SBIR-STTR Award

Early and effective hemodialysis can decrease mortality of trauma patients with acute renal failure, but current technology is not easily deployed in the field or during transit of patients. The "Redy" machine using the Sorb column was portable and utilized only 6 liters of water but did not make dialysis more automated or intrinsically safer. The SHD now being developed by Ash Medical utilizes the Sorb column and includes pressure-actuated blood pumping, single- or dual-lumen operation, an automatic sorbent saturation monitor and completely automated fluid management to make dialysis simpler and safer. In this project we will modify the SHD to meet requirements of a field-deployable and portable dialysis machine (the WDS) by including: one liter of tap water as dialysate, volumetric ultrafiltration insensitive to machine motion, visual/automatic saturation monitor, and variable bicarbonate buffering. In Phase I we will construct a prototype WDS and demonstrate that hydraulic and chemical function are suitable for rapid treatment of acute renal failure patients. In Phase II we will finalize the design of a sturdy, lightweight and small WDS machine and demonstrate that the system can also be utilized for CRRT. The WDS could be life-saving in treatment of trauma causalities with renal failure. Potential commercial application include military and natural disaster trauma victims. WDS (Waterless Dialysis System) concepts may improve the current SHD (Sorbent Hemodialysis) System for home and acute hemodialysis.

Early and effective hemodialysis can decrease mortality of trauma patients with acute renal failure. Unfortunately, current technology is not easily deployed in the field or during transport of patients. The Sorbent Hemodialysis (SHD) System now being developed using technology from Ash Medical utilizes the SORB cartridge to produce and regenerate a small dialysate volume (6 liters). The SHD improvements over current technology that make it intrinsically safer and simpler are pressure-actuated blood pumping, single- or dual-needle access, sorbent saturation monitor, and automated fluid management. The WDS makes further improvements by reducing total dialysate volume to about 2 liters, improving volumetric UF control, and adding variable bicarbonate buffering. Ordinary potable water may be used for dialysate; it will be purified by the system before use. The equipment will be made more rugged and hazard resistant for military field applications. The user interface will be customized to the requirements of military healthcare personnel. In Phase 2, we will develop the concepts whose feasibility was demonstrated in Phase 1, to produce a prototype system that will be suitable for testing in a FDA-approved Investigational Device Exemption (IDE) clinical trial. Potential commercial applications include trauma victims in military and natural disaster situations. Waterless Dialysis System (WDS) innovations could improve SHD performance in home and acute dialysis. Incorporation of WDS features in SHD systems may make the SHD useful during patient transport.

Keywords:
hemodialysis, nighttime hemodialysis, sorbent dialysis, daily dialysis, continuous renal replacement therapy, crrt, sled