System and method for treatment of mood and/or anxiety disorders by electrical brain stimulation and/or drug infusion

• US 20020013612A1
• Filed: 06/15/2001
• Published: 01/31/2002
• Est. Priority Date: 06/20/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Whitehurst, Todd K.
• Granted Patent: US 6,782,292 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A system and method for introducing one or more stimulating drugs and/or applying electrical stimulation to the brain to treat mood and/or anxiety disorders uses an implantable system control unit (SCU), specifically an implantable signal/pulse generator (IPG) or microstimulator with two or more electrodes in the case of electrical stimulation, and an implantable pump with one or more catheters in the case of drug infusion. In cases requiring both electrical and drug stimulation, one or more SCUs are used. Alternatively and preferably, when needed, an SCU provides both electrical stimulation and one or more stimulating drugs. In a preferred embodiment, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one SCU includes a sensor, and the sensed condition is used to adjust stimulation parameters.

Claims

1. A method of treating patients with mood and/or anxiety disorders, comprising:

implanting at least one system control unit in the skull or the brain of the patient, wherein the at least one unit controls the delivery of at least one stimulus to at least one area of the brain affecting mood and/or anxiety disorders;

applying the at least one stimulus to the at least one area of the brain in order to at least in part alleviate symptoms of the mood and/or anxiety disorder of the patient being treated,

wherein the at least one area of the brain is selected from at least one of the anterior cingulate gyrus, the dorsal prefrontal cortex, the dorsal raphe nuclei, the median raphe nuclei, the locus coeruleus, the ventral prefrontal cortex, the thalamus, the medial thalamus, the cerebellar vermis, the amygdala, the orbitofrontal cortex, and the caudate nucleus.

2. The method of treatment of claim 1 wherein the system control unit is connected to at least two electrodes, and wherein the stimulus comprises electrical stimulation delivered via the at least two electrodes.

3. The method of treatment of claim 1 wherein the system control unit is connected to at least one catheter, and wherein the stimulus comprises stimulation via one or more drugs delivered through the at least one catheter.

4. The method of treatment of claim 1 wherein the system control unit is connected to at least two electrodes and to at least one catheter, and wherein the stimulus comprises both electrical stimulation delivered via the at least two electrodes and stimulation via one or more drugs delivered through the at least one catheter.

5. The method of claim 1 wherein the stimulation increases excitement of at least one area of the brain affecting mood and/or anxiety disorders that exhibits chronic decreased activity.

6. The method of claim 5 wherein the stimulation is applied to one or more of the anterior cingulate gyrus, the dorsal prefrontal cortex, the dorsal raphe nuclei, the median raphe nuclei, and the locus coeruleus.

7. The method of claim 5 wherein the stimulation is electrical stimulation delivered at a frequency less than about 100 Hz.

8. The method of claim 5 wherein the stimulation is drug stimulation provided by at least one of an excitatory neurotransmitter agonist, an inhibitory neurotransmitter antagonist, an agent that increases the level of an excitatory neurotransmifter, and an agent that decreases the level of an inhibitory neurotransmitter.

9. The method of claim 8 wherein the excitatory drug is at least one of norepinephrine, epinephrine, glutamate, acetylcholine, serotonin, dopamine, and an agonist thereof.

10. The method of claim 1 wherein the stimulation decreases excitement of at least one area of the brain affecting mood and/or anxiety disorders that exhibits chronic increased activity.

11. The method of claim 10 wherein the stimulation is applied to one or more of the ventral prefrontal cortex, the thalamus, the medial thalamus, the cerebellar vermis, the amygdala, the orbitofrontal cortex, and the caudate nucleus.

12. The method of claim 10 wherein the stimulation is electrical stimulation delivered at a frequency greater than about 100 Hz.

13. The method of claim 10 wherein the stimulation is drug stimulation provided by at least one of an inhibitory neurotransmitter agonist, an excitatory neurotransmitter antagonist, an agent that increases the level of an inhibitory neurotransmitter, an agent that decreases the level of an excitatory neurotransmitter, and a local anesthetic agent.

14. The method of claim 13 wherein the inhibitory drug is at least one of GABA, glycine, dopamine, an agonist thereof, and lidocaine.

