Implantable medical device (IMD) system configurable to subject a patient to a stress test and to detect myocardial ischemia within the patient

• US 6,882,883 B2
• Filed: 08/31/2001
• Issued: 04/19/2005
• Est. Priority Date: 08/31/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stadler, Robert W., Stylos, Lee, Condie, Catherine R.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/945,195
• Publication Number:
  US 20030045908A1
• Time in Patent Office: 1,327 Days
• Field of Search: 607/4, 607/5, 607/11, 607/30, 607/32, 600/510, 600/515, 600/516, 600/517, 600/518
• US Class Current: 607/11
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/4884 inducing physiological or psychological stress, e.g. applications for stress testing
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39

Abstract

Various implantable medical devices (IMDs) are disclosed for implantation in a patient. The IMD includes pacing circuitry configured to selectively produce pacing pulses at a programmable pacing rate. In one embodiment, the IMD is configurable to subject a patient to a stress test. The IMD may be configurable to subject the patient to the stress test at the time specified by stored timing information, or in response to a signal (e.g., from a patient activator). Another embodiment of the implantable medical device (IMD) includes sensor circuitry, a memory for storing data, and a control unit. The sensor circuitry produces sensor data relating to cardiac condition. The control unit is configurable to store the sensor data in the memory until a trigger signal is received. Methods are described for performing a stress test in a patient with an IMD, and for subsequently reproducing cardiac operational states.

Claims

1. An implantable medical device (IMD) for implantation in a patient to detect symptomatic and asymptomatic myocardial ischemia, comprising:

pacing circuitry configured to selectively produce pacing pulses at a programmable pacing rate for delivery to muscle tissue of a heart of the patient,

wherein the pacing circuitry is configurable to subject the patient to a variety of stress tests, and wherein the variety of stress tests further comprise;

(i) a first stress test protocol wherein the programmable pacing rate is slowly increased at from between about five paces per minute (ppm) to about ten ppm from a start rate to a stop rate, wherein the stop rate is greater than the start rate, and the patient'"'"'s response to the first stress test protocol is acquired and stored in a memory structure as a part of a stress test data set;

(ii) a second stress test protocol wherein the IMD is configurable to store timing information specifying a time the IMD is to subject the patient to the first stress test protocol, and to subject the patient to the first stress test protocol at the time, day and/or date specified by the timing information, and the patient'"'"'s response to the second stress test protocol is acquired and stored in the memory structure as a part of the stress test data set; and

(iii) a third stress test protocol wherein the protocol comprises recreating the physiologic conditions of a previously stored episode of paced or intrinsic symptomatic myocardial ischemia that were stored in the memory structure after the patient triggers an episode storage event, and the patient'"'"'s response to the third stress test protocol is acquired and stored in the memory structure as a part of the stress test data set.

2. The implantable medical device (IMD) as recited in claim 1, wherein the timing information specifies a frequency and a time of day the IMD is to subject the patient to the stress test.

3. The implantable medical device (IMD) as recited in claim 1, wherein the IMD is adapted to receive a signal, and configurable to subject the patient to at least one of the first, second and third stress test protocol in response to the signal.

4. The implantable medical device (IMD) as recited in claim 3, wherein the signal is a radio frequency signal.

5. The implantable medical device (IMD) as recited in claim 1, wherein the IMD is configurable to detect at least one sign of myocardial ischemia within the patient during the first, second and third stress test protocols, and wherein the IMD is configurable to abort each the stress test protocols when the at least one sign of myocardial ischemia is detected within the patient.

6. The implantable medical device (IMD) as incited in claim 5, wherein the at least one sign of myocardial ischemia comprises deviation of an ST segment of an electrogram (EGM) waveform from an isoelectric baseline of the electrogram (EGM) waveform.

7. The implantable medical device (IMD) as recited in claim 1, wherein the IMD is adapted to receive a signal, and configurable to abort at least one of the first, second and third stress test protocols in progress at a time the signal is received.

8. The implantable medical device (IMD) as recited in claim 7, wherein the signal is a radio frequency signal.

9. The implantable medical device (IMD) as recited in claim 1, wherein during at least the first stress test protocol, the pacing rate is monotonically increased from the start rate to the stop rate.

10. The implantable medical device (IMD) as recited in claim 1, wherein during at least the first stress test protocol, the pacing rate is increased from the start rate to the stop rate by:

(i) programming the pacing rate to be the start rate, and (ii) at pre-selected time intervals, reprogramming the pacing rate to be a sum of a current value of the pacing rate and a pre-selected rate-of-change value.

11. The implantable medical device (IMD) as recited in claim 1, wherein the stress test data set comprises electrogram (EGM) waveform data produced within the IMD.

12. The implantable medical device (IMD) as recited in claim 11, wherein the IMD is coupled to receive a signal from at least one intrathoracic electrode, and wherein the electrogram (EGM) waveform is an intrathoracic electrogram (EGM) waveform.

