DEVELOPMENT OF PEDIATRIC CATHETERS THAT REDUCE X-RAY USE

THE LONG TERM OBJECTIVE OF THIS PROJECT IS TO COMMERCIALIZE A TOTALLY NEW ENDOTRACHEAL TUBE THAT PROVIDES A NEW MEANS TO DETERMINE THE TUBE'S POSITION WITH A SPECIAL SENSING INSTRUMENT. THE TUBE AND SENSING INSTRUMENT CONCEPT HAVE BEEN DESIGNED FOR USE IN PEDIATRIC RESPIRATORY SUPPORT PROCEDURES. THE NEW DEVICE OFFERS THREE DISTINCT HEALTH CARE BENEFITS OVER EXISTING TECHNOLOGIES. THEY ARE: (1) REDUCTION IN X-RAY EXPOSURE IN PEDIATRIC PATIENTS, PARTICULARLY SIGNIFICANT IN THOSE PATIENTS WHO REQUIRE LONG TERM INTUBATION, (2) IMPROVEMENT OF OPERATING ROOM PEDIATRIC ANESTHESIOLOGY PROCEDURES BY PROVIDING NONINVASIVE, REAL TIME, DIRECT DETERMINATION OF ENDOTRACHEAL TUBE POSITION IN THE TRACHEA, AND (3) REDUCTION IN X-RAY RELATED COSTS OF PATIENTS REQUIRING LONG TERM RESPIRATORY SUPPORT PROCEDURES. THE NEW TUBE INCORPORATES IN ITS WALL AN ELECTROMAGNETIC FIELD INTERFERENCE ELEMENT, AND IT IS THIS ELEMENT WHICH IS DETECTED BY THE SENSING INSTRUMENT. THE TECHNICAL FEASIBILITY AND THE POTENTIAL CLINICAL UTILITY OF ENGINEERING PROTOTYPES OF THE PRODUCT CONCEPT HAVE ALREADY BEEN SUGGESTED BY A PRELIMINARY STUDY WHICH COMPARED THE TUBE POSITION AS DETERMINED BY THE INSTRUMENT WITH CONVENTIONAL X-RAY METHODOLOGY IN CADAVERS AT THE CHILDREN'S HOSPITAL MEDICAL CENTER (BOSTON, MA). THE PROPOSED GRANT WOULD PROVIDE FUNDS TO DEVELOP PRODUCTION PROTOTYPES OF THE COMPANY'S NEW PEDIATRIC ENDOTRACHEAL TUBES THAT WILL BE SUITABLE FOR CLINICAL EVALUATION. FOLLOWING COMPLETION OF THIS RESEARCH (PHASE I), A CLINICAL EVALUATION OF THE DEVELOPED PRODUCT WOULD BE INITIATED FOR PEDIATRIC PATIENTS.