Systems and methods for treatment of diabetes by electrical brain stimulation and/or drug infusion

• US 6,922,590 B1
• Filed: 11/06/2001
• Issued: 07/26/2005
• Est. Priority Date: 11/21/2000
• 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:
  US09/993,085
• Time in Patent Office: 1,358 Days
• Field of Search: 607/62, 607/116, 607/117, 607/118, 607/61, 607/60, 607/44, 607/45, 607/72, 607/73, 607/3, 607/2, 607/66, 607/500, 607/58, 604/890.1, 604/891.1, 604/66, 604/500, 600/373, 600/383, 600/365
• US Class Current: 607/45
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• 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: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

Systems and methods for introducing one or more stimulating drugs and/or applying electrical stimulation to the brain to at least treat or prevent diabetes uses at least one system control unit (SCU) producing electrical pulses delivered via electrodes implanted in the brain and/or producing drug infusion pulses, wherein the stimulating drug(s) are delivered to targeted areas in the brain.

Claims

1. A method of preventing diabetes or treating patients with diabetes, comprising:

implanting at least one system control unit in at least one of the skull and 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 diabetes;

applying the at least one stimulus to the at least one area of the brain that exhibits chronic abnormal activity, in order to prevent or treat diabetes,

wherein the area is the nucleus of the solitary tract.

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

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

4. The method of claim 1 wherein the stimulus is at least one stimulating drug.

5. The method of claim 1 wherein the stimulus is electrical stimulation.

6. The method of claim 1 wherein the stimulus is electrical stimulation and at least one stimulating drug.

7. The method of claim 1 further comprising applying the stimulus in coordination with delivery of a medication.

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 1 further comprising implanting more than one system control unit.

10. The method of claim 1 wherein implanting at least one system control unit comprises implanting at least one microstimulator.

11. A method of preventing metabolic disorders or treating patients with metabolic disorders, comprising:

implanting at least one system control unit in at least one of the skull and 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 a metabolic disorder;

applying the at least one stimulus to the at least one area of the brain that exhibits chronic abnormal activity, in order to prevent or treat the metabolic disorder,

wherein the area is the nucleus of the solitary tract.

12. The method of claim 11, further comprising:

sensing at least one condition indicating a need for said at least one stimulus in order to treat or prevent metabolic disorder;

wherein the at least one sensed condition is at least one of electrical activity of the brain, nerve activity, muscle activity, body mass, impedance, pH, neurotransmitter level, neurotransmitter breakdown product level, hormone level, ketone level, glucose level, electrolyte level, enzyme level, cytokine level, medication level, other drug level, and level of any other bloodborne substance.

13. The method of claim 12 wherein the at least one system control unit is configured to use the sensed condition to control the delivery of the at least one stimulus.

14. The method of claim 12 wherein the at least one sensed condition is the level of one or more of Neuropeptide Y (NPY), serotonin, one or more catecholamines, adrenocorticotrophic hormone (ACTH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), growth hormone (GH), thyroid stimulating hormone (TSH), leptin, ghrelin, AGRP, orexin-A, orexin-B, cholecystokinin (CCK), glucagon, and glucocorticoids.

15. The method of claim 11 wherein implanting the at least one system control unit further comprises:

implanting at least one pump, the pump having;

at least one infusion outlet; and

fluid connections connecting the at least one pump to the at least one infusion outlet; and

wherein the at least one stimulus is at least one stimulating drug delivered to the at least one area of the brain in order to treat or prevent metabolic disorders.

16. The method of claim 15 wherein the at least one pump and the at least one infusion outlet are further configured to deliver a liquid that increases excitement of the at least one area of the brain that exhibits chronic decreased activity;

and

wherein the at least one area of the brain the nucleus of the solitary tract.

17. The method of claim 16 wherein the at least one pump and the at least one infusion outlet are further configured to deliver at least one of an excitatory neurotransmitter agonist, a medication that increases levels of at least one excitatory neurotransmitter, an excitatory hormone agonist, an inhibitory neurotransmitter antagonist, an inhibitory hormone antagonist, corticotropin releasing factor, a corticotropin releasing factor agonist, bombesin, a bombesin agonist, glucagon-like peptide 1, a glucagon-like peptide 1 agonist, serotonin, a serotonin agonist, leptin, a leptin agonist, a ghrelin antagonist, an AGRP antagonist, an MC4-R agonist, an MC3-R agonist, an orexin-A antagonist, an orexin-B antagonist, an OX1R antagonist an OX2R antagonist cholecystokinin, end a cholecystokinin agonist.

18. The method of claim 15 wherein the at least one pump and the at least one infusion outlet are further configured to deliver a liquid that decreases excitement of the at least one area of the brain that exhibits chronic increased activity.

19. The method of claim 18 wherein the at least one pump and the at least one infusion outlet are further configured to deliver at least one of an inhibitory neurotransmitter agonist, a medication that increases the level of an inhibitory neurotransmitter, an inhibitory hormone agonist, an excitatory neurotransmitter antagonist, and/or an excitatory hormone antagonist.

20. The method of claim 11 wherein implanting the at least one system control unit further comprises:

implanting at least two electrodes configured to apply electrical stimulation to the at least one area of the brain in order to prevent or treat metabolic disorders; and

connecting the at least one system control unit to the at least two electrodes, through which the electrical stimulation is delivered to the at least one area adjacent to the electrodes.

21. The method of claim 20 wherein the at least one system control unit is further configured to control the delivery of electrical stimulation pulses at less than about 100 to 150 Hz;

and

wherein the at least one area of the brain is the nucleus of the solitary tract.

22. The method of claim 20 wherein the at least one system control unit is further configured to control the delivery of electrical simulation pulses at greater than about 100 to 150 Hz.

23. The method of claim 11 wherein the at least one system control unit is configured to conform to the profile of the skull.

24. The method of claim 11 wherein the at least one system control unit is at least one microstimulator.