Implantable stimulation device and method for determining ventricular and atrial sensitivity thresholds

• US 6,311,089 B1
• Filed: 08/20/1999
• Issued: 10/30/2001
• Est. Priority Date: 05/14/1996
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Levine, Paul A., Mann, Brian M., Endaya, Melinda
• Primary Examiner(s): Layno, Carl
• Application Number:
  US09/378,149
• Time in Patent Office: 802 Days
• Field of Search: 607/9, 607/30
• US Class Current: 607/30
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/3714 Atrial capture

Abstract

A pacemaker programmer and diagnostic system retrieves information stored within a pacemaker and analyzes the retrieved data in real time. The stored information can be retrieved by a telemetry communication link. The programmer includes features for allowing the physician to interactively adjust program parameters while viewing the results of parameter changes in real-time. The programmer performs a ventricular sensitivity threshold test by setting the stimulation device to an atrial tracking mode, and by assessing the ventricular sensing of the pacemaker. If ventricular sensing is confirmed, the processor performs a ventricular sensitivity threshold test to determine the pacemaker ventricular sensitivity threshold, and then automatically adjusts the ventricular sensitivity to within a safety margin from the ventricular sensitivity threshold. The programmer also performs an atrial sensitivity threshold test by setting the stimulation device to the atrial tracking mode, and by assessing the atrial sensing of the pacemaker. If atrial sensing is confirmed, the programmer determines whether the base rate is less than the sensed atrial rate by 20 BPM or more; if so, the processor performs an atrial sensitivity threshold test to determine the pacemaker atrial sensitivity threshold, and automatically adjusts the atrial sensitivity to within a safety margin from the atrial sensitivity threshold.

Claims

1. A method of determining a ventricular sensitivity threshold in a stimulation device having programmable AV delay and ventricular sensitivity, the method comprising:

automatically determining an optimum AV delay value;

automatically adjusting the AV delay to the optimum AV delay value;

adjusting the ventricular sensitivity until a ventricular sensitivity threshold is identified;

setting the ventricular sensitivity to within a safety margin value from the ventricular sensitivity threshold; and

performing an automatic ventricular sensing test using the optimum AV delay value and the ventricular sensitivity setting within the safety margin value,

wherein determining the optimum AV delay value comprises;

automatically determining if intact conduction exists by detecting the presence of R-waves in a lengthened AV delay interval; and

determining the optimum AV delay value as the value which permits conduction of R-waves.

2. The method, as recited in claim 1, further comprises restoring the AV delay value upon completion of the ventricular sensing test.

3. A method of determining ventricular sensitivity threshold in a stimulation device having programmable AV delay, ventricular sensitivity, and post-ventricular refractory period (PVARP), the method comprising:

automatically determining an optimum AV delay value;

automatically adjusting the AV delay to the optimum AV delay value;

lengthening the post-ventricular refractory period (PVARP);

adjusting the ventricular sensitivity until a ventricular sensitivity threshold is identified;

setting the ventricular sensitivity to within a safety margin value from the ventricular sensitivity threshold; and

performing an automatic ventricular sensing test using the optimum AV delay value and the ventricular sensitivity setting within the safety margin value.

4. The method, as recited in claim 3, further comprising restoring the post ventricular refractory period (PVARP) upon completion of the ventricular sensing test.

5. A stimulation device having a programmable AV delay, comprising:

a pulse generator;

sensing circuitry, coupled to the pulse generator, and having a programmable ventricular sensitivity configured to sense R-waves; and

a processor, coupled to the pulse generator and to the sensing circuitry, and programmed to verify intact conduction by detecting the presence of the R-waves in a lengthened AV delay interval, wherein if intact conduction exists, then the processor is programmed to initiate a ventricular sensitivity threshold test using the lengthened AV delay interval, the processor further being programmed to adjust ventricular sensitivity until a threshold value is determined and also to subsequently set the ventricular sensitivity to a safety margin value from the threshold value; and

wherein the processor is programmed to decrease a ventricular rate in the absence of intact conduction.

9. The device, as recited in claim 5, the pulse generator is a dual-chamber cardiac implantable device.

6. A stimulation device having a programmable AV delay, comprising:

a pulse generator;

sensing circuitry, coupled to the pulse generator, and having a programmable ventricular sensitivity configured to sense R-waves; and

a processor, coupled to the pulse generator and to the sensing circuitry, and programmed to verify intact conduction by detecting the presence of the R-waves in a lengthened AV delay interval, wherein if intact conduction exists, then the processor is programmed to initiate a ventricular sensitivity threshold test using the lengthened AV delay interval, the processor further being programmed to adjust ventricular sensitivity until a threshold value is determined and also to subsequently set the ventricular sensitivity to a safety margin value from the threshold value; and

wherein the processor is programmed to restore the AV delay upon completion of the ventricular sensitivity threshold test.

