A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.

A prosthetic heart valve includes a radially expandable annular frame and a valve body disposed inside the frame. The valve body includes three leaflets configured to regulate the flow of blood through the frame in one direction. The prosthetic heart valve also includes an annular inner skirt secured to an inner surface of the frame. The inner skirt, has an inflow edge oriented toward an inflow end of the frame, an outflow edge oriented toward an outflow end of the frame, and first and second lateral edges extending from the inflow edge to the outflow edge, wherein the first lateral edge and the second lateral edge are secured together. The first lateral edge and the second lateral edge are oriented at an oblique angle relative to a plane that is perpendicular to a central longitudinal axis of the frame.

An axial cast hole is formed to have a large diameter side end on one side at a draft angle. A large diameter hole is formed on the one side to form a stepped surface between the large diameter hole and the axial cast hole. The stepped surface has an inner periphery end located on a plane perpendicular to the axial direction. A tool is moved from the one side toward the other side coaxially with the axial cast hole to make contact with the stepped surface. The tool is moved subsequently to cut the inner periphery of the axial cast hole between the large diameter hole and the first port. The tool is moved subsequently to cut the inner periphery of the axial cast hole on the other side relative to the first port.

A prosthetic heart valve includes a radially expandable annular frame and a valve body disposed inside the frame. The valve body includes three leaflets configured to regulate the flow of blood through the frame in one direction. The prosthetic heart valve also includes an annular inner skirt secured to an inner surface of the frame. The inner skirt has an inflow edge oriented toward an inflow end of the frame, an outflow edge oriented toward an outflow end of the frame, and first and second lateral edges extending from the inflow edge to the outflow edge, wherein the first lateral edge and the second lateral edge are secured together. The first lateral edge and the second lateral edge are oriented at an oblique angle relative to a plane that is perpendicular to a central longitudinal axis of the frame.

A prosthetic heart valve includes an expandable stent frame including struts arranged in a zig-zag pattern and leaflets supported within the frame. The leaflets allow blood to flow in only one direction through the frame for replacing the function of a native heart valve, wherein each leaflet has a downstream edge and a cusp edge with opposing side edges. An inner skirt is positioned inside the frame and includes leaflet supports extending from an upstream ring portion of the skirt. The leaflet supports taper in width in a direction extending from the upstream end portion of the frame toward the downstream end portion of the frame. Each leaflet support is disposed between and coupled to adjacent side edges of two adjacent leaflets.

A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.

A method of deploying a prosthesis within a native mitral valve is disclosed. The expandable frame preferably includes about twelve proximal anchors, wherein the proximal anchors have free ends positioned radially outwardly from the frame in an expanded configuration. The expandable frame preferably includes about twelve distal anchors, wherein the distal anchors also have a free ends positioned radially outwardly from the frame and extend toward a proximal end when the frame is in the expanded configuration. A valve body is supported within the frame for preventing blood flow in one direction. The expandable frame is radially expanded during deployment, which causes the free ends of the proximal and distal anchors to move closer together. In the expanded configuration, the proximal anchors are positioned on an inflow side of the native mitral valve and the distal anchors are positioned on an outflow side of the native mitral valve.

A prosthesis and a method of manufacturing the prosthesis for controlling flow through a bodily lumen are provided. The prosthesis includes a body having a proximal portion, a distal portion and a lumen extending therethrough. The prosthesis also includes a valve operably connected to the body. The valve has a proximal portion, a distal portion and a lumen extending through the valve, where the valve lumen is connected to the body lumen. The valve is configured to be closed in the absence of an antegrade pressure and a retrograde pressure, the retrograde pressure being greater than the antegrade pressure. The valve includes a material portion operably connected to the valve, the material portion providing increased stiffness to the valve relative to the valve alone, wherein the material portion is configured to facilitate self-reversion of the valve to the closed configuration.

A prosthesis and a method of manufacturing the prosthesis for controlling flow through a bodily lumen are provided. The prosthesis includes a body having a proximal portion, a distal portion and a lumen extending therethrough. The prosthesis also includes a valve operably connected to the body. The valve has a proximal portion, a distal portion and a lumen extending through the valve, where the valve lumen is connected to the body lumen. The valve is configured to be closed in the absence of an antegrade pressure and a retrograde pressure, the retrograde pressure being greater than the antegrade pressure. The valve includes a material portion operably connected to the valve, the material portion providing increased stiffness to the valve relative to the valve alone, wherein the material portion is configured to facilitate self-reversion of the valve to the closed configuration.

A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient's heart.