Removable Stents for Neonates with Cyanotic Congenital Heart Disease(CCHD)

描述（由申请人提供）：目前许多形式的先天性心脏病的治疗需要从出生后不久开始进行多次外科手术，随之而来的是高发病率和潜在死亡率。另一种有希望的治疗方法是在动脉导管未闭（PDA）内放置支架，以推迟最终修复，直到孩子长大，风险更低。为了克服临床医生在新生儿中使用这种新手术所遇到的困难，以及由于使用的支架不是为此目的而设计的并发症，提出了一种专门为新生儿PDA植入设计的新型支架。一个由工程师和儿科心脏病专家组成的跨学科团队将(1)确定/记录在新生儿PDA中植入支架的要求，包括移除；(2)用幻影进行分析和体外研究，以确定最有希望的支架和移除器械候选设计；(3)在合适的动物模型中进行体内先导研究，以评估部署、可捕获性、可追踪性和放射不透明性；(4)开展长期动物试验，评估安全性和有效性。在后一项研究中，建议的支架设计将与目前使用的支架进行比较，涉及维持PDA的通畅，组织炎症以及在存在粘附内皮组织的情况下安全地从PDA中移除。这些研究将为完成PDA支架治疗新生儿紫绀型先天性心脏病的开发奠定坚实的基础。

DESCRIPTION (provided by applicant): Current treatment of many forms of congenital heart disease requires multiple surgical procedures starting shortly after birth, with attendant high morbidity and potential mortality. A promising alternative treatment calls for placing a stent in te patent ductus arteriosus (PDA), in order to delay definitive repair until the child is older and wil have a lower risk. A novel stent specifically designed for implantation in the neonate PDA is proposed, in order to overcome the difficulties that clinicians have experienced with this new procedure in newborns, complications arising from the fact that the stents used were not designed for this purpose. An interdisciplinary team of engineers and pediatric cardiologists will (1) identify/document the requirements for a stent to be implanted in the newborn PDA, including removal; (2) perform analytical and in vitro studies with phantoms to identify the most promising candidate designs for the stent and removal instrumentation; (3) conduct an in vivo pilot study in a suitable animal model to evaluate deployment, recaptureability, trackability and radiopacity; and (4) conduct a pilot long-term animal study to assess safety and efficacy. In this latter study, proposed stent designs will be compared with stents currently being used, in regard to maintenance of patency of the PDA, tissue inflammation, and safe removal from the PDA in the presence of adherent endothelial tissue. These studies will form a compelling foundation for completing development of a PDA stent for treatment of Cyanotic Congenital Heart Disease in neonates.