Methods and devices for accurately classifying cardiac activity

• US 10,220,219 B2
• Filed: 01/08/2018
• Issued: 03/05/2019
• 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:
  US15/864,640
• Publication Number:
  US 20180126182A1
• Time in Patent Office: 421 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. An implantable cardiac monitoring device comprising operational circuitry and a plurality of electrodes electrically coupled to the operational circuitry, the operational circuitry being configured to perform a method of cardiac signal analysis comprising:

the operational circuitry receiving an electrical signal from the electrodes and detecting a series of events in the electrical signal and identifying intervals between consecutive detected events;

the operational circuitry using morphology analysis to identify overdetections of electrical signals emanating from the heart of a patient in 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; and

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

wherein the operational circuitry comprises a memory for storing cardiac data and the operational circuitry is configured to use the estimated cardiac rate to determine whether to store data in the memory.

2. The implantable cardiac monitoring device of claim 1, wherein the operational circuitry is configured to store data in the memory in response to identifying overdetections.

3. The implantable cardiac monitoring device 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 that occur between individual detected events that are not noisy.

4. The implantable cardiac monitoring device 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 by the operational circuitry as an overdetection.

5. The implantable cardiac monitoring device 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.

6. A cardiac stimulus device comprising operational circuitry and a plurality of electrodes electrically coupled to the operational circuitry, the operational circuitry being configured to perform a method of cardiac signal analysis comprising:

the operational circuitry receiving an electrical signal from the electrodes and detecting a series of events in the electrical signal and identifying intervals between consecutive detected events;

the operational circuitry using morphology analysis to identify overdetections of electrical signals emanating from the heart of a patient in 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; and

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

wherein the operational circuitry further comprises stimulus circuitry for generating a therapeutic stimulus to a patient, further wherein the operational circuitry is configured to use the estimated cardiac rate to determine whether cardiac stimulus is needed and, if so, to deliver the cardiac stimulus to the patient.

7. An implantable cardiac stimulus device in the form of the cardiac stimulus device of claim 6 further comprising a hermetically sealed housing to contain the operational circuitry.

8. The implantable cardiac stimulus device of claim 7 further comprising a lead having at least one of the electrodes thereon.

9. The implantable cardiac stimulus device of claim 7 wherein all of the electrodes are disposed on the hermetically sealed housing.

10. The cardiac stimulus device of claim 6, 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 that occur between individual detected events that are not noisy.

11. The cardiac stimulus device of claim 6, 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 by the operational circuitry as an overdetection.

12. The cardiac stimulus device of claim 6, 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.

13. A method of cardiac signal analysis in medical device comprising operational circuitry and a plurality of electrodes electrically coupled to the operational circuitry, the method of cardiac signal analysis comprising:

the operational circuitry detecting a series of events in a signal sensed using the electrodes and 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; and

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

wherein the medical device further comprises stimulus circuitry for generating a therapeutic stimulus to a patient, and, when cardiac stimulus is needed, using the stimulus circuitry to deliver the cardiac stimulus to the patient.

14. The method of cardiac signal analysis of claim 13 further comprising using the estimated cardiac rate to determine whether cardiac stimulus is needed.

15. The method of claim 13 wherein the medical device is an implantable medical device having a hermetically sealed housing for containing the operational circuitry and at least one lead having one or more lead electrodes thereon, such that the step of detecting a series of events in the signal uses a signal sensed with at least one of the lead electrodes.

16. The method of claim 13 wherein the medical device is an implantable medical device having a hermetically sealed housing for containing the operational circuitry, wherein all of the electrodes are disposed on the hermetically sealed housing, such that the step of detecting a series of events in the signal uses a signal sensed with only electrodes disposed on the hermetically sealed housing.

17. The method of claim 13 further comprising 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 that occur between individual detected events that are not noisy.

18. The method of claim 13 wherein the step of the operational circuitry performing morphology analysis to identify overdetections from the series of events comprises:

comparing detected events to a morphology template to generate correlation scores;

characterizing a series of correlation scores as High or Low;

identifying High-Low-High patterns; and

in response to identifying a High-Low-High pattern is identified, identifying the detected event having the Low correlation score as an overdetection.

19. A method of cardiac signal analysis in medical device comprising operational circuitry and a plurality of electrodes electrically coupled to the operational circuitry, the method of cardiac signal analysis comprising:

the operational circuitry detecting a series of events in a signal sensed using the electrodes and 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; and

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

wherein the medical device is an implantable cardiac monitoring device that comprises a memory for storing cardiac data,

wherein the method further comprises using the estimated cardiac rate to determine whether to store data in the memory and, if so, storing data in the memory.

20. The method of claim 19, further comprising storing data in the memory in response to identifying overdetections.