Method for manufacturing high durability heart valve

摘要

An improved heart bioprosthetic device having a metal frame wireform or stent having an outer external surface. The metal frame has a bond layer coating at least a portion of the external surface and a coating layer disposed on at least a portion of the bond layer. The bond layer comprises a metal selected from the group consisting of: chromium, titanium, zirconium, aluminum, platinum, palladium, and niobium. The coating layer is selected from the group consisting of: a metal nitride, a metal oxide, a metal carbide, and combinations thereof. The coating layer may have a thickness of about 10 μm or less and a grain size of about 10 nm to about 15 nm, and may be characterized as polycrystalline with randomly-oriented grains with both cubic and orthorhombic phases. In one embodiment, the bond layer comprises chromium and the coating layer comprises chromium nitride.

主权项

1. A method for manufacturing a prosthetic heart valve to improve the fatigue life of a metal frame thereof, the method comprising:
disposing a bond layer over at least a portion of a metal frame of a prosthetic heart valve, the bond layer comprising at least one elemental metal; vacuum depositing a coating layer over at least a portion of the bond layer, the coating layer comprising at least one of a metal oxide, a metal nitride, or a metal carbide; and securing a plurality of leaflets to the metal frame, the plurality of leaflets defining a one-way valve for blood flow therethrough.