SBIR Phase I: Integrated Manufacturing of Artificial Valves for Medical Use

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to improve clinical outcomes for patients needing valves for vascular (veins) or urinary systems. It is difficult to make artificial versions of the fluid control elements, such as valves, that are biocompatible and withstand the physical forces associated with their function, as well as the changing environment associated with aging. The proposed project advances a system to make artificial sutureless devices. The proposed project will optimize the materials and variables of manufacturing a polymer valve integrated with durable polymer encapsulation of a structural Nitinol frame. This Nitinol-polymer structure must withstand long-term challenging in vivo conditions while maintaining a physical interface that does not experience premature delamination and loss of device functionality. Polyurethane materials have excellent mechanical properties for rigorous applications and history of use in implants. This project explores the phase space of relevant parameters for manufacturing and deployment of these valves at scale. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.