Pacemaker with automatic lower rate limit drop

• US 5,861,011 A
• Filed: 02/14/1997
• Issued: 01/19/1999
• Est. Priority Date: 02/14/1997
• Status: Expired due to Fees

• Current Assignee: Vitatron Medical BV
• Original Assignee: Vitatron Medical BV
• Inventors: Stoop, Gustaaf A. P.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/800,413
• Time in Patent Office: 704 Days
• Field of Search: 607/17, 607/18, 607/25, 607/19
• US Class Current: 607/25
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371

Abstract

There is provided an implanted pacemaker having a system and method for determining a measure of the circadian rhythm of a patient and adjusting the pacemaker nighttime setting of lower rate limit to correspond to the determined circadian rhythm. In a preferred embodiment, the circadian rhythm is determined by examining daily variations in QT interval. In a first QT embodiment of the invention, when QT interval becomes longer than a parameter QT_-- sleep, which represents a value associated with patient nighttime, the LRL is dropped to a night value and maintained at such value for a predetermined duration. In another embodiment, the start of night LRL is determined as a function of when QT interval becomes longer than a sleep value for a predetermined elapsed time, and LRL is changed back to a day value when QT interval drops back down to a shorter value than the sleep value and stays there for an elapsed period of time. In yet another algorithm in accordance with this invention, the sleep value of QT interval is adapted so that the night period when QT interval is longer than the sleep value more closely corresponds to desired time of sleep, and the start of night LRL and the start of Day LRL are shifted to correspond to the detected night period. Additionally, other pacing parameters such as the escape interval hysteresis value may be varied based on determinations of the circadian rhythm.

Claims

1. A pacemaker for generating pace pulses for delivery to a patient, the pacemaker having a pulse generator, sensing means for sensing a parameter which has a circadian variation characterized by nighttime change in a first direction and daytime change in a second direction, control means for controlling pacing rate, and comprising LRL means for controlling the lower rate limit at which said pace pulses are generated, said LRL means having:

first means for determining a first value of said parameter which is a measure of the recent extreme value of said parameter in said first direction,

second means for setting a night value of said parameter,

third means for determining night conditions as a function of when said parameter is between said night value and said first value, and

adjusting means for adjusting said lower rate limit to a lower night value during said night conditions.

2. The pacemaker as described in claim 1, wherein said sensing means senses the QT interval following delivered pace pulses, whereby said parameter is QT interval.

3. The pacemaker as described in claim 2, wherein said first means comprises means for determining a value representative of maximum QT interval, and said second means has means for setting said night value to a QT interval value which is less than said maximum QT interval.

4. The pacemaker as described in claim 3, wherein said third means comprises means for determining when said QT interval increases from a value less than said night value to a value more than said night value.

5. The pacemaker as described in claim 4, wherein said third means comprises means for determining start of a night condition based on said QT interval maintaining a value greater than said night value for a predetermined time.

6. The pacemaker as described in claim 1, comprising duration means for storing a time duration corresponding to desired sleep duration, and wherein said third means comprises means determining end of a night condition when a said night condition has extended for said time duration.

7. The pacemaker as described in claim 6, comprising means for adjusting said duration measure as a function of patient history.

8. A rate responsive implantable pacemaker, having pace pulse generator means for generating pace pulses, rate control means for controlling the rate of generated pace pulses, QT means for continuously determining QT values, and rate limit means for setting a lower rate limit on said pace pulse rate, comprising:

QT max means for obtaining a measure of the daily maximum value of QT,

night means for determining a start of night as a function of QT variations relative to said maximum value, and

said rate means having LRL means for normally maintaining a lower rate limit at a first value, and for adjusting said lower rate limit to a lower value at said start of night.

9. The pacemaker as described in claim 8, comprising timing means for timing out a night duration, and wherein said LRL means comprises day means for setting said lower rate limit to said first value upon timing out said night duration.

10. A rate responsive implantable pacemaker for pacing a patient'"'"'s heart, having pace pulse generator means for generating pace pulses, rate control means for controlling the rate of generated pace pulses, QT means for continuously determining the value of a QT interval, and rate limit means for setting a lower rate limit on said pace pulse rate, comprising:

start night means for setting said lower rate limit to a lower night value at a first adjustable time, end night means for setting said lower rate limit to a higher value at a second adjustable time, and adjusting means for adjusting both of said first and second times as a function of variations of said QT interval.

11. The pacemaker as described in claim 10, further comprising QT max means for obtaining a measure of the daily maximum value of QT, sleep means for determining a sleep value of QT which is shorter than said maximum value by a given amount, duration means for determining the duration of time each night that QT is longer than said sleep value, and wherein said adjusting means adjusts said first and second times as a function of said nightly time duration.

12. A method of controlling the available pacing rate of a pacemaker implanted in a patient so as to adapt to nighttime conditions, comprising:

controlling pacing during daytime conditions with a first set of criteria;

determining a nighttime duration, and controlling pacing during said nighttime duration with a second set of criteria;

sensing a QT interval which varies with the patient'"'"'s circadian rhythm, and accumulating data representative of variations of said QT interval;

determining from said accumulated data information representative of the patient'"'"'s circadian rhythm; and

adjusting said nighttime duration as a function of said information.

13. The method as described in claim 12, wherein said first set of criteria comprises a day lower rate limit, and said second set of criteria comprises a night lower rate limit.

14. The method as described in claim 12, wherein said second criteria comprises a nighttime hysteresis escape interval.

15. The method as described in claim 12, comprising evaluating said accumulated data daily, and adjusting said nighttime duration whenever a said daily evaluation indicates that said duration can be adjusted to better match the patient'"'"'s circadian rhythm.

16. The method as described in claim 15, comprising setting a start of said nighttime duration and an end of said nighttime duration, and wherein said adjusting comprises shifting either said start or end.

17. A rate responsive pacemaker having a pulse generator for generating pace pulses, and rate control means for controlling the rate of said generated pace pulses in accordance with a set of rate criteria, comprising:

parameter means for continuously determining a parameter which varies with the patient'"'"'s circadian rhythm,

data means for collecting and storing data representative of nighttime variations of said determined parameter, and

adapting means for adapting said rate criteria as a function of said stored data.

18. The pacemaker as described in claim 17, wherein said rate control means comprises means for setting a night lower rate limit, and said adapting means adapts said night lower rate limit.

19. The pacemaker as described in claim 18, wherein said parameter means comprises QT means for determining QT interval, and said data means has means for collecting and storing data representative of daily maximum value of QT interval.