System and method for sensing and detection in an extra-cardiovascular implantable cardioverter defibrillator

• US 9,956,423 B2
• Filed: 04/28/2016
• Issued: 05/01/2018
• Est. Priority Date: 04/27/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhang, Xusheng, Cao, Jian, Greenhut, Saul E., Stadler, Robert W.
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US15/140,802
• Publication Number:
  US 20170312532A1
• Time in Patent Office: 733 Days
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61N 1/3925 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

Abstract

An extra-cardiovascular implantable cardioverter defibrillator senses R-waves from a first cardiac electrical signal by a first sensing channel and stores a time segment of a second cardiac electrical signal in response to each sensed R-wave. The ICD determines intervals between successively sensed R-waves and, in response to at least a predetermined number of the intervals being less than a tachyarrhythmia detection interval, analyzes at least a portion of the time segment of the second cardiac electrical signal corresponding to a most recent one of the sensed R-waves to confirm the most recent one of the R-waves. The ICD updates an unconfirmed beat count in response to the most recent one of the R-waves not being confirmed and withholds detection of a tachyarrhythmia episode in response to the unconfirmed beat count being equal to or greater than a rejection threshold.

Claims

1. An extra-cardiovascular implantable cardioverter defibrillator (ICD), comprising:

a sensing circuit comprising;

a first sensing channel configured to receive a first cardiac electrical signal via a first extra-cardiovascular sensing electrode vector coupled to the extra-cardiovascular ICD and to sense a first plurality of R-waves in response to crossings of a first R-wave sensing threshold by the first cardiac electrical signal, and

a second sensing channel configured to receive a second cardiac electrical signal via a second extra-cardiovascular sensing electrode vector coupled to the extra-cardiovascular ICD and different than the first extra-cardiovascular sensing electrode vector;

a memory; and

a control circuit coupled to the sensing circuit and the memory and configured to;

store a time segment of the second cardiac electrical signal in the memory in response to each one of the first plurality of R-waves sensed by the first sensing channel;

determine a first plurality of intervals between successive ones of the first plurality of R-waves sensed by the first sensing channel;

in response to at least a first predetermined number of the first plurality of intervals being less than a tachyarrhythmia detection interval, analyze at least a portion of the time segment of the second cardiac electrical signal corresponding to a most recent one of the R-waves sensed by the first sensing channel to confirm the most recent one of the R-waves;

update an unconfirmed beat count in response to the most recent one of the R-waves not being confirmed based on the analyzing of at least the portion of the corresponding time segment;

in response to a second predetermined number of the first plurality of intervals being less than a tachyarrhythmia detection interval, compare the unconfirmed beat count to a rejection threshold; and

withhold detection of a tachyarrhythmia episode in response to the unconfirmed beat count being equal to or greater than the rejection threshold.

2. The extra-cardiovascular ICD of claim 1, wherein the control circuit is configured to analyze at least the portion of the corresponding time segment of the second cardiac electrical signal to confirm the most recent one of the R-waves sensed by the first sensing channel by:

determining a maximum amplitude from at least the portion of the time segment of the second cardiac electrical signal;

determining a ratio of the maximum amplitude and a preceding maximum amplitude determined from a preceding time segment of the second cardiac electrical signal corresponding to a preceding confirmed R-wave; and

confirming the most recent one of the R-waves in response to the ratio being greater than a ratio threshold.

3. The extra-cardiovascular ICD of claim 2, wherein the control circuit is configured to determine the maximum amplitude by determining a differential signal of at least the portion of the corresponding time segment and determine a maximum absolute peak amplitude of the differential signal.

4. The extra-cardiovascular ICD of claim 2, wherein the control circuit is further configured to:

determine an event time interval from a first event time of the preceding confirmed R-wave to a second event time of the maximum amplitude; and

determine the ratio threshold based on the event time interval.

5. The extra-cardiovascular ICD of claim 4, wherein the control circuit is configured to determine the ratio threshold from time-varying ratio threshold values comprising a starting first ratio threshold value and at least one of a step-wise drop to a second ratio threshold value and a time-based decaying ratio threshold value.

6. The extra-cardiovascular ICD of claim 4, further comprising a look-up table stored in the memory and comprising a plurality of ratio threshold values and a time interval corresponding to each one of the plurality of ratio threshold values;

wherein the control circuit determines the ratio threshold from the look-up table by retrieving one of the plurality of the ratio threshold values stored for a time interval that corresponds to the determined event time interval.

7. The extra-cardiovascular ICD of claim 1, wherein the control circuit is further configured to pass the time segment of the second cardiac electrical signal through a notch filter prior to analyzing at least the portion of the time segment of the second cardiac electrical signal to confirm the most recent one of the R-waves.

8. The extra-cardiovascular ICD of claim 1, wherein the control circuit is further configured to control the memory to overwrite the time segment of the second cardiac electrical without analyzing the time segment to confirm the most recent one of the R-waves when a count of the first plurality of intervals that are less than the tachyarrhythmia detection interval is less than the first predetermined number.

