Device features and design elements for long-term adhesion

• US 8,560,046 B2
• Filed: 05/12/2011
• Issued: 10/15/2013
• 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.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US13/106,750
• Publication Number:
  US 20110279963A1
• Time in Patent Office: 887 Days
• Field of Search: 600/372, 600/382, 600/391, 600/392, 600/393, 600/509
• US Class Current: 600/392
• 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 forming a watertight enclosure;

an electronic component contained within the watertight enclosure of the housing;

at least two flexible wings integral with and extending from the housing, wherein each wind comprises an electrical connection and a mechanical connection;

at least two electrodes integral with the wings so as to be inseparable from the wings during use of the device, wherein each of the electrodes extends through a bottom surface of one of the wings;

an adhesive layer covering at least a portion of the bottom surface of each of the wings for adhesion of the device to skin of the mammal, wherein the adhesive layer does not cover a bottom surface of the housing;

wherein the electrodes are configured to move toward and away from each other, causing the housing to move toward and away from the mammal'"'"'s body in response to movement of the mammal; and

,

wherein the electrical connections are not relied upon for mechanical support.

2. The electronic device of claim 1, wherein the electronic component includes a processor, the processor having a memory with computer readable instructions to record signals from the electrodes while the electronic device is attached to the mammal.

3. The electronic device of claim 1, further comprising a flap connected to each wing and extending below the housing, wherein the adhesive layer covers at least a portion of a bottom surface of each flap.

4. The electronic device of claim 3, further comprising a connector segment configured to connect the flaps together.

5. The electronic device of claim 4, wherein the connector segment is located at least partially below the housing, but is not directly attached to the bottom surface of the housing.

6. The electronic device of claim 4, wherein the adhesive layer covers at least a portion of a bottom surface of the connector segment.

7. The electronic device of claim 1, further comprising a hinge portion between the housing and each wing, wherein each of the hinge portions is configured to allow the device to bend between the housing and each wing.

8. The electronic device of claim 1, wherein the adhesive layer is configured to absorb fluids.

9. The electronic device of claim 8, wherein the adhesive layer comprises a hydrocolloid adhesive.

10. The electronic device of claim 1, wherein the wings and the housing are made from one type of material.

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

12. The electronic device of claim 11 wherein the wings are made from a fabric.

13. The electronic device of claim 11 wherein the material used to make the wings includes a synthetic fiber.

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

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

16. The electronic device of claim 15 wherein the pressure sensitive adhesive is selected from the group consisting of:

a polyacrylate, a polyisobutlene, and a polysiloxane.

17. The electronic device of claim 1, wherein the housing is thicker at a center of the housing than at edges of the housing.

18. The electronic device of claim 1, further comprising a diffusion barrier between the adhesive layer and each of the wings.

19. The electronic device of claim 18 further comprising a polyester diffusion barrier.

20. The electronic device of claim 1, further comprising a material layer between the bottom surfaces of the wings and the adhesive layer, wherein the material layer is configured to prevent diffusion of adhesive components from the adhesive layer to the wing.

21. The electronic device of claim 1, wherein the bottom surface of the housing is not directly attached to the mammal when the electrodes are in contact with the mammal.

22. The electronic device of claim 1, wherein the electronic component is housed within, but is unattached to, the watertight enclosure such that it can move freely within the housing.

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

a housing forming a watertight enclosure;

a first flexible wing integral with and extending laterally from the housing;

a second flexible wing integral with and extending laterally from the housing without overlapping the first wing;

wherein each wing comprises an electrical and a mechanical connection;

a first electrode integral with the first wing so as to be inseparable from the first wing during use of the device, wherein the first electrode extends through a bottom surface of the first wing;

a second electrode integral with the second wing so as to be inseparable from the second wing during use of the device, wherein the second electrode extends through a bottom surface of the second wing;

an electronic component contained within the watertight enclosure of the housing, the electronic component comprising an electronic memory configured to receive and store an electronic signal from the first and second electrodes while the electronic device is attached to the mammal; and

an adhesive layer on a portion of a bottom surface of the first wing and the second wing and not on a bottom surface of the housing,

wherein, when the device is worn on the mammal, only the adhesive layer is directly attached to the mammal and the bottom surface of the housing is not directly attached to the mammal;

wherein the electrodes are configured to move toward and away from each other, causing the housing to move toward and away from the mammal'"'"'s body in response to movement of the mammal; and

,

wherein the electrical connections are not relied upon for mechanical support.

24. The electronic device of claim 23, wherein the portion of the bottom surface of the first wing and the second wing does not include the first and second electrodes.

25. The electronic device of claim 23, wherein the first wing, the second wing, and the housing are formed from the same material.

