US2003195466A1PendingUtilityA1

Dual balloon central venous line catheter temperature control system

Assignee: ALSIUS CORPPriority: Feb 19, 1999Filed: May 8, 2003Published: Oct 16, 2003
Est. expiryFeb 19, 2019(expired)· nominal 20-yr term from priority
A61F 7/123A61B 2018/00011A61F 2007/126A61M 1/369A61M 5/44
47
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Claims

Abstract

A system for controlling patient temperature uses a central venous line catheter having axially spaced distal and proximal heat exchange balloons. The central venous line catheter is provided with one or more lumens for providing access to the central blood supply of the patient, and with additional lumens for communicating heat exchange fluid to the balloons. Heat exchange fluid temperature is controlled through a feed back loop in which patient temperature is sensed and used to control a temperature control unit comprising a heating device and/or a cooling device in heat exchange relationship with the heat exchange fluid. A tubing set transports the heat exchange fluid between the central venous line and the temperature control unit, with a pump serving to circulate the fluid in a closed fluid circuit in the system.

Claims

exact text as granted — not AI-modified
1 . A heat exchange catheter comprising: 
 a catheter body having at least a heat exchange fluid supply lumen and a heat exchange fluid return lumen; and    at least a distal balloon and a proximal balloon on the catheter body, the balloons and lumens being arranged such that heat exchange fluid flows serially through the balloons.    
     
     
         2 . The catheter of  claim 1 , further comprising an intermediate fluid pathway between the distal and proximal balloons and a heat exchange fluid inlet port formed in the supply lumen, the inlet port allowing heat exchange fluid to flow into the distal balloon and intermediate fluid pathway.  
     
     
         3 . The catheter of  claim 2 , further comprising an occlusion in the heat exchange fluid return lumen, the occlusion causing heat exchange fluid to flow from the distal balloon into the proximal balloon.  
     
     
         4 . The catheter of  claim 1 , further comprising first and second access lumens terminating in respective first and second access ports communicating with the exterior of the catheter, the access ports being axially spaced from each other.  
     
     
         5 . The catheter of  claim 4 , wherein the catheter is provided with a distal tip, the first access port being disposed at the distal tip and the second access port being disposed between the distal and proximal balloons.  
     
     
         6 . A heat exchange catheter comprising: 
 a catheter body having at least a heat exchange fluid supply lumen, a heat exchange fluid return lumen, and first and second access lumens terminating in respective first and second access ports, the access ports being axially spaced from each other; and    at least a distal balloon and a proximal balloon on the catheter body.    
     
     
         7 . The catheter of  claim 6 , wherein the catheter defines a distal tip, the first access port being established at the distal tip, the second access port being established between the distal and proximal balloons.  
     
     
         8 . The catheter of  claim 6 , wherein heat exchange fluid flows serially through the heat exchange fluid supply lumen, then to one of the distal and proximal balloons, then to the other of the distal and proximal balloons, then to the heat exchange fluid return lumen.  
     
     
         9 . A central venous line catheter comprising: 
 a substantially elongate structure configured for establishing central venous access, said structure having a proximal portion and a distal portion and defining at least a first access lumen in communication with the exterior of the structure at said proximal and distal portions;    a proximal and a distal balloon disposed axially along the substantially elongate structure, the proximal and distal balloons adapted to effect heat exchange with the central venous system;    a heat exchange fluid supply lumen in fluid communication with the distal balloon;    a heat exchange fluid return lumen in fluid communication with the proximal balloon;    wherein a serial fluid flow path is established from the distal balloon to the proximal balloon such that fluid flows from the supply lumen, to the distal balloon, then to a segment of the return lumen, then to the proximal balloon, then to the remainder of a return lumen.    
     
     
         10 . The catheter of  claim 9 , further comprising an occlusion for preventing fluid flow between the segment of the return lumen and the remainder of the return lumen.  
     
     
         11 . The catheter of  claim 9 , further comprising a second access lumen in communication with the exterior of the structure at said proximal and distal portions.  
     
     
         12 . The catheter of  claim 11 , wherein the first and second access lumens are in fluid communication with the exterior of the substantially elongate structure at respective first and second access ports, the first access port being disposed distally of the distal balloon and the second access port being disposed proximally of the distal balloon.  
     
     
         13 . The catheter of  claim 12 , wherein the second access port is disposed distally of the proximal balloon.  
     
