Methods and devices for accurately classifying cardiac activity

• US 9,878,172 B2
• Filed: 04/26/2016
• Issued: 01/30/2018
• Est. Priority Date: 03/07/2008
• Status: Active Grant

• Current Assignee: Cameron Incorporated (Schlumberger NV)
• Original Assignee: Cameron Incorporated (Schlumberger NV)
• Inventors: Allavatam, Venugopal, Palreddy, Surekha, Sanghera, Rick, Warren, Jay A.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US15/138,623
• Publication Number:
  US 20160236001A1
• Time in Patent Office: 644 Days
• 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 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61N 1/3704 Circuits specially adapted therefor, e.g. for sensitivity control
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Methods, systems, and devices for signal analysis in an implanted cardiac monitoring and treatment device such as an implantable cardioverter defibrillator. In illustrative 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. New methods for organizing the use of morphology and rate analysis in an overall architecture for rhythm classification and cardiac signal analysis are also discussed.

Claims

1. A method of cardiac signal analysis in an implantable medical device (IMD), the IMD including a number of implantable electrodes and operational circuitry for analyzing signals obtained via the implantable electrodes, the IMD further comprising a therapy delivery capacitor and a charging circuit associated with the therapy delivery capacitor, the charging circuit configured to selectively charge the therapy delivery capacitor to prepare for delivery of cardiac cardioversion or defibrillation therapy when enabled by the operational circuitry, the method comprising:

the operational circuitry detecting a set of events in a signal including detecting a plurality of cardiac cycles;

the operational circuitry analyzing the set of events to determine whether any of the set of events meets criteria for likely overdetection and applying flags to each event of a subset of the events which meet criteria for likely overdetection;

the operational circuitry generating a corrected interval for each event in the subset of events, wherein the corrected interval includes an interval preceding an event from the subset of events combined with an interval following the event;

the operational circuitry determining that a cardiac arrhythmia is likely occurring using at least one corrected interval; and

the operational circuitry, in response to determining that the cardiac arrhythmia is likely occurring, performing a charge confirmation analysis comprising analyzing a pattern of flags within the set of events to determine whether therapy should be delivered.

2. The method of claim 1, wherein:

in response to the charge confirmation analysis being satisfied, the operational circuitry is configured to enable the charging circuit; and

in response to the charge confirmation analysis not being satisfied, the operational circuitry is configured to detect an additional event and again perform the steps of determining whether a cardiac arrhythmia is likely occurring and, in response to determining that a cardiac arrhythmia is likely occurring, performing the charge confirmation analysis on a new set of detected events including the additional detected event.

3. The method of claim 1, wherein the charge confirmation analysis further comprises determining whether at least a first threshold quantity of the set of events in have the flags and in response to the set of events not having the first threshold quantity of flags, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy.

4. The method of claim 3, wherein the step of analyzing a pattern of flags comprises:

determining whether at least a second threshold quantity of set of events in the have the flags;

in response to the set of events having at least the second threshold quantity, determining whether a tolerance variable exceeds a tolerance threshold and;

in response to the tolerance variable meeting the tolerance threshold, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy; and

in response to the tolerance variable not meeting the tolerance threshold, incrementing the tolerance variable and finding the charge confirmation analysis is not satisfied.

5. The method of claim 1, wherein the step of analyzing a pattern of flags comprises:

determining whether at least a threshold quantity of the set of events in the have the flag;

in response to the set of events having at least the threshold quantity of flags, determining whether a tolerance variable exceeds a tolerance threshold and;

in response to the tolerance variable meeting the tolerance threshold, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy; and

in response to the tolerance variable not meeting the tolerance threshold, incrementing the tolerance variable and finding the charge confirmation analysis is not satisfied.

6. The method of claim 5, wherein the step of analyzing a pattern of flags comprises, in response to set of events not having at least the threshold quantity, determining whether alternating ones of the set of events are marked with the flags and, in response to determining the alternating ones of the set of events are marked with the flags, resetting the tolerance variable and finding that the charge confirmation analysis is not satisfied.

