Extracranial implantable devices, systems and methods for the treatment of neuropsychiatric disorders

• US 10,195,435 B2
• Filed: 11/10/2016
• Issued: 02/05/2019
• Est. Priority Date: 10/05/2009
• Status: Active Grant

• Current Assignee: NeuroSigma, Inc., Regents of the University of California (University of California)
• Original Assignee: NeuroSigma, Inc., Regents of the University of California (University of California)
• Inventors: Degiorgio, Christopher M., Cook, Ian A., Ekchian, Leon
• Primary Examiner(s): Dietrich, Joseph M
• Application Number:
  US15/348,097
• Publication Number:
  US 20170056660A1
• Time in Patent Office: 817 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, cognitive, and behavioral disorders (collectively, neuropsychiatric disorders) via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive systems, devices and 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, nasal and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein.

Claims

1. A method for treating a neuropsychiatric disorder by trigeminal nerve stimulation, comprising:

implanting a subcutaneous electrode assembly below an epidermis and above a pericranium of a patient to place a first electrode contact laterally to a first ophthalmic nerve on one side of the patient'"'"'s forehead and to place a second electrode contact medially to the first ophthalmic nerve; and

applying electrical signals to the subcutaneous electrode assembly at specified operational parameters to treat the neuropsychiatric disorder.

2. The method of claim 1, wherein the implanting comprises implanting the subcutaneous electrode assembly below the epidermis and above the pericranium of the patient to place a third electrode contact laterally to a second ophthalmic nerve on an opposing side of the patient'"'"'s forehead and to place a fourth electrode contact medially to the second ophthalmic nerve.

3. The method of claim 1, wherein the first ophthalmic nerve comprises the supraorbital nerve, the supratrochlear nerve, or both.

4. The method of claim 1, wherein the electrical signals are applied to minimize current penetration into the patient'"'"'s brain such that a charge density at a surface of the patient'"'"'s brain does not exceed 20 μ

C/cm².

5. The method of claim 1, wherein the applying comprises applying electrical signals at a frequency between approximately 20 and 300 Hz, at a current of 0.1 to 3 mA, and at a pulse duration of less than or equal to 500 μ

s.

6. The method of claim 1, wherein the applying comprises applying electrical signals at a frequency between approximately 20 and 300 Hz, at a pulse duration between approximately 50 and 500 μ

s, at an output current density of not greater than approximately 25 mA/cm², and a charge density of not greater than approximately 10 μ

C/cm² at the patient'"'"'s cerebral cortex.

7. The method of claim 1, wherein the neuropsychiatric disorder is selected from the group consisting of a mood disorder, a cognitive disorder, a behavioral disorder, an anxiety disorder, or a combination thereof.

8. The method of claim 1, wherein the neuropsychiatric disorder is a disorder affecting attention, cognition, behavior, or a combination thereof.

9. The method of claim 1, wherein the neuropsychiatric disorder is depression or major depressive disorder.

10. The method of claim 1, wherein the neuropsychiatric disorder is post-traumatic stress disorder.

11. A method for treating a neuropsychiatric disorder by trigeminal nerve stimulation, comprising:

implanting a subcutaneous electrode assembly below an epidermis and above a pericranium of a patient to place a first electrode contact laterally to a first supraorbital nerve on one side of the patient'"'"'s forehead and to place a second electrode contact medially to the first supraorbital nerve; and

applying electrical signals to the subcutaneous electrode assembly at specified operational parameters to treat the neuropsychiatric disorder.

12. The method of claim 11, wherein the implanting comprises implanting the subcutaneous electrode assembly below the epidermis and above the pericranium of the patient to place a third electrode contact laterally to a second supraorbital nerve on an opposing side of the patient'"'"'s forehead and to place a fourth electrode contact medially to the second supraorbital nerve.

13. The method of claim 11, wherein the implanting comprises implanting the subcutaneous electrode assembly below the epidermis and above the pericranium of the patient to place a third electrode contact laterally to a first supratrochlear nerve on the one side of the patient'"'"'s forehead and to place a fourth electrode contact medially to the first supratrochlear nerve.

14. The method of claim 13, wherein the implanting comprises implanting the subcutaneous electrode assembly below the epidermis and above the pericranium of the patient to place a fifth electrode contact laterally to a second supraorbital nerve on an opposing side of the patient'"'"'s forehead, a sixth electrode contact medially to the second supraorbital nerve, a seventh electrode contact laterally to a second supratrochlear nerve on the opposing side of the patient'"'"'s forehead, and an eighth electrode contact medially to the second supratrochlear nerve.

15. The method of claim 11, wherein the electrical signals are applied to minimize current penetration into the patient'"'"'s brain such that a charge density at a surface of the patient'"'"'s brain does not exceed 20 μ

C/cm².

16. The method of claim 11, wherein the applying comprises applying electrical signals at a frequency between approximately 20 and 300 Hz, at a current between approximately 0.1 and 3 mA, at a pulse duration between approximately 50 and 500 μ

s, at an output current density of not greater than approximately 25 mA/cm², at a charge density of not greater than approximately 10 μ

C/cm² at the patient'"'"'s cerebral cortex, or a combination thereof.

17. The method of claim 11, wherein the neuropsychiatric disorder is selected from the group consisting of a mood disorder, a cognitive disorder, a behavioral disorder, an anxiety disorder, or a combination thereof.

18. The method of claim 11, wherein the neuropsychiatric disorder is a disorder affecting attention, cognition, behavior, or a combination thereof.

19. The method of claim 11, wherein the neuropsychiatric disorder is depression or major depressive disorder.

20. The method of claim 11, wherein the neuropsychiatric disorder is post-traumatic stress disorder.