System and method for composite display of subcutaneous cardiac monitoring data

• US 10,813,567 B2
• Filed: 10/07/2019
• Issued: 10/27/2020
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Bardy, Gust H., Dreisbach, Ezra M.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US16/595,226
• Publication Number:
  US 20200029847A1
• Time in Patent Office: 386 Days
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7203 : for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence

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

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.