System and method for identifying and responding to P-wave oversensing in a cardiac system

• US 10,328,274 B2
• Filed: 04/24/2017
• Issued: 06/25/2019
• Est. Priority Date: 06/08/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhang, Xusheng, Degroot, Paul J.
• Primary Examiner(s): Manuel, George
• Application Number:
  US15/495,104
• Publication Number:
  US 20170354827A1
• Time in Patent Office: 792 Days
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/353 Detecting P-waves
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• 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 1/36507 controlled by gradient or slope of the heart potential
• 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

A cardiac medical system, such as an implantable cardioverter defibrillator (ICD) system, receives a cardiac electrical signal by and senses cardiac events when the signal crosses an R-wave sensing threshold. The system determines at least one sensed event parameter from the cardiac electrical signal for consecutive cardiac events sensed by the sensing circuit and compares the sensed event parameters to P-wave oversensing criteria. The system detects P-wave oversensing in response to the sensed event parameters meeting the P-wave oversensing criteria; and adjusts at least one of an R-wave sensing control parameter or a therapy delivery control parameter in response to detecting the P-wave oversensing.

Claims

1. An implantable cardioverter defibrillator (ICD) system, comprising:

a sensing circuit configured to;

receive a cardiac electrical signal from electrodes coupled to the ICD, and

sense a plurality of consecutive cardiac events from the cardiac electrical signal, each one of the plurality of consecutive cardiac events being sensed as an R-wave in response to the cardiac electrical signal crossing an R-wave sensing threshold;

a therapy delivery circuit configured to deliver electrical stimulation therapy to a patient'"'"'s heart via electrodes coupled to the ICD; and

a control circuit configured to;

determine at least one sensed event parameter from the cardiac electrical signal for each one of the plurality of consecutive cardiac events sensed as an R-wave by the sensing circuit;

compare the sensed event parameters to P-wave oversensing criteria;

detect P-wave oversensing in response to the sensed event parameters meeting the P-wave oversensing criteria, the P-wave oversensing corresponding to at least one P-wave being falsely sensed as at least one of the plurality of consecutive cardiac events that is sensed as an R-wave by the sensing circuit; and

adjust at least one of an R-wave sensing control parameter or a therapy delivery control parameter in response to detecting the P-wave oversensing.

2. The system of claim 1, wherein the control circuit is configured to:

determine the at least one sensed event parameter by determining event time intervals between the plurality of consecutive cardiac events;

compare the event time intervals to at least a first time interval threshold;

detect a cluster of sensed events based on at least a threshold number of the event intervals being less than the first time interval threshold and at least one of the event intervals being greater than the first time interval threshold and consecutive with the threshold number of event intervals ; and

detect the P-wave oversensing in response to detecting the cluster of sensed events.

3. The system of claim 2, wherein the control circuit is further configured to detect the P-wave oversensing by:

comparing the cluster of cardiac events to the P-wave oversensing criteria; and

identifying the cluster of cardiac events as P-wave oversensing when the cluster of cardiac events meets the P-wave oversensing criteria.

4. The system of claim 2, wherein the control circuit is further configured to:

determine if a threshold number of clusters of cardiac events is detected based on determining time intervals between sensed cardiac events;

determine at least one morphology feature of each the detected clusters of sensed events in response to the threshold number of clusters of cardiac events being detected;

compare the at least one morphology feature to P-wave oversensing criteria; and

identify each cluster of cardiac events having the at least one morphology feature meeting the P-wave oversensing criteria as P-wave oversensing.

5. The system of claim 2, wherein the control circuit is configured to:

determine a maximum peak amplitude of each of the detected clusters of cardiac events;

compare the maximum peak amplitude to an amplitude threshold; and

identify each detected cluster of cardiac events having the maximum peak amplitude less than the amplitude threshold as P-wave oversensing.