13. The implantable medical device (IMD) as recited in claim 11, wherein the IMD is coupled to receive a signal generated within the heart, and wherein the electrogram (EGM) waveform is an intracardiac electrogram (EGM) waveform.

14. The implantable medical device (IMD) as recited in claim 11, wherein the electrogram (EGM) waveform comprises an ST segment and an isoelectric baseline, and wherein the EGM data comprises a measurement of deviation of the ST segment from the isoelectric baseline.

15. The implantable medical device (IMD) as recited in claim 1, wherein the IMD is coupled to receive sensor data, and wherein the stress test data set comprises the sensor data.

16. The implantable medical device (IMD) as recited in claim 1, wherein the stress test data set comprises pacing threshold data produced within the IMD and indicative of an amount of energy dissipated by the pacing circuitry while producing the pacing pulses.

17. The implantable medical device (IMD) as recited in claim 1, wherein the stress test data set comprises arrhythmia data produced within the IMD and indicative of detected arrhythmias of the heart of the patient.

18. The implantable medical device (IMD) as recited in claim 1, wherein the IMD is coupled to receive a first intrinsic depolarization signal and a second intrinsic depolarization signal from the heart of the patient, and wherein the IMD is configurable to operate in a demand mode, and wherein in the demand mode, if the second intrinsic depolarization signal is not received within a predetermined time period, determined by the pacing rate, after the first intrinsic depolarization signal is received, the pacing circuitry is signaled to produce one of the pacing pulses.

19. The implantable medical device (IMD) as recited in claim 1, wherein during an initial portion of one of the first stress test protocol and the second stress test protocol:

(i) the programmed pacing rate is programmed such that the pacing rate is increased from a start rate to a stop rate, and (ii) stress test data set is acquired and stored within the IMD, and wherein during a final portion of one of the first stress test protocol and the second stress test protocol the pacing rate is programmed such that the programmed pacing rate is decreased from the stop rate to the start rate, and the IMD provides the stress test data stored within the IMD.

20. The implantable medical device (IMD) as recited in claim 1, wherein the IMD is a pacemaker.

21. The implantable medical device (IMD) as recited in claim 1, wherein pacing pulses received by the muscle tissue of the heart cause the muscle tissue to depolarize.

22. An implantable medical device for implantation in a patient, comprising;

pacing circuitry configured to selectively produce pacing pulses at a programmable pacing rate for delivery to muscle tissue of a heart of the patient;

a memory for storing data, including a stress test data set; and

a control unit coupled to the pacing circuitry and the memory, wherein the control unit is configurable to subject the patient to a variety of stress test protocols, and wherein;

during a first the stress test protocol the control unit programs the pacing rate such that the pacing rate is increased incrementally at about between five paces per minute and ten ppm from a start rate to a stop rate, wherein the stop rate is greater than the start while acquiring and storing the stress test data set in the memory; and

during a second stress test protocol the control unit recreates the physiologic conditions of a previously stored episode of paced or intrinsic symptomatic myocardial ischemia that were stored in the memory after the patient triggers an episode storage event, and the patient'"'"'s response to the third stress test protocol is acquired and stored in the memory as a part of the stress test data set, wherein the device further comprises;

a clock circuit coupled to the control unit and configured to keep track of time; and

a telemetry unit coupled to the control unit and configured to send and receive signals and data; and

wherein the control unit is configurable to receive timing data or a trigger signal via the telemetry unit, wherein the timing data specifies a time the IMD is to subject the patient to the stress test so that the clock circuit or the trigger signal to subject the patient to one of the first stress test protocol and the second stress test protocol at the time specified by the timing data or upon receipt of the trigger signal, respectively.

23. The implantable medical device (IMD) as recited in claim 22, wherein the timing data specifies a frequency and a time of day the IMD is to subject the patient to the stress test.

24. The implantable medical device (IMD) as recited in claim 22, further comprising a telemetry unit coupled to the control unit and configured to send and receive signals and data, wherein the control unit is configurable to subject the patient to one of the variety of stress test protocols in response to a signal received via the telemetry unit.

25. The implantable medical device (IMD) as recited in claim 24, wherein the signal is a radio frequency signal.

26. The implantable medical device (IMD) as recited in claim 22, wherein the control unit is configurable to detect at least one sign of myocardial ischemia within the patient during one of the variety of stress test protocols, and wherein the control unit is configurable to abort and applied one of the variety of stress test protocols when the at least one sign of myocardial ischemia is detected within the patient.

27. The implantable medical device (IMD) as recited in claim 26, wherein the at least one sign of myocardial ischemia comprises deviation of an ST segment of an electrogram (EGM) waveform from an isoelectric baseline of the electrogram (EGM) waveform.

28. The implantable medical device (IMD) as recited in claim 22, further comprising a telemetry unit coupled to the control unit and configured to send and receive signals and data, wherein the control unit is configurable to abort a stress test in progress at a time a signal is received via the telemetry unit.

