Development of a Polymeric Percutaneous Pulmonary Valve for Use in Young Children

项目摘要： 先天性心脏病（CHD）仍然是最常见的出生缺陷类别，也是导致先天性心脏病的主要原因。 发达国家的儿童死亡率。在构成冠心病的结构缺陷中， 肺动脉瓣（PV）功能障碍是一种常见的异常，经常需要手术干预 和替换。通过心脏直视手术进行瓣膜置换术， 患者，并代表了家庭的主要经济和情感负担。最常用的阀门 用于幼儿肺动脉瓣置换的瓣膜是生物来源的（例如人类尸体瓣膜）。 这种替代品供应短缺，并且具有其他固有的缺点，例如长期性能差。 持久性和诱导宿主免疫应答的倾向。这些因素的结合导致了一个循环 重复的外科手术干预，使用瓣膜，几乎是可用的，注定要迅速失败。 PolyVascular公司试图通过开发聚合物支架安装瓣膜（SMV）来解决这些问题， 包括安装在金属支架内的聚合物衍生的小叶， 侵入性经导管技术，避免了重复手术的负担，有可能改善 耐用性和功能。 本附录旨在支持Larry Scott博士进行医疗器械博士后培训 根据PA-18-837与PolyVascular共同开发。该建议包括两个培训部分： 研究计划，Scott博士将采用ISO 5840-3下的方法来评估 建议的SMV，在一系列大小。他将获得设备制造、流体动力学 阀的性能和阀的延长的耐久性。所有步骤都将在质量 系统，斯科特博士将获得遵守这一系统的经验。第二个培训部分涉及 他的职业和导师计划，其中斯科特博士将利用在得克萨斯州的创业生态系统的优势， 医疗中心，通过Enventure和其他当地机构的课程。他将获得经验， 在FDA器械开发框架内，具有创业精神和负责任的研究行为 批准他的研究计划的两个要素都是为了利用斯科特博士的跨学科团队， 研究人员，并准备他的职业生涯在医疗设备开发。

Project Summary: Congenital heart disease (CHD) remains the most common category of birth defect and a leading cause of childhood death in the developed world. Of the constellation of structural defects that comprise CHD, dysfunctional pulmonary valves (PV) are a common abnormality, and frequently require surgical intervention and replacement. Valve replacement through open heart surgery carries substantial risk and discomfort for patients, and represents a major financial and emotional burden for families. The most commonly used valves for pulmonary valve replacement in young children are biologically-derived (e.g. human cadaveric valves). Such replacements are in short supply, and have other inherent disadvantages, such as poor long-term durability, and propensity to induce a host immune response. The combination of these factors leads to a cycle of repeat surgical interventions, using valves that are scarcely available and destined for rapid failure. PolyVascular has sought to address these issues by developing a polymeric stent-mounted valve (SMV), comprised of polymer-derived leaflets mounted within a metal stent, that can be delivered via minimally invasive transcatheter techniques, avoiding the burden of repeat surgeries, with potential for improved durability and function. The present supplement is meant to support Dr. Larry Scott toward postdoctoral training in medical device development with PolyVascular, under PA-18-837. The proposal consists of two training components: in the Research Plan, Dr. Scott will employ methods under ISO 5840-3 to evaluate alternative materials for the proposed SMVs, across a range of sizes. He will gain training in device manufacture, hydrodynamic performance of the valves, and extended durability of the valves. All steps will be conducted under a quality system, and Dr. Scott will gain experience in adhering to this system. A second training component involves his Career and Mentorship Plan, in which Dr. Scott will take advantage of the startup ecosystem in the Texas Medical Center, through courses at Enventure and other local institutions. He will gain experience in entrepreneurship and responsible conduct of research, within the framework of device development for FDA approval. Both elements of his Research Plan are intended to avail Dr. Scott of an interdisciplinary team of researchers, and ready him for a career in medical device development.