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术的瓣膜是生物衍生的（例如，人尸体瓣膜）。 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Kelly McKinzey的医疗器械开发培训， PolyVascular为领导健康相关研究和开发的独立职业做准备， 小型企业，编号为PA-18-837。该建议包括两个培训部分：在研究计划中， 女士McKinzey将采用替代方法制造瓣叶，并根据PolyVascular的 标准方法。她将获得支架安装瓣膜制造、聚合物化学、ISO 5840-3方面的培训 实验室试验、ISO 10993生物相容性试验、灭菌确认和包装确认。所有步骤 将在质量体系下进行，McKinzey女士将获得遵守该体系的经验。一 第二个培训部分涉及她的职业和导师计划，在该计划中，她将利用 通过Enventure和其他当地机构的课程，在德克萨斯州医疗中心的创业生态系统。她 将获得创业和负责任的研究行为的经验，在设备的框架内 开发以获得FDA批准。提案的这两个要素都是为了围绕麦金齐女士， 她是一个经验丰富的研究人员组成的跨学科团队，为她在医疗器械开发领域的职业生涯做好了准备。

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 Kelly McKinzey’s training in medical device development with PolyVascular in preparation for an independent career leading health-related research and development for small businesses, under PA-18-837. The proposal consists of two training components: in the Research Plan, Ms. McKinzey will employ alternate methods for leaflet fabrication, and test these against PolyVascular’s standard methods. She will gain training in stent mounted valve manufacturing, polymer chemistry, ISO 5840-3 benchtop testing, ISO 10993 biocompatibility testing, sterilization validation, and packaging validation. All steps will be conducted under a quality system, and Ms. McKinzey will gain experience in adhering to this system. A second training component involves her Career and Mentorship Plan, in which she will take advantage of the startup ecosystem in the Texas Medical Center, through courses at Enventure and other local institutions. She will gain experience in entrepreneurship and responsible conduct of research, within the framework of device development for FDA approval. Both elements of the proposal are intended to surround Ms. McKinzey with an interdisciplinary team of experienced researchers, and ready her for a career in medical device development.