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

• US 10,433,751 B2
• Filed: 11/01/2018
• Issued: 10/08/2019
• 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:
  US16/178,463
• Publication Number:
  US 20190069794A1
• Time in Patent Office: 341 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 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 (SpO₂), blood carbon dioxide level (pCO₂), 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 (SpO₂), blood carbon dioxide level (pCO₂), 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 (SpO₂), blood carbon dioxide level (pCO₂), 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 (SpO₂), blood carbon dioxide level (pCO₂), 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.