Operation of an extracardiovascular implantable cardioverter defibrillator (ICD) during implantation of another medical device

• US 10,286,221 B2
• Filed: 04/29/2016
• Issued: 05/14/2019
• Est. Priority Date: 04/29/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sawchuk, Robert T.
• Primary Examiner(s): Levicky, William J
• Application Number:
  US15/143,114
• Publication Number:
  US 20170312531A1
• Time in Patent Office: 1,110 Days
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Techniques are disclosed for determining, by an extracardiovascular implantable cardioverter defibrillator (ICD) implanted in a patient, whether one or more test therapy signals generated by another medical device implanted in the patient is detected. In response to detecting the one or more test therapy signals, the extracardiovascular ICD provides an indication that the extracardiovascular ICD has detected the one or more test therapy signals. In some examples, the indication is an audible tone provided to a clinician. In some examples, the other medical device is an intracardiac cardiac pacing device, and the one or more test therapy signals comprises a plurality of anti-tachycardia pacing (ATP) pulses.

Claims

1. An extracardiovascular implantable cardioverter defibrillator (ICD) configured for implantation in a patient, the extracardiovascular ICD comprising:

communication circuitry configured to receive, from an external device, a telemetric command to enter a concomitant medical device implantation mode;

sensing circuitry configured to receive, via a plurality of electrodes, one or more test therapy signals generated by an intracardiac pacing device (IPD) implanted in the patient; and

processing circuitry, wherein at least one of the sensing circuitry or the processing circuitry is configured to detect the one or more test therapy signals, the processing circuitry further configured to;

cause the extracardiovascular ICD to enter the concomitant medical device implantation mode in response to receiving the telemetric command;

cause the extracardiovascular ICD to disable at least one of ventricular tachyarrhythmia detection or ventricular tachyarrhythmia therapy in response to the extracardiovascular ICD entering the concomitant medical device implantation mode;

detect the one or more test therapy signals while the extracardiovascular ICD is in the concomitant medical device implantation mode;

in response to detection of the one or more test therapy signals while the extracardiovascular ICD is in the concomitant medical device implantation mode, control the extracardiovascular ICD to provide an indication that the extracardiovascular ICD has detected the one or more test therapy signals;

cause the extracardiovascular ICD to exit the concomitant medical device implantation mode; and

in response to the extracardiovascular ICD exiting the concomitant medical device implantation mode, cause the extracardiovascular ICD to re-enable at least one of ventricular tachyarrhythmia detection or ventricular tachyarrhythmia therapy.

2. The extracardiovascular ICD of claim 1, wherein the one or more test therapy signals comprise a first set of one or more test therapy signals, and

wherein the processing circuitry is further configured to initiate a timer in response to the extracardiovascular ICD entering the concomitant medical device implantation mode, and

wherein, to cause the extracardiovascular ICD to exit the concomitant medical device implantation mode, the processing circuitry is further configured to cause the extracardiovascular ICD to exit the concomitant medical device implantation mode in response to one of expiration of the timer without the sensing circuitry detecting a second set of one or more test therapy signals or the processing circuitry providing an indication that the extracardiovascular ICD has detected the second set one or more test therapy signals.

3. The extracardiovascular ICD of claim 1, wherein the processing circuitry is further configured to:

control at least one of the sensing circuitry to detect, via the plurality of electrodes, ventricular tachyarrhythmia or therapy delivery circuitry of the extracardiovascular ICD to deliver ventricular tachyarrhythmia therapy;

install a software update in response to receiving the telemetric command, wherein the software update comprises instructions for the concomitant medical device implantation mode including instructions that cause the extracardiovascular ICD to disable the at least one of the ventricular tachyarrhythmia detection or the ventricular tachyarrhythmia therapy in response to entering the concomitant medical device implantation mode; and

remove the software update after providing the indication that the extracardiovascular ICD has detected the one or more test therapy signals.

4. The extracardiovascular ICD of claim 1, further comprising sound generation circuitry, wherein the processing circuitry configured to control the extracardiovascular ICD to provide the indication that the extracardiovascular ICD has detected the one or more test therapy signals is further configured to control the sound generation circuitry to provide an audible indication to a clinician.

5. The extracardiovascular ICD of claim 1, wherein the processing circuitry configured to control the extracardiovascular ICD to provide the indication that the extracardiovascular ICD has detected the one or more test therapy signals is further configured to control the communication circuitry to provide the indication to the IPD.

6. The extracardiovascular ICD of claim 1, further comprising at least one lead including at least one of the plurality of electrodes, the at least one lead configured to be implanted in subcutaneous tissue of the patient.

7. The extracardiovascular ICD of claim 1, further comprising at least one lead including at least one of the plurality of electrodes, the at least one lead configured to be implanted in a subcutaneous tissue and a sub-sternal tissue of the patient.

