SBIR Phase II: Development of a Distal Locking Hemodialysis Catheter System

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a new Distal Locking Hemodialysis Catheter System that will be the first to provide clinicians with a tool to manage the most significant complications (infection, thrombosis, and loss of lock solution) associated with chronic hemodialysis catheter use. More than 430,000 Americans currently receive hemodialysis treatments, and this prevalence is expected to grow 3-5% each year. A significant portion of the $29 billion spent annually treating ESRD patients in the U.S. is dedicated to managing complications with vascular access ? many of which are associated with catheters. It typically costs between $2,000 and $40,000 per patient to treat a blood-borne infection, which translates to more than $3 billion each year in the U.S. There is a need for this product to allow physicians to confidently use whatever lock therapy is clinically best on a per-patient basis. The catheter system will enable for the development and FDA approval of new, non-antibiotic antimicrobial agents, which have been unable to gain/maintain approval due to concerns of leakage. The device has the potential to be a market leader in the $3 billion U.S. market for vascular access devices and accessories. The proposed project shall improve and further evaluate a Distal Locking Hemodialysis Catheter System. Over 400,000 Americans undergo hemodialysis annually. Common complications are catheter-related bloodstream infection, thrombosis and thrombotic occlusions, each of which can be fatal. The primary solution to these complications is the use of heparin and antimicrobial lock solutions. However, existing catheters present the possibility of accidental infusion of these highly concentrated solutions into the circulation during the locking procedure or during the locked period between uses of the catheter. These leakages increase the risk of toxicity, and FDA-approved anticoagulants that leak into the systemic circulation can cause minor or major bleeding. The catheter system being developed in this project will significantly decrease complications tied to the loss of lock solutions, such as life-threatening infections, toxicity and bleeding events. The research shall include refinement of the catheter?s design (material selection and mechanical tests); ensuring that manufacture of catheters is consistent; and additional testing in vivo. The project is expected to demonstrate that the catheter system is compatible with lock solutions, shows adequate flow rate, has sufficient mechanical integrity, can be manufactured consistently, and is demonstrated to be biocompatible with an in vivo model.