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Since 1990, development of the Helmholtz-Institute at Aachen ventricular assist device (HIA-VAD) was mainly based on animal tests performed at the University of Groningen. Although various in vitro tests had been performed previously, animal testing resulted in significant improvements of the HIA-VAD with regard to hemodynamics and pump handling. The most important design improvement was a new trileaflet polyurethane valve, which was designed as a blood-pump valve with an emphasis on opening behavior and flow resistance. Excellent hydrodynamic performance and sufficient durability of this new valve were confirmed by various in vitro tests. Further design and manufacturing improvements resulted in a completely transparent pump, which can be easily deaired and optically controlled. Final pump design was evaluated during subsequent animal tests, and the results are very promising in view of an efficient cardiac support system.

The aim of this new three-leaflet valve development was to design a leaflet with minimum membrane stresses during performance. This is achieved by manufacturing the valve leaflets shaped almost flat in a medium opening position. Thus, the leaflets have two stable positions, one with maximum opening area and the other with favorable stress distribution in the closed position. The transition between the two end positions is achieved through a two-dimensional rolling motion without buckling and with minimum membrane stresses (bulge forces). The manufacturing technique is dip-coating in polyurethane. Hydrodynamic evaluation of the J-3 valve in steady and pulsatile flow showed minimum pressure drop compared to other commercially available valves. Laser-Doppler-anemometry studies indicated very low shear stresses in the flow field downstream of the valve. In durability tests prototypes have reached lifetimes of up to 17 years. In conclusion, the J-3 valve shows superior hydrodynamic performance thereby reducing potential thrombus formation. Minimization of stresses within the valve leaflets through design could reduce calcification.

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