Hybrid neuroprosthesis for the treatment of brain disorders

• US 6,497,699 B1
• Filed: 08/09/2000
• Issued: 12/24/2002
• Est. Priority Date: 08/09/2000
• Status: Expired due to Fees

• Current Assignee: The Research Foundation for The State University of New York (State University of New York)
• Original Assignee: The Research Foundation for The State University of New York (State University of New York)
• Inventors: Ludvig, Nandor, Kovacs, Lorant
• Primary Examiner(s): Tanner, Harry B.
• Application Number:
  US09/634,172
• Time in Patent Office: 867 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604/65, 604/66, 604/67, 604/788.01, 604/288.04, 604/93.01, 604/500, 604/503, 600/372, 600/373, 600/374, 600/377, 600/378, 600/382, 600/383, 600/544, 600/545
• US Class Current: 604/891.1
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: Y10S 977/903 for conversion, containment, or destruction of hazardous material

Abstract

A miniature apparatus for the treatment of brain disorders is provided which is a combination of electronic and pharmacological devices placed and powered entirely within the human body. The apparatus is based on the dual, electrical—molecular, nature of intercellular communication in the brain. The hybrid neuroprosthesis monitors the electrical activity of a dysfunctioning brain area, analyzes the incoming electrical signals, and delivers drug molecules into the dysfunctioning area to correct its function. The apparatus delivers drugs into the brain in such a way that the timing and duration of the drug deliveries are determined by the brain'"'"'s own electrical activity. The hybrid neuroprosthesis includes (a) an electrophysiological recording electrode implanted in a dysfunctioning brain site, (b) a miniature electrical signal conditioner to amplify, filter and digitize the incoming electrophysiological signals, (c) a cannula or catheter implanted in the dysfunctioning brain site, (d) a miniature, refillable pump for driving drug solutions through the cannula or catheter, (e) a microcontroller which analyzes on-line the digitized electrophysiological signals and either activates or inactivates the pump on the basis of the analyzed electrophysiological data, (f) a miniature radiotelemetry system which provides data transfer between the apparatus and the outside world, and (g) a rechargeable power supply to power the components of the apparatus. The recording electrode can be complemented with a neurochemical sensor to transmit not only electrophysiological but also neurochemical information from the dysfunctioning brain area to the microcontroller. The components of the apparatus are encapsulated in medical grade silicon.

Claims

1. An apparatus for the treatment of brain disorders in a subject, the apparatus comprising:

a drug delivery means implanted in the subject for delivering at least one drug solution to the brain of the subject;

a drug driving means for delivering the at least one drug solution to the drug delivery means;

a recording electrode implanted in the brain for outputting a first electrical signal characteristic of an electrical activity of the brain;

a neurochemical sensor for detecting neurochemical signals of the brain and converting the neurochemical signals to a second electrical signal; and

a microcontroller controlling the drug driving means on the basis of the first and second electrical signals.

2. The apparatus of claim 1, wherein the drug driving means is subcutaneously disposed in the subject.

3. The apparatus of claim 1, wherein the microcontroller is subcutaneously disposed in the subject.

4. The apparatus of claim 1, wherein the drug delivery means is a cannula.

5. The apparatus of claim 4, wherein the cannula is a multi-port cannula having a plurality of ports, each port delivering the at least one drug solution to a corresponding portion of the brain.

6. The apparatus of claim 4, wherein the cannula is a intraventricular cannula for delivering the at least one drug solution to a substantial portion of the brain.

7. The apparatus of claim 4, wherein the drug delivery means is a catheter.

8. The apparatus of claim 1, wherein the drug delivery means is implanted in the brain of the subject.

9. The apparatus of claim 1, wherein the drug delivery means is implanted in the ventricular system of the subject.

10. The apparatus of claim 1, wherein the drug driving means further includes a drug reservoir for holding the drug solution.

11. The apparatus of claim 10, wherein the drug reservoir is subcutaneously disposed in the subject.

12. The apparatus of claim 11, further comprising a reservoir input for supplying the at least one drug solution to the drug reservoir, the reservoir input being in fluid communication with the drug reservoir and externally accessible on a surface of the skin of the subject.

13. The apparatus of claim 12, wherein the reservoir input is a self-sealing syringe fitting.

14. The apparatus of claim 1, wherein the recording electrode is an EEG electrode.

15. The apparatus of claim 1, wherein the recording electrode outputs a signal corresponding to a rate of neuron cell firings per unit time.

16. The apparatus of claim 1, further comprising an electrical signal conditioner disposed between the recording electrode and the microcontroller for recording the signal from the brain and inputting the recorded signal to the microcontroller.

