The U.S. Army is requesting proposals for a "Waterless Dialysis System".
The document requesting proposals for this project is DoD 2001.2 SBIR Solicitation. Here is the home page for the Department of Defense Small Business Innovation Research Program (SBIR) and Small Business Technology Transfer Progam (SBTT).
OBJECTIVE: To develop a portable and self-contained waterless system for hemodialysis or continuous renal replacement therapy (CRRT) in the field hospital or for casualties in transit.
DESCRIPTION: Acute renal failure remains a significant predictor of mortality in trauma casualties, and treatment with hemodialysis is considerably resource- and time-intensive. Current systems also are not condusive to providing treatment in transit. With conventional �single-pass� hemodialysis technology, used dialysate is discarded--requiring 120-190 liters of purified water per treatment (which in turn is generated from 1000-1500 liters of source water). Alternatively, the used dialysate can be regenerated by passing it through a sorbent cartridge, reducing the water requirements to 6 liters per treatment. While this is an improvement, further reduction or elimination of the water requirement would have significant impact both on the resource demands and the potential for portability.
While any creative or innovative solution which meets the objectives is acceptable, it is expected that successful submissions will be adaptations of either or both of two current technologies: (a) sorbent cartridge dialysis (Refs. 1 and 3) and (b) bioartificial hemoperfusion devices (Refs. 2 and 4)
The proposed system should have a zero or near-zero (< 1 liter/treatment) dialysate water requirement while providing adequate metabolic control for critically-ill casualties with acute renal failure. It should be sturdy, lightweight, and carry a small enough footprint that it can be used for treatment of casualties in transit. It should have volumetric ultrafiltration control in order that fluid removal from the patient can be carefully regulated. It should be capable of both hemodialysis [blood flow rates=250-350 ml/min for hemodynamically stable patients) and CRRT [blood flow rates=100-200 ml/min for hemodynamically unstable patients). It should have a simple [preferably visual) means of indicating when the dialysis cartridge or regenerator needs to be replaced.
PHASE I: Development of system concept and validation using suitable patient surrogates (batched blood and animal studies). The system should meet the above criterion for dialysate conservation (< 1 liter/treatment in a equivalent human patient). The system should demonstrate capability of adequate metabolic control with the following targets: normalized [dimensionless) urea clearance > 1.0, serum potassium < 5.5 mEq/L, serum bicarbonate > 20 mEq/L. The safety of the regenerated dialysate must be demonstrated by content analysis, using national standards for dialysis water dervied by the Association for the Advancement of Medical Instrumentation.
PHASE II: Development of prototype unit to include volumetric flow regulation and CRRT mode. Volume removal should be achievable in a range of at least 0-1000 ml/hr, with < 10% deviation from desired to actual rate. Blood flow rates for hemodialysis mode [250-350 ml/min) and CRRT mode [100-200 ml/min) should likewise show < 10% deviation from desired to actual rate. Other pertinent design characteristics are durability and portability. At the conclusion of this phase, there should be completion of necessary work for submission of prototype for FDA approval.
PHASE III: Clinical testing of unit in chronic and acute hemodialysis patients. A waterless dialysis system will have commercial applications in humanitarian and disaster relief endeavors, developing nations, and home dialysis.
REFERENCES:
1) Cobe Renal Care, Inc. Sorbent Dialysis Primer, 4th ed. Lakewood, CO: Cobe Renal Care, 1993.
2) Humes, HD. Bioartificial kidney for full renal replacement therapy. Semin Nephrol 2000 20:71-82, 2000.
3) Shapiro, WB. The current state of sorbent hemodialysis. Semin. Dial. 3:40-45, 1990.
4) Stockmann, HB, CA Hiemstra, RL Marquet, and JN Ijzermans. Extracorporeal perfusion for the treatment of acute liver failure. Ann Surg. 231:460-70, 2000.
KEYWORDS: hemodialysis, continuous renal replacement therapy, water conservation
TPOC: James D. Oliver, MAJ, MC Phone: (301) 319-9445 Fax: (301) 319-9616 Email: james.oliver@na.amedd.army.mil 2nd TPOC: James L. Atkins, COL, MC Phone: (301) 319-9216 Fax: (301) 319-9616 Email: james.atkins@na.amedd.army.mil
[This message has been edited by Gary Peterson (edited 09-28-2001).]
The first time I did dialysis it was in a rural hosp. associated with several isolated military bases. It was REDY machine that we were told was left from Vietman. Supposedly would fx with "swamp water" if necessary. The medic that taught us nurses had used it in the field during the conflict. Is this machine still fx??
