Detection of medical electrical lead issues

• US 10,143,424 B2
• Filed: 08/14/2015
• Issued: 12/04/2018
• Est. Priority Date: 08/14/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gunderson, Bruce D., Reinke, James D.
• Primary Examiner(s): Lee, Erica
• Application Number:
  US14/826,396
• Publication Number:
  US 20170042482A1
• Time in Patent Office: 1,208 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/276 Protection against electrode failure
• 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 5/35 by template matching
• 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 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

An implantable medical device includes a sensing module configured to receive a cardiac electrical signal via electrodes carried by a medical electrical lead coupled to the implantable medical device and a control module configured to detect a lead issue. The sensing module is configured to produce cardiac sensed event signals and spike detect signals. The control module is configured to determine event intervals defined by consecutive ones of the received cardiac sensed event signals and the received spike detect signals and identify one or more received spike detect signals as lead issue spikes based on at least one of the determined event intervals.

Claims

1. An implantable cardiac device comprising:

a sensing module electrically coupled to one or more electrodes carried by a medical electrical lead coupled to the implantable medical device, the sensing module including;

a cardiac event detector configured to receive a cardiac electrical signal sensed via at least one of the electrodes carried by the medical electrical lead coupled to the implantable medical device, detect cardiac event signals from the cardiac electrical signal, and produce a cardiac sensed event signal for each of the detected cardiac event signals; and

a spike detector distinct from the cardiac event detector and configured to receive the cardiac electrical signal, detect non-physiological spikes in the cardiac electrical signal, and produce a spike detect signal for each of the detected non-physiological spikes; and

a control module electrically coupled to the sensing module, the control module being configured to;

receive event signals comprising the cardiac sensed event signals and the spike detect signals from the sensing module;

in response to receiving each of the spike detect signals, determine an event interval defined by the respective spike detect signal and a most recent preceding event signal;

identify one or more of the received spike detect signals as lead issue spikes based on at least one of the determined event intervals;

detect a lead issue of the medical electrical lead when a threshold number of spike detect signals are identified as lead issue spikes; and

generate an alert in response to the lead issue being detected.

2. The device of claim 1, wherein the control module is further configured to establish a minimum lead issue event interval;

and

identify the received spike detect signal as a lead issue spike when a determined event interval ending with the received spike detect signal is longer than the minimum lead issue event interval.

3. The device of claim 2, wherein:

the sensing module is configured to apply at least one of a first blanking period upon detecting a cardiac event by the cardiac event detector and a second blanking period upon detecting a non-physiological spike by the spike detector;

the control module is configured to establish the minimum lead issue event interval as an applied one of the first blanking period and the second blanking period plus a predefined electromagnetic interference exclusion interval.

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

determine an event interval metric from the determined event intervals;

and

withhold identifying the received spike detect signal as a lead issue spike when the event interval metric is less than a tachycardia detection interval.

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

determine if an event interval starting with the received spike detect signal and ending on one of the received cardiac sensed event signals is less than a lead issue coupling interval; and

identify the received spike detect signal as a lead issue spike when the event interval ending on the received cardiac sensed event signal is less than the lead issue coupling time interval.

6. The device of claim 1, wherein the control module is further configured to identify the received spike detect signal as a lead issue spike by:

determining a morphology feature of a cardiac electrical signal spike associated with the received spike detect signal;

comparing the morphology feature to lead issue spike detection criteria; and

identifying the received spike detect signal as a lead issue spike when the lead issue spike detection criteria are satisfied.

7. The device of claim 6, wherein the control module is configured to determine the morphology feature by at least one of determining a descending slope of the cardiac electrical signal spike and determining whether the cardiac electrical signal spike is monophasic.

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

detect a train of pacing pulses in response to a plurality of the determined event intervals; and

reject one or more of the received spike detect signals as being a lead issue spike in response to detecting the train of pacing pulses.

9. The device of claim 1, wherein:

the sensing module further comprises a quiet timer, the sensing module further configured to;

activate the quiet timer for a first quiet time interval in response to producing the spike detect signal,

withhold producing a next spike detect signal during the first quiet time interval;

re-activate the quiet timer for a second quiet time interval in response to detecting a spike during the first quiet time interval; and

the control module is configured to;

monitor the quiet timer in response to receiving the spike detect signal, and

withhold identifying the received spike detect signal as a lead issue spike when the quiet timer is re-activated for at least the second quiet time interval.

