Medical device for selective intrathecal spinal cooling in aortic surgery and spinal trauma

• US 6,379,331 B2
• Filed: 03/29/2001
• Issued: 04/30/2002
• Est. Priority Date: 03/01/1999
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Coaxis Incorporated (Trimble Inc.)
• Inventors: Barbut, Denise R., Heinemann, Mark-Hein, Patterson, Russel H.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/823,168
• Publication Number:
  US 20010020159A1
• Time in Patent Office: 397 Days
• Field of Search: 604/27, 604/28, 604/500, 604/508, 604/113, 604/158, 604/164.01, 607/96, 607/113, 607/117
• US Class Current: 604/113
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

The invention provides a medical device having two elongate catheters, a pump, a refrigeration system, and a manometer. Each catheter has a proximal end, a distal end, a lumen therebetween and communicating with a distal port. The proximal ends of the catheters are connected to the pump and the refrigeration system. The distal ends are adapted for insertion into the subarachnoid space. The cerebral spinal fluid is aspirated from the first catheter to the pump, cooled to below body temperature, and returned to the second catheter. The flow rate of the cerebral spinal fluid is adjusted according the CSF pressure and temperature. Methods of using the devices in treating patients suffering from spinal trauma and undergoing aortic surgery are also disclosed.

Claims

1. A method for preventing neurologic damage, comprising the steps of:

providing first and second elongate tubular members, each member having a lumen communicating with a port at a distal end;

inserting the first tubular member between lumbar vertebrae into the subarachnoid space;

inserting the second tubular member between lumbar vertebrae into the subarachnoid space, and advancing the distal port cephalad and locating the port in the cervical or thoracic region of the spine;

aspirating or draining cerebral spinal fluid (CSF) from the spinal column through one of the first tubular member or second tubular member;

cooling the CSF by extracorporeal refrigeration; and

perfusing the CSF into the spinal column through the other of the first tubular member or second tubular member, wherein the spinal cord is cooled to below normal body temperature, and wherein CSF pressure is reduced to and maintained at a level substantially below normal CSF pressure.

2. The method of claim 1, wherein the first and second tubular members are inserted over a needle.

3. The method of claim 1, further comprising the step of measuring CSF pressure using a manometer.

4. The method of claim 1, wherein the method cools the spinal cord to prevent neurologic damage during inadequate spinal perfusion.

5. The method of claim 1, further comprising the step of releasing CSF to reduce the pressure in the subarachnoid space.

6. The method of claim 1, further comprising the step of performing aortic surgery.

7. The method of claim 6, wherein the surgery is any one of thoracic and abdominal aortic aneurysm repair.

8. The method of claim 1, further comprising the step of mixing CSF with Ringer'"'"'s lactate solution.

9. The method of claim 1, further comprising the step of adjusting the CSF flow rate.

10. The method of claim 1, further comprising the step of measuring CSF temperature.

11. The method of claim 1, further comprising the step of infusing fluid or neuroprotective agent into the subarachnoid space.

23. The method of claim 1, wherein the method cools the spinal cord to prevent neurologic damage during inadequate spinal perfusion.

12. A method for preventing neurologic damage, comprising the steps of:

providing first and second elongate tubular members, each member having a lumen communicating with a port at a distal end;

inserting the first tubular member between lumbar vertebrae into the subarachnoid space;

inserting the second tubular member between low cervical vertebrae into the subarachnoid space, and advancing the distal port cephalad or caudal and locating the port in the cervical, thoracic, or lumbar region of the spine;

aspirating cerebral spinal fluid (CSF) from the spinal column through one of the first tubular member or second tubular member;

cooling the CSF by extracorporeal refrigeration; and

perfusing the CSF into the spinal column through the other of the first tubular member or second tubular member, wherein the spinal cord is cooled to below normal body temperature and wherein CSF pressure is reduced to and maintained at a level substantially below normal CSF pressure.

13. The method of claim 12, wherein the first and second tubular members are inserted over a needle.

14. The method of claim 12, further comprising the step of measuring CSF pressure using a manometer.

15. The method of claim 12, further comprising the step of releasing CSF to reduce the pressure in the subarachnoid space.

16. The method of claim 12, further comprising the step of performing aortic surgery.

17. The method of claim 16, wherein the surgery is any one of thoracic and abdominal aortic aneurysm repair.

18. The method of claim 12, further comprising the step of infusing fluid into the subarachnoid space, and wherein the CSF is mixed with the fluid.

19. The method of claim 18, wherein the fluid is Ringer'"'"'s lactate or saline solution.

20. The method of claim 12, further comprising the step of adjusting the CSF flow rate.

21. The method of claim 12, wherein the second tubular member is inserted between vertebrae C6 and C7.

22. The method of claim 12, wherein the second tubular member is inserted between vertebrae C7 and T1.

24. A method for treating stroke, comprising the steps of:

providing first and second elongate tubular members, each member having a lumen communicating with a port at a distal end;

inserting the first tubular member between lumbar vertebrae into the subarachnoid space;

inserting the second tubular member between lumbar vertebrae into the subarachnoid space, and advancing the distal port cephalad and locating the port in the cervical or thoracic region of the spine;

aspirating or draining cerebral spinal fluid (CSF) from the spinal column through one of the first tubular member or second tubular member;

perfusing the CSF into the spinal column through the other of the first tubular member or second tubular member, wherein CSF pressure is reduced to and maintained at a level substantially below normal CSF pressure; and

injecting one or more pharmaceutical agents through the other of the first tubular member or second tubular member.

25. The method of claim 24, wherein the one or more pharmaceutical agents is a neuroprotective agent.

26. The method of claim 24, wherein the one or more pharmaceutical agents causes cooling of the spinal cord.

27. The method of claim 24, further comprising the step of cooling the CSF by extracorporeal refrigeration.

28. The method of claim 27, wherein the spinal cord is cooled to below normal body temperature.

29. The method of claim 24, wherein the first and second tubular members are inserted over a needle.

30. The method of claim 24, further comprising the step of measuring CSF pressure using a manometer.

31. The method of claim 24, further comprising the step of releasing CSF to reduce the pressure in the subarachnoid space.

32. The method of claim 24, further comprising the step of performing aortic surgery.

33. The method of claim 32, wherein the surgery is any one of thoracic and abdominal aortic aneurysm repair.

34. The method of claim 24, further comprising the step of mixing CSF with Ringer'"'"'s lactate solution.

35. The method of claim 24, further comprising the step of measuring CSF temperature.