Detection of medical electrical lead issues and therapy control

• US 9,533,165 B1
• Filed: 08/19/2015
• Issued: 01/03/2017
• Est. Priority Date: 08/19/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gunderson, Bruce D.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/829,697
• Time in Patent Office: 503 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• 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 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems
• 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 implantable medical device is configured to detect saturation events from a cardiac electrical signal, detect a tachyarrhythmia based at least in part on the cardiac electrical signal, responsive to detecting the tachyarrhythmia, and compare the detected saturation events to lead issue criteria. If the detected saturation events satisfy lead issue criteria, a therapy for treating the tachyarrhythmia is withheld by the implantable medical device.

Claims

1. An implantable medical device, comprising:

sensing circuitry to receive a first cardiac electrical signal via electrodes carried by a medical electrical lead when the medical electrical lead is coupled to the implantable medical device;

therapy delivery circuitry to deliver a tachyarrhythmia therapy to a patient'"'"'s heart; and

a control module coupled to the sensing circuitry and the therapy delivery circuitry and configured to;

detect one or more saturation events from the first cardiac electrical signal;

detect a tachyarrhythmia based at least in part on the first cardiac electrical signal;

responsive to detecting the tachyarrhythmia, compare the detected saturation events to lead issue criteria; and

withhold the tachyarrhythmia therapy when the lead issue criteria are satisfied.

2. The device of claim 1, wherein the control module is configured to detect the saturation events by:

detecting one of a positive saturation amplitude and a negative saturation amplitude of the first cardiac electrical signal;

counting consecutive sample points of the first cardiac electrical signal that occur at or above the detected one of the positive saturation amplitude and the negative saturation amplitude;

comparing the sample point count to a saturation event threshold;

detecting the saturation event when the sample point count reaches the saturation event threshold.

3. The device of claim 1, wherein the control module is configured to:

store a polarity of each of the detected saturation events; and

determine that the lead issue criteria are met when at least one of the detected saturation events is positive and at least one of the detected saturation events is negative.

4. The device of claim 1, wherein the control module is configured to:

detect the tachyarrhythmia in response to analyzing the first cardiac electrical signal over a first time interval;

compare saturation events detected during the first time interval to a first lead issue criterion of the lead issue criteria;

compare saturation events detected during a second time interval to a second lead issue criterion of the lead issue criteria, the second time interval being longer than the first time interval and extending earlier in time from a time that the tachyarrhythmia is detected than the first time interval; and

determine that the lead issue criteria are satisfied in response to both the first lead issue criterion and the second lead issue criterion being satisfied.

5. The device of claim 4, wherein the control module is further configured to:

determine that the first lead issue criterion is satisfied when at least one saturation event is detected during the first time interval; and

determine that the second lead issue criterion is satisfied when at least one saturation event having a positive polarity and at least one saturation event having a negative polarity are detected during the second time interval.

6. The device of claim 5, wherein the control module is configured to:

determine a saturation event duration for each of the saturation events;

compare a variation of the saturation event durations to an irregularity criterion; and

determine that the lead issue criteria are met when the first lead issue criterion is satisfied, the second lead issue criterion is satisfied, and the variation of the saturation event durations satisfy the irregularity criterion.

7. The device of claim 1, wherein the control module is configured to:

determine a saturation event duration for each of the saturation events;

compare a variation of the saturation event durations to an irregularity criterion; and

determine that the lead issue criteria are met when the variation of the saturation event durations satisfy the irregularity criterion.

8. The device of claim 1, wherein the control module is further configured to:

detect a lead integrity alert condition; and

enable the detecting of the saturation events in response to detecting the lead integrity alert condition.

9. The device of claim 1, wherein the control module is further configured to:

control the therapy delivery circuitry to deliver the tachyarrhythmia therapy when the lead issue criteria are not satisfied;

detect next saturation events after the therapy is delivered;

redetect the tachyarrhythmia after the therapy is delivered;

compare at least one of the detected saturation events and the next saturation events to the lead issue criteria in response to the tachyarrhythmia being redetected; and

withhold a next therapy in response to the lead issue criteria being satisfied.

10. The device of claim 1, wherein:

the sensing circuitry receives a second cardiac electrical signal; and

the control module is configured to;

analyze the second cardiac electrical signal in response to detecting the tachyarrhythmia from the first cardiac electrical signal if the tachyarrhythmia detection is an initial detection of a tachyarrhythmia episode;

determine if the initial detection is due to noise oversensing in response to the analyzing of the second cardiac electrical signal;

withhold the therapy in response to the initial detection being due to noise oversensing;

redetecting the tachyarrhythmia episode; and

determining if the lead issue criteria are satisfied by the detected saturation events when the tachyarrhythmia episode is redetected.

11. The device of claim 1, wherein:

the sensing circuitry receives a second cardiac electrical signal; and

the control module is configured to;

detect a lead integrity alert condition;

enable detection of the saturation events in response to detecting the lead integrity alert condition;

determine if the lead issue criteria are satisfied when the tachyarrhythmia detection is an initial detection of a tachyarrhythmia episode;

withhold the therapy in response to the lead issue criteria being satisfied;

analyze the second cardiac electrical signal when the tachyarrhythmia detection is an initial detection of the tachyarrhythmia episode and the lead issue criteria are not satisfied;

determine if the initial detection is due to noise oversensing in response to the analyzing of the second cardiac electrical signal;

control the therapy delivery circuitry to deliver the tachyarrhythmia therapy when the initial detection is not due to noise oversensing and the lead issue criteria are not satisfied;

redetect the tachyarrhythmia episode after the therapy is delivered;

detect next saturation events after the therapy is delivered;

compare at least one of the detected saturation events and the next saturation events to the lead issue criteria in response to the tachyarrhythmia being redetected; and

withhold a next therapy in response to the lead issue criteria being satisfied.

