SBIR-STTR Award

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

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.