7. A stimulation device having a programmable AV delay, comprising:

a pulse generator;

sensing circuitry, coupled to the pulse generator, and having a programmable ventricular sensitivity configured to sense R-waves;

a processor, coupled to the pulse generator and to the sensing circuitry, and programmed to verify intact conduction by detecting the presence of the R-waves in a lengthened AV delay interval, wherein if intact conduction exists, then the processor is programmed to initiate a ventricular sensitivity threshold test using the lengthened AV delay interval, the processor further being programmed to adjust ventricular sensitivity until a threshold value is determined and also to subsequently set the ventricular sensitivity to a safety margin value above the threshold value;

wherein the device further comprises a timing circuitry, coupled to the processor, and configured to control the AV delay and a post-ventricular refractory period (PVARP);

wherein the processor is further programmed to automatically lengthen the post-ventricular refractory period (PVARP) during the sensitivity threshold test to reduce the possibility of premature and retrograde P-waves.

8. The device, as recited in claim 7, wherein the processor is further programmed to automatically restore the post ventricular refractory period (PVARP) subsequent to the sensitivity threshold test.

10. A programmer for determining ventricular sensitivity threshold in a stimulation device having programmable AV delay, ventricular sensitivity, and post-ventricular refractory period (PVARP), the programmer comprising:

sensing circuitry for automatically determining an optimum AV delay value;

a processor connected to said sensing circuitry for causing the AV delay to be automatically adjusted to the optimum AV delay value and for the post-ventricular refractory period (PVARP) to be lengthened;

the processor causing the ventricular sensitivity to be adjusted until a ventricular sensitivity threshold is identified, and the ventricular sensitivity to be set within a safety margin value from the ventricular sensitivity threshold; and

the processor performing an automatic ventricular threshold sensing test using the optimum AV delay value and the ventricular sensitivity setting within the safety margin value.

11. The programmer, as recited in claim 10, wherein the processor decreases a ventricular rate in the absence of intact conduction.

12. The programmer, as recited in claim 10, wherein the processor is programmed to restore the AV delay upon completion of the ventricular sensitivity threshold test.

13. The programmer, as recited in claim 10, wherein the processor automatically restores the post ventricular refractory period (PVARP) upon completion of the ventricular sensitivity threshold test.

14. A method of determining ventricular sensitivity threshold in a stimulation device having programmable AV delay and ventricular sensitivity, the method comprising:

automatically determining an optimum AV delay value;

automatically adjusting the AV delay to the optimum AV delay value;

adjusting the ventricular sensitivity until a ventricular sensitivity threshold is identified;

setting the ventricular sensitivity to a prescribed safety margin value above the ventricular sensitivity threshold; and

performing a sensing test using the optimum AV delay value.

15. A method for determining a ventricular sensitivity in a stimulation device having an adjustable ventricular sensitivity, the method comprising:

setting the stimulation device to an atrial tracking mode, if the stimulation device is operating in a non-atrial tracking mode;

assessing ventricular sensing of the stimulation device;

if ventricular sensing is confirmed, performing a ventricular sensitivity threshold test to determine a ventricular sensitivity threshold of the stimulation device; and

automatically adjusting the ventricular sensitivity to within a safety margin from the ventricular sensitivity threshold.

16. The method, as recited in claim 15, further including restoring the operation of the stimulation device to the non-atrial tracking mode.

17. The method, as recited in claim 15, wherein setting the stimulation device to the atrial tracking mode includes setting the stimulation device to a dual chamber pacing mode.

18. The method, as recited in claim 15, wherein the stimulation device has an adjustable AV delay;

wherein if ventricular sensing is not confirmed, then automatically increasing the AV delay; and

reassessing ventricular sensing of the stimulation device.

19. The method, as recited in claim 18, further including determining whether the AV delay has reached a maximum value;

and

wherein if the AV delay has reached the maximum value, determining if the stimulation device is operating in an atrial tracking mode.

