Health-monitor patch

• US 9,700,222 B2
• Filed: 12/23/2015
• Issued: 07/11/2017
• Est. Priority Date: 12/02/2011
• Status: Active Grant

• Current Assignee: Lumiradx UK Ltd
• Original Assignee: Lumiradx UK Ltd
• Inventors: Gaudet, Paul J., Ohlenbusch, Norbert, Oliver, Steven R., Blackadar, Thomas P., Quinlan, Thomas J., Zhang, Jianwei, Monahan, David P.
• Primary Examiner(s): Cohen, Lee S
• Application Number:
  US14/757,584
• Publication Number:
  US 20160242654A1
• Time in Patent Office: 566 Days
• Field of Search: 600391-393
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/28 for electrocardiography [ECG]
• CPC Class Codes: A61B 5/7214 using signal cancellation, e.g. based on input of two identical physiological sensors spaced apart, or based on two signals derived from the same sensor, for different optical wavelengths
• CPC Class Codes: G01C 22/006 Pedometers
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A health-monitor patch comprising at least one physiological sensor and digital processor is configured to be adhered to the skin of a subject. A health-monitor patch may further include an accelerometer and may detect cardiac waveforms, activity performed by the subject, and a body orientation of the subject. A health-monitor patch may be disposable, in some embodiments, and used for outpatient monitoring. Aspects of noise cancellation and reel-to-reel manufacturing are also described.

Claims

1. A health-monitor patch configured to be adhered to the skin of a subject, the health monitor patch comprising:

a substrate;

two monitor electrodes supported by the substrate and configured to receive two signals from two locations on the skin of the subject;

a processor supported by the substrate and configured to process signals from the two monitor electrodes;

a battery supported by the substrate and connected to supply power to the processor;

a noise electrode supported by the substrate and configured to provide an electrical path from the skin of the subject at a location separate from the two locations; and

a conductive shield connected to the noise electrode and a terminal of the battery, wherein the conductive shield extends over at least portions of two conductors connected between the two monitor electrodes and the processor.

2. The health-monitor patch of claim 1, wherein the noise electrode is configured to provide the electrical path from the skin of the subject at a location between the two locations.

3. The health-monitor patch of claim 1, wherein the conductive shield and two conductors are arranged such that noise detected by the noise electrode couples from the conductive shield to the two conductors.

4. The health-monitor patch of claim 3, further comprising a differential amplifier configured to receive input signals from the two monitor electrodes and provide an output signal representative of a cardiac waveform.

5. The health-monitor patch of claim 4, wherein the processor is disposed on a printed circuit board (PCB) assembly and the conductive shield comprises an electrostatic discharge (ESD) shield that extends over the PCB assembly.

6. The health-monitor patch of claim 5, wherein the health-monitor patch is formed as a flexible strip and the ESD shield comprises a conductive polymer film.

7. The health-monitor patch of claim 1, further comprising a silicone casing surrounding the processor, wherein the two monitor electrodes and noise electrode comprise conductive silicone regions at a surface of the silicone casing that are infused with a conductive material.

8. The health-monitor patch of claim 7, further comprising a replaceable electrode strip configured to be adhered to the surface and provide electrical connections between the two monitor electrodes and two hydrogel monitor electrodes located on the replaceable electrode strip and between the noise electrode and a hydrogel noise electrode.

9. The health-monitor patch of claim 8, wherein the hydrogel noise electrode is located on the replaceable electrode strip between the two hydrogel monitor electrodes.

10. The health-monitor patch of claim 8, wherein the replaceable electrode strip comprises a conductive adhesive disk configured to adhere to one of the two monitor electrodes and provide an electrical connection to one of the two hydrogel monitor electrodes.

11. The health-monitor patch of claim 8, wherein the replaceable electrode strip comprises:

a patch adhesion layer having first vias for the two hydrogel monitor electrodes and the hydrogel noise electrode;

a skin adhesion layer having second vias for the two hydrogel monitor electrodes and the hydrogel noise electrode; and

hydrogel electrode assemblies located at the first and second vias.

12. The health-monitor patch of claim 11, wherein the hydrogel electrode assemblies comprise:

a conductive adhesive disk formed from conductive adhesive tape;

a conductive disk formed from a flexible conductive polymer film and connected to the conductive adhesive disk; and

a hydrogel electrode contacting to the conductive disk.

13. The health-monitor patch of claim 1, further comprising a plurality of flexible and flexible adhesive levels that are adhered together to form the health-monitor patch, wherein the two monitor electrodes and noise electrode comprise hydrogel electrodes.

14. The health-monitor patch of claim 13, wherein a first of the levels comprises:

a first adhesive element formed from conductive adhesive tape and arranged to electrically connect a first of the two monitor electrodes and a first signal input at a printed circuit board (PCB) assembly on which the processor is disposed; and

a second adhesive element formed from conductive adhesive tape and arranged to electrically connect a second of the two monitor electrodes and a second signal input at the PCB assembly.

15. The health-monitor patch of claim 14, wherein a second of the levels comprises the conductive shield and the conductive shield comprises an ESD shield that extends over the first adhesive element and the second adhesive element.

16. The health-monitor patch of claim 15, further comprising a third adhesive element formed from conductive adhesive tape and arranged to electrically connect the noise electrode and the ESD shield.

17. The health-monitor patch of claim 14, wherein the first adhesive element and the second adhesive element adhere to a conductor on a first side and adhere to an insulating layer on a second opposing side.

18. The health-monitor patch of claim 1, further comprising an accelerometer and/or gyroscope, and wherein the processor is configured to process a signal from the accelerometer and/or gyroscope to determine a body orientation of the subject.

19. The health-monitor patch of claim 1, wherein the conductive shield extends over the terminal of the battery and the noise electrode.

20. The health-monitor patch of claim 1, wherein the conductive shield extends over all conductors that connect the conductive shield to the terminal of the battery and the noise electrode.

21. The health-monitor patch of claim 1, wherein the conductive shield is less than about two millimeters from the portions of the two conductors.