System and method for recording and storing medical data in response to a programmable trigger

• US 5,908,392 A
• Filed: 03/13/1996
• Issued: 06/01/1999
• Est. Priority Date: 03/13/1996
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Wilson, Raymond J., Sloman, Laurence S.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/596,895
• Time in Patent Office: 1,175 Days
• Field of Search: 600/509, 600/513, 600/515, 600/518, 600/516, 600/517, 600/519, 600/521, 600/522, 600/523, 607/2, 607/4, 607/5, 607/6, 607/9, 607/14, 607/17-26, 607/30, 607/62, 607/32
• US Class Current: 600/509
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

The system of the present invention records and stores, in long-term memory and in form of data snapshots, medical data acquired prior to and subsequent to an occurrence of cardiac episodes and implantable device functions defined as important by the medical practitioner. The system provides the medical practitioner with the ability to specify trigger criteria representative of important cardiac episodes and implantable device functions. The system of the present invention allows the medical practitioner to control the amount of medical data stored in the data snapshots. The system allows the medical practitioner to specify a mode of storing data snapshots when the maximum storage capacity of long-term memory has been reached. In a first mode, the system stores data snapshots in a circular buffer manner, overwriting the older data snapshots. In a second mode, the system stops storing new data snapshots after the maximum storage capacity of long-term memory has been reached.

Claims

1. A diagnostic system for use with an implantable medical device, the system comprising:

sensing means for acquiring medical data from a heart;

first storage means for temporarily storing the medical data acquired by the sensing means;

a first selection means for selecting at least one trigger criteria from a plurality of trigger criteria;

second storage means for storing the at least one programmable trigger criterion;

first control means for applying the at least one trigger criterion to the medical data stored in the first storage means and for determining whether the at least one trigger criteria has been met; and

third storage means responsive to the first control means, for storing medical data acquired before and after the first control means determines that at least one trigger criterion has been met.

2. The diagnostic system of claim 1, wherein:

the medical data comprises at least two cardiac events; and

the medical data further comprises event time data representative of the time between a current cardiac event and a previous cardiac event.

3. The diagnostic system of claim 2, wherein the medical data comprises at least one waveform.

4. The diagnostic system of claim 3, further comprising:

a physiological sensor for sensing a physiological parameter of the body; and

selection means for selecting the physiological sensor for the at least one waveform.

5. The diagnostic system of claim 3, further comprising:

second control means for defining a predetermined number of samples for the at least one waveform that may be acquired by the sensing means during a single cardiac cycle.

6. The diagnostic system of claim 3, wherein the first storage means comprises:

fourth storage means for temporarily storing the current cardiac event and also for storing the corresponding event time data; and

fifth storage means for temporarily storing the at least one waveform.

7. The diagnostic system of claim 6, further comprising:

second control means for defining a first data limit for the fourth storage means, wherein the first data limit is representative of the maximum number of the at least one cardiac events that may be stored in the fourth storage means; and

third control means for defining a second data limit for the fifth storage means, wherein the second data limit is representative of a maximum number of samples for the at least one waveform that may be stored in the fifth storage means.

8. The diagnostic system of claim 7, wherein the fourth and the fifth storage means are circular buffers, and wherein:

after the first data limit is reached the first control means overwrites the at least one cardiac event and the event time data stored in the fourth storage means with a newly acquired at least one cardiac event; and

after the second data limit is reached the first control means overwrites the at least one waveform stored in the fifth storage means with a newly acquired at least one waveform.

9. The diagnostic system of claim 8, wherein the third storage means further comprises:

sixth storage means responsive to the first control means, for storing at least one event snapshot, wherein the at least one event snapshot is representative of the at least one cardiac event and of the event time data acquired before and after the first control means determine that the at least one trigger criterion has been met; and

seventh storage means responsive to the first control means, for storing at least one waveform snapshot, wherein the at least one waveform snapshot is representative of the at least one waveform acquired before and after the first control means determine that the at least one trigger criterion has been met.

10. The diagnostic system of claim 9, further comprising:

fourth control means for disabling the sixth storage means; and

eleventh control means for disabling the seventh storage means.

