Intra-aortic balloon counterpulsation with concurrent hypothermia

• US 9,533,086 B2
• Filed: 11/09/2015
• Issued: 01/03/2017
• 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, Timothy R.
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US14/936,507
• Publication Number:
  US 20160058931A1
• Time in Patent Office: 421 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: 1/1
• 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 system for controlling body temperature and providing intra-aortic counterpulsation in a human or animal subject, said system comprising:

an endovascular heat exchanger positionable in the vasculature of the subject and useable to exchange heat with blood flowing through the subject'"'"'s vasculature;

an intra-aortic counterpulsation balloon positionable in the aorta of the subject and useable to provide intra-aortic counterpulsation; and

drive and control apparatus operative to control the endovascular heat exchanger and the intra-aortic counterpulsation balloon.

2. A system according to claim 1 wherein the drive and control apparatus comprises at least one controller or computer programmed to i) control inflation/deflation of the counterpulsation balloon in response to received electrocardiogram signals to thereby effect intra-aortic counterpulsation and ii) control the temperature of the endovascular heat exchanger in response to received temperature signals representative of patient body temperature.

3. A system according to claim 2 wherein the drive and control apparatus are located in a single console positionable near the subject.

4. A system according to claim 2 wherein the drive and control apparatus are located in a plurality of consoles positionable near the subject.

5. A system according to claim 1 further comprising:

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

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

6. A system according to claim 1 wherein the endovascular heat exchanger comprises a heat exchanger through which heat exchange fluid is circulated.

7. A system according to claim 6 wherein the endovascular heat exchanger comprises a heat exchange balloon through which heat exchange fluid is circulated.

8. A system according to claim 7 wherein the heat exchange balloon comprises a single-lobed heat exchange balloon.

9. A system according to claim 7 wherein the heat exchange balloon comprises a multi-lobed heat exchange balloon.

10. A system according to claim 1 wherein the endovascular heat exchanger is curved or twisted.

11. A system according to claims 10 wherein the endovascular heat exchanger comprises at least one tubular balloon member disposed in a helical configuration.

12. A system according to claim 1 wherein the endovascular heat exchanger is located on a first catheter and the intra-aortic counterpulsation balloon is located on a second catheter.

13. A system according to claim 1 wherein the endovascular heat exchanger is configured to disrupt laminarity of blood flow adjacent to the endovascular heat exchanger thereby enhancing the efficiency by which the endovascular heat exchanger exchanges heat with blood flowing through the subject'"'"'s vasculature.

14. A system according to claim 1 wherein the endovascular heat exchanger is positioned on a catheter that has an inflow lumen and an outflow lumen, said inflow lumen and said outflow lumen being connected to the endovascular heat exchanger so that heat exchange fluid may circulate in the inflow lumen, through the endovascular heat exchanger and then out of the outflow lumen.

15. A system according to claim 14 wherein the drive and control apparatus comprises a heater/cooler apparatus for warming of cooling the temperature of a heat exchange fluid and a heat exchange fluid pump for pumping the heat exchange fluid in the inflow lumen, through the endovascular heat exchanger and then out of the outflow lumen.

16. A system according to claim 15 wherein the drive and control apparatus further comprises an inflation pump for pumping inflation fluid into and out of the counterpulsation balloon at specific times to cause the counterpulsation balloon to inflate and deflate.

17. A system according to claim 15 wherein the drive and control apparatus comprises at least one controller or computer that receives a) sensed body temperature signals from a body temperature sensor and b) a target body temperature input by a user of the system, said at least one computer or controller being programmed to then control the heater/cooler and heat exchange fluid pump to maintain the sensed body temperature at or near the user input target temperature.

18. A system according to claim 16 wherein the drive and control apparatus comprises at least one controller or computer that receives an electrocardiogram signal and is programmed to control the inflation pump to cause repetitive inflation deflation of the counterpulsation balloon in temporal relationship to the received electrocardiogram signal to thereby effect intra-aortic counterpulsation.

19. A system according to claim 1 wherein the system is useable to cool the subject to a hypothermic temperature that causes a temperature-induced increase in the subject'"'"'s cardiac output while also providing intra-aortic balloon counterpulsation.

20. A system for controlling body temperature and providing intra-aortic counterpulsation in a human or animal subject, said system comprising:

an endovascular heat exchange catheter positionable in the vasculature of the subject and useable to exchange heat with blood flowing through the subject'"'"'s vasculature to cool at least a portion of the subject'"'"'s body to a temperature that is at least 1°

C. below normothermia;

an intra-aortic counterpulsation balloon catheter positionable in the aorta of the subject and useable to provide intra-aortic counterpulsation; and

drive and control apparatus operative to control the endovascular heat exchange catheter and the intra-aortic counterpulsation balloon catheter so as to effect intra-aortic balloon counterpulsation while cooling or maintaining the temperature of at least a portion of the subject'"'"'s body to a temperature that is at least 1°

C. below normothermia.