Abstract: Disclosed are embodiments of replacement heart valves. Embodiments may include a collapsible and expandable frame comprising rows of cells. The frame may include a plurality of axial connection portions extending between top ends and bottom ends of the cells, wherein each axial connecting portion is shaped to bend for accommodating temporary changes in cell height during non-uniform compression of the replacement heart valve. Frames having these features are advantageous when advancing a replacement heart valve through a funnel-shaped compression tool. The axial connection portions are sufficiently flexible to accommodate changes in frame shapes during compression while also being sufficiently resilient for enhancing the structural integrity of the frame in the fully deployed state. The replacement heart valves are preferably dual-frame heart valves, wherein the axial connection portions form a portion of an inner frame and wherein an outer frame is provided for engaging tissue and forming a seal.

Abstract: Apparatuses, systems, and methods for prosthetic valves. Embodiments of prosthetic valves may include sealing bodies configured for an anchor to at least partially pass through. The pass through may allow for the sealing body to seal to a portion of a patient's heart in the event of a miscapture of a leaflet by the anchor. Embodiments may include modular valve systems and prosthetic valves including anchors for coupling to chordae, trabeculae, or papillary structures of a patient's heart. Embodiments may include prosthetic valves including anchors for engaging calcification of a patient's native valve.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.

Abstract: A heart valve prosthesis for replacing a native mitral valve includes a self-expanding frame with a plurality of anchoring members disposed along the lower region. A valve body is positioned within the self-expanding frame and includes a plurality of leaflets configured to allow blood flow through the self-expanding frame in only one direction. A skirt surrounds the self-expanding frame and is spaced apart therefrom for contacting surrounding tissue and impeding blood flow around the self-expanding frame. The skirt may be reinforced with wires to help maintain a desired shape. The leaflets in the valve body are preferably connected to the self-expanding frame through one or more intermediate components such that the valve body is spaced radially inwardly from an inner surface of the self-expanding frame.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location.

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: 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 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 method of implanting a prosthetic apparatus preferably includes delivering the prosthetic apparatus to a native mitral valve and exposing ventricular anchors and a spacer body of the prosthetic apparatus from a distal end portion of a delivery apparatus. The ventricular anchors are controllably and forcibly expanded outwardly from the spacer body to an expanded configuration. The prosthetic apparatus is positioned relative to the native mitral valve such that native mitral valve leaflets are located between the ventricular anchors and the spacer body. The ventricular anchors are then contracted radially inwardly toward the spacer body to a compressed configuration. In the compressed configuration, the native mitral valve leaflets are secured between the ventricular anchors and the spacer body. After implantation, the spacer body is held between the native mitral valve leaflets, thereby blocking regurgitation and improving the function of the native mitral valve.

Abstract: A prosthetic heart valve includes a collapsible and expandable frame having a main body, an atrial portion, and at least one ventricular anchor. The atrial portion extends radially outwardly relative to the main body and the ventricular anchor extends from a ventricular end of the main body. The main body and the atrial portion are preferably separate metal components that are coupled together via sutures or a fabric member. The prosthetic heart valve also includes a valve structure that is supported in the main body of the frame. The valve structure has a plurality of leaflets for regulating the flow of blood in one direction.

Abstract: A heart valve prosthesis for replacing a native mitral valve includes a self-expanding frame with a plurality of anchoring members disposed along the lower region. A valve body is positioned within the self-expanding frame and includes a plurality of leaflets configured to allow blood flow through the self-expanding frame in only one direction. A skirt surrounds the self-expanding frame and is spaced apart therefrom for contacting surrounding tissue and impeding blood flow around the self-expanding frame. The skirt may be reinforced with wires to help maintain a desired shape. The leaflets in the valve body are preferably connected to the self-expanding frame through one or more intermediate components such that the valve body is spaced radially inwardly from an inner surface of the self-expanding frame.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. Disclosed are a number of features that can improve steerability or release of the prosthesis into the body location.

Abstract: A prosthesis can be configured to grasp intralumenal tissue when deployed within a body cavity and prevent axial flow of fluid around an exterior of the prosthesis. The prosthesis can include an expandable frame configured to radially expand and contract for deployment within the body cavity and a valve body. The expandable frame can include a frame body and a supplemental frame. The valve body can include a plurality of leaflets and one or more intermediate components. The one or more intermediate components can couple at least a portion of the leaflets to the expandable frame. The prosthesis can include an annular flap positioned around an exterior of the expandable frame.

Abstract: A prosthetic heart valve includes a collapsible and expandable frame having a main body, an atrial portion, and at least one ventricular anchor. The atrial portion extends radially outwardly relative to the main body and the ventricular anchor extends from a ventricular end of the main body. The main body and the atrial portion are preferably separate metal components that are coupled together via sutures or a fabric member. The prosthetic heart valve also includes a valve structure that is supported in the main body of the frame. The valve structure has a plurality of leaflets for regulating the flow of blood in one direction.

Abstract: Embodiments of prosthetic valves for implantation within a native mitral valve are provided. One embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve member. In some cases, the prosthetic valves also include ventricular anchors and/or an atrial portion coupled to and disposed outside of the main body. Methods, devices, and systems for delivering such prosthetic valves to the native mitral valve and implanting them therein are also provided.

Abstract: Embodiments of prosthetic valves for implantation within a native mitral valve are provided. One embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve member. In some cases, the prosthetic valves also include ventricular anchors and/or an atrial portion coupled to and disposed outside of the main body. Methods, devices, and systems for delivering such prosthetic valves to the native mitral valve and implanting them therein are also provided.