Method and apparatus for detection of intrinsic depolarization following high energy cardiac electrical stimulation

• US 9,586,051 B2
• Filed: 04/23/2015
• Issued: 03/07/2017
• Est. Priority Date: 04/23/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Greenhut, Saul E., Hemming, Michael T.
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US14/693,933
• Publication Number:
  US 20160310746A1
• Time in Patent Office: 684 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• 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: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• 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 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: G06F 2218/10 by analysing the shape of a waveform, e.g. extracting parameters relating to peaks
• CPC Class Codes: G06F 2218/14 by matching peak patterns

Abstract

A medical device is configured to deliver a high-energy electrical stimulation pulse to a patient that produces a post-stimulation polarization signal. A cardiac signal analyzer of the medical device is configured to detect a cardiac electrical signal superimposed on the post-stimulation polarization signal, determine at least one feature of the detected cardiac electrical signal, compare the feature to criteria that differentiate an intrinsic cardiac event during the post-stimulation polarization signal from an evoked response signal and identify the detected cardiac electrical signal as the intrinsic cardiac event if the feature meets the criteria.

Claims

1. A method performed by a medical device system, comprising:

delivering a electrical stimulation pulse to a patient that produces a post-stimulation polarization signal;

tracking a decaying slope of the post-stimulation polarization signal;

detecting a cardiac electrical signal superimposed on the post-stimulation polarization signal in response to detecting a change in polarity of the decaying slope of the post-stimulation polarization signal;

determining a feature of the detected cardiac electrical signal;

comparing the feature to criteria that differentiate an intrinsic cardiac event during the post-stimulation polarization signal from an evoked response signal; and

identifying the detected cardiac electrical signal as the intrinsic cardiac event if the feature meets the criteria.

2. The method of claim 1, further comprising:

starting a pacing escape interval upon delivering the electrical stimulation pulse; and

restarting the pacing escape interval in response to identifying the cardiac electrical signal as the intrinsic cardiac event.

3. The method of claim 1, further comprising:

detecting an acceleration of the decaying slope of the post-stimulation polarization signal and detecting a cardiac electrical signal superimposed on the post-stimulation polarization signal in response to detecting the acceleration of the decaying slope of the post-stimulation polarization signal.

4. The method of claim 1, further comprising:

setting a blanking interval after delivering the electrical stimulation pulse to extend beyond a time of an expected evoked response signal caused by the electrical stimulation pulse; and

detecting the cardiac electrical signal after the blanking interval expires.

5. The method of claim 1, wherein:

determining the feature comprises determining if the detected cardiac electrical signal is at least a biphasic signal having at least one positive-going peak relative to a decaying portion of the polarization signal and at least one negative-going peak relative to the decaying portion of the polarization signal;

identifying the detected cardiac electrical signal as the intrinsic cardiac event comprises identifying the detected cardiac electrical signal as the intrinsic cardiac event when it is determined that the cardiac electrical signal is at least a biphasic signal; and

further comprising identifying the detected cardiac electrical signal as an evoked response signal caused by the electrical stimulation pulse when it is determined that the detected cardiac electrical signal is a monophasic signal having a single one of a positive-going peak and a negative going peak relative to the decaying portion of the polarization signal.

6. The method of claim 1, wherein:

delivering the stimulation pulse comprises delivering the stimulation pulse to cause an evoked response signal that occurs during the post-stimulation polarization signal;

determining the feature comprises determining at least one of a signal width and a signal area of the detected cardiac electrical signal;

comparing the feature to the criteria comprises comparing at least one of the signal width and the signal area to a respective signal width threshold that is less than a signal width of the evoked response signal and a signal area threshold that is less than a signal area of the evoked response signal; and

identifying the detected cardiac electrical signal as the intrinsic cardiac event comprises identifying the detected cardiac electrical signal as the intrinsic cardiac event when it is determined that at least one of the signal width and the signal area is less than the signal width threshold and the signal area threshold respectively.

7. The method of claim 1, wherein:

determining the feature comprises determining a time interval between the delivery of electrical stimulation pulse and the detection of the cardiac electrical signal;

comparing the feature to the criteria comprises comparing the time interval to a time interval threshold; and

identifying the detected cardiac electrical signal as the intrinsic cardiac event comprises identifying the detected cardiac electrical signal as the intrinsic cardiac event when it is determined that the time interval is greater than the time interval threshold.

8. The method of claim 1, further comprising:

establishing an intrinsic event waveform template;

wherein determining the feature of the detected cardiac electrical signal comprises determining a waveform morphology of the detected cardiac electrical signal;

wherein comparing the feature to the criteria comprises determining a correlation between the waveform morphology and the template and comparing the correlation to a threshold;

wherein identifying the detected cardiac electrical signal as the intrinsic cardiac event comprises identifying the detected cardiac electrical signal as the intrinsic cardiac event when it is determined that the correlation is greater than the threshold.

9. The method of claim 1, further comprising:

disabling a cardiac event sensing module during the post-stimulation polarization signal;

enabling a cardiac signal analyzer during the post-stimulation polarization signal to detect the cardiac electrical signal and identify the cardiac signal as being one of the intrinsic cardiac event and an evoked response.

10. The method of claim 1, wherein delivering the electrical stimulation pulse comprises delivering a high-energy electrical stimulation pulse as one of a cardioversion/defibrillation shock pulse and an extracardiac pacing pulse having a pacing pulse energy greater than 1 milliJoule.

