IP Requirement: Medical University of South Carolina IP

Experience Requirement:

– Mechanical Design

– Rapid Prototyping

Nearly a million people in the US suffer from end stage renal disease, the permanent loss of kidney function, and require dialysis at least three times a week to survive. Hemodialysis is the most common method of dialysis and requires cannulation of an arteriovenous fistula (AVF) or arteriovenous graft (AVG) in the arm with a 15-gauge needle to filter out a patient’s entire blood volume. The process has had little innovation over the years:

1. Nurses/technicians (some trained for only a 1-2 months) feel for a “thrill” or utilize a stethoscope to identify the best area on arm to cannulate
2. A dialysis needle that is 3x bigger than that used for a flu shot is inserted into AVF/AVG
3. Patients lay with a sharp needle in their arm in place for hours during dialysis
4. Needle removed on completion, patient applies manual pressure over wound (1 to 15 mins)

The problems are numerous. While the body attempts to plug the needle hole through platelet/thrombus formation and tissue scar formation during manual pressure application, the graft itself is inevitably irreversibly damaged after repetitive and/or inaccurate cannulations. Subsequently, patients develop AVFs/AVGs with large holes causing hematomas and pseudoaneurysms (Fig. 1A/B), in which urgent surgical care is warranted, such as a fistulogram or open revision/ligation. Thus, we believe there is a need to 1) reduce the destructiveness of dialysis needles and existing canulation methods, and 2) reliably repair graft damage following cannulation.