Systems and methods for electrical stimulation of sphenopalatine ganglion and other branches of cranial nerves

• US 9,174,049 B2
• Filed: 01/27/2014
• Issued: 11/03/2015
• Est. Priority Date: 01/27/2013
• Status: Active Grant

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/164,927
• Publication Number:
  US 20140214120A1
• Time in Patent Office: 645 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0546 Nasal electrodes
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Devices, systems and methods are disclosed for modulating cranial nerves, such as the sphenopalatine ganglion, to treat a medical condition of a patient, such as cluster headache. A stimulation device is advanced transnasally to a target site at or adjacent to the nasopharyngeal mucosa posterior to the middle turbinate. Electrical impulses are applied through one or more electrodes in the stimulation device to the target nerve sufficient to modulate the nerve and treat the medical condition.

Claims

1. A system for modulating a cranial nerve to treat a medical condition of a patient comprising:

a stimulation device comprising one or more electrodes configured for advancement through a nostril of a patient to a target site adjacent to or near the cranial nerve and one or more antennas;

a power source configured for positioning externally to a patient and further configured to transmit electrical energy wirelessly through an outer skin surface of the patient to the stimulation device at the target site, wherein the one or more antennas are configured for receiving the electrical energy from the power source at the target site;

a pulse generator coupled to the power source and the stimulation device and configured to apply one or more electrical impulses to the electrodes sufficient to modulate the cranial nerve.

2. The system of claim 1 wherein the cranial nerve is a sphenopalatine ganglion.

3. The system of claim 1 wherein the medical condition is primary headache.

4. The system of claim 1 wherein the medical condition is cluster headache.

5. The system of claim 1 wherein the antennas have a substantially non-linear configuration.

6. The system of claim 5 wherein the stimulation device further comprises an energy storage device for storing the electrical energy received by the antenna(s).

7. The system of claim 1 wherein the stimulation device is configured to be positioned adjacent to or near a mucosa area posterior to a middle turbinate of the patient.

8. The system of claim 1 further comprising one or more anchors configured to extend through a mucosa within a nose of the patient, the stimulation device being configured for positioning adjacent to the mucosa and coupled to the anchors.

9. The system of claim 1 further comprising one or more anchors configured to extend into a rigid structure within a nose of the patient, the stimulation device being configured for positioning adjacent said rigid structure and coupled to the anchors.

10. The system of claim 1 further comprising a lead blank configured for advancement through a mucosa of a sphenopalatine fossa to a target site adjacent to or near the cranial nerve, wherein the lead blank comprises a distal tip configured to generate a path for the stimulation device to follow to the target site.

11. A method for modulating a cranial nerve to treat a medical condition in a patient comprising:

advancing one or more electrodes through a nostril of the patient to a target site adjacent to or near a cranial nerve;

generating one or more electrical impulses sufficient to modulate the cranial nerve; and

wirelessly transmitting the one or more electrical impulses from a power source external to the patient through an outer skin surface of the patient to the electrodes at the target site.

12. The method of claim 11 wherein the cranial nerve is a sphenopalatine ganglion.

13. The method of claim 11 wherein the medical condition is primary headache.

14. The method of claim 11 wherein the medical condition is cluster headache.

15. The method of claim 11 further comprising advancing one or more antennas with the electrodes to the target site, the antennas having a substantially non-linear configuration and wherein the wirelessly transmitting step is carried out by transmitting the electrical impulses to the antennas.

16. The method of claim 15 further comprising wirelessly transmitting electrical energy to the antennas, storing the electrical energy and using the electrical energy to apply the electrical impulses to the cranial nerve.

17. The method of claim 11 wherein the target site is adjacent to or near a mucosa area posterior to a middle turbinate of the patient.

18. The method of claim 11 further comprising securing the electrodes adjacent to a mucosa within the nose of the patient.

19. The method of claim 18 wherein the securing step is carried out by driving one or more anchors through the mucosa and attaching the electrodes to the anchors.

20. The method of claim 18 wherein the securing step is carried out by driving one or more anchors into a rigid structure within the nose of the patient and attaching the electrodes to the anchors.

21. The method of claim 11 further comprising:

advancing a lead blank through the nostril of the patient and through a mucosa of a sphenopalatine fossa to the target site adjacent to or near the cranial nerve to generate a path for the electrodes; and

advancing the electrodes along the path to the target site.