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

适用于患有紫绀型先天性心脏病 (CCHD) 的新生儿的可拆卸支架

• 批准号: 8334860
• 负责人: JAMES Hunter GOLDIE
• 金额: $ 24.65万
• 依托单位: INFOSCITEX CORPORATION
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-06 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8334860
• 关键词: Acute; Adverse effects; Age; Animal Model; Animals; Aorta; Area; Biliary; Birth; Caliber; Catheters; Child; Childhood; Clinical Engineering; Coronary artery; Development; Dimensions; Ductus Arteriosus; Engineering; Evaluation; Excision; Foundations; Government; Heart; Heart Diseases; Hormones; Hypoplastic Left Heart Syndrome; Image; Implant; In Vitro; Inflammation; Legal patent; Length; Life; Longitudinal Studies; Lung; Maintenance; Measures; Morbidity - disease rate; Newborn Infant; Operative Surgical Procedures; Patent Ductus Arteriosus; Performance; Persons; Pilot Projects; Positioning Attribute; Procedures; Property; Pulmonary artery structure; Radial; Risk; Rupture; Safety; Stents; Testing; Time; Tissues; Variant; alternative treatment; base; biomaterial compatibility; congenital heart disorder; design; experience; implantation; in vivo; instrumentation; mortality; neonate; novel; prototype; repaired; tool

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. PUBLIC HEALTH RELEVANCE: While significant improvement in treatment of CHD has already been made, including a 30% reduction in mortality over the past decade, there is a still a long way to go and as a whole this area has been significantly underfunded. Successful development of a new stent, specifically designed for implantation in the PDA in neonates, would represent a major contribution toward this end, providing a safer and less invasive means for treating cyanotic congenital heart disease, including hypoplastic left heart syndrome (HLHS), the deadliest of all congenital heart diseases during the first year of life. Currently, the survivl of these neonates requires that they undergo invasive and highly risky open-heart procedures shortly after birth, whereas the availability of a safe and effective PDA stent for would permit delay of invasive surgery until an age when the child is at much lower risk.

描述（由申请人提供）：当前对许多形式的先天性心脏病的治疗需要在出生后不久开始进行多种手术程序，而随之而来的是高发病率和潜在的死亡率。一种有希望的替代治疗要求将支架放置在Arteriosus（PDA）中，以延迟确定的维修直到孩子年龄较大，并且威尔的风险较低。为了克服临床医生在新生儿的新手术中遇到的困难，提出了一种专门为植入新生儿PDA植入的新型支架，这是由于并非为此目的而设计的，这引起了并发症。工程师和儿科心脏病专家的跨学科团队将（1）识别/记录将支架植入新生儿PDA的要求，包括删除； （2）对幻影进行分析和体外研究，以识别支架和去除仪器的最有希望的候选设计； （3）在合适的动物模型中进行一项体内试验研究，以评估部署，可重复性，可追踪性和放射线性； （4）进行试点长期的动物研究，以评估安全性和有效性。在后一项研究中，在维持PDA的通畅性，组织炎症和在存在依从性内皮组织的情况下，将将提议的支架设计与当前使用的支架进行比较。这些研究将构成令人信服的基础，以完成PDA支架的开发，用于治疗新生儿的氰基先天性心脏病。 公共卫生相关性：虽然已经对冠心病的治疗进行了显着改善，包括在过去十年中降低30％的死亡率，但还有很长的路要走，整个地区的资金大大不足。成功开发了一个新的支架，专门为植入新生儿的植入而设计的，将为这一目标做出重大贡献，为治疗cyanotic先天性心脏病的治疗提供了一种更安全且较少的侵入性手段，包括恐怖分子左心脏综合征（HLHS），是治疗cyanotic疾病。在生命的第一年，所有先天性心脏病中最致命的人。目前，这些新生儿的生存要求他们在出生后不久接受侵入性且风险高大的开心手术，而可用的安全有效的PDA支架可以允许延迟入侵性手术，直到孩子处于较低年龄的年龄风险。