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

• US 9,352,165 B2
• Filed: 04/17/2014
• Issued: 05/31/2016
• Est. Priority Date: 04/17/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhang, Xusheng
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/255,158
• Publication Number:
  US 20150297907A1
• Time in Patent Office: 775 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A method and medical device for detecting a cardiac event that includes sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector sensing a first interval and a second sensing vector simultaneously sensing a second, determining, for each of the first interval and the second interval, whether each beat of the plurality of beats is one of a match beat and a non-match beat, determining whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat, determining, for each of the first interval and the second interval, the number of beats determined to be both a non-match beat and a high confidence beat is greater than a non-match threshold, and determining whether to deliver therapy for the cardiac event in response to identifying of each of the first interval and the second interval as being one of shockable and not shockable.

Claims

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

sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector sensing a first interval of the cardiac signal comprising a plurality of beats during a predetermined time period and a second sensing vector simultaneously sensing a second interval of the cardiac signal comprising a plurality of beats during the predetermined time period;

determining, for each of the first interval and the second interval, whether each beat of the plurality of beats is one of a match beat and a non-match beat;

determining whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat;

determining, for each of the first interval and the second interval, the number of beats determined to be both a non-match beat and a high confidence beat is greater than a non-match threshold;

identifying each of the first interval and the second interval as being one of shockable and not shockable in response to the number of beats identified as being both a non-match beat and a high confidence beat; and

determining whether to deliver therapy for the cardiac event in response to identifying of each of the first interval and the second interval as being one of shockable and not shockable.

2. The method of claim 1, wherein determining whether each beat of the plurality of beats is one of a match beat and a non-match beat comprises:

determining a fourth order difference signal corresponding to the beat;

determining a template alignment point and a beat alignment point in response to the fourth order difference signal;

aligning the template and the beat in response to the template alignment point and the beat alignment point; and

determining a morphology match metric between the aligned template and the beat.

3. The method of claim 2, wherein determining whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat comprises:

determining a number of pulses associated with the beat being less than a narrow pulse threshold; and

comparing the number of pulses associated with the beat being less than a narrow pulse threshold to a narrow pulse count threshold.

4. The method of claim 3, wherein determining a number of pulses associated with the beat being less than a narrow pulse threshold comprises determining, for each pulse associated with a beat, whether both a pulse width is less than a pulse width threshold and a pulse amplitude is greater than a pulse amplitude threshold.

5. The method of claim 2, wherein determining whether each beat of the plurality of beats is one of a match beat and a non-match beat comprises:

comparing a slope of the fourth order difference signal to a maximum slope threshold;

determining pulses associated with the beat in response to the comparing;

determining a pulse amplitude for each pulse; and

determining a maximum pulse amplitude in response to the determined amplitudes.

6. The method of claim 5, wherein determining whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat comprises:

determining, for each pulse, whether a width of the pulse is less than a narrow pulse width threshold;

determining, for each pulse, whether the determined pulse amplitude is greater than a pulse amplitude threshold;

determining a number of the determined pulses that are both less than the narrow pulse threshold and greater than the pulse amplitude threshold; and

determining whether the number of the determined pulses that are both less than the narrow pulse threshold and greater than the pulse amplitude threshold is greater than a beat confidence threshold.

7. The method of claim 6, wherein the pulse width threshold is approximately 23 milliseconds, the pulse amplitude threshold is equal to a fraction of the slope of the fourth order difference signal, and the beat confidence threshold is five beats.

8. The method of claim 6, further comprising:

identifying each of the first interval and the second interval as being one of shockable and not shockable in response to gross morphology metrics of the first interval and the second interval;

determining whether the number of non-match beats is greater than a non-match threshold;

identifying each of the first interval and the second interval as being one of shockable and not shockable in response determining whether the number of non-match beats is greater than a non-match threshold; and

determining whether beats of the plurality of beats determined to be low confidence beats is greater than a first low confidence threshold, wherein the identifying each of the first interval and the second interval as being one of shockable and not shockable in response to both the gross morphology metrics and the determining whether the number of non-match beats is greater than a non-match threshold is excluded from the determination of whether to deliver therapy in response to beats of the plurality of beats determined to be low confidence beats being greater than the first low confidence threshold.

9. The method of claim 8, further comprising:

determining whether beats of the plurality of beats determined to be low confidence beats is greater than a first low confidence threshold; and

determining whether beats of the plurality of beats determined to be low confidence beats is greater than a second low confidence threshold less than the first low confidence threshold, wherein the determination of whether to deliver therapy is made in response to the identification of each of the first interval and the second interval as being one of shockable and not shockable only in response to the gross morphology metrics in response to beats of the plurality of beats determined to be low confidence beats not being greater than the first low confidence threshold and being greater than the second low confidence threshold.

10. The method of claim 9, wherein the determination of whether to deliver therapy is made in response to only the identification of each of the first interval and the second interval as being one of shockable and not shockable in response to both the gross morphology metrics and the determining whether the number of non-match beats is greater than a non-match threshold in response to beats of the plurality of beats determined to be low confidence beats both not being greater than the first low confidence threshold and not being greater than the second low confidence threshold.

