding a device in a conduit or orifice of a human body includes a balloon member that is movable from a first configuration to a second configuration. External surfaces of the balloon member can collectively have a non-cylindrical cross-section relative to a main axis of the balloon member, such that the external surfaces of the balloon member generally conform to the anatomical shape of the conduit or orifice when the balloon member is in the second configuration.

Abstract: A prosthetic spacer assembly includes a spacer body, a first anchor, and a second anchor. The first anchor and the second anchor are each connected to the spacer body. The first anchor is configured to capture a first native valve leaflet between the first anchor and the spacer body. The second anchor is configured to capture a second native valve leaflet between the second anchor and the spacer body.

Abstract: A method of implanting a prosthetic mitral heart valve includes advancing a guidewire through a femoral vein, an atrial septum, and a native mitral valve. A guide catheter is advanced over the guidewire and a delivery catheter is advanced through the guide catheter. A mitral valve assembly is disposed along a distal end of the delivery catheter. The mitral valve assembly includes a stent and a valve having three leaflets. The stent has a flared inlet end, an outlet end, and an intermediate portion with a plurality of prongs disposed along its outer surface. The mitral valve assembly is deployed with the flared inlet end positioned in a left atrium and the intermediate portion positioned between native mitral valve leaflets. The prongs penetrate surrounding tissue for preventing upward migration of the mitral valve assembly and the flared inlet end is shaped for preventing downward migration.

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.