The potential of polymeric heart valves (PHV) prostheses is to combine the hemodynamic performances of biological valves with the durability of mechanical valves. The aim of this work is to design and develop a new tri-leaflet prosthetic heart valve (HV) made from styrenic block copolymers. A computational finite element model was implemented to optimize the thickness of the leaflets, to improve PHV mechanical and hydrodynamic performances. Based on the model outcomes, 8 prototypes of the designed valve were produced and tested in vitro under continuous and pulsatile flow conditions, as prescribed by ISO 5840 Standard. A specially designed pulse duplicator allowed testing the PHVs at different flow rates and frequency conditions. All the PHVs met the requirements specified in ISO 5840 Standard in terms of both regurgitation and effective orifice area (EOA), demonstrating their potential as HV prostheses.

中文翻译：

---

新开发的三叶聚合物心脏瓣膜假体

聚合物心脏瓣膜 (PHV) 假体的潜力在于将生物瓣膜的血液动力学性能与机械瓣膜的耐用性相结合。这项工作的目的是设计和开发一种由苯乙烯嵌段共聚物制成的新型三叶人工心脏瓣膜 (HV)。实施了计算有限元模型以优化小叶的厚度，以提高 PHV 的机械和流体动力学性能。根据模型结果，按照 ISO 5840 标准的规定，在连续和脉动流条件下生产和测试了所设计阀门的 8 个原型。专门设计的脉冲复制器允许在不同的流速和频率条件下测试 PHV。