IP Library Granted Patent US 11,786,159
Granted Patent B2
US 11,786,159 · App. 17/948,080 · Granted Oct 17, 2023

Self-authenticating electrocardiography and physiological sensor monitor

Inventors: Jason Felix (Vashon Island, WA); Gust H. Bardy (Carnation, WA); Jon Mikalson Bishay (Lexington, KY)
Assignee: BARDY DIAGNOSTICS, INC.
A61B5/259A61B5/0006A61B5/0022A61B5/282A61B5/318A61B5/335A61B5/6823A61B2562/08
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Quick Facts
Patent No.
US 11,786,159
App. No.
17/948,080
Granted
Oct 17, 2023
Kind
B2
Abstract

A self-authenticating electrocardiography and physiological sensor monitor is provided. A strip includes two rounded ends with a mid-section between the rounded ends. An electrocardiographic electrode is provided on each of the rounded ends. A flexible circuit is mounted to a surface of the strip and includes a circuit trace electrically coupled to each of the electrocardiographic electrodes. A flash memory is positioned on one of the rounded ends to store ECG data collected via the electrocardiographic electrodes and a battery is positioned on one of the rounded ends. A processor is positioned on one of the rounded ends and configured to execute an authentication protocol that checks voltage of the battery and a state of the flash memory, and determines an expiration of the strip.

Claims (55)

1. An electrocardiography and physiological sensor monitor, comprising:

a strip comprising two rounded ends with a mid-section between the rounded ends and adhesive on one side to adhere to a chest of a patient;

an electrocardiographic electrode on each of the rounded ends;

a flexible circuit mounted to a surface of the strip and comprising a circuit trace electrically coupled to each of the electrocardiographic electrodes;

flash memory positioned on one of the rounded ends to store ECG data collected via the electrocardiographic electrodes;

a battery positioned on one of the rounded ends; and

a monitor recorder comprising a processor and a flash memory, configured to be received by the strip, such that upon being connected to the flexible circuit mounted on the surface of the strip, the processor executes a power up sequence that checks voltage of the battery, checks a state of the flash memory, and determines an expiration of the strip adhered to the patient's chest based on an amount of data written by the processor and further configured to execute an authentication protocol with a crypto circuit on the strip to confirm the strip meets predetermined quality standards as part of the power up sequence.

2. The electrocardiography and physiological sensor monitor according to claim 1 , further comprising on one of the rounded ends of the strip at least one of:

a SpO 2 sensor;

blood pressure sensor;

temperature sensor;

respiratory rate sensor;

glucose sensor;

airflow sensor; and

volumetric pressure sensing.

3. The electrocardiography and physiological sensor monitor according to claim 1 , further comprising:

a wireless interface configured to interface with wearable or implantable physiology monitors.

4. The electrocardiography and physiological sensor monitor according to claim 1 , further comprising:

a non-conductive receptacle positioned on the same rounded end as the battery and configured to house the battery.

5. The electrocardiography and physiological sensor monitor according to claim 1 , further comprising:

adhesive covering at least a portion of a surface of the strip to adhere the strip to skin of a patient.

6. The electrocardiography and physiological sensor monitor according to claim 1 , wherein the adhesive covers only the rounded ends leaving the midsection free of adhesive.

7. The electrocardiography and physiological sensor monitor according to claim 1 , further comprising: read-only memory configured to periodically store the data that is used to determine the expiration of the strip.

8. The electrocardiography and physiological sensor monitor according to claim 7 , wherein a threshold is applied to the data stored in the read-only memory to determine the expiration of the strip.

9. The electrocardiography and physiological sensor monitor according to claim 8 , wherein the strip is determined to be expired when the threshold is satisfied by the data stored in the read-only memory.

10. The electrocardiography and physiological sensor monitor according to claim 1 , further comprising:

a pair of cutouts in the strip configured to form the mid-section.

11. An electrocardiography and physiological sensor monitor, comprising:

a strip comprising two rounded ends with a narrow mid-section between the rounded ends and adhesive on one side to adhere to a chest of a patient;

an electrocardiographic electrode on each of the rounded ends;

a flexible circuit mounted to a surface of the strip and comprising a circuit trace electrically coupled to each of the electrocardiographic electrodes;

flash memory positioned on one of the rounded ends to store ECG data collected via the electrocardiographic electrodes;

a battery positioned on one of the rounded ends;

a non-conductive receptacle positioned on the same rounded end as the battery and configured to house the battery; and

a monitor recorder comprising a processor and a flash memory, configured to be received by the strip, such that upon being connected to the flexible circuit mounted on the surface of the strip, the processor executes a power up sequence that checks voltage of the battery, checks a state of the flash memory, and determines an expiration of the strip adhered to the patient's chest based on an amount of data written by the processor and further configured to execute an authentication protocol with a crypto circuit on the strip to confirm the strip meets predetermined quality standards as part of the power up sequence.

12. The electrocardiography and physiological sensor monitor according to claim 11 , further comprising on one of the rounded ends of the strip at least one of:

a SpO 2 sensor;

blood pressure sensor;

temperature sensor;

respiratory rate sensor;

glucose sensor;

airflow sensor; and

volumetric pressure sensing.

13. The electrocardiography and physiological sensor monitor according to claim 11 , further comprising:

a wireless interface configured to interface with wearable or implantable physiology monitors.

14. The electrocardiography and physiological sensor monitor according to claim 11 , further comprising:

a patient feedback button to mark cardiac events.

15. The electrocardiography and physiological sensor monitor according to claim 11 , further comprising:

adhesive covering at least a portion of a surface of the strip to adhere the strip to skin of a patient.

16. The electrocardiography and physiological sensor monitor according to claim 11 , wherein the adhesive covers only the rounded ends leaving the midsection free of adhesive.

17. The electrocardiography and physiological sensor monitor according to claim 11 , further comprising: read-only memory configured to periodically store the data that is used to determine the expiration of the strip.

18. The electrocardiography and physiological sensor monitor according to claim 17 , wherein a threshold is applied to the data stored in the read-only memory to determine the expiration of the strip.

19. The electrocardiography and physiological sensor monitor according to claim 18 , wherein the strip is determined to be expired when the threshold is satisfied by the data stored in the read-only memory.

20. The electrocardiography and physiological sensor monitor according to claim 11 , further comprising:

a pair of cutouts in the strip configured to form the mid-section.

Continuity (7)
Continuation 16558231 · Sep 2, 2019
Continuation 15602007 · May 22, 2017
Continuation 14082066 · 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 20230017469A1 · Jan 19, 2023