This proposal describes the development of a microangioplasty catheter for use in intracranial arterial disease. The intracranial arterial system requires a catheter with excellent trackability and steerability to maneuver the tortuous arteries atraumatically. The indications for the catheter will for the intracranial percutaneous angioplasty of arterial stenosis and vasospasm, stent deployment, artery remodelling and occlusion testing. The shaft of the catheter will use a novel design and manufacturing method different than conventional catheters. Conventional catheters are composed of multiple tubings joined end-to-end which are prone to kinking. The body of this new catheter will be a metal tube in which grooves and apertures are chemically etched into the tube. This new design will have different patterns throughout the catheter and is less prone to kinking and allow for varying zones of flexibility throughout the shaft. This microangioplasty catheter would have characteristics required by neuroradiologists for the treatment of intracranial disease. The currently commercially available catheters do not meet the needs of this growing medical field. Different prototypes of the microangioplasty catheter will be bench tested to determine the best-etched patterns, hydrophilic coating and balloon technology choice for intracranial use. Optimizing the etching process and developing the manufacturing process will be done so the microangioplasty catheter can be manufactured under United States Good Manufacturing Process (GMP) in a cost-effective manner. Commercialization will occur after 510(k) clearance from the Food and Drug Administration.
Inverventional neuroradiology is one of the most innovative and fastest growing segments of the medical device industry. Interventional neurological procedures offer enormous benefits to the patient in the form of reduced trauma, morbidity and hospital stay. Technological advances in access devices and imaging equipment are helping to expand potentially treatable disease. There currently is only microangioplasty balloon catheter approved for intracranial use that is deemed inadequate in most situations. This project would benefit a large number of patients that presently treated with substandard devices or left without any treatment.
