Physiological recording device

• US 7,489,959 B1
• Filed: 10/01/2007
• Issued: 02/10/2009
• Est. Priority Date: 09/07/2001
• Status: Expired due to Fees

• 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:
  US11/906,234
• Time in Patent Office: 498 Days
• Field of Search: 600/372
• 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 physiological recording electrode for measuring biopotential from the lower layers of the epidermis of the skin comprising:

a physiological electrode comprising a substrate having an upper and lower surface and at least one penetrator(s) protruding from the upper surface of the substrate, the at least one penetrator having an aspect ratio of less than about 1.5, and

an electrically conductive coating which is applied to the substrate of the physiological electrode with the at least one penetrator;

wherein the penetrator(s) is capable of piercing through the stratum corneum or outer layer of the epidermis and the physiological electrode is capable of transmitting an electric potential from a lower layer of the epidermis of the skin.

2. The physiological electrode in claim 1, further comprising an adhesive collar for mounting the physiological electrode to the skin.

3. The physiological electrode in claim 1, the physiological electrode comprising at least two penetrators, the at least two penetrators being individually addressable.

4. The physiological electrode in claim 1, wherein the physiological electrode has a low impedance path from the upper surface of the physiological electrode to an output connector.

5. The physiological electrode in claim 1, wherein the upper surface of the physiological electrode is formed from another surface, the other surface having an image of the desired surface features of the physiological electrode.

6. A method of forming a physiological recording electrode having an upper and a lower surface and desired surface features, the method comprising the step of:

forming a physiological electrode comprising an upper surface, a lower surface and at least one penetrator(s) protruding from the upper surface of the physiological electrode from another surface, the other surface having an image of the desired surface features of the physiological electrode

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

7. The method of forming the physiological recording electrode of claim 6, wherein the at least one penetrator has an aspect ratio of less than about 1.5.

8. The method of forming the physiological recording electrode of claim 6, further comprising the step of applying an adhesive collar to the physiological electrode, the adhesive collar being used to mount the physiological electrode to a subject'"'"'s skin.

9. The method of forming the physiological recording electrode of claim 6, wherein at least two penetrators are formed on the upper surface of the physiological electrode and the at least two penetrators are individually addressable.

10. The method of forming the physiological recording electrode of claim 6, further including the step of applying a film or coating to the upper surface of the physiological electrode.

11. A method of forming a 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 physiological electrode comprising an upper surface, a lower surface and at least one penetrator(s) protruding from the upper surface of the physiological electrode

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

12. The method of forming the physiological recording electrode of claim 11, wherein the at least one penetrator has an aspect ratio of less than about 1.5.

13. The method of forming the physiological recording electrode of claim 11, further comprising the step of applying an adhesive collar to the physiological electrode, the adhesive collar being used to mount the physiological electrode to a subject'"'"'s skin.

14. The method of forming the physiological recording electrode of claim 11, wherein at least two penetrators are formed on the upper surface of the physiological electrode and the at least two penetrators are individually addressable.

15. The method of forming the physiological recording electrode of claim 11, further including the step of applying a film or coating to the upper surface of the physiological electrode.

16. A method of forming a physiological recording electrode having an upper and a lower surface and desired surface features, the method comprising the step of:

forming a physiological electrode comprising an upper surface, a lower surface and at least one penetrator(s) protruding from the upper surface of the physiological electrode from another surface, the other surface having an image of the desired surface features of the physiological electrode; and

applying an electrically conductive coating or film to the upper surface of the physiological electrode

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

17. The method of forming the physiological recording electrode of claim 16, wherein the at least one penetrator has an aspect ratio of less than about 1.5.

18. The method of forming the physiological recording electrode of claim 16, further comprising the step of applying an adhesive collar to the physiological electrode, the adhesive collar being used to mount the physiological electrode to a subject'"'"'s skin.

19. The method of forming the physiological recording electrode of claim 16, wherein at least two penetrators are formed on the upper surface of the physiological electrode and the at least two penetrators are individually addressable.

20. The method of forming the physiological recording electrode of claim 16, wherein the physiological electrode has a low impedance path from the upper surface of the physiological electrode to an output connector.