Physiological monitoring device

• US 10,271,754 B2
• Filed: 06/12/2018
• Issued: 04/30/2019
• Est. Priority Date: 01/24/2013
• Status: Active Grant

• Current Assignee: iRhythm Technologies Incorporated
• Original Assignee: iRhythm Technologies Incorporated
• Inventors: Bahney, Timothy J., Ho, Hung H., Park, Shena H., Sepulveda, Genaro S., Day, Mark J., Tamura, Yuriko
• Primary Examiner(s): Stoklosa, Joseph A
• Assistant Examiner(s): Antiskay, Brian M
• Application Number:
  US16/006,719
• Publication Number:
  US 20180289274A1
• Time in Patent Office: 322 Days
• Field of Search: 600382, 600386, 600388, 600393, 600508-509
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured

Abstract

The present invention relates to a physiological monitoring device. Some embodiments of the invention allow for long-term monitoring of physiological signals. Further embodiments may also allow for the monitoring of secondary signals such as motion.

Claims

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

a plurality of flexible wings extending laterally from a rigid housing, each flexible wing configured to conform to a surface of the mammal and comprising a lower substrate layer, an upper substrate layer, and a bottom surface comprising a long-term adhesive, the long-term adhesive configured to adhere to the skin of the mammal;

wherein the plurality of flexible wings comprise a first material and the rigid housing comprises a second material, the second material more rigid than the first material;

a hardware processor housed within the rigid housing, the rigid housing configured to prevent deformation of the hardware processor in response to movement of the mammal;

a flexible electrode embedded within each flexible wing, each electrode configured to provide conformal contact with a non-planar surface of the skin of the mammal during movement of the mammal;

an electrode trace positioned between the upper substrate layer and the lower substrate layer, the upper substrate layer comprising a rim extending horizontally outward beyond the lower substrate layer, the rim being thinner in a vertical plane than an adjacent portion of the flexible wing and configured to reduce edge-lift of the flexible wing from the skin of the mammal; and

wherein each electrode trace extends outward from the rigid housing, each electrode trace conforming to an upper surface of a flexible electrode, the electrode traces and the flexible electrodes configured to remain conformal with the skin of the mammal during bending of the skin.

2. The electronic device of claim 1, wherein each electrode trace conforms to the entire upper surface of a flexible electrode.

3. The electronic device of claim 1, wherein the electrode traces comprise a third material and the flexible electrodes comprise a fourth material, the third material different from the fourth material.

4. The electronic device of claim 1, further comprising a plurality of tabs, each tab extending from the housing and positioned over an electrode trace, wherein each tab is configured to provide strain relief to an electrode trace.

5. The electronic device of claim 1, wherein the plurality of electrode traces are not relied upon for mechanical support.

6. The electronic device of claim 1, wherein the rigid housing comprises a first hook, the first hook configured to engage a second hook, the second hook attached to a battery holder, the first hook more rigid than the second hook.

7. The electronic device of claim 1, wherein the rigid housing comprises a patient trigger configured to depress and record an instance of a perceived cardiac event, the patient trigger covering a majority of the top surface of the rigid housing.

8. The electronic device of claim 7, further comprising a support post positioned beneath the patient trigger, the support post configured to remain rigid during depression of the patient trigger.

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

10. The electronic device of claim 1, wherein each electrode trace is positioned between an upper substrate layer and a lower substrate layer.

11. The electronic device of claim 10, wherein the upper substrate layer extends outward beyond the lower substrate layer.

12. The electronic device of claim 1, wherein each wing comprises a rim, the rim thinner than an adjacent portion of the wing and configured to prevent edge-lift of the flexible wing.

13. An electronic device for monitoring physiological signals in a mammal, the device comprising:

a plurality of flexible wings extending laterally from a rigid housing, each flexible wing configured to conform to a surface of the mammal and comprising a lower substrate layer, an upper substrate layer, and a bottom surface comprising a long-term adhesive, the long-term adhesive configured to adhere to the skin of the mammal;

wherein each wing comprises an upper substrate layer and a lower substrate layer, the upper substrate layer extending outward from the wing beyond the lower substrate layer, the lower substrate layer and the upper substrate layer adhered together by a substrate adhesive positioned between the upper substrate layer and the lower substrate layer;

a hardware processor positioned within the housing;

a flexible electrode embedded within each flexible wing, each electrode configured to provide conformal contact with a non-planar surface of the skin of the mammal during movement of the mammal;

an electrode trace positioned between the upper substrate layer and the lower substrate layer, the upper substrate layer comprising a rim extending horizontally outward beyond the lower substrate layer, the rim being thinner in a vertical plane than an adjacent portion of the flexible wing and configured to reduce edge-lift of the flexible wing from the skin of the mammal; and

wherein each electrode trace extends outward from the rigid housing, the electrode traces and the flexible electrodes configured to remain conformal with the skin of the mammal during bending of the skin.

14. The electronic device of claim 13, wherein the housing comprises an upper housing member and a lower housing member, the upper housing member configured to detachably connect to the lower housing member.

15. The electronic device of claim 13, wherein an underside of the housing comprises a plurality of dimples configured to allow airflow between the surface of the mammal and the housing.

16. The electronic device of claim 14, further comprising an upper gasket and a lower gasket positioned between the upper housing member and the lower housing member.

17. The electronic device of claim 13, wherein the hardware processor further comprises spring fingers, the spring fingers configured to provide a reusable electrical connection with a detachable power unit.

18. The electronic device of claim 13, wherein the long-term adhesive is a hydrocolloid.

19. The electronic device of claim 13, wherein the electrode traces extend into the housing.

20. The electronic device of claim 13, wherein the rigid housing comprises a patient trigger configured to depress and record an instance of a perceived cardiac event, the patient trigger covering a majority of the top surface of the rigid housing.