6. The system of claim 2, wherein the control circuit is further configured to:

determine a morphology match score between each of the sensed events of each detected cluster of cardiac events and a previously determined R-wave template;

compare each morphology match score to a match score threshold; and

identify each cluster of cardiac events having at least a predetermined portion of the determined morphology match scores for the respective cluster of cardiac events being less than a match score threshold.

7. The system of claim 2, wherein the control circuit is further configured to:

determine a peak amplitude from the cardiac electrical signal for each of the plurality of consecutive cardiac events;

determine a morphology matching score for each of the plurality of consecutive cardiac events by comparing the cardiac electrical signal to a pre-determined R-wave template;

determine a first pattern of the peak amplitudes determined for the consecutive cardiac events by labeling each of the peak amplitudes as one of high or low based on a comparison of the peak amplitudes to an amplitude threshold;

determine a second pattern of the morphology matching scores determined for the consecutive cardiac events by labeling each of the morphology matching scores as one of match or non-match based on a comparison of the morphology matching scores to an R-wave matching threshold;

determine a third pattern of the event time intervals determined for the consecutive cardiac events by labeling each of the event time intervals as one of short or long based on a comparison of the event time intervals to the event interval threshold; and

detect the cluster of sensed events based on at least one of the first pattern, the second pattern and the third pattern being an alternating pattern.

8. The system of claim 1, further comprising a memory coupled to the control circuit and a telemetry circuit comprising a transceiver for transmitting and receiving data from an external medical device,

the control circuit further configured to store cardiac electrical signal data in the memory in response to identifying the P-wave oversensing and control the telemetry circuit to transmit the stored cardiac electrical signal data to the external medical device.

9. The system of claim 1, wherein the P-wave oversensing criteria comprises a first set of P-wave oversensing criteria and a second set of P-wave oversensing criteria, and the control circuit is configured to:

detect and identify a first cluster of cardiac events sensed by the sensing circuit based on the first set of P-wave oversensing criteria;

detect and identify a second cluster of cardiac events sensed by the sensing circuit based on the second set of P-wave oversensing criteria;

control the therapy delivery circuit to provide one of a first therapy response in response to identifying the first cluster of cardiac events or a second therapy response in response to identifying the second cluster of cardiac events, the first therapy response different than the second therapy response.

10. The system of claim 9, wherein the first therapy response comprises delivering at least one bradycardia pacing pulse, and the second therapy response comprises withholding delivery of a tachyarrhythmia therapy.

11. The system of claim 1, wherein the control circuit is configured to:

adjust the therapy control parameter by enabling R-wave confirmation in response to identifying the P-wave oversensing;

set a bradycardia pacing escape interval;

compare the cardiac electrical signal to R-wave confirmation criteria in response to the sensing circuit sensing a cardiac event;

reset the pacing escape interval in response to confirming the sensed cardiac event as being an R-wave based on comparing the cardiac electrical signal to the R-wave confirmation criteria;

allow the pacing escape interval to continue running in response to not confirming the sensed cardiac event as being an R-wave based on comparing the cardiac electrical signal to the R-wave confirmation criteria.

12. The system of claim 1, wherein the control circuit is configured to:

detect a tachyarrhythmia episode based on the cardiac electrical signal;

reject the tachyarrhythmia episode detection in response to identifying the P-wave oversensing.

13. The system of claim 1, wherein the control circuit is further configured to:

determine the at least one sensed event parameter by determining a maximum peak amplitude of the cardiac electrical signals corresponding to each cardiac event sensed by the sensing circuit;

compare the sensed event parameters to the P-wave oversensing criteria by comparing the maximum peak amplitude determined for each sensed event to a maximum P-wave amplitude threshold; and

detect the P-wave oversensing in response to the maximum peak amplitude of a sensed cardiac event being less than the P-wave amplitude threshold.

14. The system of claim 13, wherein the control circuit is further configured to:

set an interval timer in response to the sensing circuit sensing a cardiac event;

reset the interval timer in response to the maximum peak amplitude being greater than the maximum P-wave amplitude threshold; and

allow the interval timer to continue running in response to the maximum peak amplitude being less than the maximum P-wave amplitude threshold.

