IP Library Granted Patent US 10,433,751
Granted Patent B2
US 10,433,751 · App. 16/178,463 · Granted Oct 8, 2019

System and method for facilitating a cardiac rhythm disorder diagnosis based on subcutaneous cardiac monitoring data

Inventors: Gust H. Bardy (Carnation, WA); Ezra M. Dreisbach (Vashon, WA)
Assignee: Bardy Diagnostics, Inc.
A61B5/0456A61B5/0245A61B5/02405A61B5/044A61B5/0422A61B5/0432A61B5/04085A61B5/04087A61B5/04525A61B5/686A61B5/6823A61B5/7203A61B5/0205A61B5/02055A61B5/046A61B5/04011A61B5/04017A61B5/0464A61B5/0468A61B5/742A61B2560/0468A61B2562/162
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Quick Facts
Patent No.
US 10,433,751
App. No.
16/178,463
Granted
Oct 8, 2019
Kind
B2
Abstract

A system and method for facilitating a cardiac rhythm disorder diagnosis based on subcutaneous cardiac monitoring data with the aid of a digital computer are provided. Cutaneous action potentials of a patient are recorded as electrocardiogram (EGC) data over a set time period using a subcutaneous insertable cardiac monitor. A set of R-wave peaks is identified within the ECG data and an R-R interval plot is constructed. A difference between recording times of successive pairs of the R-wave peaks in the set is determined. A heart rate associated with each difference is also determined. The pairs of the R-wave peaks and associated heart rate are plotted as the R-R interval plot. A diagnosis of cardiac disorder is facilitated based on patterns of the plotted pairs of the R-wave peaks and the associated heart rates in the R-R interval plot.

Claims (58)

1. A system for facilitating a cardiac rhythm disorder diagnosis based on subcutaneous cardiac monitoring data, comprising:

a subcutaneous insertable cardiac monitor, comprising:

an implantable housing for implantation within a living body, the implantable housing comprised of a biocompatible material;

at least one pair of electrocardiographic (ECG) sensing electrodes provided on a ventral surface and on opposite ends of the implantable housing operatively placed to facilitate sensing in closest proximity to low amplitude, low frequency content cardiac action potentials that are generated during atrial activation; and

electronic circuitry provided within the housing assembly comprising a low power microcontroller operable to execute under modular micro program control as specified in firmware, an ECG front end circuit interfaced to the microcontroller and configured to capture the cardiac action potentials sensed by the pair of ECG sensing electrodes which are output as ECG signals, and non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the ECG signals; and

a download station adapted to retrieve the stored samples of the ECG signals from the subcutaneous insertable cardiac monitor as ECG data;

a computer comprising a processor and memory within which code for execution by the processor is stored, the processor configured to:

receive the ECG data retrieved by the download station;

identify a set of R-wave peaks within the ECG data;

construct an R-R interval plot, comprising:

determine a difference between recording times of successive pairs of the R-wave peaks in the set and determine a heart rate associated with each difference;

plot the pairs of the R-wave peaks and associated heart rate as the R-R interval plot; and

accentuate in the R-R interval plot spatial differences in frequently-occurring ranges of the heart rate and de-emphasize the spatial differences in ranges of the heart rate where a deviation from the frequently-occurring ranges exists using a non-linear scale for the heart rate; and

a display to facilitate diagnosis of a cardiac disorder of the patient based on patterns of the plotted pairs of the R-wave peaks and the associated heart rates in the R-R interval plot.

2. A system in accordance with claim 1 , the processor further configured to:

form a diagnosis based on heart rate variability patterns in the R-R interval plot.

3. A system in accordance with claim 2 , the processor further configured to:

detect atrial fibrillation by identifying a Gaussian-type distribution of heart rate variability in the duration R-R interval plot.

4. A system in accordance with claim 1 , wherein the processor is configured to form:

a background information plot with the R-R interval plot comprising one or more of activity amount, activity intensity, posture, syncope impulse detection, respiratory rate, blood pressure, oxygen saturation (SpO 2 ), blood carbon dioxide level (pCO 2 ), glucose, lung wetness, and temperature; and

background information layered to or keyed with the R-R interval plot comprising one or more of activity amount, activity intensity, posture, syncope impulse detection, respiratory rate, blood pressure, oxygen saturation (SpO 2 ), blood carbon dioxide level (pCO 2 ), glucose, lung wetness, and temperature.

5. A system in accordance with claim 1 , wherein the display displays the R-R interval plot with one or more views of at least a portion of the ECG data as contextual data for the R-R interval plot.

6. A system in accordance with claim 1 , wherein each ECG data view comprises one of a near field view providing ECG data corresponding to the data for the R-wave peak pairs at a center of the R-R interval plot and an intermediate field view providing presentation of additional ECG data than the near field view.