9. The extra-cardiovascular ICD of claim 1, wherein the control circuit is configured to analyze at least the portion of the time segment of the second cardiac electrical signal in response to at least one of:

at least two of the first plurality of intervals being less than a tachycardia detection interval, or

at least three of the first plurality of intervals being less than a fibrillation detection interval.

10. The extra-cardiovascular ICD of claim 1, further comprising an extra-cardiovascular lead coupled to the ICD, wherein at least one electrode of the first extra-cardiovascular sensing electrode vector is carried by the extra-cardiovascular lead.

11. The extra-cardiovascular ICD of claim 1, further comprising a therapy delivery circuit configured to deliver an anti-tachyarrhythmia therapy to a patient'"'"'s heart via extra-cardiovascular electrodes coupled to the extra-cardiovascular ICD,

wherein the control circuit is further configured to:

detect the tachyarrhythmia episode in response to the second predetermined number of the first plurality of intervals being less than the tachyarrhythmia detection interval and the unconfirmed beat count being less than the rejection threshold, and

control the therapy delivery circuit to deliver the anti-tachyarrhythmia therapy in response to detecting the tachyarrhythmia episode.

12. The extra-cardiovascular ICD of claim 1, wherein the first sensing electrode vector has a first inter-electrode spacing and the second sensing electrode vector has a second inter-electrode spacing, the second inter-electrode spacing being greater than the first inter-electrode spacing.

13. The extra-cardiovascular ICD of claim 1, wherein the control circuit is further configured to:

determine a second plurality of intervals between successive R-waves from the second cardiac electrical signal;

determine if a third predetermined number of the second plurality of intervals are less than the tachyarrhythmia detection interval in response to the second predetermined number of the first plurality of intervals being less than the tachyarrhythmia detection interval; and

compare the unconfirmed beat count to the rejection threshold in response to the third predetermined number of the second plurality of intervals being less than the tachyarrhythmia detection interval.

14. The extra-cardiovascular ICD of claim 13, wherein:

the second sensing channel is further configured to sense a second plurality of R-waves in response to crossings of a second R -wave sensing threshold by the second cardiac electrical signal;

the control circuit is configured to determine the second plurality of intervals by determining intervals between successive R-waves sensed by the second sensing channel.

15. The extra-cardiovascular ICD of claim 13, wherein the control circuit is further configured to determine the second plurality of intervals by:

determining a maximum amplitude from at least the portion of the corresponding time segment of the second cardiac electrical signal;

determining a ratio of the maximum amplitude and a preceding maximum amplitude determined from a preceding time segment of the second cardiac electrical signal corresponding to a preceding confirmed R-wave;

confirming the most recent one of the R-waves in response to the ratio being greater than a ratio threshold;

determining one of the second plurality of intervals as an event interval from a time of the maximum amplitude to a time corresponding to the preceding confirmed R-wave.

16. A method performed by an extra-cardiovascular implantable cardioverter defibrillator (ICD), comprising:

sensing a first plurality of R-waves by a first sensing channel of a sensing circuit of the extra-cardiovascular ICD in response to crossings of a first R-wave sensing threshold by a first cardiac electrical signal, the first cardiac electrical signal received by the first sensing channel via a first extra-cardiovascular sensing electrode vector coupled to the extra-cardiovascular ICD;

storing a time segment of a second cardiac electrical signal in response to each one of the first plurality of R-waves sensed by the first sensing channel, the second cardiac electrical signal received via a second extra-cardiovascular sensing electrode vector by a second sensing channel of the extra-cardiovascular ICD;

determining by a control circuit of the extra-cardiovascular ICD a first plurality of intervals between successive ones of the first plurality of R-waves sensed by the first sensing channel;

in response to at least a first predetermined number of the first plurality of intervals being less than a tachyarrhythmia detection interval, analyzing at least a portion of the time segment of the second cardiac electrical signal corresponding to a most recent one of the R-waves sensed by the first sensing channel to confirm the most recent one of the R-waves;

updating an unconfirmed beat count in response to the most recent one of the R-waves not being confirmed based on the analyzing of at least the portion of the corresponding time segment;

in response to a second predetermined number of the first plurality of intervals being less than the tachyarrhythmia detection interval, comparing the unconfirmed beat count to a rejection threshold; and

withholding detection of a tachyarrhythmia episode in response to the unconfirmed beat count being equal to or greater than the rejection threshold.

17. The method of claim 16, wherein analyzing at least the portion of the corresponding time segment of the second cardiac electrical signal to confirm the R-waves sensed by the first sensing channel comprises:

determining a maximum amplitude from at least the portion of the time segment of the second cardiac electrical signal;

determining a ratio of the maximum amplitude and a preceding maximum amplitude determined from a preceding time segment of the second cardiac electrical signal corresponding to a preceding confirmed R-wave; and

confirming the most recent one of the R-waves in response to the ratio being greater than a ratio threshold.

18. The method of claim 17, further comprising determining the maximum amplitude by determining a differential signal of at least the portion of the corresponding time segment and determining a maximum absolute peak amplitude of the differential signal.

19. The method of claim 17, further comprising:

determining an event time interval from a first event time of the preceding confirmed R-wave to a second event time of the maximum amplitude; and

determining the ratio threshold based on the event time interval.

