A Novel Polymer Trileaflet Heart Valve

新型聚合物三叶心脏瓣膜

• 批准号: 6583973
• 负责人: Leonard Pinchuk
• 金额: $ 9.93万
• 依托单位: INNOVIA, LLC
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-10 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6583973
• 关键词: bioengineering /biomedical engineering; biomaterial compatibility; biomaterial development /preparation; biomaterial interface interaction; biomedical equipment development; clinical research; hemodynamics; human tissue; implant; medical implant science; polymers; prosthetic heart valve

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.

描述（由申请人提供）：自1960年以来，人工心脏瓣膜已成功使用，通常可改善心脏瓣膜病患者的寿命和预后。 然而，10年死亡率仍在30- 55%的范围内，需要改进瓣膜设计，以最大限度地减少血栓形成和结构退化，并改善发病率和死亡率结局。 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，在体内长期材料降解。 该提案描述了一种合适的材料和适当的阀门设计，将克服这些限制。 该I期SBIR项目的目标是通过可行性阶段进一步开发新型聚合物心脏瓣膜的商业化，在可行性阶段，将证明新瓣膜将很有可能显示出足够的生物相容性，沿着改善的血液动力学和体内组织瓣膜的长期耐久性。 为确保可行性，需要回答以下四个问题。 1. 阀门的合适材料是什么？ 2. 阀门的适当设计是什么？ 3. 阀门能否以可重复和可靠的工艺制造？ 4. 与市售组织瓣膜相比，瓣膜是否能改善血流动力学？ 我们的初步结果将表明，已经进行了大量的工作来回答这些问题。 为了完成可行性分析，将执行以下具体目标。 1. 聚合物的机械特性，包括静态和动态分析。 2. 通过在受控体外流动条件下测量血小板沉积比较聚合物材料的血栓形成潜力。 3. 提高制造过程的可靠性和可重复性。 4. 与适当组织瓣膜的体外血流动力学比较。

项目成果

A novel small animal model for biocompatibility assessment of polymeric materials for use in prosthetic heart valves.

一种新型小动物模型，用于评估用于人工心脏瓣膜的聚合物材料的生物相容性。

• DOI: 10.1002/jbm.a.32562
• 发表时间: 2010
• 期刊: Journal of biomedical materials research. Part A
• 作者: Wang,Qiang;McGoron,AnthonyJ;Pinchuk,Leonard;Schoephoerster,RichardT
• 通讯作者: Schoephoerster,RichardT

In-vivo assessment of a novel polymer (SIBS) trileaflet heart valve.

新型聚合物（SIBS）三叶心脏瓣膜的体内评估。

• 发表时间: 2010
• 期刊: The Journal of heart valve disease
• 作者: Wang,Qiang;McGoron,AnthonyJ;Bianco,Richard;Kato,Yasushi;Pinchuk,Leonard;Schoephoerster,RichardT
• 通讯作者: Schoephoerster,RichardT