METHODS AND SYSTEMS FOR INDUCING THERAPEUTIC HYPOTHERMIA IN A PRE-HOSPITAL, FIELD, OR AMBULANCE SETTING

• US 20090099518A1
• Filed: 08/14/2008
• Published: 04/16/2009
• Est. Priority Date: 08/14/2007
• Status: Abandoned Application

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Magers, Mike
• Application Number:
  US12/192,045
• Publication Number:
  US 20090099518A1
• Time in Patent Office: Days
• US Class Current: 604/113
• CPC Class Codes: A61F 2007/0076 remote from the spot to be heated or cooled
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

Systems and methods are provided for inducing a therapeutic state of hypothermia in a patient. Cold biocompatible liquid is infused into a patient at a defined temperature and pressure and at a fairly rapid rate to quickly induce hypothermia. In one system, cold liquid is provided from a flowing source. In another, cold liquid is forced out of a refrigerated bag, the pressure on the bag arising from air pressure on the bag, an infusor cuff, or any other technique which may apply such pressure. The cold liquid may be cooled in advance of the infusion or via a cold plate which forms a portion of the system.

Claims

1. An apparatus for inducing a therapeutic state of hypothermia, comprising:

a. a disposable/reusable unit, including;

i. a pressurizable bag configured to store a liquid-containing bag;

ii. a pressurizer in pressure communication with the pressurizable bag, to cause a set pressure to be incident in the liquid-containing bag, wherein liquid may be caused to flow at the set pressure out of the liquid-containing bag;

iii. a sensor to sense the pressure incident in the liquid-containing bag or of the pressurizer;

iv. a controller to control the pressurizer, the controller having an input from the sensor, wherein the controller operates the pressurizer to maintain the set pressure;

b. a fixed base unit, including;

i. a cold plate;

ii. a temperature sensor to monitor the temperature of the cold plate; and

c. an intravenous line to deliver the cooled liquid to a blood vessel of a patient.

2. The apparatus of claim 1, wherein the cold plate is configured to cool the liquid in the liquid-containing bag to a temperature of between about 0°

C. and 10°

C.

3. The apparatus of claim 1, wherein the cold plate includes a thermoelectric cooler.

4. The apparatus of claim 1, wherein the intravenous line further comprises an air in-line eliminator.

5. An apparatus for inducing a therapeutic state of hypothermia, comprising:

a. a housing configured to store a flexible bag containing a liquid to be cooled, the housing including a refrigerator to cool the flexible bag and the liquid within;

b. a pressurizer in pressure communication with the flexible bag, to cause a determinable pressure to be incident on the flexible bag, wherein upon activation of a valve liquid is caused to flow out of the flexible bag;

c. a controller to control the pressurizer, wherein the controller operates the pressurizer to maintain the determinable pressure to between about 100-500 mmHg+/−

20%;

d. an intravenous line coupled to the valve to deliver the cooled liquid to a blood vessel of a patient.

6. The apparatus of claim 5, wherein the determinable pressure is such that the pressure of the liquid in the intravenous line is greater than a blood pressure of the patient but less than about 10 psi.

7. The apparatus of claim 5, wherein the determinable pressure is about 300 mmHg.

8. The apparatus of claim 5, wherein the housing refrigerator is configured to cool the liquid in the flexible bag to a temperature of between about 0°

C. and 10°

C.

9. The apparatus of claim 5, wherein the housing refrigerator includes a thermoelectric cooler.

10. The apparatus of claim 5, wherein the intravenous line further comprises an air in-line eliminator.

11. The apparatus of claim 9, wherein a cold plate on the thermoelectric cooler forms one wall of the housing for the flexible bag, and wherein the flexible bag is mounted adjacent the one wall, and wherein a wall opposite the cold plate is formed by a door.

12. The apparatus of claim 11, wherein an interior of the housing, in which is disposed the flexible bag, is air-tight, and further comprising:

a. an air pump to supply pressurized air to the interior of the housing;

b. a pressure sensor within the interior of the housing to sense the air pressure within, wherein a signal corresponding to the sensed pressure is delivered to the controller.

13. The apparatus of claim 11, wherein a clutched stepper motor, or AC/DC motor, is coupled to the door, to force the door against the flexible bag, and thus to pressurize the flexible bag.

