Devices, systems and methods for treatment of neuropsychiatric disorders

• US 10,322,283 B2
• Filed: 05/25/2017
• Issued: 06/18/2019
• Est. Priority Date: 10/05/2009
• Status: Active Grant

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: DeGiorgio, Christopher, Cook, Ian A., Covalin, Alejandro, Miller, Patrick R., Schrader, Lara
• Primary Examiner(s): Manuel, George
• Application Number:
  US15/605,288
• Publication Number:
  US 20170259063A1
• Time in Patent Office: 754 Days
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle

Abstract

The present disclosure relates to methods, devices and systems used for the treatment of mood, anxiety, post traumatic stress disorder, and cognitive and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, cutaneous methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infraorbital, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, infraorbital, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Claims

1. A system for stimulation of auriculotemporal nerves to treat a neuropsychiatric disorder, the system comprising:

a pulse generator configured to apply electrical signals at a frequency between approximately 20 and 300 Hertz, at a pulse duration between approximately 50 and 500 microseconds, at an output current density of not greater than approximately 25 mA/cm² and an output charge density of not greater than approximately 10 microCoulomb/cm² at the cerebral cortex; and

a cutaneous electrode assembly in electrical communication with the pulse generator, the cutaneous electrode assembly comprising;

a first electrode comprising at least one contact configured for cutaneous placement directly over or adjacent an auriculotemporal nerve on one side of a patient'"'"'s face; and

a second electrode comprising at least one contact configured for cutaneous placement directly over or adjacent another auriculotemporal nerve on the other side of the patient'"'"'s face.

2. The system of claim 1, wherein the first electrode and the second electrode are disposed on a strip electrode.

3. The system of claim 1, wherein the first electrode is provided separately from the second electrode.

4. The system of claim 1, wherein the first and second electrodes are configured for cutaneous placement near or at the patient'"'"'s ears.

5. The system of claim 1, wherein the cutaneous electrode assembly further comprises a retainer element configured to secure the cutaneous electrode assembly to the patient'"'"'s face.

6. The system of claim 1, wherein the neuropsychiatric disorder is depression, post-traumatic stress disorder, a mood disorder, an anxiety disorder, a cognitive disorder, a behavioral disorder, or a combination thereof.

7. The system of claim 1, further comprising a cable and lead wires operably connecting the neurostimulator and the cutaneous electrode assembly.

8. The system of claim 1, further comprising a regulation device configured to regulate current output to reduce current penetration below a surface of the skull bone.

9. The system of claim 8 wherein the regulation device is configured to limit the current output below approximately 30-50 mA.

10. A kit for the stimulation of the auriculotemporal nerves to treat the neuropsychiatric disorder or condition, the kit comprising:

the system according to claim 1; and

instructions for placement of the cutaneous electrode assembly on a patient for treatment of a neuropsychiatric disorder.

11. The kit of claim 10, further comprising instructions for applying electrical signals to the electrode assembly for treatment of a neuropsychiatric disorder.

12. A method for treating a neuropsychiatric disorder by auriculotemporal nerve stimulation, the method comprising:

placing a first electrode of a cutaneous electrode assembly directly over or adjacent to an auriculotemporal nerve on one side of a patient'"'"'s face;

placing a second electrode of the cutaneous electrode assembly directly over or adjacent to another auriculotemporal nerve on the other side of the patient'"'"'s face; and

applying electrical signals to the cutaneous electrode assembly at specified operational parameters to treat the neuropsychiatric disorder,

wherein the applying comprises applying electrical signals at a frequency between approximately 20 and 300 Hertz, at a pulse duration between approximately 50 and 500 microseconds, at an output current density of not greater than approximately 25 mA/cm² and an output charge density of not greater than approximately 10 microCoulomb/cm² at the cerebral cortex.

13. The method of claim 12, wherein the neuropsychiatric disorder is depression, post-traumatic stress disorder, a mood disorder, an anxiety disorder, a cognitive disorder, a behavioral disorder, or a combination thereof.

14. The method of claim 12, further comprising limiting, by a regulation device, a current output of the electrical signals below approximately 30-50 mA.

15. The method of claim 12, wherein the first electrode and the second electrode are disposed on a strip electrode.

16. The method of claim 12, wherein the first electrode is provided separately from the second electrode.

17. The method of claim 12, further comprising securing, by a retainer element, the cutaneous electrode assembly to the patient'"'"'s face.

18. The method of claim 12, further comprising regulating, by a regulation device, a current output to reduce current penetration below a surface of the skull bone.