Modulating function of neural structures near the ear

• US 9,272,157 B2
• Filed: 12/03/2012
• Issued: 03/01/2016
• Est. Priority Date: 05/02/2010
• Status: Active Grant

• Current Assignee: Nervive, Inc.
• Original Assignee: Nervive, Inc.
• Inventors: Borsody, Mark Klingler
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): LANNU, JOSHUA DARYL DEANON
• Application Number:
  US13/692,226
• Publication Number:
  US 20130150653A1
• Time in Patent Office: 1,184 Days
• Field of Search: 600/9, 600/13, 600/14, 607/2, 607/62
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence
• CPC Class Codes: A61N 2007/0026 Stimulation of nerve tissue
• CPC Class Codes: A61N 5/0622 Optical stimulation for exciting neural tissue

Abstract

Stimulation of the facial nerve system (e.g., electrically, electromagnetically, etc.) in ischemic 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 and/or placed in proximity to the ear in order to stimulate the facial nerve system non-invasively (e.g., using an electromagnetic field). The device can be used in the emergency treatment of acute stroke or chronically variations for long-term maintenance of blood flow to the brain and stroke prevention. Additional embodiments of the device may be adapted for use on different regions of the body.

Claims

1. An apparatus, comprising:

one or more electrically-conductive elements;

a positioning ear piece insertable into an ear canal of a subject;

an energy-regulating housing adapted to contain the one or more electrically-conductive elements, the energy regulating housing adapted to electrically insulate the one or more electrically-conductive elements and dissipate heat, the energy-regulating housing comprising;

a first surface configured to face a subject and rest against an external ear of the subject and comprise materials having lower thermal conductivity than other surfaces of the housing,

a second surface configured to enclose the positioning ear piece and comprising heat resistant materials,

and a third surface configured to face away from the subject and comprising materials having a higher thermal conductivity than the first surface,

wherein the first, second, and third surfaces are electrically insulating;

a stimulus generator in electrical communication with the one or more electrically-conductive elements and configured to deliver stimulus energy to the one or more electrically-conductive elements in a manner that allows the one or more electrically-conductive elements to generate an electromagnetic field to stimulate a portion of a neural system of the subject; and

a power source in communication with the stimulus generator for providing stimulus energy to the stimulus generator.

2. The apparatus of claim 1, wherein the delivered stimulus energy is electrical energy.

3. The apparatus of claim 1, wherein the one or more electrically-conductive elements are shaped substantially as a coil, and wherein the energy-regulating housing is configured to be in substantial contact with a lateral surface of a head of the subject.

4. The apparatus of claim 1, wherein the energy-regulating housing is configured to be in substantial contact with a pinna of an ear of the subject.

5. The apparatus of claim 2, wherein the one or more electrically-conductive elements are adapted to focus the generated electromagnetic field upon a single target that is a particular distance from a contact surface of the one or more electrically-conductive elements.

6. The apparatus of claim 5, wherein the particular distance is 2-4 cm from the contact surface of the one or more electrically-conductive elements.

7. The apparatus of claim 1, wherein the apparatus further comprises a case associated with the energy-regulating housing, the case comprising a component that absorbs or dissipates heat.

8. The apparatus of claim 7, wherein the component of the case comprises a phase-change material.

9. The apparatus of claim 7, wherein the component of the case comprises a heat sink.

10. The apparatus of claim 7, wherein the component of the case comprises a radiator.

11. The apparatus of claim 1, wherein the positioning ear piece is configured to create an angle between a surface of the energy-regulating housing and a surface of the subject.

12. The apparatus of claim 1, wherein the energy-regulating housing comprises a cone of ferromagnetic material.

13. The apparatus of claim 2, further comprising an automated or programmable stimulus controller configured to control the stimulus generator.

14. The apparatus of claim 2, further comprising one or more sensors or sensor functions configured to be applied to the subject or the apparatus and configured to provide input for regulating the delivery of stimulus energy to the one or more electrically-conductive elements by the stimulus generator.

15. The apparatus of claim 14, wherein the one or more sensors are configured to measure blood flow.

16. The apparatus of claim 14, wherein the one or more sensors are configured to detect metal in a vicinity of the energy-regulating housing, within a vicinity of an area of application to the subject, or implanted within the subject in a vicinity of an ear of the subject.

17. The apparatus of claim 14, wherein the one or more electrically-conductive elements comprise the one or more sensors.

18. The apparatus of claim 1, wherein the one or more electrically-conductive elements comprises sensor configured to magnetize blood components or detect signals emitted by magnetized blood components.

