IP Library Granted Patent US 11,744,513
Granted Patent B2
US 11,744,513 · App. 17/740,009 · Granted Sep 5, 2023

Electrocardiography and respiratory monitor

Inventors: Gust H. Bardy (Carnation, WA); Jon Mikalson Bishay (Lexington, KY); Jason Felix (Vashon, WA)
Assignee: BARDY DIAGNOSTICS, INC.
A61B5/4818A61B5/0006A61B5/0022A61B5/02055A61B5/087A61B5/14532A61B5/14552A61B5/259A61B5/282A61B5/335A61B5/6832A61B5/7282A61B7/003G16H40/67A61B5/021A61B5/03A61B5/0816A61B5/1118A61B5/14551
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Quick Facts
Patent No.
US 11,744,513
App. No.
17/740,009
Granted
Sep 5, 2023
Kind
B2
Abstract

A monitoring apparatus is provided. A strip includes a first end section, a second end section opposite the first end section, and a midsection between the first end section and the second end section, and further includes a first surface and a second surface. An adhesive covers a portion of the first surface of the strip. Only two electrocardiographic electrodes are included. A flexible circuit is mounted to the second surface of the strip. An accelerometer, a respiratory sensor, and a wireless transceiver are provided on the second surface of the strip. A processor is positioned over a portion of the flexible circuit and coupled to the electrodes and the wireless transceiver.

Claims (50)

1. An apparatus, comprising:

a patch, comprising:

a strip with a first end section, a second end section opposite the first end section, and a midsection between the first end section and the second end section, wherein the strip comprises a first surface and a second surface;

only two electrocardiographic electrodes comprising a first electrocardiographic electrode and a second electrocardiographic electrode, wherein the first electrocardiographic electrode is provided on the first surface of the first end section of the strip and the second electrocardiographic electrode is positioned on the first surface on the second end section of the strip;

an adhesive covering a portion of the first surface of the strip, wherein the adhesive covering the portion of the first surface of the strip is provided on the first end section and the second end section only leaving the midsection free of the adhesive, wherein the adhesive extends along the strip past the electrode on at least one of the first and second end sections;

a flexible circuit mounted to the second surface of the strip and comprising a first circuit trace electrically coupled to the first electrocardiographic electrode and a second circuit trace electrically coupled to the second electrocardiographic electrode; and

one or more sensors each provided on the second surface of the strip, on one of the first and second end sections of the strip; and

a processor positioned on one of the first or second end sections over a portion of the flexible circuit and coupled to the first electrocardiographic electrode, the second electrocardiographic electrode, and the wireless transceiver, and configured to execute under modular micro program control as specified in firmware to read samples of ECG signals, buffer the samples of the ECG signals, compress the buffered samples of the ECG signals, buffer the compressed samples of the ECG signals, and write the compressed buffered samples into a non-volatile flash memory.

2. An apparatus according to claim 1 , further comprising at least one of:

a blood pressure sensor provided on the strip;

a temperature sensor provided on the strip;

a respiratory rate sensor provided on the strip;

a glucose sensor provided on the strip; and

a volumetric pressure sensor provided on the strip.

3. An apparatus according to claim 2 , wherein a respiratory rate event is detected upon a rate of respiration or an amplitude of movement of a patient's chest during the patient's respiration via data received by the respiratory rate sensor.

4. An apparatus according to claim 2 , wherein a body temperature is determined based on data received via the temperature sensor.

5. An apparatus according to claim 1 , wherein a free fall event is detected based on data received from the accelerometer.

6. An apparatus according to claim 1 , wherein the processor is configured to receive data regarding the patient, from the respiratory rate sensor, to read a sample of the data from the respiratory rate sensor, and to store the sample into the memory.

7. An apparatus according to claim 1 , wherein the electrocardiographic signals are analog and the sample is digitized prior to being stored into the memory.

8. An apparatus according to claim 1 , wherein the strip tapers inward from the first end section and the second end section.

9. An apparatus according to claim 1 , wherein the strip comprises an hourglass-like shape.

10. An apparatus according to claim 1 , wherein portions of the first surface along each of the first end section and the second end section are covered in the adhesive to adhere the strip to skin of a patient and further wherein a portion of the first surface along the midsection is not covered in adhesive.

