Internet-based system for evaluating ECG waveforms to determine the presence of p-mitrale and p-pulmonale

• US 9,282,894 B2
• Filed: 10/08/2013
• Issued: 03/15/2016
• Est. Priority Date: 10/08/2012
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: OtoSense, Inc. (Analog Devices, Inc.)
• Inventors: Banet, Matthew, Dhillon, Marshal Singh, Pede, Susan Meeks, Terry, Andrew, Feld, Gregory Kent, Meza-Guinea, Adolfo
• Primary Examiner(s): LEVICKY, WILLIAM J
• Application Number:
  US14/048,701
• Publication Number:
  US 20140107511A1
• Time in Patent Office: 889 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/30 Input circuits therefor
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• 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 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

The present invention provides an improved, Internet-based system that seamlessly collects cardiovascular data from a patient before, during, and after a procedure for EP or an ID. During an EP procedure, the system collects information describing the patient'"'"'s response to PES and the ablation process, ECG waveforms and their various features, HR and other vital signs, HR variability, cardiac arrhythmias, patient demographics, and patient outcomes. Once these data are collected, the system stores them on an Internet-accessible computer system that can deploy a collection of user-selected and custom-developed algorithms. Before and after the procedure, the system also integrates with body-worn and/or programmers that interrogate implanted devices to collect similar data while the patient is either ambulatory, or in a clinic associated with the hospital. A data-collection/storage module, featuring database interface, stores physiological and procedural information measured from the patient.

Claims

1. A system for determining a presence of p-mitrale and p-pulmonale in a test patient'"'"'s heart, comprising:

an electrocardiogram (ECG)-measuring system configured to measure an ECG waveform from a test patient; and

a computer system comprising

a database stored on a non-transitory storage medium operably linked to the computer system, the database comprising a set of data fields wherein each data field in the set corresponds to an individual comparison patient in a plurality of comparison patients and wherein each data field comprises an ECG waveform obtained from the individual comparison patient and a parameter indicating the presence of p-mitrale and p-pulmonale in the individual comparison patient'"'"'s heart, wherein the database is operably connected to the ECG-measuring system to receive the test patient'"'"'s ECG waveform and store the test patient'"'"'s ECG waveform in a data field corresponding to the test patient,

an ECG-analysis software system configured to

(i) receive the ECG waveforms from the database corresponding to each individual comparison patient in the plurality of comparison patients and to process the ECG waveform in each data field to extract a set of parameters from an individual comparison patient'"'"'s ECG waveform,

(ii) correlate the set of parameters to the presence of p-mitrale and p-pulmonale in the individual comparison patient,

(iii) processes multiple data fields to determine an average correlation factor mapping the set of parameters from each individual comparison patient'"'"'s ECG waveform to the parameter indicating the presence of p-mitrale and p-pulmonale in each individual comparison patient'"'"'s heart, and

(iv) evaluate the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart by extracting a new set of parameters from the test patient'"'"'s ECG waveform, and then comparing the new set of parameters to the average correlation factor to estimate a new parameter indicating the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart.

2. The system of claim 1, wherein the ECG-analysis software system is further configured to process the test patient'"'"'s ECG waveform to determine the temporal location of at least one of the following parameters:

P wave, Q wave, R wave, S wave, T wave, and U wave.

3. The system of claim 2, wherein the ECG-analysis software system is further configured to determine at least one of the following parameters from the P wave, Q wave, R wave, S wave, T wave, and U wave:

PR interval, ST segment, PR segment, QRS interval, and QT interval.

4. The system of claim 1, wherein the ECG-analysis software system is further configured to process the test patient'"'"'s ECG waveform to determine the magnitude of at least one of the following parameters:

P wave, Q wave, R wave, S wave, T wave, and U wave.

5. The system of claim 3, wherein the average correlation factor correlates a width of the P wave to the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart.

6. The system of claim 5, wherein the ECG-analysis software system is further configured to determine the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart when the width of the P wave exceeds a pre-determined value.

7. The system of claim 6, wherein the pre-determined value is about 50 ms.

8. The system of claim 5, wherein the ECG-analysis software system is further configured to determine the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart when the P wave has an amplitude that exceeds a pre-determined value.

