The Influence of Manufacturing Methods on the Function and Performance of a Synthetic Leaflet Heart Valve

Abstract

There is considerable interest in polyurethane synthetic leaflet heart valves for both ventricular assist devices and direct implantation in the body. Two different manufacturing methods, thermal forming, and dip casting, of the leaflets have been investigated. There were only small differences in the hydrodynamic function of the valves made by the two methods. However, the durability of dip cast valves was far superior to the thermally formed film fabricated leaflets, with all of the dip cast valves reaching 160 million cycles without failure. This study indicates that a correctly designed and manufactured polyurethane synthetic leaflet heart valve has the potential for long-term implantation in the body.