The valve replacement therapy is the standard treatment for severe heart valve diseases. Nowadays, two types of commercial prosthesis are available: mechanical and biological, but both of them have severe limitations. Moreover, alternative therapeutic approach for valve replacement, based on minimally invasive techniques (MIAVR), motivates the search for new valve materials. In this study a polyurethane-based self-expandable tri-leaflets heart valve compatible with MIAVR procedure is proposed. The device is based on the development, fabrication and characterization of three different elements: the leaflets, the polymeric stent for supporting the leaflets, and the external metallic stent for anchoring the valve to the native aortic root. The polymeric stent and the valve leaflets were fabricated using a thermoplastic silicone-polycarbonate-urethane using 3D printing and spray technology while the external metallic stent was made in nickel titanium (Nitinol) to obtain a self-expandable valve after the crimping process. The three elements were assembled in the completed device and tested by crimping, fatigue and fluid-dynamic test. The novel polymeric valve proposed showed promising results about valve crimping capabilities, durability and fluid dynamic performances. This approach could offer advantages such as low cost and to produce a tailor-made device basing on patient's imaging data. Moreover, the selected biomaterial offers the potential to have a device that could need of permanent anticoagulation and lack of calcification.

瓣膜置换疗法是严重心脏瓣膜疾病的标准治疗方法。如今，有两种类型的商业义肢可供使用：机械义肢和生物义肢，但它们都有严重的局限性。此外，基于微创技术（MIAVR）的替代性瓣膜置换治疗方法促使人们寻找新的瓣膜材料。在这项研究中，提出了一种与MIAVR程序兼容的基于聚氨酯的自膨胀三叶心瓣膜。该设备基于三种不同元素的开发，制造和表征：小叶，用于支撑小叶的聚合物支架以及用于将瓣膜锚固至天然主动脉根的外部金属支架。聚合物支架和瓣膜小叶使用3D打印和喷涂技术使用热塑性有机硅-聚碳酸酯-氨基甲酸酯制造，而外部金属支架由镍钛（Nitinol）制成，在压接过程之后获得可自膨胀的瓣膜。将这三个元件组装在完整的设备中，并通过压接，疲劳和流体动力学测试进行测试。提出的新型聚合物阀在阀的压接能力，耐用性和流体动力学性能方面显示出令人鼓舞的结果。这种方法可以提供诸如低成本的优势，并可以根据患者的成像数据生产量身定制的设备。而且，所选的生物材料提供了一种可能需要永久性抗凝和缺乏钙化的装置的潜力。