The invention relates to a system for replacing a heart valve that is diseased owing to inflammation and/or an infection. The system has: a stent system with at least one expandable stent; and a replacement heart valve which is secured to the at least one stent and has at least two heart valve leaflets. The at least one stent has a coating with an antimicrobial substance or an antimicrobially effective carrier material, preferably on the inner side and/or the outer side.

Prosthetic mitral valves described herein can be deployed using a transcatheter mitral valve delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native mitral valve. This document describes prosthetic heart valve designs that interface with native mitral valve structures to create a fluid seal, thereby minimizing mitral regurgitation and paravalvular leaks. This document also describes prosthetic heart valve designs and techniques to manage blood flow through the left ventricular outflow tract. In addition, this document describes prosthetic heart valve designs and techniques that reduce the risk of interference between the prosthetic valves and chordae tendineae.

A prosthetic mitral valve includes an anchor assembly, an annular strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The annular strut frame is disposed radially within the anchor assembly. An atrial end of the annular strut frame is attached to the anchor assembly such that a ventricular end of the annular strut frame is spaced away from the anchor assembly.

An embodiment of the invention includes a sewing cuff for aortic heart valves that better approximates native anatomy by better mating with the crown-like anatomical annulus. Limiting distortion of the crown-like annulus provides better blood flow and overall valve function and provides a physician greater ease of implantation since native anatomy is not flattened. Thus, the surgeon may attach sutures to the fibrous tissue of the crown-like anatomical annulus without distorting the shape of the native anatomy. An embodiment includes a scalloped sewing cuff assembly (with semilunar arches) that tracks the crown-like annulus. Another embodiment provides a sewing cuff positioned over the majority of the valve's length, thus allowing the surgeon greater flexibility as to where he or she can attach sutures to the surgical annulus. Conventional valves, which are primarily “low-profile” devices, do not offer such ability. Other embodiments are described herein.

A modular heart valve prosthesis includes a first heart valve device and a second heart valve device. The first heart valve device includes a first valve support including a first prosthetic valve disposed within the valve support, and an anchoring frame surrounding the first valve support and coupled to the first valve support. The first prosthetic valve includes synthetic fabric leaflets having a first thickness. The second heart valve device includes a second valve support including a second prosthetic valve disposed within the second valve support. The second prosthetic valve includes tissue leaflets having a second thickness, wherein the second thickness is greater than the first thickness. In a first configuration, the second heart valve device is separate from the first heart valve device, and in a second configuration, the second heart valve device is disposed within the first valve support of the first heart valve device.

An anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. When installed by a delivery device, the anchors can be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.

Disclosed are devices and methods for delivering several sutures accurately and simultaneously around the perimeter of an annular prosthetic device (prosthetic heart valve, annuloplasty ring, etc.) to secure the prosthetic device within a native heart valve region. Devices can comprise a proximal handle portion including an actuator and a distal suturing portion including several curved and straight needles arrayed around the shaft axis. The straight needles and the curved needles are configured to simultaneously guide a plurality of sutures through the native tissue and through the annular prosthetic device. The actuator can cause the straight needles to move axially relative to the curved needles and can also cause the curved needles to rotate, such that the motions are coordinated to simultaneously place all the sutures.

A percutaneous heart valve prosthesis including a collapsible valve body frame has a first end and a second end. The valve body frame is formed by a plurality of sub-frame members, each sub-frame member having a general form of a diamond with acute-angled vertices and oblique-angled vertices, wherein adjacent sub-frame members are joined at the oblique-angled vertices. A flexible skirt made from a non-biologic material extends around a periphery of the valve body frame. A one-way valve including a plurality of flexible valve leaflets is positioned within the valve body frame. The first end of the valve body frame is sized to pass through a valve orifice associated with a heart valve to be replaced and the second end of the valve body frame is sized so as not to pass through a valve orifice.

This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve.