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: 8653305
• 负责人: Anna M Galea
• 金额: $ 24.49万
• 依托单位: VIVONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8653305
• 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.

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在出生后不久开始多次外科手术，伴随着高发病率和潜在死亡率。一种有希望的替代治疗方法是在动脉导管未闭（PDA）中放置支架，以延迟最终修复，直到孩子长大，风险降低。提出了一种专门设计用于植入新生儿PDA的新型支架，以克服临床医生在新生儿中使用这种新手术时遇到的困难以及由于所使用的支架并非为此目的而设计而产生的并发症。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，包括取出;（2）使用体模进行分析和体外研究，以确定最有希望的支架和取出工具的候选设计;（3）在合适的动物模型中进行体内初步研究，以评价展开、可回收性、可跟踪性和不透射线性;以及（4）进行长期初步动物研究，以评估安全性和有效性。在后一项研究中，将在PDA通畅性维持、组织炎症和存在粘附内皮组织时从PDA中安全取出方面，将拟定支架设计与目前使用的支架进行比较。这些研究将形成一个令人信服的基础，完成开发的PDA支架治疗紫绀型先天性心脏病的新生儿。