Methods and devices for accurately classifying cardiac activity

• US 9,763,619 B2
• Filed: 01/15/2016
• Issued: 09/19/2017
• Est. Priority Date: 05/07/2008
• Status: Expired due to Fees

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Warren, Jay A., Sanghera, Rick, Allavatam, Venugopal, Palreddy, Surekha
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US14/996,423
• Publication Number:
  US 20160128630A1
• Time in Patent Office: 613 Days
• 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 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/35 by template matching
• 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 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Methods, systems, and devices for signal analysis in an implanted cardiac monitoring and treatment device such as an implantable cardioverter defibrillator. In some examples, captured data including detected events is analyzed to identify likely overdetection of cardiac events. In some illustrative examples, when overdetection is identified, data may be modified to correct for overdetection, to reduce the impact of overdetection, or to ignore overdetected data. Several examples emphasize the use of morphology analysis using correlation to static templates and/or inter-event correlation analysis.

Claims

1. An implantable cardiac stimulus (ICS) system comprising:

a canister;

a plurality of electrodes exposed external to the canister configured for implantation in a patient;

operational circuitry disposed within the canister, operatively coupled to the plurality of electrodes, and configured to;

capture cardiac signals occurring within a patient using one or more of the plurality of electrodes;

detect electrical events in the captured cardiac signals;

identify an event representation for one of the detected electrical events;

compare the event representation to a template having a template fiducial point by identifying an event fiducial point of the event representation and aligning the template fiducial point and the event fiducial point to one another and calculating a first correlation between the event representation and the template when so aligned;

again compare the event representation to the template, this time by selecting a misalignment of the template fiducial point and the event fiducial point to yield a second correlation;

select a correlation result for the one of the detected electrical events from at least the first correlation or the second correlation whichever indicates greater correlation; and

use the correlation result to determine whether the patient has a cardiac condition which requires therapy; and

a power source disposed within the canister and configured to power the operational circuitry;

wherein the event fiducial point is a selected sample of the event representation, and the template fiducial point is a selected sample of the template.

2. The ICS of claim 1 wherein the operational circuitry is further configured to deliver therapy to the patient using the one or more of the plurality of electrode if, using the correlation result, the operational circuitry determines the patient has a cardiac condition that requires therapy.

3. The ICS of claim 1 wherein the operational circuitry is configured to use the correlation result to determine whether the patient has a cardiac condition which requires therapy by:

calculating a plurality of calculation results using respective first and second correlation results for a plurality of detected electrical events;

identifying likely inaccurate event detection;

determining that the correlation result is lower than other, similarly calculated correlation results; and

determining that the detected electrical event corresponding to the correlation result was an overdetection.

4. The ICS of claim 3 wherein the operational circuitry is configured to identify likely inaccurate event detection by observing whether the plurality of calculation results demonstrate a pattern indicating overdetection.

5. The ICS of claim 1 wherein the operational circuitry is configured to use the correlation result to determine whether the patient has a cardiac condition which requires therapy by comparing a series of correlation results to determine whether a monomorphic condition is occurring.

6. The ICS of claim 5 wherein the operational circuitry is configured to deliver anti-tachycardia pacing using one or more of the plurality of electrodes if a monomorphic condition is occurring.

7. The ICS of claim 5 wherein the operational circuitry includes defibrillation therapy circuitry including an H-Bridge output circuit, a capacitor and a charger, and wherein the operational circuitry is configured to delay a planned defibrillation therapy output if a monomorphic condition is occurring.

8. The ICS of claim 1 wherein the operational circuitry is configured to use the correlation result to determine whether the patient has a cardiac condition which requires therapy by comparing the correlation result to a threshold and, if the threshold is met, determining that the detected electrical event corresponding to the correlation result is not indicating a cardiac condition which requires therapy.

9. The ICS of claim 1 wherein the operational circuitry is further configured to again compare the event representation to the template by misaligning the event fiducial point from the template fiducial point and calculating a third correlation between the event representation and the template;

wherein the second correlation is calculated with the event fiducial point aligned one or more samples before the template fiducial point, and the third correlation is calculated with the event fiducial point aligned one or more samples after the template fiducial point.

10. The ICS of claim 1 wherein the plurality of electrodes comprises:

a first electrode disposed on the canister; and

at least two electrodes disposed on a lead configured for coupling to the canister.

11. A method of operation in an implantable cardiac device system comprising a canister housing operational circuitry and a plurality of electrodes exposed external to the canister and coupled to the operational circuitry, the method comprising:

capturing cardiac signals occurring within a patient using one or more of the plurality of electrodes;

detecting electrical events in the captured cardiac signals using the operational circuitry;

identifying an event representation for one of the detected electrical events using the operational circuitry;

comparing, using the operational circuitry, the event representation to a template having a template fiducial point by identifying an event fiducial point of the event representation and aligning the template fiducial point and the event fiducial point to one another and calculating a first correlation between the event representation and the template when so aligned;

again comparing, using the operational circuitry, the event representation to the template, this time by selecting a misalignment of the template fiducial point and the event fiducial point to yield a second correlation;

selecting, using the operational circuitry, a correlation result for the one of the detected electrical events from at least the first correlation or the second correlation whichever indicates greater correlation; and

using the correlation result to determine, using the operational circuitry, whether the patient has a cardiac condition which requires therapy;

wherein the event fiducial point is a selected sample of the event representation, and the template fiducial point is a selected sample of the template.

12. The method of claim 11 further comprising delivering therapy to the patient using the one or more of the plurality of electrode if, using the correlation result, it is determined that the patient has a cardiac condition that requires therapy.

13. The method of claim 11 in which the step of using the correlation result to determine whether the patient has a cardiac condition which requires therapy is performed by:

calculating a plurality of calculation results using respective first and second correlation results for a plurality of detected electrical events;

identifying likely inaccurate event detection;

determining that the correlation result is lower than other, similarly calculated correlation results; and

determining that the detected electrical event corresponding to the correlation result was an overdetection.

14. The method of claim 13 wherein the step of identifying likely inaccurate event detection by observing whether the plurality of calculation results demonstrate a pattern indicating overdetection.

15. The method of claim 11 wherein the step of using the correlation result to determine whether the patient has a cardiac condition which requires therapy is performed by comparing a series of correlation results to determine whether a monomorphic condition is occurring.

16. The method of claim 15 further comprising delivering anti-tachycardia pacing using the one or more of the plurality of electrodes if a monomorphic condition is occurring.

17. The method of claim 15 wherein the operational circuitry includes defibrillation therapy circuitry including an H-Bridge output circuit, a capacitor and a charger, and wherein the method includes delaying a planned defibrillation therapy output if a monomorphic condition is occurring.

18. The method of claim 11 wherein the step of using the correlation result to determine whether the patient has a cardiac condition which requires therapy is performed by comparing the correlation result to a threshold and, if the threshold is met, determining that the detected electrical event corresponding to the correlation result is not indicating a cardiac condition which requires therapy.

19. The method of claim 11 further comprising again comparing the event representation to the template by misaligning the event fiducial point from the template fiducial point and calculating a third correlation between the event representation and the template;

wherein the second correlation is calculated with the event fiducial point aligned one or more samples before the template fiducial point, and the third correlation is calculated with the event fiducial point aligned one or more samples after the template fiducial point, wherein the step of selecting from at least the first correlation or the second correlation whichever indicates greater correlation includes selecting the greatest of the first, second and third correlations.

20. The method of claim 11 wherein the plurality of electrodes comprises:

a first electrode disposed on the canister; and

at least two electrodes disposed on a lead configured for coupling to the canister.