SELF-EXPANDABLE HEART VALVE WITH STABILIZERS

摘要

A prosthetic heart valve having an internal support frame with a continuous, undulating leaflet frame defined therein. The leaflet frame has three cusp regions positioned at an inflow end intermediate three commissure regions positioned at an outflow end thereof. The leaflet frame may be cloth covered and flexible leaflets attached thereto form occluding surfaces of the valve. The support frame further includes three cusp positioners rigidly fixed with respect to the leaflet frame and located at the outflow end of the support frame intermediate each pair of adjacent commissure regions. The valve is desirably compressible so as to be delivered in a minimally invasive manner through a catheter to the site of implantation. Upon expulsion from catheter, the valve expands into contact with the surrounding native valve annulus and is anchored in place without the use of sutures. In the aortic valve position, the cusp positioners angle outward into contact with the sinus cavities, and compress the native leaflets if they are not excised. The support frame may be formed from a flat sheet of Nitinol that is bent into a three-dimensional configuration and heat set.

主权项

1. A prosthetic aortic heart valve, comprising:
three bioprosthetic leaflets each having an arcuate outer edge opposite a generally linear coapting edge and two tabs on either end of the coapting edge that project laterally beyond the outer edge; a self-expandable generally tubular leaflet support frame arranged around a flow axis, the leaflet support frame defining three commissures distributed 120° apart around the flow axis, wherein one tab each of two adjacent leaflets are secured to each commissure; a fabric covering on both sides of the leaflet support frame to which the arcuate outer edge of each leaflet secures; and three uncovered outwardly flared U-shaped stabilizing members integrally formed with the leaflet support frame having outer apices distributed 120° apart around the flow axis offset 60° from the three commissures that contact the surrounding aorta and help stabilize and anchor the heart valve in its implant position.