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

• US 10,238,862 B2
• Filed: 04/10/2018
• Issued: 03/26/2019
• 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: Cook, Ian A., DeGiorgio, Christopher M.
• Primary Examiner(s): Levicky, William J
• Application Number:
  US15/949,987
• Publication Number:
  US 20180229029A1
• Time in Patent Office: 350 Days
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36089 Addiction or withdrawal from substance abuse such as alcohol or drugs
• CPC Class Codes: A61N 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/361 Phantom sensations, e.g. tinnitus
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

The present disclosure relates to methods, devices and systems used for the treatment of medical disorders via stimulation of the superficial elements of the trigeminal nerve. 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 treatment of a medical disorder by trigeminal nerve stimulation, comprising:

implanting an implantable electrode assembly including a first contact and a second contact above a pericranium and below an epidermis at a patient'"'"'s forehead such that the first contact is in contact with a supraorbital nerve and the second contact is in contact with an adjacent supratrochlear nerve; and

applying electrical signals to the electrode assembly to stimulate the supraorbital nerve and the adjacent supratrochlear nerve at the patient'"'"'s forehead to modulate a body system of the patient to treat the medical disorder selected from the group consisting of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD).

2. The method of claim 1, wherein the implanting comprises implanting the implantable electrode assembly including a third contact.

3. The method of claim 1, wherein the applying of the electrical signals comprises applying electrical signals at a frequency between 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.

4. The method of claim 1, wherein the applying of the electrical signals comprises applying electrical signals at a frequency between 20 and 300 Hertz, at a pulse duration between 50 and 500 microseconds, at an output current density of not greater than 10 mA/cm², and a charge density of not greater than 10 microCoulomb/cm² at the patient'"'"'s cerebral cortex.

5. The method of claim 1, wherein the applying of the electrical signals comprises applying electrical signals at an output current density of not greater than 10 mA/cm².

6. The method of claim 1, wherein the applying of the electrical signals comprises applying electrical signals at an output current density of between 2.5 and 5 mA/cm².

7. The method of claim 1, wherein the applying of the electrical signals comprises applying electrical signals at an output current density of not greater than 7 mA/cm².

8. The method of claim 1, wherein the implanting comprises implanting the implantable electrode assembly including a third contact and a fourth contact such that the third contact is in contact with a remaining supraorbital nerve and the fourth contact is in contact with an adjacent remaining supratrochlear nerve, wherein the applying of the electrical signals to the electrode assembly is further to stimulate the remaining supraorbital nerve and the adjacent remaining supratrochlear nerve at the patient'"'"'s forehead to modulate the body system to treat the medical disorder.