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

determine whether a therapy delivery device that is configured to deliver an electrical stimulation therapy is present in the patient; and

adjust the identifying of the one or more of the received spike detect signals as lead issue spikes based on whether the therapy delivery device is present.

11. The device of claim 1, wherein the medical electrical lead comprises an extravascular implantable medical lead carrying one or more extravascular electrodes that are not on or within the heart of the patient, the device further comprising a therapy delivery module coupled to the control module and configured to deliver electrical shocks to a patient'"'"'s heart under the control of the control module via at least a portion of the one or more extravascular electrodes carried by the extravascular medical electrical lead.

12. An implantable cardiac device comprising:

a sensing module electrically coupled to one or more electrodes carried by a medical electrical lead coupled to the implantable medical device, the sensing module including;

a cardiac event detector configured to receive a cardiac electrical signal sensed via at least one of the electrodes carried by the medical electrical lead coupled to the implantable medical device, detect cardiac event signals from the cardiac electrical signal, and produce a cardiac sensed event signal for each of the detected cardiac event signals; and

a spike detector configured to receive the cardiac electrical signal, detect non-physiological spikes in the cardiac electrical signal, and produce a spike detect signal for each of the detected non-physiological spikes; and

a control module electrically coupled to the sensing module, the control module being configured to;

receive the cardiac sensed event signals and the spike detect signals from the sensing module;

determine event intervals defined by consecutive ones of the received cardiac sensed event signals and the received spike detect signals;

identify one or more of the received spike detect signals as lead issue spikes based on at least one of the determined event intervals;

detect a lead issue of the medical electrical lead when a threshold number of spike detect signals are identified as lead issue spikes; and

generate an alert in response to the lead issue being detected wherein the control module is further configured to;

establish a maximum lead issue event interval;

determine the event intervals by determining at least one event interval ending with one of the received spike detect signals;

compare the event interval ending with the received spike detect signal to the maximum lead issue event interval; and

identify the received spike detect signal as a lead issue spike when the event interval ending with the received spike detect signal is less than the maximum lead issue event interval.

13. The device of claim 12, wherein the control module is configured to establish the maximum lead issue event interval by determining a minimum expected pacing interval at which a pacing pulse is expected to be delivered by another medical device.

14. The device of claim 12, wherein the control module is configured to establish the maximum lead issue event interval by:

determining an event interval metric from the determined event intervals; and

subtracting a maximum expected pacing cycle change from the event interval metric.

15. A method of identifying a lead issue of a medical electrical lead comprising:

receiving a cardiac electrical signal by a sensing module of an implantable medical device via electrodes carried by the medical electrical lead coupled to the implantable medical device,

detecting cardiac event signals from the cardiac electrical signal by a cardiac event detector of the sensing module;

producing a cardiac sensed event signal for each of the detected cardiac event signals,

detecting non-physiological spikes in the cardiac electrical signal by a spike detector of the sensing module, the spike detector being distinct from the cardiac event detector;

producing a spike detect signal for each of the detected non-physiological spikes;

receiving event signals by a control module of the implantable medical device, the event signals comprising the cardiac sensed event signals and the spike detect signals produced by the sensing module;

in response to receiving each of the spike detect signals, determining an event interval defined by the respective spike detect signals and a most recent preceding event signal;

identifying one or more of the received spike detect signals as lead issue spikes based on at least one of the determined event intervals;

detecting a lead issue of the medical electrical lead when a threshold number of the spike detect signals are identified as lead issue spikes; and

generating an alert in response to detecting the lead issue.

16. The method of claim 15, further comprising:

establishing a minimum lead issue event interval;

determining an event interval ending with the received spike detect signal; and

identifying the received spike detect signal as the lead issue spike when the event interval ending with the received spike detect signal is longer than the minimum lead issue event interval.

17. The method of claim 16, further comprising:

applying at least one of a first blanking period upon detecting a cardiac event by the cardiac event detector and a second blanking period upon detecting a non-physiological spike by the spike detector; and

establishing the minimum lead issue event interval as an applied one of the first blanking period and the second blanking period plus a predefined electromagnetic interference exclusion interval.

