IP Library Granted Patent US 11,653,870
Granted Patent B2
US 11,653,870 · App. 17/944,899 · Granted May 23, 2023

System and method for display of subcutaneous cardiac monitoring data

Inventors: Gust H. Bardy (Carnation, WA); Ezra M. Dreisbach (Vashon, WA)
Assignee: BARDY DIAGNOSTICS, INC.
A61B5/352A61B5/0245A61B5/02405A61B5/259A61B5/282A61B5/287A61B5/333A61B5/339A61B5/35A61B5/686A61B5/6823A61B5/7203A61B5/0205A61B5/02055A61B5/316A61B5/341A61B5/361A61B5/363A61B5/364A61B5/742A61B2560/0468A61B2562/162
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Quick Facts
Patent No.
US 11,653,870
App. No.
17/944,899
Granted
May 23, 2023
Kind
B2
Abstract

A system and method for display of subcutaneous cardiac monitoring data are provided. Cutaneous action potentials of a patient and other sensed data associated with the 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, the associated heart rates in the R-R interval plot, and background data based on the other sensed data.

Claims (34)

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

a subcutaneous insertable cardiac monitor, comprising:

an implantable housing for implantation within a patient;

a plurality of electrocardiographic (ECG) sensing electrodes;

at least one sensor interfaced to a micro-controller and configured to sense data associated with the patient; and

electronic circuitry provided within the housing comprising the 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 plurality of ECG sensing electrodes which are output as ECG signals, and a memory electrically interfaced with the microcontroller and operable to continuously store samples of the ECG signals as ECG data and the sensor data; 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 and the sensor data recorded by the subcutaneous insertable cardiac monitor;

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

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

generate a diagnostic composite plot using the R-R intervals, the heart rates, and the sensor data, the plot comprising a plurality of views, wherein at least some of the views are associated with at least a portion of the ECG data, and wherein at least one of the views is based on the sensor data.

2. A system according to claim 1 , wherein the at least one sensor comprises one or more of an actigraphy sensor, an SpO 2 sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an airflow sensor, and volumetric pressure sensing sensor.

3. A system according to claim 2 , wherein the sensor data comprises 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, and temperature.

4. A system according to claim 1 , wherein one of the views associated with at least the portion of the ECG data comprises a plot of the R-R intervals.

5. A system according to claim 1 , wherein at least three of the views are temporarily keyed to each other and a change in centering of one of the views changes centering of remaining of the three views.

6. A system according to claim 1 , the system further comprising:

a wireless transceiver comprises in the electronic circuitry;

an external feedback device configured to wirelessly interface with the subcutaneous cardiac monitoring device via the wireless transceiver.

7. A system according to claim 6 , the system further comprising:

an external buzzer wirelessly interfaced to the micro-controller and configured to output feedback to the patient.

8. A system according to claim 7 , wherein the buzzer is comprised within the external feedback device.

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

recording cardiac action potentials of a patient over a time period by a subcutaneous insertable cardiac monitor, the subcutaneous insertable cardiac monitor comprising an implantable housing for implantation within the patient, a plurality of electrocardiographic (ECG) sensing electrodes provided on the implantable housing, at least one sensor interfaced to a micro-controller and configured to sense data associated with the patient, electronic circuitry provided within the housing comprising the 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 memory electrically interfaced with the microcontroller and operable to continuously store samples of the ECG signals as ECG data and the sensor data;

receiving by a computer the ECG data and the sensor data recorded by the subcutaneous insertable cardiac monitor;

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 peaks as R-R intervals and determining by the computer a heart rate associated with each time difference;

generating by the computer a diagnostic composite plot using the R-R intervals, the heart rates, and the sensor data, the plot comprising a plurality of views, wherein at least some of the views are associated with at least a portion of the ECG data, and wherein at least one of the views is based on the sensor data.

10. A method according to claim 9 , wherein the at least one sensor comprises one or more of an actigraphy sensor, an SpO 2 sensor, a blood pressure sensor, a temperature sensor, a respiratory rate sensor, a glucose sensor, an airflow sensor, and volumetric pressure sensing sensor.

11. A method according to claim 10 , wherein the sensor data comprises 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, and temperature.

12. A method according to claim 9 , wherein one of the views associated with at least the portion of the ECG data comprises a plot of the R-R intervals.

13. A method according to claim 9 , wherein at least three of the views are temporarily keyed to each other and a change in centering of one of the views changes centering of remaining of the three views.

14. A method according to claim 9 , wherein the electronic circuitry further comprises a wireless transceiver comprises configured to wirelessly interface to an external feedback device.

15. A method according to claim 14 , wherein the micro-controller is wirelessly interfaced to an external buzzer and configured to output feedback to the patient via the patient.

16. A method according to claim 15 , wherein the buzzer is comprised within the external feedback device.

Continuity (14)
Continuation 17080757 · Oct 26, 2020
Continuation 16595226 · Oct 7, 2019
Continuation 16178463 · Nov 1, 2018
Continuation In Part 16102608 · Aug 13, 2018
Continuation In Part 15832385 · Dec 5, 2017
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
Provisional Application 62132497 · Mar 12, 2015
Provisional Application 61882403 · Sep 25, 2013
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