摘要 |
A heart valve prosthesis for use as an aortic or pulmonary replacement valve, or as a mitral or tricuspid valve includes leaflets that are reinforced through the use of oriented fiber components in a laminated composite, in which the leaflets of the valve are reinforced with fiber-reinforcing materials oriented along lines of stress in the material, thus to provide a long-lived valve that provides strength at points of maximal stress that have hitherto been foci for material failure. In a preferred embodiment involving a stentless valve, the reinforcing materials are optimized in terms of the density and orientation of the fibers in the composite materials, thus to extend the life of a stentless valve, with the valve requiring no anti-coagulants as is the case with mechanical valves and exhibiting no hemolysis in which red cells are damaged by the action of mechanical valves. Longevity exceeds thirty five years in most cases, making replacement of such a valve a remote possibility. In one embodiment, oriented fiber components of various geometries are provided by laying fibers in specific orientation over a curved mold to which polymer sheets are laminated.
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