Apparatus and method for the treatment of headache

• US 8,560,075 B2
• Filed: 10/13/2009
• Issued: 10/15/2013
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: Alejandro Covalin
• Original Assignee: Alejandro Covalin
• Inventors: Covalin, Alejandro
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US12/578,369
• Publication Number:
  US 20100030299A1
• Time in Patent Office: 1,463 Days
• Field of Search: 607/46, 607/139, 600/13
• US Class Current: 607/46
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

A battery-operated transcutaneous electrical nerve stimulator (TENS) to treat headache pain in an abortive and/or preventive manner. The TENS unit and its electrodes are built into a unitary device which facilitates a self-administered treatment. In some embodiments, the pulses are monophasic. In other embodiments, pairs of biphasic pulses are provided, wherein each pair of biphasic pulses includes a first pulse having a first polarity separated by a gap in time from a second pulsed having an opposite polarity. In some embodiments, each pulse in each biphasic pair is of a duration equal to that of the other pulse of the pair. In some embodiments, the duration of each pulse is between about 50 microseconds and about 400 microseconds, and the gap in time between pulses of a pair is between about 50 and 100 microseconds.

Claims

1. A method for treating a headache of a patient, the method comprising:

providing a portable head-band-mounted, transcutaneous electrical nerve stimulator (TENS) having;

a first electrode set having a plurality of non-invasive comb-like electrodes physically connected to a common electrode base and each electrically connected to a first signal output of the TENS,

a second electrode set having one or more non-invasive comb-like electrodes physically connected to the common electrode base, wherein the first electrode set and the second electrode set are configured to be simultaneously placed in contact with the patient'"'"'s head, and wherein the second electrode set is electrically connected to a second signal output of the TENS, and

a headband-type assembly that, after it has been placed on the patient'"'"'s head, provides hands-free operation that does not require further handling and secures the first electrode set and the second electrode set against the patient'"'"'s head, such that the first electrode set is held against a first elongated posterior area of the patient'"'"'s head, and the second electrode set is held against a second elongated posterior area of the patient'"'"'s head, wherein the first area and the second area are in a cranial-caudal relationship to one another;

supporting, using the headband-type assembly, the head-band-mounted TENS on the patient'"'"'s head such that the patient is free to move while stimulation is being applied;

receiving, by the TENS, an activation indication; and

based on the activation indication, providing a plurality of electrical pulses between the first signal output of the TENS and the second signal output of the TENS such that the electrical pulses are applied between the first area and the second area in a vertical caudal-cranial direction transcutaneously to the patient'"'"'s head, wherein the plurality of electrical pulses are configured to be charge-balancing and short enough in duration to stimulate nerves of the patient while minimizing stimulation of muscle contraction, in order to treat headache pain.

2. The method of claim 1, wherein the providing of the plurality of electrical pulses includes providing biphasic pairs of substantially square pulses, each pair of pulses including a first pulse having a first polarity and a duration of between about 50 microseconds and about 400 microseconds and, after a first gap-in-time delay of between about 50 microseconds and about 100 microseconds, a second, following, pulse having a second polarity, opposite the first polarity, and a duration of between about 50 microseconds and about 400 microseconds, and a second gap-in-time delay that is longer than the combined duration of the first pulse, first gap-in-time delay and second pulse.

3. The method of claim 2, wherein the providing of the TENS includes housing the TENS and the first and second electrode set in a unitary device that has no external wires, and wherein the unitary device facilitates a self-administered treatment by the patient.

4. The method of claim 2, wherein the providing of the plurality of electrical pulses treats headache pain in an abortive manner.

5. The method of claim 2, wherein the providing of the plurality of electrical pulses treats headache pain in a preventive manner.

6. The method of claim 2, wherein the electrodes of the first electrode set are grouped into a first group, wherein the electrodes of the second electrode set are grouped into a second group, wherein the first group is located at a distance from the second group that is greater than a distance between any two adjacent electrodes in each group.

7. The method of claim 2, wherein the first pulse has a duration of about 100 microseconds and, after the first gap-in-time delay of about 75 microseconds, the second pulse has a duration of about 100 microseconds.

