Microneedle electrode

• US 8,588,884 B2
• Filed: 05/28/2010
• Issued: 11/19/2013
• Est. Priority Date: 05/28/2010
• Status: Expired due to Fees

• Current Assignee: Emkinetics, Inc.
• Original Assignee: Emkinetics, Inc.
• Inventors: Hegde, Anant V., Rajguru, Amit, Burnett, Daniel Rogers, Hermanson, Christopher
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US12/790,619
• Publication Number:
  US 20110295100A1
• Time in Patent Office: 1,271 Days
• Field of Search: 600/372, 600/373, 600/391, 607/142, 607/149
• US Class Current: 600/372
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/257 using adhesive means, e.g. adhesive pads or tapes
• CPC Class Codes: A61B 5/262 Needle electrodes
• CPC Class Codes: A61B 5/274 using snap or button fasteners
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/296 for electromyography [EMG]

Abstract

In certain variations, methods, systems and/or devices for enhancing conductivity of an electrical signal through a subject'"'"'s skin using one or more microneedle electrodes are provided. A microneedle electrode may be applied to the subject'"'"'s skin by placing the microneedle electrode in direct contact with the subject'"'"'s skin. The microneedles of the microneedle electrode may be inserted into the skin such that the microneedles pierce stratum corneum of the skin up to or through dermis of the skin. An electrical signal passes or is conducted through or across the microneedle electrode and the subject'"'"'s skin, where impedance of the microneedle electrode is minimal and greatly reduced compared to existing technologies.

Claims

1. A method of enhancing conductivity of an electrical signal through a subject'"'"'s skin using a microneedle electrode comprising:

applying a microneedle electrode to the subject'"'"'s skin by placing microneedles of the microneedle electrode in direct contact with the subject'"'"'s skin;

inserting the microneedles of the microneedle electrode into the skin such that the microneedles pierce stratum corneum of the skin up to dermis of the skin; and

allowing an electrical signal to pass through the microneedle electrode where impedance of the microneedle electrode is less than 10 ohms, wherein the microneedle electrode comprises a conductive metal substrate having microneedles extending therefrom which is formed by etching or cutting a microneedle pattern into a sheet of conductive metal and bending the microneedles to a desired angle.

2. The method of claim 1, wherein the microneedle electrode is placed in direct contact with the subject'"'"'s skin without a conductive gel positioned between the microneedle electrode and the subject'"'"'s skin and where impedance across the microneedle electrode and the subject'"'"'s skin is less than 350 ohms.

3. The method of claim 1, wherein inserting the microneedles into the subject'"'"'s skin secures the microneedle electrode to the subject'"'"'s skin.

4. The method of claim 1, further comprising securing the microneedle electrode to the subject'"'"'s skin with an adhesive.

5. The method of claim 1, further comprising recording an electrical physiological signal of a subject'"'"'s body via the microneedle electrode.

6. The method of claim 5, further comprising maintaining electrode to tissue electrical contact between the microneedle electrode and the subject'"'"'s skin in a manner sufficient for performing EKG, ECG, EEG, or EMG recordings.

7. The method of claim 1, wherein the microneedle electrode comprises a stud and a substrate with an array of microneedles extending therefrom, wherein the stud is attached to a bottom surface of the substrate by a direct electrical connection allowing for conductivity throughout the electrode.

8. The method of claim 7, wherein the microneedle electrode further comprises an eyelet, wherein the stud is attached to the eyelet by a direct mechanical and electrical connection and the eyelet is attached to a bottom surface of the substrate by a direct electrical connection allowing for conductivity throughout the electrode.

9. The method of claim 1, wherein the conductive metal substrate having microneedles extending therefrom is a stainless steel substrate.

10. The method of claim 1, wherein the conductive metal substrate having microneedles extending therefrom is formed by chemical etching a microneedle pattern into a strip of conductive metal and bending the microneedles to an angle of ninety degrees.

11. The method of claim 1, wherein a conductive gel is not positioned between the microneedles and the subject'"'"'s skin.

12. A microneedle electrode for providing enhanced conductivity of an electrical signal through a subject'"'"'s skin comprising:

a conductive metal substrate having a top surface, a bottom surface and an array of microneedles extending from the top surface which is formed by etching or cutting a microneedle pattern into a sheet of conductive metal and bending the microneedles to a desired angle, wherein the microneedle electrode is adapted for direct contact between the microneedles and a subject'"'"'s skin and configured to pierce stratum corneum of the skin up to dermis of the skin; and

a stud connected to the bottom surface of the substrate by a direct electrical connection allowing for conductivity throughout the electrode, wherein the microneedle electrode is configured to allow an electrical signal to pass through the microneedle electrode and impedance of the microneedle electrode is less than 10 ohms.

13. The microneedle electrode of claim 12, further comprising an adhesive layer, wherein the stud is attached to the bottom surface of the substrate by a direct electrical connection through an opening in the adhesive layer.

14. The microneedle electrode of claim 12, wherein no conductive gel or adhesive is positioned on the top surface of the substrate or between the microneedles and the subject'"'"'s skin.

15. The microneedle electrode of claim 12, wherein the stud is connected to the substrate by an eyelet.

16. The microneedle electrode of claim 15, wherein the stud and eyelet are pressed together to form a strong mechanical joint and electrical connection.

17. The microneedle electrode of claim 15, further comprising a fabric layer, wherein the stud and eyelet have a direct mechanical and electrical connection through an opening in the fabric layer.

18. The microneedle electrode of claim 15, further comprising a foam layer, wherein the stud and eyelet have a direct mechanical and electrical connection through an opening in the foam layer.

19. The microneedle electrode of claim 15, wherein the eyelet and substrate are pressed together to form a strong mechanical joint and electrical connection.

20. The microneedle electrode of claim 15, wherein the eyelet and substrate are connected by welding, soldering or by using conductive adhesives to form a strong electrical connection.

21. The microneedle electrode of claim 12, wherein the microneedle electrode is a sensor configured to record physiological signals in a subject'"'"'s body.

22. The microneedle electrode of claim 12, wherein the microneedle electrode is a defibrillator configured to transmit electrical current and voltage into a subject'"'"'s body.

23. The microneedle electrode of claim 12, wherein the stud is connected to the substrate by an eyelet without an intervening layer of material positioned between the stud and eyelet connection.

24. The method of claim 12, wherein the conductive metal substrate having a top surface, a bottom surface and an array of microneedles extending from the top surface is a stainless steel substrate.

25. A method of enhancing physiological signal detection through a subject'"'"'s skin using a microneedle electrode comprising:

applying a microneedle electrode to the subject'"'"'s skin by placing microneedles of the microneedle electrode in direct contact with the subject'"'"'s skin;

inserting the microneedles of the microneedle electrode into the skin such that the microneedles pierce stratum corneum of the skin up to dermis of the skin; and

detecting a physiological signal through the microneedle electrode where impedance of the microneedle electrode is less than 10 ohms, wherein the microneedle electrode comprises a conductive metal substrate having microneedles extending therefrom which is formed by etching or cutting a microneedle pattern into a sheet of conductive metal and bending the microneedles to a desired angle.