A Novel Polymer Trileaflet Heart Valve

描述（由申请人提供）：自1960年以来，心脏瓣膜假体已成功使用，并普遍改善了瓣膜性心脏病患者的寿命和症状。然而，10年死亡率仍在30-55%之间，需要改进瓣膜设计，以尽量减少血栓形成的可能性和结构退化，并改善发病率和死亡率。聚合物三叶瓣膜提供自然的瓣膜血流动力学，具有足够的耐久性，可以长期使用。不幸的是，由于与血液的氧化反应以及材料承受的高动态拉伸和弯曲应力，这些阀门在体内长期降解，迄今为止尚未成功。本建议描述了一种合适的材料和合适的阀门设计，可以克服这些限制。第一阶段SBIR项目的目标是通过可行性阶段进一步发展新型聚合物基心脏瓣膜的商业化，在此阶段将证明新瓣膜在体内具有足够的生物相容性以及改善的血液动力学和长期耐用性。为了实现可行性，需要回答以下四个问题。1. 这种阀门的合适材料是什么？2. 阀门的合适设计是什么？3. 阀门能否在可重复和可靠的工艺中制造？4. 与市售的组织瓣膜相比，这种瓣膜能改善血流动力学吗？我们的初步结果将表明，为了回答这些问题，我们已经做了很多工作。为了完成可行性分析，将执行以下具体目标。1. 聚合物的力学特性，包括静态和动态分析。2. 通过测量血小板沉积在受控体外流动条件下的聚合物材料的比较血栓形成电位。3. 提高了制造过程的可靠性和可重复性。4. 合适组织瓣膜的体外血流动力学比较。

DESCRIPTION (provided by applicant): Heart valve prostheses have been used successfully since 1960 and generally result in improvement in the longevity and symptomatology of patients with valvular heart disease. However, 10-year mortality rates still range from 30-55%, and improvements in valve design are required to minimize thrombotic potential and structural degradation and to improve morbidity and mortality outcomes. Polymer trileaflet valves offer natural valve hemodynamics with the potential for sufficient durability for long-term use. Unfortunately these valves have not been successful to date because of long-term material degradation in vivo through a combination of oxidative reactions with blood and the high dynamic tensile and bending stresses borne by the material. This proposal describes a suitable material and appropriate valve design that will overcome these limitations. The goal of this Phase I SBIR project is to further the development toward commercialization of a novel polymer-based heart valve through a feasibility stage, where it will be demonstrated that the new valve will have a high likelihood of displaying sufficient biocompatibility along with improved hemodynamics and long-term durability over tissue valves in vivo. Answers to the following four questions are required for feasibility. 1. What is the appropriate material for the valve? 2. What is the appropriate design for the valve? 3. Can the valve be fabricated in a repeatable and reliable process? 4. Will the valve provide improved hemodynamics over commercially available tissue valves? Our preliminary results will demonstrate that much work has already been performed to answer these questions. To complete the feasibility analysis, the following specific aims will be performed. 1. Mechanical characterization of the polymer, including both static and dynamic analysis. 2. Comparative thrombogenic potential of the polymer material by measuring platelet deposition under controlled in vitro flow conditions. 3. Improved reliability and repeatability of the fabrication processes. 4. Comparative in vitro hemodynamics with an appropriate tissue valve.