Percutaneously implantable replacement heart valve device and method of making same

摘要

A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

主权项

1. A percutaneously implantable replacement heart valve device for implantation in a patient, comprising:
an expandable stent member having an inner channel, the expandable stent member collapsible and configured for percutaneous delivery; and a valve means made of biocompatible tissue material and attached to the expandable stent member, the valve means including an outer cuff layer and two to four individual leaflets, wherein each of the two to four individual leaflets is rectangular in shape in side elevation view, wherein a crease is located between a base of the two to four individual leaflets and the outer cuff layer, and wherein after implantation in the patient, the valve means resides as a single element entirely within the inner channel of the expandable stent member, wherein only the two to four individual leaflets reside radially inward from the outer cuff layer, and wherein the valve means is formed without cutting slits into said biocompatible tissue material to form said leaflets.