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

儿科泵肺系统的开发和临床前试验资格

基本信息

批准号：
10179452
负责人：
Bartley P GriffIth
金额：
$ 74.42万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-04-15 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10179452
关键词：
Acute Address Adherence Adolescent Adult Advanced Development Animal Experiments Animals Biochemical Biomedical Engineering Blood Blood Cells Blood Platelets Blood flow Blood gas Brain Embolism Carbon Dioxide Cardiac Cardiogenic Shock Cardiopulmonary Cardiopulmonary Bypass Case Study Cellular Structures Child Child Support Childhood Chronic Clinic Clinical Coagulation Process Data Deposition Detection Development Devices Diagnostic Event Extracorporeal Membrane Oxygenation Failure Fiber Gases Generations Geometry Heart Heart Diseases Heart failure Hemolysis Hemorrhage Heparin Hour Human Infant Injury International Intervention Investigation Lung Mechanics Membrane Modeling Modification Monitor Morbidity - disease rate Motor Neonatal Operative Surgical Procedures Organ Oxygen Oxygenators Patients Performance Physiological Plasma Platelet Activation Preclinical Testing Pump Pump lung Quality of life Readiness Refractory Registries Reporting Resistance Respiratory Failure Running Series Sheep Support System Surface System Technology Testing Thrombosis Translating Weaning Weighing patient base biomaterial compatibility blood pump compare effectiveness conventional therapy design exhaust experience experimental study good laboratory practice hemodynamics improved improved outcome in vivo industry partner manufacturability mortality multidisciplinary novel novel therapeutics patient mobility pediatric patients portability preclinical development preclinical evaluation preclinical trial pressure respiratory sensor surface coating ventricular assist device verification and validation

项目摘要

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.

项目概要患有肺部或心脏疾病的幼儿需要可靠、有效的心肺支持装置失败是众所周知的。对于那些对传统疗法耐药的儿科患者，通过体外膜肺氧合 (ECMO) 进行积极的机械循环干预或心室辅助装置（VAD）可能会提高生存的可能性。 ECMO 系统之所以有吸引力，是因为它们密切模拟生理气体交换和循环支持；但在实践中，这些系统因其操作复杂性、机械故障、回路血栓和出血并发症而受到限制。系统儿科 ECMO 在过去十年中没有发生重大变化。改善成果以支持患有心力衰竭或肺衰竭的儿童主要是由于更好的选择和管理患者。需要新设计的 ECMO 系统来持续降低发病率和死亡率。我们建议贡献基于先进生物工程原理的新一代ECMO系统专注于优化血流路径和儿科 ICU 通过生化增强患者活动能力涂层以减少血小板粘附。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适合幼儿和成人。这些设备将独特配置的中空纤维膜与新颖的血泵技术，产生超紧凑的系统，具有低预冲量和改进的生物相容性。该儿科模型称为 Pedi Pump-Lung (PediPL)，专门设计用于对于体重 5-25 公斤的患者，最长 30 天，其 1) 状态不够稳定，无法脱离心肺功能手术后搭桥； 2) 患有严重的原发性呼吸衰竭或与心脏相关的继发性衰竭疾病; 3) 经历严重的心源性休克并需要紧急支持。该项目的目标是完善和完成 PediPL 及相关产品的开发 ECMO 支持系统中的配件可实现动态呼吸和心肺支持，对生产临床级 PediPL 和临床前的准备情况进行临床前评估测试符合良好生产规范 (GMP) 和良好实验室规范 (GLP) 预期 510 K 许可和研究设备豁免 (IDE) 批准美国食品和药物管理局。