IP Library Granted Patent US 11,350,864
Granted Patent B2
US 11,350,864 · App. 17/396,001 · Granted Jun 7, 2022

Adhesive physiological monitoring device

Inventors: Jeffrey Joseph Abercrombie, II (Oakland, CA); Genaro Sebastian Sepulveda (Oakland, CA); Shena Hae Park (San Francisco, CA); Ryan James Wensley (San Francisco, CA); James Kihyun Lee (San Francisco, CA); Thomas Burnell Reeve, III (San Francisco, CA)
Assignee: iRhythm Technologies, Inc.
A61B5/257A61B5/282A61B5/6833H05K5/0026H05K5/0086H05K5/0226H05K7/1427A61B2562/0215A61B2562/0217A61B2562/166A61B2562/227
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Quick Facts
Patent No.
US 11,350,864
App. No.
17/396,001
Granted
Jun 7, 2022
Kind
B2
Abstract

The present disclosure relates to a cardiac monitoring device and systems/methods relating to same. Preferred embodiments may include adhesive layers having channels for transpiring moisture to promote long term adhesion of the device to a subject. The adhesive layer may be surrounded by a non-adhesive lining to inhibit substrate layers from folding under the adhesive. In some embodiments, the adhesive layer may be replaceable. In some embodiments, the adhesive layer may extend beneath a substrate coupled to a housing but not be adhered to the overlying substrate layers. The angles of the edges of the adhesive layer may be configured to minimize peeling forces. Substrate layers above the adhesive layer may be perforated to promote transpiration of moisture and/or provide conformability to the substrate. The perforations may promote anisotropic resistance to compression and/or extension of the substrate.

Claims (35)

1. An electronic device for monitoring physiological signals in a user, the device comprising:

a housing enclosing a circuit board;

a flexible wing extending from the housing and configured to conform to a surface of the user, the flexible wing having a bottom surface, a top surface, and a thickness between the bottom surface and the top surface;

an electrode coupled to the flexible wing, the electrode in electrical communication with the circuit board and being configured to be positioned in conformal contact with the surface of the user to detect the physiological signals;

an adhesive layer coupled to the bottom surface of the flexible wing for adhering the electronic device to the user, the adhesive layer having a lower surface, an upper surface interfacing with the bottom surface of the flexible wing, and a thickness between the lower surface and the upper surface, the adhesive layer comprising a plurality of channels extending from the lower surface to the upper surface of the adhesive layer, the plurality of channels configured to transport moisture from the surface of the user below the lower surface of the adhesive layer through the thickness of the adhesive layer to a second material; and

a non-adhesive liner or coating surrounding a peripheral edge of the adhesive layer, the liner or coating configured to prevent the peripheral edge from adhering to the bottom surface of the flexible wing, the flexible wing extending beyond the peripheral edge of the adhesive layer to form a border surrounding at least a portion of the periphery of the adhesive layer.

2. The electronic device of claim 1 , wherein the adhesive layer comprises a hydrocolloid.

3. The electronic device of claim 1 , wherein the flexible wing is configured to allow moisture to transpire through the thickness of the flexible wing from the bottom surface to the top surface.

4. The electronic device of claim 1 , wherein the flexible wing and/or the adhesive layer comprises an adhesive matrix and a fiber matrix, the fiber matrix configured to wick moisture from the surface of the user.

5. The electronic device of claim 4 , wherein the fiber matrix is disposed as a layer above the adhesive layer.

6. The electronic device of claim 4 , wherein the fiber matrix is disposed within at least some of the plurality of channels.

7. The electronic device of claim 4 , wherein the fiber matrix comprises wool, nylon, polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), or thermoplastic elastomers (TPE).

8. The electronic device of claim 1 , wherein the plurality of channels comprise capillary tube structures oriented substantially normal to the lower surface and the upper surface.

9. The electronic device of claim 1 , wherein the plurality of channels comprises rows and/or columns of channels oriented substantially orthogonal to the lower surface and the upper surface.

10. The electronic device of claim 9 , wherein the plurality of channels comprises columns configured to be aligned entirely or partially with a height of the user in an upright position to promote gravity-assisted drainage of moisture from beneath the adhesive layer.

11. The electronic device of claim 1 , wherein the plurality of channels comprises an arrangement of spiraling channels formed in a plane substantially parallel to the lower surface and the upper surface, the spiraling channels extending from a substantially central point of the adhesive layer.

12. The electronic device of claim 1 , wherein each of the plurality of channels is no further than approximately 8 mm from another channel in a horizontal plane substantially parallel to the upper surface and the lower surface.

