Cooperative Agreement 2151744

SBIR PHASE II: MULTIMODAL DIAGNOSTIC MICROSENSORS FOR MONITORING CATHETER-BASED THERAPIES -THE BROADER IMPACT/COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE II PROJECT WILL BE TO IMPROVE DETECTION AND ENABLE PREDICTION OF IMPLANTABLE DEVICE FAILURE. THE FIRST TARGET APPLICATION IS HYDROCEPHALUS, A LIFE-LONG, INCURABLE DISEASE CHARACTERIZED BY A BUILDUP OF CEREBROSPINAL FLUID (CSF) IN THE BRAIN?S VENTRICLES. HYDROCEPHALUS IS TREATABLE BY CHRONICALLY IMPLANTING A SHUNT TO DIVERT CSF FROM THE BRAIN INTO THE ABDOMINAL CAVITY. AROUND 90,000 SHUNTS ARE IMPLANTED IN THE US EACH YEAR. HOWEVER, THESE SHUNTS FAIL AT ALARMING RATES (40% WITHIN THE 1ST YEAR OF USE), LEADING FIRST TO NONSPECIFIC SYMPTOMS SUCH AS HEADACHES AND BLURRED VISION AND THEN TO PERMANENT BRAIN DAMAGE AND DEATH WITHOUT CLINICAL INTERVENTION. DIAGNOSING SHUNT FAILURE IS DIFFICULT AND INVOLVES A PROLONGED ASSESSMENT PERIOD WITH COSTLY IMAGING STUDIES AND INVASIVE SHUNT TAPS. THE PROPOSED SENSOR MODULE CAN BE INTEGRATED WITH ALREADY-COMMERCIALIZED SHUNT SYSTEMS AND MAY ALLOW REMOTE, ON-DEMAND MEASUREMENT OF SHUNT STATUS, THERAPEUTIC EFFICACY, AND PATIENT HEALTH, ULTIMATELY IMPROVING CLINICAL OUTCOMES WHILE REDUCING OVERALL TREATMENT COSTS. THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE II PROJECT WILL FOCUS ON THE INTEGRATION OF VARIOUS MICROSENSORS TO GENERATE A DIAGNOSTIC DATA SET FOR DATA ANALYTICS. THIS DATA SET WILL SIGNIFICANTLY ADVANCE THE SCIENTIFIC/MEDICAL UNDERSTANDING OF HYDROCEPHALUS, WHICH IS LIMITED TODAY BY THE PAUCITY OF DATA ON CSF DYNAMICS OVER TIME. THE SYSTEM WOULD INCLUDE SEVERAL FIRST-TO-MARKET CAPABILITIES, INCLUDING CHRONIC REPEATED MEASUREMENT OF CSF DYNAMICS AND AUTOMATED WIRELESS TRANSDUCTION FROM MULTIPLE SENSORS TO A CLOUD-BASED DATABASE FOR ANALYSES AND DISSEMINATION. THE SMART SHUNT SYSTEM WILL ENABLE REMOTE, ON-DEMAND MONITORING OF SHUNT STATUS, GIVING PHYSICIANS THE DATA NECESSARY FOR TIMELY DIAGNOSIS AND PREDICTION OF SHUNT FAILURE. AT-HOME ELECTRONIC SHUNT MONITORING WILL ALLOW PHYSICIANS TO QUANTITATIVELY AND PROACTIVELY MANAGE PATIENTS? DISEASE IN REAL-TIME, AND THEREBY IMPROVE THEIR QUALITY OF LIFE. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.