Development of a Surgical and Transcatheter Polymeric Heart Valve

外科和经导管聚合物心脏瓣膜的开发

• 批准号: 8315236
• 负责人: Jack Cabell Griffis
• 金额: $ 15万
• 依托单位: MEDSHAPE SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8315236
• 关键词: Academia; Acute; Address; Adult; Age-Years; Animals; Area; Artificial Heart; Biological Assay; Bioprosthesis device; Blood; Businesses; Calcified; Cardiac Surgery procedures; Cardiovascular system; Childhood; Clinical; Coagulation Process; Commit; Development; Devices; Doppler Echocardiography; Drops; Environment; Extravasation; FDA approved; Failure; Family suidae; Fatigue; Figs - dietary; Health Care Costs; Heart; Heart Rate; Heart Valve Diseases; Heart Valves; Hour; Immune response; Implant; Industry; Injection of therapeutic agent; Laboratory Research; Marketing; Measures; Mechanics; Memory; Methods; Modeling; Molds; Operative Surgical Procedures; Perforation; Phase; Plague; Polymers; Population; Positioning Attribute; Process; Property; Resistance; Resources; Scientist; Shapes; Small Business Technology Transfer Research; Solutions; Sterility; Stress; Structure; Surface; Surface Properties; Systolic Pressure; Techniques; Testing; Thrombosis; Translating; Translations; United States; Universities; Water; Work; absorption; biocompatible polymer; calcification; commercialization; cost; heart valve replacement; hemodynamics; implantation; improved; in vivo; innovation; man; material fatigue; novel; polyetheretherketone; pressure; programs; prototype

DESCRIPTION (provided by applicant): 10.3 million Bioprosthetic heart valves (BHV) have been implanted since 1980 in the United States alone, but the solution for a durable, non-calcifying bioprosthesis still eludes us. High rates of structural failures and rapid calcificationin BHVs, has veered a gradual shift towards the development of polymeric heart valves (PHV). Biocompatible polymers are excellent materials for heart valves for their tunable mechanical properties (for improved durability), tunable surface properties (for reduced calcification), and the ability to program hemocompatibility (for non-thrombogenecity). Few polymeric materials have already been tested for heart valves, yet one that packages the three essential properties of durability, anti-calcific, and non-thrombogenic still remains to be developed. The intellectual merit of this STTR Phase I proposal is to develop a polymeric heart valve using a novel ultra-polymer, polyetheretherketone (PEEK), to fully address the essential properties for cardiovascular applications. This proposal will establish that PEEK may provide an ideal materials solution for artificial heart valves, for both surgical and transcatheter deploy-ability. The mechanical properties of PEEK are up to an order of magnitude higher than traditional polymers with excellent fatigue resistance, low water absorption, and highly inert structure. PEEK structures can be molded to shape, woven, and/or non-woven to avoid regions of stress concentration (where structural failure of BHV occurs), and are hemocompatible to avoid thrombosis. Furthermore, PEEK can be processed to demonstrate shape memory, which allows its use for transcatheter valve deploy-ability. In this application, we propose the testing of a PEEK heart valve for its hemodynamic ability, mechanical durability, thrombogenicity, and acute in vivo function in a swine model. To develop and translate the PEEK valve for clinical use, a committed academia-industry partnership is established between the heart valve research laboratory at Emory University, and a shape-memory polymer development company, MedShape Solutions Inc. Our team synergizes expertise and resources in heart valve development and testing at Emory University; and polymer innovation, processing and commercialization of FDA-approved polymeric devices at Medshape Solutions Inc. PUBLIC HEALTH RELEVANCE: The burden of valvular heart disease is significant in the United States, prevalent in 2.5% of the total population (8.75 million) and 13.3% of adults beyond 65 years of age (5.78 million) in 2011. Replacement of the diseased heart valves with man-made mechanical or bioprosthetic valves is a routine cardiac surgical procedure today, yet one which is plagued with high rates of failure due to the need for anti-coagulation therapy with mechanical valves and the rapid degeneration associated with bioprosthetic valves. In this application, we propose the development and testing of a novel polymeric heart valve, prepared from a resilient, highly durable material with exquisite shape memory properties.

描述（由申请人提供）：自1980年以来，仅在美国就植入了1,030万个生物体系心脏瓣膜（BHV），但是对于持久，不估计的生物植被的解决方案仍然使我们陷入困境。较高的结构故障和快速钙化在BHV中，逐渐转向聚合心脏瓣膜（PHV）的发展。生物相容性聚合物是可调机械性能（提高耐用性），可调表面特性（用于钙化降低）以及对血液相容性进行编程（对于非thrombogenenecity）的能力的出色材料。很少有聚合物材料已经测试过心脏瓣膜，但是一种包装耐用性，抗钙化和非平稳性的三种基本特性仍然有待开发。该Sttr I期提案的智力优点是使用新型的超聚合物（PEEK）开发聚合物心脏瓣膜，以充分解决心血管应用的基本特性。该提议将确定PEEK可以为手术和经导管部署能力提供人工心脏瓣膜的理想材料解决方案。 PEEK的机械性能比传统聚合物高的数量级高，具有出色的抗疲劳性，低吸收性和高惰性结构。可以将窥视结构模制成塑形，编织和/或未编织，以避免应力浓度区域（发生BHV的结构性故障），并且可以避免血栓形成。此外，可以处理PEEK以演示形状内存，从而使其用于经导管阀可部署。在此应用中，我们提出了PEEK心脏瓣膜在猪模型中的血液动力学能力，机械耐用性，血栓形成性和急性功能的测试。为了开发和翻译PEEK阀以供临床使用，在埃默里大学的心脏阀研究实验室与Shape-Memory Polymer Development Company，Medshape Solutions Inc.在Medshape Solutions Inc.中建立了一个致力于学术界的行业合作伙伴关系。我们的团队在Emory University的心脏瓣膜开发和测试中协同促进了专业知识和资源；以及在Medshape Solutions Inc.上的FDA批准聚合物设备的聚合物创新，处理和商业化。 公共卫生相关性：瓣膜心脏病的负担在美国很大，占总数的2.5％（875万）和2011年65岁以上（578万）以上的成年人中的13.3％。替换患病的心脏瓣膜。随着人造或生物心理的速度，它是一个常规的频率，但它是一个常规的速度，但它是一项途径，但它是一项途径，但它是一个plagiact的速度。机械瓣膜和与生物假体瓣膜相关的快速变性。在此应用中，我们提出了一种新型聚合物心脏瓣膜的开发和测试，这是由具有精美形状记忆特性的弹性，高度耐用的材料制备的。