8. The method of claim 2, wherein the first and second electrode set are mounted in a device head, the method further comprising disabling power to the first and second electrode set plurality of electrodes if no pressure is applied to the device head, and enabling pulsed power to the first and second electrode set if pressure is applied.

9. The method of claim 2, wherein each one of the first and second electrode set is hollow, and wherein the first and second electrode set are mounted in a device head, the method further comprising:

dispensing a conductive gel through each one of the first and second electrode set of hollow electrodes; and

disabling power to each one of the first and second electrode set of hollow electrodes if no pressure is applied to the device head.

10. The method of claim 1, wherein the providing of the plurality of electrical pulses includes stimulating one or more of the nerve structures selected from the group consisting of the right greater occipital nerve, the left greater occipital nerve, the right least (third) occipital nerve, the left least (third) occipital nerve, the right lesser occipital nerve, the left lesser occipital nerve, the right great auricular nerve, and the left great auricular nerve.

11. The method of claim 1, wherein the providing of the plurality of electrical pulses includes providing unspaced biphasic pairs of pulses, each pair of pulses including a first pulse having a first polarity and a duration of between about 50 microseconds and about 400 microseconds and a second, immediately following, pulse having a second polarity, opposite the first polarity, and a duration of between about 50 microseconds and about 400 microseconds and then a gap-in-time delay such that the pulse repetition rate is between about 200 Hz and about 1000 Hz.

12. The method of claim 1, wherein the second electrode set includes a plurality of electrodes.

13. The method of claim 1, wherein the providing of the plurality of electrical pulses includes providing pairs of biphasic electrical pulses, each pair of biphasic electrical pulses including a first pulse of a first polarity and a second pulse of a second opposite polarity and a zero voltage during a first gap-in-time delay of between about 50 microseconds and about 100 microseconds between the first pulse having the first polarity and the second pulse having the second polarity, opposite the first polarity, and then a zero voltage during a second gap-in-time delay immediately following the second pulse that is longer than the combined duration of the first pulse, first gap-in-time delay and second pulse.

14. An apparatus for treating a headache of a patient, the apparatus comprising:

a portable head-band-mounted, transcutaneous electrical nerve stimulator (TENS) having a common electrode base;

a first electrode set having a plurality of non-invasive comb-like electrodes physically connected to the common electrode base and each electrically connected to a first signal output of the TENS,

a second electrode set having one or more non-invasive comb-like electrodes physically connected to the common electrode base, wherein the first electrode set and the second electrode set are configured to be simultaneously placed in contact with the patient'"'"'s head, and wherein the second electrode set is electrically connected to a second signal output of the TENS, and

a headband-type assembly that, after it has been placed on the patient'"'"'s head, supports the head-band-mounted TENS on the patient'"'"'s head such that the patient is free to move while stimulation is being applied, provides hands-free operation that does not require further handling, and secures the first electrode set and the second electrode set against the patient'"'"'s head, such that the first electrode set is held against a first elongated posterior area of the patient'"'"'s head, and the second electrode set is held against a second elongated posterior area of the patient'"'"'s head, wherein the first area and the second area are in a cranial-caudal relationship to one another,

wherein the TENS presents a plurality of electrical pulses between the first signal output of the TENS and the second signal output of the TENS such that the electrical pulses are applied between the first area and the second area in a vertical caudal-cranial direction transcutaneously to the patient'"'"'s head, wherein the pulses are configured to be charge-balancing and short enough in duration to stimulate nerves of the patient while minimizing stimulation of muscle contraction, in order to treat headache pain.

15. The apparatus of claim 14, wherein the TENS includes a circuit configured to output the plurality of electrical pulses as a series of biphasic pairs of substantially square pulses, each pair of pulses including a first pulse having a first polarity and a duration of between about 50 microseconds and about 400 microseconds and, after a gap-in-time delay of between about 50 microseconds and about 100 microseconds, a second, following, pulse having a second polarity, opposite the first polarity, and a duration of between about 50 microseconds and about 400 microseconds.

16. The apparatus of claim 15, wherein the TENS unit and the first and second electrode set are housed in a unitary device, wherein the unitary device has no exposed wiring, and wherein the unitary device facilitates a self-administered treatment by the patient.

