Devices, systems and methods for treatment of neuropsychiatric disorders

• US 9,682,236 B2
• Filed: 01/19/2016
• Issued: 06/20/2017
• 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: Cook, Ian A., Covalin, Alejandro, DeGiorgio, Christopher, Miller, Patrick R., Schrader, Lara
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US15/001,096
• Publication Number:
  US 20160129254A1
• Time in Patent Office: 518 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 cutaneous electrode assembly for stimulation of trigeminal nerves to treat a neuropsychiatric disorder, the cutaneous electrode assembly comprising:

a first contact configured for placement on a first region of a patient'"'"'s face;

a second contact configured for placement on a second region of the patient'"'"'s face; and

an insulating connection region connecting the first contact and the second contact, wherein the first contact and the second contact are spaced apart according to a distance between a first cutaneous distribution of the trigeminal nerves and a second cutaneous distribution of the trigeminal nerves.

2. The cutaneous electrode assembly of claim 1, wherein the trigeminal nerves to be stimulated comprise a superficial ophthalmic branch, an infraorbital branch, a mentalis branch, or a combination thereof.

3. The cutaneous electrode assembly of claim 1, wherein the trigeminal nerves to be stimulated comprise a supraorbital nerve.

4. The cutaneous electrode assembly of claim 1, wherein the trigeminal nerves to be stimulated comprise an auriculotemporal nerve.

5. The cutaneous electrode assembly of claim 1, wherein the trigeminal nerves to be stimulated comprise a zygomaticofacial nerve.

6. The cutaneous electrode assembly of claim 1, further comprising a retainer element configured to secure the cutaneous electrode assembly to the patient'"'"'s face.

7. The cutaneous electrode assembly 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.

8. A kit for the stimulation of the trigeminal nerve to treat the neuropsychiatric disorder or condition, the kit comprising:

the cutaneous electrode assembly according to claim 1; and

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

9. The kit of claim 8, further comprising:

a neurostimulator; and

instructions for applying electrical signals to the electrode assembly for treatment of a neuropsychiatric disorder.

10. A system for stimulation of trigeminal nerves to treat a neuropsychiatric disorder or condition, the system comprising:

a neurostimulator; and

a cutaneous electrode assembly comprising;

a first contact configured for placement on a first region of a patient'"'"'s face;

a second contact configured for placement on a second region of the patient'"'"'s face; and

an insulating connection region connecting the first contact and the second contact, wherein the first contact and the second contact are spaced apart according to a distance between a first cutaneous distribution of the trigeminal nerves and a second cutaneous distribution of the trigeminal nerves.

11. The system of claim 10, further comprising a cable and lead wires operably connecting the neurostimulator and the cutaneous electrode assembly.

12. The system of claim 10, further comprising a regulation device configured to regulate current output to minimize or prevent current penetration below the surface of the skull bone.

13. The system of claim 10, further comprising a retainer element configured to secure the cutaneous electrode assembly to the patient'"'"'s face.

14. The system of claim 10, wherein the trigeminal nerves to be stimulated comprise a superficial ophthalmic branch, an infraorbital branch, a mentalis branch, or a combination thereof.

15. The system of claim 10, wherein the trigeminal nerves to be stimulated comprise a supraorbital nerve.

16. The system of claim 10, wherein the trigeminal nerves to be stimulated comprise an auriculotemporal nerve.

17. The system of claim 10, wherein the trigeminal nerves to be stimulated comprise an zygomaticofacial nerve.

18. The system of claim 10, 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.