Mini ECMO Life Support System

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 llwill 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. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: The value of prolonged extracorporeal life support for infantsis well established. The success of this technology has been accomplished using a variety of devices that are designed for older children and adults, but are not well suited for infants. The goal of this research project is to design and produce a life support system specifically for infants, called MiniECMO, which will make the entire technology safer, simpler, and less expensive for current and future applications.