SBIR Phase I: A Novel Valved Hemodialysis Catheter

Phase One Medical, Llc, Hingham MA

Investigators

Abstract

This Small Business Innovation Research Phase I project will develop a novel hemodialysis catheter with an integrated distal valve that can be opened and closed from the proximal hub. Chronic hemodialysis catheter use is associated with significant complications such as infection, thrombosis and loss of lock solution. This novel device will be the first to provide clinicians with a tool to manage these complications. The research objectives include refining the design of the distal valve; refining the design of the proximal hub; and an in vitro assessment of lock solution loss and catheter thrombosis. The project will create and evaluate at least three distal valve design concepts, with the most promising prototype being optimized for performance and manufacturability. Proximal hub designs will be similarly evaluated and optimized. The final distal valve and proximal hub designs also will be validated and verified to ensure they meet product performance requirements. A published in vitro model will be used to study the final device?s ability to prevent loss of lock solution and its tendency for catheter thrombosis. The novel device is expected to have improved outcomes compared to standard catheters. The broader impact/commercial potential of this project is a disruptive, novel hemodialysis catheter for the vascular access device market, which was valued at over $3 billion in the U.S. in 2009 and is estimated to reach more than $4.6 billion by 2016. Furthermore, the new catheter could provide the healthcare system incredible savings because a significant portion of the $29 billion spent annually treating end-stage renal disease (ESRD) patients is dedicated to managing complications with vascular access ? many of which are associated with catheters, such as serious infections, thrombosis and loss of stock solution. If successful, the proposed project should reduce catheter complications, leading to improved clinical outcomes, higher levels of patient satisfaction and lower overall healthcare costs.