11. The diagnostic system of claim 9, further comprising:

fourth control means, responsive to the first control means, for transferring the medical data stored in the fourth storage means to the sixth storage means, after the first control means determine that the at least one trigger criterion has been met;

fifth control means, responsive to the first control means, for transferring the medical data stored in the fifth storage means to the seventh storage means, after the first control means determine that the at least one trigger criterion has been met;

first recording means, responsive to the first control means, for recording into the sixth and the seventh storage means, after the first control means determine that the at least one trigger criterion has been met, data representative of the at least one trigger criterion which has been met, and data representative of the time and date during which the at least one trigger criterion has been met.

12. The diagnostic system of claim 11, further comprising:

sixth control means for defining a third data limit for the sixth storage means, wherein the third data limit is representative of the number of the at least one cardiac events that must be stored in the sixth storage means after the recording means record the data representative of the time and date during which the at least one trigger criterion has been met; and

seventh control means for defining a fourth data limit for the seventh storage means, wherein the fourth data limit is representative of maximum number of samples for the at least one waveform that must be stored in the seventh storage means after the recording means record the data representative of the time and date during which the at least one trigger criterion has been met.

13. The diagnostic system of claim 12, wherein after the recording means record data representative of the time and date during which the at least one trigger criterion has been met, the first control means:

stores the at least one cardiac event newly acquired by the sensing means, and the event time data in the sixth storage means instead of the fourth storage means until the third data limit is reached; and

stores the at least one waveform newly acquired by the sensing means in the seventh storage means instead of the fifth storage means until the fourth data limit is reached.

14. The diagnostic system of claim 13, wherein the first control means:

stores a marker representative of the end of the at least one event snapshot, in the sixth storage means when the third data limit is reached; and

stores a marker representative of the end of the at least one waveform snapshot, in the seventh storage means when the fourth data limit is reached.

15. The diagnostic system of claim 14, further comprising:

eighth control means for defining a fifth data limit representative of the maximum number of the at least one event snapshots which may be stored in the sixth storage means; and

ninth control means for defining a sixth data limit representative of the maximum number of the at least one waveform snapshots which may be stored in the seventh storage means.

16. The diagnostic system of claim 15, further comprising tenth control means for defining whether the sixth and seventh storage means operate as circular buffers, wherein:

when the sixth storage means is defined as a circular buffer, after the fifth data limit is reached the first control means overwrites the at least one event snapshot stored in the sixth storage means with a newly generated at least one event snapshot, starting with the first at least one event snapshot stored in the sixth storage means; and

wherein when the sixth storage means is defined as standard buffer, after the fifth data limit is reached the first control means disables the sixth storage means so that no further event snapshots may be stored; and

when the seventh storage means is defined as a circular buffer, after the sixth data limit is reached the first control means overwrites the at least one waveform snapshot stored in the seventh storage means with a newly generated at least one waveform snapshot, starting with the first at least one waveform snapshot stored in the seventh storage means; and

wherein when the seventh storage means is defined as standard buffer, after the sixth data limit is reached the first control means disables the seventh storage means so that no further waveform snapshots may be stored.

17. A diagnostic method for use with a medical device implanted in a patient, the method comprising the steps of:

(a) acquiring medical data from a heart;

(b) temporarily storing the medical data acquired during the acquiring step;

(c) selecting at least one trigger criterion from a plurality of trigger criteria;

(d) storing the at least one programmable trigger criteria;

(e) applying the at least one trigger criteria to the medical data stored during step (b);

(f) determining whether the at least one trigger criteria has been met; and

(g) storing medical data acquired before and after the determination at step (e) that at least one trigger criterion has been met.

18. The diagnostic method of claim 17, wherein the medical data comprises at least two cardiac events and event time data representative of the time between each of the at least two cardiac events.

19. The diagnostic method of claim 18, wherein the medical data comprises at least one waveform.

20. The diagnostic method of claim 19, further comprising the step of:

(h) selecting a physiological sensor as a source for the at least one waveform.

21. The diagnostic method of claim 19, further comprising the step of:

(h) defining the amount of the at least one waveform that may be acquired at step (a) during a single cardiac cycle.

