Methods for the treatment of a normal pressure hydrocephalus

• US 7,189,221 B2
• Filed: 03/04/2003
• Issued: 03/13/2007
• Est. Priority Date: 11/10/1998
• Status: Expired due to Term

• Current Assignee: Integra Lifesciences Corporation (Integra LifeSciences Holdings Corporation)
• Original Assignee: Integra Lifesciences Corporation (Integra LifeSciences Holdings Corporation)
• Inventors: Saul, Tom, Sussman, Marvin, Silverberg, Gerald, McGuire, Dawn
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): Mehta; Bhisma
• Application Number:
  US10/382,086
• Publication Number:
  US 20040068221A1
• Time in Patent Office: 1,470 Days
• Field of Search: 604 8- 10, 604/500, 604/503, 604/505, 604/506, 604/28, 604/30
• US Class Current: 604/500
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves

Abstract

Normal pressure hydrocephalus is treated by removing cerebralspinal fluid (CSF) from a CSF space of a patient. In particular, CSF is drained while pressure within the CSF space remains within an expected normal range for the patient.

Claims

1. A method for treating patients suffering from normal pressure

hydrocephalus (NPH), said method comprising:

identifying a patient suffering from NPH; and

establishing a drain path from a cerebrospinal fluid (CSF) space of the patient, wherein the drain path will (a) drain CSF at a substantially continuous flow rate so long as pressure in the CSF space remains within a normal range, and/or (b) drain a target volume of CSF while pressure in the CSF space remains within the normal range; and

wherein the drain path provides substantially continuous flow, at a 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.

2. A method as in claim 1, wherein identifying the patient comprising diagnosing symptoms selected form the group consisting of dementia, incontinence, and apraxia of gait.

3. A method as in claim 1, wherein the patient further suffers from Alzheimer'"'"'s disease (AD).

4. A method as in claim 1, wherein the patient does not suffer from Alzheimer'"'"'s disease (AD).

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

6. A method in claim 1, wherein the drain path will remove CSF at a rate in the range from 0.01 ml/minute to 0.1 ml/minute over said pressure range.

7. A method as in claim 6, 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.

8. 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.

9. A method as in claim 8, wherein the CSF flow rate varies by no more than ±

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

10. A method as in claim 9, wherein the CSF flow rate varies by no more than ±

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

11. A method as in claim 1, wherein the drain path will stop the flow of CSF from the subarachnoid region when differential pressure falls to a preselected pressure below 75 mm H₂O.

12. 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 m/minute to 0.2 ml/minute while pressure in the CSF space varies from −

170 mm H₂O to 200 mm H₂O.

13. A method as in claim 12, wherein the flow control component is adapted us control the CSF flow at a rate in the range of 0.03 ml/minute to 0.1 ml/minute over said pressure range.

14. A method as in claim 13, 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.

15. A method as in claim 12, wherein the flow control component establishes CSF flow which varies no more than ±

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

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

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

17. A method as in claim 16, wherein the flow control component establishes a CSF flow rate which varies by no more ±

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

18. A method as in claim 12, further comprising stopping the flow of CSF from the CSF space when differential pressure falls below 75 mm H₂O.

19. A method as in claim 1, wherein flow path modules flow through a flow path to remove the target volume of CSF within a predetermined time period.

20. A method as in claim 19, wherein the predetermined time period is one day.

21. A method as in claim 20, wherein the target volume is the same for each one-day time period.

22. A method as in claim 19, wherein the flow path removes different target volumes of CSF in at least some successive predetermined time periods.

23. A method as in claim 19, wherein the flow path removes target volumes of CSF in predetermined time periods having different lenghts.

24. A method as in claim 21, wherein the target volume of CSF to be removes in the one-day period is in the range from 15 ml to 1500 ml.

25. A method as in claim 19, wherein the flow path modulates flow by opening an on-off valve disposed in the flow path.

26. A method as in claim 25, wherein the time the valve has been opened is measured and the valve is closed after a preselected period of time has elapsed.

27. A method as in claim 25, wherein the volume of CSF which has been removed is measured and the valve is closed after predetermined volume of removed fluid has been measured.

28. A method as in claim 25, wherein the valve is opened and closed once during each predetermined time period.

29. A method as in claim 28, wherein the valve is opened for a period in the range from 1 hour to 8 hours and provides a flow rate of 0.5 ml/hour to 40 ml/hour.

30. A method as in claim 28, wherein the valve is opened from 2 to 10⁸ times each predetermined period.

31. A method as in claim 30, wherein the valve is opened for a preselected time sufficient to drain a volume of CSF in the range from 10⁻

5 ml to 40 ml while the valve is open.

32. A method as in claim 19, wherein the flow path is arranged so that the CSF volume removed in any 15-minute period will not exceed 15 ml and in one-hour period will not exceed 50 ml.

33. A method as in claim 19, wherein the flow path modulates flow by filling an accumulator with a predetermined volume of CSF and draining CSF from the accumulator after the accumulator has been filled.

34. A method as in claim 33, wherein the accumulator has a predetermined fill volume in the range from 10⁻

5 to 40 ml and the accumulator is filled and drained from 1 time to 1.5×

10⁶ times during each one-day period.