IP Library Granted Patent US 10,251,576
Granted Patent B2
US 10,251,576 · App. 15/934,888 · Granted Apr 9, 2019

System and method for ECG data classification for use in facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer

Inventors: Gust H. Bardy (Carnation, WA); Ezra M. Dreisbach (Vashon, WA)
Assignee: Bardy Diagnostics, Inc.
A61B5/0456A61B5/0245A61B5/02405A61B5/044A61B5/046A61B5/04017A61B5/0432A61B5/0464A61B5/04085A61B5/04087A61B5/04525A61B5/6823A61B5/7203A61B5/0205A61B5/0468A61B5/742
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Quick Facts
Patent No.
US 10,251,576
App. No.
15/934,888
Granted
Apr 9, 2019
Kind
B2
Abstract

A system and method for ECG data classification for use in facilitating diagnosis of cardiac rhythm disorders is provided. ECG data is obtained via an electrocardiography monitor with a patient button. A press of the patient button is identified within the ECG data. A button window with a segment of data prior to and after the button press is defined within the ECG data. The ECG data is divided into blocks. Noise detection analysis is applied to the data blocks. A classification of noise or valid data is assigned to each data block based on the noise detection analysis. At least one data block that overlaps the button window is assigned the noise classification. The at least one data block is trimmed to align with one of the start and end of the button window. The trimmed blocks assigned with the noise classification are removed from the data.

Claims (60)

1. A system for ECG data classification for use in facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer, comprising:

a database to store ECG data obtained via an electrocardiography monitor comprising a patient button and an extended wear electrode patch, wherein the extended wear electrode patch comprises a backing, a pair of electrocardiographic electrodes conductively exposed on a contact surface of each end of the backing, a non-conductive receptacle adhered to an outward-facing surface of the backing and comprising a plurality of electrical pads, a battery electrically interfaced to a pair of the electrical pads on the non-conductive receptacle, and a circuit affixed on each end of the backing; and

a server comprising a central processing unit, memory, an input port to receive the ECG data from the database, and an output port, wherein the central processing unit is configured to:

identify within the ECG data at least one press of the patient button;

define within the ECG data a button window comprising a segment of data prior to and after the press of the patient button;

divide the ECG data into blocks;

apply noise detection analysis to the blocks of ECG data;

assign a classification comprising one of noise and valid data to each ECG data block based on the noise detection analysis;

identify at least one block of ECG data assigned the noise classification that overlaps the button window;

trim the at least one block of ECG data to align with one of the start and end of the button window; and

remove from the ECG data the blocks and the trimmed blocks assigned with the noise classification.

2. A system in accordance with claim 1 , wherein the central processing unit performs an analysis of the ECG data after the blocks assigned the noise classification have been removed and identifies at least one cardiac event based on the analysis.

3. A system in accordance with claim 1 , wherein the central processing unit performs the noise detection analysis by:

identifying features;

identifying repeating patterns of the features;

generating a matrix with the identified features and patterns;

generating at least one matrix with weights for the identified features and patterns; and

assigning a value for each of the noise classification and the valid classification to each block based on the weight matrix.

4. A system in accordance with claim 3 , wherein the central processing unit determines the features by applying one or more sliding filters to the ECG data.

5. A system in accordance with claim 3 , wherein the central processing unit selects one such block the classification assigned the highest value for that block.

6. A system in accordance with claim 5 , wherein the central processing unit applies a time threshold to a period of identified noise in each of one or more blocks and assigns a noise classification to one such block when the noise classification has a higher value than the valid classification and the period of identified noise exceeds the time threshold.

7. A system in accordance with claim 6 , wherein the central processing unit removes from each block of ECG data a predetermined amount of data from a beginning of the block from consideration during the noise detection analysis.

8. A system in accordance with claim 1 , wherein the electrocardiography monitor further comprises:

a monitor recorder having a sealed housing adapted to be removably secured into the non-conductive receptacle of the electrode patch, wherein the scaled housing comprises a set of electrical contacts that protrude from a bottom surface and that correspond with further electrical pads on the non-conductive receptacle and comprising:

a micro-controller operable to sense electrocardiographic signals through the electrocardiographic electrodes via the pair of the electrical pads; and

a flash memory electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals.