14. An apparatus for inducing a therapeutic state of hypothermia, comprising:

a. a holder for an IV bag;

b. a housing configured to store a cassette having a serpentine path, the serpentine path fluidically coupled to the IV bag, the housing including a refrigerator to cool the cassette and the liquid within;

c. a pump in pressure communication with the liquid to cause the liquid to be at a determinable pressure, wherein upon activation of a valve, liquid is caused to flow at the determinable pressure;

d. an intravenous line coupled to the valve to deliver the cooled liquid to a blood vessel of a patient.

15. A kit for inducing a therapeutic state of hypothermia, comprising:

a. a cooling and pressurizing apparatus, including;

i. a housing configured to store a flexible bag containing a liquid, the housing including a refrigerator to cool the flexible bag and the liquid within;

ii. a pressurizer in pressure communication with the flexible bag, to cause a determinable pressure to be incident on the flexible bag, wherein liquid may be caused to flow out of the flexible bag;

b. an intravenous line to deliver the cooled liquid to a blood vessel of a patient;

c. an introduction set to install the intravenous line in a patient.

16. An apparatus for use in delivering a cooled liquid from a liquid-containing package to the vasculature of a subject in need thereof, comprising:

a. a portable unit adapted to contain at least one liquid-containing package comprising a dispensing port for discharging the liquid therethrough, wherein the portable unit or the liquid containing package is adapted to receive a line for delivering the liquid to the subject; and

b. a fixed base unit, including;

i. a power supply system; and

ii. a means for cooling the liquid-containing package when contained by the portable unit;

the portable unit being attachable and detachable to the fixed base unit.

17. The apparatus of claim 16, wherein the portable unit further comprises a pressurizer adapted to be in pressure communication with the package to cause a set pressure to be incident in the package, wherein the liquid is caused to flow out of the package upon activation of a valve.

18. The apparatus of claim 17, wherein the portable unit further comprises a sensor to sense the pressure of the pressurizer or incident in the package, and a controller to control the pressurizer;

the controller having an input from the sensor, wherein the controller operates the pressurizer to maintain the set pressure.

19. The apparatus of claim 17, wherein the portable unit further comprises a battery that powers the pressurizer.

20. The apparatus of claim 19, wherein the battery is rechargeable and the fixed base unit further comprises a charger for the battery.

21. The apparatus of claim 17, wherein the pressurizer is a pressurizable bag configured to store the package.

22. The apparatus of claim 17, wherein the pressurizer is a pressurizable infusion cuff.

23. The apparatus of claim 17, wherein the pressurizer acts via pneumatic compression of the package.

24. The apparatus of claim 17, wherein the pressurizer acts via mechanical compression of the package.

25. The apparatus of claim 17, wherein the pressurizer is a pump.

26. The apparatus of claim 17, wherein the set pressure is such that when the line is in fluid communication with the liquid in the package the pressure of the liquid in the line is greater than a blood pressure of the subject but less than about 10 psi.

27. The apparatus of claim 26, wherein the pressure of the liquid is about 100-500 mmHg±

20%.

28. The apparatus of claim 16, wherein the portable unit is adapted to contain two liquid-containing packages.

29. The apparatus of claim 17, wherein the portable unit is adapted to contain two liquid-containing packages and the pressurizer is adapted to be in pressure communication with both packages.

30. The apparatus of claim 17, wherein the portable unit is adapted to contain two liquid-containing packages, and comprises two pressurizers, each pressurizer adapted to be in pressure communication with a separate package.

31. The apparatus of claim 16, further comprising the line for delivering the liquid to the subject.

32. The apparatus of claim 31, wherein the line further comprises an air in-line eliminator.

33. The apparatus of claim 28 further comprising the line for delivering the liquid to the subject and a manifold system to connect both liquid-containing packages to the line at the same time.

34. The apparatus of claim 28 further comprising the line for delivering the liquid to the subject and a manifold system to connect both liquid-containing packages to the line sequentially.

35. The apparatus of claim 16, wherein the cooling means is configured to cool the liquid in the liquid-containing package to a temperature of between about 0°

C. and 10°

C.

36. The apparatus of claim 35, wherein the cooling means is configured to cool the liquid to a temperature of about 4°

C.

37. The apparatus of claim 16, wherein the cooling means includes a cold plate.

38. The apparatus of claim 37, wherein the cold plate includes a thermoelectric cooler.

39. The apparatus of claim 16, wherein the fixed base unit further comprises a temperature sensor and a controller to monitor and to control the temperature of the cooling means.

40. The apparatus of claim 39, wherein the fixed base unit further comprises a display to display a signal from the temperature sensor.