Unitary multi-electrode biopotential signal sensor and method for making same

• US 6,961,603 B2
• Filed: 06/17/2003
• Issued: 11/01/2005
• Est. Priority Date: 06/17/2003
• Status: Expired due to Fees

• Current Assignee: Instrumentarium Dental Incorporated (Envista Holdings Corporation)
• Original Assignee: Instrumentarium Corporation
• Inventors: Merilainen, Pekka
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US10/463,500
• Publication Number:
  US 20040260166A1
• Time in Patent Office: 868 Days
• Field of Search: 600/373, 600/382, 600/383, 600/393, 607/115, 607/116, 607/139, 607/148
• US Class Current: 600/383
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61B 5/325 Preparing electrode sites, e.g. by abrasion
• CPC Class Codes: A61B 5/685 Microneedles

Abstract

A unitary, multi-electrode biopotential signal sensor is formed of injection molded plastic. A plurality of electrode areas containing spikes are defined in a base member of the sensor. The remaining areas of the base member are formed to have a greater flexibility than the electrode areas, as by being thinner or being perforated. The spikes and electrode areas of the base member are coated with a conductor layer to form the electrodes. Conductors on the base member lead to connectors to provide biopotential signals from the electrodes.

Claims

1. A unitary, multi-electrode sensor for detecting biopotential signals from the skin of a subject, said sensor comprising:

a base member formed of a non-conductive material and having a surface suitable for being placed in contiguity with the skin of the subject;

a plurality of electrode areas defined in said surface of said base member, each of said electrode areas having a plurality of spikes extending therefrom for penetrating the skin of the subject when the sensor is placed on the skin of the subject, said spikes and the electrode areas defined in said base member comprising an integral structure of a common material, said common material possessing structural properties and being formed such that said spikes have sufficient stiffness to penetrate the subject'"'"'s skin, the electrode areas have sufficient stiffness to support and stabilize said spikes, and the portions of said base member not occupied by said electrode areas are more flexible than said electrode areas to facilitate placement of the sensor on the skin of the subject;

an electrically conductive coating applied at least to said spikes of each of said electrode areas to form a biopotential signal electrode from each of said electrode areas on said surface of said base member; and

an electrical lead electrically coupled to the spikes of each of said electrodes for providing biopotential signals from said electrodes.

2. The multi-electrode sensor of claim 1 wherein said electrically conductive coating is applied to said electrode areas to form said biopotential signal electrodes.

3. The multi-electrode sensor of claim 1 wherein said electrode areas are thicker in a dimension generally normal to said surface than portions of said base member not occupied by said electrode areas.

4. The multi-electrode sensor of claim 3 wherein the thickness of said electrode areas is at least approximately 0.5 mm and the thickness of portions of said base member not occupied by said electrode areas is less than approximately 0.5 mm.

5. The multi-electrode sensor of claim 4 wherein said thickness of said electrode areas is between 0.5 and 1 mm and the thickness of portions of said base member not occupied by said electrode areas is between 0.2 and 0.5 mm.

6. The multi-electrode sensor of claim 1 wherein portions of said base member not occupied by said electrode areas contain perforations for rendering said portions of said base member flexible.

7. The multi-electrode sensor of claim 1 wherein said sensor is formed to detect a biopotential signal from the skin of the subject by said electrodes in the absence of a wetting agent or conductive gel.

8. The multi-electrode sensor of claim 1 wherein said electrical leads are formed from an electrically conductive layer on said base member.

9. The multi-electrode sensor of claim 8 wherein said electrical leads are formed from said electrically conductive coating.

10. The multi-electrode sensor of claim 1 including connectors on said base member, said electrical leads being connected to said connectors.

11. The multi-electrode sensor of claim 10 wherein said connectors are located on an edge of said base member.

12. The multi-electrode sensor of claim 10 wherein said connectors are formed as male connector members.

13. The multi-electrode sensor of claim 1 further including an adhesive layer on said surface of said base member.

14. The multi-electrode sensor of claim 13 wherein said adhesive layer occupies portions of said surface not occupied by said electrode areas.

15. The multi-electrode sensor according to claim 1 wherein said common material of said sensor is a plastic material.

16. The multi-electrode sensor according to claim 15 wherein said common material of said sensor is a polycarbonate material.

17. The multi-electrode sensor according to claim 15 wherein said sensor is formed of injection molded plastic material.

18. The multi-electrode sensor according to claim 1 further defined as one for obtaining EEG biopotential signals from the head of the subject.

19. The multi-electrode sensor according to claim 18 further defined as one for obtaining EEG biopotential signals from the forehead of a subject.

20. The multi-electrode sensor of claim 1 further defined as one for obtaining electrocardiographic signals from the body of the subject.

21. The multi-electrode sensor of claim 1 further defined as one for obtaining electromyographic signals from the body of the subject.