Cognitive function within a human brain

• US 20070060974A1
• Filed: 12/16/2005
• Published: 03/15/2007
• Est. Priority Date: 12/17/2004
• Status: Active Grant

• Current Assignee: Functional Neuromodulation, Inc. (Functional Neuromodulation, Ltd.)
• Original Assignee: Functional Neuromodulation, Inc. (Functional Neuromodulation, Ltd.)
• Inventors: Lozano, Andres
• Granted Patent: US 8,000,795 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 27/006 Cerebrospinal drainage; Accessories therefor, e.g. valves
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36092 Mental training
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Methods and apparatus for improving cognitive function within a human. The invention utilizes an implanted device, such as an implantable signal generator or an implantable pump, to affect tissue elements within a Papez circuit of the human brain as well as tissue upstream or downstream from the Papez circuit. The implanted device delivers treatment therapy to thereby improve cognitive function by the human. A sensor may be used to detect various symptoms of the cognitive disorder. A microprocessor algorithm may then analyze the output from the sensor to regulate delivery of the stimulation and/or drug therapy.

Claims

1. A method for improving cognitive function within a human by means of an implantable signal generator and a lead having a proximal end coupled to the signal generator and a distal portion having at least one electrode, the method comprising:

(A) implanting at least one electrode so that the stimulation portion lies at least in communication with tissue elements wherein the tissue elements are selected from the group consisting of tissue within a Papez circuit of a human brain, tissue within a downstream target of the Papez circuit, and tissue within an upstream input to the Papez circuit;

(B) coupling the proximal end of the implanted electrode to the signal generator; and

(C) improving cognitive function by the human by operating the signal generator to deliver stimulation to the tissue elements of the Papez circuit.

2. A method as claimed in claim 1, wherein (C) is performed in relation to a learning task.

3. A method as claimed in claim 2, wherein the learning task is selected from the group consisting of a memory task, a cognitive task, and a motor task.

4. A method, as claimed in claim 1, wherein (A) comprises bilaterally implanting at least two electrodes.

5. A method as claimed in claim 1, wherein (A) comprises implanting the at least one electrode so that the stimulation portion lies in communication with tissue elements of the Papez circuit selected from the group consisting of the formix and the mammilothalamic tracts.

6. A method, as claimed in claim 1, wherein (C) comprises selecting amplitude, width and frequency of stimulation by the electrode.

7. A method, as claimed in claim 1, wherein (C) comprises operating the signal generator to pulse at a frequency between 0 Hertz and 300 Hertz.

8. A method, as claimed in claim 1, wherein (C) comprises operating the signal generator to pulse at a pulse amplitude between 0 Volts and 10 Volts.

9. A method, as claimed in claim 1, wherein (C) comprises operating the signal generator to pulse at a pulse width between 0 μ

Seconds and 400 μ

Seconds.

10. A method as claimed in claim 1, further comprising:

(D) sensing a characteristic indicative of the extent of cognitive function and generating a sensor signal; and

(E) regulating the operation of the signal generator in response to the sensor signal.

11. A method, as claimed in claim 10, wherein (D) comprises detecting a neurochemical characteristic of the cognitive function.

12. A method, as claimed in claim 10, wherein (D) comprises detecting a neurochemical characteristic selected from the group consisting of a neurotransmitter level, a pH concentration, an ion concentration, a lactate level, cerebral blood flow, glucose utilization, and oxygen extraction.

13. A method, as claimed in claim 10, wherein (D) comprises detecting an electro-physiological characteristic of the cognitive function.

14. A method, as claimed in claim 13, wherein (D) comprises detecting an electro-physiological characteristic selected from the group consisting of the activity of single neurons, local field potentials, event related potentials, an electroencephalogram, and an electrocorticogram.

15. A method as claimed in claim 10, wherein (E) comprises executing a control algorithm.

16. A method, as claimed in claim 10, wherein (E) comprises adjusting at least one parameter of the stimulation, the parameter being selected from the group consisting of amplitude, pulse width and frequency.

17. A method as claimed in claim 1, further comprising:

(D) sensing a characteristic indicative of the extent of cognitive function and generating a sensor signal; and

(E) if the sensor signal is outside of a predetermined threshold, improving cognitive function by initiating stimulation therapy by the signal generator.

