Mini ECMO Life Support System

描述(由申请人提供)：20年来，延长体外生命支持(ECLS ECMO)一直是对其他治疗无效的严重心肺衰竭婴儿的标准治疗。30,000多例患者的健康存活率从心脏骤停时的40%到胎粪吸入时的95%不等。治疗方法的改进减少了足月新生儿呼吸衰竭对ECMO的需求，但对大龄新生儿呼吸衰竭、心力衰竭和败血症的应用正在增加。ECMO使用的设备是来自几家制造商的单独组件，在现场组装，并在标签外使用。最近，三家公司将这些设备整合为一个集成的“ECMO系统”。这些是为年龄较大的儿童和成年人设计的，但需要对婴儿进行重大修改。该项目的目标是设计、测试和生产一种专门针对婴儿(1至10公斤，1天至2岁)的生命支持系统；我们称之为微型ECMO。L阶段的目标包括将MC3生物肺和MPump设备与盒式加热模块和自动扫气控制器集成在一起。该系统将被我们独特的无血栓形成的NO分泌聚合物覆盖，以减少或消除全身抗凝的需要。原型系统将在体外制造和测试，以证明安全性、有效性和耐用性。将进行一项体内试点研究，以测量GS交换的持久性、小肺的特性，并评估血栓形成能力。第二阶段将包括对MiniECMO的安全性和有效性的扩展测试，开发一种临床可用的设备，以及根据研究设备豁免(IDE)对10名患者进行的临床试验。密歇根大学体外生命支持实验室和密歇根重症护理咨询公司是这一领域的领导者，可以在四年内将这项技术变为现实。

DESCRIPTION (provided by applicant): For twenty years prolonged extracorporeal life support (ECLS ECMO) has been standard treatment for infants with severe heart or lung failure unresponsive to other treatment. The healthy survival rate in over 30,000 cases ranges from 40% in cardiac arrest to 95% in meconium aspiration. Improved treatment has resulted in decreased need for ECMO in full term neonatal respiratory failure, but the application to respiratory failure in older infants, cardiac failure, and sepsis is increasing. The devices used fr ECMO are individual components from several manufacturers, assembled on site, and used "off label." Recently three companies have combined the devices into an integrated "ECMO system." These are designed for older children and adults but require substantial modification for infants. The goal of this project is to design, test, and produce a life support system specifically for infants (1 through 10 kg, 1 day to 2 years age); we call this MiniECMO. Phase l aims include integration of the MC3 BioLung and MPump devices with cartridge heat modules and an automated sweep gas controller. The system will be coated with our unique nonthrombogenic NO secreting polymer to decrease or eliminate the need for systemic anticoagulation. The prototype system will be fabricated and tested in vitro to demonstrate safety, efficacy and durability. A pilot in vivo study will be conducted to measure durability of gs exchange, properties of the MiniLung, and to evaluate thrombogenicity. Phase ll will include extended testing of MiniECMO for safety and efficacy, development of a clinical ready device, and a clinical trial for ten patients conducted under an investigational device exemption (IDE). The University of Michigan Extracorporeal Life Support Lab and Michigan Critical Care Consultants are the leaders in this field and can bring this technology to reality in four years.