17. The apparatus of claim 15, wherein the electrodes of the first electrode set are grouped into a first group, wherein the electrodes of the second electrode set are grouped into a second group, wherein the first group and the second group are located at a distance from one another that is greater than a distance between any two adjacent electrodes in each group.

18. The apparatus of claim 15, further comprising a conductive gel applicator that selectively dispenses gel from a reservoir within the apparatus.

19. The apparatus of claim 18, further comprising one or more gel-delivery channels built into at least one of the second electrode set and operatively connected to the reservoir.

20. The apparatus of claim 15, wherein the first and second electrode set are shaped and configured to facilitate contact between the first and second electrode set and skin of the patient in bodily locations where hair would otherwise impede such contact.

21. The apparatus of claim 15, wherein each one of the first and second electrode set has a comb-tooth shape to ensure that hair is combed out of the way as the patient moves the plurality of electrodes over the skin.

22. The apparatus of claim 15, wherein the apparatus is small enough that a person can carry it around comfortably.

23. The apparatus of claim 14, wherein the TENS includes a circuit configured to output a plurality of electrical biphasic pulses, each pair of pulses including a first pulse having a first polarity and a duration of between about 50 microseconds and about 400 microseconds and, after a first gap-in-time delay of between about 50 microseconds and about 100 microseconds, a second, following, pulse having a second polarity, opposite the first polarity, and a duration of between about 50 microseconds and about 400 microseconds, and then a second gap-in-time delay that is longer than the combined duration of the first pulse, first gap-in-time delay and second pulse.

24. The apparatus of claim 14, wherein the second electrode set includes a plurality of electrodes.

25. The apparatus of claim 14, wherein the TENS includes a circuit configured to output the plurality of electrical pulses as a series of biphasic pairs of pulses, each pair of pulses including a first pulse having a first polarity and a duration of and about 100 microseconds, a second pulse having a second polarity, opposite the first polarity, and a duration of about 100 microseconds, and a zero voltage during a gap-in-time delay of about 75 microseconds between the first pulse and the second pulse.

26. The apparatus of claim 14, wherein the TENS includes a circuit configured to output the plurality of electrical pulses as a series of biphasic pairs of pulses, each pair of pulses including a first pulse having a first polarity and a duration of between about 50 microseconds and about 400 microseconds and, after a gap-in-time delay of between about 50 microseconds and about 100 microseconds, a second, following, pulse having a second polarity, opposite the first polarity, and a duration of between about 50 microseconds and about 400 microseconds.

27. An apparatus for treating a headache of a patient, the apparatus comprising:

a portable head-band-mounted, transcutaneous electrical nerve stimulator (TENS) having;

a first electrode set having a plurality of non-invasive comb-like electrodes physically connected to a common electrode base and each electrically connected to a first signal output of the TENS,

a second electrode set having one or more non-invasive comb-like electrodes physically connected to the common electrode base, wherein the first electrode set and the second electrode set are configured to be simultaneously placed in contact with the patient'"'"'s head, and wherein the second electrode set is electrically connected to a second signal output of the TENS, and

a headband-type assembly that, after it has been placed on the patient'"'"'s head, provides hands-free operation that secures the first electrode set and the second electrode set against the patient'"'"'s head, such that the first electrode set is held against a first elongated posterior area of the patient'"'"'s head, and the second electrode set is held against a second elongated posterior area of the patient'"'"'s head, wherein the first area and the second area are in a cranial-caudal relationship to one another;

means for supporting, using the headband-type assembly, the head-band-mounted TENS on the patient'"'"'s head such that the patient is free to move while stimulation is being applied;

means for receiving, by the TENS, an activation indication; and

means, based on the activation indication, for providing a plurality of electrical pulses between the first signal output of the TENS and the second signal output of the TENS such that the electrical pulses are charge-balancing and are short enough in duration, when applied between the first area and the second area in a vertical caudal-cranial direction transcutaneously to the patient head, to stimulate nerves of the patient while minimizing stimulation of muscle contraction, in order to treat headache pain.

28. The apparatus of claim 27, wherein the second electrode set includes a plurality of electrodes.