Method and apparatus for transdermal stimulation over the palmar and plantar surfaces

• US 9,339,641 B2
• Filed: 03/15/2013
• Issued: 05/17/2016
• Est. Priority Date: 01/17/2006
• Status: Active Grant

• Current Assignee: Emkinetics, Inc.
• Original Assignee: Emkinetics, Inc.
• Inventors: Rajguru, Amit, Burnett, Daniel R.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US13/840,936
• Publication Number:
  US 20140046423A1
• Time in Patent Office: 1,159 Days
• Field of Search: 607/2, 607/40, 607/115, 607/144, 607/46
• US Class Current: 1/1
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: A61N 2/004 specially adapted for a specific therapy
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

Various methods and devices for providing transdermal electrical stimulation therapy to a patient are provided. In certain variations, a method may include positioning a stimulator electrode over a glabrous skin surface overlying a target nerve of a subject. Electrical stimulation may be delivered through or across the glabrous skin surface to the target nerve to stimulate the target nerve, while remaining safe and tolerable to the patient. Electrical stimulation may be delivered at frequencies that may be painful or intolerable when applied over non-glabrous surfaces of the body. Various applicators or devices for providing transdermal electrical stimulation therapy are also provided.

Claims

1. A method for providing transdermal electrical stimulation therapy to a subject comprising:

positioning a stimulator electrode over a glabrous skin surface overlying a palm of the subject;

delivering, via a pulse generator, electrical stimulation transdermally through the glabrous skin surface and to a target nerve or tissue within the hand to stimulate the target nerve or tissue within the hand until pain felt by the subject is mitigated;

providing feedback signals based on F-wave detection, and

adjusting or optimizing the electrical stimulation delivered through the glabrous skin surface and to the target nerve or tissue within the hand based on the F-wave detection.

2. The method of claim 1, wherein the electrical stimulation is delivered at a frequency of about 5 Hz to about 60 Hz, while remaining safe and tolerable to the subject.

3. The method of claim 1, wherein the stimulator electrode is a surface electrode.

4. The method of claim 1. wherein the electrical stimulation is delivered intermittently or on a chronic basis.

5. The method of claim 1. further comprising:

detecting nerve stimulation via at least one sensor positioned on the subject;

receiving a signal from the sensor indicative of the detected electrical stimulation thereby providing a feedback about the efficacy of the applied electrical stimulation therapy such that the therapy is adjusted or optimized.

6. The method of claim 5, wherein the feedback is queried such that the electrical stimulation therapy is adjusted to ensure that a minimum amount of energy is being applied to stimulate the target nerve within the hand while reducing the risk of burns or intolerance.

7. The method of claim 5, wherein the feedback is queried such that the positioning of the stimulator electrode is adjusted to optimize the electrical stimulation therapy.

8. The method of claim 5, wherein the sensor is selected from the group consisting of a surface electrode, microneedle electrode, or motion sensor.

9. The method of claim 5, wherein afferent nerve stimulation is detected.

10. The method of claim 1, further comprising positioning a ground electrode on the subject to facilitate penetration of an electrical current through the glabrous surface to stimulate the target nerve within the hand.

11. The method of claim 1, wherein the stimulator electrode is attached to the glabrous skin surface with an adhesive.

12. The method of claim 1, wherein the stimulator electrode is positioned over the glabrous skin surface with an ergonomic applicator.

13. The method of claim 12, wherein the applicator is a glove or brace configured to he positioned against the palmar surface of a hand such that the electrode delivers electrical stimulation to a target nerve within the hand.

14. The method of claim 12, wherein the applicator and/or one or more electrodes are coated with a pain relief drug.

15. The method of claim 1, wherein the electrical stimulation is automatically paused for a preset amount of time every 10 minutes to overcome habituation.

16. The method of claim 1, wherein the electrical stimulation is automatically paused for a preset amount of time every 10 minutes based on feedback provided by a sensor regarding target nerve stimulation or habituation.

17. The method of claim 1, wherein once tetany is detected in a patient, indicating that a threshold frequency of the applied stimulation has been reached, the strength of the applied stimulation is automatically or manually decreased.

18. The method of claim 1, wherein electrical stimulation is provided by delivering a cycle comprising a preset number of pulses followed by a pause in stimulation, followed by a preset number of pulses, and repeating the cycle as necessary.

19. The method of claim 1, wherein the pain felt by the subject is migraine pain.

20. The method of claim 19, wherein the stimulator electrode is coated with a pain relief drug.

21. The method of claim 19, wherein the stimulator electrode is a surface electrode.

22. The method of claim 19, wherein the electrical stimulation is provided by delivering a cycle comprising a preset number of pulses followed by a pause in. stimulation, followed by a preset number of pulses, and repeating the cycle as necessary.

23. The method of claim 22, wherein the electrical stimulation is delivered at a frequency of about 5 Hz to about 60 Hz.

24. The method of claim 1, further comprising providing feedback signals based on M-wave detection such that the electrical stimulation delivered through the glabrous skin surface and to a target nerve or tissue within the hand may be adjusted or optimized based on the M-wave detection.

25. The method of claim 21, further comprising providing feedback signals based on M-wave detection such that the electrical stimulation delivered through the glabrous skin surface of the palm and to a target nerve or tissue within the hand may be adjusted or optimized based on the M-wave detection.