22. The diagnostic method of claim 19, wherein step (b) further comprises the steps of:

(h) temporarily storing the at least one cardiac event and the event time data in a first memory location; and

(i) temporarily storing the at least one waveform in a second memory location.

23. The diagnostic method of claim 22, further comprising the steps of:

defining a first memory limit for the first memory location, wherein the first memory limit is representative of the maximum number of the at least one cardiac events that may be stored in the first memory location; and

defining a second memory limit for the second memory location, wherein the second memory limit is representative of the maximum number of samples for the at least one waveform that may be stored in the second memory location.

24. The diagnostic method of claim 23, wherein steps (h) and (i) store the medical data in circular buffers, and further comprises the steps of:

(j) overwriting the at least one cardiac event and the event time data stored in the first memory location with an at least one cardiac event newly acquired at step (a) after the first memory limit is reached; and

(k) overwriting the at least one waveform stored in the second memory location with an at least one waveform newly acquired at step (a), after the second memory limit is reached.

25. The diagnostic method of claim 24, wherein step (f) further comprises the steps of:

(l) storing at least one event snapshot in a third memory location, wherein the at least one event snapshot is representative of the at least one cardiac event and of the event time data acquired before and after the determination at step (e) that the at least one trigger criterion has been met; and

(m) storing at least one waveform snapshot in a fourth memory location, wherein the at least one waveform snapshot is representative of the at least one waveform acquired before and after the determination at step (e) that the at least one trigger criterion has been met.

26. The diagnostic method of claim 25, further comprising the steps of:

(z) disabling the third memory location; and

(aa) disabling the fourth memory location.

27. The diagnostic method of claim 25, further comprising the steps of:

(n) transferring the contents of the first memory location to the third memory location, after the determination at step (e) that the at least one trigger criterion has been met;

(o) transferring the contents of the second memory location to the fourth memory location, after the determination at step (e) that the at least one trigger criterion has been met; and

(p) recording into the third and fourth memory locations, after step (o), data representative of the at least one trigger criterion which has been met, and data representative of the time and date during which the at least one trigger criterion has been met.

28. The diagnostic method of claim 27, further comprising the steps of:

(q) defining a third memory limit for the third memory location, wherein the third memory limit is representative of the number of the at least one cardiac events that must be stored in the third memory location after step (p); and

(r) defining a fourth memory limit for the fourth memory location, wherein the fourth memory limit is representative of a maximum number of samples for the at least one waveform that must be stored in the fourth memory location after step (p).

29. The diagnostic method of claim 28, further comprising the steps of:

(s) storing the at least one cardiac event newly acquired at step (a) and the event time data, in the third memory location instead of the first memory location until the third memory limit is reached; and

(t) storing the at least one waveform newly acquired at step (a) in the fourth memory location instead of the second memory location until the fourth memory limit is reached.

30. The diagnostic method of claim 29, further comprising the steps of:

(u) storing a marker representative of the end of the at least one event snapshot, in the third memory location when the third memory limit is reached; and

(v) storing a marker representative of the end of the at least one waveform snapshot, in the fourth memory location when the fourth memory limit is reached.

31. The diagnostic method of claim 30, further comprising the steps of:

(w) defining a fifth memory limit representative of the maximum number of the at least one event snapshots which may be stored in the third memory location; and

(x) defining a sixth memory limit representative of the maximum number of the at least one waveform snapshots which may be stored in the fourth memory location.

32. The diagnostic method of claim 31, further comprising the step of:

(y) defining whether the third and the fourth memory locations operate as circular buffers or as standard buffers, wherein;

when the third memory location is defined as a circular buffer, after the fifth memory limit is reached, a newly generated at least one event snapshot overwrites the older at least one event snapshot stored in the third memory location; and

wherein when the third memory location is defined as standard buffer, after the fifth memory limit is reached the third memory location is disabled so that no further event snapshots may be stored; and

when the fourth memory location is defined as a circular buffer, after the sixth memory limit is reached, a newly generated at least one waveform snapshot overwrites the older at least one event snapshot stored in the fourth memory location; and

wherein when the fourth memory location is defined as standard buffer, after the sixth memory limit is reached, the fourth memory location is disabled so that no further waveform snapshots may be stored.

