EGM recording system for implantable medical device

• US 5,776,168 A
• Filed: 04/03/1996
• Issued: 07/07/1998
• Est. Priority Date: 04/03/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gunderson, Bruce D.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/627,306
• Time in Patent Office: 825 Days
• Field of Search: 607/5, 607/9, 607/27, 607/28
• US Class Current: 607/27
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents

Abstract

An EGM recording system in an implantable medical device of the type comprising an implantable pulse generator (IPG) and a lead system including one or more sensing leads each having a proximal end coupled to the IPG and a distal end with at least one pace/sense electrode in contact with a patient'"'"'s heart. A short interval counter (SIC) is incremented by oversense events occurring within a short interval (SI), that is shorter than typical fibrillation event intervals, following a preceding paced or sensed event (except for certain ventricular event sequences). At the same time, the near-field and/or far-field EGM is detected, digitized and temporarily stored in a FIFO buffer as EGM data. When the first oversense event is detected within the SI, a time limited epoch of the corresponding EGM data is stored in a register in a rolling buffer. Subsequent EGM epochs with date/time stamps are stored in other registers of the rolling buffer at programmed counts of the SIC on a FIFO basis. Associated data, e.g., a date/time stamp of the recorded event and the oversense interval triggering storage, may also be recorded in similar buffers. The stored EGM epochs and associated data are later telemetered out to an external programmer for analysis. Lead integrity problems (including loose connections of the lead to the IPG) or electromagnetic interference (EMI) causing oversensing by the sense amplifiers can be diagnosed from the EGM epochs and associated stored data.

Claims

1. In an implantable cardiac medical device having the capability of sensing cardiac events on a sensing lead positioned in relation with the patient'"'"'s heart and storing the electogram (EGM) of the heart in device memory in response thereto, a method of recording an EGM epoch in an oversensing condition comprising the steps of:

establishing oversense event criteria;

sensing cardiac events using the sensing lead;

establishing an oversense short interval following the sensing of a cardiac event;

identifying cardiac events sensed using said sensing lead occurring within said oversense short interval as oversense events;

counting oversense events to produce an oversense event count;

comparing the oversense event count with said oversense event criteria; and

recording an EGM epoch using said sensing lead in said device memory in response to the oversense event count meeting said oversense event criteria.

2. The method of claim 1 wherein said recording step further comprises:

recording said EGM epoch over an EGM epoch time window that precedes and follows the oversense event in device memory in response to the oversense event count meeting said oversense event criteria.

3. The method of claim 2 wherein the recording step further comprises recording an EGM epoch each time that the oversense event count meets said oversense event criteria to produce a plurality of recorded EGM epochs.

4. The method of claim 3 wherein said recording step further comprises recording the EGM epoch in response to an oversense event count equal to one.

5. The method of claim 4 wherein said step of establishing the oversense event criteria comprises defining plurality of values and wherein said recording step farther comprises recording an EGM each time the oversense event count equals a said defined value.

6. The method of claim 1 wherein said step of recording an EGM epoch further comprises recording a far-field EGM epoch from said sensing lead.

7. The method of claim 1 wherein said step of recording an EGM epoch further comprises recording a near-field EGM epoch from said sensing lead.

8. The method of claim 1 further comprising the step of recording the date and time that the EGM epoch is recorded in device memory.

9. The method of claim 1 further comprising the steps of:

in conjunction with identifying sensed cardiac events as oversense events, measuring the interval separating an oversense event from a preceding paced or sensed event; and

in conjunction with the recording step, recording the measured interval with the EGM epoch that is recorded in device memory in association with the oversense event.

10. In an implantable cardiac medical device having means for providing a cardiac therapy in response to a sensed condition and having device memory for storage of a cardiac electrogram (EGM), a system for responding to an oversense condition that may incorrectly result in provision of the therapy, comprising:

means for definiteness event count criteria;

a sensing lead having at least one sense electrode positioned in relation to a patient'"'"'s heart;

sense amplifier means for sensing electrical signals conducted on the sensing lead including depolarizations of the heart and providing a sensed event signal in response thereto;

means for establishing an oversense short interval following a sensed event signal;

means for identifying sensed event signals occurring within said oversense short interval as oversense events;

means for counting the oversense events to produce an oversense event count;

means for comparing the oversense event count with oversense said event count criteria; and

means for recording an EGM epoch from said lead system in said device memory in response to the oversense count meeting said oversense event count criteria.

11. The system of claim 10 wherein said recording means further comprises:

means for recording said EGM epoch over an EGM epoch time window that precedes and follows the oversense event in said device memory in response to said oversense count meeting said oversense event count criteria.

12. The system of claim 11 wherein said recording means comprises means for recording an EGM epoch each time that said oversense event count meets said oversense event count criteria.

13. The system of claim 12 wherein said recording means further comprises means for recording the EGM epoch in response to an oversense event count equal to one.

14. The system of claim 13 wherein said oversense event count criteria defining means comprises means for defining a plurality of values and said recording means further comprises means for recording EGM each time said oversense event count equals a said defined value.

15. The system of claim 10 wherein said recording means comprises means for recording an EGM epoch each time that said oversense event count meets said oversense event count criteria.

16. The system of claim 10 wherein:

said lead system comprises at least one sensing lead and first sensing electrode in proximal relation to said patient'"'"'s heart and a further remote second sensing electrode; and

said EGM epoch further comprises a far-field EGM epoch recorded from said first and second electrodes.

17. The system of claim 10 wherein:

said lead system comprises first and second sensing leads and electrodes in proximal relation to said patient'"'"'s heart; and

said EGM epoch further comprises a near-field EGM epoch recorded from said first and second electrodes.

