Device features and design elements for long-term adhesion

• US 9,241,649 B2
• Filed: 05/08/2013
• Issued: 01/26/2016
• Est. Priority Date: 05/12/2010
• Status: Active Grant

• Current Assignee: iRhythm Technologies Incorporated
• Original Assignee: iRhythm Technologies Incorporated
• Inventors: Kumar, Uday N., Livingston, Peter H., Day, Mark J., Park, Shena H., Willis, William F., Righter, William H., Bahney, Tim
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US13/890,144
• Publication Number:
  US 20130245415A1
• Time in Patent Office: 993 Days
• Field of Search: 600/372, 600/382, 600391-393, 600/509
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• 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 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

An electronic device for long-term adhesion to a mammal includes a housing with an electronic component. The electronic device may include a first wing and a second wing, each being integrally formed with the housing. An electrode is positioned on a bottom surface of each of the wings, the electrodes electrically connected to the electronic component. An adhesive layer is provided for adhesion to a surface of the mammal. The adhesive layer may cover a portion of the bottom surfaces of the wings but generally does not cover the electrode or a bottom surface of the housing. A method of applying an electronic device to a mammal includes removing first and second adhesive covers from first and second wings of the electronic device to expose an electrode and an adhesive coated on a bottom surface of each wing.

Claims

1. An electronic device for long-term adhesion to a mammal, the device comprising:

a housing;

a physiologic data collection circuit contained in the housing;

at least two wings extending laterally from the housing, wherein each wing includes a hinge adjacent the housing;

an electrode integral with a bottom surface of each of the wings so as to be inseparable from the wings during use of the device, the electrodes electrically connected to the physiologic data collection circuit;

an adhesive layer on the bottom surfaces of the wings, wherein the adhesive layer provides adhesion to the skin of the mammal;

wherein the housing is attached to the mammal'"'"'s skin only via the adhesive layer on the wings and is not directly attached to the skin of the mammal when the electrodes are in contact with the mammal;

wherein each hinge extends from the housing to each adhesive layer, each hinge configured to bend at a first intersection between the hinge and the housing and at a second intersection between the hinge and the adhesive layer;

wherein the wings are flexibly coupled to the housing to enable the electrodes to move toward and away from each other within a horizontal plane parallel to the mammal'"'"'s skin, and to enable the housing to move toward and away from the mammal'"'"'s body within a vertical plane perpendicular to the mammal'"'"'s skin in response to movement of the mammal; and

,

wherein the hinges are configured such that forces generated from the movement of the mammal are distributed along each hinge.

2. The electronic device of claim 1, wherein the wings are more flexible than the housing.

3. The electronic device of claim 1, wherein the wings and the housing are made from the same material.

4. The electronic device of claim 1, wherein the wings and the housing are made from different materials.

5. The electronic device of claim 1, wherein each hinge is thinner than an adjacent portion of the wing of which it is a part.

6. The electronic device of claim 1, further comprising a flap connected to each wing, the flaps extending below the housing but not directly attached to the bottom surface of the housing, wherein the adhesive layer extends onto a bottom surface of each flap.

7. The electronic device of claim 6, further comprising a connector segment configured to connect the flaps together without directly attaching to the bottom surface of the housing.

8. The electronic device of claim 1, further comprising a second adhesive layer functioning as an adhesion guard protecting the adhesive.

9. The electronic device of claim 8, wherein the second adhesive layer adds adhesive surface area to the first adhesive layer to distribute forces over a larger area.

10. The electronic device of claim 1, wherein the adhesive comprises an adhesive that can absorb fluids.

11. The electronic device of claim 10, wherein the adhesive comprises a hydrocolloid adhesive.

12. The electronic device of claim 1, wherein the adhesive comprises a pressure-sensitive adhesive.

13. The electronic device of claim 12, wherein the pressure-sensitive adhesive is selected from the group consisting of a polyacrylate, a polyisobutylene and a polysiloxane.

14. The electronic device of claim 1, further comprising:

an additional adhesive layer between at least one wing and the adhesive layer; and

a material layer between the at least one wing and the adhesive layer.

15. The electronic device of claim 1, wherein the at least two wings comprise two wings extending from approximately opposite ends of the housing.

16. The electronic device of claim 15, further comprising at least one additional wing extending from the housing without overlapping the two wings.

17. The electronic device of claim 1, wherein the physiologic data collection circuit extends along only a portion of a distance between the electrodes.

18. The electronic device of claim 1, wherein the physiologic data collection circuit is configured to collect cardiac rhythm data from the mammal.

19. The electronic device of claim 1, wherein a shape of the boundary of the device is a compound curve.

20. The electronic device of claim 1, further comprising flaps configured to counteract external forces acting to dislodge the device.

21. The electronic device of claim 1, further comprising an electronic memory within the housing, the electronic memory configured to store physiologic data.

22. A device for monitoring cardiac rhythms of a mammal, the device comprising:

a floating section configured to move toward and away from the body of the mammal;

a skin-adhering section extending laterally out from the floating section;

two electrodes integral with a bottom surface of the skin-adhering section and disposed along the bottom surface;

an adhesive layer disposed along the bottom surface of the skin-adhering section except along portions of the bottom surface containing the electrodes, wherein the adhesive layer is not disposed along a bottom surface of the floating section;

electronics disposed in the floating section, the electronics comprising an electronic memory, the electronic memory configured to store physiologic data;

wherein, when the device is worn on the mammal, only the adhesive layer is directly attached to the mammal, and the floating section is not directly adhered to the mammal such that the floating section can move toward and away from the body of the mammal in response to movement of the mammal; and

,

wherein the floating section is configured such that forces generated from the movement of the mammal are distributed along an area between the adhesive layer and the electronics such that the generated forces are not concentrated at a single location.

23. A device as in claim 22, wherein the skin-adhering section includes two hinge portions, each hinge portion located adjacent to a connection of the skin-adhering section with the floating section.

24. An electronic device for long-term adhesion to a mammal, the device comprising:

a housing;

a physiologic data collection circuit contained in the housing;

at least two wings extending laterally from the housing, wherein each wing includes a hinge portion adjacent the housing;

an electrode carried by a bottom surface of each of the wings, the electrodes electrically connected to the physiologic data collection circuit;

an adhesive layer on the bottom surfaces of the wings, wherein the adhesive layer provides adhesion to the skin of the mammal, and wherein the housing is attached to the mammal'"'"'s skin via the adhesive layer on the wings and is not directly attached to the skin of the mammal when the electrodes are in contact with the mammal;

wherein the wings are flexibly coupled to the housing to enable the electrodes to move toward and away from each other within a horizontal plane parallel to the mammal'"'"'s skin, and to enable the housing to move toward and away from the mammal'"'"'s body within a vertical plane perpendicular to the mammal'"'"'s skin, in response to movement of the mammal; and

,

wherein the hinge portions are configured such that forces generated from the movement of the mammal are distributed along each hinge portion.

25. The electronic device of claim 24, further comprising an electronic memory within the housing, the electronic memory configured to store physiologic data.