Design of a new polymeric heart valve prosthesis.

The potential of Polymeric Heart Valves (PHV) is to combine the good haemodynamic performances of biological valves with the durability of mechanical valves. The aim of this work is to design and develop a new supra-annular tri-leaflet prosthetic heart valve made from styrenic block co-polymers. A computational finite element model was implemented to optimize the thickness of the leaflets and the orientation of the polymer microstructures, to improve PHV mechanical and hydrodynamic performance. Based on the model outcomes, a prototype valve was developed, and 8 valves were developed and tested in vitro under continuous and pulsatile flow conditions, as prescribed by ISO5840 Standard. A specially designed pulse duplicator allowed testing of the PHVs at different flow rates and frequency conditions. All the PHVs met the requirements specified in ISO5840, in terms of both regurgitation and Effective Orifice Area (EOA), demonstrating their potential as heart valve prostheses.