Apparatus and method for monitoring and treatment of brain disorders

• US 20070060973A1
• Filed: 09/12/2005
• Published: 03/15/2007
• Est. Priority Date: 09/12/2005
• Status: Active Grant

• Current Assignee: New York University
• Original Assignee: New York University
• Inventors: Blumenfeld, Walter, Devinsky, Orrin, Ludvig, Nandor, Medveczky, Geza, Kuzniecky, Ruben, Kovacs, Lorant, Doyle, Werner
• Granted Patent: US 9,042,974 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/4839 combined with drug delivery

Abstract

A method and system for treating brain disorders comprises detecting activity of a first target area of the brain via a first implanted sensor and determining the presence of target brain activity by analyzing the detected brain activity in combination with treating the user based upon the determined presence of target brain activity by supplying a first therapeutic agent to the first target area via a first implanted fluid delivery member including at least one distal opening adjacent to the first target area. In addition, the system may be used as well for testing the effectiveness of drugs.

Claims

1. A method of treating brain disorders, comprising the steps of:

detecting activity of a first target area of the brain via a first implanted sensor;

determining the presence of target brain activity by analyzing the detected brain activity; and

treating the user based upon the determined presence of target brain activity by supplying a first therapeutic agent to the first target area via a first implanted fluid delivery member including at least one distal opening adjacent to the first target area.

2. The method according to claim 1, wherein the first sensor is a neurochemical sensor.

3. The method according to claim 2, wherein the first sensor is implanted adjacent to the first target area.

4. The method according to claim 2, further comprising a fluid reservoir implanted remote from the brain.

5. The method according to claim 4, wherein the first sensor is implanted adjacent to the fluid reservoir for analyzing fluid within the fluid reservoir.

6. The method according to claim 1, wherein the first sensor includes an electrode implanted adjacent to the first target area.

7. The method according to claim 6, wherein the electrode is an electrophysiological recording electrode.

8. The method according to claim 1, wherein the at least one distal opening of the first implanted fluid delivery member comprises a plurality of perforations defining an active area of the first implanted fluid delivery member.

9. The method according to claim 8, further comprising the step of flushing the first implanted fluid delivery member with a cleansing fluid.

10. The method according to claim 1, wherein the presence and onset of brain disorder activity is determined by means of a vector-based signal analysis, comprising the steps of:

converting the detected brain activity into a series of vectors;

analyzing a magnitude and a direction of individual vectors; and

analyzing a frequency of a plurality of target vectors related by at least one of magnitude and direction.

11. The method according to claim 10, wherein the vector analysis utilizes control data corresponding to the target brain activity.

12. The method according to claim 10, wherein one of the magnitude and direction of the individual vectors is compared to a corresponding threshold value and wherein individual vectors wherein the one of the magnitude and direction exceeds the threshold value are included in the plurality of target vectors.

13. The method according to claim 1, wherein a telemetry system communicates the results of the detection and analysis of brain activity to an external output device.

14. The method according to claim 13, wherein the telemetry system receives data transmitted from an external device to control the delivery of the first therapeutic agent.

15. The method according to claim 13, wherein the delivery of the first therapeutic agent is controlled based on a vector analysis of data from the implanted sensor.

16. The method according to claim 1, wherein the first therapeutic agent is supplied to the first implanted fluid delivery member by an implanted pump.

17. The method according to claim 16, wherein the pump obtains the first therapeutic agent from an implanted reservoir.

18. The method according to claim 17, wherein the reservoir includes a plurality of chambers with the first therapeutic agent stored in a first one of the chambers and a second therapeutic agent stored in a second one of the chambers, the pump drawing from each of the first and second chambers to supply desired amounts of each of the first and second therapeutic agents to the first implanted fluid delivery member.

19. The method according to claim 17, wherein the reservoir includes a plurality of chambers with the first therapeutic agent stored in a first one of the chambers and a second therapeutic agent stored in a second one of the chambers, the pump drawing from each of the first and second chambers to supply a first amount of the first therapeutic agent to the first implanted fluid delivery member and a second amount of the second therapeutic agent to a second implanted fluid delivery member for application to a second target area of the brain.

20. The method according to claim 17, wherein the reservoir is subcutaneously disposed, further comprising the step of refilling the contents of the reservoir through the surface of the skin.

21. The method according to claim 1, wherein the detected brain activity is analyzed by an implanted microprocessor.

22. The method according to claim 1, wherein the first implanted sensor and the first implanted fluid delivery member are coupled to one another.

23. The method according to claim 9, wherein the system includes an implanted processor controlling the pump to flush the fluid delivery member based on one of a schedule and data corresponding to a degree of blocking of an opening of the fluid delivery member.

