EXTRACRANIAL IMPLANTABLE DEVICES, SYSTEMS AND METHODS FOR THE TREATMENT OF NEUROLOGICAL DISORDERS

• US 20110106220A1
• Filed: 10/05/2010
• Published: 05/05/2011
• Est. Priority Date: 10/05/2009
• Status: Abandoned Application

• 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, Ekchian, Leon, Cook, Ian A.
• Application Number:
  US12/898,696
• Publication Number:
  US 20110106220A1
• Time in Patent Office: Days
• US Class Current: 607/72
• 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 neurological disorders via stimulation of the superficial elements of the trigeminal nerve (“TNS”). More specifically, minimally invasive methods of stimulation of the superficial branches of the trigeminal nerve located extracranially in the face, namely the supraorbital, supratrochlear, infratrochlear, auriculotemporal, zygomaticotemporal, zygomaticoorbital, zygomaticofacial, nasal, infraorbital, and mentalis nerves (also referred to collectively as the superficial trigeminal nerve) are disclosed herein. Systems and devices configured for therapeutic stimulation of the branches of the trigeminal nerves, such as the superficial trigeminal nerve, and their methods of application are also described.

Claims

1. A system for trigeminal nerve stimulation for treatment of a neurological disorder or condition, the system comprising:

a pulse generator; and

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

a first electrode comprising at least one contact configured for subcutaneous placement at a first region of the patient'"'"'s face, wherein the first electrode is configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve for treatment of a neurological disorder or condition by trigeminal nerve stimulation,

wherein the system is configured for minimal current penetration into a brain of a patient, and

wherein the at least one branch of the trigeminal nerve is selected from the group consisting of;

ophthalmic nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve.

2. The system of claim 1, wherein the assembly further comprises a second electrode comprising at least one contact configured for subcutaneous placement at a second region of the patient'"'"'s face, wherein the second electrode is configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve, wherein the at least one branch of the trigeminal nerve is selected from the group consisting of:

ophthalmic nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve.

3. The system of claim 2, wherein the first electrode and the second electrode are configured for implantation in proximity to, adjacent to or in contact with a same branch of the trigeminal nerve.

4. The system of claim 2, wherein the first electrode and the second electrode are configured for implantation in proximity to, adjacent to or in contact with a different branch of the trigeminal nerve.

5. The system of claim 1, further comprising a wire operably connecting the pulse generator and the subcutaneous electrode assembly.

6. The system of claim 1, further comprising a regulating device configured to regulate the maximum charge balanced output current below approximately 30-50 mA.

7. The system of claim 1, wherein the neurological disorder or condition is selected from the group consisting of:

epilepsy, seizure related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache and movement disorders.

8. The system of claim 1, wherein the pulse generator is 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.

19. A kit for trigeminal nerve stimulation for treatment of a neurological disorder or condition, the kit comprising:

the subcutaneous electrode assembly according to claim 1; and

instructions for implanting the electrode assembly in a patient for treatment of a neurological disorder or condition.

20. The kit of claim 19, further comprising:

a pulse generator; and

instructions for applying electrical signals to the electrode assembly for treatment of a neurological disorder or condition.

9. A subcutaneous electrode assembly for trigeminal nerve stimulation for treatment of a neurological disorder or condition, the assembly comprising:

a first electrode comprising at least one contact configured for subcutaneous placement at a first region of the patient'"'"'s face,

wherein the first electrode is configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve for treatment of a neurological disorder or condition by trigeminal nerve stimulation,

wherein the assembly is configured for minimal current penetration into a brain of a patient, and

wherein the at least one branch of the trigeminal nerve is selected from the group consisting of;

ophthalmic nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve.

10. The assembly of claim 9, further comprising a second electrode comprising at least one contact configured for subcutaneous placement at a second region of the patient'"'"'s face, wherein the second electrode is configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve, wherein the at least one branch of the trigeminal nerve is selected from the group consisting of:

ophthalmic nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve.

11. The assembly of claim 10, wherein the first electrode and the second electrode are configured for implantation in proximity to, adjacent to or in contact with a same branch of the trigeminal nerve.

12. The assembly of claim 10, wherein the first electrode and the second electrode are configured for implantation in proximity to, adjacent to or in contact with a different branch of the trigeminal nerve.

13. The assembly of claim 9, wherein the neurological disorder or condition is selected from the group consisting of:

epilepsy, seizure related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache and movement disorders.

14. A method for treating a neurological disorder or condition by trigeminal nerve stimulation, comprising:

implanting an electrode assembly in a patient, the subcutaneous electrode assembly comprising;

a first electrode comprising at least one contact configured for subcutaneous placement at a first region of the patient'"'"'s face,

wherein the first electrode is configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve for treatment of a neurological disorder or condition by trigeminal nerve stimulation,

wherein the assembly is configured for minimal current penetration into a brain of a patient, and

wherein the at least one branch of the trigeminal nerve is selected from the group consisting of;

ophthalmic nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve; and

applying electrical signals to the electrode assembly at specified operational parameters to treat a neurological disorder or condition.

15. The method of claim 14, wherein the assembly further comprises a second electrode comprising at least one contact configured for subcutaneous placement at a second region of the patient'"'"'s face, wherein the second electrode is configured to be implanted in proximity to, adjacent to or in contact with at least one branch of the trigeminal nerve, wherein the at least one branch of the trigeminal nerve is selected from the group consisting of:

ophthalmic nerve, infraorbital nerve, mentalis nerve, supratrochlear nerve, infratrochlear nerve, zygomaticotemporal nerve, zygomaticofacial nerve, zygomaticoorbital nerve, nasal nerve, and auriculotemporal nerve.

16. The method of claim 14, 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.

17. The method of claim 14, 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.

18. The method of claim 14, wherein the neurological disorder or condition is selected from the group consisting of:

epilepsy, seizure related disorders, acute brain injury, chronic brain injury, chronic daily headache, migraine, disorders related to migraine and headache and movement disorders.