Dry physiological recording device and method of manufacturing

• US 9,192,313 B1
• Filed: 03/14/2013
• Issued: 11/24/2015
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Orbital Research, Inc.
• Original Assignee: Orbital Research, Inc.
• Inventors: Lisy, Frederick J, Kolkowski, Brian M, Pennington, Mark
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US13/826,185
• Time in Patent Office: 985 Days
• Field of Search: 600/396
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/683 Means for maintaining contact with the body A61B5/6802 takes precedence
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6835 Supports or holders, e.g., articulated arms
• CPC Class Codes: A61B 5/6839 Anchoring means, e.g. barbs

Abstract

The present invention is directed to a physiological recording device and, more particularly, to a physiological recording device that can be used without skin preparation or the use of electrolytic gels. The invention is further directed to an encouragement ring which stabilizes and helps situate the physiological recording device on a subject'"'"'s skin to help provide a better electrical signal, increase surface area, and reduce and minimize noise and artifacts during the process of recording or monitoring a physiological signal. The invention is still further directed to surface features on a surface of the physiological recording device with a size and shape that will not substantially bend or break, which limits the depth of application of the recording device, and/or anchors the recording device during normal application. The invention is even further directed to a method for manufacturing a physiological recording device, and minimizing cost of manufacture.

Claims

1. A physiological recording device comprising:

a recording portion comprising an upper surface and a lower surface, the lower surface comprising at least one surface feature for connecting to lower layers of a subject'"'"'s skin and obtaining at least one physiological signal from the lower layers of the skin, the upper surface comprising a connector connecting the recording portion to a physiological monitoring or recording device for passing along the at least one physiological signal from the lower surface, and

a separate encouragement ring, the encouragement ring having an opening for surrounding and holding the recording portion, and a lower surface that slopes upward, with at least one radius of curvature and at least one distance of curvature, from its center so as to help stabilize and situate the device against the subject'"'"'s skin.

2. The physiological recording device of claim 1, wherein the recording portion is coated with a conductive coating and/or ionic compound, and the separate encouragement ring has no such coating or compound.

3. The physiological recording device of claim 1, wherein the at least one distance of curvature is greater than 0.2 cm.

4. The physiological recording device of claim 1, wherein the at least one distance of curvature is greater than 2.0 cm.

5. The physiological recording device of claim 1, wherein the at least one radius of curvature over substantially all of the at least one distance of curvature is greater than 0.5 cm.

6. The physiological recording device of claim 1, wherein the at least one radius of curvature over substantially all of the at least one distance of curvature is greater than 2.5 cm.

7. The physiological recording device of claim 1, comprising at least two surface features, at least one surface feature being for connecting the device to the lower layers of the subject'"'"'s skin.

8. The physiological recording device of claim 1, wherein the the size of the device is reduced in a single axis, and wherein the separate encouragement ring has multiple radii of curvature and multiple distances of curvature, and wherein the radius of curvature in the decreased axis is smaller than any other radius of curvature, and the distance of curvature in the decreased axis is smaller than any other distance of curvature.