Devices and methods for removing cerebrospinal fluids from a patient's CSF space

• US 6,875,192 B1
• Filed: 03/31/2003
• Issued: 04/05/2005
• Est. Priority Date: 11/10/1998
• Status: Expired due to Term

• Current Assignee: Integra Lifesciences Corporation (Integra LifeSciences Holdings Corporation)
• Original Assignee: Eunoe, Inc. (Integra LifeSciences Holdings Corporation)
• Inventors: Sussman, Marvin L., Saul, Tom A.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/405,116
• Time in Patent Office: 736 Days
• Field of Search: 604/264, 604 8- 10, 604/247, 604/500, 604/28, 604/30, 604/33
• US Class Current: 604/9
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

Devices and methods for removing cerebrospinal fluid (CSF) from a CSF space of a patient at relatively constant flow rates for patients having normal intracranial pressures, e.g. patients not suffering from hydrocephalus. The devices and methods provide drainage paths which permit the removal of CSF at relatively low flow rates, usually below, 0.2 ml/min, at normal intracranial pressures, e.g. an intracranial pressure between −170 mm of H₂O in upright patients and 200 mm of H₂O in reclining patients. The removal of CSF at relatively low, constant rates is particularly suitable for treating Alzheimer'"'"'s disease and other conditions related to the presence of toxic and/or pathogenic substances in the CSF.

Claims

1. A method for reducing the level of toxic substances in cerebrospinal fluid (CSF) of a patient, said method comprising:

identifying a patient suffering from a condition related to the retention and accumulation of toxic substances in the CSF and having normal intracranial pressure below 200 mm H₂O when reclining and above −

170 when upright; and

establishing a drain path from a CSF space of the patient, wherein said drain path will remove CSF at a rate in the range from 0.01 ml/minute to 0.2 ml/minute while pressure in the subarachnoid space varies over the entire normal range from −

170 mm H₂O to 200 mm H₂O.

2. A method as in claim 1, wherein the drain path will remove CSF at a rate in the range from 0.03 ml/minute to 0.1 ml/minute over said pressure range.

3. A method as in claim 2, wherein the drain path will remove CSF at a rate in the range from 0.04 ml/minute to 0.06 ml/minute over said pressure range.

4. A method as in claim 1, wherein the CSF flow rate varies by no more than ±

75% as the CSF space pressure varies over said range.

5. A method as in claim 1, wherein the drain path extends into a peritoneal space, a pleural space, the venous system, or an external space.

6. A method as in claim 1, wherein the CSF flow rate varies by no more than ±

50% as the CSF space pressure varies over said range.

7. A method as in claim 1, wherein the CSF flow rate varies by no more than ±

20% as the CSF space pressure varies over said range.

8. A method as in claim 1, wherein the drain path will stop the flow of CSF from the subarachnoid region when pressure in the CSF space falls below −

170 mm H₂O.

9. A method as in claim 1, wherein the patient suffers from a disease selected from the group consisting of Alzheimer'"'"'s disease, Down'"'"'s Syndrome, and HCHWA-D.

10. A method as in claim 1, wherein establishing comprises implanting a conduit between the CSF space to a drainage location, wherein said conduit comprises a flow control component adapted to control the CSF flow rate in the range from 0.01 ml/minute to 0.2 ml/minute while pressure in the CSF space varies from −

170 mm H₂O to 200 mm H₂O.

11. A method as in claim 10, wherein the flow control component is adapted to control the CSF flow at a rate in the range from 0.03 ml/minute to 0.1 ml/minute over said pressure range.

12. A method as in claim 10, wherein the flow control component is adapted to control the CSF flow from 0.04 ml/minute to 0.06 ml/minute over said pressure range.

13. A method as in claim 10, wherein the flow control component establishes a CSF flow rate which varies no more than ±

75% in response to a CSF space pressure which varies over said range.

14. A method as in claim 10, wherein the flow control component establishes a CSF flow rate which varies by no more than ±

50% in response to a CSF space pressure which varies over said range.

15. A method as in claim 10, wherein the flow control component establishes a CSF flow rate which varies by no more than ±

20% in response to a CSF space pressure which varies over said range.

16. A method as in claim 1, further comprising stopping the flow of CSF from the CSF space when intracranial pressure falls below −

170 mm H₂O.

17. A method for reducing the level of toxic substances in cerebrospinal fluid (CSF) of a patient, said method comprising:

identifying a patient suffering from Alzheimer'"'"'s disease and having normal intracranial pressure below 200 mm H₂O when reclining and above −

170 when upright; and

establishing a drain path from a CSF space of the patient, wherein said drain path will remove CSF at a rate in the range from 0.01 ml/minute to 0.2 ml/minute while pressure in the subarachnoid space varies over the entire normal range from −

170 mm H₂O to 200 mm H₂O.

