CA2418070A1 - Hybrid neuroprosthesis for the treatment of brain disorders - Google Patents

Hybrid neuroprosthesis for the treatment of brain disorders Download PDF

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Publication number
CA2418070A1
CA2418070A1 CA002418070A CA2418070A CA2418070A1 CA 2418070 A1 CA2418070 A1 CA 2418070A1 CA 002418070 A CA002418070 A CA 002418070A CA 2418070 A CA2418070 A CA 2418070A CA 2418070 A1 CA2418070 A1 CA 2418070A1
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Canada
Prior art keywords
drug
brain
subject
microcontroller
subcutaneously
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Granted
Application number
CA002418070A
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French (fr)
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CA2418070C (en
Inventor
Nandor Ludvig
Lorant Kovacs
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Research Foundation of State University of New York
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Individual
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Publication of CA2418070A1 publication Critical patent/CA2418070A1/en
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Publication of CA2418070C publication Critical patent/CA2418070C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14276—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body specially adapted for implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526—Head electrodes
    • A61N1/0529—Electrodes for brain stimulation
    • A61N1/0531—Brain cortex electrodes
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S977/00—Nanotechnology
    • Y10S977/902—Specified use of nanostructure
    • Y10S977/903—Specified use of nanostructure for conversion, containment, or destruction of hazardous material

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Psychology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Radiology & Medical Imaging (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Hospice & Palliative Care (AREA)
  • Electrotherapy Devices (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

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 (46)

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 an electrical signal characteristic of an electrical activity of the brain; and a microcontroller controlling the drug driving means on the basis of the electrical signal.
2. The apparatus of claim 1, wherein the drug driving means is subcutaneously disposed in the subject.
3. The apparatus of claim 1 or 2, wherein the microcontroller is subcutaneously disposed in the subject.
4. The apparatus of any one of claims 1-3, 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 any one of claims 1-3, wherein the drug delivery means is a catheter.
8. The apparatus of any one of claims 1-3, wherein the drug delivery means is a microdialysis probe.
9. The apparatus of any one of claims 1-8, wherein the drug delivery means is implanted in the brain of the subject.
10. The apparatus of any one of claims 1-8, wherein the drug delivery means is implanted in the ventricular system of the subject.
11. The apparatus of any one of claims 1-10, wherein the drug driving means further includes a drug reservoir for holding the drug solution.
12. The apparatus of claim 11, wherein the drug reservoir is subcutaneously disposed in the subject.
13. The apparatus of claim 12, 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.
14. The apparatus of claim 13, wherein the reservoir input is a self-sealing syringe fitting.
15. The apparatus of any one of claims 1-14, wherein the recording electrode is an EEG electrode.
16. The apparatus of any one of claims 1-15, wherein the recording electrode outputs a signal corresponding to a rate of neuron cell firings per unit time.
17. The apparatus of any one of claims 1-16, 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.
18. The apparatus of claim 17, wherein the electrical signal conditioner is subcutaneously disposed in the subject.
19. The apparatus of any one of claims 1-18, 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.
20. The apparatus of any one of claims 1-19, further comprising a power source for supplying power to the drug driving means and microcontroller.
21. The apparatus of claim 20, wherein the power source is a rechargeable battery.
22. The apparatus of claim 21, wherein the battery is subcutaneously disposed in the subject.
23. The apparatus of any one of claims 1-22, further comprising a container subcutaneously disposed in the subject for housing the microcontroller and drug driving means.
24. The apparatus of claim 18, further comprising a container subcutaneously disposed in the subject for housing the microcontroller, drug driving means, and electrical signal conditioner.
25. The apparatus of claim 22, further comprising a container subcutaneously disposed in the subject for housing the microcontroller, drug driving means, and battery.
26. The apparatus of claim 23, wherein the container is an elastomer case.
27. The apparatus of claim 26, wherein the elastomer case is fabricated from medical grade silicon,
28. The apparatus of any one of claims 1-27, further comprising a neurochemical sensor fox 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
29. The apparatus of any one of claims 1-28, further comprising a communication system for allowing wireless data exchange from the microcontroller to a remote location.
30. 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 an electrical signal characteristic of an electrical activity of the brain;
subcutaneously disposing a microcontroller in the subject; and controlling the drug driving means on the basis of the electrical signal to deliver the at least one drug solution to the brain of the subject.
31. The method of claim 30, wherein the drug delivery means is a mufti-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.
32. The method of claim 30, wherein the chug delivery means is a intraventricular cannula, the method further comprising the step of delivering the drug solution to a substantial portion of the brain.
33. The method of any one of claims 30-32, wherein the implanting of the drug delivery means comprises implanting the drug delivery means in the brain of the subject.
34. The method of any one of claims 30-32, wherein the implanting of the drug delivery means comprises implanting the drug delivery means in the ventricular system of the subject.
35. The method of any one of claims 30-34, further comprising the step of subcutaneously disposing a drug reservoir in the subject for holding the at least one drug solution.
36. The method of claim 35, 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.
37. The method of any one of claims 30-36, further comprising the step of outputting the electrical signal corresponding to a rata of neuron cell firings per unit time.
38. The method of any one of claims 30-37, 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.
39. The method of any one of claims 30-38, 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.
40. The method of any one of claims 30-39, further comprising the step of subcutaneously disposing a battery in the subject for supplying power to the drug driving means and microcontroller.
41. The method of any one of claims 30-40, further comprising the steps of housing the microcontroller and drug driving means in a container and subcutaneously disposing the container in the subject.
42. The method of claim 41, 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.
43. The method of any one of claims 30-42, 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.
44. The method of claim 43, 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.
45. The method of claim 43, 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.
46. The method of any one of claims 30-45, wherein the brain disorder is selected from a group consisting of stroke, epilepsy, Alzheimer's disease, and Parkinson's disease.

brain area to the microcontroller. The components of the apparatus are encapsulated in medical grade silicon.
CA2418070A 2000-08-09 2001-08-09 Hybrid neuroprosthesis for the treatment of brain disorders Expired - Fee Related CA2418070C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/634,172 US6497699B1 (en) 2000-08-09 2000-08-09 Hybrid neuroprosthesis for the treatment of brain disorders
US09/634,172 2000-08-09
PCT/US2001/024870 WO2002011703A1 (en) 2000-08-09 2001-08-09 Hybrid neuroprosthesis for the treatment of brain disorders

Publications (2)

Publication Number Publication Date
CA2418070A1 true CA2418070A1 (en) 2002-02-14
CA2418070C CA2418070C (en) 2010-06-29

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CA2418070A Expired - Fee Related CA2418070C (en) 2000-08-09 2001-08-09 Hybrid neuroprosthesis for the treatment of brain disorders

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US (1) US6497699B1 (en)
EP (1) EP1311245A4 (en)
JP (1) JP2004505675A (en)
AU (1) AU8119001A (en)
CA (1) CA2418070C (en)
HU (1) HUP0301698A2 (en)
WO (1) WO2002011703A1 (en)

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Also Published As

Publication number Publication date
EP1311245A1 (en) 2003-05-21
WO2002011703A1 (en) 2002-02-14
WO2002011703A9 (en) 2003-04-03
HUP0301698A2 (en) 2003-08-28
CA2418070C (en) 2010-06-29
JP2004505675A (en) 2004-02-26
EP1311245A4 (en) 2008-09-03
US6497699B1 (en) 2002-12-24
AU8119001A (en) 2002-02-18

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