33. In an implantable cardiac device, a system for recording and storing intracardiac electrogram waveforms, comprising:

converting means for acquiring and converting intracardiac electrogram waveforms into digitized intracardiac electrogram waveforms;

storing means, coupled to the converting means, for temporarily storing a first predetermined number of the digitized intracardiac electrogram waveforms;

detecting means for detecting when a change in a patient'"'"'s rhythm has occurred and for producing at least one rhythm-change signal in response thereto; and

control means, in response to the detecting means, for triggering the storing means to permanently store the first predetermined number of digitized intracardiac electrogram waveforms acquired before the at least one rhythm-change signal was detected, and a second predetermined number of digitized intracardiac electrogram waveforms after the at least one rhythm-change signal was detected.

34. The system as recited in claim 33, further comprising:

means for programmably defining a high atrial rate threshold; and

means for detecting when the high atrial rate threshold has been exceeded and producing a high atrial rate signal in response thereto;

wherein the rhythm-change signal comprises the high atrial rate signal.

35. The system as recited in claim 33, further comprising:

means for programmably defining a low atrial rate threshold; and

means for detecting when the low atrial rate threshold has been exceeded and producing a low atrial rate signal in response thereto;

wherein the rhythm-change signal comprises the low atrial rate signal.

36. The system as recited in claim 33, comprising:

means for programmably defining a high ventricular rate threshold; and

means for detecting when the high ventricular rate threshold has been exceeded and producing a high ventricular rate signal in response thereto;

wherein the rhythm-change signal comprises the low atrial rate signal.

37. The system as recited in claim 33, comprising:

means for programmably defining a low ventricular rate threshold; and

means for detecting when the low ventricular rate threshold has been exceeded and producing a low ventricular rate signal in response thereto;

wherein the rhythm-change signal comprises the low ventricular rate signal.

38. The system as recited in claim 33, comprising:

means for programmably defining a predetermined number of consecutive premature ventricular contractions (PVCs); and

means for detecting when the predetermined number has been exceeded and producing a high PVC signal in response thereto;

wherein the rhythm-change signal comprises the high PVC signal.

39. The system as recited in claim 33, further comprising:

means for programmably defining a predetermined number of consecutive pacemaker mediated tachycardias (PMTs); and

means for detecting when the predetermined number has been exceeded and producing a high PMT signal in response thereto;

wherein the rhythm-change signal comprises the high PMT signal.

40. In an implantable cardiac device, a system for recording and storing intracardiac electrogram waveforms, comprising:

converting means for acquiring and converting intracardiac electrogram waveforms into digitized intracardiac electrogram waveforms;

storing means, coupled to the converting means, for temporarily storing a first predetermined number of the digitized intracardiac electrogram waveforms;

programming means for selectively programming a plurality of functions into the implantable medical device;

detecting means for detecting when a change in at least one of the plurality of functions has occurred and for producing a change-in-function signal in response thereto; and

control means, in response to the detecting means, for triggering the storing means to permanently store the first predetermined number of digitized intracardiac electrogram waveforms acquired before the at least one change-in-function signal was detected, and a second predetermined number of digitized intracardiac electrogram waveforms after the at least one change-in-function signal was detected.

41. The system as recited in claim 40, wherein:

the control means includes means for selectively operating the implantable device in one of a plurality of modes of operation, the plurality of modes of operation being selectable by the programming means;

the detecting means includes means for detecting a change in at least one of the plurality of modes of operation and for producing a change-in-mode signal in response thereto; and

the at least one change-in-function signal comprises the change-in-mode signal.

42. In an implantable cardiac device, a system for recording and storing intracardiac diagnostic data, comprising:

converting means for acquiring a plurality of intracardiac diagnostic data, including intracardiac electrogram waveforms, and converting the data into digitized signals;

storing means, coupled to the converting means, for temporarily storing a first predetermined number of the digitized signals;

detecting means for detecting when a change has occurred in one of the plurality of intracardiac diagnostic data, and for producing a trigger signal in response thereto; and

control means, in response to the detecting means, for triggering the storing means to permanently store the first predetermined number of digitized signals acquired before the trigger signal was detected, and a second predetermined number of digitized signals after the trigger signal was detected.