A Novel Polymer Trileaflet Heart Valve

新型聚合物三叶心脏瓣膜

• 批准号: 6788334
• 负责人: Leonard Pinchuk
• 金额: $ 41.37万
• 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 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6788334
• 关键词: antithrombogenic surface; bioengineering /biomedical engineering; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; biomedical equipment development; clinical research; hemodynamics; 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，并普遍改善了瓣膜心脏病患者的寿命和症状。然而，10年死亡率仍在30%至55%之间。目前可用的生物心脏瓣膜由于钙化和降解，通常需要在8至15年的时间框架内进行替换，而使用时间更长的机械心脏瓣膜需要长期药物治疗以防止血液凝结。在50岁至65岁的患者体内植入什么类型的瓣膜仍然是一个两难的问题。聚合物三叶瓣提供了天然的阀门血液动力学，具有足够的耐用性，可长期使用。不幸的是，到目前为止，这些瓣膜还没有成功，因为材料在体内长期降解，通过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的组合。这项提议描述了一种合适的材料，这种材料在冠状动脉支架上的涂层取得了前所未有的成功，并通过适当的瓣膜设计，很有可能成为一种完全合成的聚合物心脏叶片假体。第一阶段SBIR项目的目标是为心脏叶瓣选择合适的材料和设计，并证明新的瓣膜将具有足够的生物兼容性以及改进的流体动力学和长期耐用性。这些目标顺利实现。第二阶段提案的具体目的和目标如下： 1.在三个组织环直径的至少三个瓣膜上进行比较加速磨损试验，其结果相当于夸特梅尔复合瓣和商用组织瓣膜15年的性能(6x10/8循环)。将定期检查阀门的磨损、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.将在羊(羊)动物模型中评估Qutremer复合材料和商业上可获得的组织瓣膜的体内比较慢性性能。至少有8只动物(6只使用夸特马复合瓣膜，2只使用组织瓣膜)将在至少20周的植入期内存活。定期进行血流动力学和实验室测量，然后进行解释、瓣膜评估和组织病理学检查。 第二阶段的完成将为将该项目转移到第三阶段，即阀门的商业化提供必要的可行性。第二阶段的主要结果将是向FDA提出申请以获得可行性调查设备豁免(IDE)所需的数据。临床试验将在这一批准之后进行。