Physiological recording device

• US 7,881,764 B1
• Filed: 12/22/2008
• Issued: 02/01/2011
• 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:
  US12/340,951
• Time in Patent Office: 771 Days
• Field of Search: 600/372, 600/373, 600/395
• 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 method of acquiring physiological signals from a subject having skin comprising

forming at least one dry electrode from a negative image having desired surface features, where said surface features include at least one penetrator sized and shaped for piercing the stratum corneum or outer layer of the epidermis and accessing the lower layers of the epidermis,

packaging the at least one dry electrode with a portable physiological recording device wherein the at least one dry electrode is capable of transmitting a signal to the recording device,

placing the at least one dry electrode in contact with the skin of the subject, and

acquiring a physiological signal from the subject.

2. The method of claim 1, wherein the at least one penetrator has an aspect ratio of less than about 1.5.

3. The method of claim 1, wherein the physiological signal acquired is ECG.

4. The method of claim 1, wherein at least two penetrators are formed on the surface of the dry electrode, and the at least two penetrators are individually addressable.

5. The method of claim 1, further including the step of applying a film or coating to the surface of the dry electrode.

6. A method of acquiring physiological signals from a subject having skin comprising

forming a physiological electrode with at least one surface feature from an image having desired surface features, where the at least one surface feature is sized and shaped for accessing the lower layers of the epidermis,

packaging the physiological electrode with a portable physiological recording device wherein the physiological electrode is capable of transmitting a signal to the portable physiological recording device,

placing the physiological electrode in contact with the skin of the subject, and acquiring a physiological signal from the subject.

7. The method of claim 6, wherein the at least one surface feature has an aspect ratio of less than about 1.5.

8. The method of claim 6, wherein the physiological signal acquired is an ECG signal.

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

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

11. A method of acquiring physiological signals from a subject having skin comprising

forming at least one physiological electrode with at least one surface feature from an image having desired surface features, where the at least one surface feature is sized and shaped for accessing the lower layers of the epidermis,

packaging the at least one physiological electrode to provide a low impedance path from the electrode'"'"'s surface to the package'"'"'s output connector,

placing the at least one physiological electrode in contact with the skin of the subject, and

acquiring a physiological signal from the subject.

12. The method of claim 11, wherein the physiological signal acquired is an ECG signal.

13. The method of claim 11, wherein the package is mounted to the subject'"'"'s skin with adhesives.

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