IP Library Granted Patent US 11,445,961
Granted Patent B2
US 11,445,961 · App. 16/558,231 · Granted Sep 20, 2022

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
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,445,961
App. No.
16/558,231
Granted
Sep 20, 2022
Kind
B2
Abstract

A self-authenticating electrocardiography and physiological sensor monitor is provided. An electrode patch includes an elongated strip and electrodes exposed on each end. A receptacle is adhered to the elongated strip and includes electrical pads. Circuit traces are electrically coupled to the electrocardiographic electrodes and the electrical pads. A monitor recorder having a sealed housing is adapted to be secured into the receptacle. Circuitry within the housing includes a microcontroller with a private key. A copy of the private key is stored on the patch. Self-authentication is performed each time the monitor recorder is inserted into a new patch by challenging the patch using a code hashed with the private key and by receiving a response from the patch in reply to the challenge. A front end circuit senses electrocardiographic signals via electrodes on the patch when the response received by the microcontroller is positive, until the electrode patch expires.

Claims (42)

1. An electrocardiography and physiological sensor monitor recorder with a self-authenticating electrocardiography monitoring circuit, comprising:

a sealed housing adapted to be removably secured on an electrode patch worn by a patient; and

electronic circuitry comprised within the housing and comprising:

a microcontroller comprising a private key or precomputed digest, wherein a copy of the private key or precomputed digest is stored on the electrode patch, and configured to perform self-authentication with the electrode patch on which the housing of the microcontroller is secured each time the housing is inserted onto the electrode patch worn by the patient to authenticate for common entity source of the electrode patch and housing by challenging the electrode patch using a code hashed with the private key or precomputed digest and by receiving a response from the electrode patch in reply to the challenge;

electrical contacts arranged on a portion of an outer surface of the housing and configured to directly contact pads on the electrode patch when the housing is inserted onto the electrode patch, wherein the self-authentication is initiated upon the contact of the pads and the electrical contacts; and

an electrocardiographic front end circuit electrically interfaced to the microcontroller to sense electrocardiographic signals via electrodes on the electrode patch when the response received by the microcontroller is positive and to continue to sense the electrocardiographic signals until the electrode patch expires.

2. The electrocardiography and physiological sensor monitor recorder according to claim 1 , wherein the electronic circuitry comprises an actigraphy sensor to sample actigraphy data and to generate interrupt signals to the microcontroller upon detection of one of the group consisting of an independent initial wake up event and free fall event.

3. The electrocardiography and physiological sensor monitor recorder according to claim 1 , wherein the electronic circuitry comprises an actigraphy sensor to sample actigraphy data comprising an orientation of the housing.

4. The electrocardiography and physiological sensor monitor recorder according to claim 2 , further comprising:

memory provided within the housing to store the actigraphy data embedded into a stream of the electrocardiographic signals.

5. The electrocardiography and physiological sensor monitor recorder according to claim 1 , wherein the electronic circuitry comprises an expansion port.

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

an external device comprising one of an SpO 2 sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, and volumetric pressure sensor interfaced to the expansion port.

7. The electrocardiography and physiological sensor monitor recorder to claim 1 , further comprising:

a feedback button comprised on the housing to mark patient events.

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

a buzzer comprised in the circuitry and comprising at least one of a speaker, magnetic resonator, and piezoelectric buzzer to output feedback.

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

memory provided within the housing.

10. A self-authenticating electrocardiography and physiological sensor monitor, comprising:

an electrode patch configured to be worn by a patient, comprising:

an elongated strip of material;

a pair of electrocardiographic electrodes exposed on a contact surface of each end of the elongated strip;

a non-conductive receptacle adhered to an outward-facing surface of the elongated strip and comprising a plurality of electrical pads; and

a circuit affixed on each end of the elongated strip and comprising a pair of circuit traces electrically coupled to the pair of the electrocardiographic electrodes and a pair of the electrical pads; and

an electrocardiography monitor recorder having a sealed housing adapted to be removably secured into the non-conductive receptacle on the electrode patch and electronic circuitry comprised within the sealed housing, comprising:

a microcontroller comprising a private key or precomputed digest, wherein a copy of the private key or precomputed digest is stored on the electrode patch worn by the patient, and configured to perform self-authentication with the electrode patch on which the electrocardiography monitor recorder is secured each time the monitor recorder is inserted into the electrode patch to authenticate for common entity source of the electrode patch and the electrocardiography monitor recorder by challenging the electrode patch using a code hashed with the private key or precomputed digest and by receiving a response from the electrode patch in reply to the challenge;

electrical contacts arranged on a portion of an outer surface of the housing and configured to directly contact pads on the electrode patch when the housing is inserted onto the electrode patch, wherein the self-authentication is initiated upon the contact of the pads and the electrical contacts; and

an electrocardiographic front end circuit electrically interfaced to the microcontroller to sense electrocardiographic signals via the pair of electrodes on the electrode patch when the response received by the microcontroller is positive and to continue to sense the electrocardiographic signals until the electrode patch expires.

11. The self-authenticating electrocardiography and physiological sensor monitor according to claim 10 , wherein the electronic circuitry comprises an actigraphy sensor to sample actigraphy data and to generate interrupt signals to the microcontroller upon detection of one of the group consisting of an independent initial wake up event and free fall event.

12. The self-authenticating electrocardiography and physiological sensor monitor according to claim 10 , wherein the electronic circuitry comprises an actigraphy sensor to sample actigraphy data comprising an orientation of the housing.

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

memory provided within the housing to store the actigraphy data embedded into a stream of the electrocardiographic signals.

14. The self-authenticating electrocardiography and physiological sensor monitor according to claim 10 , wherein the electronic circuitry comprises an expansion port.

15. The self-authenticating electrocardiography and physiological sensor monitor according to claim 14 , further comprising:

an external device comprising one of an SpO 2 sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, and volumetric pressure sensor interfaced to the expansion port.

16. The self-authenticating electrocardiography and physiological sensor monitor according to claim 10 , further comprising:

a feedback button comprised on the housing to mark patient events.

17. The self-authenticating electrocardiography and physiological sensor monitor according to claim 10 , further comprising:

a buzzer comprised in the circuitry and comprising at least one of a speaker, magnetic resonator, and piezoelectric buzzer to output feedback.

18. The self-authenticating electrocardiography and physiological sensor monitor according to claim 10 , further comprising:

memory configured to draw power from a battery provided on the electrode patch.

Assignments (2)
RELEASE OF SECURITY INTEREST (SENT FOR RECORDAL OCTOBER 25, 2021) Recorded Dec 14, 2021
From: JPMORGAN CHASE BANK, N.A.
To: BREATHE TECHNOLOGIES, INC.; HILL-ROM SERVICES, INC.; ALLEN MEDICAL SYSTEMS, INC.; WELCH ALLYN, INC.; HILL-ROM, INC.; VOALTE, INC.; BARDY DIAGNOSTICS, INC.; HILL-ROM HOLDINGS, INC.
Reel/Frame 058516/0312 →
SECURITY AGREEMENT SUPPLEMENT Recorded Oct 25, 2021
From: BARDY DIAGNOSTICS, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 058567/0677 →
Continuity (6)
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 20190380615A1 · Dec 19, 2019