18. The system of claim 10 further comprising:

means for recording the date and time that the EGM epoch is recorded in said device memory in association with the recorded EGM epoch.

19. The system of claim 10 further comprising:

means for timing the actual interval of an oversense event from a preceding paced or sensed event; and

means for recording the timed actual interval with the EGM epoch that is recorded in said device memory in association with the oversense event.

20. In an implantable pulse generator having means for sensing cardiac events through a sensing lead coupled with a patient'"'"'s heart, a device memory, means for recording an electrogram (EGM) in the device memory, means for determining the absence of a heart beat, and means for pacing the patient'"'"'s heart in response thereto, a method of recording an EGM epoch in an oversensing condition for a determination of potential sensing lead integrity failure or electromagnetic interference comprising the steps of:

establishing oversense event criteria;

sensing cardiac events using the sensing lead;

establishing an oversense interval following a preceding sensed cardiac event sensed on said sensing lead in which a further cardiac sensed event may occur;

identifying sensed cardiac events occurring within said oversense interval as oversense events;

counting said oversense events to produce an oversense event count;

comparing the oversense event count with said oversense event criteria; and

recording an EGM epoch in said device memory in response to said oversense event count meeting said oversense event criteria.

21. The method of claim 20 further comprising the step of recording a date and time that the EGM epoch is recorded in said device memory in conjunction with said recording step.

22. The method of claim 20 further comprising the steps of:

in conjunction with identifying sensed cardiac events as oversense events, measuring the interval separating an oversense event from a preceding paced or sensed event; and

in conjunction with said recording step, recording the measured interval with the EGM epoch that is recorded in said device memory in association with the oversense event.

23. In an implantable pulse generator having means for sensing ventricular events through a sensing lead coupled with the ventricle of a patient'"'"'s heart, a device memory, means for recording a ventricular electrogram (EGM) in said device memory, and means for generating ventricular pace pulses for pacing the patient'"'"'s heart, a method of recording an EGM epoch in an oversensing condition of ventricular sensed events for a determination of potential sensing lead integrity failure or electromagnetic interference comprising the steps of:

establishing oversense event criteria;

sensing ventricular events using the sensing lead;

establishing an oversense interval following a preceding ventricular sensed event or ventricular pace pulse in which a further ventricular sensed event may occur;

identifying ventricular sensed events occurring within said oversense interval as oversense events when the ventricular sensed events in the oversense interval do not follow a ventricular pace pulse delivered immediately preceding a preceding ventricular sensed event;

counting said oversense events to produce an oversense event count;

comparing the oversense event count with said oversense event criteria; and

recording a ventricular EGM epoch in said device memory in response to said oversense event count meeting said oversense event criteria.

24. The method of claim 23 further comprising the step of recording the date and time that the EGM epoch is recorded in device memory, in conjunction with the recording step.

25. The method of claim 23 further comprising the steps of:

timing the actual interval of an oversense event from a preceding pace pulse or ventricular sensed event; and

in conjunction with the recording step, recording the timed actual interval with the EGM epoch that is recorded in device memory in association with the oversense event.

26. In an implantable pulse generator having sensing ventricular events through a sensing lead coupled with the ventricle of a patient'"'"'s heart, a device memory, means for recording a ventricular electrogram (EGM) in said device memory, and means for generating ventricular pace pulses for pacing the heart, a system for recording an EGM epoch in an oversensing condition of ventricular sensed events for a determination of potential sensing lead integrity failure or electromagnetic interference comprising:

means for establishing an oversense interval following a preceding ventricular event or ventricular pace pulse in which a further ventricular sensed event may occur;

means for identifying ventricular sensed events occurring within said oversense interval as oversense events when the ventricular sensed events in the oversense interval do not follow a ventricular pace pulse delivered immediately preceding a preceding ventricular sensed event;

means for counting said oversense events to produce an oversense event count;

means for comparing the oversense event count with said oversense event criteria; and

means for recording a ventricular EGM epoch in said device memory in response to a said oversense event count meeting said oversense event criteria.

27. The system of claim 26 further comprising:

means for recording the date and time that the EGM epoch is recorded in said device memory in association with the recorded EGM epoch.

28. The system of claim 26 further comprising:

means for timing the actual interval of an oversense event from a preceding paced or sensed event; and

means for recording the timed actual interval with the EGM epoch that is recorded in said device memory in association with the oversense event.

29. In an implantable cardiac medical device having means for providing a cardiac therapy in response to a sensed condition and having a device memory for storage of the cardiac electrogram (EGM), a system for responding to an oversense condition that may incorrectly result in the provision of the therapy comprising:

a ventricular sensing lead having at least one sense electrode positioned in relation to a ventricle of a patient'"'"'s heart;

ventricular sense amplifier means for sensing electrical signals conducted on the sensing lead including ventricular depolarizations of the patient'"'"'s heart and providing a ventricular sensed event signal in response thereto;

means for establishing an oversense interval following a ventricular sensed event signal or a ventricular pace pulse;

means for identifying ventricular sensed event signals occurring within said oversense short interval as oversense events;

means for counting said oversense events to produce an oversense event count;

means for comparing the oversense event count with oversense event count criteria; and

means for recording a ventricular EGM epoch in said device memory in response to said oversense count meeting said oversense event count criteria.

30. The system of claim 29 further comprising:

means for recording the date and time that the EGM epoch is recorded in said device memory in association with the recorded EGM epoch.

31. The system of claim 29 further comprising:

means for timing the actual interval of an oversense event from a preceding paced or sensed event; and

means for recording the timed actual interval with the EGM epoch that is recorded in said device memory in association with the oversense event.