19. The apparatus of claim 18, wherein the one or more electrically-conductive elements comprising the sensor is configured to create a magnetic flux or measure magnetic disturbance created by blood flow.

20. The apparatus of claim 1, wherein the one or more electrically-conductive elements are configured to reside on opposing sides of the head of the subject such that the energy-regulating housing of the one or more electrically-conductive elements is in substantial contact with the pinnae of the ears.

21. The apparatus of claim 2, wherein the one or more electrically conductive elements are configured to be positioned on opposing sides of a head of the subject and are configured to provide stimulus energy from the stimulus generator to create a single electromagnetic field across the diameter of the head of the subject.

22. The apparatus of claim 21, wherein a portion of the one or more electrically-conductive elements is configured to reside within a mouth or an ear canal of the subject or underneath a chin of the subject to create, in conjunction with the one or more electrically conductive elements that are configured to be positioned on opposing sides of the head of the subject, the single electromagnetic field that crosses the diameter of the head of the subject.

23. The apparatus of claim 1, wherein the neural system is a facial nerve system.

24. The apparatus of claim 1, wherein the one or more electrically-conductive elements are configured for stimulation of a facial nerve system of the subject having a hemorrhagic stroke, the stimulation to constrict arteries supplying blood flow to a brain or a head of the subject, thereby reducing a likelihood of additional hemorrhage from a site of arterial rupture.

25. An apparatus, comprising:

one or more coiled electrically-conductive elements;

an energy-regulating housing adapted to contain the one or more coiled electrically-conductive elements, the energy regulating housing adapted to electrically insulate the one or more coiled electrically-conductive elements and dissipate heat;

an ear plug projecting from the energy regulating housing and configured to enter an ear canal of a mammalian subject to position the energy-regulating housing containing the one or more coiled electrically-conductive elements such that a plane of the one or more coiled elements is orthogonal to an axis of the ear canal, the one or more coiled elements configured to be oriented toward the ear canal to provide a stimulating electromagnetic field to the ear canal, wherein;

the ear plug encloses a ferromagnetic material configured to shape, amplify, or focus, within the ear canal, the stimulating electromagnetic field generated by the one or more coiled elements,

a length of the ferromagnetic material is configured to be axially aligned with the axis of the ear canal, the length of the ferromagnetic material depending inversely on a radius of the one or more coiled elements and the length of the ferromagnetic material being substantially perpendicular to a plane of the one or more coiled elements,

a stimulus generator in electrical communication with the one or more electrically-conductive elements and configured to deliver stimulus energy to the one or more electrically-conductive elements in a manner that allows the one or more coiled electrically-conductive elements to generate the stimulating electromagnetic field to stimulate a portion of a neural system of a subject; and

a power source in communication with the stimulus generator for providing stimulus energy to the stimulus generator.

26. The apparatus of claim 25, wherein the energy-regulating housing is configured to be in substantial contact with a lateral surface of a head of the subject.

27. The apparatus of claim 25, wherein the one or more coiled electrically-conductive elements are adapted to focus the generated electromagnetic field upon a single target that is a particular distance from a contact surface of the one or more coiled electrically-conductive elements.

28. The apparatus of claim 25, wherein the ear plug comprises an electrically-conductive element.

29. The apparatus of claim 25, wherein the ferromagnetic material is configured to project from a surface of the energy-regulating housing.

30. The apparatus of claim 25, wherein the ferromagnetic material and a perimeter of the one or more coiled electrically-conductive elements form an angle which measures in between 20 to 90 degrees.

31. The apparatus of claim 25, further comprising one or more sensors or sensor functions configured to be applied to the subject or the apparatus and configured to provide input for regulating the delivery of stimulus energy to the one or more coiled electrically-conductive elements by the stimulus generator.

32. The apparatus of claim 31, wherein the one or more sensors are configured to measure blood flow.

33. The apparatus of claim 25, wherein the one or more coiled electrically conductive elements are configured to be positioned on opposing sides of a head of the subject and are configured to provide stimulus energy from the stimulus generator to create a single electromagnetic field across the diameter of the head of the subject.

34. The apparatus of claim 25, wherein the ferromagnetic material is shaped along the length as a horseshoe with a substantially 180 degree bend on a side proximal to the one or more coiled elements to focus the electromagnetic field toward an end of the ferromagnetic material distal to the one or more coiled elements and into the ear canal, and wherein the one or more coiled elements, the energy-regulating housing, the ear plug, and the ferromagnetic material have axially aligned central openings.