9. A system in accordance with claim 1 , wherein one of the electrocardiographic electrodes is adhered to a region overlying the Xiphoid process on a patient's chest and an other of the electrocardiographic electrodes is adhered to the region near the manubrium on the patient's chest oriented centrally (in the midline) along the sternum upwards from the one electrocardiographic electrode.

10. A method for ECG data classification for use in facilitating diagnosis of cardiac rhythm disorders with the aid of a digital computer, comprising:

obtaining ECG data via an electrocardiography monitor comprising a patient button and an extended wear electrode patch, wherein the extended wear electrode patch comprises a backing, a pair of electrocardiographic electrodes conductively exposed on a contact surface of each end of the backing, a non-conductive receptacle adhered to an outward-facing surface of the backing and comprising a plurality of electrical pads, a battery electrically interfaced to a pair of the electrical pads on the non-conductive receptacle, and a circuit affixed on each end of the backing;

identifying within the ECG data at least one press of the patient button;

defining within the ECG data a button window comprising a segment of data prior to and after the press of the patient button;

dividing the ECG data into blocks;

applying noise detection analysis to the blocks of ECG data;

assigning a classification comprising one of noise and valid data to each ECG data block based on the noise detection analysis;

identifying at least one block of ECG data assigned the noise classification that overlaps the button window;

trimming the at least one block of ECG data to align with one of the start and end of the button window; and

removing from the ECG data the blocks and the trimmed blocks assigned with the noise classification.

11. A method in accordance with claim 10 , further comprising:

performing an analysis of the ECG data after the blocks assigned the noise classification have been removed; and

identifying at least one cardiac event based on the analysis.

12. A method in accordance with claim 10 , further comprising:

identifying features;

identifying repeating patterns of the features;

generating a matrix with the identified features and patterns;

generating at least one matrix with weights for the identified features and patterns; and

assigning a value for each of the noise classification and the valid classification to each block based on the weight matrix.

13. A method in accordance with claim 12 , further comprising:

determining the features by applying one or more sliding filters to the ECG data.

14. A method in accordance with claim 12 , further comprising:

selecting one such block the classification assigned the highest value for that block.

15. A method in accordance with claim 14 , further comprising:

applying a time threshold to a period of identified noise in each of one or more blocks; and

assigning a noise classification to one such block when the noise classification has a higher value than the valid classification and the period of identified noise exceeds the time threshold.

16. A method in accordance with claim 15 , further comprising:

from each block of ECG data, removing a predetermined amount of data from a beginning of the block from consideration during the noise detection analysis.

17. A method in accordance with claim 10 , wherein the electrocardiography monitor further comprises:

a monitor recorder having a sealed housing adapted to be removably secured into the non-conductive receptacle of the electrode patch, wherein the sealed housing comprises a set of electrical contacts that protrude from a bottom surface and that correspond with further electrical pads on the non-conductive receptacle and comprising:

a micro-controller operable to sense electrocardiographic signals through the electrocardiographic electrodes via the pair of the electrical pads; and

a flash memory electrically interfaced with the micro-controller and operable to store samples of the electrocardiographic signals.

18. A method in accordance with claim 10 , wherein one of the electrocardiographic electrodes is adhered to a region overlying the Xiphoid process on a patient's chest and an other of the electrocardiographic electrodes is adhered to the region near the manubrium on the patient's chest oriented centrally (in the midline) along the sternum upwards from the one electrocardiographic electrode.

Assignments (3)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 26, 2018
From: BARDY, GUST H.; DREISBACH, EZRA M.
To: BARDY DIAGNOSTICS, INC.
Reel/Frame 045348/0917 →
Continuity (14)
Continuation In Part 15231752 · Aug 8, 2016
Continuation 15066883 · Mar 10, 2016
Continuation In Part 14997416 · Jan 15, 2016
Continuation In Part 14614265 · Feb 4, 2015
Continuation In Part 14488230 · Sep 16, 2014
Continuation In Part 14080725 · Nov 14, 2013
Continuation In Part 15934888
Continuation In Part 15785317 · Oct 16, 2017
Continuation 15362743 · Nov 28, 2016
Division 14875622 · Oct 5, 2015
Provisional Application 62132497 · Mar 12, 2015
Provisional Application 61882403 · Sep 25, 2013
Provisional Application 62591715 · Nov 28, 2017
Related Publication 20180206752A1 · Jul 26, 2018
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