20. The method of claim 19, further comprising determining the ratio threshold from time-varying ratio threshold values comprising a starting first ratio threshold value and at least one of a step-wise drop to a second ratio threshold value and a time-based decaying ratio threshold value.

21. The method of claim 19, further comprising:

storing a look-up table in the memory of the extra-cardiovascular ICD comprising a plurality of ratio threshold values and a time interval corresponding to each one of the plurality of ratio threshold values; and

determining the ratio threshold from the look-up table by the control circuit by retrieving one of the plurality of the ratio threshold values stored for a time interval that corresponds to the determined event time interval.

22. The method of claim 16, further comprising passing the time segment of the second cardiac electrical signal through a notch filter prior to analyzing at least the portion of the time segment of the second cardiac electrical signal to confirm the most recent one of the R-waves.

23. The method of claim 16, further comprising overwriting the time segment of the second cardiac electrical without analyzing the time segment to confirm the most recent one of the R-waves when a count of the first plurality of intervals that are less than the tachyarrhythmia detection interval is less than first predetermined number.

24. The method of claim 16, further comprising analyzing at least the portion of the time segment of the second cardiac electrical signal in response to at least one of:

at least two of the first plurality of intervals being less than a tachycardia detection interval, or

at least three of the first plurality of intervals being less than a fibrillation detection interval.

25. The method of claim 16, further comprising receiving the first cardiac electrical signal by at least one extra-cardiovascular sensing electrode carried by an extra-cardiovascular lead coupled to the extra-cardiovascular ICD.

26. The method of claim 16, further comprising:

detecting the tachyarrhythmia episode in response to the second predetermined number of the first plurality of intervals being less than the tachyarrhythmia detection interval and the unconfirmed beat count being less than the rejection threshold, and

controlling a therapy delivery circuit of the extra-cardiovascular ICD to deliver the anti-tachyarrhythmia therapy in response to detecting the tachyarrhythmia episode.

27. The method of claim 16, further comprising:

sensing the first cardiac electrical signal by a first sensing electrode vector having a first inter-electrode spacing;

sensing the second cardiac electrical signal by a second sensing electrode vector having a second inter-electrode spacing, the second inter-electrode spacing being greater than the first inter-electrode spacing.

28. The method of claim 16, further comprising:

determining a second plurality of intervals between successive R-waves from the second cardiac electrical signal;

determining if a third predetermined number of the second plurality of intervals are less than the tachyarrhythmia detection interval in response to the second predetermined number of the first plurality of intervals being less than the tachyarrhythmia detection interval; and

comparing the unconfirmed beat count to the rejection threshold in response to the third predetermined number of the second plurality of intervals being less than the tachyarrhythmia detection interval.

29. The method of claim 28, further comprising:

sensing a second plurality of R-waves by the second sensing channel in response to crossings of a second R-wave sensing threshold by the second cardiac electrical signal; and

determining the second plurality of intervals by determining intervals between successive R-waves sensed by the second sensing channel.

30. The method of claim 28, wherein determining the second plurality of intervals comprises:

determining a maximum amplitude from at least the portion of the corresponding time segment of the second cardiac electrical signal;

determining a ratio of the maximum amplitude and a preceding maximum amplitude determined from a preceding time segment of the second cardiac electrical signal corresponding to a preceding confirmed R-wave;

confirming the most recent one of the R-waves in response to the ratio being greater than a ratio threshold;

determining one of the second plurality of intervals as an event interval from a time of the maximum amplitude to a time corresponding to the preceding confirmed R-wave.

31. A non-transitory, computer-readable storage medium comprising a set of instructions which, when executed by a processor of an extra-cardiovascular implantable cardioverter defibrillator (ICD), cause the extra-cardiovascular ICD to:

sense a plurality of R-waves by a first sensing channel of a sensing circuit of the extra-cardiovascular ICD in response to crossings of an R-wave sensing threshold by a first cardiac electrical signal, the first cardiac electrical signal received by the first sensing channel via a first extra-cardiovascular sensing electrode vector coupled to the extra-cardiovascular ICD;

storing a time segment of a second cardiac electrical signal in response to each one of the plurality of R-waves sensed by the first sensing channel, the second cardiac electrical signal received via a second extra-cardiovascular sensing electrode vector by a second sensing channel of the extra-cardiovascular ICD;

determining by a control circuit of the extra-cardiovascular ICD a plurality of intervals between successive ones of the plurality of R-waves sensed by the first sensing channel;

in response to at least a first predetermined number of the plurality of intervals being less than a tachyarrhythmia detection interval, analyzing at least a portion of the time segment of the second cardiac electrical signal corresponding to a most recent one of the R-waves sensed by the first sensing channel to confirm the most recent one of the R-waves;

updating an unconfirmed beat count in response to the most recent one of the R-waves not being confirmed based on the analyzing of at least the portion of the corresponding time segment;

in response to a second predetermined number of the first plurality of intervals being less than the tachyarrhythmia detection interval, comparing the unconfirmed beat count to a rejection threshold; and

withholding detection of a tachyarrhythmia episode in response to the unconfirmed beat count being equal to or greater than the rejection threshold.