9. The system of claim 8, wherein the pre-determined value is more than about 10% of an amplitude of a QRS complex measured from the ECG waveform corresponding to the test patient.

10. The system of claim 1, wherein the computer system is an Internet-accessible system.

11. The system of claim 10, wherein the Internet-accessible system further comprises a graphical user interface (GUI).

12. The system of claim 11, wherein the GUI comprises a webpage that displays the parameter indicating the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart.

13. The system of claim 1, wherein the ECG-measuring system comprises an ECG circuit configured to be worn on the patient'"'"'s body, and a transmitting circuit configured to transmit a numerical representation of the ECG waveform to the database.

14. The system of claim 13, wherein the transmitting circuit is configured to transmit the numerical representation of the ECG waveform to an Ethernet port, which then transmits the numerical representation of the ECG waveform to an Internet Protocol (IP) address associated with the database.

15. The system of claim 13, wherein the transmitting circuit is configured to transmit the numerical representation of the ECG waveform to a mobile device, which then transmits the numerical representation of the ECG waveform to an IP address associated with the database.

19. The system of claim 5, wherein the computer system is further configured to determine the presence of blockage of an artery feeding the test patient'"'"'s heart when the PR interval has a temporal variation that exceeds a pre-determined value.

20. The system of claim 19, wherein the pre-determined value is about 25%.

16. A system for evaluating a presence of p-mitrale and p-pulmonale in a test patient'"'"'s heart, comprising:

an electrocardiogram (ECG)-measuring system configured to measure an ECG waveform from a test patient; and

a computer system comprising

a database stored on a non-transitory storage medium operably linked to the computer system, the database comprising a set of data fields wherein each data field in the set corresponds to an individual comparison patient in a plurality of comparison patients and wherein each data field comprises a value of a width of a P wave extracted from an ECG waveform obtained from the individual comparison patient and a parameter indicating the presence of p-mitrale and p-pulmonale in the individual comparison patient'"'"'s heart;

an ECG-analysis software system configured to

(i) processes multiple data fields, with each data field corresponding to an individual comparison patient and to determine an average correlation factor mapping the value of the width of the P wave from each individual comparison patient to the parameter indicating the presence of p-mitrale and p-pulmonale in each individual comparison patient'"'"'s heart, and

(ii) evaluate the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart by extracting a new width of the P wave from the ECG waveform measured by the ECG-measuring system, and then comparing the new width of the P wave to the average correlation factor to estimate a new parameter indicating the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart.

17. The system of claim 16, wherein the computer system is further configured to determine the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart when the width of the P wave exceeds a pre-determined value.

18. The system of claim 17, wherein the pre-determined value is about 50 ms.

21. A system for evaluating a presence of p-mitrale and p-pulmonale in a test patient'"'"'s heart, comprising:

an electrocardiogram (ECG)-measuring system configured to measure an ECG waveform from a test patient; and

a computer system comprising

a database stored on a non-transitory storage medium operably linked to the computer system, the database comprising a set of data fields wherein each data field in the set corresponds to an individual comparison patient in a plurality of comparison patients and wherein each data field comprises a value of an amplitude of a P wave extracted from an Electrocardiogram (ECG) waveform obtained from the individual comparison patient and a parameter indicating the presence of p-mitrale and p-pulmonale in the individual comparison patient'"'"'s heart;

an ECG-analysis software system configured to

(i) processes multiple data fields, with each data field corresponding to an individual comparison patient and to determine an average correlation factor mapping the value of the amplitude of the P wave from each individual comparison patient to the parameter indicating the presence of p-mitrale and p-pulmonale in each individual comparison patient'"'"'s heart, and;

(ii) evaluate the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart by extracting a new amplitude of the P wave from the ECG waveform measured by the ECG-measuring system, and then comparing the new amplitude of the P wave to the average correlation factor to estimate a new parameter indicating the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart.

22. The system of claim 21, wherein the computer system is further configured to determine the presence of p-mitrale and p-pulmonale in the test patient'"'"'s heart when the amplitude of the P wave exceeds a pre-determined value.

23. The system of claim 22, wherein the pre-determined value is about 10% of an amplitude of QRS complex extracted from the ECG waveform.