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

a plurality of electrodes sensing cardiac signals from a plurality of electrodes, the plurality of electrodes forming a first sensing vector sensing a first interval of the cardiac signal comprising a plurality of beats during a predetermined time period and a second sensing vector simultaneously sensing a second interval of the cardiac signal comprising a plurality of beats during the predetermined time period; and

a processor configured to determine, for each of the first interval and the second interval, whether each beat of the plurality of beats is one of a match beat and a non-match beat, determine whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat, determine, for each of the first interval and the second interval, the number of beats determined to be both a non-match beat and a high confidence beat is greater than a non-match threshold, identify each of the first interval and the second interval as being one of shockable and not shockable in response to the number of beats identified as being both a non-match beat and a high confidence beat, and determine whether to deliver therapy for the cardiac event in response to identifying of each of the first interval and the second interval as being one of shockable and not shockable.

12. The medical device of claim 11, wherein determining whether each beat of the plurality of beats is one of a match beat and a non-match beat comprises:

determining a fourth order difference signal corresponding to the beat;

determining a template alignment point and a beat alignment point in response to the fourth order difference signal;

aligning the template and the beat in response to the template alignment point and the beat alignment point; and

determining a morphology match metric between the aligned template and the beat.

13. The medical device of claim 12, wherein determining whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat comprises:

determining a number of pulses associated with the beat being less than a narrow pulse threshold; and

comparing the number of pulses associated with the beat being less than a narrow pulse threshold to a narrow pulse count threshold.

14. The medical device of claim 13, wherein determining a number of pulses associated with the beat being less than a narrow pulse threshold comprises determining, for each pulse associated with a beat, whether both a pulse width is less than a pulse width threshold and a pulse amplitude is greater than a pulse amplitude threshold.

15. The medical device of claim 12, wherein determining whether each beat of the plurality of beats is one of a match beat and a non-match beat comprises:

comparing a slope of the fourth order difference signal to a maximum slope threshold;

determining pulses associated with the beat in response to the comparing;

determining a pulse amplitude for each pulse; and

determining a maximum pulse amplitude in response to the determined amplitudes.

16. The medical device of claim 15, wherein determining whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat comprises:

determining, for each pulse, whether a width of the pulse is less than a narrow pulse width threshold;

determining, for each pulse, whether the determined pulse amplitude is greater than a pulse amplitude threshold;

determining a number of the determined pulses that are both less than the narrow pulse threshold and greater than the pulse amplitude threshold; and

determining whether the number of the determined pulses that are both less than the narrow pulse threshold and greater than the pulse amplitude threshold is greater than a beat confidence threshold.

17. The medical device of claim 16, wherein the pulse width threshold is approximately 23 milliseconds, the pulse amplitude threshold is equal to a fraction of the slope of the fourth order difference signal, and the beat confidence threshold is five beats.

18. The medical device of claim 16, further comprising:

identifying each of the first interval and the second interval as being one of shockable and not shockable in response to gross morphology metrics of the first interval and the second interval;

determining whether the number of non-match beats is greater than a non-match threshold;

identifying each of the first interval and the second interval as being one of shockable and not shockable in response determining whether the number of non-match beats is greater than a non-match threshold; and

determining whether beats of the plurality of beats determined to be low confidence beats is greater than a first low confidence threshold, wherein the identifying each of the first interval and the second interval as being one of shockable and not shockable in response to both the gross morphology metrics and the determining whether the number of non-match beats is greater than a non-match threshold is excluded from the determination of whether to deliver therapy in response to beats of the plurality of beats determined to be low confidence beats being greater than the first low confidence threshold.

19. The medical device of claim 18, further comprising:

determining whether beats of the plurality of beats determined to be low confidence beats is greater than a first low confidence threshold; and

determining whether beats of the plurality of beats determined to be low confidence beats is greater than a second low confidence threshold less than the first low confidence threshold, wherein the determination of whether to deliver therapy is made in response to the identification of each of the first interval and the second interval as being one of shockable and not shockable only in response to the gross morphology metrics in response to beats of the plurality of beats determined to be low confidence beats not being greater than the first low confidence threshold and being greater than the second low confidence threshold.

20. The medical device of claim 19, wherein the determination of whether to deliver therapy is made in response to only the identification of each of the first interval and the second interval as being one of shockable and not shockable in response to both the gross morphology metrics and the determining whether the number of non-match beats is greater than a non-match threshold in response to beats of the plurality of beats determined to be low confidence beats both not being greater than the first low confidence threshold and not being greater than the second low confidence threshold.

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, the plurality of electrodes forming a first sensing vector sensing a first interval of the cardiac signal comprising a plurality of beats during a predetermined time period and a second sensing vector simultaneously sensing a second interval of the cardiac signal comprising a plurality of beats during the predetermined time period;

determining, for each of the first interval and the second interval, whether each beat of the plurality of beats is one of a match beat and a non-match beat;

determining whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat;

determining, for each of the first interval and the second interval, the number of beats determined to be both a non-match beat and a high confidence beat is greater than a non-match threshold; and

identifying each of the first interval and the second interval as being one of shockable and not shockable in response to the number of beats identified as being both a non-match beat and a high confidence beat; and

determining whether to deliver therapy for the cardiac event in response to identifying of each of the first interval and the second interval as being one of shockable and not shockable.