Intra-aortic balloon counterpulsation with concurrent hypothermia

• US 6,800,068 B1
• Filed: 10/26/2001
• Issued: 10/05/2004
• Est. Priority Date: 10/26/2001
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Machold, Timothy R., Dae, Michael W.
• Primary Examiner(s): Hayes, Michael J.
• Application Number:
  US10/015,220
• Time in Patent Office: 1,075 Days
• Field of Search: 604/113, 604/291, 604/500, 604/509, 604/106, 600/16-18, 607/96, 607/104, 607/105, 607/106, 607/113
• US Class Current: 604/113
• 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 patent'"'"'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 eletrocardiograph signals and drives the inflation/deflation of the counterpulsation balloon as well as the heating/cooling of the heat exchanger.

Claims

1. A method for treating a human or veterinary patient who suffers from a condition wherein the patient'"'"'s cardiac output is subnormal, said method comprising the steps of:

a. providing a heat exchange catheter system comprising i) a heat exchange catheter body, ii) at least one heat exchanger for exchanging heat with blood flowing through a blood vessel into which the heat exchange catheter body is inserted, iii) a temperature sensor for sensing the temperature of at least a portion of the patient'"'"'s body and iv) a controller adapted to receive an indication of the sensed patient temperature from the temperature sensor and to control the heat exchanger in response to said sensed patient temperature such that the heat exchanger will cool at least a portion of the patient'"'"'s body to a target temperature that is at least 1°

C. below nomothermia;

b. providing an intra-aortic balloon counterpulsation catheter comprising i) a counterpulsation catheter body and ii) a counterpulsation balloon useable for effecting intra-aortic balloon counterpulsion;

c. inserting the heat exchange catheter into the patient'"'"'s venous vasculature such that blood flows in heat exchange proximity to the heat exchanger;

d. inserting the intra-aortic balloon counterpulsation catheter into the patient'"'"'s vasculature such that the counterpulsation balloon is positioned within the patient'"'"'s aorta;

e. using the intra-aortic balloon counterpulsation catheter to effect intra-aortic balloon counterpulsation while the heat exchange catheter system cools the temperature of the patient'"'"'s heart to a temperature that is at least 1°

C. below normothermia; and

f. controlling said heat exchange catheter to maintain said cooling of the patient'"'"'s heart to cause an increase in cardiac output and a decrease in cardiac metabolic demand.

2. A method according to claim 1 further comprising the step of:

g. Administering an antishivering treatment to the patient.

3. A method according to claim 2 wherein the wherein the anti-shivering treatment is selected from the group of anti-shivering consisting of:

i) administering a therapeutically effective amount of an anti-shivering agent to the donor;

ii) applying warmth to the skin of the donor and iii) administering a therapeutically effective amount of an anti-shivering agent to the donor and applying warmth to the skin of the donor.

4. A method according to claim 2 wherein the anti-shivering treatment comprises administering to the donor a therapeutically effective amount of at least one anti-shivering agent selected from the group consisting of:

i) dopamine receptor antagonists;

ii) dopamine receptor agonists;

iii) k-opioid receptor agonists;

iv) opioid agonist-antagonist analgesics, v) serotonin 5HT1a receptor agonists and vi) alpha-2 adrenergic receptor agonists.

5. A method according to claim 1, wherein the patient'"'"'s body temperature is cooled to and maintained within the range of 32-34°

C. while intra-aortic counterpulsation is performed.

6. A method according to claim 1 wherein the heat exchanger is positioned in the vena cava.

7. A method according to claim 1 wherein the heat exchange catheter provided in Step A and the intra-aortic balloon counterpulsation catheter provided in Step B comprise a single catheter body having both a heat exchanger and a counterpulsation balloon thereon.

8. A method according to claim 1 wherein the heat exchange catheter provided in Step A and the intra-aortic balloon counterpulsation catheter provided in Step B comprise separate catheters.