Access related complications have always been a major concern for patients undergoinghemodialysis therapy. To put this problem into perspective, consider the following. Hospitalization of hemodialysis patients in the U.S. due to various complications of vascular access costs approximately $300 million per year (Journal of the American Society of Nephrology). Vascular access thrombosis accounts for nearly 85% of all of these hospitalized dialysis patients.

Vascular access thrombosis is the formation of a clot that either blocks or partially blocks the interior of a blood vessel, interrupting blood flow. Changes to the intima (interior lining) of a dialysis patient's access site due to repeated trauma may lead to eventual narrowing (stenosis) of the flow tract. This condition will eventually favor clot formation, and cause the loss of blood flow through the vascular access site. Thrombosis and the surgical intervention required to treat thrombosis occurs AT LEAST ONCE EVERY FIVE YEARS to approximately 33% of all hemodialysis patients in the U.S. with a vascular dialysis access (Journal of the American Society of Nephrology).

Inflammation and trauma caused by repeated damage to the interior lining (intima) of a dialysis access site by the use of sharpened steel access needles probably contributes significantly to vessel wall thickening, and almost certainly predisposes the patient to stenosis of the access site. Stenosis of the NEEDLING SECTION of a hemodialysis access site (between several frequently used points of access) is a common occurrence discovered by surgeons who repair such sites. There is good reason to believe that the use of sharpened metal needles for maintaining vascular access plays a primary role. These dialysis needles scrape up against the interior walls of the blood vessel, causing the access site harm.

The potential value of a device that allows for the efficient exchange of a sharpened steel needle used to puncture the skin for a blunt and flexible Teflon sleeve under the high flow, high pressure conditions associated with hemodialysis therapy is clear. The practice of using a pair of sharpened metal needles for as long as five hours at a time to maintain vascular access during hemodialysis therapy is likely to be slated for rapid extinction. The use of a soft and flexible Teflon sleeve during the course of hemodialysis therapy will probably become a normal standard of practice.

Use of this new device should lead to a significant reduction in the incidence of stenosis and thrombus formation within the needling section of a dialysis patient's access site. This in turn should make a great number of physicians very happy. In the minds of most hemodialysis patients, the event probably cannot happen quickly enough. The current design of AV fistula needles are extremely uncomfortable. The sharpened steel access needles are just another painful obstacle for them on thelong and difficult journey of living with the need for kidney dialysis therapy.