15. The method of claim 1 further comprising sensing at least one condition and using the at least one sensed condition to automatically determine the stimulus to apply.

16. The method of claim 15 wherein the at least one sensed condition is one or more of serotonin level, electrical activity of a neural population, a neurotransmitter level, change in a neurotransmitter level, a neurotransmitter breakdown product level, change in a neurotransmitter breakdown product level, a medication level, change in a medication level, a drug level, change in a drug level, a hormone level, change in a hormone level, level of a bloodborne substance, change in level of a bloodborne substance.

17. A method of treating patients with mood and/or anxiety disorders, comprising the steps of:

implanting at least one system control unit in the skull or the brain of the patient, wherein the at least one unit controls the delivery of at least one stimulus to at least one area of the brain affecting mood and/or anxiety disorders;

applying the at least one stimulus to the at least one area of the brain in order to at least in part alleviate symptoms of the mood and/or anxiety disorder of the patient being treated,

wherein the at least one area of the brain is selected from at least one of the anterior cingulate gyrus, the dorsal prefrontal cortex, the dorsal raphe nuclei, the median raphe nuclei, the locus coeruleus, the ventral prefrontal cortex, the thalamus, the medial thalamus, the cerebellar vermis, the amygdala, the orbitofrontal cortex, and the caudate nucleus.

18. A system for treating patients with mood and/or anxiety disorders, comprising:

at least one system control unit configured for implantation entirely within at least one of a brain and a skull;

at least one of a pump coupled to a catheter and at least two stimulating electrodes, the catheter having a discharge portion;

means for operably connecting the at least one system control unit to at least one of the catheter and the electrodes;

means for providing operating power to the at least one system control unit;

means for providing stimulation parameters to the at least one system control unit; and

means for generating stimulation pulses in accordance with the stimulation parameters;

wherein the pump and catheter and the electrodes are configured to deliver the stimulation pulses through at least one of the catheter and the electrodes to at least one area of the brain affecting mood and/or anxiety disorders.

19. The system of claim 18 wherein the system control unit is configured to conform to the profile of the skull.

20. The system of claim 18 wherein the system control unit is a microstimulator implanted entirely within the brain.

21. A therapeutic system for patients with mood and/or anxiety disorders, comprising:

at least one catheter, each catheter with a discharge portion; and

at least one system control unit having a size and shape suitable for implantation into at least one of the skull and the brain, wherein the at least one system control unit comprises;

a connector for connecting the system control unit and the at least one catheter;

a pump for storing and delivering stimulation pulses of a stimulating drug to the at least one catheter and thus to tissue adjacent to the discharge portion of the at least one catheter;

electronic circuitry that generates stimulation pulses in accordance with prescribed stimulation parameters, which electronic circuitry is operable connected to the pump;

programmable memory for receiving and storing the prescribed stimulation parameters; and

a power source for providing operating power to the electronic circuitry;

wherein the system further comprises at least one external appliance for transmitting the prescribed parameters and power to the system control unit.

22. The therapeutic system of claim 21 wherein the system control unit is configured to conform to the profile of the skull.

23. The therapeutic system of claim 21 wherein each catheter is up to about 150 mm long.

24. The therapeutic system of claim 21 wherein the system control unit further comprises at least one sensor.

25. The therapeutic system of claim 24 wherein the system control unit is configured to use the sensed condition to adjust the stimulation parameters.

26. The therapeutic system of claim 21 wherein the pump and catheter are configured to deliver a drug that increases excitement of one or more of those areas of the brain that exhibit chronic decreased activity.

27. The therapeutic system of claim 26 wherein the pump and catheter are further configured to deliver at least one of an excitatory neurotransmitter agonist, an inhibitory neurotransmitter antagonist, and a medication that increases levels of at least one excitatory neurotransmitter into the area of decreased activity.

28. The therapeutic system of claim 27 wherein the at least one catheter is configured to infuse at least one area of the brain, wherein said area is selected from the anterior cingulate gyrus, the dorsal prefrontal cortex, the dorsal raphe nuclei, the median raphe nuclei, and the locus coeruleus.

29. The therapeutic system of claim 21 wherein the pump and catheter are configured to deliver a drug that decreases excitement of one or more of those areas of the brain that exhibit chronic increased activity.

