Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

DESCRIPTION OF THE DRAWINGS

FIG. 1A is a partial cross-sectional view of the anatomy and basic structure of a human heart.

FIG. 1B is a partial cross-sectional view of a human heart.

FIG. 2A is an illustration of a frame structure for a valve according to one embodiment of the present disclosure.

FIG. 2B is an illustration of a frame structure for a valve according to one embodiment of the present disclosure.

FIG. 3A is an illustration of a frame structure and attached valve elements according to one embodiment of the present disclosure.

FIG. 3B is an illustration of a frame structure and attached valve elements according to one embodiment of the present disclosure.

FIG. 3C is an illustration of a frame structure and attached valve elements according to one embodiment of the present disclosure.

FIG. 4A is a projection of valve according to one embodiment of the present disclosure provided in a mitral annulus.

FIG. 4B is a cross-sectional side view of a valve and frame element according to one embodiment of the present disclosure during implantation.

FIG. 4C is a cross-sectional side view of a valve and frame element according to one embodiment of the present disclosure during implantation.

FIG. 5 is a plan view of a mitral annulus and implant feature according to one embodiment of the present disclosure.

FIG. 6 is a plan view of a leaflet and neochordae structure according to one embodiment of the present disclosure.

FIG. 7A is a perspective view of a mitral valve implant according to one embodiment of the present disclosure.

FIG. 7B is a perspective view of a mitral valve implant according to one embodiment of the present disclosure.

FIG. 7C is a perspective view of a mitral valve implant according to one embodiment of the present disclosure.

FIG. 8 is a plan view of a leaflet and neochordae structure according to one embodiment of the present disclosure.

DETAILED DESCRIPTION

FIG. 1A is a partial cross-sectional elevation view of a human heart. One of ordinary skill in the art will readily understand the anatomy, structure, and functions of the heart. The mitral valve is provided between the left atrium and the left ventricle, allows diastolic filling of the left ventricle from the left atrium, and prevents systolic reflux of left ventricular blood into the left atrium. The valve is connected to papillary valves via chords. Various embodiments of the present disclosure provide systems, methods and devices for replacing a native mitral valve of a human heart. It is contemplated, however, that various novel systems, methods, and devices as shown and described herein may be provided in other applications that are not limited to mitral valve replacement. For example, deformable frame members of the present disclosure may be useful as support structures in various applications and replacement valves.

FIG. 1B is a partial cross-sectional view of the human heart with a native mitral valve depicted and labelled as “bicuspid valve”.

FIG. 2A is an elevation view of a frame member 2 according to one embodiment of the present disclosure. As shown, the frame member 2 comprises a single arch 4 extending from an annular insert element 6. The frame comprises at least one attachment point 8. In FIGS. 2A-2B, the attachment points are shown as eyelet features. At least one attachment point (8B in FIG. 2A, for example) is contemplated as comprising a flexible strain-relief feature to allow the arch to bend 4 or compress to enable insertion of the device. The attachment points 8A, 8B, 8C further comprise attachment points for bioprosthetic leaflet neochordae (8A, 8C in FIG. 2A). The frame member 2 is thus capable of supporting additional features and components of a valve member.

FIG. 2B is an elevation view of a frame member 10 according to yet another embodiment of the present disclosure. As shown, the frame member 10 of FIG. 2B comprises a first and second arch 12, 14. Multiple arches are contemplated to provide a chord-free central valve orifice. Each arch 12, 14 comprises at least one attachment point 16. The attachment points 16 serve to provide a pivot or flexure point to allow the frame to deflect and/or are operable to receive and secure chord members as shown and described herein. Attachment points 8, 16 of the present disclosure are contemplated as being provided on an interior (concave) or exterior (convex) portion of the device. No limitation with respect to the number, spacing, or positioning of the attachment points is provided herewith. In some embodiments, an attachment and flexure member (8B, for example) is provided at a center or apex of the arch to efficiently enable flexure and displacement of the arch. In some embodiments, attachment points are provided off-center (8A, 8C, for example).

Frame members of the present disclosure are contemplated as comprising a variety of suitable materials. In some embodiments, arch members of the present disclosure are contemplated as comprising stainless steel, titanium, or other suitable biocompatible metals. Preferably, the frame members comprise an elastic member with a restoring force and wherein the frame member may be compressed for insertion and expand under its own properties when provided in a desired implantation position.

FIG. 3A is an elevation view of a valve element 20 according to one embodiment of the present disclosure. As shown, the valve element 20 comprises an arch member 22 with at least one attachment member 24 for receiving chordal members 26 that extend from at least one leaflet 28 that is operable to control fluid flow through the valve element