Microinfusion system for insulin administration and glucose control in neonates.

DESCRIPTION (provided by applicant): Sarcos Research Corporation proposes to develop, based on the company's existing and in-progress technologies, a micro-volume, digitally-controlled drug delivery system for administration of medications and fluids to neonate and pediatric patients. The micropump will deliver medications with sub-microliter resolution, over a wide range of delivery rates, enabling precise dose control without excess volume load. The system will be digitally-controlled using manual, programmable or closed-loop (sensor-based) interfaces. The device will be small size, watertight and disposable, facilitating nurses' effort and eliminating pump maintenance and recertification. Digital interface will enable pump tracking and treatment record retention. Next, the micropump will be integrated into a closed loop system for control of blood glucose levels by co-administration of insulin and glucose solutions while minimizing fluid load in neonate/prematurely-born patients in the NICU. Outside hospital, the proposed system will be applicable to a wide range of pediatric infusion therapies, particularly to insulin infusion therapy for treatment of diabetes. In Phase I, the microinfusion system development will be finalized; prototype tooling will be designed and fabricated, and prototype devices will be manufactured and tested. Subsequently, a preliminary animal study of co-administration of insulin and glucose will be completed. In Phase 2, Sarcos will complete final design of the system components, fabricate a pre-production series of devices, conduct verification and validation studies, complete regulatory submission to the FDA, and conduct a pilot clinical study.