IP Library Granted Patent US 10,813,567
Granted Patent B2
US 10,813,567 · App. 16/595,226 · Granted Oct 27, 2020

System and method for composite display of 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
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 10,813,567
App. No.
16/595,226
Granted
Oct 27, 2020
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 (45)

1. A system for composite display of subcutaneous cardiac monitoring data, comprising:

a subcutaneous insertable cardiac monitor, comprising:

an implantable housing for implantation within a living body;

at least one pair of electrocardiographic (ECG) sensing electrodes provided 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, a wireless transceiver configured to wirelessly couple with a download station, and a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the ECG signals as ECG data;

the download station adapted to retrieve the ECG data from the memory via the wireless transceiver; and

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 recorded by the subcutaneous insertable cardiac monitor from the download station;

identify a plurality of R-wave peaks in the ECG data;

calculate a difference between recording times of successive pairs of the R-wave peak as R-R intervals and determine a heart rate associated with each time difference;

form an R-R interval plot of the ECG data comprising the R-R intervals plotted along an x-axis of the plot and the heart rates associated with the R-R intervals plotted along a y-axis of the plot; and

generate a diagnostic composite plot comprising the R-R interval plot, a near field view of a portion of the ECG data, and an intermediate field view of a different portion of the ECG data for diagnosis of a cardiac event.

2. A system in accordance with Claim 1 , the subcutaneous cardiac monitor further comprising a wireless antenna interfaced to the wireless transceiver.

3. A system in accordance with Claim 1 , wherein the download station is configured to inductively couple with the subcutaneous insertable cardiac monitor.

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

interpret heart rate variability patterns in the diagnostic composite plot; and

form a diagnosis of a cardiac rhythm disorder.

5. A system in accordance with claim 4 , further comprising:

a cardiac rhythm therapy delivery device programmed to treat the diagnosed cardiac rhythm disorder.

6. A system in accordance with claim 4 , wherein the cardiac condition is selected from a group comprising one or more of: sinus bradycardia; sinus tachycardia; premature atrial and ventricular beats; ectopic atrial tachycardia; atrial fibrillation; atrial flutter; atrial or ventricular bigeminy, trigemny, or quadrigeminy; fusion beats; interpolated ventricular premature beats; intraventricular conduction beats; junctional rhythm; AV-nodal re-entrant tachycardia; AV re-entrant tachycardia; Wolff-Parkinson-White syndrome and pre-excitation; ventricular tachycardia; accelerated idioventricular rhythm; AV Wenckebach block; AV type II block ; Sinoatrial block.

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

filter out noise from the R-R interval plot; and

display on a display the R-R interval plot following the filtering.

8. A system in accordance with claim 1 , the processor further configured to apply one or more of a low-pass filter, a high-pass filter, and automatic gain control to the R-R interval plot.

9. A method for composite display of subcutaneous cardiac monitoring data, comprising:

recording cardiac action potentials of a patient over a set time period by a subcutaneous insertable cardiac monitor that comprises an implantable housing for implantation within a living body, at least one pair of electrocardiographic (ECG) sensing electrodes provided 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, a wireless transceiver configured to wirelessly couple with a download station, and a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the ECG signals as ECG data;

retrieving by the download station the ECG data from the memory via the wireless transceiver;

receiving by a computer, the computer comprising a processor and memory within which code for execution by the processor is stored, the ECG data recorded by the subcutaneous insertable cardiac; monitor from the download station;

identifying by the computer a plurality of R-wave peaks in the ECG data;

calculating by the computer a difference between recording times of successive pairs of the R-wave peak as R-R intervals and determining by the computer a heart rate associated with each time difference;

forming by the computer an R-R interval plot of the ECG data comprising the R-R intervals plotted along an x-axis of the plot and the heart rates associated with the R-R intervals plotted along a y-axis of the plot; and

generating by the computer a diagnostic composite plot comprising the R-R interval plot, a near field view of a portion of the ECG data, and an intermediate field view of a different portion of the ECG data for diagnosis of a cardiac event.

10. A method in accordance with Claim 9 , wherein the subcutaneous cardiac monitor further comprises a wireless antenna interfaced to the wireless transceiver.

11. A method in accordance with Claim 9 , wherein the download station is configured to inductively couple with the subcutaneous insertable cardiac monitor.

12. A method in accordance with claim 9 , further comprising:

interpreting by the computer heart rate variability patterns in the diagnostic composite plot; and

forming by the computer a diagnosis of a cardiac rhythm disorder.

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

programming a cardiac rhythm therapy delivery device to treat the diagnosed cardiac rhythm disorder.

14. A method in accordance with claim 12 , wherein the cardiac condition is selected from a group comprising one or more of: sinus bradycardia; sinus tachycardia; premature atrial and ventricular beats; ectopic atrial tachycardia; atrial fibrillation; atrial flutter; atrial or ventricular bigeminy, trigemny, or quadrigeminy; fusion beats; interpolated ventricular premature beats;

intraventricular conduction beats; junctional rhythm; AV-nodal re-entrant tachycardia; AV re-entrant tachycardia; Wolff-Parkinson-White syndrome and pre-excitation; ventricular tachycardia; accelerated idioventricular rhythm; AV Wenckebach block; AV type II block ; Sinoatrial block.

15. A method in accordance with claim 9 , further comprising:

filtering out by the computer noise from the R-R interval plot; and

displaying by the computer on a display the R-R interval plot following the filtering.

16. A method in accordance with claim 9 , the processor further configured to apply one or more of a low-pass filter, a high-pass filter, and automatic gain control to the R-R interval plot.

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 (13)
Continuation 16178463 · Nov 1, 2018
Continuation In Part 16102608 · Aug 13, 2018
Continuation In Part 16595226
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 20200029847A1 · Jan 30, 2020