Method and means for electrical stimulation of cutaneous sensory receptors

• US 8,086,322 B2
• Filed: 10/19/2005
• Issued: 12/27/2011
• Est. Priority Date: 10/19/2004
• Status: Active Grant

• Current Assignee: Meagan Medical, Inc.
• Original Assignee: Meagan Medical, Inc.
• Inventors: Schouenborg, Jens Olaf Roe
• Primary Examiner(s): Patel, Niketa I
• Assistant Examiner(s): Lavert, Nicole F
• Application Number:
  US11/253,936
• Publication Number:
  US 20060085056A1
• Time in Patent Office: 2,260 Days
• Field of Search: 600/372, 600/393, 600/373, 600/382, 600/386, 607/119, 607/115
• US Class Current: 607/115
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0468 Specially adapted for promoting wound healing
• 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 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

Electrode plate comprising a stiff or flexible electrically non-conductive plate element having a front face and a rear face and a pattern of needle-like (NL) electrodes for electrical stimulation of cutaneous thin Aδ/C fibers and conductive plate (CP) electrodes for electrical stimulation cutaneous large Aβ fibers disposed on the front face.

Claims

1. An electrode plate comprising:

an electrically non-conductive plate element having a front face and a rear face; and

a pattern of needle-like (NL) electrodes and flat conductive plate (CP) electrodes disposed on the front face of the plate element in two or more electrode combinations, each of the two or more electrode combinations having at least one NL electrode configured to apply electrical stimulation to cutaneous thin Aδ

/C fibers and at least one CP electrode configured to apply electrical stimulation to cutaneous large Aβ

fibers, and each of the CP electrodes being physically spaced and electrically separate from any needle-like protrusions on the front face of the plate element,

wherein the needle-like protrusions include the NL electrodes.

2. The electrode plate of claim 1, wherein the CP electrodes are arranged in close proximity to the NL electrodes in a manner so to make an average distance of two to four of the CP electrodes most closely disposed around one of the NL electrodes to that NL electrode substantially shorter than the corresponding distance of two to four of the most closely disposed neighboring NL electrodes.

3. The electrode plate of claim 1, further comprising a plurality of open venting bores communicating the front face with the rear face.

4. The electrode plate of claim 1, further comprising an electrically conductive or non-conductive adhesive disposed on portions of the front face for attaching the electrode plate to the skin.

5. The electrode plate of claim 1, wherein the NL electrodes include a base portion configured to control the depth of penetration of an oblong electrode element extending perpendicularly from the base portion.

6. The electrode plate of claim 5, wherein the oblong electrode element has a free end that is pointed.

7. The electrode plate of claim 1, further comprising at least one first electrical conductor coupled to at least one of the NL electrodes and at least one second electrical conductor coupled to at least one of the CP electrodes, the first and second electrical conductors separately connecting the at least one NL electrode and the at least one CP electrode to a multi-channel stimulator unit so the at least one NL electrode and the at least one CP electrode can be addressed separately.

8. The electrode plate of claim 7, wherein the first and second electrical conductors are attached to the front face of the plate element.

9. The electrode plate of claim 8, wherein the conductors are attached to the plate element by screen printing.

10. The electrode plate of claim 1, wherein

the front face of the plate element is formed with raised portions and recessed portions disposed between the raised portions,

the NL electrodes are mounted on the raised portions of the front face, and

the CP electrodes are mounted on the recessed portions of the front face.

11. The electrode plate of claim 10, wherein the raised portions are designed to carry single NL electrodes or rows of NL electrodes.

12. The electrode plate of claim 10, wherein the recessed portions provide flexibility to the plate element.

13. The electrode plate of claim 12, wherein the recessed portions are at least one of compressible, resiliently compressible, extendable, and resiliently extendable.

14. The electrode plate of claim 10, wherein

the raised portions are configured so the NL electrodes penetrate a patient'"'"'s skin to a depth of 0.1 to 10 mm.

15. The electrode plate of claim 12, wherein at least one of electrically conductive gel and electrically conductive adhesive is disposed in the recessed portions of the plate element.

16. The electrode plate of claim 15, wherein the electrically conductive gel and/or electrically conductive adhesive is disposed in electrical contact with the CP electrodes.

29. The electrode plate of claim 1, wherein the at least one NL electrode in each of the two or more electrode combinations is physically spaced 1 mm to 20 mm from the at least one CP electrode in that combination on the front face of the plate element.

17. An assembly for administration of electrical stimulation to the skin of a person comprising:

an electrode plate comprising;

an electrically non-conductive plate element having a front face and a rear face, and

a pattern of needle-like (NL) electrodes and flat conductive plate (CP) electrodes disposed on the front face of the plate element in two or more electrode combinations, each of the two or more electrode combinations having at least one NL electrode configured to apply electrical stimulation to cutaneous thin Aδ

/C fibers and at least one CP electrode configured to apply electrical stimulation to cutaneous large Aβ

fibers; and

a multi-channel stimulator unit configured to separately address the NL and CP electrodes for applying consecutive electrical stimulation to cutaneous thin Aδ

/C fibers via the NL electrodes and electrical stimulation to cutaneous large Aβ

fibers via the CP electrodes.

