A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including a plurality of leaflets is disclosed. As one example, a prosthetic heart valve includes a frame; a plurality of commissure support elements, each connected the frame and including two axially-extending members spaced apart from one another to form a window; and a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs, each commissure tab arranged adjacent to another commissure tab to form a pair of commissure tabs that are disposed in a commissure support element to form a commissure. Each commissure tab includes a series of overlapping layers that include a first set of two overlapping layers that extends through the window and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member.

An assembly and associated method for a commissure of a prosthetic heart valve is disclosed. As one example, a method includes forming a plurality of commissures with the plurality of leaflets, wherein each commissure is formed by pairing a first commissure tab of a first leaflet with an adjacent, second commissure tab of a second leaflet, and coupling a support strip to the first and second commissure tabs via sutures forming stitches along the support strip, and, for each commissure, securing the commissure to a respective support of a frame by forming one or more suture loops around an external surface of the support strip and the respective support of the frame, the suture loops being formed by end portion extensions of the sutures.

Prosthetic heart valves having elastic leaflets and an elastic support structure are described. The support structure can store a load transferred from the leaflets as potential energy and then release it in the form of kinetic energy to exhibit a precursory transition from the closed position to the open position. The support structures can exhibit a sinusoidal movement profile at a base edge during the precursory transition.

A prosthetic heart valve comprises an annular frame that is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame elongates in an axial direction when radially compressed from the radially expanded state to the radially compressed state. Leaflets are coupled to the frame such that when the frame is in the radially expanded state, the leaflets have slack in an axial direction, wherein when the frame is radially compressed to a partially radially compressed state between the radially expanded state and the radially compressed state, the leaflets are in a relaxed state, and wherein when the frame is in the radially compressed state, the leaflets are stretched in the axial direction.

An assembly and associated method for a commissure of a prosthetic heart valve is disclosed. As one example, a method includes forming a plurality of commissures with a plurality of leaflets of a prosthetic heart valve, wherein each commissure is formed by: folding each commissure tab of each leaflet into a series of overlapping layers, each folded commissure tab arranged outward of, in a lateral direction, a portion of a body of the leaflet that is directly connected to the commissure tab; pairing each folded commissure tab of each leaflet with a folded commissure tab of another leaflet; and securing at least a portion of the series of overlapping layers of each folded commissure tab in its folded 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.

Embodiments herein relate to bioprosthetic heart valves. In an embodiment, a heart valve replacement system is included having a delivery catheter can include a heart valve accommodation region; and a heart valve disposed around the delivery catheter at the heart valve accommodation region of the delivery catheter, the heart valve can include a frame; and a plurality of valve leaflets coupled to the frame; wherein the valve leaflets include an animal tissue, the animal tissue can include from 15% to 50% by weight water; and from 20% to 70% by weight glycerol; a package defining an interior volume, wherein the delivery catheter and the heart valve are disposed within the package. Other embodiments are also included herein.

Prosthetic heart valve leaflet with a fixed end and a free end characterized by the fact that it has a variable thickness.

Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilatation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.

A loading device for crimping a prosthetic heart valve without an internal support member includes a cone having a cone body with a tapering diameter and defining a lumen therethrough and a cone base extending radially from the cone body. The cone base may couple to a funnel also having a tapering diameter and defining a lumen therethrough. The cone may be coupled to the funnel such that the lumen of the cone is aligned with the lumen of the funnel along a longitudinal axis of the loading device. The cone body may define a plurality of slots configured to receive the tines extending from the prosthetic heart valve as the valve is pulled through the loading device and compressed from an expanded state to a collapsed state by the tapering diameter of the cone and the funnel to be disposed inside a delivery device.