Intra-aortic balloon counterpulsation with concurrent hypothermia

• US 7,959,643 B2
• Filed: 09/02/2004
• Issued: 06/14/2011
• Est. Priority Date: 10/26/2001
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Machold, Timothy R., Dae, Michael W.
• Primary Examiner(s): Farah; Ahmed M
• Assistant Examiner(s): ROANE, AARON F
• Application Number:
  US10/933,970
• Publication Number:
  US 20050043579A1
• Time in Patent Office: 2,476 Days
• Field of Search: 600 16- 18, 604/94.01, 604/96.01, 604/106, 604/113, 604/291, 604/500, 604/509, 606/22, 606/25, 606/27, 606/28, 606/31, 606192-194, 607/96, 607104-106, 607/113
• US Class Current: 606/192
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 19/00 Local anaesthesia syringes therefor A61M5/00; Hypothermia A61M5/42 takes precedence; cooling blood in a bypass of the arterial system A61M1/36
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 60/139 inside the aorta, e.g. intra-aortic balloon pumps
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/36 for specific blood treatment; for specific therapy
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/508 Electronic control means, e.g. for feedback regulation
• CPC Class Codes: A61M 60/843 Balloon aspects, e.g. shapes or materials
• CPC Class Codes: A61M 60/884 being associated to additional implantable blood treating devices

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.

Claims

1. A heat exchange/intra-aortic counterpulsation system comprising:

an elongate heat exchange/counterpulsation catheter having a proximal end, a distal end and a plurality of lumens;

a counterpulsation balloon located on the catheter and useable for effecting intra-aortic balloon counterpulsation;

a heat exchanger located on the catheter that receives a heat exchange fluid through a lumen of the catheter and has a heat exchange surface for exchanging heat with a patient'"'"'s flowing blood when positioned within the vasculature of the patient to substantially raise or lower the patient'"'"'s body temperature without causing the heat exchange fluid to enter the patient'"'"'s vasculature;

at least one drive/control apparatus to i) control inflation/deflation of the counterpulsation balloon in response to received electrocardiogram signals to thereby effect intraortic counterpulsation and ii) deliver heat exchange fluid to the heat exchanger to vary the temperature of the heat exchange surface in response to received temperature signals representative of patient body temperature;

a temperature monitoring apparatus for providing temperature signals representative of patient body temperature to the drive/control apparatus; and

an electrocardiogram monitoring apparatus for providing electrocardiogram signals to the drive/control apparatus.

2. A device according to claim 1 wherein the heat exchanger comprises a heat exchanger through which heat exchange fluid is circulated.

3. A device according to claim 2 wherein said heat exchanger comprises a heat exchange balloon.

4. A device according to claim 3 wherein the heat exchanger comprises a single-lobed heat exchange balloon.

5. A device according to claim 3 wherein the heat exchanger comprises a multi-lobed heat exchange balloon.

6. A device according to claim 3 wherein the heat exchange balloon and the counterpulsation balloon comprise a single balloon that is located on the catheter and useable for both counterpulsation and heat exchange.

7. A device according to claim 1 wherein at least a portion of the heat exchanger is metallic.

8. A device according to claim 1 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.

9. A device according to claim 1 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.

10. A device according to claim 9 wherein the first location is closer to the distal end of the catheter than the second location.

11. A device according to claim 9 wherein the second location is closer to the distal end of the catheter than the first location.

12. A device according to claim 9 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.