18. The assembly of claim 17, wherein at least one first CP electrode is controlled by the stimulator unit to function as a reference electrode for the NL electrodes while the NL electrodes apply electrical stimulation to cutaneous thin Aδ

/C fibers and at least one second CP electrode applies electrical stimulation to cutaneous large Aβ

fibers.

19. The assembly of claim 18, wherein at least two first CP electrodes are coupled as anodes in their function as reference electrodes.

20. The assembly of claim 18, wherein the stimulator is programmed to use a majority or all of the CP electrodes as first CP electrodes, except the at least one second CP electrode.

21. The assembly of claim 17, wherein one of the CP electrodes and a neighboring one of the NL electrodes are phase-locked.

22. The assembly of claim 21, wherein consecutive pairs or other combinations of CP and NL electrodes apply electrical stimulation in a random pattern.

23. The assembly of claim 21, wherein consecutive pairs or other combinations of CP and NL electrodes apply electrical stimulation in an orderly pattern.

24. The assembly of claim 17, wherein the stimulator is configured to provide current to the CP electrodes for stimulating Aβ

fibers with pulse trains (bursts) having a burst frequency of from 0.1 Hz to 10 Hz;

an internal frequency of from 50 Hz-400 Hz;

a burst length per CP electrode of up to 100 ms;

a pulse duration of from 0.05 ms to 0.3 ms; and

a current amplitude of up to 50 mA.

25. The assembly of claim 17, wherein the stimulator is configured to provide current to the NL electrodes for stimulating Aδ

/C fibers with single pulses of from 0.1 Hz to 10 Hz;

a pulse duration of from 0.5 to 10.0 ms; and

a current amplitude of up to 2 mA.

26. The electrode plate of claim 17, wherein

the pattern of NL electrodes and CP electrodes is made up of two or more rows extending across the front face of the plate element that each include two or more pairs of NL electrodes and CP electrodes, and

the multi-channel stimulator unit is configured to apply electrical stimulation to cutaneous thin Aδ

/C fibers progressively from a first row to an adjacent row across the front face of the plate element.

27. The electrode plate of claim 26, wherein applying electrical stimulation to cutaneous thin Aδ

/C fibers progressively from one row to an adjacent row across the front face of the plate element includes applying electrical stimulation using entire rows of NL electrode and CP electrodes.

28. The electrode plate of claim 26, wherein at least one of the two or more pairs of NL electrodes and CP electrodes in at least one row of the two or more rows shares at least one CP electrode with at least one of the two or more pairs of NL electrodes and CP electrodes in at least one adjacent row of the two or more rows.

30. A treatment device comprising:

an electrode plate made of electrically non-conductive material having a front face and a rear face;

a plurality of needle-like (NL) electrodes disposed on the front face of the electrode plate;

a plurality of flat conductive plate (CP) electrodes disposed on the front face of the electrode plate physically spaced and electrically separate from any needle-like protrusions on the front face of the electrode plate, the needle-like protrusions including the NL electrodes; and

a stimulator for concurrently applying electrical stimulation to cutaneous large Aβ

fibers via the CP electrodes and to cutaneous thin Aδ

/C fibers via the NL electrodes,

wherein the plurality of NL electrodes and the plurality of CP electrodes are disposed on the front face of the electrode plate in two or more electrode combinations, each of the two or more electrode combinations having at least one NL electrode and at least one CP electrode.

31. The electrode plate of claim 30, wherein each of the two or more electrode combinations has at least one NL electrode physically spaced 1 mm to 20 mm from at least one CP electrode on the front face of the plate element.

32. A treatment device comprising:

an electrode plate made of electrically non-conductive material having a front face and a rear face;

a plurality of needle-like (NL) electrodes disposed on the front face of the electrode plate;

a plurality of flat conductive plate (CP) electrodes disposed on the front face of the electrode plate physically spaced and electrically separate from any needle-like protrusions on the front face of the electrode plate, the needle-like protrusions including the NL electrodes; and

a stimulator for concurrently administering transcutaneous electrical stimulation via the CP electrodes and intracutaneous electrical stimulation via the NL electrodes,

wherein the plurality of NL electrodes and the plurality of CP electrodes are disposed on the front face of the electrode plate in two or more electrode combinations, each of the two or more electrode combinations having at least one NL electrode and at least one CP electrode.

33. The electrode plate of claim 32, wherein each of the two or more electrode combinations has at least one NL electrode physically spaced 1 mm to 20 mm from at least one CP electrode on the front face of the plate element.