Development, manufacturing and validation of a single-leaflet mechanical heart valve prosthesis.

A new single-leaflet mechanical heart valve prosthesis was developed and evaluated in vitro and in vivo. The basic design of the closing body is S-shaped, with the leading and trailing edges parallel to the flow direction. This closing body has an additional cross camber and a fixed axis of rotation. The bearing pins of the disc are guided within oblong through bores of the housing, resulting in a self-cleaning effect. The valve housing has a nozzle-shaped configuration in order to avoid flow separation at the inlet and to reduce the associated pressure loss. Development and optimization studies were carried out by means of upscale valve models. After manufacturing of the closing body from pyrolytic carbon and of the orifice from titanium final hydrodynamic evaluation was carried out according to ISO 5840. The results were comparable or better than for bileaflet valves, the cavitation threshold was above a left ventricular dP/dt of 5500 mmHg/sec. The excellent in vitro results were confirmed by in vivo animal studies in calves and sheep with implantation times of 12 months and six months, respectively. These studies were carried out at the RWTH Aachen and at the NIH, Washington. Without any anticoagulation treatment the valves showed excellent results, confirming the concept of a valve design based on advanced engineering techniques.