30. The therapeutic system of claim 29 wherein the pump and catheter are further configured to deliver at least one of an inhibitory neurotransmitter agonist, an excitatory neurotransmitter antagonist, and a medication that increases the level of an inhibitory neurotransmitter into the area of increased activity.

31. The therapeutic system of claim 30 wherein the at least one catheter is configured to infuse at least one area of the brain, wherein said area is selected from the ventral prefrontal cortex, the thalamus, the medial thalamus, the cerebellar vermis, the amygdala, the orbitofrontal cortex, and the caudate nucleus.

32. A therapeutic system for patients with mood and/or anxiety disorders, comprising:

at least two electrodes; and

at least one system control unit having a size and shape suitable for implantation in at least one of the skull and brain, wherein the at least one system control unit comprises;

electronic circuitry that generates stimulation pulses in accordance with prescribed stimulation parameters, which electronic circuitry is operable connected to the at least two electrodes through which the stimulation pulses may be delivered to tissue adjacent to the electrodes;

programmable memory for receiving and storing the prescribed stimulation parameters; and

a power source for providing operating power to the electronic circuitry.

33. The therapeutic system of claim 32 wherein the system control unit is configured to conform to the profile of the skull.

34. The therapeutic system of claim 32 wherein the system control unit is a microstimulator implanted entirely within the brain.

35. The therapeutic system of claim 32 wherein the system control unit has leads up to about 150 mm long.

36. The therapeutic system of claim 32 wherein the electronic circuitry is configured to generate stimulation pulses at less than about 50 to 100 Hz.

37. The therapeutic system of claim 36 wherein the at least two electrodes are configured to apply the stimulation pulses to at least one area of the brain, wherein said area is selected from the anterior cingulate gyrus, the dorsal prefrontal cortex, the dorsal raphe nuclei, the median raphe nuclei, and the locus coeruleus.

38. The therapeutic system of claim 32 wherein the electronic circuitry is configured to generate stimulation pulses at greater than about 50 to 100 Hz.

39. The therapeutic system of claim 38 wherein the at least two electrodes are configured to apply the stimulation pulses to at least one area of the brain, wherein said area is selected from the ventral prefrontal cortex, the thalamus, the medial thalamus, the cerebellar vermis, the amygdala, the orbitofrontal cortex, and the caudate nucleus.

40. The therapeutic system of claim 32 wherein the system control unit further comprises at least one sensor.

41. The therapeutic system of claim 40 wherein the system control unit is configured to use the sensed condition to adjust the stimulation parameters.

42. A system for applying electrical stimulation to a brain, comprising:

at least one system control unit configured for implantation entirely within a brain;

at least two stimulating electrodes operably connected to the at least one system control unit;

means for providing operating power to the at least one system control unit;

means for providing stimulation parameters to the at least one system control unit; and

means for generating stimulation pulses in accordance with the stimulation parameters;

wherein the at least two electrodes are configured to deliver the stimulation pulses through at least one of the electrodes to at least one area of the brain.

43. The system of claim 42 wherein the system control unit is a microstimulator implanted entirely within the brain.

44. The system of claim 42 wherein the system control unit has leads up to about 150 mm long.

45. The system of claim 42 wherein the system control unit further comprises at least one sensor.

46. The system of claim 45 wherein the system control unit is configured to use the sensed condition to adjust the stimulation parameters.

47. A system for applying electrical stimulation to a brain, comprising:

at least two electrodes; and

at least one system control unit having a size and shape suitable for implantation entirely within a brain, wherein the at least one system control unit comprises;

electronic circuitry that generates stimulation pulses in accordance with prescribed stimulation parameters;

electrical connections connecting the electronic circuitry to the at least two electrodes through which the stimulation pulses may be delivered to tissue adjacent to the electrodes;

programmable memory for receiving and storing the prescribed stimulation parameters; and

a power source for providing operating power to the electronic circuitry.

48. The system of claim 47 wherein the system control unit is a microstimulator implanted entirely within the brain.

49. The system of claim 47 wherein the system control unit has leads up to about 150 mm long.

50. The system of claim 47 wherein the system control unit further comprises at least one sensor.

51. The system of claim 50 wherein the system control unit is configured to use the sensed condition to adjust the stimulation parameters.