SYSTEM AND METHOD FOR STIMULATING SENSORY NERVES

• US 20100274327A1
• Filed: 04/28/2010
• Published: 10/28/2010
• Est. Priority Date: 10/19/2004
• Status: Active Grant

• Current Assignee: Meagan Medical, Inc.
• Original Assignee: Meagan Medical, Inc.
• Inventors: JOHNSON, Timothy J., AUNE, Erling Jensen JR., CARROLL, William J., SCHOUENBORG, Jens Olaf Roe
• Granted Patent: US 8,417,352 B2
• Time in Patent Office: Days
• US Class Current: 607/72
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36034 specified by the stimulation parameters

Abstract

An electrotherapy system for stimulating sensory nerves within skin tissue includes a electrode carrier, a pulse generator, an array of skin-penetrating electrodes and surface skin electrodes, a pulse conditioning circuit, and a power source. The system administers biphasic pulsed current at the surface skin electrodes and monophasic pulsed current at each skin-penetrating electrode. The skin-penetrating surfaces and skin contact surfaces of the electrotherapy system may be sterilized or may be replaceable for outpatient reusability.

Claims

1. An electrotherapy system for stimulating sensory nerves within skin tissue, said system comprising:

an electrode carrier having an external non-conductive coating;

a pulse generator electrically connected to said electrode carrier;

an array of skin-penetrating electrodes formed on said electrode carrier or removably attached to but electrically coupled to said electrode carrier;

at least one surface skin electrode formed on said electrode carrier or separately from but electrically attached to said electrode carrier; and

a pulse conditioning circuit operatively connected between said at least one surface skin electrode and said array of skin-penetrating electrodes,

wherein said pulse generator produces a biphasic pulsed current at said at least one surface skin electrode capable of passing said biphasic pulsed current through the skin tissue; and

,

wherein said pulse generator and said pulse conditioning circuit collectively produce a monophasic pulsed current at each of said skin-penetrating electrodes capable of passing said monophasic pulsed current through the skin tissue.

2. The system of claim 1, wherein said pulse generator provides each of said skin-penetrating electrodes with a pulse train of about 0.1 to 10 Hertz, each pulse in said pulse train characterized by a pulse duration of about 0.5 to 10.0 milliseconds and a current amplitude of up to about 2 milliamperes.

3. The system of claim 2, wherein said current amplitude during a pulse onset reaches a maximum current amplitude of about 0.5 to 2 milliamperes within about 0.25 milliseconds at most from said pulse onset, said maximum current amplitude generated by said pulse conditioning circuit, and wherein said current amplitude is reduced by about 5 to 50 percent thereafter for the remainder of said pulse duration.

4. The system of claim 1, wherein said pulse generator provides said at least one surface skin electrode with pulse trains having a burst frequency of about 0.1 to 10 Hertz, a pulse string frequency within the burst of about 50 to 400 Hertz, a burst duration per each one of said at least one surface skin electrode of up to about 100 milliseconds, a pulse duration of about 0.05 to 0.3 milliseconds, and a current amplitude of up to approximately 50 milliamperes.

5. The system of claim 1, wherein said biphasic and monophasic pulsed currents are configured to administer electroanalgesia at said surface skin electrode and at each of said skin-penetrating electrodes in a non-consecutive pattern of transcutaneous electrical nerve stimulation and skin-penetrating electrical nerve stimulation.

6. The system of claim 1, wherein said pulse conditioning circuit includes at least one of a capacitor in parallel with a resistor, a semiconductor field effect transistor, a digital signal processor, and an inductor.

7. The system of claim 1, wherein each of said skin-penetrating electrodes is configured to target Aδ

and C nerve fibers within the skin tissue and said at least one surface skin electrode is configured to target Aβ

nerve fibers within the skin tissue.

8. The system of claim 1, wherein said array of skin-penetrating electrodes is removably attached to said electrode carrier and is disposable.

9. The system of claim 1, further comprising:

an antimicrobial agent infused within or layered upon said array of skin-penetrating electrodes and within or upon said non-conductive coating for reducing microbial reproduction on each of said skin-penetrating electrodes and non-conductive coating.

10. The system of claim 1, further comprising:

a disinfecting mechanism configured to reduce microbial reproduction on each of said skin-penetrating electrodes and electrode carrier when coupled with said array of skin-penetrating electrodes and said electrode carrier.

11. The system of claim 10, wherein said disinfecting mechanism reduces microbial reproduction with at least one of boiling water and steam.

12. The system of claim 10 further including:

a rechargeable power source; and

a recharging mechanism configured to recharge said power source.

13. The system of claim 12 further comprising:

a housing configured integrally to enclose said disinfecting mechanism and said recharging mechanism.

14. A method for electrically stimulating sensory nerves within skin tissue, comprising:

a) applying pulsed current to Aβ

nerve fibers via at least one surface skin electrode;

b) applying pulsed current to Aδ and

C nerve fibers via at least one skin-penetrating electrode from an array of skin-penetrating electrodes in a pattern with said step of applying pulsed current to Aβ

nerve fibers;

c) effecting a waveform with which said pulsed current is applied to Aδ and

C nerve fibers; and

d) repeating said steps a) through c).

15. The method of claim 14, wherein said step of applying pulsed current to Aβ

nerve fibers via said at least one surface skin electrode and said step of applying pulsed current to Aδ and

C nerve fibers via at least one skin-penetrating electrode of said array of skin-penetrating electrodes in a pattern includes delivering pulsed current to said at least one surface skin electrode and at least one skin-penetrating electrode by pulsing said at least one surface skin electrode concurrently with at least one skin-penetrating electrode in various combinations.