18. The method of claim 15, further comprising:

determining an event interval metric from the determined event intervals; and

withholding identifying the received spike detect signal as a lead issue spike when the event interval metric is less than a tachycardia detection interval.

19. The method of claim 15, further comprising:

determining if an event interval starting with a received spike detect signal and ending on a received cardiac sensed event signal is less than a lead issue coupling interval; and

identify the received spike detect signal as a lead issue spike when the event interval ending on the received cardiac sensed event signal is less than the lead issue coupling time interval.

20. The method of claim 15, wherein identifying the received spike detect signal as a lead issue spike further comprises:

determining a morphology feature of a cardiac electrical signal spike associated with the received spike detect signal;

comparing the morphology feature to lead issue spike detection criteria; and

identifying the received spike detect signal as a lead issue spike when the lead issue spike detection criteria are satisfied.

21. The method of claim 20, wherein determining the morphology feature comprises at least one of determining a descending slope of the cardiac electrical signal spike and determining whether the cardiac electrical signal spike is monophasic.

22. The method of claim 15, further comprising:

detecting a train of pacing pulses in response to a plurality of the determined event intervals; and

rejecting one or more of the received spike detect signals as being a lead issue spike in response to detecting the train of pacing pulses.

23. The method of claim 15, further comprising:

activating a quiet timer included in the sensing module for a first quiet time interval in response to producing the spike detect signal,

withholding producing a next spike detect signal during the first quiet time interval;

re-activating the quiet timer for a second quiet time interval in response to detecting a spike during the first quiet time interval;

monitoring the quiet timer by the control module in response to receiving the spike detect signal from the sensing module, and

withholding identifying the received spike detect signal as being a lead issue spike in response to the quiet timer being re-activated for at least the second quiet time interval.

24. The method of claim 15, further comprising:

determining whether a therapy delivery device that is configured to deliver an electrical stimulation therapy is present in the patient; and

adjusting the identifying of the one or more of the received spike detect signals as lead issue spikes based on whether the therapy delivery device is present.

25. A method of identifying a lead issue of a medical electrical lead comprising:

receiving a cardiac electrical signal by a sensing module of an implantable medical device via electrodes carried by the medical electrical lead coupled to the implantable medical device,

detecting cardiac event signals from the cardiac electrical signal by a cardiac event detector of the sensing module;

producing a cardiac sensed event signal for each of the detected cardiac event signals,

detecting non-physiological spikes in the cardiac electrical signal by a spike detector of the sensing module;

producing a spike detect signal for each of the detected non-physiological spikes;

establishing a maximum lead issue event interval;

receiving the cardiac sensed event signals and the spike detect signals produced by the sensing module by a control module of the implantable medical device;

determining event intervals defined by consecutive ones of the received cardiac sensed event signals and the received spike detect signals, wherein determining the event intervals comprises determining at least one event interval ending with one of the received spike detect signals;

identifying one or more of the received spike detect signals as lead issue spikes based on at least one of the determined event intervals by comparing the event interval ending with the received spike detect signal to the maximum lead issue event interval and identifying the received spike detect signal as a lead issue spike when the event interval ending with the received spike detect signal is less than the maximum lead issue event interval;

detecting a lead issue of the medical electrical lead when a threshold number of the spike detect signals are identified as lead issue spikes; and

generating an alert in response to detecting the lead issue.

26. The method of claim 25, wherein establishing the maximum lead issue event interval comprises determining a minimum expected pacing interval at which a pacing pulse is expected to be delivered by another medical device.

27. The method of claim 25, wherein establishing the maximum lead issue event interval comprises:

determining an event interval metric from the determined event intervals; and

subtracting a maximum expected pacing cycle change from the event interval metric.

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

determine event intervals defined by cardiac sensed event signals and spike detect signals produced by a cardiac event detector and a spike detector distinct from the cardiac event detector, respectively, of a sensing module of the implantable medical device, the sensing module configured to receive a cardiac electrical signal via electrodes carried by a medical electrical lead coupled to the implantable medical device and detect cardiac event signals and non-physiological spikes from the cardiac electrical signal;

identify one or more of the spike detect signals as lead issue spikes based on at least one of the determined event intervals defined by a received spike detect signal and a most recent preceding event signal;

detect a lead issue of the medical electrical lead when a threshold number of the spike detect signals are identified as lead issue spikes; and

generate an alert in response to detecting the lead issue.