Dry physiological recording electrode

• US 6,785,569 B2
• Filed: 09/07/2001
• Issued: 08/31/2004
• Est. Priority Date: 09/07/2001
• Status: Expired due to Term

• Current Assignee: Orbital Research, Inc.
• Original Assignee: Orbital Research, Inc.
• Inventors: Prince, Troy S., Skebe, Gerard G., Lisy, Frederick J., Schmidt, Robert N.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US09/949,044
• Publication Number:
  US 20030050550A1
• Time in Patent Office: 1,089 Days
• Field of Search: 600/372, 600/373, 600/382, 600/386, 600/391-393, 600/395, 607/149, 607/152
• US Class Current: 600/372
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/263 characterised by the electrode materials
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/325 Preparing electrode sites, e.g. by abrasion
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/685 Microneedles
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

The present invention relates to a dry physiological recording electrode that can be used without skin preparation or the use of electrolytic gels. The dry physiological recording electrode comprising a substrate having an upper and a lower surface, and at least one penetrator(s) protruding from the upper surface of the substrate. The penetrator(s) is capable of piercing through the stratum corneum or outer layer of the skin, and transmitting an electric potential from the lower layers of the epidermis through the penetrator(s) which can be measured, or detecting agents from the lower layers of the epidmermis primarily the stratum germinativum layer. At least one epidermis stop may be provided resulting in the formation of detritus troughs interposed between adjacent penetrator(s) and epidermis stops. The present invention also includes a method of sensing biopotentials in the skin.

Claims

1. A dry physiological recording electrode comprising a substrate having an upper a lower surface, and at least one penetrator(s) formed from a conductive coating and protruding from the upper surface of the substrate

wherein the penetrator(s) has an aspect ratio less than about 1.5, is capable of piercing the stratum corneum or outer lay of the skin, and transmitting an electric potential from the lower layers of epidermis through the penetrator(s) which can be measured.

2. The dry physiological recording electrode in claim 1, wherein the substrate is a flexible polymer.

3. The dry physiological recording electrode in claim 2, where in the flexible polymer is electrically insulating.

4. The dry physiological recording electrode in claim 3, wherein the conductive coating is selected from the group consisting of silver, silver chloride, nickel, titanium, aluminum, copper, gold, gold chloride and combinations thereof.

5. The dry physiological recording electrode in claim 3, wherein each penetrator(s) has a height of from about 20 to about 150 μ

m.

6. The dry physiological recording electrode in claim 3, wherein a through is interposed and formed between the at least one epidermal stop(s) and the at least one penetrator(s), the through when provided allowing for a more accurate placement of the at least one penetrator(s) by allowing for displacement of a subject'"'"'s hair and other detritus on the skin in the through(s).

7. The dry physiological recording electrode in claim 1, wherein the penetrator(s) has edge(s) or a side(s) and a slope for the edge(s) or side(s) of the penetrator(s) is less than about 60 degrees over substantially all of the edge(s) or side(s) of the penetrator(s).

8. A dry physiological recording electrode comprising a thin metal sheet having an upper and a lower edge, and at least one penetrator(s) protruding from the upper edge of the thin metallic sheet

wherein the penetrator(s) from the thin metal sheet is capable of piercing through the stratum corneum or outer layer or of the skin and transmitting an electric potential from the lower layers of the epidermis through the penetrator(s) which can be measured.

9. The dry physiological recording electrode in claim 8, wherein th penetrator(s) are formed by chemically etching the thin metal sheet.

10. The dry physiological recording electrode in claim 9, wherein the thin metal sheet is stainless steel.

11. The dry physiological recording electrode in claim 10, wherein each penetrator(s) had a height of from about 20 to about 150 μ

m.

12. The dry physiological recording electrode in claim 8, wherein the aspect ratio for the penetrator(s) is less than about 2.

13. The dry physiological recording electrode in claim 8, wherein the penetrator(s) has an edge(s) or a side(s) and a slope for the edge(s) or side(s) of the penetrator(s) is less an about 60 degrees over substantially all of the edge(s) or side(s) of the penetrator(s).

14. The dry physiological recording electrode in claim 8, further comprising at least one epidermal(s) stop protruding from the upper edge of the substrate.

15. The dry physiological recording electrode in claim 14, wherein a trough is interposed and formed between the at least one epidermal stop(s) and the at least one penetrator(s) the trough when provided allowing for a more accurate placement of the at least one penetrator(s) by allowing for displacement of a subject'"'"'s hair and other detritus on the skin in the trough(s).

16. A dry physiological recording electrode comprising a silicon substrate having an upper and a lower surface, and at least one penetrator(s) protruding from the upper surface of the silicon substrate

wherein the penetrator(s) has an aspect ratio less than about 1.5, is capable of piercing through the stratum corneum or outer layer of the epidermis and transmitting an electric potential from the lower layers of the epidermis through the penetrator(s) which can be measured.

17. The dry physiological recording electrode in claim 16, is formed from silicon wafers.

18. The dry physiological recording electrode in claim 16, wherein the penetrator(s) are pyramidal in shape.

19. The dry physiological recording electrode in claim 16, wherein each penetrator(s) has a height of from about 20 to about 150 μ

m.

20. The dry physiological recording electrode in claim 16, further comprising at least one epidermal stop protruding from the upper surface of the substrate.

21. The dry physiological recording electrode in claim 20, wherein a trough is interposed and formed between the at least one epidermal stop(s) and the at least one penetrator(s), the trough when provided allowing for a more accurate placement of the at least one penetrator(s) by allowing for displacement of a subject'"'"'s hair and other detritus on the skin in the trough(s).