SBIR Phase II: Catheters with Anticoagulation and Fibrinolytic Properties

This Small Business Innovation Research (SBIR) Phase II project will develop blood-compatible biomaterials for end-stage renal dialysis (ESRD) catheters through an integrated biological coating (IBC) that combines protein passivation, anticoagulation, and fibrinolytic mechanisms on the surface. Phase II work will build on the Phase I demonstration that internal and external surfaces of BaSO4-loaded polyurethane catheters were activated by an electron cyclotron resonance (ECR) process that promoted uniform deposition of an IBC coating. In the Phase II project, the coating process will be optimized and deposition equipment will be upgraded to enhance reliability and repeatability. Finished catheters will be produced and evaluated for blood compatibility through in vitro human blood testing and ex vivo sheep shunt model experiments. Finished IBC catheters will also undergo rigorous mechanical, biocompatibility, and toxicity testing to show compliance with FDA standards. The principal commercial application of this project will be on the catheter industry. The proposed technology will also find applications in coatings for other blood-contacting devices such as grafts, polymeric stents , valves and by-pass systems.