26. The electronic device of claim 23, wherein the first wing, the second wing and the housing integrally form a monolithic structure.

27. The electronic device of claim 23, wherein an angle formed by the first wing, the second wing, and the housing is between approximately 90°

and 180°

.

28. The electronic device of claim 27, wherein the angle is approximately 180°

.

29. The electronic device of claim 27, wherein the angle is approximately 135°

.

30. The electronic device of claim 23, wherein the electrical connection comprises:

a first wire connecting the first electrode and the electronic memory; and

a second wire connecting the second electrode and the electronic memory.

31. The electronic device of claim 30, wherein each of the first and second wires includes slack between the electrode to which it is attached and the electronic memory.

32. The electronic device of claim 31, wherein the slack is located in a portion of each wing that is configured to bend or flex.

33. The electronic device of claim 23, wherein the first wing includes a first hinged portion adjacent a junction between the first wing and the housing, and wherein the second wing includes a second hinged portion adjacent a junction between the second wing and the housing.

34. The electronic device of claim 23, wherein at least the bottom surface of the housing is not adhered to the mammal when signals from the electrodes are being recorded in the electronic memory.

35. The electronic device of claim 23, further comprising a first flap connected to the first wing medial to the first electrode and a second flap connected to the second wing medial to the second electrode, wherein each flap extends below the housing.

36. The electronic device of claim 35, further comprising a connector segment configured to connect the flaps together.

37. The electronic device of claim 36, wherein the connector segment is located at least partially below the housing, but is not directly attached to the bottom surface of the housing.

38. The electronic device of claim 23, wherein the electronic component is housed within, but is unattached to, the watertight enclosure such that it can move freely within the housing.

39. A method of applying an electronic device having a housing including a watertight enclosure, an electronic component housed within the watertight enclosure, a first wing integral with the housing, and a second wing integral with the housing to a mammal for long-term adhesion, the method comprising:

removing a first adhesive cover from the first wing of the electronic device to expose a first electrode and an adhesive on a bottom surface of the first wing;

placing the exposed first electrode into contact with skin of the mammal by adhering the adhesive on the bottom surface of the first wing to the skin;

removing a second adhesive cover from the second wing of the electronic device to expose a second electrode and an adhesive on a bottom surface of the second wing; and

placing the second exposed electrode into contact with the skin of the mammal by adhering the adhesive on the bottom surface of the second wing to the skin;

wherein the electrodes are integral with the wings so as to be inseparable from the wings during use of the device;

wherein each wing comprises an electrical and a mechanical connection;

wherein the electrodes are configured to move toward and away from each other, causing the housing to move toward and away from the mammal'"'"'s body in response to movement of the mammal;

wherein the electrical connections are not relied upon for mechanical support; and

wherein, after performing the removing and the placing steps, the housing is not directly attached to the skin but is held in position on the mammal only by the adhesive on the first and the second wings.

40. The method of claim 39, wherein the electronic device comprises a first flap connected to the first wing and a second flap connected to the second wing, the first and second flaps each extending below the housing, wherein the step of removing the first adhesive cover from the first wing further comprises exposing an adhesive on a bottom surface of the first flap, and wherein the step of removing the second adhesive cover from the second wing further comprises exposing an adhesive on the bottom surface of a second flap.

41. The method of claim 40, wherein, after performing the removing and the placing steps, the housing is held in position on the mammal using only the adhesive on the first wing, the second wing, the first flap and the second flap.

42. The method of claim 39, further comprising, after placing the second exposed electrode into contact with the skin, wearing the device on the skin continuously without removal for greater than 7 days.

43. A method of applying an electronic device having a housing including a watertight enclosure, an electronic component housed completely within the watertight enclosure, a first wing integral with the housing, and a second wing integral with the housing to a mammal for long-term adhesion, the method comprising:

removing a first adhesive cover from the first wing of the electronic device to expose a first electrode and an adhesive on a bottom surface of the first wing;

removing a second adhesive cover from the second wing of the electronic device to expose a second electrode and an adhesive on a bottom surface of the second wing; and

placing the exposed electrodes into contact with skin of the mammal by adhering the adhesive to the skin;

wherein the electrodes are integral with the wings so as to be inseparable from the wings during use of the device;

wherein each wing comprises an electrical and a mechanical connection;

wherein the electrodes are configured to move toward and away from each other, causing the housing to move toward and away from the mammal'"'"'s body in response to movement of the mammal;

wherein the electrical connections are not relied upon for mechanical support; and

wherein, after performing the removing and the placing steps, the housing is not directly attached to the mammal but is held in position on the mammal only by the adhesive on the first and the second wings.

44. The method of claim 43, further comprising, after placing the exposed electrodes into contact with the skin, wearing the device on the skin continuously without removal for greater than 7 days.