Modulating function of the facial nerve system or related neural structures via the ear

• US 9,339,645 B2
• Filed: 04/28/2011
• Issued: 05/17/2016
• Est. Priority Date: 05/02/2010
• Status: Active Grant

• Current Assignee: Nervive, Inc.
• Original Assignee: Nervive, Inc.
• Inventors: Borsody, Mark Klingler
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US13/096,889
• Publication Number:
  US 20110270361A1
• Time in Patent Office: 1,846 Days
• Field of Search: 607 55- 57, 607/2, 607/62, 607/116
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0541 Cochlear electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling

Abstract

Stimulation of the facial nerve system (e.g., electrically, electromagnetically, etc.) in stroke patients will cause dilation of occluded arteries and dilation of surrounding arteries, allowing for blood flow to circumvent the obstruction and reach previously-deprived tissue. The device approaches the facial nerve and its branches in the vicinity of the ear. In use, the device can be inserted into the ear canal or placed in proximity to the ear in order to stimulate the facial nerve system without puncturing the tympanic membrane (e.g., using an electromagnetic field). The device can also be advanced into the middle ear through a puncture created in the tympanic membrane. Branches of the facial nerve in the middle ear can then be stimulated directly (e.g., by application of electrical current). The device can be used in the emergency treatment of acute stroke or as chronically-implanted/inserted variations for long-term maintenance of blood flow to the brain and stroke prevention.

Claims

1. An apparatus, comprising:

an insulating guide sheath moveable toward and away from an ear of a mammalian subject, the insulating guide sheath including a guide piece that is configured to enter an ear canal of the mammalian subject, and an external portion that is attached to the guide piece and that is configured to be placed against an external ear of the mammalian subject, the guide piece and the external portion being axially aligned;

a coil with elongated ends enclosed within the external portion of the insulating guide sheath, wherein the coil is disposed to be placed in proximity to the ear while within the external portion by insertion of the guide piece within the ear canal to position the external portion against the external ear;

a stimulus generator in electrical communication with the coil through the elongated ends for supplying current to the coil such that the current flowing through the coil generates a stimulating magnetic field from the coil, wherein;

the guide piece within the ear canal is configured to position the external portion containing the coil such that the stimulating magnetic field from the coil is oriented toward the ear canal for stimulating a neural structure of a facial nerve system of the mammalian subject through the ear,

the guide piece encloses a magnetic material and has a length that is perpendicular to a plane of the coil, the magnetic material configured to shape, amplify, or focus the stimulating magnetic field generated by the coil within the ear canal, and

the coil, the external portion of the insulating guide sheath surrounding the coil, the guide piece, and the magnetic material have axially aligned central openings that are penetrable to light and sound; and

a power source in electrical communication with the stimulus generator for providing power to the stimulus generator for supplying the current to the coil.

2. The apparatus of claim 1, wherein the stimulus generator is further configured for applying a current to the coil sufficient to stimulate the facial nerve system in the vicinity of the ear.

3. The apparatus of claim 1, further comprising a stimulus controller attached to the stimulus generator for adjusting the current to the coil based on one or more physiological or pathophysiological responses of the subject, the responses selected from the group consisting of:

taste sensation;

audition;

lacrimation;

nasal drainage;

nasal congestion;

salivation;

sound sensitivity;

face, head, or hand movements;

speech production or arrest;

sensation of body movement;

eye movements;

cranial blood flow;

direct or indirect activity of a nerve; and

severity of neurological dysfunction of the subject.

4. The apparatus of claim 1, further comprising a stimulus controller attached to the stimulus generator for adjusting the current to the coil for activating the neural structure of the facial nerve system to improve blood flow to the brain of the subject or to enhance delivery of a blood-borne pharmacologic agent to treat stroke or another condition of the subject.

5. The apparatus of claim 1, further comprising a specialized speculum insertable into the ear of the subject, the speculum having an opening through which light can be transmitted to allow direct visualization of an anatomical structure within the ear.

6. The apparatus of claim 1, further comprising one or more leads connecting the stimulus generator to the coil.

7. The apparatus of claim 1, wherein the stimulus generator further comprises a wireless transmitter and a wireless receiver, the wireless transmitter being located outside of a body of the subject and at least a portion of the wireless receiver being electrically coupled to the coil, wherein the wireless transmitter is configured for wirelessly transmitting instructions to the wireless receiver to supply the current to the coil.

8. The apparatus of claim 7, wherein the wireless receiver and the wireless transmitter are electromagnetically or inductively coupled.

9. The apparatus of claim 7, further comprising:

one or more wires electrically coupling the power source to the wireless transmitter;

circuitry in the wireless transmitter to drive the wireless transmitter to transmit a stimulus energy to the wireless receiver; and

circuitry in the wireless receiver adapted to receive the stimulus energy and apply the current to the coil.

10. The apparatus of claim 1, further comprising an ear piece attached to the insulating guide sheath and configured to reach around the ear to hold the insulating guide sheath against the external ear.

11. The apparatus of claim 1, wherein the guide piece is a sound-dampening ear plug.

12. The apparatus of claim 1, wherein the guide piece of the insulating guide sheath is configured to fit against a surface within the ear canal for holding the external portion of the insulating guide sheath against the external ear of the mammalian subject such that the coil is held perpendicular to an axis of the ear canal.

13. The apparatus of claim 1, wherein the coil is circular- or ring-shaped.

14. The apparatus of claim 1, wherein the coil is figure-8- or cloverleaf-shaped.

15. The apparatus of claim 1, wherein a length of the guide piece is such that the guide piece extends into the ear canal to a distance that is less than half a length of the ear canal.

16. The apparatus of claim 1, wherein a circumference of the guide piece is such that the guide piece is in contact with an internal surface of the ear canal around the circumference of the guide piece.

17. The apparatus of claim 1, wherein a diameter of the external portion of the insulating guide sheath is greater than a diameter of an opening to the ear canal.

18. The apparatus of claim 1, wherein the elongated ends of the coil comprise a current inflow wire and a current outflow wire that terminate in the coil.

19. The apparatus of claim 1, wherein the insulating guide sheath is designed to insulate the coil with elongated ends from the ear of the subject while current is supplied to the coil.