DESIGN FOR TELEMETRIC ICP MONITORING

THE NEED TO MONITOR INTRACRANIAL PRESSURE (ICP) FOR INTENSIVE CARE SITUATIONS INVOLVING HEAD INJURY, POSTCRANIOTOMY HEMORRHAGE, OR CERTAIN BRAIN DISORDERS HAS BEEN WELL ESTABLISHED. FOR EXAMPLE, ESTIMATES OF HEAD INJURIES IN THE UNITED STATES THAT ARE CONSIDERED MODERATE OR SEVERE AND WHERE ELEVATED ICP MAY OCCUR VARY FROM 150,000TO 375,000 ANNUALLY. DESPITE THE APPARENT NEED TO MONITOR ICP, NO MONITORING SYSTEM HAS BEEN ADOPTED FOR UNIVERSAL USE, PRIMARILY DUE TO CONCERNS ABOUT INFECTION AND RELIABILITY. LIFESENSORS, INC., SEEKS TO TEST ITS NEW DESIGN CONCEPT FOR A TOTALLY IMPLANTABLE ICP MONITORING SENSOR THAT HAS A MINIMAL RISK OF INFECTION OVER EXTENDED PERIODS. THE DESIGNREPRESENTS A MAJOR ADVANCE OF A TELEMETRIC TECHNOLOGY DEVELOPED OVER 10 YEARS AGO AT THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE. IN PHASE I, THE COMPANY PLANS TO COMPLETE WORKING DRAWINGS FOR, AND TO FABRICATE AND TEST PROTOTYPE IMPLANTS IN, A SIMULATED PHYSIOLOGICAL ENVIRONMENT OF 0.9 PERCENT SALINE AT BODY TEMPERATURE TO DEMONSTRATE A MAJOR REDUCTION IN BASELINE DRIFT, AND TO ELIMINATE CASE INTEGRITY PROBLEMS ASSOCIATED WITH THE ORIGINAL DESIGN. THE DESIGN OBJECTIVES INCLUDE A BASELINE DRIFT OF LESS THAN 0.2 MMH2O (0.015 MMHG) PER DAY AND A PRESSURE RANGE OF +100 MMHG.