On average, more than 1,800,000 sessions of hemodialysis are performed each week in the U.S. by more than 600,000 end stage renal disease (ESRD) patients. A grave danger to any of these patients is Venous Needle Dislodgement (VND), a catastrophic and potentially deadly unintended removal of the needle pumping blood back into the body. Incident rate estimates vary widely, but in any given week, possibly more than 200 hemodialysis patients will suffer an incidence of VND. VND is a constant and ever-present danger that looms over each and every one of the ~100,000,000 hemodialysis sessions performed each year in the US alone. The entire industry is in dire need of an inexpensive, practical and widely applicable solution that can easily insure patient safety during hemodialysis. To fill this need, Hemotek has invented the V-Needle, a disposable failsafe dialysis safety product that will protect hemodialysis patients from deadly bleed-out during incidences of VND. The V-Needle will be a low-cost, easy-to-manufacture, and simple-to-operate system that will protect patients from the devastating effects of VND. It will be offered a a stand-in replacement to existing hemodialysis needles. The V-Needle will detect and restrict errant blood flow during VND using cleverly designed failsafe mechanical technology. Feasibility assessment of this Phase I SBIR study requires the following three specific aims: Specific-aim #1, Flow Restriction Design: In this aim we design and demonstrate an optimized internal needle flow restriction mechanism that will consistently generate tubing back pressures high enough to trigger hemodialysis machine shut-off during VND.
Specific Aim #2, VND detection Design: Here we develop a spring-loaded needle-based skin sensing technology that can be used to both identify the likely occurrence of VND and initiate the corrective flow restriction mechanism of Aim #1.
Specific Aim #3 : Working prototype Manufacture: Finally, we integrate both skin-sensing and flow restriction technologies into a working V-Needle prototype and validate performance on a mock circulatory set-up using porcine skin. The patent-pending V-Needle has the potential to save lives, improve patient care and provide priceless peace of mind for hemodialysis patients and care providers. Phase I will result in a bench-tested prototype design showing product feasibility. In Phase II, Hemotek will optimize the prototype into a robust, high-volume manufactured, commercially viable product. Phase II R&D efforts will center on product verification and validation, including biocompatibility testing, functionality testing, nd simulated use testing. In addition a robust Medical Device Design History file will be developed to enable an efficient FDA review. At the end of Phase II Hemotek will have a full working and validated version of the V-Needle ready for 510(k) submission to the FDA and subsequent mass manufacture.
In the US, there are more than 1.8 million sessions of hemodialysis every week. A grave danger faced by every dialysis patient is venous needle dislodgement (VND), the inadvertent disconnection of the line pumping blood back into the body after filtration. In this Phase I SBIR application, Hemotek proposes the design and development of a novel hemodialysis needle, the V-Needle. The V-Needle will automatically detect VND and work to immediately shut off the blood flow, saving lives and increasing dialysis safety.