Bioelectric sensor device and methods

• US 9,320,446 B2
• Filed: 03/27/2014
• Issued: 04/26/2016
• Est. Priority Date: 12/09/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gillberg, Jeffrey, Ghosh, Subham
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US14/227,719
• Publication Number:
  US 20150157225A1
• Time in Patent Office: 761 Days
• Field of Search: 600/372, 600/382, 600/386, 600391-393
• US Class Current: 1/1
• 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 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6805 Vests
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/683 Means for maintaining contact with the body A61B5/6802 takes precedence
• CPC Class Codes: A61B 5/68335 including release sheets or liners

Abstract

Various embodiments of a bioelectric sensor device for sensing bioelectric data from a human body are disclosed. The device can include a flexible substrate, a plurality of sensors arranged in a sensor array on a sensor array portion of the substrate, an electrically conductive network located on the substrate, and a plurality of lines of weakness formed in the sensor array portion of the substrate. In one or more embodiments, each line of weakness is configured to enhance separation of the sensor array portion of the substrate along a separation line that extends between at least two sensors of the plurality of sensors. The device can also include a left reference electrode proximate a distal end of a left reference electrode arm of the substrate and a right reference electrode proximate a distal end of a right reference electrode arm of the substrate.

Claims

1. A bioelectric sensor device for sensing bioelectric data from a human body, the device comprising:

a flexible dielectric substrate comprising a first major surface and a second major surface, wherein the substrate further comprises a sensor array portion comprising a center, a left reference electrode arm comprising a proximal end and a distal end, a right reference electrode arm comprising a proximal end and a distal end, and a contact array arm comprising a proximal end and a distal end, wherein the proximal end of the contact array arm is attached to the sensor array portion of the substrate;

a plurality of sensors arranged in a sensor array on the sensor array portion of the substrate, wherein each sensor of the plurality of sensors is configured to sense bioelectric data when in contact with skin;

an electrically conductive network located on the substrate, wherein the electrically conductive network comprises a plurality of electrically conductive paths, wherein each electrically conductive path of the plurality of electrically conductive paths extends from one sensor of the plurality of sensors to a contact array on the contact array arm, wherein the contact array comprises a plurality of contacts on the contact array arm proximate the distal end of the contact array arm;

a left reference electrode proximate the distal end of the left reference electrode arm and a right reference electrode proximate the distal end of the right reference electrode arm, wherein the left reference electrode is electrically connected to a contact in the contact array and the right reference electrode is electrically connected to a contact in the contact array; and

a plurality of lines of weakness formed in the sensor array portion of the substrate, wherein each line of weakness of the plurality of lines of weakness is configured to enhance separation of the sensor array portion of the substrate along a separation line that extends between at least two sensors of the plurality of sensors.

2. A device according to claim 1, wherein the sensor array portion of the substrate comprises a left edge, a right edge, a top edge extending from the left edge to the right edge, and a bottom edge extending from the left edge to the right edge, and wherein a first line of weakness of the plurality of lines of weakness extends between the top edge and the bottom edge of the sensor array portion, and further wherein a first sensor of the plurality of sensors is located between the first line of weakness and the left edge of the sensor array portion such that separation of the substrate along the first line of weakness removes the first sensor from the device.

3. A device according to claim 2, wherein a second line of weakness of the plurality of lines of weakness extends between the top edge and the bottom edge of the sensor array portion, and further wherein a second sensor of the plurality of sensors is located between the second line of weakness and the first line of weakness such that separation of the substrate along the second line of weakness removes the second sensor from the device.

4. A device according to claim 3, wherein a third line of weakness of the plurality of lines of weakness extends between the top edge and the bottom edge of the sensor array portion, and further wherein a third sensor of the plurality of sensors is located between the third line of weakness and the second line of weakness such that separation of the substrate along the third line of weakness removes the third sensor from the device.

5. A device according to claim 4, wherein a fourth line of weakness of the plurality of lines of weakness extends between the first line of weakness and the second line of weakness such that separation of the substrate along the first, second, and fourth lines of weakness removes the second sensor of the plurality of sensors from the device without removing the first sensor and wherein an electrically conductive path of the plurality of electrically conductive paths that extends from the first sensor to the contact array remains after separation of the second sensor.

6. A device according to claim 5, wherein a fifth line of weakness of the plurality of lines of weakness extends between the left edge and the center of the sensor array portion, wherein any of the lines of weakness of the plurality of lines of weakness that extend between the top edge and the bottom edge of the sensor array portion between the left edge and the center of the sensor array portion intersect the fifth line of weakness.

7. A device according to claim 6, wherein at least one sensor of the plurality of sensors is located between the fifth line of weakness and the top edge of the sensor array portion and wherein at least one sensor of the plurality of sensors is located between the fifth line of weakness and the bottom edge of the sensor array portion.

8. A device according to claim 7, wherein a sixth line of weakness of the plurality of lines of weakness extends between the right edge and the center of the sensor array portion, wherein any of the lines of weakness of the plurality of lines of weakness that extend between the top edge and the bottom edge of the sensor array portion between the right edge and the center of the sensor array portion intersect with the sixth line of weakness.

