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

• US 8,958,880 B2
• Filed: 10/05/2010
• Issued: 02/17/2015
• 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, Cook, Ian A., Ekchian, Leon
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US12/898,685
• Publication Number:
  US 20110112603A1
• Time in Patent Office: 1,596 Days
• Field of Search: 607/45, 607/46
• US Class Current: 607/45
• 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 in a patient so that a first electrode contact is in contact with a supraorbital nerve on one side of a patient'"'"'s forehead and so that a second electrode contact is in contact with a supraorbital nerve on an opposing side of the patient'"'"'s forehead; and

applying electrical signals to the electrode assembly so that current flows between the first electrode contact and the second electrode contact at specified operational parameters to treat the neuropsychiatric disorder, wherein the electrical signals are applied to minimize current penetration into a brain for the patient such that a charge density at the brain'"'"'s surface does not exceed 20 μ

C/cm².

2. The method of claim 1, wherein the step of applying electrical signals comprises applying electrical signals at a frequency between approximately 20 and 300 Hertz, at a current of 0.1 to 3 milliamperes (mA) and at a pulse duration of less than or equal to 500 microseconds.

3. The method of claim 1, wherein the step of applying electrical signals 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 a charge density of not greater than approximately 10 microCoulomb/cm² at the cerebral cortex.

4. The method of claim 1, wherein the neuropsychiatric disorder is selected from the group consisting of:

mood disorder, cognitive disorder, behavioral disorder and anxiety disorder.