Modulating function of neural structures near the ear

• US 10,105,549 B2
• Filed: 02/29/2016
• Issued: 10/23/2018
• 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 D
• Application Number:
  US15/056,326
• Publication Number:
  US 20160175605A1
• Time in Patent Office: 967 Days
• 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. A method of stimulating a portion of a neural system of a subject through an ear of the subject, via a stimulator apparatus having a stimulus generator, one or more electrically-conductive elements, and an energy regulating housing adapted to contain and to electrically insulate the one or more electrically-conductive elements and to dissipate heat, the method comprising:

delivering, via the stimulus generator, stimulus energy to the one or more electrically-conductive elements for a specified period of time to stimulate the portion of the neural system of the subject through an ear of the subject;

after lapse of the specified period of time, assessing whether criteria for ceasing stimulation are satisfied, the criteria comprising a threshold for blood flow increase that is set based on a baseline blood flow measurement; and

based on the assessing;

responsive to determining that the criteria for ceasing stimulation are satisfied, ceasing delivery of the stimulus energy via the stimulus generator, or

responsive to determining that the criteria for ceasing stimulation are not satisfied, adjusting delivery of the stimulation energy until the criteria are satisfied.

2. The method of claim 1, wherein delivering the stimulus energy comprises:

enabling positioning of the stimulator apparatus in a vicinity of the portion of the neural system of the subject by;

arranging a first surface of the energy regulating housing to face the subject and rest against an external ear of the subject, the first surface comprising materials having lower thermal conductivity than other surfaces of the housing;

inserting a positioning ear piece into an ear canal of the subject, the positioning ear piece enclosed by a second surface comprising heat resistant materials; and

arranging a third surface of the energy regulating housing to face away from the subject, the third surface comprising materials having a higher thermal conductivity than the first surface,

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

3. The method of claim 1, further comprising:

determining whether a condition exists that would interfere with stimulation of the portion of the neural system of the subject with the stimulator apparatus; and

responsive to determining existence of an interfering condition, performing an adjustment to remove or alleviate the interfering condition.

4. The method of claim 3, wherein determining existence of the interfering condition comprises detecting, via the one or more electrically conductive elements, presence of an object comprising a metallic material within a specified vicinity of the stimulator apparatus.

5. The method of claim 3, wherein performing the adjustment further comprises absorbing or dissipating heat from the apparatus.

6. The method of claim 1, further comprising providing a functional nerve block for application to a pure somatic motor or a somatic sensory component of the neural system of the subject to improve tolerability of the simulation by the subject.

7. The method of claim 6, wherein the nerve block is a pharmacological agent.

8. The method of claim 6, wherein the nerve block is an electrical current applied by an electrode of the stimulator apparatus.

9. The method of claim 6, wherein the nerve block is an electromagnetic field created by at least one of the one or more electrically-conductive elements of the stimulator apparatus.

10. The method of claim 1, wherein delivering the stimulus energy further comprises delivering, by the stimulus generator, electromagnetic pulses.

11. The method of claim 10, wherein the electromagnetic pulses are of substantially biphasic shape and are of 100-450 microseconds duration and 0.5-2.0 Tesla-field strength.

12. The method of claim 10, wherein the electromagnetic pulses are delivered at 5-20 Hertz frequency in a continuous manner for less than 5 minutes.

13. The method of claim 1, wherein the stimulus energy is delivered intermittently.

14. The method of claim 1, wherein assessing whether criteria for ceasing stimulation are satisfied comprises determining whether a specified amount of time has lapsed from an onset of the stimulation or determining whether a specified number of stimulus pulses have been delivered.

15. The method of claim 1, wherein assessing whether the criteria for ceasing stimulation are satisfied further comprises evaluating feedback obtained from the subject or a feedback signal measured from a sensor associated with the apparatus to determine whether the criteria for ceasing stimulation are satisfied.

16. The method of claim 1, wherein assessing whether the criteria for ceasing stimulation are satisfied comprises measuring a parameter of the delivered stimulus energy and comparing the measured parameter against a specified threshold value.

17. The method of claim 1, further comprising obtaining the baseline blood flow measurement with a sensor of the apparatus;

and setting the threshold for blood flow increase based on the baseline blood flow measurement.

18. The method of claim 1, wherein delivering the stimulus energy further comprises setting a duration, intensity, frequency, or waveform, as a function of blood flow, electroencephalography potentials, intracranial pressure, or a duration of a condition of the subject.

19. The method of claim 1, further comprising:

determining efficacy of the delivery of stimulus energy; and

responsive to determining that the efficacy was insufficient, enabling insertion of an electrically-conductive material, pharmacological agent, or anesthetic in a portion of an ear of the subject.