7. The method of claim 5, wherein the step of analyzing a pattern of flags comprises:

observing, within the set of events, whether pairs of events show an alternating pattern in which a first occurring of a pair of events from the pairs of events is not marked with a flag, and a second occurring of the pair is marked with a flag and, in response, finding that the pair is an alternating pair; and

determining whether a threshold quantity of alternating pairs occur within the set of events and, in response to determining the threshold quantity of alternating pairs occurs, resetting the tolerance variable and, in response to determining that the threshold quantity of alternating pairs does not occur, determining whether the tolerance variable meets the tolerance threshold and;

in response to the tolerance variable meeting the tolerance threshold, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy; and

in response to the tolerance variable not meeting the tolerance threshold, incrementing the tolerance variable and finding the charge confirmation analysis is not satisfied.

8. An implantable cardiac stimulus device (ICSD) comprising electrodes for capturing data from a recipient of the ICSD and operational circuitry coupled to the electrodes to analyze signals captured from the recipient, the ICSD also comprising a therapy delivery capacitor and a charging circuit associated with the therapy delivery capacitor, the charging circuit configured to selectively charge the therapy delivery capacitor to prepare for delivery of cardiac cardioversion or defibrillation therapy when enabled by the operational circuitry, wherein the operational circuitry is configured to perform the following:

detecting events in a signal captured from the electrodes, including detecting a plurality of cardiac cycles;

analyzing the detected events to determine whether overdetection is likely occurring and applying a flag to detected events which meet criteria for likely overdetection;

determining that a cardiac arrhythmia is likely occurring;

in response to determining that the cardiac arrhythmia is likely occurring, performing a charge confirmation analysis comprising analyzing any flags applied to the detected events to identify a pattern of flags, wherein the operational circuitry is configured to withhold charging in response to identifying a pre-specified pattern of flags; and

enabling the charging circuit if the charge confirmation analysis is satisfied;

or

detecting an additional event if the charge confirmation analysis is not satisfied and again performing the steps of determining whether a cardiac arrhythmia is likely occurring and, if so, performing the charge confirmation analysis on a new set of detected events including the additional detected event.

9. The ICSD of claim 8, wherein the operational circuitry is further configured such that analyzing any flags applied to the detected events to identify a pattern of flags comprises determining whether at least a first threshold quantity of detected events in a set of detected events have the flag and if not, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy.

10. The ICSD of claim 9, wherein the operational circuitry is further configured such that the step of analyzing any flags applied to the detected events to identify a pattern of flags comprises:

determining whether at least a second threshold quantity of detected events in the set of detected events have the flag;

if at least the second threshold quantity is found, determining whether a tolerance variable exceeds a tolerance threshold and;

if the tolerance variable meets the tolerance threshold, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy;

or

if the tolerance variable does not meet the tolerance threshold, incrementing the tolerance variable and finding the charge confirmation analysis is not satisfied.

11. The ICSD of claim 8, wherein the operational circuitry is further configured such that the step of analyzing any flags applied to the detected events to identify a pattern of flags comprises:

determining whether at least a threshold quantity of detected events in the set of detected events have the flag;

if at least the threshold quantity is found, determining whether a tolerance variable exceeds a tolerance threshold and;

if the tolerance variable meets the tolerance threshold, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy;

or

if the tolerance variable does not meet the tolerance threshold, incrementing the tolerance variable and finding the charge confirmation analysis is not satisfied.

12. The ICSD of claim 11, wherein the operational circuitry is further configured such that the step of analyzing any flags applied to the detected events to identify a pattern of flags comprises, if the threshold quantity is not found, determining whether alternating ones of the detected events are marked with the flags and, if so, resetting the tolerance variable and finding that the charge confirmation analysis is not satisfied.

