Selective brain and spinal cord hypothermia method and apparatus

• US 6,699,269 B2
• Filed: 04/29/2002
• Issued: 03/02/2004
• Est. Priority Date: 04/30/2001
• Status: Active Grant

• Current Assignee: Rohit K. Khanna
• Original Assignee: Rohit K. Khanna
• Inventors: Khanna, Rohit Kumar
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/136,003
• Publication Number:
  US 20020198579A1
• Time in Patent Office: 673 Days
• Field of Search: 607/96, 607/104-107, 606/20-23, 606/25-26
• US Class Current: 607/105
• CPC Class Codes: A61F 2007/0056 for cooling
• 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

Abstract

The invention provides a method and apparatus for performing selective hypothermia to the brain and spinal cord for injury protection without the need for systemic cooling. A flexible catheter is inserted into the cerebral lateral ventricle or spinal subdural space. The catheter has three lumens with a heat transfer element. Two lumens of the catheter circulate a coolant and communicate at the distal heat transfer element for transfer of heat from the cerebrospinal fluid. The third lumen of the catheter allows for drainage of the cerebrospinal fluid. In another embodiment, the catheter has two lumens that circulate the coolant and communicate at the distal heat tranfer element. In another embodiment, a larger surface area cooling template is placed in the subdural space of the brain or the subdural/epidural space of the spine. The template has a conduit that circulates a coolant through the lumen of the template thereby cooling the surrounding brain or spinal cord.

Claims

1. A method for selectively cooling the central nervous system comprising the steps of:

A. providing a heat exchange catheter device which comprises;

i) an elongate flexible catheter with a proximal and distal end, ii) two lumens which communicate at the distal end through which a heat exchange fluid is circulated, iii) a heat exchanger located at the distal end of the catheter allowing transfer of heat between the said heat exchanger and its surroundings;

B. inserting the catheter into a cerebrospinal fluid or epidural space;

C. circulating the heat exchange fluid with temperature below the body temperature through the catheter, thereby transferring heat from the cerebrospinal fluid to the cool heat exchange fluid and subsequently cooling the central nervous system.

2. The method of claim 1, further comprising the steps of:

D. providing a temperature sensor placed on the said catheter at or adjacent to the distal end of the catheter so that it senses the temperature of the cerebrospinal fluid and/or the central nervous system;

E. providing an external heat exchange fluid temperature and flow regulator connected to the proximal end of the said catheter;

F. achieving a desired temperature of the central nervous system by controlling the amount of heat transferred between the heat exchanger and the cerebrospinal fluid through regulation of the heat exchange fluid temperature and flow rate.

3. The method of claim 1, wherein the said catheter further comprises one or more sensors at or adjacent to the distal end of the catheter selected from a group consisting of:

pressure, temperature, oxygenation, carbonation, metabolite, and pH sensors.

4. The method of claim 1, wherein the said heat exchanger is made from a material selected from die group comprising of:

metal, plastic, or latex.

5. The method of claim 1, wherein the said heat exchange fluid is made from a material selected from the group comprising of:

a compressed refrigerant, a coolant, saline, lactated Ringer'"'"'s solution, or water cooled by extracorporeal refrigeration.

6. The method of claim 1, wherein a coolant in the liquid form circulates to the said distal heat exchanger which acts like an evaporator thereby transferring heat from the surrounding area and returning the coolant in its gaseous format to an external condenser.

7. The method of claim 1, wherein the said cerebrospinal fluid space being a ventricle of the brain with the said catheter secured to the skull.

8. A method of claim 1, wherein hypothermia is used for cerebral insult following either trauma, ischemia, hypoxia, seizure, and/or cerebral swelling.

9. The method of claim 1, wherein the said cerebrospinal fluid space being the subarachnoid or subdural space of die spine thereby selectively cooling the spinal cord.

10. The method of claim 1, wherein the said catheter is placed in the epidural space of the spine.

11. A method of claim 1, wherein hypothermia is used for protection of the spinal cord following either trauma, ischemia, swelling, or aortic aneurysm surgery.

12. The method of claim 1, wherein the said catheter outer lumen expands when the heat exchange fluid is circulated.

13. The method of claim 1, wherein the said catheter is placed in the epidural space of the spine.

14. A method for selectively cooling the central nervous system comprising the steps of:

A. providing a flexible elongated catheter with three lumens and a distal heat conductive element with one of the lumens communicating with the external space through one or more ports at the distal end;

B. inserting the catheter into the cerebrospinal fluid space of the brain or the subdural space of the spine;

C. circulating a cool fluid through one of the catheter lumens which communicates with a second lumen at the distal heat conductive element of the catheter thereby cooling the cerebrospinal fluid without any exposure of the circulating fluid to the external environment;

D. the third lumen of the catheter providing cerebrospinal fluid drainage through said ports communicating from the lumen to the external environment at the distal end of the catheter.

