Method and apparatus for verifying discriminating of tachycardia events in a medical device having dual sensing vectors

• US 9,610,025 B2
• Filed: 07/23/2014
• Issued: 04/04/2017
• Est. Priority Date: 07/01/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhang, Xusheng
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US14/339,156
• Publication Number:
  US 20160000350A1
• Time in Patent Office: 986 Days
• Field of Search: 607 14, 600515, 600 5, 600512
• 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 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61B 5/346 Analysis of electrocardiograms
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• 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: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• 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
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A method and medical device for detecting a cardiac event that includes sensing cardiac signals from a plurality of electrodes, sensing a plurality of beats in response to the sensed cardiac signals, identifying each beat of the plurality of beats as one of a normal beat and a not normal beat, determining at least one of whether a number of beats identified as a normal beat is greater than a normal beat threshold, whether an RR interval associated with the beats identified as being a normal beat is less than a threshold interval, and whether RR intervals associated with the beats identified as being normal beats are within an RR interval range, and identifying the cardiac event as being one of shockable and not shockable in response to the determining.

Claims

1. A method of detecting a cardiac event in a medical device, comprising:

sensing cardiac signals from a plurality of electrodes;

sensing a plurality of beats in response to the sensed cardiac signals;

identifying each beat of the plurality of beats as one of a normal beat and a not normal beat;

determining whether a number of beats identified as a normal beat is greater than a normal beat threshold;

determining, in response to the number of beats identified as a normal beat being greater than the normal beat threshold, whether an RR interval associated with the beats identified as being a normal beat is less than a threshold interval;

determining whether RR intervals associated with the beats identified as being normal beats are within an RR interval range; and

identifying the cardiac event as being one of shockable and not shockable in response to the determining.

2. The method of claim 1, wherein the plurality of electrodes form a first sensing vector and a second sensing vector, the method further comprising:

performing a gross morphology analysis of a signal sensed along the first sensing vector during a predetermined sensing window and a signal sensed along the second sensing vector during the predetermined sensing window; and

identifying the cardiac event as being one of shockable and not shockable in response to the performed gross morphology analysis.

3. The method of claim 2, further comprising determining whether to deliver a therapy to treat the cardiac event in response to both the identifying the cardiac event as being one of shockable and not shockable in response to the determining and the identifying the cardiac event as being one of shockable and not shockable in response to the performed gross morphology analysis.

4. The method of claim 1, wherein determining whether RR intervals associated with the beats identified as being normal beats are within an RR interval range comprises:

comparing a duration of a first RR interval of the RR intervals associated with the beats identified as being normal beats to durations of RR intervals of the RR intervals associated with the beats identified as being normal beats other than the first RR interval to generate interval differences;

determining whether the interval differences are less than a relative interval difference threshold; and

determining the RR intervals associated with the beats identified as being normal beats are within the RR interval range in response to all of the interval differences being less than the relative interval difference threshold.

5. The method of claim 1, further comprising:

determining a distribution of the beats identified as being normal beats;

comparing the determined distribution of the beats identified as being normal beats to a distribution threshold; and

further identifying the cardiac event as being one of shockable and not shockable in response to the comparing.

6. The method of claim 1, further comprising:

sensing the cardiac signals over consecutive predetermined sensing windows, the consecutive predetermined sensing windows comprising a first sensing window and a second sensing window occurring subsequent to the first sensing window;

determining a distribution of the beats identified as normal beats occurring within the first sensing window and the second sensing window; and

further identifying the cardiac event as being one of shockable and not shockable in response to the determined distribution.

7. The method of claim 6, wherein determining a distribution of the beats identified as normal beats occurring within the first sensing window and the second sensing window comprises determining whether one or more of the beats identified as being normal beats occur within the second sensing window.

8. The method of claim 1, further comprising:

comparing a number of beats identified as being normal beats to a number identified as being not normal to a predetermined threshold; and

further identifying the cardiac event as being one of shockable and not shockable in response to the comparing.

9. The method of claim 8, wherein the predetermined threshold comprises a proportion of the plurality of beats.

10. A medical device for detecting a cardiac event, comprising:

a plurality of electrodes sensing cardiac signals having a plurality of beats; and

a processor configured to identify each beat of the plurality of beats as one of a normal beat and a not normal beat, determine whether a number of beats identified as a normal beat is greater than a normal beat threshold, determine, in response to the number of beats identified as a normal beat being greater than the normal beat threshold, whether an RR interval associated with the beats identified as being a normal beat is less than a threshold interval, determine whether RR intervals associated with the beats identified as being normal beats are within an RR interval range, and identify the cardiac event as being one of shockable and not shockable in response to the determining.

11. The medical device of claim 10, wherein the plurality of electrodes form a first sensing vector and a second sensing vector, the processor further configured to perform a gross morphology analysis of a signal sensed along the first sensing vector during a predetermined sensing window and a signal sensed along the second sensing vector during the predetermined sensing window, and identify the cardiac event as being one of shockable and not shockable in response to the performed gross morphology analysis.

