Apparatus and method for esophageal cooling

Abstract

A balloon catheter is used in a closed-loop heat exchange system for manipulating the temperature of a patient. The balloon catheter is positioned in the stomach of the patient, and then expanded with a heat exchange fluid delivered through a lumen formed in the shaft of the catheter. The balloon catheter comes into contact with the wall of the stomach, and the stomach substantially conforms around the expanded balloon catheter. The heat exchange fluid is allowed to flow continuously into and out of the balloon catheter. Heat is exchanged between the balloon catheter and the stomach so as to controllably alter the temperature of at least a portion of the patient. Anti-shivering mechanisms and automatic control based on temperature feedback from the patient may be used in connection with the heat exchange system.

1 . (canceled) 
     
     
         2 . An esophageal heat exchange device comprising:
 a heat transfer shaft insertable into an esophagus of a patient,   the heat transfer shaft having a first fluid lumen having a proximal end and a distal end and a second fluid lumen having a proximal end and a distal end,   the distal end of the first fluid lumen in fluid communication with the distal end of the second fluid lumen such that heat exchange medium introduced into the proximal end of the first fluid lumen flows from the first fluid lumen to the second fluid lumen,   the first and second fluid lumens of the heat transfer shaft having a side by side configuration; and   an output port for removing the heat exchange medium from the proximal end of the second fluid lumen.   
     
     
         3 . The esophageal heat exchange device of  claim 1 , further comprising a pump in fluid communication with the first and second_fluid lumens, the pump configured to pump heat exchange medium into the proximal end of the first fluid lumen and out of the proximal end of the second fluid lumen. 
     
     
         4 . The esophageal heat exchange device of  claim 3 , further comprising a master control unit housing a heater or cooler for adding or removing heat to/from the heat transfer shaft; and
 wherein heat is exchanged between the esophagus and the heat exchange medium circulating in the heat transfer shaft so as to controllably alter the temperature of at least a portion of the patient.   
     
     
         5 . The esophageal heat exchange device of  claim 1 , further comprising a temperature sensor in communication with the master control unit. 
     
     
         6 . The esophageal heat exchange device of  claim 5 , wherein the master control controls the temperature of the heat exchange fluid flowing to the first fluid lumen based on signals received from the temperature sensor. 
     
     
         7 . The esophageal heat exchange device of  claim 1 , wherein the heat exchange shaft is formed of a flexible material 
     
     
         8 . The esophageal heat exchange device of  claim 1 , wherein the heat exchange shaft is formed of a radiopaque material. 
     
     
         9 . The esophageal heat exchange device of  claim 1 , wherein the heat exchange shaft is formed from a material visible to ultrasound. 
     
     
         10 . A heat exchange apparatus for removing heat from, or adding heat to, an esophagus of a patient, comprising:
 a heat transfer shaft insertable into an esophagus of a patient, the heat transfer shaft including   a first fluid lumen having a proximal end and a distal end and   a second fluid lumen having a proximal end and a distal end,   the distal end of the first fluid lumen being in fluid communication with the distal end of the second fluid lumen such that a heat exchange fluid introduced into the proximal end of the first fluid lumen flows from the distal end of the first fluid lumen into the distal end of the second fluid lumen,   the first fluid lumen and the second fluid lumen of the heat transfer shaft having a side by side configuration;   a pump in fluid communication with the first fluid lumen and the second fluid lumen, the pump configured to pump heat exchange fluid through the first fluid lumen and the second fluid lumen;   a master control unit housing a heater or cooler unit; and   wherein heat is exchanged between the esophagus and the heat exchange fluid circulating within the heat transfer shaft so as to controllably alter the temperature of at least a portion of the patient.   
     
     
         11 . The apparatus according to  claim 10 , further comprising a temperature sensor in communication with the master control unit. 
     
     
         12 . The apparatus according to  claim 11 , wherein the master control controls the temperature of the heat exchange fluid flowing to the first fluid lumen in response to signals received from the temperature sensor. 
     
     
         13 . The apparatus according to  claim 10 , wherein the heat transfer shaft is formed of a radiopaque material. 
     
     
         14 . The apparatus according to  claim 10 , wherein the heat transfer shaft is formed from a material visible to ultrasound. 
     
     
         15 . The apparatus according to  claim 10 , wherein the heat transfer shaft is formed of a flexible material. 
     
     
         16 . A method for cooling or heating at least a portion of a patient using heat exchange therapy, comprising:
 introducing a heat transfer shaft into an esophagus of a patient, the heat transfer shaft having a first fluid lumen having a proximal end and a distal end and a second fluid lumen having a proximal end and a distal end, the first fluid lumen and the second fluid lumen of the heat transfer shaft having a side by side configuration, the distal ends of the first and second fluid lumens being in fluid communication; and   circulating a heat exchange fluid into the first fluid lumen and through the second fluid lumen to add or to remove heat from the esophagus of the patient.   
     
     
         17 . The method of  claim 16 , wherein circulating the heat exchange fluid includes pumping the heat exchange fluid through the first fluid lumen and the second fluid lumen. 
     
     
         18 . The method of  claim 16 , further comprising sensing a temperature of the heat exchange medium. 
     
     
         19 . The method of  claim 18 , further comprising controlling the temperature of the heat exchange fluid by adding or removing heat from the heat exchange fluid. 
     
     
         20 . The method according to  claim 16 , wherein the heat transfer shaft is formed of a radiopaque material. 
     
     
         21 . The method according to  claim 16 , wherein the heat transfer shaft is formed from a material visible to ultrasound. 
     
     
         22 . The method according to  claim 16 , wherein the heat transfer shaft is formed of a flexible material. 
     
     
         23 . The esophagus heat exchange device of  claim 2 , wherein the heat transfer shaft has a distal end configured to be positioned in a stomach of the patient during heat exchange therapy. 
     
     
         24 . The heat exchange apparatus of  claim 10 , wherein the heat transfer shaft has a distal end configured to be positioned in the stomach of the patient during heat exchange therapy. 
     
     
         25 . The method of  claim 16 , wherein the heat transfer shaft has a distal end, and wherein introducing the heat transfer shaft includes positioning the distal end of the heat transfer shaft into a stomach of the patient during heat exchange therapy.