18. A method as in claim 17, wherein the drain path will remove CSF at a rate in the range from 0.03 ml/minute to 0.1 ml/minute over said pressure range.

19. A method as in claim 18, wherein the drain path will remove CSF at a rate in the range from 0.04 ml/minute to 0.06 ml/minute over said pressure range.

20. A method as in claim 17, wherein the CSF flow rate varies by no more than ±

75% as the CSF space pressure varies over said range.

21. A method as in claim 17, wherein the drain path extends into a peritoneal space, a pleural space, the venous system, or an external space.

22. A method as in claim 17, wherein the CSF flow rate varies by no more than ±

50% as the CSF space pressure varies over said range.

23. A method as in claim 17, wherein the CSF flow rate varies by no more than ±

20% as the CSF space pressure varies over said range.

24. A method as in claim 17, wherein the drain path will stop the flow of CSF from the subarachnoid region when pressure in the CSF space falls below −

170 mm H₂O.

25. A method as in claim 17, wherein establishing comprises implanting a conduit between the CSF space to a drainage location, wherein said conduit comprises a flow control component adapted to control the CSF flow rate in the range from 0.01 ml/minute to 0.2 ml/minute while pressure in the CSF space varies from −

170 mm H₂O to 200 mm H₂0.

26. A method as in claim 25, wherein the flow control component is adapted to control the CSF flow at a rate in the range from 0.03 ml/minute to 0.1 ml/minute over said pressure range.

27. A method as in claim 25, wherein the flow control component is adapted to control the CSF flow from 0.04 ml/minute to 0.06 ml/minute over said pressure range.

28. A method as in claim 25, wherein the flow control component establishes a CSF flow rate which varies no more than ±

75% in response to a CSF space pressure which varies over said range.

29. A method as in claim 25, wherein the flow control component establishes a CSF flow rate which varies by no more than ±

50% in response to a CSF space pressure which varies over said range.

30. A method as in claim 25, wherein the flow control component establishes a CSF flow rate which varies by no more than ±

20% in response to a CSF space pressure which varies over said range.

31. A method as in claim 17, further comprising stopping the flow of CSF from the CSF space when intracranial pressure falls below −

170 mm H₂O.

32. Apparatus for draining cerebrospinal fluid (CSF) from a CSF space of a patient, said apparatus comprising:

an access component having an inlet and an outlet; and

a flow control component connectable to the outlet of the access component to establish a drain path, wherein said flow control component is adapted to control the CSF flow rate in the range from 0.01 ml/minute to 0.2 ml/minute while pressure in the CSF space varies over the entire range from −

170 mm H₂O to 200 mm H₂O.

33. Apparatus as in claim 32, wherein the drain path is adapted to control the CSF flow at a rate in the range from 0.03 ml/minute to 0.1 ml/minute over said pressure range.

34. Apparatus as in claim 33, wherein the drain path is adapted to control the CSF flow from 0.04 ml/minute to 0.06 ml/minute over said pressure range.

35. Apparatus as in claim 32, wherein the flow control component establishes a CSF flow rate which varies no more than ±

75% in response to a CSF space pressure which varies over said range.

36. Apparatus as in claim 32, wherein the flow control component establishes a CSF flow rate which varies by no more than ±

50% in response to an CSF space pressure which varies over said range.

37. Apparatus as in claim 32, wherein the flow control component establishes a CSF flow rate which varies by no more than ±

20% in response to an CSF space pressure which varies over said range.

38. Apparatus as in claim 32, further comprising a disposal component connectable to the flow control component.

39. Apparatus as in claim 32, wherein the flow control element will stop the flow of CSF from the CSF space when intracranial pressure falls below −

170 mm H₂O.

40. Apparatus for draining cerebrospinal fluid (CSF) from a CSF space of a patient'"'"'s brain, said apparatus comprising:

an access component having an inlet and an outlet; and

a diaphragm valve connectable to the outlet of the access component and including a pressure-responsive diaphragm, a contoured plug, and an orifice which receives the contoured plug and permits the flow of CSF therethrough, wherein one of the plug and orifice is coupled to the diaphragm so that the plug and orifice will move reflective to each other in response to changes in pressure of CSF from the outlet of the access component against the diaphragm, wherein the contoured plug has a profile adapted to control the CSF flow rate through the orifice in the range from 0.01 ml/minute to 0.2 ml/minute while pressure in the CSF space varies over the entire range from −

170 mm H₂O to 200 mm H₂O.

41. Apparatus as in claim 40, wherein the orifice is coupled directly to the diaphragm.

42. Apparatus as in claim 40, further comprising a disposal component connectable to the diaphragm valve.

43. Apparatus as in claim 40, where the contoured plug profile is selected to remove CSF at a rate in the range from 0.03 ml/minute to 0.1 ml/minute over said pressure range.