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Abstract: FR-PO768

Protecting Patients from Venous Needle Dislodgement (VND): An Improved AV Fistula Set

Session Information

Category: Dialysis

  • 603 Hemodialysis: Vascular Access

Author

  • ROUSCHE, PATRICK, Hemotek Medical Inc., Rohnert Park, California, United States
Background

Venous needle dislodgement (VND) is a serious patient risk for any dialysis session at home or in the clinic. Inadvertent removal of the venous line during dialysis therapy is at very least inconvient, leading to spilled blood. At worst, even just one minute of unmitigated VND at 400 mL/min can lead to hemorrhagic shock; if the VND goes undetected for 5 minutes, patients can die from exsanguination. Clinics are faced with biohazard exposure, therapy disruption and patient injury/death. Hemodialysis machines are programmed to automatically detect pressure variations between fully inserted and dislodged needles during therapy, but often fail to accurately detect VND. We introduce here a patent-pending AV fistula modification which protects patients from the risks of VND.

Methods

The standard butterfly design of traditional AV fistulas was modified to incorporate a small 'sensing' feature on the underside of the needle used to determine if the inserted AV fistula remains in close contact with patient skin. When the system detects VND, flow through the needle is immediately restricted, resulting in quick and automatic shut-off of the machine pump. The needle is otherwise designed to look and feel the same as a traditional AV fistula needle.

Results

Essential to performance testing of the new AV fistula, is its ability to pass normal amounts of fluid flow in the 'ON SKIN' condition and its ability to restrict flow when in the 'OFF SKIN' position. We used a benchtop flow system to determine the forces associated with flow termination during simulated VND. Results suggest fluid flow disruption of up to 95% through the V-Needle during simulated 'dislodgement' is achievable with closing forces of ~15 grams, a force level that can easily be tolerated on the human skin over the typical dialysis therapy.

Conclusion

The V-Needle offers a simple and elegant solution to the problem of Venous Needle Dislodgement. Fluid flow termination in the event of dislodgement can be achieved with low forces, allowing a product solution which is easily implemented in the clinic or home.

Hemotek Medical's V-Needle protects patients from VND

Funding

  • NIDDK Support