Cryotreatment device and method

Abstract

Devices and methods for cooling vessel walls to inhibit restenosis in conjunction with medical procedures such as coronary artery angioplasty. 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. 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. Some cooling catheters are coiled perfusion catheters supporting longer cooling periods by allowing perfusing blood flow simultaneously with vessel wall cooling.

What is claimed is: 
     
         1 . A catheter for creating a plurality of cold zones within a vessel, comprising:
 a tubular shaft having a distal region;   a plurality of coolant distribution tubes disposed within the tubular shaft and extending distally therefrom, the coolant distribution tubes each having a lumen and a distal delivery port in fluid communication with the lumen, wherein the coolant distribution tubes are rotatable within the tubular shaft to point the ports toward a target area within a vessel to create a plurality of cold zones within the vessel; and   an inflatable balloon disposed near the distal region having an interior in fluid communication with the delivery ports.   
     
     
         2 . The catheter of  claim 1 , wherein the delivery ports are laterally facing, and a length of each tube extending distally from the tubular shaft is different from the other tubes, creating a pattern of cold zones disposed longitudinally along an inner wall of the inflatable balloon. 
     
     
         3 . The catheter of  claim 1 , wherein the balloon includes an exhaust port for exhausting fluid. 
     
     
         4 . The catheter of  claim 3 , wherein the exhaust port is at a distal end of the tubular shaft. 
     
     
         5 . The catheter of  claim 1 , further comprising an instrument probe having a pressure sensor and an ultrasonic device disposed within the interior of the balloon. 
     
     
         6 . The catheter of  claim 1 , wherein the plurality of coolant distribution tubes are rotated such that each port is facing in a different direction. 
     
     
         7 . The catheter of  claim 1 , wherein the plurality of coolant distribution tubes are disposed such that all of the ports are facing in the same direction. 
     
     
         8 . A catheter for creating a plurality of cold zones within a vessel, comprising:
 a tubular shaft having a distal region;   an inflatable balloon disposed near the distal region of the tubular shaft;   a plurality of individually rotatable tubes disposed axially with the tubular shaft, the plurality of tubes extending different distances into the balloon, the plurality of tubes each having a lumen extending therethrough and a distal delivery port in fluid communication with the lumen, wherein the plurality of tubes are individually rotatable relative to the tubular shaft to rotate the delivery ports and direct cooling fluid through the lumen to various target areas within a vessel to create the plurality of cold zones within the vessel, wherein the delivery ports are in fluid communication with an interior of the balloon.   
     
     
         9 . The catheter of  claim 8 , wherein the balloon includes an exhaust port for exhausting fluid. 
     
     
         10 . The catheter of  claim 9 , wherein the exhaust port is at a distal end of the tubular shaft. 
     
     
         11 . The catheter of  claim 8 , further comprising a pressure sensor disposed within the interior of the balloon. 
     
     
         12 . The catheter of  claim 8 , wherein the delivery ports are all laterally facing. 
     
     
         13 . A catheter for creating a plurality of cold zones within a vessel, comprising:
 a tubular shaft having a distal region;   an inflatable balloon disposed near the distal region of the tubular shaft;   a plurality of movable tubes disposed axially with the tubular shaft, the tubes extending into the balloon, the tubes each having a lumen extending therethrough in fluid communication with a distal delivery port on a distal tip of the tube, wherein the tubes are rotatable within the balloon to move the delivery ports and direct cooling fluid through the lumens to various target areas within a vessel to create the plurality of cold zones, wherein the delivery ports are laterally facing and in fluid communication with an interior of the balloon.   
     
     
         14 . The catheter of  claim 13 , further comprising a pressure sensor disposed within the interior of the balloon. 
     
     
         15 . The catheter of  claim 14 , further comprising an ultrasonic device disposed within the interior of the balloon. 
     
     
         16 . The catheter of  claim 15 , wherein the pressure sensor and ultrasonic device are disposed on an instrument probe. 
     
     
         17 . The catheter of  claim 16 , wherein the instrument probe and the tubes are independently moveable. 
     
     
         18 . The catheter of  claim 13 , further comprising a temperature sensor disposed within the interior of the balloon. 
     
     
         19 . The catheter of  claim 13 , wherein the tubes extend to different locations within the inflatable balloon. 
     
     
         20 . The catheter of  claim 13 , wherein the delivery ports are each facing a different direction.