18. A method, as claimed in claim 1, further comprising:

(D) implanting at least one secondary electrode so that a secondary stimulation portion lies in communication with a predetermined portion of a brain;

(E) coupling the secondary electrode to the signal generator; and

(F) operating the signal generator to stimulate the brain.

19. A method, as claimed in claim 1, further comprising:

(D) implanting at least one catheter so that a secondary stimulation portion lies in communication with the tissue elements wherein the tissue elements are selected from the group consisting of tissue within a Papez circuit of a human brain, tissue within a downstream target of the Papez circuit, and tissue within an upstream input to the Papez circuit;

(E) coupling the catheter to a pump; and

(F) operating the pump to deliver drug to the brain to thereby improve cognitive function by the human.

20. A therapeutic treatment method for improving cognitive function within a human by means of an implantable pump and at least one catheter having a proximal end coupled to the pump and a discharge portion for infusing therapeutic dosages of at least one drug, the method comprising:

(A) implanting the catheter so that the discharge portion lies in communication with tissue element wherein the tissue elements are selected from the group consisting of tissue within a Papez circuit of a human brain, tissue within a downstream target of the Papez circuit, and tissue within an upstream input to the Papez circuit;

(B) coupling the catheter to the pump; and

(C) improving cognitive function by the human by operating the pump to deliver the at least one drug to the tissue elements.

21. A method as claimed in claim 20, wherein (C) is performed in relation to a learning task.

22. A method as claimed in claim 21, wherein the learning task is selected from the group consisting of a memory task, a cognitive task, and a motor task.

23. A method as claimed in claim 20, wherein (A) comprises implanting the at least one catheter so that the discharge portion lies in communication with tissue elements of the Papez circuit selected from the group consisting of selected from the group consisting of the formix and the mammilothalamic tracts.

24. A method, as claimed in claim 20, wherein (C) comprises selecting a time interval for drug delivery.

25. A method, as claimed in claim 20, wherein (C) comprises delivering at least one drug dosage.

26. A method, as claimed in claim 20, wherein (C) comprises providing a constant drug delivery.

27. A method, as claimed in claim 20, wherein (C) comprises providing an intermittent drug delivery.

28. A method as claimed in claim 20, further comprising:

(D) sensing a characteristic indicative of the extent of cognitive function and generating a sensor signal; and

(E) regulating the operation of the pump in response to the sensor signal.

29. A method, as claimed in claim 28, wherein (D) comprises detecting a neurochemical characteristic of the cognitive function.

30. A method, as claimed in claim 28, wherein (D) detecting a neurochemical characteristic selected from the group consisting of a neurotransmitter level, a pH concentration, an ion concentration, a lactate level, cerebral blood flow, glucose utilization, and oxygen extraction.

31. A method, as claimed in claim 28, wherein (D) comprises detecting an electro-physiological characteristic of the cognitive function.

32. A method, as claimed in claim 28, wherein (D) comprises detecting an electro-physiological characteristic selected from the group consisting of the activity of single neurons, local field potentials, event related potentials, an electroencephalogram, and an electrocorticogram.

33. A method as claimed in claim 28, wherein (E) comprises executing a control algorithm.

34. A method of using one or more drugs to improving cognitive function within a human by means of an implantable pump and a catheter having a proximal end coupled to said pump and a discharge portion for infusing therapeutic dosages of said one or more drugs, as well as a signal generator and an implantable electrode having a proximal end and a stimulation portion, the method:

(A) surgically implanting the electrode so that the stimulation portion lies in communication with tissue elements wherein the tissue elements are selected from the group consisting of tissue within a Papez circuit of a human brain, tissue within a downstream target of the Papez circuit, and tissue within an upstream input to the Papez circuit;

(B) surgically implanting said catheter so that the discharge portion lies adjacent a predetermined infusion site in the brain;

(C) improving cognitive function by operating the signal generator to deliver high frequency stimulation the tissue elements; and

(D) improving cognitive function by operating the pump to discharge a predetermined dosage of at least one drug through the discharge portion of the catheter into the predetermined infusion site.