8. The extracardiovascular ICD of claim 1, wherein the processing circuitry configured to control the extracardiovascular ICD to provide the indication that the extracardiovascular ICD has detected the one or more test therapy signals is further configured to control the extracardiovascular ICD to provide a telemetric indication to the external device.

9. A non-transitory computer readable medium comprising instructions for causing at least one programmable processor of an extracardiovascular ICD configured for implantation in a patient to:

cause the extracardiovascular ICD to enter a concomitant medical device implantation mode in response to receiving a telemetric command to enter the concomitant medical device implantation mode;

cause the extracardiovascular ICD to disable at least one of ventricular tachyarrhythmia detection or ventricular tachyarrhythmia therapy in response to the extracardiovascular ICD entering the concomitant medical device implantation mode;

detect one or more test therapy signals generated by an intracardiac pacing device (IPD) implanted in the patient while the extracardiovascular ICD is in the concomitant medical device implantation mode; and

in response to detection of the one or more test therapy signals while the extracardiovascular ICD is in the concomitant medical device implantation mode, control the extracardiovascular ICD to provide an indication that the extracardiovascular ICD has detected the one or more test therapy signals;

cause the extracardiovascular ICD to exit the concomitant medical device implantation mode; and

in response to the extracardiovascular ICD exiting the concomitant medical device implantation mode, cause the extracardiovascular ICD to re-enable at least one of ventricular tachyarrhythmia detection or ventricular tachyarrhythmia therapy.

10. A system comprising:

a first implantable medical device comprising therapy delivery circuitry and a first plurality of electrodes, wherein the first medical device is configured to deliver one or more test therapy signals via the therapy delivery circuitry and the first plurality of electrodes; and

a second implantable medical device comprising an extracardiovascular implantable cardioverter defibrillator (ICD), the extracardiovascular ICD comprising;

communication circuitry configured to receive, from an external device, a telemetric command to enter a concomitant medical device implantation mode;

sensing circuitry configured to receive, via a second plurality of electrodes, the one or more test therapy signals; and

processing circuitry, wherein at least one of the sensing circuitry or the processing circuitry is configured to detect the one or more test therapy signals, the processing circuitry further configured to;

cause the extracardiovascular ICD to enter the concomitant medical device implantation mode in response to receiving the telemetric command;

cause the extracardiovascular ICD to disable at least one of ventricular tachyarrhythmia detection or ventricular tachyarrhythmia therapy in response to the extracardiovascular ICD entering the concomitant medical device implantation mode;

detect the one or more test therapy signals while the extracardiovascular ICD is in the concomitant medical device implantation mode;

in response to detection of the one or more test therapy signals while the extracardiovascular ICD is in the concomitant medical device implantation mode, control the second implantable medical device to provide a first indication that the second implantable medical device has detected the one or more test therapy signals;

cause the extracardiovascular ICD to exit the concomitant medical device implantation mode; and

in response to the extracardiovascular ICD exiting the concomitant medical device implantation mode, cause the extracardiovascular ICD to re-enable at least one of ventricular tachyarrhythmia detection or ventricular tachyarrhythmia therapy.

11. The system of claim 10,

wherein the processing circuitry of the second implantable medical device configured to control the second implantable medical device to provide the first indication that the second implantable medical device has detected the one or more test therapy signals is further configured to control the second implantable medical device to provide the first indication to the first implantable medical device, and

wherein the first implantable medical device is further configured to:

receive, via communication circuitry of the first implantable medical device, the first indication that the second implantable medical device has detected the one or more test therapy signals; and

provide, via the communication circuitry of the first implantable medical device, a second indication that the second implantable medical device has detected the one or more test therapy signals in response to detecting the first indication.

12. The system of claim 10, wherein the first implantable medical device is a pacing device, and the one or more test therapy signals comprises at least one cardiac pacing pulse.

13. The system of claim 12, wherein the at least one cardiac pacing pulse comprises a plurality of anti-tachycardia pacing (ATP) therapy pulses.

14. The system of claim 12, wherein the pacing device is an intracardiac pacing device comprising a housing configured for implantation within a heart of the patient.