13. The ICSD of claim 11, wherein the operational circuitry is further configured such that the step of analyzing any flags applied to the detected events to identify a pattern of flags comprises:

observing, within the set of detected events, whether pairs of detected events show an alternating pattern in which a first occurring of a pair of detected events is not marked with a flag, and a second occurring of the pair is marked with a flag and, if so, finding that the pair is an alternating pair; and

determining whether a threshold quantity of alternating pairs occur within the set of detected events and, if so, resetting the tolerance variable or, if not, determining whether the tolerance variable meets a tolerance threshold and;

if the tolerance variable meets the tolerance threshold, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy;

or

if the tolerance variable does not meet the tolerance threshold, incrementing the tolerance variable and finding the charge confirmation analysis is not satisfied.

14. An implantable cardiac stimulus device (ICSD) comprising a canister housing operational circuitry, the canister configured for coupling to a lead having one or more electrodes, the operational circuitry configured to receive a signal from a plurality of electrodes when a lead is coupled to the canister, the ICSD also comprising a therapy delivery capacitor and a charging circuit associated with the therapy delivery capacitor, the charging circuit configured to selectively charge the therapy delivery capacitor to prepare for delivery of cardiac cardioversion or defibrillation therapy when enabled by the operational circuitry, wherein the operational circuitry is configured to perform the following:

detecting events in a signal captured from the electrodes, including detecting a plurality of cardiac cycles;

analyzing the detected events to determine whether overdetection is likely occurring and applying a flag to detected events which meet criteria for likely overdetection;

determining that a cardiac arrhythmia is likely occurring;

in response to determining that the cardiac arrhythmia is likely occurring, performing a charge confirmation analysis comprising analyzing any flags applied to the detected events to identify a pattern of the flags within a set of detected events to determine whether therapy should be delivered, wherein the operational circuitry is configured to withhold charging in response to identifying a pre-specified pattern of flags; and

enabling the charging circuit if the charge confirmation analysis is satisfied;

or

detecting an additional event if the charge confirmation analysis is not satisfied and again performing the steps of determining whether a cardiac arrhythmia is likely occurring and, if so, performing the charge confirmation analysis on a new set of detected events including the additional detected event.

15. The ICSD of claim 14, wherein the operational circuitry is further configured such that analyzing any flags applied to the detected events to identify a pattern of flags comprises determining whether at least a first threshold quantity of detected events in a set of detected events have the flag and if not, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy.

16. The ICSD of claim 14, wherein the operational circuitry is further configured such that the step of analyzing any flags applied to the detected events to identify a pattern of flags comprises:

determining whether at least a threshold quantity of detected events in the set of detected events have the flag;

if at least the threshold quantity is found, determining whether a tolerance variable exceeds a tolerance threshold and;

if the tolerance variable meets the tolerance threshold, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy;

or

if the tolerance variable does not meet the tolerance threshold, incrementing the tolerance variable and finding the charge confirmation analysis is not satisfied.

17. The ICSD of claim 16, wherein the operational circuitry is further configured such that the step of analyzing any flags applied to the detected events to identify a pattern of flags comprises, if the threshold quantity is not found, determining whether alternating ones of the detected events are marked with the flags and, if so, resetting the tolerance variable and finding that the charge confirmation analysis is not satisfied.

18. The ICSD of claim 16, wherein the operational circuitry is further configured such that the step of analyzing any flags applied to the detected events to identify a pattern of flags comprises:

observing, within the set of detected events, whether pairs of detected events show an alternating pattern in which a first occurring of a pair of detected events is not marked with a flag, and a second occurring of the pair is marked with a flag and, if so, finding that the pair is an alternating pair; and

determining whether a threshold quantity of alternating pairs occur within the set of detected events and, if so, resetting the tolerance variable or, if not, determining whether the tolerance variable meets the tolerance threshold and;

if the tolerance variable meets the tolerance threshold, finding the charge confirmation analysis to be satisfied and initiating charging for delivery of therapy;

or

if the tolerance variable does not meet the tolerance threshold, incrementing the tolerance variable and finding the charge confirmation analysis is not satisfied.