Methods and devices for accurately classifying cardiac activity

• US 8,929,977 B2
• Filed: 12/04/2013
• Issued: 01/06/2015
• 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:
  US14/096,285
• Publication Number:
  US 20140094868A1
• Time in Patent Office: 398 Days
• Field of Search: 600/516
• US Class Current: 600/516
• 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. An implantable cardiac stimulus device (ICSD) comprising a canister housing operational circuitry and a lead electrode assembly including a plurality of electrodes disposed thereon, with the lead electrode assembly configured to couple to the canister to electrically couple the operational circuitry to the electrodes on the lead electrode assembly, the operational circuitry being configured to perform a method of cardiac signal analysis comprising:

the operational circuitry detecting a series of events;

the operational circuitry identifying intervals between consecutive detected events;

the operational circuitry using morphology analysis to identify overdetections from the series of events;

whenever an overdetection is identified, the operational circuitry combining an interval preceding the overdetection and an interval following the overdetection to form a combined interval;

following the morphology analysis to identify overdetections, the operational circuitry certifying combined intervals and intervals that are not adjacent to overdetections;

the operational circuitry estimating a cardiac rate using only certified intervals; and

the operational circuitry using the estimated cardiac rate to make therapy decisions.

2. The ICSD of claim 1 wherein the operational circuitry is further configured to perform a step of waveform appraisal including determining whether individual detected events are noisy, and wherein the step of identifying intervals between consecutive detected events in the series of events comprises identifying only intervals between individual detected events that are not noisy as determined in the waveform appraisal step.

3. The ICSD of claim 1 wherein the operational circuitry is further configured such that each detected event is affiliated with a sample window composed of a number of signal amplitude samples and the morphology analysis includes Wide Complex Analysis in which an overdetection is identified when first and second detected events are separated by an interval that is shorter than a predetermined Wide Complex threshold interval and at least one of the following conditions is identified:

the first and second detected events are of opposing polarity;

or

a Peak interval for the first and second detected events is less than a predetermined threshold, wherein the Peak interval is defined as the lesser of;

a) an interval between the maximum amplitude sample of the first detected event and the maximum amplitude sample of the second detected event, and

b) an interval between the minimum amplitude sample of the first detected event and the minimum amplitude sample of the second detected event;

such that, if the Wide Complex analysis is satisfied, one of the first and second events is marked as an overdetection.

4. The ICSD of claim 3 wherein, if the Wide Complex analysis is satisfied, then the operational circuitry is configured such that:

if a morphology template exists for the ICSD, whichever of the first and second detected events shows lesser correlation to the morphology template is marked as the overdetection;

or

if no morphology template exists for the ICSD, the later in time of the first and second detected events is marked as the overdetection.

5. The ICSD of claim 3 wherein the operational circuitry is further configured such that the morphology analysis also includes a template morphology analysis in which:

detected events are compared to a morphology template to generate correlation scores;

a series of correlation scores are characterized as High or Low;

High-Low-High patterns are identified as indicating overdetection; and

if a High-Low-High pattern is identified, the detected event having the Low correlation score is identified as an overdetection.

6. The ICSD of claim 1 wherein the operational circuitry is further configured such that the morphology analysis includes a template morphology analysis in which:

detected events are compared to a morphology template to generate correlation scores;

a series of correlation scores are characterized as High or Low;

High-Low-High patterns are identified as indicating overdetection; and

if a High-Low-High pattern is identified, the detected event having the Low correlation score is identified as an overdetection.

7. An implantable device comprising a canister housing operational circuitry configured for use in an implantable cardiac stimulus system, the canister being configured to couple to a lead electrode assembly including a plurality of electrodes disposed thereon to electrically couple the operational circuitry to the electrodes on the lead electrode assembly, the operational circuitry being configured to perform a method of cardiac signal analysis comprising:

the operational circuitry detecting a series of events using a signal received from at least one electrode of the lead electrode assembly when electrically coupled thereto;

the operational circuitry identifying intervals between consecutive detected events;

the operational circuitry using morphology analysis to identify overdetections from the series of events;

whenever an overdetection is identified, the operational circuitry combining an interval preceding the overdetection and an interval following the overdetection to form a combined interval;

following the morphology analysis to identify overdetections, the operational circuitry certifying combined intervals and intervals that are not adjacent to overdetections;

the operational circuitry estimating a cardiac rate using only certified intervals; and

the operational circuitry using the estimated cardiac rate to make therapy decisions.

8. The implantable device of claim 7 wherein the operational circuitry is further configured to perform a step of waveform appraisal including determining whether individual detected events are noisy, and wherein the step of identifying intervals between consecutive detected events in the series of events comprises identifying only intervals between individual detected events that are not noisy as determined in the waveform appraisal step.

