ELECTRODE PATCH MONITORING DEVICE

• US 20110190615A1
• Filed: 05/15/2009
• Published: 08/04/2011
• Est. Priority Date: 05/16/2008
• Status: Active Grant

• Current Assignee: Verathon Incorporated (Roper Technologies, Inc.)
• Original Assignee: Heartscape Technologies, Inc. (Roper Technologies, Inc.)
• Inventors: McKean, Wesley James, Phillips, Paul David, McGregor, Brian
• Granted Patent: US 8,818,482 B2
• Time in Patent Office: Days
• US Class Current: 600/372
• CPC Class Codes: A61B 2562/0215 Silver or silver chloride containing
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An electrode patch monitoring device that enables fast and accurate application is described. According to some embodiments, the electrode patch monitoring device comprises an array of electrodes for monitoring bioelectrical data that are formed on a flexible substrate. The electrode patch monitoring device may be available in a plurality of sizes, and various methods are provided for selecting an appropriate size according to the physiology of a patient. Methods for applying the electrode patch monitoring device to the patient'"'"'s body are also provided.

Claims

1. A sensor device for monitoring bioelectrical data, the sensor device comprising:

first and second electrically conductive traces formed on a flexible substrate;

an electrically insulating layer overlaid on at least a portion of the first electrically conductive trace and at least a portion of the second electrically conductive trace; and

a first electrode for receiving a bioelectric signal, the first electrode being formed at least in part on a portion of the electrically insulating layer directly over the second electrically conductive trace;

wherein the first electrode is electrically connected with the first electrically conductive trace and is electrically insulated from the second electrically conductive trace.

2. The sensor device of claim 1, wherein the electrically insulating layer comprises an aperture, and wherein the first electrically conductive trace forms an electrical connection with the first electrode via the aperture.

3. The sensor device of claim 1, further comprising:

a plurality of electrodes for receiving bioelectric signals, each of the plurality of electrodes being formed at least in part on one or more portions of the electrically insulating layer directly over the second electrically conductive trace.

4. The sensor device of claim 1, further comprising:

a second electrode for receiving a bioelectric signal, the second electrode being formed on the flexible substrate and being electrically connected with the second electrically conductive trace.

5. The sensor device of claim 4, further comprising:

a third electrically conductive trace formed on the flexible substrate, wherein the first electrode is formed at least in part on a second portion of the electrically insulating layer directly over the third electrically conductive trace and the first electrode is electrically insulated from the third electrically conductive trace.

6. The sensor device of claim 1, wherein the flexible substrate comprises first and second parallel slots, and wherein the first slot extends along a first side of the first electrode and the second slot extends along a second, opposite side of the first electrode.

7. The sensor device of claim 6, wherein at least a portion of each of the first and second electrically conductive traces extend lengthwise in a direction parallel to the first and second slots.

8. The sensor device of claim 6, wherein the sensor device comprises a first column of electrodes between the first and second parallel slots.

9. The sensor device of claim 8, wherein a plurality of electrodes in the first column of electrodes are formed at least in part on one or more portions of the electrically insulating layer directly over the second electrically conductive trace.

10. The sensor device of claim 1, wherein the flexible substrate comprises a plurality of parallel slots separated by a plurality of a plurality of strips, and wherein each strip of the plurality of strips comprises a column of electrodes formed thereon.

11. The sensor device of claim 10, wherein each of the plurality of parallel slots extends more than half of the length of the substrate.

12. The sensor device of claim 10, wherein a respective distance between each pair of adjacent columns of electrodes is fixed.

13. A method for forming on a flexible substrate a plurality of electrodes in a predefined pattern, the method comprising:

forming on the flexible substrate a plurality of electrically conductive traces;

forming an electrically insulating layer over the plurality of electrically conductive traces, the electrically insulating layer comprising a plurality of apertures to expose ends of each of the plurality of electrically conductive traces; and

forming a plurality of electrodes on the flexible substrate, wherein each of the plurality of electrodes forms an electrical connection with an end of at least one of the plurality of electrically conductive traces, and wherein at least one of the plurality of electrodes is formed at least in part on the electrically insulating layer.

14. The method of claim 13, wherein the at least one of the plurality of electrodes is formed at least in part on a portion of the electrically insulating layer directly over one or more of the plurality of electrically conductive traces.

15. The method of claim 13, further comprising:

forming a plurality of slots in the substrate;

wherein forming a plurality of electrodes on the flexible substrate comprises forming a plurality of columns of electrodes, the columns of electrodes being separated by the slots in the substrate.

16. A method for applying to a patient a sensor device for monitoring bioelectric data, the method comprising:

selecting a sensor device of an appropriate size at least in part by measuring a predetermined anatomical distance or by comparing said predetermined anatomical distance against at least one predetermined length;

removing a portion of a backing material from a flexible substrate of the sensor device to expose at least some adhesive;

positioning the sensor device on the patient'"'"'s body in a predetermined orientation, wherein at least one indicium on the flexible substrate is aligned with a prescribed anatomical region of the patient'"'"'s body; and

applying the at least some adhesive onto the patient'"'"'s skin, wherein orientation of the sensor device with respect to the patient'"'"'s body is maintained and alignment between the at least one indicium and the prescribed anatomical region of the patient'"'"'s body is maintained.

17. The method of claim 16, wherein the predetermined anatomical distance is a distance between inner edges of the patient'"'"'s shoulder joints.

18. The method of claim 16, further comprising:

removing the backing material entirely from the flexible substrate to expose remaining adhesive; and

applying the remaining adhesive onto the patient'"'"'s skin by smoothing the flexible substrate over the patient'"'"'s body, wherein the orientation of the sensor device with respect to the patient'"'"'s body is maintained and the alignment between the at least one indicium and the prescribed anatomical region of the patient'"'"'s body is maintained.

19. The method of claim 16, wherein selecting a sensor device of an appropriate size comprises selecting the appropriate size from a set of three or four available sizes.

20. The method of claim 16, wherein selecting a sensor device of an appropriate size comprises comparing said predetermined anatomical distance against at least one predetermined length.