EVALUATION OF PHYSIOLOGICAL EFFECTS OF AN ARTIFICIAL SPHINCTER

THE UBTL DIVISION OF TECHNOLOGY RESEARCH ASSOCIATES, INC. PROPOSES TO CONDUCT A PRELIMINARY EVALUATION OBSERVING THE EFFECTS RESULTING FROM THE APPLICATION OF A CONSTRICTION DEVICE OF NEW AND NOVEL DESIGN ON THE COLON OF ANIMALS. THEDEVICE IS INTENDED TO PROVIDE AN ALTERNATIVE TO THE KOCH POUCH AS AN INDWELLING CONTAINER AND THE ONLY AVAILABLE ALTERNATIVE TO THE SIMPLE EXTERNAL STOMA WHICH REQUIRES A BAG ATTACHED TO THE SKIN. WITH THE PROPOSED DEVICE, THE PATIENT WOULD BE ABLE TO OPEN OR CLOSE THE COLON ON DEMAND, ALLEVIATING MUCH OF THE PHYSICAL AND PSYCHOLOGICAL PROBLEM THAT NOW EXISTS. THE EXPERIMENTS PROPOSED WILL SERVE TO DEMONSTRATE THE FEASIBILITY OF LONG-TERM (TO 6 MONTHS) CONSTRICTION CYCLES ON THE COLON AND THE OPTIMUM DESIGN OF THE CONSTRICTING MECHANISM. IMPORTANT MEASUREMENTS OF COLONPRESSURE, SAFE COLON CONSTRICTION FORCES AND OBSERVATION OF VENOUS FLOW IN THE MESENTERY WILL BE COLLECTED. AT THE END OF THE PROJECT, THE DATA WILL BE USED TO FORMULATE A COMPREHENSIVE ANIMAL AND CLINICAL TEST PROGRAM TO MEET THE REQUIREMENTS OF THE FOOD AND DRUG ADMINISTRATION LEADING TO CLINICAL TRIALS OF AN ARTIFICIAL SPHINCTER.