9. The implantable device of claim 7 wherein the operational circuitry is further configured such that each detected event is affiliated with a sample window composed of a number of signal amplitude samples and the morphology analysis includes Wide Complex Analysis in which an overdetection is identified when first and second detected events are separated by an interval that is shorter than a predetermined Wide Complex threshold interval and at least one of the following conditions is identified:

the first and second detected events are of opposing polarity;

or

a Peak interval for the first and second detected events is less than a predetermined threshold, wherein the Peak interval is defined as the lesser of;

a) an interval between the maximum amplitude sample of the first detected event and the maximum amplitude sample of the second detected event, and

b) an interval between the minimum amplitude sample of the first detected event and the minimum amplitude sample of the second detected event;

such that, if the Wide Complex analysis is satisfied, one of the first and second events is marked as an overdetection.

10. The implantable device of claim 9 wherein, if the Wide Complex analysis is satisfied, then the operational circuitry is configured such that:

if a morphology template exists for the ICSD, whichever of the first and second detected events shows lesser correlation to the morphology template is marked as the overdetection;

or

if no morphology template exists for the ICSD, the later in time of the first and second detected events is marked as the overdetection.

11. The implantable device of claim 9 wherein the operational circuitry is further configured such that the morphology analysis also includes a template morphology analysis in which:

detected events are compared to a morphology template to generate correlation scores;

a series of correlation scores are characterized as High or Low;

High-Low-High patterns are identified as indicating overdetection; and

if a High-Low-High pattern is identified, the detected event having the Low correlation score is identified as an overdetection.

12. The implantable device of claim 7 wherein the operational circuitry is further configured such that the morphology analysis includes a template morphology analysis in which:

detected events are compared to a morphology template to generate correlation scores;

a series of correlation scores are characterized as High or Low;

High-Low-High patterns are identified as indicating overdetection; and

if a High-Low-High pattern is identified, the detected event having the Low correlation score is identified as an overdetection.

13. A method of cardiac signal analysis in an implantable cardiac stimulus device (ICSD), the ICSD comprising a canister housing operational circuitry and a lead electrode assembly including a plurality of electrodes disposed thereon, with the lead electrode assembly configured to couple to the canister to electrically couple the operational circuitry to the electrodes on the lead electrode assembly, the method of cardiac signal analysis comprising:

the operational circuitry detecting a series of events;

the operational circuitry identifying intervals between consecutive detected events;

the operational circuitry using morphology analysis to identify overdetections from the series of events;

whenever an overdetection is identified, the operational circuitry combining an interval preceding the overdetection and an interval following the overdetection to form a combined interval;

following the morphology analysis to identify overdetections, the operational circuitry certifying combined intervals and intervals that are not adjacent to overdetections;

the operational circuitry estimating a cardiac rate using only certified intervals; and

the operational circuitry using the estimated cardiac rate to make therapy decisions.

14. The method of claim 13 further comprising the operational circuitry performing waveform appraisal on the series of detected events including determining whether individual detected events are noisy;

wherein the step of identifying intervals between consecutive detected events in the series of events comprises identifying only intervals between individual detected events that are not noisy as determined in the waveform appraisal step.

15. The method of claim 13 wherein each detected event is affiliated with a sample window composed of a number of signal amplitude samples and the morphology analysis includes Wide Complex Analysis in which an overdetection is identified when first and second detected events are separated by an interval that is shorter than a predetermined Wide Complex threshold interval and at least one of the following conditions is identified:

the first and second detected events are of opposing polarity;

or

a Peak interval for the first and second detected events is less than a predetermined threshold, wherein the Peak interval is defined as the lesser of;

a) an interval between the maximum amplitude sample of the first detected event and the maximum amplitude sample of the second detected event, and

b) an interval between the minimum amplitude sample of the first detected event and the minimum amplitude sample of the second detected event;

such that, if the Wide Complex analysis is satisfied, one of the first and second events is marked as an overdetection.

16. The method of claim 15, if the Wide Complex analysis is satisfied, then the method comprises:

if a morphology template exists for the ICSD, whichever of the first and second detected events shows lesser correlation to the morphology template is marked as the overdetection;

or

if no morphology template exists for the ICSD, the later in time of the first and second detected events is marked as the overdetection.

17. The method of claim 15 further wherein the morphology analysis also includes a template morphology analysis in which:

detected events are compared to a morphology template to generate correlation scores;

a series of correlation scores are characterized as High or Low;

High-Low-High patterns are identified as indicating overdetection; and

if a High-Low-High pattern is identified, the detected event having the Low correlation score is identified as an overdetection.

18. The method of claim 13 further comprising the operational circuitry performing a template morphology analysis in which:

detected events are compared to a morphology template to generate correlation scores;

a series of correlation scores are characterized as High or Low;

High-Low-High patterns are identified as indicating overdetection; and

if a High-Low-High pattern is identified, the detected event having the Low correlation score is identified as an overdetection.