20. The method, as recited in claim 19, wherein if the stimulation device is operating in an atrial tracking mode, setting the stimulation device to a non-atrial tracking mode, decreasing a test rate to a predetermined value, and reassessing the ventricular sensing of the stimulation device;

and

wherein if the stimulation device is not operating in an atrial tracking mode, resetting any parameter that has changed during the execution of the method to a base value, and disabling the ventricular sensitivity threshold test.

21. A programmer for determining a ventricular sensitivity in a stimulation device having an adjustable ventricular sensitivity, the programmer comprising:

a processor for setting the stimulation device to an atrial tracking mode if the stimulation device is operating in a non-atrial tracking mode;

the processor assessing ventricular sensing of the stimulation device;

if ventricular sensing is confirmed, the processor performing a ventricular sensitivity threshold test to determine the ventricular sensitivity threshold of the stimulation device; and

the processor automatically adjusting the ventricular sensitivity to within a safety margin from the ventricular sensitivity threshold.

22. The programmer, as recited in claim 21, wherein the processor further restores the operation of the stimulation device to the non-atrial tracking mode.

23. The programmer, as recited in claim 21, wherein the stimulation device has an adjustable AV delay;

wherein if ventricular sensing is not confirmed, the processor automatically increases the AV delay and reassesses the ventricular sensing of the stimulation device; and

wherein if the AV delay has not reached a maximum value, the processor reassesses the ventricular sensing of the stimulation device.

24. The programmer, as recited in claim 23, wherein if the AV delay has reached a maximum value, the processor determines if the stimulation device is operating in an atrial tracking mode, and if it is, the processor sets the stimulation device to a non-atrial tracking mode, decreases a test rate to a predetermined value, and reassesses the ventricular sensing of the stimulation device;

and

wherein if the AV delay has reached a maximum value, the processor determines if the stimulation device is operating in an atrial tracking mode, and if it is not, the processor resets any changed parameter to a base value, and disables the ventricular sensitivity threshold test.

25. A method for determining an atrial sensitivity in a stimulation device having adjustable base rate and atrial sensitivity, the method comprising:

setting the stimulation device to an atrial tracking mode, if the stimulation device is operating in a non-atrial tracking mode;

assessing atrial sensing of the stimulation device and determining a sensed atrial rate;

if atrial sensing is confirmed, determining whether the base rate is less than the sensed atrial rate by at least a predetermined value;

if the base rate is less than the sensed atrial rate by at least the predetermined value, then performing an atrial sensitivity threshold test to determine an atrial sensitivity threshold of the stimulation device; and

automatically adjusting the atrial sensitivity to within a safety margin from the atrial sensitivity threshold.

26. The method, as recited in claim 25, wherein determining whether the base rate is less than the sensed atrial rate by at least a predetermined value including determining whether the base rate is less than the sensed atrial rate by at least 20 beats per minute.

27. The method, as recited in claim 25, further including restoring the operation of the stimulation device to the non-atrial tracking mode.

28. The method, as recited in claim 25, wherein the stimulation device has an adjustable test rate;

and

wherein if atrial sensing is not confirmed, then automatically decreasing the test rate to a predetermined value, prior to performing the atrial sensitivity threshold test.

29. The method, as recited in claim 25, further including increasing a post ventricular atrial refractory period (PVARP) of the stimulation device prior to performing the atrial sensitivity threshold test.

30. A programmer for determining an atrial sensitivity in a stimulation device having adjustable base rate and atrial sensitivity, the programmer comprising:

a processor for setting the stimulation device to an atrial tracking mode if the stimulation device is operating in a non-atrial tracking mode;

the processor assessing atrial sensing of the stimulation device;

if atrial sensing is confirmed, the programmer determining whether the base rate is less than the sensed atrial rate by at least a predetermined value;

if the base rate is less than the sensed atrial rate by at least the predetermined value, the processor performing an atrial sensitivity threshold test to determine the atrial sensitivity threshold of the stimulation device; and

the processor automatically adjusting the atrial sensitivity to within a safety margin from the atrial sensitivity threshold.

31. The programmer, as recited in claim 30, wherein the processor further restores the operation of the stimulation device to the non-atrial tracking mode.

32. The programmer, as recited in claim 30, wherein the stimulation device has an adjustable AV delay;

and

wherein if atrial sensing is not confirmed, the processor automatically decreases a test rate to a predetermined value, prior to performing the atrial sensitivity threshold test.

33. The programmer, as recited in claim 30, wherein the processor increases a post ventricular atrial refractory period (PVARP) of the stimulation device prior to performing the atrial sensitivity threshold test.