29. The implantable medical device (IMD) as recited in claim 28, wherein the signal is a radio frequency signal.

30. The implantable medical device (IMD) as recited in claim 22, wherein during the stress test, the control unit programs the pacing rate such that the pacing rate is monotonically increased from the start rate to the stop rate.

31. The implantable medical device (IMD) as recited in claim 22, wherein during the stress test, the control unit (i) programs the pacing rate to be the start rate, and (ii) at pre-selected time intervals, reprograms the pacing rate to be a sum of a current value of the pacing rate and a pre-selected rate-of-change value.

32. The implantable medical device (IMD) as recited in claim 22, further comprising electrode sensing circuitry coupled to receive electrode signals and configured to produce electrogram (EGM) waveform data derived from an electrogram (EGM) waveform, wherein the stress test data set comprises the electrogram (EGM) waveform data.

33. The implantable medical device (IMD) as recited in claim 32, wherein the electrode sensing circuitry is coupled to receive electrode signals from at least one intrathoracic electrode and configured to produce intrathoracic electrogram (EGM) waveform data, and wherein the stress test data set comprises the intrathoracic electrogram (EGM) waveform data.

34. The implantable medical device (IMD) as recited in claim 32, wherein the electrode sensing circuitry is coupled to receive electrode signals from at least one intracardiac electrode and configured to produce intracardiac electrogram (EGM) waveform data, and wherein the stress test data set comprises the intracardiac electrogram (EGM) waveform data.

35. The implantable medical device (IMD) as recited in claim 32, wherein the electrogram (EGM) waveform comprises an ST segment and an isoelectric baseline, and wherein the electrogram (EGM) waveform data comprises data indicative of a deviation of the ST segment from the isoelectric baseline.

36. The implantable medical device (IMD) as recited in claim 22, wherein the control unit is coupled to receive sensor data, and wherein the stress test data set comprises the sensor data.

37. The implantable medical device (IMD) as recited in claim 22, wherein the control unit is coupled to receive pacing threshold data produced within the IMD and indicative of an amount of energy dissipated by the pacing circuitry while producing the pacing pulses, and wherein the stress test data set comprises the pacing threshold data.

38. The implantable medical device (IMD) as recited in claim 22, wherein the control unit is coupled to receive arrhythmia data produced within the IMD and indicative of detected arrhythmias of the heart of the patient, and wherein the stress test data set comprises the arrhythmia data.

39. The implantable medical device (IMD) as recited in claim 22, further comprising timing/pacing control circuitry coupled to receive a first intrinsic depolarization signal and a second intrinsic depolarization signal from the heart of the patient, wherein the IMD is programmable to operate in a demand mode, and wherein in the demand mode, if the timing/pacing control circuitry does not receive the second intrinsic depolarization signal within a predetermined time period, determined by the pacing rate, after the timing/pacing control circuitry receives the first intrinsic depolarization signal, the timing/pacing control circuitry is configured to signal the pacing circuitry to produce one of the pacing pulses.

40. The implantable medical device (IMD) as recited in claim 22, further comprising a telemetry unit coupled to the control unit and configured to send and receive signals and data, wherein during an initial portion of the first stress test protocol, the control unit:

(i) programs the pacing rate such that the pacing rate is increased from the start rate to the stop rate, and (ii) acquires and stores the stress test data in the memory, and wherein during a final portion of the first stress test protocol, the control unit;

(iii) programs the pacing rate such that the pacing rate is decreased from the stop rate to the start rate, and (iv) provides the stress test data set stored in the memory via the telemetry unit.

41. A medium for producing control signals for executing an instruction set in an implantable medical device (IMD) to perform a method of detecting a symptomatic or asymptomatic episode of myocardial ischemia, said medium comprising:

(i) instructions for performing a first stress test protocol wherein a programmable pacing rate is slowly increased at from between about five paces per minute (ppm) to about ten ppm from a start rate to a stop rate, wherein the stop rate is greater than the start rate, and including instructions for acquiring and storing a patient'"'"'s response to the first stress test protocol in a memory structure as a part of a stress test data set;

(ii) instructions for performing a second stress test protocol according to stored timing information specifying a time the IMD is to subject the patient to the first stress test protocol, and including instructions to subject the patient to the first stress test protocol at the time, day and/or date specified by the timing information, and including instructions for acquiring and storing the patient'"'"'s response to the second stress test protocol in the memory structure as a part of the stress test data set; and

(iii) instructions for performing a third stress test protocol wherein the protocol comprises recreating the physiologic conditions of a previously stored episode of paced or intrinsic symptomatic myocardial ischemia that were stored in the memory structure after the patient triggers an episode storage event, and including acquiring and storing the patient'"'"'s response to the third stress test protocol in the memory structure as a part of the stress test data set.