A Novel Polymer Trileaflet Heart Valve

新型聚合物三叶心脏瓣膜

• 批准号: 6874453
• 负责人: Leonard Pinchuk
• 金额: $ 33.63万
• 依托单位: INNOVIA, LLC
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-03-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6874453
• 关键词: antithrombogenic surface; bioengineering /biomedical engineering; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; biomedical equipment development; clinical research; human tissue; implant; medical implant science; polymers; prosthetic heart valve; sheep

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%. Currently available biological-based heart valves, due to calcification and degradation, generally require replacement in the 8 to 15 year time frame whereas mechanical heart valves, which last longer, require chronic drug regimens to prevent blood clotting. A dilemma still exists on what type of valve to implant into patients between the ages of 50 and 65 years old. 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 that is enjoying unheard of success as coatings on coronary stents and, with the appropriate valve design, stands a very good chance of functioning as a totally synthetic polymer heart vane prosthesis. The goal of the Phase I SBIR project was to select the appropriate materials and designs for the heart leaflet valve and to demonstrate that the new valve will have a high likelihood of displaying sufficient biocompatibility along with improved fluid dynamics and long-term durability. These goals were successfully met. The Specific Aims and goals of the Phase II proposal are as follows: 1. Comparative accelerated wear testing on a minimum of three valves at three tissue annulus diameters for the equivalent of 15 years of performance (6xl0/8 cycles) on a Quatromer composite valve and a commercially available tissue valve. The valves will be periodically examined for wear, material fatigue, and hemodynamic performance. Finally, failure modes after further cycling will be determined. 2. Comparative chronic in vivo performance of the Quatromer composite and commercially available tissue valve will be assessed in an ovine (sheep) animal model. A minimum of eight animals (six with Quatromer composite valves, two with tissue valves) will survive an implantation period of at least 20 weeks. Hemodynamic and laboratory measurements will be performed periodically followed by explanation, valve evaluation, and histopathology. The completion of Phase II will provide the necessary feasibility to transfer the project to Phase III, commercialization of the valve. The primary outcome of Phase II will be the data required for an application to the FDA to obtain a Feasibility Investigational Device Exemption (IDE). Clinical trials will follow this approval.

描述（由申请人提供）： 自1960年以来，人工心脏瓣膜已被成功使用，并且通常导致患有瓣膜性心脏病的患者的寿命和心脏病学的改善。然而，10年死亡率仍然在30- 55%之间。由于钙化和降解，目前可用的生物基心脏瓣膜通常需要在8至15年的时间范围内更换，而机械心脏瓣膜持续时间更长，需要长期药物方案来防止血液凝固。在50至65岁的患者中植入何种类型的瓣膜仍然存在困境。聚合物三叶瓣膜提供自然的瓣膜血流动力学，具有足够的长期使用耐久性。不幸的是，这些瓣膜迄今为止还没有成功，因为通过与血液的氧化反应和材料承受的高动态拉伸和弯曲应力的组合，材料在体内长期降解。该提案描述了一种合适的材料，该材料作为冠状动脉支架上的涂层获得了前所未有的成功，并且在适当的瓣膜设计下，很有可能用作完全合成的聚合物心脏叶片假体。I期SBIR项目的目标是为心脏瓣叶瓣膜选择适当的材料和设计，并证明新瓣膜将很有可能表现出足够的生物相容性沿着改善的流体动力学和长期耐久性。这些目标已成功实现。第二阶段提案的具体目的和目标如下： 1.在三种组织瓣环直径下对至少三个瓣膜进行加速磨损对比试验，等同于Quatromer复合瓣膜和市售组织瓣膜的15年性能（6x 10/8次循环）。将定期检查瓣膜的磨损、材料疲劳和血流动力学性能。最后，将确定进一步循环后的失效模式。 2.将在绵羊动物模型中评估Quatromer复合瓣膜和市售组织瓣膜的比较性长期体内性能。至少8只动物（6只植入Quatromer复合瓣膜，2只植入组织瓣膜）将在至少20周的植入期内存活。将定期进行血流动力学和实验室测量，随后进行解释、瓣膜评价和组织病理学检查。 第二阶段的完成将为项目转入第三阶段提供必要的可行性，即阀门的商业化。II期的主要结局将是向FDA申请获得可行性研究器械豁免（IDE）所需的数据。临床试验将遵循这一批准。