11. An apparatus according to claim 1 , wherein the patch comprises flash memory overlying the first end section.

12. An apparatus according to claim 1 , wherein the strip is configured for placement on a chest of a patient.

13. An apparatus according to claim 1 , wherein the first circuit trace originates and terminates in the first end section.

14. An apparatus according to claim 1 , wherein the second circuit trace extends between the first end section and the second end section.

15. An apparatus, comprising:

a patch, comprising:

a strip with a first end section, a second end section opposite the first end section and a midsection, wherein the strip comprises a first surface and a second surface and at least a portion of the midsection is narrower than portions of the first end section and the second end section;

only two electrocardiographic electrodes comprising a first electrocardiographic electrode and a second electrocardiographic electrode, the first electrocardiographic electrode conductively exposed on the first surface along the first end section of the strip and the second electrocardiographic electrode conductively exposed on the first surface along the second end section of the strip;

an adhesive covering a portion of the first surface of the strip, wherein the adhesive covering the portion of the first surface of the strip is provided on the first end section and the second end section only leaving the midsection free of the adhesive, wherein the adhesive extends along the strip past the electrode on at least one of the first and second end sections;

a flexible circuit mounted to the second surface of the strip and comprising a first circuit trace and a second circuit trace, the first circuit trace electrically coupled to the first electrocardiographic electrode, the second circuit trace electrically coupled to the second electrocardiographic electrode;

one or more sensors each provided on the second surface of the strip on one of the first or second end sections; and

a processor positioned over a portion of the flexible circuit on the first end section and electrically coupled to the first electrocardiographic electrode, the second electrode, the wireless transceiver, and the memory, and configured to execute under modular micro program control as specified in firmware to read samples of ECG signals, buffer the samples of the ECG signals, compress the buffered samples of the ECG signals, buffer the compressed samples of the ECG signals, and write the compressed buffered samples into a non-volatile flash memory.

16. An apparatus according to claim 15 , further comprising at least one of:

a blood pressure sensor provided on the strip;

a temperature sensor provided on the strip;

a glucose sensor provided on the strip; and

a volumetric pressure sensor provided on the strip.

17. An apparatus according to claim 15 , wherein a respiratory rate event is detected upon a rate of respiration or an amplitude of movement of a patient's chest during the patient's respiration via data received by the respiratory sensor.

18. An apparatus according to claim 16 , wherein a body temperature is determined based on data received via the temperature sensor.

19. An apparatus according to claim 15 , wherein a free fall event is detected based on data received from the accelerometer.

20. An apparatus according to claim 15 , wherein the processor is configured to receive data regarding the patient, from the respiratory sensor, to read a sample of the data, and to store the sample into the memory.

21. An apparatus according to claim 15 , wherein the electrocardiographic signals are analog and the samples are digitized prior to being stored into the memory.

22. An apparatus according to claim 15 , wherein the strip tapers inward from the first end section and the second end section.

23. An apparatus according to claim 15 , wherein the strip comprises an hourglass-like shape.

24. An apparatus according to claim 15 , wherein portions of the first surface along each of the first end section and the second end section are covered in the adhesive to adhere the strip to skin of a patient and further wherein a portion of the first surface along the midsection is not covered in adhesive.

25. An apparatus according to claim 15 , wherein the strip is configured for placement on a chest of a patient.

26. An apparatus according to claim 15 , wherein the first circuit trace originates and terminates in the first end section.

27. An apparatus according to claim 15 , wherein the second circuit trace extends between the first end section and the second end section.

Continuity (11)
Continuation 17367536 · Jul 5, 2021
Continuation 16835228 · Mar 30, 2020
Continuation 16389863 · Apr 19, 2019
Continuation 15966882 · Apr 30, 2018
Continuation 15406550 · Jan 13, 2017
Continuation 15181082 · Jun 13, 2016
Continuation 14082102 · Nov 15, 2013
Continuation In Part 14080717 · Nov 14, 2013
Continuation In Part 14080725 · Nov 14, 2013
Provisional Application 61882403 · Sep 25, 2013
Related Publication 20220257177A1 · Aug 18, 2022