12. The medical device of claim 11, wherein the processor is further configured to determine whether to deliver a therapy to treat the cardiac event in response to both the identifying the cardiac event as being one of shockable and not shockable in response to the determining and the identifying the cardiac event as being one of shockable and not shockable in response to the performed gross morphology analysis.

13. The medical device of claim 10, wherein determining whether RR intervals associated with the beats identified as being normal beats are within an RR interval range comprises:

comparing a duration of a first RR interval of the RR intervals associated with the beats identified as being normal beats to durations of RR intervals of the RR intervals associated with the beats identified as being normal beats other than the first RR interval to generate interval differences;

determining whether the interval differences are less than a relative interval difference threshold; and

determining the RR intervals associated with the beats identified as being normal beats are within the RR interval range in response to all of the interval differences being less than the relative interval difference threshold.

14. The medical device of claim 10, wherein the processor is further configured to determine a distribution of the beats identified as being normal beats, compare the determined distribution of the beats identified as being normal beats to a distribution threshold, and further identify the cardiac event as being one of shockable and not shockable in response to the comparing.

15. The medical device of claim 10, wherein the processor is further configured to sense the cardiac signals over consecutive predetermined sensing windows, the consecutive predetermined sensing windows comprising a first sensing window and a second sensing window occurring subsequent to the first sensing window, determine a distribution of the beats identified as normal beats occurring within the first sensing window and the second sensing window, and further identify the cardiac event as being one of shockable and not shockable in response to the determined distribution.

16. The medical device of claim 15, wherein determining a distribution of the beats identified as normal beats occurring within the first sensing window and the second sensing window comprises determining whether one or more of the beats identified as being normal beats occur within the second sensing window.

17. The medical device of claim 10, wherein the processor is further configured to compare a number of beats identified as being normal beats to a number identified as being not normal to a predetermined threshold, and further identify the cardiac event as being one of shockable and not shockable in response to the comparing.

18. The medical device of claim 17, wherein the predetermined threshold comprises a proportion of the plurality of beats.

19. A method of detecting a cardiac event in a medical device, comprising:

sensing cardiac signals from a plurality of electrodes;

sensing a plurality of beats in response to the sensed cardiac signals;

identifying each beat of the plurality of beats as one of a normal beat and a not normal beat;

determining at least one of whether a number of beats identified as a normal beat is greater than a normal beat threshold, whether an RR interval associated with the beats identified as being a normal beat is less than a threshold interval, and whether RR intervals associated with the beats identified as being normal beats are within an RR interval range; and

identifying the cardiac event as being one of shockable and not shockable in response to the determining, wherein determining whether RR intervals associated with the beats identified as being normal beats are within an RR interval range comprises;

comparing a duration of a first RR interval of the RR intervals associated with the beats identified as being normal beats to durations of RR intervals of the RR intervals associated with the beats identified as being normal beats other than the first RR interval to generate interval differences;

determining whether the interval differences are less than a relative interval difference threshold; and

determining the RR intervals associated with the beats identified as being normal beats are within the RR interval range in response to all of the interval differences being less than the relative interval difference threshold, and wherein determining whether the interval differences are less than a relative interval difference threshold comprises determining whether the durations of RR intervals of the RR intervals associated with the beats identified as being normal beats other than the first RR interval are within one sixteenth of the duration of the first RR interval.

20. A medical device for detecting a cardiac event, comprising:

a plurality of electrodes sensing cardiac signals having a plurality of beats; and

a processor configured to identify each beat of the plurality of beats as one of a normal beat and a not normal beat, determine at least one of whether a number of beats identified as a normal beat is greater than a normal beat threshold, whether an RR interval associated with the beats identified as being a normal beat is less than a threshold interval, and whether RR intervals associated with the beats identified as being normal beats are within an RR interval range, and identify the cardiac event as being one of shockable and not shockable in response to the determining, wherein determining whether RR intervals associated with the beats identified as being normal beats are within an RR interval range comprises;

comparing a duration of a first RR interval of the RR intervals associated with the beats identified as being normal beats to durations of RR intervals of the RR intervals associated with the beats identified as being normal beats other than the first RR interval to generate interval differences;

determining whether the interval differences are less than a relative interval difference threshold; and

determining the RR intervals associated with the beats identified as being normal beats are within the RR interval range in response to all of the interval differences being less than the relative interval difference threshold, and wherein determining whether the interval differences are less than a relative interval difference threshold comprises determining whether the durations of RR intervals of the RR intervals associated with the beats identified as being normal beats other than the first RR interval are within one sixteenth of the duration of the first RR interval.

21. A non-transitory, computer-readable storage medium storing instructions for causing a processor included in a medical device to perform a method for determining a cardiac event, the method comprising:

sensing cardiac signals from a plurality of electrodes;

sensing a plurality of beats in response to the sensed cardiac signals;

identifying each beat of the plurality of beats as one of a normal beat and a not normal beat;

determining whether a number of beats identified as a normal beat is greater than a normal beat threshold;

determine, in response to the number of beats identified as a normal beat being greater than the normal beat threshold, whether an RR interval associated with the beats identified as being a normal beat is less than a threshold interval;

determine whether RR intervals associated with the beats identified as being normal beats are within an RR interval range; and

identify the cardiac event as being one of shockable and not shockable in response to the determining.