Non-invasive systems, devices, and methods for selective brain cooling

• US 9,320,644 B2
• Filed: 07/25/2012
• Issued: 04/26/2016
• Est. Priority Date: 07/25/2011
• Status: Active Grant

• Current Assignee: Neurosave, Inc.
• Original Assignee: Neurosave, Inc.
• Inventors: Kreck, Thomas, Rodgers, Seth, Sas, Ian
• Primary Examiner(s): SCHMIDT, EMILY LOUISE
• Application Number:
  US13/558,108
• Publication Number:
  US 20130030411A1
• Time in Patent Office: 1,371 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2007/0002 Head or parts thereof
• CPC Class Codes: A61F 2007/0063 for cooling
• CPC Class Codes: A61F 2007/0071 using a resistor, e.g. near the spot to be heated
• CPC Class Codes: A61F 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0088 Radiating heat
• CPC Class Codes: A61F 2007/0091 inflatable
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0288 during operations
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0409 with mean for closing the oesophagus
• CPC Class Codes: A61M 16/0436 Special fillings therefor
• CPC Class Codes: A61M 16/0438 Liquid-filled
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0475 having openings in the tube
• CPC Class Codes: A61M 16/0479 above the cuff, e.g. giving access to the upper trachea
• CPC Class Codes: A61M 16/0495 with tongue depressors
• 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 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3606 : cooled
• CPC Class Codes: A61M 2210/0618 : Nose

Abstract

Methods, systems, and devices are disclosed for providing selective and non-selective cooling and warming of a patient. Multiple embodiments of devices are disclosed for performing rapid induction and maintenance of therapeutic hypothermia either in a hospital setting or in the field so that hypothermic treatment can be quickly instituted before significant tissue damage occurs. Methods are also disclosed for targeting brain cooling by irrigating the upper airway, aerodigestive tract, and/or more generalized cooling by irrigating the esophagus and/or stomach.

Claims

1. A method for cooling the brain, comprising:

directing a non-nebulized free flowing fluid through a plurality of catheters into the aerodigestive tract of a patient such that at least a portion of the free flowing fluid is in direct contact with tissue of the aerodigestive tract and where the free flowing fluid cools blood flowing between the aortic arch and the brain;

actively removing the free flowing fluid from the aerodigestive tract of the patient through at least one of the plurality of catheters; and

recirculating at least a portion of the free flowing fluid through a heat exchanger and the aerodigestive tract where the volume of free flowing fluid directed to the aerodigestive tract is substantially equal to the volume of free flowing fluid that is actively removed from the aerodigestive tract through the plurality of catheters until reaching a brain to body core temperature gradient of at least 3°

C.

2. The method of claim 1, further comprising:

recirculating the fluid through the plurality of catheters until reaching a brain to body core temperature gradient of from 3°

C. to 25°

C.

3. The method of claim 1, further comprising:

recirculating the fluid through the plurality of catheters until reaching a brain to body core temperature gradient of from 4°

C. to 12°

C.

4. The method of claim 1, where the fluid comprises electrolytes.

5. The method of claim 1, where the fluid comprises antibacterial agents.

6. The method of claim 1, where the fluid comprises propylene glycol.

7. The method of claim 1, where the fluid is hypertonic.

8. The method of claim 1, where the fluid comprises mucosal protectants.

9. The method of claim 1, where the brain to body core temperature gradient remains substantially constant for at least 1 hour.

10. The method of claim 1, further comprising:

activating a warming device to warm at least a portion of the patient.

11. The method of claim 1, further comprising:

reducing blood flow to the patient'"'"'s brain.

12. The method of claim 11, where reducing blood flow to the brain comprises sedating the patient.

13. The method of claim 11, where reducing blood flow to the brain comprises decreasing blood pressure.

14. The method of claim 11, where reducing blood flow comprises administering barbiturates, propofol, benzodiazepines, lidocaine, etomidate, caffeine, alcohol, narcotics, cocaine, beta-blockers, anti-migraine medications, vasoconstrictors, and/or clonidine to the patient.

