ABSTRACT
One of the most critical components regarding the durability of the ReinHeart total artificial heart (TAH) is its biocompatible diaphragm, which separates the drive unit from the ventricles. Hence, a durability tester was designed to investigate its required 5-year lifetime. The aim of this study was to prove the validity of accelerated testing of the polyurethane diaphragm. The durability tester allows simultaneous testing of 12 diaphragms and mimics physiological conditions. To accelerate the time of testing, it operates with an increased speed at a frequency of 8 Hz. To prove the correctness of this acceleration, a servo-hydraulic testing machine was used to study the effect of different frequencies and their corresponding loads. Thereby the viscoelastic behavior of the polyurethane was investigated. Additionally, high-speed video measurements were performed. The force against frequency and the high-speed video measurements showed constant behavior. In the range of 1-10 Hz, the maximum resulting forces varied by 3%, and the diaphragm movement was identical. Frequencies below 10 Hz allow a valid statement of the diaphragm's mechanical durability. Viscoelasticity of the polyurethane in the considered frequency-range is negligible. The accelerated durability test is applicable to polyurethane diaphragms, and the results are applicable to TAH use. The reliability of the diaphragm for a lifetime of 5 years was found to be 80% with a confidence of 62%.