7. A system in accordance with claim 1 , wherein the set of R-wave peaks is collected over a period of at least 40 minutes.

8. A system in accordance with claim 1 , the processor further configured to:

select the set of R-wave peaks by identifying a potential cardiac event within the ECG data and obtaining a portion of the ECG data corresponding to a time during, prior to, and after the potential cardiac event as the set of R-wave peaks.

9. A system in accordance with claim 8 , the processor further configured to:

represent the potential cardiac event in the R-R interval plot via a temporal point of reference.

10. A system in accordance with claim 9 , wherein the display displays the temporal point of reference in the R-R interval plot in one of a center and another location.

11. A method for facilitating a cardiac rhythm disorder diagnosis based on subcutaneous cardiac monitoring data, comprising:

recording cardiac action potentials of a patient over a set time period using a subcutaneous insertable cardiac monitor, the subcutaneous insertable cardiac monitor comprising an implantable housing for implantation within a living body, the implantable housing comprised of a biocompatible material, the subcutaneous insertable cardiac monitor further comprising at least one pair of electrocardiographic (ECG) sensing electrodes provided on a ventral surface and on opposite ends of the implantable housing operatively placed to facilitate sensing in closest proximity to low amplitude, low frequency content cardiac action potentials that are generated during atrial activation, the subcutaneous insertable cardiac monitor further comprising electronic circuitry provided within the housing assembly, the electronic circuitry comprising a low power microcontroller operable to execute under modular micro program control as specified in firmware, an ECG front end circuit interfaced to the microcontroller and configured to capture the cardiac action potentials sensed by the pair of ECG sensing electrodes which are output as ECG signals, and a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the ECG signals; and

retrieving the stored samples of the ECG signals as ECG data;

identifying a set of R-wave peaks within the ECG data;

constructing an R-R interval plot, comprising:

determining a difference between recording times of successive pairs of the R-wave peaks in the set;

determining a heart rate associated with each difference;

plotting the pairs of the R-wave peaks and associated heart rate as the R-R interval plot; and

accentuating in the R-R interval plot spatial differences in frequently-occurring ranges of the heart rate and de-emphasizing the spatial differences in ranges of the heart rate where a deviation from the frequently-occurring ranges exists using a non-linear scale for the heart rate; and

facilitating diagnosis of a cardiac disorder of the patient based on patterns of the plotted pairs of the R-wave peaks and the associated heart rates in the R-R interval plot.

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

forming a diagnosis based on heart rate variability patterns in the R-R interval plot.

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

detecting atrial fibrillation by identifying a Gaussian-type distribution of heart rate variability in the duration R-R interval plot.

14. A method in accordance with claim 11 , further comprising at least one of:

including a background information plot with the R-R interval plot comprising one or more of activity amount, activity intensity, posture, syncope impulse detection, respiratory rate, blood pressure, oxygen saturation (SpO 2 ), blood carbon dioxide level (pCO 2 ), glucose, lung wetness, and temperature; and

layering or keying background information with the R-R interval plot comprising one or more of activity amount, activity intensity, posture, syncope impulse detection, respiratory rate, blood pressure, oxygen saturation (SpO 2 ), blood carbon dioxide level (pCO 2 ), glucose, lung wetness, and temperature.

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

displaying the R-R interval plot with one or more views of at least a portion of the ECG data as contextual data for the R-R interval plot.

16. A method in accordance with claim 11 , wherein each ECG data view comprises one of a near field view providing ECG data corresponding to the data for the R-wave peak pairs at a center of the R-R interval plot and an intermediate field view providing presentation of additional ECG data than the near field view.

17. A method in accordance with claim 11 , wherein the set of R-wave peaks is collected over a period of at least 40 minutes.

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

selecting the set of R-wave peaks, comprising:

identifying a potential cardiac event within the ECG data; and

obtaining a portion of the ECG data corresponding to a time during, prior to, and after the potential cardiac event as the set of R-wave peaks.

19. A method in accordance with claim 18 , further comprising:

representing the potential cardiac event in the R-R interval plot via a temporal point of reference.

20. A method in accordance with claim 19 , further comprising:

displaying the temporal point of reference in the R-R interval plot in one of a center and another location.

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 Jun 6, 2019
From: BARDY, GUST H.; DREISBACH, EZRA M.
To: BARDY DIAGNOSTICS, INC.
Reel/Frame 049392/0488 →
Continuity (11)
Continuation In Part 16102608 · Aug 13, 2018
Continuation In Part 15832385 · Dec 5, 2017
Continuation 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
Provisional Application 62132497 · Mar 12, 2015
Provisional Application 61882403 · Sep 25, 2013
Related Publication 20190069794A1 · Mar 7, 2019
Cited By (15)
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