Development of a polymer bileaflet valve to realize a low-cost pulsatile blood pump

The final goal of this study is to realize a low-cost pulsatile blood pump especially for patients with acute heart failure or postoperative low cardiac output syndrome. In support of the pump, two types of polymer bileaflet valves with different configuration of the valve seats were developed. Influence of the leaflet thickness on the hydrodynamics of the prototype was preliminarily investigated among 70 microm, 100 microm, and 150 microm. As to the valves with the thinner leaflets, buckling of the leaflets was observed, which induced a large amount of regurgitation at valve closure. However, by thickening the leaflet to 150 microm, the mean flow of the prototype and the second model could be successfully comparable to the Medtronic-Hall valve. Moreover, accelerated fatigue tests showed that reinforcement of the valve seat with the additional spokes in the second model extended the durability by four times as compared with the prototype, equivalent to an in vivo duration of over one month.