Design, manufacturing and testing of a green non-isocyanate polyurethane prosthetic heart valve
Sofia Ferreira Melo, Alicia Nondonfaz, Abdelhafid Aqil, Anna Pierrard, Alexia Hulin, Céline Delierneux, Bartosz Ditkowski, Maxime Gustin, Maxime Legrand, Bibian M. E. Tullemans, Sanne L. N. Brouns, Alain Nchimi, Raoul Carrus, Astrid Dejosé, Johan W. M. Heemskerk, Marijke J. E. Kuijpers, J. Ritter, Ulrich Steinseifer, Johanna C. Clauser, Christine Jérôme, Patrizio Lancellotti, Cécile Oury
Abstract
, and used to produce aortic valves. PHU elastomers reinforced with a polyester mesh show mechanical properties similar to native valve leaflets. These NIPUs do not cause hemolysis. Interestingly, both platelet adhesion and contact activation-induced coagulation are strongly reduced on NIPU surfaces, indicating low thrombogenicity. Fibroblasts and endothelial cells maintain normal growth and shape after indirect contact with NIPUs. Fluid-structure interaction (FSI) allows modeling of the ideal valve design, with minimal shear stress on the leaflets. Injection-molded valves are tested in a pulse duplicator and show ISO-compliant hydrodynamic performance, comparable to clinically-used bioprostheses. Poly(tetrahydrofuran) (PTHF)-NIPU patches do not show any evidence of calcification over a period of 8 weeks. NIPUs are promising sustainable biomaterials for the manufacturing of improved prosthetic valves with low thrombogenicity.