Dry physiological recording electrode

• US 7,032,301 B1
• Filed: 06/22/2004
• Issued: 04/25/2006
• 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:
  US10/874,075
• Time in Patent Office: 672 Days
• Field of Search: 600/372, 600/373, 600/386, 600391-393, 600/395, 607/149, 607/152, 298/25
• US Class Current: 29/825
• 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 method of forming a dry physiological recording electrode having an upper and a lower surface and desired surface features, the method comprising the step of:

forming in a mold by injection molding, casting or deposition a dry physiological electrode comprising an upper surface, a lower surface and at least one penetrator(s) protruding from the upper surface of the dry physiological electrode

wherein the at least one penetrator is capable of piercing through the stratum corneum or outer layer of the skin and transmitting an electric potential from a lower layer of the epidermis of the skin.

2. The method in claim 1, further comprising the step of coating a film layer onto the upper surface of the dry physiological recording electrode.

3. The method in claim 2, wherein the film layer creates individually addressable leads.

4. The method in claim 1, wherein each penetrator(s) has a height of from about 20 to about 150 μ

m.

5. The method in claim 1, wherein the at least one penetrator(s) has an aspect ratio of less than about 1.5.

6. The method in claim 1, further comprising the step of doping the upper surface of the dry physiological electrode to increase the conductivity of the dry physiological electrode.

7. The method in claim 1, wherein the dry physiological electrode is formed to be used for EMG.

8. The method in claim 1, wherein the dry physiological electrode is formed to be used for EKG.

9. The method in claim 1, wherein the dry physiological electrode is formed to be used for EEG.

10. A method of forming a device having an upper and a lower surface and desired surface features, the device for measuring biological characteristics or biopotential from the lower layers of the epidermis of the skin, the method comprising the step of:

forming in a mold by injection molding, casting or deposition a device comprising an upper surface, a lower surface, at least one first penetrator(s) protruding from the upper surface of the device and at least one second penetrator (s) having an aspect ratio of less than about 1.5 protruding from the upper surface of the device

wherein the at least one first penetrator is capable of piercing through the stratum corneum or outer layer of the skin and transmitting an electric potential from a lower layer of the epidermis of the skin and the at least one second penetrator assists in anchoring the device to a subject'"'"'s skin.

11. The method in claim 10, further comprising the step of coating a film layer onto the upper surface of the device.

12. The method in claim 11, wherein the film layer creates individually addressable leads.

13. The method in claim 10, wherein each penetrator(s) has a height of from about 20 to about 150 μ

m.

14. The method in claim 10, further comprising the step of doping the upper surface of the device to increase the conductivity of the device.