METHOD AND APPARATUS FOR TRANSDERMAL STIMULATION OVER THE PALMAR AND PLANTAR SURFACES

• US 20170266443A1
• Filed: 03/30/2017
• Published: 09/21/2017
• Est. Priority Date: 10/02/2006
• Status: Active Grant

• Current Assignee: Emkinetics, Inc.
• Original Assignee: Emkinetics, Inc.
• Inventors: RAJGURU, Amit, BURNETT, Daniel R., VERGARA, Alexander, HEMATI, Michael
• Granted Patent: US 10,786,669 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/685 Microneedles
• 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 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• 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 2/006 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

Abstract

The disclosure describes devices and methods for providing transdermal electrical stimulation therapy to a subject including positioning a stimulator electrode over a glabrous skin surface overlying a palm of the subject and delivering electrical stimulation via a pulse generator 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 so that pain felt by the subject is mitigated. The pulses generated during the electrical stimulation therapy may include pulses of two different magnitudes.

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; and

delivering electrical stimulation via a pulse generator 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 so that pain felt by the subject is mitigated;

wherein the pulses generated during the electrical stimulation therapy include pulses of a first amplitude and pulses of a second amplitude, where the first amplitude is different from the second amplitude.

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 sensor senses an M-Wave.

7. The method of claim 6 wherein a parameter of the M-Wave is displayed to the subject.

8. The method of claim 5 wherein the sensor senses an F-Wave.

9. The method of claim 8 wherein a parameter of the F-Wave is displayed to the subject.

10. 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.

11. 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.

12. The method of claim 5, wherein the sensor is a surface electrode.

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

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

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

16. The method of claim 15, wherein the applicator is a glove or brace configured to be positioned against the palmar surface of a hand such that the electrode delivers electrical stimulation to a target nerve within the hand.

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

18. 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.

19. 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.

20. 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.

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