Patent ID: 8109995

Claim:
A method of making a percutaneously implantable replacement heart valve, comprising: (a) forming a transverse linear crease in a sheet of tissue membrane to provide an outer cuff layer and an inner leaflet layer in the sheet of tissue membrane, wherein the transverse linear crease is oriented substantially parallel to a first edge and a second edge of the sheet of tissue membrane; (b) partitioning the inner leaflet layer by forming two additional linear creases in the sheet of tissue membrane, the two additional linear creases oriented substantially perpendicular to the transverse linear crease to provide three individual valve leaflets, wherein the three individual valve leaflets are bordered in part by the two additional linear creases, the two additional linear creases extending from the transverse linear crease to a free edge of the inner leaflet layer; and (c) attaching the sheet of tissue membrane with the transverse linear crease and the two additional linear creases to a collapsible and expandable stent member such that the sheet of tissue membrane resides as a single element entirely within an inner channel of the collapsible and expandable stent member, wherein only the inner leaflet layer resides radially inward from the outer cuff layer, and wherein a first lateral edge of the sheet of tissue membrane adjoins a second lateral edge of the sheet of tissue membrane; wherein the inner leaflet layer contacts the outer cuff layer along each of the two additional linear creases; and wherein the first edge includes the free edge of the inner leaflet layer, and wherein at least portions of the inner leaflet layer reside substantially radially adjacent and in contact with the outer cuff layer within the collapsible and expandable stent member to form a contiguous double-layer folded construct.