15. The method of claim 14, further comprising the steps of:

F. providing a temperature sensor placed on the said catheters at or adjacent to the distal end of the catheter so that it senses the temperature of the cerebrospinal fluid;

G. providing an external circulating fluid temperature and flow regulator connected to the proximal end of the said first catheter;

H. achieving a desired temperature of the cerebrospinal fluid through regulation of the circulating fluid temperature and flow rate;

I. providing a pressure sensor placed on the said catheters at or adjacent to the distal end of the catheter so that it senses the pressure of the cerebrospinal fluid and/or brain;

I. maintaining the cerebrospinal fluid and/or brain pressure within a desired range through regulation of the circulating fluid flow rate and amount of cerebrospinal fluid drainage.

16. The method of claim 14, wherein the said catheter further comprises one or more sensors at or adjacent to the distal end of the catheter selected from a group consisting of:

pressure, temperature, oxygenation, carbonation, metabolite, and pH sensors.

17. The method of claim 14, wherein the said conductive element is made from a material selected from the group consisting of:

metal, plastic or latex.

18. The method of claim 14, wherein the said cool fluid is made from a material selected from the group consisting of:

a compressed refrigerant, a coolant, saline, lactated Ringer'"'"'s solution, or water cooled by extracorporeal refrigeration.

19. The method of claim 14, wherein a coolant in the liquid form circulates to the said distal heat conductive element which acts like an evaporator thereby transferring heat from the surrounding area and returning the coolant in its gaseous format to an external condenser.

20. The method of claim 14, wherein said cerebrospinal fluid space being a ventricle of the brain with the said catheter secured to the skull.

21. The method of claim 14, wherein hypothermia is used for cerebral insult following either trauma, ischemia, hypoxia, seizure, and/or cerebral swelling.

22. The method of claim 14, wherein the said cerebrospinal fluid space being the subdural space of the spine thereby selectively cooling the spinal cord.

23. The method of claim 14, wherein hypothermia is used for protection of the spinal cord following either trauma, ischemia, swelling, or aortic aneurysm surgery.

24. The said catheter of claim 14, wherein the outer lumen expands when the heat exchange fluid is circulated.

25. A method for selectively cooling the central nervous system comprising the steps of:

A. providing a flexible heat exchange template of varying length and width with small thickness and a proximal and distal end;

B. proximal end of the said heat exchange template consisting of a conduit that allows heat exchange fluid to circulate in the template lumen;

C. inserting the template into the subdural or epidural space of the brain or spinal cord;

D. circulating the heat exchange fluid with temperature below the body temperature through the template, thereby transferring heat from the nervous system to the cool heat exchange fluid;

E. returning the heat exchange fluid through the proximal conduit to an external cooler.

26. The method of claim 25, wherein insertion of the template into the subdural or epidural space of the brain follows a craniotomy or burr hole placement.

27. The method of claim 25, wherein insertion of the template into the subdural or epidural space of the spinal cord follows a laminectomy or laminotomy.

28. The method of claim 25, further comprising the steps of:

F. providing a temperature sensor placed on the said template so that it senses the temperature of the brain or spinal cord;

G. providing an external heat exchange fluid temperature and flow regulator connected to the proximal end of the said template;

H. achieving a desired temperature of the brain or spinal cord by controlling the amount of heat transferred from the heat exchanger through regulation of the heat exchange fluid temperature and flow rate.

29. The method of claim 25, wherein the said template further comprises one or more sensors at or adjacent to the distal end of the catheter selected from a group consisting of:

pressure, temperature, oxygenation, carbonation, metabolite, and pH sensors.

30. The method of claim 25, wherein the said heat exchange fluid circulates through two lumens in the said template which communicate at the distal end.

31. The method of claim 25, wherein the said heat exchange fluid enters the said template through one or more internal conduits of various lengths in the said lumen of the template.

32. The method of claim 25, wherein the said heat exchange template is made from a material selected from the group comprising of:

metal, plastic, or latex.

33. The method of claim 25, wherein the said heat exchange fluid is made from a material selected from the group comprising of:

a compressed refrigerant, a coolant, saline, lactated Ringer'"'"'s solution, or water.

34. The method of claim 25, wherein the said template includes a working lumen with a distal port for communicating with the subarachnoid, subdural or epidural space.