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

• US 6,782,292 B2
• Filed: 06/15/2001
• Issued: 08/24/2004
• 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.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/882,560
• Publication Number:
  US 20020013612A1
• Time in Patent Office: 1,166 Days
• Field of Search: 607/3, 607/45, 607/72, 607/115-117, 607/120, 607/153, 128/898, 604/20, 604/21, 604/53, 604/890.1, 604/891.1, 604/892.11, 604/65-67, 604/93
• 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 stimulus increases excitement of the at least one area of the brain affecting mood and/or anxiety disorders that exhibits chronic decreased activity; and

wherein the at least one stimulus 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.

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 is electrical stimulation delivered at a frequency less than about 100 Hz.

6. The method of claim 1 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 neurotransmitter, and an agent that decreases the level of an inhibitory neurotransmitter.

7. The method of claim 6 wherein the excitatory drug is at least one of norepinephrine, epinephrine, glutamate, acetylcholine, serotonin, dopamine, and an agonist thereof.

8. 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.

9. The method of claim 8 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.

10. 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 stimulus decreases excitement of at least one area of the brain affecting mood and/or anxiety disorders that exhibits chronic increased activity; and

wherein the at least one stimulus is applied to the cerebellar vermis.

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

12. 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.

13. The method of claim 12 wherein the inhibitory drug is at least one of GABA, glycine, dopamine, an agonist thereof, and lidocaine.

14. The method of claim 10 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.

15. The method of claim 10 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.

16. The method of claim 10 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.

17. The method of claim 10 further comprising sensing at least one condition and using the at least one sensed condition to automatically determine the stimulus to apply.

18. The method of claim 17 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.