MINIATURIZED HEMO-AND PERITONEAL DIALYSIS MACHINE

THE OBJECTIVE OF THIS RESEARCH PROJECT IS TO PRODUCE A PORTABLE, MINIATURIZED DIALYSIS MACHINE WHICH IS SIMPLE, SAFE, AND SYMPTOM-FREE IN OPERATION. THIS DIALYSIS MACHINE SHOULD ALLOW THE AVERAGE HEMO-OR PERITONEAL DIALYSIS PATIENT TO PERFORM DIALYSIS BY HIMSELF AT HOME, UNASSISTED. THE MACHINE WILL BE SMALL (12 LBS.), PORTABLE, AND TOTALLY SELF-CONTAINED (WITHOUT NEED FOR CONNECTION TO WATER SUPPLY OR TO ELECTRIC CURRENT SUPPLY). TO ACHIEVE THIS GOAL, ASH MEDICAL SYSTEMS, INC., WILL COMBINE 5 TECHNOLOGIES WHICH HAVE BEEN DEVELOPED AT PURDUE UNIVERSITY IN THE LAST 8 YEARS. 1) A ZEOLITE-BASED SORBENT SUSPENSION. 2) A NOVEL METHOD OF OPERATION OF PLATE DIALYZERS USING A SORBENT SUSPENSION IN DIALYSATE. 3) A COMPUTER CONTROL SYSTEM OPTIMIZING BLOOD FLOW. 4) A HIGHLY SENSITIVE DOPPLER ULTRASOUND PARTICLE MONITOR 5) CONTINUOUSLY OPERATING CHEMICAL SENSORS. THE FIRST PHASE OF THIS PROJECT IS TO COMBINE THESE INDIVIDUALLY PROVEN TECHNOLOGIES INTO A SINGLE, LOW COST, SIMPLISTIC DIALYSIS MACHINE AS DEPICTED IN FIGURE 1 (PAGE 9), OF THIS PROPOSAL. THIS DIALYZER WILL ALLOW SINGLE-BUTTON INITIATION OF PRIMING, DIALYSIS, AND RINSING (TO A PRESET HEMATOCRIT LEVEL IN THE EFFLUENT). AT THE END OF PHASE I, A CLINICAL PROTOTYPE WILL BE COMPLETED, AND DATA ON ITS EFFICACY AND SAFETY WILL BE AVAILABLE TO PURSUE FDA APPROVAL UNDER PHASE II OF THE SBIR GRANTING SYSTEM.