Development and Pre-Clinical Trial Qualification of a Pediatric Pump-Lung System for Children

项目摘要 为患有肺病或心脏病的幼儿提供可靠和有效的心肺支持设备的必要性 失败已成定局。对于那些对传统疗法无效的儿科患者， 体外膜肺氧合(ECMO)积极的机械循环干预 脑室辅助装置(VADs)可能会提高存活率。ECMO系统很有吸引力，因为 它们非常接近地模拟生理气体交换和循环支持；但在实践中，这些系统 受限于其操作复杂性、机械故障、电路中的血块和出血并发症。系统 对于儿科ECMO，在过去十年中没有实质性的变化。改善了支助工作的成果 患有心肺衰竭的儿童主要是因为更好地选择和管理 病人。为了继续降低发病率和死亡率，需要一个新设计的ECMO系统。 我们建议贡献基于先进生物工程原理的新一代ECMO系统 重点关注优化的血流路径和儿科ICU通过生化手段增强患者的机动性 减少血小板粘附性的涂层。 我们与行业合作伙伴合作开发了一系列微型、集成泵-氧合器 对儿童和成人都适用。这些设备将独特配置的中空纤维膜与 新的血泵技术，导致超紧凑型系统具有低预充量和改进 生物兼容性。这种儿科模型被称为佩迪泵-肺(PediPL)，是专门为UP设计的 体重5-25公斤的患者1)不够稳定，不能脱离体外循环 手术后搭桥；2)有严重的原发呼吸衰竭或继发性心脏衰竭 疾病；3)经历严重的心源性休克，需要紧急支持。 该项目的目标是完善和完成儿科物流和相关的开发 ECMO支持系统中的附件，允许非卧床呼吸和心肺支持 进行临床前评估，准备生产临床级别的PediPL和临床前 测试是否符合良好制造规范(GMP)和良好实验室规范(GLP) 预期510 K许可和调查设备豁免(IDE)批准来自 美国食品和药物管理局。

Project Summary The need for reliable and effective cardiopulmonary support devices for young children with lung or heart failure is well established. For those pediatric patients who become refractory to conventional therapies, aggressive mechanical circulatory intervention through extracorporeal membrane oxygenation (ECMO) or ventricular assist devices (VADs), may improve the likelihood of survival. ECMO systems are attractive since they closely simulate physiological gas exchange and circulatory support; but in practice, these systems are limited by their operational complexity, mechanical failure, clots in circuit, and bleeding complications. Systems for pediatric ECMO have not changed substantially in the last decade. Improved outcomes in support of children with either heart or lung failure have been principally due to better selection and management of the patients. A newly designed ECMO system is required for continued reduction in the morbidity and mortality. We propose to contribute a new generation ECMO system based on advanced bioengineering principles focused on an optimized blood flow path and pediatric ICU-enhanced patient mobility with biochemical coatings to reduce platelet adherence. We in partnership with industry partners have developed a series of miniature, integrated pump-oxygenators for both young children and adults. These devices combine uniquely configured hollow fiber membranes with novel blood pump technology, resulting in ultra-compact systems with a low priming volume and improved biocompatibility. The pediatric model, called Pedi Pump-Lung (PediPL), is specifically designed for use for up to 30 days in patients weighing 5-25 kg who 1) are not sufficiently stable to be weaned from cardiopulmonary bypass after surgery; 2) have severe primary respiratory failure or secondary failure associated with cardiac disease; and 3) experience profound cardiogenic shock and require urgent support. The objectives of this project are to refine and complete development of the PediPL and associated accessories into an ECMO support system permitting ambulatory respiratory and cardiopulmonary support and to conduct pre-clinical evaluation of readiness for manufacturing of the clinical grade PediPL and pre-clinical testing in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in anticipation of anticipation of 510 K clearance and an Investigational Device Exemption (IDE) approval from FDA.