15. The system of claim 14, wherein the control circuit is configured to set the interval timer to a pacing escape interval and control the therapy delivery circuit to deliver a pacing pulse in response to the interval timer expiring.

16. The system of claim 1, further comprising an extra-cardiovascular lead carrying at least one of the electrodes coupled to the ICD.

17. A method comprising:

receiving a cardiac electrical signal;

sensing a plurality of consecutive cardiac events from the cardiac electrical signal, each one of the plurality of consecutive cardiac events being sensed as an R-wave in response to the cardiac electrical signal crossing an R-wave sensing threshold;

determining at least one sensed event parameter from the cardiac electrical signal for each one of the plurality of consecutive sensed cardiac events;

comparing the sensed event parameters to P-wave oversensing criteria;

detecting P-wave oversensing in response to the sensed event parameters meeting the P-wave oversensing criteria, the P-wave oversensing corresponding to at least one P-wave being falsely sensed as at least one of the plurality of consecutive cardiac events that is sensed as an R-wave by the sensing circuit; and

adjusting at least one of an R-wave sensing control parameter or a therapy delivery control parameter in response to detecting the P-wave oversensing.

18. The method of claim 17, further comprising

determining the at least one sensed event parameter by determining event time intervals between the plurality of consecutive cardiac events;

comparing the event time intervals to at least a first time interval threshold;

detecting a cluster of sensed events based on at least a threshold number of the event intervals being less than the first time interval threshold and at least one of the event intervals being greater than the first time interval threshold and consecutive with the threshold number of event intervals; and

detecting the P-wave oversensing based on detecting the cluster of sensed events.

19. The method of claim 18, further comprising detecting the P-wave

oversensing by:

comparing the cluster of cardiac events to the P-wave

oversensing criteria; and

identifying the cluster of cardiac events as P-wave oversensing when the cluster of cardiac events meets the P-wave oversensing criteria.

20. The method of claim 18, further comprising:

determining if a threshold number of clusters of cardiac events is detected based on determining time intervals between sensed cardiac events;

determining at least one morphology feature of each the detected clusters of sensed events in response to the threshold number of clusters of cardiac events being detected;

comparing the at least one morphology feature to P-wave oversensing criteria; and

identifying each cluster of cardiac events having the at least one morphology feature meeting the P-wave oversensing criteria as P-wave oversensing.

21. The method of claim 18, further comprising:

determining a maximum peak amplitude of each of the detected clusters of cardiac events;

comparing the maximum peak amplitude to an amplitude threshold; and

identifying each detected cluster of cardiac events having the maximum peak amplitude less than the amplitude threshold as P-wave oversensing.

22. The method of claim 18, further comprising:

determining a morphology match score between each of the sensed events of each detected cluster of cardiac events and a previously determined R-wave template;

comparing each morphology match score to a match score threshold; and

identifying each cluster of cardiac events having at least a predetermined portion of the determined morphology match scores for the respective cluster of cardiac events being less than a match score threshold.

23. The method of claim 17, further comprising:

storing cardiac electrical signal data in a memory in response to identifying the P-wave oversensing; and

transmitting the stored cardiac electrical signal data to an external medical device.

24. The method of claim 17, further comprising:

storing in the memory the P-wave oversensing criteria comprising a first set of P-wave oversensing criteria and a second set of P-wave oversensing criteria;

detecting and identifying a first cluster of sensed cardiac events based on the first set of P-wave oversensing criteria;

detecting and identifying a second cluster of sensed cardiac events based on the second set of P-wave oversensing criteria;

providing one of a first therapy response in response to identifying the first cluster of cardiac events or a second therapy response in response to identifying the second cluster of cardiac events, the first therapy response different than the second therapy response.

