SBIR Phase II: Development of a novel graft to provide safe and reliable vascular access for hemodialysis patients

The broader/commercial impact of this Phase II Small Business Innovation Research (SBIR) project will advance the development of a device to eliminate complications associated with maintenance hemodialysis, a life-sustaining therapy for patients suffering from renal failure. Hemodialysis (HD) enables blood to be withdrawn and cycled through a dialysis machine that performs the function of the failed kidneys. This process must be repeated at regular intervals and thus requires repeated, high flow access to circulating blood. Adverse events due to mode of access and device failure are frequent, costing the healthcare system billions of dollars per year and leading to significant morbidity and mortality for patients. Currently, no technology on the market addresses dialysis graft needle injury or graft material degradation due to needle trauma. The proposed device will minimize injury levels and decrease the probability of serious complications for chronic HD patients. The proposed Phase II SBIR project will advance a technology for prosthetic arteriovenous grafts (AVGs) for hemodialysis. The general principle is to engineer a graft with a backplate material optimized for rigidity to prevent needle injury, while maintaining sufficient flexibility to maximize optimal flow. The technical objectives include: 1) systems engineering to optimize the cost and performance trade space; 2) advanced biocompatibility testing; 3) design verification and validation testing. 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.