Dry penetrating recording device

• US 6,782,283 B2
• Filed: 09/07/2001
• Issued: 08/24/2004
• Est. Priority Date: 09/07/2001
• Status: Active Grant

• 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:
  US09/949,055
• Publication Number:
  US 20030050548A1
• Time in Patent Office: 1,082 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 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 penetrating device, one embodiment of which can be used as a 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) are 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 skin 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 and a lower surface, and at least one penetrator(s) protruding from the upper surface of the substrate

wherein the penetrator(s) has a height of from about 20 to about 150 μ

m, has an aspect ration less than about 1.5;

is substantially non-chemically reactive and is capable of piercing through the stratum corneum or outer layer of the skin and transmitting electric potential from the lower layers of the epidermis which can be measured.

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

3. The dry physiological recording electrode in claim 1, further comprising at least one epidermis stop protruding from the upper surface of the substrate.

4. The dry physiological recording electrode in claim 3, wherein a trough is interposed and formed between the at least one epidermis 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 subjects hair and other detritus on the skin in the trough(s).

5. The method of sensing biopotential in the skin comprising the steps of;

a) applying an electrode comprising at least one penetrator(s) to a human or animal body having skin comprising an epidermis comprising a stratum corneum or upper layer and lower layers of epidermis, and a dermis, the penetrator(s) has an aspect ratio less than about 1.5;

b) piercing through the stratum corneum or upper layer of the skin with the pentrator(s) such that the penetrator(s) does not enter the dermis of the skin;

c) transmitting an electric potential from the lower layers of the epidermis of the skin through the penetrator(s); and

d) measuring the electric voltage.

6. The method of sensing biopotential in the skin in claim 5, wherein each penetrator(s) has a height of from about 20 to about 150 μ

m.

7. The method sensing biopotential in the skin in claim 5, wherein the electrode further comprises at least one epidermis stop.

8. The dry physiological recording electrode in claim 7, wherein a trough is interposed and formed between the at least one epidermis 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 subjects hair and other detritus on the skin in the trough(s).

9. A device for measuring biological characteristics or biopotential from the lower layers of the epidermis comprising a substrate having an upper and a lower surface, at least one penetrator(s) protruding from the upper surface of the substrate,

wherein the penetrator(s) has an aspect ratio of less than about 1.5.

10. The device of claim 9, wherein the device comprises a coating on the penetrator(s).

11. The device in claim 9, further comprising at least one epidermis stop protruding from the upper surface of the substrate.

12. The device in claim 11, wherein a trough is interposed and formed between the at least one epidermis 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 subjects hair and other detritus on the skin in the trough(s).

13. The device in claim 9, wherein each penetrator(s) has a height of from about 20 to about 150 μ

m.

14. A device for measuring biological characteristics or biopotential from the lower layers of the epidermis comprising a substrate having an upper and a lower surface, at least one penetrator(s) and at least one epidermis stop protruding from the upper surface of the substrate,

wherein a trough is interposed and formed between the at least one epidermis 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).

15. The device in 14, wherein the aspect ratio of the penetrator(s) is less than about 2.

16. The device in 15, wherein the penetrator(s) has a height of from about 20 to about 150 μ

m.

17. The device in 16, 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) of less than about 60 degrees over substantially all of the edge or side of the penetrator(s).