Intra-aortic balloon counterpulsation with concurrent hypothermia

• US 8,430,899 B2
• Filed: 06/14/2011
• Issued: 04/30/2013
• 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: Dae, Michael W., Machold, Timmothy R.
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US13/160,285
• Publication Number:
  US 20120095282A1
• Time in Patent Office: 686 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, 128/898
• 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 method for treating a human or veterinary patient who suffers from congestive heart failure or another condition wherein the patients cardiac output is subnormal, said method comprising the steps of

a. providing a heat exchange/intra-aortic counterpulsation catheter comprising i) an elongate catheter having a proximal end and a distal end, said catheter being advancable, distal-end-first, into the aorta of the patient, ii) 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 to a temperature that is at least 1°

C. below normothermia;

b. advancing the heat exchange/intra-aortic counterpulsation catheter, distal end first, into the patient'"'"'s aorta such that the counterpulsation balloon is positioned in the thoracic aorta;

c. driving and controlling the counterpulsation balloon and heat exchanger so as to effect intra-aortic balloon counterpulsation while cooling and/or maintaining the temperature of at least a portion of the patient'"'"'s body to a temperature that is at least 1°

C. below normothermia.

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

d. administering an antishivering treatment to the patient.

3. 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.

4. A method according to claim 2 wherein the anti-shivering treatment is selected from the group of anti-shivering treatments 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.

5. 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) α

-opioid receptor agonists;

iv) opioid agonist-antagonist analgesics;

v) serotonin 5HT1a receptor agonists and vi) alpha-2 adrenergic receptor agonists.

6. A method for treating a human or veterinary patient who suffers from congestive heart failure or another condition wherein the patients cardiac output is subnormal, said method comprising the steps of:

a. providing a heat exchange catheter comprising i) a heat exchange catheter body and 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;

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 counterpulsation;

c. inserting the heat exchange catheter into the patient'"'"'s 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; and

,

f. using the heat exchange catheter to cool the temperature of at least a portion of the patient'"'"'s body to a temperature that is at least 1°

C. below normothermia.

7. A method according to claim 6 further comprising the step of:

g. administering an antishivering treatment to the patient.

8. A method according to claim 7 wherein the wherein the anti-shivering treatment is selected from the group of anti-shivering treatments 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.

9. A method according to claim 7 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) a-opioid receptor agonists;

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

10. A method according to claim 6 wherein the patient'"'"'s body temperature is cooled to and maintained within the range of 32-34°

C. while intra-aortic counterpulsation is performed.

11. A method according to claim 6 wherein the heat exchanger is positioned in a vein.

12. A method according to claim 11 wherein the heat exchanger is positioned in the vena cava.