25. The method of claim 24, wherein the first therapy response comprises delivering at least one bradycardia pacing pulse, and the second therapy response comprises withholding delivery of a tachyarrhythmia therapy.

26. The method of claim 17, further comprising:

wherein adjusting the therapy control parameter comprises enabling R-wave confirmation in response to identifying the P-wave oversensing;

setting a bradycardia pacing escape interval;

comparing the cardiac electrical signal to R-wave confirmation criteria in response to sensing a cardiac event;

resetting the pacing escape interval in response to confirming the sensed cardiac event as being an R-wave based on comparing the cardiac electrical signal to the R-wave confirmation criteria; and

allowing the pacing escape interval to continue running in response to not confirming the sensed cardiac event as being an R-wave based on comparing the cardiac electrical signal to the R-wave confirmation criteria.

27. The method of claim 17, further comprising:

detecting a tachyarrhythmia episode based on the cardiac electrical signal;

rejecting the tachyarrhythmia episode detection in response to identifying the P-wave oversensing.

29. The method of claim 17, further comprising:

determining the at least one sensed event parameter by determining a maximum peak amplitude of the cardiac electrical signals corresponding to each sensed cardiac event;

comparing the sensed event parameters to the P-wave oversensing criteria by comparing the maximum peak amplitude determined for each sensed event to a maximum P-wave amplitude threshold; and

detecting the P-wave oversensing in response to the maximum peak amplitude of a sensed cardiac event being less than the P-wave amplitude threshold.

30. The method of claim 29, further comprising:

setting an interval timer in response to a cardiac event;

resetting the interval timer in response to the maximum peak amplitude being greater than the maximum P-wave amplitude threshold; and

allowing the interval timer to continue running in response to the maximum peak amplitude being less than the maximum P-wave amplitude threshold.

31. The method of claim 30, wherein setting the interval times comprises setting the interval timer to a pacing escape interval, the method further comprising delivering a pacing pulse in response to the interval timer expiring.

28. The method of 17, further comprising:

determining a peak amplitude from the cardiac electrical signal for each of the plurality of consecutive cardiac events;

determining a morphology matching score for each of the plurality of consecutive cardiac events by comparing the cardiac electrical signal to a pre-determined R-wave template;

determining a first pattern of the peak amplitudes determined for the consecutive cardiac events by labeling each of the peak amplitudes as one of high or low based on a comparison of the peak amplitudes to an amplitude threshold;

determining a second pattern of the morphology matching scores determined for the consecutive cardiac events by labeling each of the morphology matching scores as one of match or non-match based on a comparison of the morphology matching scores to an R-wave matching threshold;

determining a third pattern of the event time intervals determined for the consecutive cardiac events by labeling each of the event time intervals as one of short or long based on a comparison of the event time intervals to the event interval threshold; and

detecting the cluster of sensed events based on at least two of the first pattern, the second pattern and the third pattern being an alternating pattern.

32. A non-transitory, computer-readable storage medium comprising a set of instructions which, when executed by a control circuit of a medical system, cause the system to:

receive a cardiac electrical signal by a sensing circuit via electrodes coupled to the medical system;

sense a plurality of consecutive cardiac events from the cardiac electrical signal, each one of the plurality of consecutive cardiac events being sensed as an R-wave in response to the cardiac electrical signal crossing an R-wave sensing threshold;

determine by a control circuit of the medical system at least one sensed event parameter from the cardiac electrical signal for each one of the plurality of consecutive cardiac events sensed as an R-wave by the sensing circuit;

compare the sensed event parameters to P-wave oversensing criteria;

detect P-wave oversensing in response to the sensed event parameters meeting the P-wave oversensing criteria, the P-wave oversensing corresponding to at least one P-wave being falsely sensed as at least one of the plurality of consecutive cardiac events that is sensed as an R-wave by the sensing circuit; and

adjust at least one of an R-wave sensing control parameter or a therapy delivery control parameter in response to detecting the P-wave oversensing.