The sole effective treatment for most patients with heart valve disease is valve replacement by implantation of mechanical or biological prostheses. However, mechanical valves represent high risk of thromboembolism, and biological prostheses are prone to early degeneration. In this work, we aim to determine the potential of novel environmentally-friendly non-isocyanate polyurethanes (NIPUs) for manufacturing synthetic prosthetic heart valves. Polyhydroxyurethane (PHU) NIPUs are synthesized via an isocyanate-free route, tested in vitro, 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.

中文翻译：

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绿色非异氰酸酯聚氨酯人工心脏瓣膜的设计、制造和测试

对于大多数心脏瓣膜疾病患者来说，唯一有效的治疗方法是通过植入机械或生物假体进行瓣膜置换。然而，机械瓣膜存在血栓栓塞的高风险，而生物假体容易早期退化。在这项工作中，我们的目标是确定新型环保非异氰酸酯聚氨酯（NIPU）在制造合成人工心脏瓣膜方面的潜力。聚羟基聚氨酯 (PHU) NIPU通过无异氰酸酯途径合成，经过体外测试，并用于生产主动脉瓣。用聚酯网增强的 PHU 弹性体表现出与天然瓣膜小叶相似的机械性能。这些 NIPU 不会引起溶血。有趣的是，血小板粘附和接触激活诱导的凝血在 NIPU 表面上都大大减少，表明血栓形成性较低。成纤维细胞和内皮细胞在与 NIPU 间接接触后保持正常生长和形状。流固耦合 (FSI) 允许对理想瓣膜设计进行建模，并且小叶上的剪切应力最小。注塑阀门在脉冲复制机中进行了测试，并显示出符合 ISO 的流体动力学性能，可与临床使用的生物假体相媲美。聚四氢呋喃 (PTHF)-NIPU 贴片在 8 周内未显示任何钙化迹象。NIPU 是一种很有前途的可持续生物材料，可用于制造具有低血栓形成性的改进型人工瓣膜。