13. The electronic device of claim 1 , wherein the border extends at least about 9 mm laterally from the peripheral edge of the adhesive layer.

14. The electronic device of claim 1 , wherein the non-adhesive liner or coating comprises a silicone.

15. The electronic device of claim 1 , wherein:

the adhesive layer is a replaceable adhesive layer, and a peripheral edge of the adhesive layer extends entirely to the peripheral edge of the flexible wing at ends of the flexible wing positioned opposite to the housing.

16. An electronic device for monitoring physiological signals in a user, the device comprising:

a housing enclosing a circuit board;

a wing extending from the housing and configured to conform to a surface of the user, the wing having a bottom surface, a top surface, and a thickness between the bottom surface and the top surface;

an electrode coupled to the wing, the electrode in electrical communication with the circuit board and being configured to be positioned in conformal contact with the surface of the user to detect the physiological signals;

an adhesive layer coupled to the bottom surface of the wing for adhering the electronic device to the user, the adhesive layer having a lower surface, an upper surface interfacing with the bottom surface of the wing, and a thickness between the lower surface and the upper surface, wherein the adhesive layer comprises a plurality of channels extending from the lower surface to the upper surface of the adhesive layer; and

a non-adhesive liner or coating surrounding a peripheral edge of the adhesive layer, the liner or coating configured to prevent the peripheral edge from adhering to the bottom surface of the flexible wing, the flexible wing extending beyond the peripheral edge of the adhesive layer to form a border surrounding at least a portion of the periphery of the adhesive layer.

17. The electronic device of claim 16 , further comprising:

a first electrode trace and a second electrode trace extending from the housing, the first electrode trace comprising the electrode positioned at a distal end of the electrode trace in electrical communication with the circuit board and being configured to be positioned in conformal contact with a surface of the user to detect the physiological signals,

wherein the housing comprises a flexible body configured to conform to the surface of the user and having a bottom surface, a top surface, and a thickness between the bottom surface and the top surface, the flexible body being coupled to the bottom surface of the housing and the first and second electrode traces,

wherein the adhesive layer does not extend below the housing and below at least a portion of a length of the first electrode trace and below at least a portion of the length of the second electrode trace.

18. The electronic device of claim 17 , wherein the flexible body is configured to be cut along a side of the flexible body above the housing and the portions of the first and second electrode traces below which the adhesive layer does not extend and along a side of the flexible body below the housing and the portions of the first and second electrode traces below which the adhesive layer does not extend, such that the flexible body is configured to be lifted up off of the surface of the user below the housing and the portions of the first and second electrode traces below which the adhesive layer does not extend when the device is adhered to the surface of the user.

19. The electronic device of claim 17 , wherein the flexible body is divided along a side of the flexible body above the housing and the portions of the first and second electrode traces below which the adhesive layer does not extend and along a side of the flexible body below the housing and the portions of the first and second electrode traces below which the adhesive layer does not extend, such that the flexible body is configured to be lifted up off of the surface of the user below the housing and the portions of the first and second electrode traces below which the adhesive layer does not extend when the device is adhered to the surface of the user.

20. The electronic device of claim 17 , wherein the flexible body is removably coupled to the bottom surface of the housing and the first and second electrode traces.

21. The electronic device of claim 17 , wherein the flexible body is adhered to the bottom surface of the housing and the first and second electrode traces.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded Mar 7, 2024
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: IRHYTHM TECHNOLOGIES, INC.
Reel/Frame 066767/0250 →
SECURITY INTEREST Recorded Jan 3, 2024
From: IRHYTHM TECHNOLOGIES, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 066189/0322 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 29, 2022
From: ABERCROMBIE, JEFFREY JOSEPH, II; SEPULVEDA, GENARO SEBASTIAN; PARK, SHENA HAE; WENSLEY, RYAN JAMES; LEE, JAMES KIHYUN; REEVE, THOMAS BURNELL, III
To: IRHYTHM TECHNOLOGIES, INC.
Reel/Frame 059714/0207 →
Continuity (2)
Provisional Application 63062293 · Aug 6, 2020
Related Publication 20220039719A1 · Feb 10, 2022
Cited By (15)
US 1,063,079 US 1,083,114 US 12,213,791 US 12,245,859 US 12,245,860 US 12,274,554 US 12,303,275 US 12,303,277 US 12,324,668 US 12,357,212 US 12,402,819 US 12,408,856 US 12,507,931 US 12,582,339 US 12,603,173