15. An extracardiovascular implantable cardioverter defibrillator (ICD) configured for implantation in a patient, the extracardiovascular ICD comprising:

communication circuitry;

sound generation circuitry;

therapy delivery circuitry configured to deliver ventricular tachyarrhythmia therapy;

sensing circuitry configured to receive, via a plurality of electrodes, one or more test therapy signals generated by an intracardiac pacing device (IPD) implanted in the patient, wherein the sensing circuitry is further configured to detect, via the plurality of electrodes, ventricular tachyarrhythmia; and

processing circuitry, wherein at least one of the sensing circuitry or the processing circuitry is configured to detect the one or more test therapy signals, the processing circuitry further configured to receive, via the communication circuitry, a telemetric command to enter a concomitant medical device implantation mode via the communication circuitry, and, in response to receiving the telemetric command;

enter the concomitant medical device implantation mode; and

initiate a timer,

wherein, while in the concomitant medical device implantation mode, the processing circuitry is configured to;

disable at least one of the ventricular tachyarrhythmia detection or the ventricular tachyarrhythmia therapy;

detect the one or more test therapy signals while the extracardiovascular ICD is in the concomitant medical device implantation mode;

in response to the detection of the one or more test therapy signals while the extracardiovascular ICD is in the concomitant medical device implantation mode, control the sound generation circuitry to provide an audible indication that the extracardiovascular ICD has detected the one or more test therapy signals; and

exit the concomitant medical device implantation mode and re-enable the at least one of the ventricular tachyarrhythmia detection or the ventricular tachyarrhythmia therapy in response to one of expiration of the timer without the detection of the one or more test therapy signals or providing the audible indication.

16. A method comprising:

receiving, by an extracardiovascular implantable cardioverter defibrillator (ICD) implanted in a patient and from an external device, a telemetric command to enter a concomitant medical device implantation mode;

entering, by the extracardiovascular ICD, the concomitant medical device implantation mode in response to receiving the telemetric command;

disabling, by the extracardiovascular ICD, at least one of ventricular tachyarrhythmia detection or ventricular tachyarrhythmia therapy in response to the extracardiovascular ICD entering the concomitant medical device implantation mode;

detecting, by the extracardiovascular ICD, one or more test therapy signals generated by another medical device implanted in the patient while the extracardiovascular ICD is in the concomitant medical device implantation mode; and

in response to detecting the one or more test therapy signals while the extracardiovascular ICD is in the concomitant medical device implantation mode, providing, by the extracardiovascular ICD, an indication that the extracardiovascular ICD has detected the one or more test therapy signals;

exiting, by the extracardiovascular ICD, the concomitant medical device implantation mode; and

in response to exiting the concomitant medical device implantation mode, re-enabling, by the extracardiovascular ICD, the at least one of ventricular tachyarrhythmia detection or ventricular tachyarrhythmia therapy.

17. The method of claim 16, wherein the one or more test therapy signals comprise a first set of one or more test therapy signals,

the method further comprising initiating, by the extracardiovascular ICD, a timer in response to entering the concomitant medical device implantation mode,

wherein exiting, by the extracardiovascular ICD, the concomitant medical device implantation mode comprises exiting the concomitant medical device implantation mode in response to one of expiration of the timer without detecting a second set of one or more test therapy signals or providing an indication that the extracardiovascular ICD has detected the second set one or more test therapy signals.

18. The method of claim 16, further comprising:

installing, by the extracardiovascular ICD, a software update in response to receiving the telemetric command, wherein the software update comprises instructions for the concomitant medical device implantation mode including instructions that cause the extracardiovascular ICD to disable the at least one of the ventricular tachyarrhythmia detection or the ventricular tachyarrhythmia therapy in response to entering the concomitant medical device implantation mode; and

removing, by the extracardiovascular ICD, the software update after providing the indication that the extracardiovascular ICD has detected the one or more test therapy signals.

19. The method of claim 16, wherein providing the indication that the extracardiovascular ICD has detected the one or more test therapy signals comprises providing a non-telemetric indication.

20. The method of claim 19, wherein providing the non-telemetric indication comprises providing an audible indication to a clinician.

21. The method of claim 16, wherein providing the indication that the extracardiovascular ICD has detected the one or more test therapy signals delivered by the other medical device comprises providing a telemetric indication to the other medical device.

22. The method of claim 16, wherein the extracardiovascular ICD comprises a subcutaneous ICD configured to sense a cardiac signal and deliver an anti-tachyarrhythmia shock from a subcutaneous location.

23. The method of claim 16, wherein the extracardiovascular ICD comprises a sub-sternal ICD configured to sense a cardiac signal and deliver an anti-tachyarrhythmia shock from an extracardiovascular and sub-sternal location.

24. The method of claim 16, further comprising:

determining, by the extracardiovascular ICD, that the one or more test therapy signals was detected as a tachyarrhythmic event; and

providing, by the extracardiovascular ICD, an indication that the one or more test therapy signals was detected as a tachyarrhythmic event.

25. The method of claim 16, wherein the other medical device comprises a pacing device, and the one or more test therapy signals comprises at least one cardiac pacing pulse.

26. The method of claim 25, wherein the at least one cardiac pacing pulse comprises a plurality of anti-tachycardia pacing (ATP) therapy pulses.

27. The method of claim 25, wherein the pacing device comprises an intracardiac pacing device comprising a housing configured for implantation within a heart of the patient.