16. The method of claim 15, wherein said pattern is at least one of random, phase-locked, predetermined, and orderly.

17. The method of claim 15, wherein said pattern includes pulsing said at least one surface skin electrode and at least one of said skin-penetrating electrodes starting at a first side of the electrode carrier and proceeding sequentially to a second side of the electrode carrier so as to cause a sensation of sweeping stimulation that mimics scratching or massaging the skin tissue.

18. The method of claim 15, wherein said step of applying pulsed current to Aβ

nerve fibers via said at least one surface skin electrode and said step of applying pulsed current to Aδ and

C nerve fibers via at least one skin-penetrating electrode of said array of skin-penetrating electrodes in a pattern includes delivering pulsed current to said at least one surface skin electrode and at least one skin-penetrating electrode in pairs each comprising one surface skin electrode and one skin-penetrating electrode.

19. The method of claim 15, wherein said step of applying pulsed current to Aβ

nerve fibers via said at least one surface skin electrode produces a signal in the Aβ

nerve fibers that arrives at a spinal cord at least one of prior to and overlapping in time with a signal produced in the Aδ and

C nerve fibers by said step of applying pulsed current to Aδ and

C nerve fibers via said at least one skin-penetrating electrode of said array of skin-penetrating electrodes.

20. The method of claim 14, wherein said step of applying pulsed current to Aβ

nerve fibers via at least one surface skin electrode includes applying pulse trains having a burst frequency of about 0.1 to 10 Hertz, a pulse string frequency within the burst of about 50 to 400 Hertz, a burst duration per each one of said at least one surface skin electrode of up to about 100 milliseconds, a pulse duration of about 0.05 to 0.3 milliseconds, and a current amplitude of up to about 50 milliamperes.

21. The method of claim 14, wherein said step of applying pulsed current to Aδ

and C nerve fibers via at least one skin-penetrating electrode of said array of skin-penetrating electrodes includes applying a pulse train of about 0.1 to 10 Hertz, each pulse in said pulse train being characterized by a pulse duration of about 0.5 to 10.0 milliseconds and a current amplitude of up to about 2 milliamperes.

22. The method of claim 21, wherein each pulse in said pulse train has a pulse onset that reaches a maximum current amplitude of about 0.5 to 2 milliamperes within about 0.25 milliseconds at most from said pulse onset, and wherein said current amplitude is reduced by about 5 to 50 percent thereafter for the remainder of said pulse duration.

23. The method of claim 14, further comprising:

reducing microbial reproduction on said array of skin-penetrating electrodes.

24. The method of claim 23, wherein said step of reducing microbial reproduction includes disinfecting each skin-penetrating electrode of said array of skin-penetrating electrodes with at least one of boiling water and steam.

25. The method of claim 23, wherein said step of reducing microbial reproduction includes infusing or layering said each skin-penetrating electrode of said array of skin-penetrating electrodes with an antimicrobial agent.

26. The method of claim 14, further comprising:

providing a power source coupled with said at least one surface skin electrode and said array of skin-penetrating electrodes to supply power to the electrodes; and

recharging the power source.

27. An appliance for electro-stimulating skin tissue, said appliance comprising:

a printed circuit board (PCB) including an external non-conductive coating;

at least one surface skin electrode formed or mounted on said PCB and configured to electrically contact the skin tissue;

an array of skin-penetrating electrodes formed or mounted on said PCB and configured to electrically contact the skin tissue;

an electrical circuit formed or mounted on said PCB and operatively coupled to said at least one surface skin electrode and to each skin-penetrating electrode of said array of skin-penetrating electrodes, said electrical circuit including a pulse generator configured to produce a biphasic pulsed current at the skin tissue via said at least one surface skin electrode and to produce a monophasic pulsed current at each of said skin-penetrating electrodes; and

a disinfecting mechanism configured to reduce microbial reproduction on said PCB when coupled thereto.

28. The appliance of claim 27, wherein said pulse generator provides said at least one surface skin electrode with pulse trains having a burst frequency of about 0.1 to 10 Hertz, a pulse string frequency within the burst of about 50 to 400 Hertz, a burst duration per each one of said at least one surface skin electrode of up to about 100 milliseconds, a pulse duration of about 0.05 to 0.3 milliseconds, and a current amplitude of up to about 50 milliamperes.

29. The appliance of claim 27, wherein said pulse generator provides said each skin-penetrating electrode with a pulse train of about 0.1 to 10 Hertz, each pulse in said pulse train characterized by a pulse duration of about 0.5 to 10.0 milliseconds and a current amplitude of up to about 2 milliamperes, and wherein said current amplitude during a pulse onset reaches a maximum current amplitude of about 0.5 to 2 milliamperes within about 0.25 milliseconds at most from said pulse onset, said maximum current amplitude being generated by said pulse generator, and wherein said current amplitude is reduced by about 5 to 50 percent thereafter for the remainder of said pulse duration.

30. The appliance of claim 27, wherein the PCB is flexible and conformable to the skin tissue.

31. The appliance of claim 27 further comprising:

an antimicrobial agent infused within or layered upon said array of skin-penetrating electrodes and within or upon said non-conductive coating thereby to reduce microbial reproduction on each of said skin-penetrating electrodes and non-conductive coating.

32. The appliance of claim 27, wherein said biphasic and monophasic pulsed currents are configured to administer electroanalgesia at said surface skin electrode and at each of said skin-penetrating electrodes in a pattern of transcutaneous electrical nerve stimulation and skin-penetrating electrical nerve stimulation.

33. The appliance of claim 32, wherein said pattern at least one of random, phase-locked, predetermined, and orderly.

34. The appliance of claim 27 further including:

a rechargeable power source; and

a recharging mechanism configured to recharge the power source.

35. The appliance of claim 34 further comprising:

a housing configured integrally to enclose said disinfecting mechanism and said recharging mechanism.