Importance

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Abstract

Devices and methods for cooling vessel walls to inhibit restenosis in conjunction with medical procedures such as coronary artery angioplasty. Stenosed vessel walls can be cooled prior to angioplasty, after angioplasty, or both. The invention is believed to inhibit restenosis through cooling to a temperature near freezing, preferably without causing substantial vessel wall cell death. One catheter device includes a distal tube region having coolant delivery holes radially and longitudinally distributed along the distal region. In some devices, holes spray coolant directly onto the vessel walls, with the coolant absorbed into the blood stream. In other embodiments, a balloon or envelope is interposed between the coolant and the vessel walls and the coolant returned out of the catheter through a coolant return lumen. Some direct spray devices include an occlusion device to restrict blood flow past the region being cooled. Pressure, temperature, and ultrasonic probes are included in some cooling catheters. Pressure control valves are included in some devices to regulate balloon interior pressure within acceptable limits. In applications using liquid carbon dioxide as coolant, the balloon interior pressure can be maintained above the triple point of carbon dioxide to inhibit dry ice formation. Some cooling catheters are coiled perfusion catheters supporting longer cooling periods by allowing perfusing blood flow simultaneously with vessel wall cooling. One coiled catheter is biased to assume a coiled shape when unconstrained and can be introduced into the body in a relatively straight shape, having a stiffening wire inserted through the coil strands.

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First Claim