12. A method, comprising:

receiving a cardiac electrical signal by a sensing circuitry of an implantable medical device via electrodes carried by a medical electrical lead when the medical electrical lead is coupled to the implantable medical device;

detecting one or more saturation events from the cardiac electrical signal by a control module of the implantable medical device;

detecting a tachyarrhythmia based at least in part on the cardiac electrical signal;

responsive to detecting the tachyarrhythmia, comparing the detected saturation events to lead issue criteria; and

withholding a tachyarrhythmia therapy when the lead issue criteria are satisfied.

13. The method of claim 12, wherein detecting one of the saturation events comprises:

detecting one of a positive saturation amplitude and a negative saturation amplitude of the cardiac electrical signal;

counting consecutive sample points of the first cardiac electrical signal that occur at or above the detected one of the positive saturation amplitude and the negative saturation amplitude;

comparing the sample point count to a saturation event threshold; and

detecting the saturation event when the sample point count reaches the saturation event threshold.

14. The method of claim 12, further comprising:

storing a polarity of each of the detected saturation events; and

determining that the lead issue criteria are met when at least one of the detected saturation events is positive and at least one of the detected saturation events is negative.

15. The method of claim 12, further comprising:

detecting the tachyarrhythmia in response to analyzing the first cardiac electrical signal over a first time interval;

comparing saturation events detected during the first time interval to a first lead issue criterion of the lead issue criteria;

comparing saturation events detected during a second time interval to a second lead issue criterion of the lead issue criteria, the second time interval being longer than the first time interval and extending earlier in time from a time that the tachyarrhythmia is detected than the first time interval; and

determining that the lead issue criteria are satisfied in response to both the first lead issue criterion and the second lead issue criterion being satisfied.

16. The method of claim 15, further comprising:

determining that the first lead issue criterion is satisfied when at least one saturation event is detected during the first time interval; and

determining that the second lead issue criterion is satisfied when at least one saturation event having a positive polarity and at least one saturation event having a negative polarity are detected during the second time interval.

17. The method of claim 16, further comprising:

determining a saturation event duration for each of the detected saturation events;

comparing a variation among the saturation event durations to an irregularity criterion; and

determining that the lead issue criteria are met when the first lead issue criterion is satisfied, the second lead issue criterion is satisfied, and the variation among the saturation event durations satisfy the irregularity criterion.

18. The method of claim 12, further comprising:

determining a saturation event duration for each of the detected saturation events;

comparing a variation among the saturation event durations to an irregularity criterion; and

determining that the lead issue criteria are met when the variation among the saturation event durations satisfy the irregularity criterion.

19. The method of claim 12, further comprising:

detecting a lead integrity alert condition; and

enabling the detecting of the saturation events in response to detecting the lead integrity alert condition.

20. The method of claim 12, further comprising:

delivering the therapy when the lead issue criteria are not satisfied;

detecting next saturation events after the therapy is delivered;

redetecting the tachyarrhythmia after the therapy is delivered;

comparing at least one of the detected saturation events and the next saturation events to the lead issue criteria in response to the tachyarrhythmia being redetected; and

withholding a next therapy in response to the lead issue criteria being satisfied.

21. The method of claim 12, further comprising:

receiving a second cardiac electrical signal by the sensing circuitry;

analyzing the second cardiac electrical signal in response to detecting the tachyarrhythmia if the tachyarrhythmia detection is an initial detection of a tachyarrhythmia episode;

determining if the initial detection is due to noise oversensing in response to the analyzing of the second cardiac electrical signal;

withholding the therapy in response to the initial detection being due to noise oversensing;

redetecting the tachyarrhythmia episode; and

determining if the lead issue criteria are satisfied by the detected saturation events when the tachyarrhythmia episode is redetected.

22. The method of claim 12, further comprising:

receiving a second cardiac electrical signal by the sensing circuitry;

detecting a lead integrity alert condition;

enabling detection of the saturation events in response to detecting the lead integrity alert condition;

determining if the lead issue criteria are satisfied when the tachyarrhythmia detection is an initial detection of a tachyarrhythmia episode;

withholding the therapy in response to the lead issue criteria being satisfied;

analyzing the second cardiac electrical signal when the tachyarrhythmia detection is an initial detection of the tachyarrhythmia episode and the lead issue criteria are not satisfied;

determining if the initial detection is due to noise oversensing in response to the analyzing of the second cardiac electrical signal;

delivering the therapy when the initial detection is not due to noise oversensing and the lead issue criteria are not satisfied;

redetecting the tachyarrhythmia episode after the therapy is delivered;

detecting next saturation events after the therapy is delivered;

comparing at least one of the detected saturation events and the next saturation events to the lead issue criteria in response to the tachyarrhythmia being redetected; and

withholding a next therapy in response to the lead issue criteria being satisfied.

23. A non-transitory computer readable storage medium comprising instructions which when executed by a processor of an implantable medical device cause the implantable medical device to:

detect one or more saturation event from a cardiac electrical signal received by the implantable medical device via electrodes carried by a medical electrical lead when the medical electrical lead is coupled to the implantable medical device;

detect a tachyarrhythmia based at least in part on the cardiac electrical signal;

responsive to detecting the tachyarrhythmia, compare the detected saturation events to lead issue criteria; and

withhold a tachyarrhythmia therapy when the lead issue criteria are satisfied.