THIS PHASE I APPLICATION REQUESTS SUPPORT TO DEVELOP A UNIQUE, PATENTABLE, MEDICAL DEVICE FOR USE IN CHEST PHYSIO- THERAPY.

THIS PHASE I APPLICATION REQUESTS SUPPORT TO DEVELOP A UNIQUE, PATENTABLE, MEDICAL DEVICE FOR USE IN CHEST PHYSIO- THERAPY. THE DEVICE STIMULATES MUCOUS TRANSPORT RATES AND MUCOCILIARY CLEARANCE. THE SPECIFIC AIM OF THIS PROJECT IS TO DESIGN, CONSTRUCT, AND CONDUCT ANIMAL TESTING OF THE DEVICE. TESTING WILL BE DONE IN SHEEP; MEASUREMENTS OF MUCOUS TRANSPORT RATES, LUNG CLEARANCE, RECOVERY OF MUCOUS, AND RESPIRATORY FUNCTION WILL BE TAKEN. THE OBJECTIVES OF THESE EXPERIMENTS WILL BE: (1) TO DEVELOP SPECIFICATIONS FOR THE DEVICE; (2) DETERMINE WHICH PARAMETERS ARE IMPORTANTTO THE BIOLOGICAL RESPONSE; AND (3) TO PRODUCE THE MOST EFFICIENT AND PRACTICAL DEVICE/SUBJECT INTERPHASE. A PHASE II APPLICATION WILL FOLLOW THAT WILL PROVIDE FOR MANUFACTUREOF PROTOTYPES FOR CLINICAL TESTING. THE CLINICAL TRIALS WILL BE DESIGNED TO DUPLICATE IN HUMANS THE RESULTS OBTAINEDIN SHEEP. THE STUDY POPULATION WILL CONSIST OF PATIENTS WITH NORMAL MUCOUS PRODUCTION BUT IMPAIRED MUCOCILIARY CLEARANCE, E.G., POSTOPERATIVE PATIENTS AND PATIENTS WITH COPIOUS MUCOUS PRODUCTION DUE TO CHRONIC BRONCHITIS AND CYSTIC FIBROSIS. THIS DEVICE WILL HAVE WIDE CLINICAL APPLICATIONS IN ACUTE CARE, EXTENDED CARE, AND IN THE HOME. IT COULD FAVORABLY IMPACT ON HEALTH CARE COSTS BY DECREASINGTHE NEED FOR AND DURATION OF HOSPITALIZATION FOR ACUTE OR EXTENDED CARE.