Cardiovascular Eng. Tech. (2014), https://doi.org/10.1007/s13239-014-0194-6
Abstract
In recent years new innovations improved the technology of devices for transcatheter heart valve replacement. In order to fabricate an efficient, durable, less thrombogenic and very thin heart valved stent for transcatheter implantation, heart valve leaflets of Nitinol (NiTi) thin film were developed. This work presents a method to fabricate NiTi thin film leaflets for transcatheter aortic valve replacements. NiTi valve leaflets were fabricated in different film thicknesses (10, 15 and 20 µm) by magnetron sputter deposition and a subsequent forming process. Pulsatile testing was performed to investigate the transvalvular pressure differences during systole and diastole as well as the effective orifice area of the valves. Furthermore, the steady backflow leakage rate under hydrostatic pressure was evaluated. Two samples from Edwards Lifescience (SAV 19 mm, and Perimount Magna 25 mm) were taken as a reference. In this experimental study, we present first in vitro test results of the newly developed NiTi leaflets.