9. A device according to claim 8, wherein at least one sensor of the plurality of sensors is located between the sixth line of weakness and the top edge of the sensor array portion and wherein at least one sensor of the plurality of sensors is located between the sixth line of weakness and the bottom edge of the sensor array portion.

10. A device according to claim 2, further comprising at least one alignment marker positioned on the substrate and extending between the top edge and the bottom edge of the sensor array portion at the center of the sensor array portion.

11. A device according to claim 10, wherein the at least one alignment marker comprises radiopaque material.

12. A device according to claim 1, wherein the sensor array portion of the substrate comprises a left edge, a right edge, a top edge extending from the left edge to the right edge, and a bottom edge extending from the left edge to the right edge, wherein the proximal end of the left reference electrode arm and the proximal end of the right reference electrode arm are attached to the sensor array portion of the flexible dielectric substrate.

13. A device according to claim 12, wherein the proximal end of the left reference electrode arm and the proximal end of the right reference electrode arm are attached to the bottom edge of the sensor array portion of the flexible dielectric substrate.

14. A device according to claim 12, wherein the proximal end of the left reference electrode arm and the proximal end of the right reference electrode arm are attached to the top edge of the sensor array portion of the flexible dielectric substrate.

15. A device according to claim 12, wherein the proximal end of the left reference electrode arm is located inside the plurality of lines of weakness such that the left reference electrode arm remains attached to the sensor array portion of the flexible dielectric substrate after separation of the sensor array portion along any line of weakness of the plurality of lines of weakness.

16. A device according to claim 12, wherein the proximal end of the right reference electrode arm is located inside the plurality of lines of weakness such that the right reference electrode arm remains attached to the sensor array portion of the flexible dielectric substrate after separation of the sensor array portion along any line of weakness of the plurality of lines of weakness.

17. A device according to claim 1, wherein the proximal end of the left reference electrode arm and the proximal end of the right reference electrode arm are attached to the contact array arm of the flexible dielectric substrate.

18. A device according to claim 1, wherein the sensor array portion of the substrate comprises a left edge, a right edge, a top edge extending from the left edge to the right edge, and a bottom edge extending from the left edge to the right edge, wherein the proximal end of the contact array arm is attached to the bottom edge of the sensor array portion.

19. A device according to claim 1, wherein the contact array arm comprises adhesive on the second major surface of the substrate proximate the proximal end of the contact array arm.

20. A device according to claim 1, wherein the flexible dielectric substrate further comprises a second left reference electrode arm comprising a proximal end and a distal end, and a second right reference electrode arm comprising a proximal end and a distal end.

21. A device according to claim 20, further comprising a second left reference electrode proximate the distal end of the second left reference electrode arm and a second right reference electrode proximate the distal end of the second right reference electrode arm, wherein the second left reference electrode is electrically connected to a contact in the contact array and the second right reference electrode is electrically connected to a contact in the contact array.

22. A device according to claim 21, wherein the sensor array portion of the substrate comprises a left edge, a right edge, a top edge extending from the left edge to the right edge, and a bottom edge extending from the left edge to the right edge, wherein the proximal end of the second left reference electrode arm and the proximal end of the second right reference electrode arm are attached to the sensor array portion of the flexible dielectric substrate.

23. A device according to claim 22, wherein the proximal end of the second left reference electrode arm and the proximal end of the second right reference electrode arm are attached to the bottom edge of the sensor array portion of the flexible dielectric substrate.

24. A device according to claim 22, wherein the proximal end of the second left reference electrode arm and the proximal end of the second right reference electrode arm are attached to the top edge of the sensor array portion of the flexible dielectric substrate.

25. A device according to claim 22, wherein the proximal end of the second left reference electrode arm is located inside the plurality of lines of weakness such that the second left reference electrode arm remains attached to the sensor array portion of the flexible dielectric substrate after separation of the sensor array portion along any line of weakness of the plurality of lines of weakness.

26. A device according to claim 22, wherein the proximal end of the second right reference electrode arm is located inside the plurality of lines of weakness such that the second right reference electrode arm remains attached to the sensor array portion of the flexible dielectric substrate after separation of the sensor array portion along any line of weakness of the plurality of lines of weakness.

27. A method of removing a sensor of the plurality of sensors from a bioelectric sensor device, comprising:

providing a bioelectric sensor device according to claim 1, wherein the sensor array portion of the substrate comprises a left edge, a right edge, a top edge extending from the left edge to the right edge, and a bottom edge extending from the left edge to the right edge; and

separating the sensor array portion of the substrate along a line of weakness of the plurality of lines of weakness that extends between the top edge and the bottom edge of the sensor array portion, wherein the sensor is located between the line of weakness and the left edge of the sensor array portion.

28. A method according to claim 27, further comprising removing an additional sensor of the plurality of sensors by separating the sensor array portion of the substrate along an additional line of weakness that extends between the top edge and the bottom edge of the sensor array portion, wherein the additional sensor is located between the additional line of weakness and the right edge of the sensor array portion.