24. The method according to claim 23, wherein the pump supplies, from a first chamber, the cleansing fluid and supplies, from a second chamber, the first therapeutic agent.

25. The method according to claim 23, wherein the fluid delivery member includes a plurality of perforations in an active distal area thereof.

26. The method according to claim 10, wherein the vector-based signal analysis further comprises the step of determining a first set of parameters for the calculated vectors predictive of onset of target brain activity and a second set of parameters for the calculated vectors indicating the onset of target brain activity.

27. The method according to claim 1, wherein an active portion of the fluid delivery member includes a plurality of perforations extending through an outer wall to an internal lumen thereof, further comprising the step of implanting the fluid delivery member in a subdural space of the user with the active portion of the fluid delivery member located adjacent to the target area.

28. The method according to claim 27, further comprising the step of providing a seal between a dura mater/arachnoid and an outer surface of the cerebral cortex of the user enclosing the active portion of the fluid delivery member.

29. The method according to claim 28, further comprising:

implanting a second fluid delivery member and a second sensor at a second target brain area; and

supplying one of the first therapeutic agent and a second therapeutic agent to the second target area via the second implanted fluid delivery member.

30. The method according to claim 10, wherein the conversion of the detected brain activity into a series of vectors, the analysis of the magnitude and direction of individual vectors and the analysis of the frequency of a plurality of target vectors related by at least one of magnitude and direction are performed by a single device.

31. The method according to claim 10, wherein the conversion of the detected brain activity into a series of vectors, the analysis of the magnitude and direction of individual vectors and the analysis of the frequency of a plurality of target vectors related by at least one of magnitude and direction are distributed over a plurality of devices.

32. The method according to claim 1, further comprising the step of transmitting a signal from a device outside the body to control the supply of the first therapeutic agent to the first target area via the first implanted fluid delivery member.

33. The method according to claim 9, further comprising the step of transmitting a signal from a device outside the body to control the flushing of the first fluid delivery member.

34. The method according to claim 1, wherein the detected brain activity is analyzed by an implanted controller and wherein the implanted controller controls the supply of the first therapeutic agent to the first target area.

35. A system for treating brain disorders, comprising:

a first sensor for implantation a first target area of the brain to detect data corresponding to target brain activity;

an implantable processor analyzing data received from the first sensor to determine the presence of target brain activity;

a first fluid delivery for implantation adjacent to the first target area; and

a controller analyzing data received from the first sensor and supplying a first therapeutic fluid to the first target area via the first fluid delivery member when target brain activity is detected.

36. The system according to claim 35, wherein the first sensor is implanted within a subdural space adjacent to the first target area of the brain.

37. The system according to claim 35, further comprising:

a second sensor for implantation at a second target area of the brain to detect data corresponding to target brain activity; and

a second fluid delivery member for implantation adjacent to the second target area, the processor analyzing data received from the first and second sensors and supplying one of the first therapeutic fluid and a second therapeutic fluid to the second target area via the second fluid delivery member when target brain activity is detected.

38. The system according to claim 35, wherein the first sensor is a neurochemical sensor.

39. The system according to claim 35, further comprising a fluid reservoir implanted remote from the brain.

40. The system according to claim 35, wherein the first fluid delivery member includes at least one distal opening having a plurality of perforations defining an active area of the first fluid delivery member.

41. The system according to claim 35, wherein processor utilizes a vector-based signal analysis to converting the detected brain activity into a series of vectors, the processor analyzes a magnitude and a direction of individual vectors and the processor analyzes a frequency of a plurality of target vectors related by at least one of magnitude and direction.

42. The system according to claim 35, further comprising a telemetry system communicating data to an external output device.

43. The system according to claim 35, further comprising an implanted pump supplying to the first fluid delivery member a cleansing fluid for flushing the first fluid delivery member.

44. The system according to claim 43, wherein the implanted pump supplies the first therapeutic agent and the cleansing fluid to the first fluid delivery member.

45. The system according to claim 35, wherein the processor includes a first one of a plurality of devices, the plurality of devices including a microprocessor, a digital signal processor, a programmable logic array, a programmable logic device, a field programmable device and an application specific integrated circuit.

46. The system according to claim 45, wherein the processor includes a second one of the plurality of devices.

47. The system according to claim 46, wherein the first and second ones of the plurality of devices are the same types of devices.

48. The system according to claim 46, wherein the first and second ones of the plurality of devices are different types of devices.

49. The system according to claim 42, wherein the data communicated to an external device includes results of the detection and analysis of brain activity.

50. The system according to claim 42, wherein the data communicated to an external device includes one of EEG signals, status related to an operational status of the system, and programming updates.