System and method for stimulating sensory nerves

• US 8,417,352 B2
• Filed: 04/28/2010
• Issued: 04/09/2013
• Est. Priority Date: 10/19/2004
• Status: Active Grant

• Current Assignee: Meagan Medical, Inc.
• Original Assignee: Meagan Medical, Inc.
• Inventors: Carroll, William J., Aune, Erling Jensen Jr., Johnson, Timothy J., Schouenborg, Jens Olaf Roe
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US12/769,382
• Publication Number:
  US 20100274327A1
• Time in Patent Office: 1,077 Days
• Field of Search: 607/9, 607/115, 600372-373, 600/377, 600/382, 600/396, 600/393
• US Class Current: 607/115
• 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 disposed on said electrode carrier, each of said skin-penetrating electrodes including a needle-like protrusion;

at least one surface skin electrode disposed on said electrode carrier, said at least one surface skin electrode being physically spaced and electrically separate from any needle-like protrusions disposed on the 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. The electrotherapy system of claim 1, wherein

the electrode carrier is molded around the array of skin-penetrating electrodes;

or

the array of skin-penetrating electrodes is formed separately and removably attached to the electrode carrier.

15. The electrotherapy system of claim 1, wherein

the at least one surface skin electrode is screen-printed on the electrode carrier;

or

the at least one surface skin electrode is formed separately and removably attached to the electrode carrier.

16. 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 disposed on said PCB and configured to electrically contact the skin tissue, said at least one surface skin electrode being physically spaced and electrically separate from any needle-like protrusions disposed on the electrode carrier;

an array of skin-penetrating electrodes disposed on said PCB and configured to electrically contact the skin tissue, each of said skin-penetrating electrodes including a needle-like protrusion;

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.

17. The appliance of claim 16, 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.

18. The appliance of claim 16, 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.

19. The appliance of claim 16, wherein the PCB is flexible and conformable to the skin tissue.

20. The appliance of claim 16 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.

21. The appliance of claim 16, 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.

22. The appliance of claim 21, wherein said pattern at least one of random, phase-locked, predetermined, and orderly.

23. The appliance of claim 16 further including:

a rechargeable power source; and

a recharging mechanism configured to recharge the power source.

24. The appliance of claim 23 further comprising:

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

25. The appliance of claim 16, wherein

the PCB is molded around the array of skin-penetrating electrodes;

or

the array of skin-penetrating electrodes is formed separately and removably attached to the PCB.

26. The appliance of claim 16, wherein

the at least one surface skin electrode is screen-printed on the PCB;

or

the at least one surface skin electrode is formed separately and removably attached to the PCB.