     
         14 . A patient temperature control system comprising: 
 a central venous line catheter having a proximal portion and a distal portion and defining at least a first access lumen in communication with the exterior of the catheter at the proximal and distal portions;    a proximal and a distal balloon disposed axially along the central venous line catheter, the proximal and distal balloons adapted to effect heat exchange with the central venous system;    a heat exchange fluid supply lumen in fluid communication with the distal balloon;    a heat exchange fluid return lumen in fluid communication with the proximal balloon; and    a temperature control unit for providing heat exchange fluid to the heat exchange fluid supply lumen and for receiving heat exchange fluid from the heat exchange fluid return lumen, the heat exchange control unit adapted to change the temperature of a heat exchange fluid circulated in the proximal and distal balloons,    wherein a serial fluid flow path is established between the proximal and distal balloons.    
     
     
         15 . The patient temperature control system of  claim 14 , further comprising at least one probe for sensing patient temperature, the temperature control unit automatically changing the temperature of the heat exchange fluid in accordance with the sensed patient temperature.  
     
     
         16 . The patient temperature control system of  claim 15 , further comprising a temperature controller for activating the temperature control unit when patient temperature deviates from a predetermined range.  
     
     
         17 . The patient temperature control system of  claim 15 , wherein the temperature control unit comprises at least one cooling device for cooling the heat exchange fluid.  
     
     
         18 . The patient temperature control system of  claim 15 , wherein the temperature control unit comprises at least one heating device for heating the heat exchange fluid.  
     
     
         19 . The patient temperature control system of  claim 14 , further comprising at least one tubing set in fluid communication with the heat exchange fluid supply and return lumens and the temperature control unit, the tubing set delivering fluid between the central venous line catheter and the temperature control unit.  
     
     
         20 . The patient temperature control system of  claim 14 , further comprising means for providing an indication of patient temperature change.  
     
     
         21 . The patient temperature control system of  claim 14 , further comprising at least one central venous line catheter anchor engaged with the catheter and including structure configured to affix the catheter to the patient.  
     
     
         22 . The patient temperature control system of  claim 14 , wherein a serial fluid flow path is established from the distal balloon to the proximal balloon such that fluid flows from the supply lumen, to the distal balloon, then to a segment of the return lumen, then to the proximal balloon, then to the remainder of a return lumen.  
     
     
         23 . The catheter of  claim 22 , further comprising an occlusion for preventing fluid flow between the segment of the return lumen and the remainder of the return lumen.  
     
     
         24 . The catheter of  claim 14 , further comprising a second access lumen in communication with the exterior of the central venous line catheter at said proximal and distal portions.  
     
     
         25 . The catheter of  claim 24 , wherein the first and second access lumens are in fluid communication with the exterior of the central venous line catheter at respective first and second access ports, the first access port being disposed distally of the distal balloon and the second access port being disposed proximally of the distal balloon.  
     
     
         26 . The catheter of  claim 25  wherein the second access port is disposed distally of the proximal balloon.  
     
     
         27 . A patient temperature control system comprising: 
 a central venous line catheter having distal and proximal balloons disposed axially thereon;    means for sensing the temperature of the patient; and    means for controlling the temperature of the distal and proximal balloons in accordance with the means for sensing the temperature of the patient.    
     
     
         28 . The patient temperature control system of  claim 27 , wherein the means for controlling the temperature effects a temperature change of a heat exchange fluid circulated in the distal and proximal balloons.  
     
     
         29 . The patient temperature control system of  claim 27 , wherein the means for sensing is a bladder probe.  
     
     
         30 . The patient temperature control system of  claim 27 , wherein the means for sensing is an esophageal probe.  
     
     
         31 . The patient temperature control system of  claim 27 , wherein the means for sensing is a rectal probe.  
     
     
         32 . The patient temperature control system of  claim 27 , wherein the means for sensing is a tympanic temperature sensor.  
     
     
         33 . The patient temperature control system of  claim 27 , wherein the means for sensing is a blood stream probe.  
     
     
         34 . A method for reducing patient body temperature comprising: 
 warming the patient externally;    introducing a catheter into the body of the patient; and    circulating a cooling fluid in the catheter such that the cooling fluid is in heat exchange relationship with the blood flow of the patient.    
     
     
         35 . The method of  claim 34 , wherein the step of warming is implemented using heating blankets.  
     
     
         36 . The method of  claim 34 , wherein the catheter is a central venous line catheter.  
     
     
         37 . The method of  claim 36 , wherein the central venous line catheter is provided with at least a pair of axially disposed balloons adapted to contain the circulating cooling fluid therein.

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