11. A medical device, comprising:

a therapy delivery module configured to deliver a electrical stimulation pulse to a patient that produces a post-stimulation polarization signal; and

a cardiac signal analyzer configured to receive a cardiac electrical signal developed across a pair of electrodes coupled to the medical device and configured to;

track the post-stimulation polarization signal by a peak tracking circuit to detect a change in polarity of the decaying slope of the post-stimulation polarization signal;

detect from the received electrical signal a cardiac electrical signal superimposed on the post-stimulation polarization signal in response to detecting the change in polarity of the decaying slope of the post-stimulation polarization signal;

determine a feature of the detected cardiac electrical signal;

compare the feature to criteria that differentiate an intrinsic cardiac event during the post-stimulation polarization signal from an evoked response signal; and

identify the detected cardiac electrical signal as the intrinsic cardiac event if the feature meets the criteria.

12. The device of claim 11, further comprising a control module configured to:

start a pacing escape interval upon delivery of the electrical stimulation pulse; and

restart the pacing escape interval in response to the cardiac signal analyzer identifying the cardiac electrical signal as the intrinsic cardiac event.

13. The device of claim 11, wherein the cardiac signal analyzer is configured to detect an acceleration of the decaying slope of the post-stimulation polarization signal and

detect a cardiac electrical signal superimposed on the post-stimulation polarization signal in response to detecting the acceleration of the decaying slope of the post-stimulation polarization signal.

14. The device of claim 11, wherein the cardiac signal analyzer is further configured to:

set a blanking interval after the electrical stimulation pulse is delivered, the blanking interval extending beyond a time of an expected evoked response signal caused by the electrical stimulation pulse; and

detect the cardiac electrical signal after the blanking interval expires.

15. The device of claim 11, wherein the cardiac signal analyzer is further configured to:

determine the feature by determining if the detected cardiac electrical signal is at least a biphasic signal having at least one positive-going peak relative to a decaying portion of the polarization signal and at least one negative-going peak relative to the decaying portion of the polarization signal;

identify the detected cardiac electrical signal as the intrinsic cardiac event when the cardiac electrical signal is determined to be at least a biphasic signal; and

identify the cardiac electrical signal as an evoked response signal caused by the electrical stimulation pulse when the cardiac electrical signal is determined to be a monophasic signal having a single one of a positive-going peak and a negative going peak relative to the decaying portion of the polarization signal.

16. The device of claim 11, wherein:

the therapy delivery module is configured to deliver the stimulation pulse to cause an evoked response signal that occurs during the post-stimulation polarization signal; and

the cardiac signal analyzer is further configured to;

determine the feature by determining at least one of a signal width and a signal area of the detected cardiac electrical signal;

compare the feature to the criteria by comparing at least one of the signal width and the signal area to a respective signal width threshold that is less than a signal width of the evoked response signal and a signal area threshold that is less than a signal area of the evoked response signal; and

identify the detected cardiac electrical signal as the intrinsic cardiac event by identifying the detected cardiac electrical signal as the intrinsic cardiac event when it is determined that at least one of the signal width and the signal area is less than the signal width threshold and the signal area threshold respectively.

17. The device of claim 11, wherein the cardiac signal analyzer is further configured to:

determine the feature by determining a time interval between the delivery of electrical stimulation pulse and the detection of the cardiac electrical signal;

compare the feature to the criteria by comparing the time interval to a time interval threshold; and

identify the detected cardiac electrical signal as the intrinsic cardiac event by identifying the detected cardiac electrical signal as the intrinsic cardiac event when it is determined that the time interval is greater than the time interval threshold.

18. The device of claim 11, wherein the cardiac signal analyzer is further configured to:

establish an intrinsic event waveform template;

determine the feature of the detected cardiac electrical signal by determining a waveform morphology of the detected cardiac electrical signal;

compare the feature to the criteria by determining a correlation between the waveform morphology and the template and comparing the correlation to a threshold; and

identify the detected cardiac electrical signal as the intrinsic cardiac event by identifying the detected cardiac electrical signal as the intrinsic cardiac event when it is determined that the correlation is greater than the threshold.

19. The device of claim 11, further comprising:

a cardiac event sensing module configured to set an auto-adjusting sensing threshold for sensing cardiac events; and

a control module configured to;

disable the cardiac event sensing module during the post-stimulation polarization signal; and

enable the cardiac signal analyzer during the post-stimulation polarization signal to detect the cardiac electrical signal and identify the cardiac signal as being one of the intrinsic cardiac event and an evoked response caused by the electrical stimulation pulse.

20. The device of claim 11, wherein the therapy delivery module is configured to deliver the electrical stimulation pulse as one of a cardioversion/defibrillation shock pulse and an extracardiac pacing pulse having a pulse energy of at least 1 milliJoule.

21. The device of claim 11, wherein the medical device is an implantable cardioverter defibrillator coupled to extracardiac electrodes for delivering the electrical stimulation pulse and for sensing the cardiac electrical signal.

23. The device of claim 11, wherein the cardiac signal analyzer is further configured to:

identify an evoked response signal superimposed on the post-stimulation polarization signal after the electrical stimulation pulse; and

detect the superimposed cardiac electrical signal during the same post-stimulation polarization signal after the identified evoked response signal.

22. A non-transitory, computer-readable medium storing a set of instructions which, when executed by a processor of a medical device, cause the medical device to:

deliver a electrical stimulation pulse to a patient that produces a post-stimulation polarization signal;

track the post-stimulation polarization signal by a peak tracking circuit to detect a change in polarity of the decaying slope of the post-stimulation polarization signal;

detect a cardiac electrical signal superimposed on the post-stimulation polarization signal in response to detecting the change in polarity of the decaying slope of the post-stimulation polarization signal;

determine a feature of the detected cardiac electrical signal;

compare the feature to criteria that differentiate an intrinsic cardiac event during the post-stimulation polarization signal from an evoked response signal; and

identify the detected cardiac electrical signal as the intrinsic cardiac event if the feature meets the criteria.