15. The method of claim 1, further comprising:

monitoring a temperature of at least one of the patient'"'"'s brain and the patient'"'"'s body core.

16. The method of claim 15, where monitoring a temperature of the patient'"'"'s brain comprises disposing a bolt comprising a temperature sensor in the patient'"'"'s brain.

17. The method of claim 15, where monitoring a temperature of the patient'"'"'s brain and the patient'"'"'s body core comprises administering a magnetic resonance imaging procedure.

18. The method of claim 15, where monitoring a temperature of the patient'"'"'s brain comprises inserting a temperature sensor intravenously in the jugular and positioning the temperature sensor near the brain.

19. The method of claim 1 further comprising cooling the brain without the use of a cooling reservoir that, at least partially, surrounds a patient'"'"'s head.

20. A method for cooling the spinal column, comprising:

directing a non-nebulized free flowing fluid through a plurality of catheters into the aerodigestive tract of a patient such that at least a portion of the free flowing fluid is in direct contact with tissue of the aerodigestive tract and where the free flowing fluid cools blood flowing between the aortic arch and the brain;

actively removing the free flowing fluid from the aerodigestive tract of the patient; and

recirculating at least a portion of the free flowing fluid through a heat exchanger and the aerodigestive tract where the volume of free flowing fluid that is directed to the aerodigestive tract is substantially equal to the volume of free flowing fluid that is actively removed from the aerodigestive tract until reaching a spinal column to body core temperature gradient of at least 3°

C.

21. An apparatus for cooling the brain, the apparatus comprising:

a first catheter configured to direct a non-nebulized free flowing fluid into an aerodigestive tract of a patient where at least a portion the free flowing fluid is in direct contact with tissue of the aerodigestive tract and where the free flowing fluid cools blood flowing between the aortic arch and the brain;

a second catheter configured to remove the free flowing fluid from the aerodigestive tract of the patient; and

a recirculation system configured to actively recirculate at least a portion of the free flowing fluid through a heat exchanger and the aerodigestive tract where the volume of free flowing fluid that is directed to the aerodigestive tract is substantially equal to the volume of free flowing fluid that is actively removed from the aerodigestive tract until reaching a brain to body core temperature gradient of at least 3°

C.

22. The apparatus of claim 21, further comprising:

recirculating the fluid through the plurality of catheters until reaching a brain to body core temperature gradient of from 3°

C. to 25°

C.

23. The apparatus of claim 21, further comprising:

recirculating the fluid through the plurality of catheters until reaching a brain to body core temperature gradient of from 4°

C. to 12°

C.

24. The apparatus of claim 21, where the fluid comprises electrolytes.

25. The apparatus of claim 21, where the fluid comprises antibacterial agents.

26. The apparatus of claim 21, where the fluid comprises propylene glycol.

27. The apparatus of claim 21, where the fluid is hypertonic.

28. The apparatus of claim 21, where the fluid comprises mucosal protectants.

29. The apparatus of claim 21, where the recirculation system is configured to actively recirculate at least a portion of the free flowing fluid to maintain the brain to body core temperature gradient substantially constant for at least 1 hour.

30. The apparatus of claim 21, further comprising:

a warming device to warm at least a portion of the patient.

31. The apparatus of claim 21, further comprising a third catheter for administering barbiturates, propofol, benzodiazepines, lidocaine, etomidate, caffeine, alcohol, narcotics, cocaine, beta-blockers, anti-migraine medications, vasoconstrictors, and/or clonidine to the patient.

32. The apparatus of claim 21, further comprising a first and a second temperature sensor where the first temperature sensor measures the patient'"'"'s brain temperature and the second temperature sensor measures the patient'"'"'s body core temperature.

33. The apparatus of claim 32, where at least one of the first and second temperature sensors comprises an intravenous temperature sensor.

34. The apparatus of claim 33 where the at least one temperature sensor is positioned intravenously in the jugular and the temperature sensor is positioned near the brain.

35. The apparatus of claim 21, further defined as not comprising a cooling reservoir that, at least partially, surrounds a patient'"'"'s head.