Methods and apparatus for deep brain stimulation

• US 8,626,298 B2
• Filed: 05/13/2013
• Issued: 01/07/2014
• Est. Priority Date: 04/10/2008
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/893,253
• Publication Number:
  US 20130253625A1
• Time in Patent Office: 239 Days
• Field of Search: 607/45, 600/544, 606/41, 604/101.03, 604/507
• US Class Current: 607/42
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2210/0681 Sinus (maxillaris)
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0546 Nasal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

The present invention provides systems, apparatus and methods for treating nerve disorders in the brain. An electrode is introduced into a patient'"'"'s sinus cavity and an electrical impulse is applied to the electrode to modulate one or more target nerves in the brain to treat the disorder. In preferred embodiments, the electrode is positioned within a sinus cavity adjacent to or near the frontal cortex of the brain and the electrical signal is sufficient to modulate, stimulate and/or inhibit nerves within the frontal cortex. The electrode may be movable between a collapsed or compact configuration for introduction into the sinus cavity and an expanded configuration for contacting tissue within the sinus cavity to deliver the electrical impulse through the tissue to the target nerves in the brain.

Claims

1. A method for treating a nerve disorder in a patient, comprising:

introducing an electrode into a sinus cavity of the patient by advancing an expandable enclosure into the sinus cavity, wherein the electrode is housed within the expandable enclosure; and

applying an electrical impulse through the electrode to a target region in the patient'"'"'s brain, the electrical impulse being sufficient to modulate one or more nerves in the target region to treat the nerve disorder.

2. The method of claim 1, wherein the target region is the frontal cortex of the brain.

3. The method of claim 1, wherein the electrical impulse is sufficient to inhibit nerve activity in the target region.

4. The method of claim 1, wherein the electrical impulse is sufficient to depolarize nerve membranes in the target region.

5. The method of claim 1, wherein the introducing step is carried out by advancing the expandable enclosure through a nostril of the patient and into the sinus cavity.

6. The method of claim 1, wherein the sinus cavity is at least one of the frontal sinus, the sphenoidal sinus and the ethmoid sinus.

7. The method of claim 1, wherein the nerve disorder is at least one of epilepsy, Parkinson'"'"'s disease, depression, eating disorder, obesity, mood disorder, obsessive-compulsive disorder, hyperphagia, addiction, dystonia, essential tremor and chronic pain.

8. The method of claim 1, further comprising expanding the expandable enclosure after introducing the electrode into the sinus cavity of the patient, and contacting a tissue of the sinus cavity.

9. The method of claim 1, further comprising contacting a tissue of the sinus cavity with an electrically-permeable portion of an outer wall of the enclosure.

10. The method of claim 9, wherein the electrode is housed within the enclosure, and further comprising delivering electrically conductive fluid into the enclosure such that the conductive fluid electrically couples the electrode with the electrically-permeable portion of the outer wall of the enclosure.

11. The method of claim 9, wherein the outer wall is the electrode, and further comprising delivering fluid into the enclosure to expand the enclosure.

12. The method of claim 11, wherein the fluid is electrically conductive, and further comprising applying the electrical impulse through the electrically conductive fluid to the outer wall of the enclosure.

13. The method of claim 10, wherein contacting a tissue of the sinus cavity with an electrically-permeable portion of an outer wall of the enclosure comprises expanding the enclosure from a deflated position to an inflated position.

14. The method of claim 13, wherein expanding the enclosure is carried out by delivering the electrically conductive fluid into an interior of the enclosure.

15. The method of claim 12, further comprising inflating the enclosure with the electrically conductive fluid such that the electrode is substantially centrally located within an interior volume of the enclosure.

16. A system for treating a nerve disorder comprising:

an electrode;

an introducer coupled to the electrode and configured for advancing the electrode into a sinus cavity adjacent to or near a target region in a brain of the patient;

a source of electrical energy coupled to the electrode and configured for applying an electrical impulse through the electrode to the target region, the electrical impulse being sufficient to modulate one or more nerves in the target region to treat the nerve disorder; and

an enclosure coupled to the source of electrical energy and the introducer, the enclosure having an outer wall surrounding an interior, the outer wall having at least one section that is formed from an electrically-permeable material.

17. The system of claim 16, wherein the electrode is movable between a compact configuration for introduction into the sinus cavity and an expanded configuration for contacting tissue within the sinus cavity.

18. The system of claim 16, further comprising a fluid delivery device fluidly coupled to the interior of the enclosure for delivering electrically conductive fluid to said interior such that the electrically-permeable section of the outer wall is electrically coupled to the electrical energy source.

19. The system of claim 18, wherein the electrode is housed within the interior of the enclosure.

20. The system of claim 18, wherein the introducer comprises a hollow tube having an internal passageway with a proximal opening coupled to the fluid delivery device and a distal opening coupled to the interior of the enclosure.

21. The system of claim 16, wherein the enclosure is a balloon movable between a deflated position for introduction through a nostril into the sinus cavity of the patient and an inflated position for contacting tissue within the sinus cavity.

22. The system of claim 21, wherein the electrode is substantially centrally located within the balloon in the inflated position.

23. The system of claim 16, further comprising a return electrode adapted for contact with the patient, wherein the electrode and the return electrode are adapted such that the electro-magnetic field emanating from the electrode is in a substantially radial pattern.

24. The system of claim 16, wherein the source of electrical energy is an electrical signal generator and the electrical impulse is of a frequency between about 1 Hz to about 3000 Hz, a pulse duration of between about 10 us to about 1000 us, and an amplitude of between about 1 volt to about 20 volts.