Intra-aortic balloon counterpulsation with concurrent hypothermia

Abstract

Devices, systems and methods for treating disorders characterized by low cardiac output. The devices, systems and methods use intra-aortic balloon counterpulsation in combination with hypothermia of all or a portion of a human or veterinary patient's body to improve coronary perfusion and cardiac output. To effect the hypothermia, a heat exchange catheter may be positioned in the a patient's vasculature separately from the intra-aortic balloon counterpulsation catheter. Alternatively, a combination Intra-aortic balloon counterpulsation/heat exchange catheter may be utilized. Such combination catheter comprises a) a catheter sized for insertion into the aorta, b) a counterpulsation balloon and c) a heat exchanger. A drive/control system receives temperature and electrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

1 .- 25 . (canceled) 
     
     
         26 . A catheter device comprising:
 an elongate catheter having a proximal end and a distal end, said catheter being advancable, distal-end-first, into the aorta of a human or veterinary patient;   a counterpulsation balloon useable for effecting intra-aortic balloon counterpulsation; and,   a heat exchanger useable to cool at least a portion of the patient's body   
     
     
         27 . A device according to  claim 26  wherein the heat exchanger comprises a heat exchanger through which heat exchange fluid is circulated. 
     
     
         28 . A device according to  claim 27  wherein said heat exchanger comprises a heat exchange balloon. 
     
     
         29 . A device according to  claim 28  wherein the heat exchanger comprises a single-lobed heat exchange balloon. 
     
     
         30 . A device according to  claim 28  wherein the heat exchanger comprises a multi-lobed heat exchange balloon. 
     
     
         31 . A device according to  claim 26  wherein at least a portion of the heat exchanger is metallic. 
     
     
         32 . A device according to  claim 28  wherein the heat exchange balloon and the counterpulsation balloon comprise a single balloon that is useable for both counterpulsation and heat exchange. 
     
     
         33 . A device according to  claim 26  wherein the heat exchanger comprises a heat exchange surface and wherein the device further comprises a flow disruption surface associated with the heat exchange surface, the flow disruption surface being configured to disrupt the laminarity of blood flow adjacent to the heat exchange surface, thereby enhancing the efficiency by which the heat exchanger exchanges heat with the flowing blood. 
     
     
         34 . A device according to  claim 26  wherein the counterpulsation balloon is positioned at a first location on the catheter and the heat exchanger comprises a heat exchange surface located at a second location on the catheter. 
     
     
         35 . A device according to  claim 34  wherein the first location is closer to the distal end of the catheter than the second location. 
     
     
         36 . A device according to  claim 34  wherein the second location is closer to the distal end of the catheter than the first location. 
     
     
         37 . A device according to  claim 34  wherein the heat exchanger and the counterpulsation balloon comprise a single balloon which is a) configured and useable to effect intra-aortic counterpulsation and b) receives a heat exchange medium such that heat is exchanged between the heat exchange medium and the blood, through at least a portion of the balloon. 
     
     
         38 . A system comprising a heat exchange/intra-aortic counterpulsation catheter device according to  claim 26 , further in combination with:
 apparatus attachable to the catheter and useable to cause a) inflation and deflation of the counterpulsation balloon in response to the patient's cardiac cycle to effect intra-aortic balloon counterpulsation that results in a beneficial effect on the patient and b) at least cooling of the heat exchanger to cause cooling of at least a portion of the patient's body to a temperature that is at least 1 degree C. below normothermia.   
     
     
         39 . A catheter device comprising:
 an elongate catheter;   a counterpulsation balloon on the catheter;   a heat exchanger on the catheter;   at least one inflation/deflation lumen extending through the catheter for passing inflation fluid into and out of the counterpulsation balloon; and   inflow and outflow lumens extending through the catheter for circulation of a heat exchange medium through the heat exchanger.   
     
     
         40 . A device according to  claim 39  wherein the heat exchanger comprises a balloon through which the heat exchange medium circulates. 
     
     
         41 . A device according to  claim 39  wherein the counterpulsation balloon and the heat exchanger comprise separate structures, the counterpulsation balloon being positioned at a first location on the catheter and the heat exchanger being positioned at a second location on the catheter. 
     
     
         42 . A device according to  claim 41  wherein the first location is closer to a distal end of the catheter than the second location. 
     
     
         43 . A device according to  claim 41  wherein the second location is closer to a distal end of the catheter than the first location. 
     
     
         44 . A device according to  claim 39  wherein the heat exchanger and the counterpulsation balloon comprise a single balloon which provides both counterpulsation and heat exchange. 
     
     
         45 . A system comprising a device according to  claim 39  further in combination with:
 apparatus attachable to the catheter and useable to cause a) inflation and deflation of the counterpulsation balloon and b) circulation of heat exchange medium through the heat exchanger.