17. The apparatus of claim 16, wherein the electrical signal conditioner is subcutaneously disposed in the subject.

18. The apparatus of claim 1, wherein the microcontroller further comprises an electrical signal conditioner having an amplifier for amplifying the signal, a filter for filtering the noise from the analog signal, and an analog to digital converter for converting the filtered analog signal to a digital signal, the digital signal being input to the microcontroller.

19. The apparatus of claim 1, further comprising a power source for supplying power to the drug driving means and microcontroller.

20. The apparatus of claim 19, wherein the power source is a rechargeable battery.

21. The apparatus of claim 20, wherein the battery is subcutaneously disposed in the subject.

22. The apparatus of claim 1, further comprising a container subcutaneously disposed in the subject for housing the microcontroller and drug driving means.

23. The apparatus of claim 17, further comprising a container subcutaneously disposed in the subject for housing the microcontroller, drug driving means, and electrical signal conditioner.

24. The apparatus of claim 21, further comprising a container subcutaneously disposed in the subject for housing the microcontroller, drug driving means, and battery.

25. The apparatus of claim 22, wherein the container is an elastomer case.

26. The apparatus of claim 25, wherein the elastomer case is fabricated from medical grade silicon.

27. The apparatus of claim 1, further comprising a neurochemical sensor for detecting neurochemical signals of the brain and converting the neurochemical signals to electrical signals, the microcontroller also analyzing the converted electrical signals from the neurochemical sensor and controlling the drug driving means on the basis thereof.

28. The apparatus of claim 1, further comprising a communication system for allowing wireless data exchange from the microcontroller to a remote location.

29. A method for treating brain disorders in a subject, the method comprising the steps of:

implanting a drug delivery means in the subject for delivering at least one drug solution to the brain of the subject;

subcutaneously disposing a drug driving means in the subject for delivering the at least one drug solution to the drug delivery means;

implanting a recording electrode in the brain of the subject for outputting a first electrical signal characteristic of an electrical activity of the brain;

implanting a neurochemical sensor in the brain for detecting neurochemical signals of the brain and converting the neurochemical signals to a second electrical signal;

subcutaneously disposing a microcontroller in the subject; and

controlling the drug driving means on the basis of the first and second electrical signals to deliver the at least one drug solution to the brain of the subject.

30. The method of claim 29, wherein the drug delivery means is a multi-port cannula having a plurality of ports, the method further comprising the step of delivering the drug solution to each port corresponding to a different portion of the brain.

31. The method of claim 29, wherein the drug delivery means is a intraventricular cannula, the method further comprising the step of delivering the drug solution to a substantial portion of the brain.

32. The method of claim 29, wherein the implanting of the drug delivery means comprises implanting the drug delivery means in the brain of the subject.

33. The method of claim 29, wherein the implanting of the drug delivery means comprises implanting the drug delivery means in the ventricular system of the subject.

34. The method of claim 29, further comprising the step of subcutaneously disposing a drug reservoir in the subject for holding the at least one drug solution.

35. The method of claim 34, wherein the step of subcutaneously disposing a drug reservoir in the subject further comprises disposing a reservoir input in fluid communication with the drug reservoir on a surface of the skin of the subject and further comprising the step of supplying the drug solution to the drug reservoir through the reservoir input.

36. The method of claim 29, further comprising the step of outputting the electrical signal corresponding to a rate of neuron cell firings per unit time.

37. The method of claim 29, further comprising the step of subcutaneously disposing a recorder in the subject between the recording electrode and the microcontroller for recording the signal from the brain and inputting the recorded signal to the microcontroller.

38. The method of claim 29, further comprising the steps of amplifying the signal, filtering the analog signal, and converting the filtered analog signal into digital signal being input to the microcontroller.

39. The method of claim 29, further comprising the step of subcutaneously disposing a battery in the subject for supplying power to the drug driving means and microcontroller.

40. The method of claim 29, further comprising the steps of housing the microcontroller and drug driving means in a container and subcutaneously disposing the container in the subject.

41. The method of claim 40, wherein the step of subcutaneously disposing the container in the subject comprises subcutaneously disposing the container at the base of the brain and back of the neck.

42. The method of claim 29, wherein the controlling step comprises the step of supplying power to the drug driving means to deliver drug solution to the brain of the subject when the electrical signal reaches a predetermined threshold.

43. The method of claim 42, wherein the supplying step comprises the step of continuing to supply power to the drug driving means for a predetermined time to deliver a predetermined amount of drug solution to the brain.

44. The method of claim 42, wherein the supplying step comprises the step of continuing to supply power to the drug driving means until the signal retracts from the predetermined threshold.

45. The method of claim 29, wherein the brain disorder is selected from a group consisting of stroke, epilepsy, Alzheimer'"'"'s disease, and Parkinson'"'"'s disease.