A method of assembling a prosthetic heart valve includes providing a collapsible and expandable stent having an annulus section and an aortic section. The annulus section has a first diameter in a relaxed condition and a second diameter less than the first diameter in a collapsed condition. A constraint is applied to the stent to constrain the annulus section to a predetermined diameter between the first and second diameters. Applying a cuff and/or a plurality of leaflets to the stent in the constrained condition enables less material to be used. The resultant prosthetic valve is therefore able to be collapsed to a smaller diameter for introduction into a patient.

Examples of the disclosure are directed toward a valve device comprising an opening and a leaflet and methods of operating and manufacturing the valve device. In some embodiments, the leaflet is a three-dimensional thin-film leaflet, and the leaflet comprises a dome portion. In a first configuration, the leaflet of the valve device may occlude the opening of the device. In a second configuration, the leaflet may not occlude the opening, and blood may flow across the opening of the device. The valve device may be collapsible for transportation in a catheter.

A single piece stent construction having a plurality of commissure posts, each of which extends upwardly from a solid ring along a bend line and generally along a central longitudinal axis of the stent.

Various examples address support structures (e.g., prosthetic valve support structures or frames) that incorporate a frame that, upon transitioning to a deployed configuration, include a proximal section has increased stiffness, or resistance to deformation in a transverse plane to a longitudinal axis of a device, including resistance to a change in shape, size, or both. Such an increase in transverse deformation resistance may be measured as an increase in radial compressive resistance or an increase in flat plate stiffness, for example, or both. Such increases in transverse deformation resistance may be realized through a reduction in length of the increased stiffness region of the support structure, such as through longitudinal compression of the region following an initial radial expansion of the region.

A collapsible stent for an implantable prosthetic valve incorporates leaflet-supporting members having relatively large surface area in comparison to other members defining the remainder of the stent. The leaflet-supporting members may have openings extending through them. The valve leaflets may be attached to the stent so that an attached edge of each leaflet extends along the leaflet-supporting members and is attached to the members by polymer integral with the leaflet overlying the leaflet supporting members and extending into the openings of the leaflet supporting members. The secure attachment resists stress on the leaflets.

Methods for generating aortic heart valve leaflets are disclosed wherein the aortic sinus surfaces (the inner surfaces of the sinuses of Valsalva) are used as a template to generate geometric representations of replacement aortic heart valve leaflets. As such, sinus-matched replacement leaflets can be sized and shaped according to the patient-specific geometry of the aortic root. Patient-specific aortic valve assemblies based on aortic root and sinus geometry are also described. Methods for estimating the coaptation area of a sinus-matched valve and assessing whether the valve is functionally competent for implantation are described.

A replacement heart valve implant may include a tubular anchor member actuatable between a delivery and a deployed configuration, the tubular anchor member including an inflow end, an outflow end, and a plurality of anchor member intersection points, and defining a longitudinal axis extending from the inflow end to the outflow end, a plurality of valve leaflets, and a seal member secured to the tubular anchor member at the inflow end. An end surface of each of the plurality of valve leaflets may abut an inner-facing surface of the seal member. The plurality of valve leaflets each define a secured end and a free end. The secured end may be attached to the seal member adjacent the inflow end. The secured end may define the end surface, and the end surface may face toward the outflow end when the plurality of valve leaflets is in an everted position.

A heart valve prosthesis includes a valve member having a flexible leaflet arrangement and a valvular support structure to support the flexible leaflet arrangement. The flexible leaflet arrangement includes a plurality of flexible leaflets. Each flexible leaflet forms a free edge. The free edges are configured to abut one another in a closed position to block blood flow in a retrograde flow direction. When viewed in a cross-sectional plane transverse to the antegrade flow direction, a first of the flexible leaflets extends across a first opening angle and a second of the flexible leaflets extends across a second opening angle different from the first opening angle. The free edge the first of the flexible leaflets has a first convex curvature and the free edge of the second of the flexible leaflets has a second convex curvature different than the first convex curvature.

This document provides devices and methods for the treatment of heart conditions. For example, this document provides prosthetic heart valves and transcatheter heart valve replacement methods. The prosthetic heart valves can be configured into a low-profile configuration for containment within a small diameter delivery sheath. The prosthetic heart valves include can include a valve member attached to a stent frame. In some embodiments, the valve member is a molded biomaterial with a novel shape and resulting performance characteristics. Localized protective covering members can be attached to the stent frame to prevent the valve member from contacting the stent frame as the valve member cycles between its open and closed configurations.

A self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, a combined inner frame/outer frame support structure for a prosthetic valve, and methods for deploying such a valve for treatment of a patient in need thereof, are disclosed.