Apparatus and Method Of Gastric Cooling Using Balloon Catheter

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.

What is claimed: 
     
         1 . A method of manipulating the temperature of a patient comprising:
 positioning a catheter having a heat exchange balloon and a shaft in the a patient such that the heat exchange balloon is located within the stomach of a patent;   introducing a heat exchange fluid into the heat exchange balloon such that the heat exchange balloon expands to a size and shape that distends the stomach;   controlling the temperature of the heat exchange fluid;   allowing the heat exchange fluid to circulate within the heat exchange balloon, wherein heat is exchanged between the heat exchange balloon and the distended stomach so as to controllably alter the temperature of at least a portion of the patient.   
     
     
         2 . The method of  claim 1 , wherein the heat exchange fluid flows continuously in a closed-loop during the step of allowing the heat exchange fluid to circulate within the heat exchange balloon. 
     
     
         3 . The method of  claim 1 , further comprising maintaining the heat exchange fluid at a temperature different from normothermia. 
     
     
         4 . The method of  claim 1 , further comprising maintaining the heat exchange fluid at a temperature different from normothermia for a period of time sufficient to modify the core body temperature of the patient. 
     
     
         5 . The method of  claim 1 , wherein the heat exchange fluid is a liquid. 
     
     
         6 . The method of  claim 1 , wherein the heat exchange fluid is a gas. 
     
     
         7 . The method of  claim 1 , wherein the heat exchange balloon is elastic. 
     
     
         8 . The method of  claim 1 , wherein the heat exchange balloon is inelastic. 
     
     
         9 . The method of  claim 1 , further comprising:
 monitoring the patient with a temperature probe to obtain a monitored temperature;   automatically controlling the step of exchanging heat between the heat exchange balloon and the distended stomach based on the monitored temperature.   
     
     
         10 . The method of  claim 1 , further comprising:
 inserting a temperature probe into the vasculature of the patient;   monitoring the temperature sensed by said probe;   automatically controlling the step of exchanging heat between the heat exchange balloon and the distended stomach based on the monitored temperature sensed by the probe.   
     
     
         11 . The method of  claim 1 , further comprising: administering an anti-shivering mechanism to the patient during the step of exchanging heat between the heat exchange balloon and the stomach. 
     
     
         12 . The method of  claim 11 , wherein the step of administering the anti-shivering mechanism includes administering a therapeutically effective amount of an anti-shivering agent to the patient and applying warmth to the skin of the patient. 
     
     
         13 . The method of  claim 1 , wherein the shaft of the catheter is located in the esophagus of the patient, and the shaft is sized and shaped so as to not block saliva drainage in the esophagus while the heat exchange fluid is being circulated within the heat exchange balloon. 
     
     
         14 . A method of manipulating the temperature of a patient comprising:
 positioning a catheter having a heat exchange balloon and a shaft in a patient such that the heat exchange balloon is located in the stomach of the patient;   introducing a heat exchange fluid having a temperature into the heat exchange balloon; wherein the shaft of the catheter is located in the esophagus and is sized and shaped so as to not block saliva drainage in the esophagus while the heat exchange fluid is being circulated within the heat exchange balloon;   allowing the heat exchange fluid to circulate within the heat exchange balloon, wherein heat is exchanged between the heat exchange balloon and the stomach so as to controllably alter the temperature of at least a portion of the patient;   monitoring the temperature of the patient;   controlling the temperature of the heat exchange fluid based on the monitored temperature.   
     
     
         15 . The method of  claim 14 , wherein the heat exchange fluid flows continuously in a closed-loop during the step of allowing the heat exchange fluid to circulate within the heat exchange balloon. 
     
     
         16 . The method of  claim 14 , maintaining the heat exchange fluid at a temperature different from normothermia for a period of time sufficient to modify the core body temperature of the patient. 
     
     
         17 . The method of  claim 14 , wherein the heat exchange fluid is a liquid. 
     
     
         18 . The method of  claim 14 , wherein the heat exchange fluid is a gas. 
     
     
         19 . The method of  claim 14 , wherein the heat exchange balloon is elastic. 
     
     
         20 . The method of  claim 14 , wherein the heat exchange balloon is inelastic. 
     
     
         21 . The method of  claim 14 , wherein the step of monitoring the temperature of the patient further includes:
 inserting a temperature probe into the vasculature of the patient;   monitoring the temperature sensed by said probe;   automatically controlling the step of exchanging heat between the heat exchange balloon and the stomach based on the monitored temperature sensed by said probe.   
     
     
         22 . The method of  claim 14 , further comprising: administering an anti-shivering mechanism to the patient during the step of exchanging heat between the heat exchange balloon and the stomach. 
     
     
         23 . The method of  claim 22 , wherein the step of administering the anti-shivering mechanism includes administering a therapeutically effective amount of an anti-shivering agent to the patient and applying warmth to the skin of the patient. 
     
     
         24 . The method of  claim 14 , wherein the heat exchange balloon expands to a size and shape that distends the stomach during the step of introducing the heat exchange fluid into the heat exchange balloon.