Self-sealing needle guide system for reliable hemodialysis

PROJECT SUMMARY
More than 500,000 Americans are living with end-stage kidney disease, and most of them require life-
sustaining hemodialysis treatments three times a week. Despite major improvements over the past several
decades, the average life expectancy for dialysis patients is still only 5-10 years. Moreover, the financial burden
is significant: dialysis patients comprise about 1% of those on Medicare, yet their care accounts for over 7% of
the Medicare budget. There is a pressing need to improve both patient outcomes and the cost-effectiveness of
hemodialysis treatment; the single most important problem facing patients being treated with hemodialysis is
safe and reliable cannulation. To address these challenges, we developed an implantable device that aims to
improve vascular access. The device features a 3D-printed titanium shell that accurately guides the hemodialysis
needle to the correct insertion point, while a titanium-nitride coated valve stops bleeding immediately upon
needle removal. This new cutting-edge device minimizes the risks for infection, incorrect needle placement, and
excessive bleeding, making hemodialysis treatments safer, more efficient, and easier to administer. In this phase-
I SBIR proposal, we will use state-of-the-art materials and engineering techniques to refine the manufacturability
and operational parameters of our device. Then through a large animal preclinical study, we will evaluate device
functionality, tissue integration, inflammatory profile as well as infection and bleeding risks. Our results will pave
the way for a comprehensive large-scale GLP-certified animal study and a first-in-human trial. Our device has
the potential to be a disruptive technology in nephrology, improve the quality of life for dialysis patients, and
possibly facilitate wider adoption of home-based hemodialysis treatments.

Grant Number: 1R43DK141421-01
NIH Institute/Center: NIH
Principal Investigator: Jason Bobe