System and method for modulating the base rate during sleep for a rate-responsive cardiac pacemaker

• US 5,476,483 A
• Filed: 06/10/1994
• Issued: 12/19/1995
• Est. Priority Date: 06/10/1994
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Florio, Joseph J., Bornzin, Gene A., Arambula, Elia R.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/258,292
• Time in Patent Office: 557 Days
• Field of Search: 607/77
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

A system and method are provided for modulating the base rate of a transfer function for a rate-responsive cardiac pacemaker. Activity sensor measurements are used to derive activity variance measurements, which in turn are used to modulate the base pacing rate. In one embodiment, a histogram is used to store activity variance measurements collected over a period of about a week. The histogram is used to derive an activity variance threshold, which is compared to current activity variance measurements to determine if the patient is sleeping. If the patient is deemed to be sleeping, the pacing rate is set to a rate that comfortably meets the patient'"'"'s low metabolic demands during sleep. In alternative embodiments, the activity variance measurements are applied to a base rate slope to modulate the base pacing rate.

Claims

1. A rate-responsive pacemaker for administering pacing pulses to a patient'"'"'s heart, the pacemaker including memory means for storing a predetermined transfer function that correlates sensor level measurements representative of the patient'"'"'s metabolic need to heart rate, the predetermined transfer function being characterized by a base pacing rate, a maximum pacing rate, and a transition segment defining pacing rates between the base pacing rate and the maximum pacing rate, the rate-responsive pacemaker comprising:

a pulse generator for generating pacing pulses at a selectable rate between the base pacing rate and the maximum pacing rate in accordance with the predetermined transfer curve;

a physiological sensor for generating raw sensor signals indicative of the patient'"'"'s level of metabolic need;

a processor, coupled to the pulse generator and the physiological sensor, for controlling the rate of pacing pulses, the processor including;

(a) means for processing the raw sensor signals to derive the sensor level measurements;

(b) means for determining an appropriate heart rate for the patient'"'"'s level of metabolic need based on the sensor level measurements and the corresponding heart rate defined by the predetermined transfer function;

(c) means for causing the pulse generator to generate pacing pulses at the appropriate heart rate;

(d) means for deriving first variance measurements based on the sensor level measurements, the first variance measurements being based on the difference between a current sensor level measurement and at least one earlier sensor level measurement; and

(e) means for modulating the base pacing rate in accordance with the first variance measurements.

2. The pacemaker of claim 1, wherein:

the memory further includes means for storing a resting rate and a sleeping rate that is lower than the resting rate; and

the modulating means includes means for modulating the base pacing rate between the resting rate and the sleeping rate.

3. The pacemaker of claim 2, wherein:

the memory further includes means for storing a sensor measurement threshold and a variance measurement threshold; and

the processor includes means for setting the base pacing rate to the sleeping rate when a current sensor measurement is below the sensor measurement threshold and a current first variance measurement is below the variance measurement threshold.

4. The pacemaker of claim 3, wherein the processor includes means for setting the base pacing rate to the resting rate when either the current sensor measurement meets or exceeds the sensor measurement threshold, or the current first variance measurement meets or exceeds the variance measurement threshold.

5. The pacemaker of claim 3, wherein the processor includes means for maintaining a running average of the sensor measurements in the memory, the running average defining the sensor measurement threshold.

6. The pacemaker of claim 5, wherein the processor includes means for maintaining the running average by digitally filtering the sensor measurements using a time constant of about 18 hours.

7. The pacemaker of claim 3, wherein:

the memory includes means for storing first variance measurements derived during a predetermined period of time as a histogram, the histogram including a plurality of bins ranging from a lowest bin to a highest bin, each bin being associated with a different first variance measurement value; and

the processor includes means for deriving the variance measurement threshold by determining a bin associated with the highest first variance measurement derived while the patient was sleeping.

8. The pacemaker of claim 7, wherein:

the memory further includes means for storing a value representing a fraction of time that the patient sleeps each day;

the processor includes means for maintaining a value in the memory representing a total number of first variance measurements stored in the memory during the predetermined period of time; and

the processor includes means for deriving the highest first variance measurement derived while the patient was sleeping by;

estimating a number of first variance measurements that were derived while the patient was sleeping during the predetermined period of time in accordance with the stored fraction of time that the patient sleeps each day and the stored total number of first variance measurements; and

counting the first variance measurements stored in the histogram, starting with the lowest bin and proceeding through successively higher bins until the estimated number of first variance measurements that were derived while the patient was sleeping have been counted, the bin associated with the last count defining the highest first variance measurement derived while the patient was sleeping.

9. The pacemaker of claim 7, wherein the patient predetermined period of time is about one week.

10. The pacemaker of claim 1, wherein the processor includes means for deriving each first variance measurement by taking an absolute value of a difference between a current sensor measurement and an earlier sensor measurement, and filtering the result with a recursive, low pass digital filter.

11. The pacemaker of claim 10, wherein the current sensor measurement is derived by the processor about 26 seconds after the processor derives the earlier sensor measurement.

12. The pacemaker of claim 1, wherein:

the memory includes means for storing a base rate slope and a sleeping rate that defines a minimum heart rate maintained by the pacemaker; and

the the base pacing rate by increasing the base pacing rate from the sleeping rate by an amount defined by the product of the base rate slope and the first variance measurements.

13. The pacemaker of claim 12, wherein:

the sensor measurements derived by the processor comprise second variance measurements; and

the processor includes means for correlating the second variance measurements to the transition segment of the transfer function to derive to determine the appropriate heart rate for the patient'"'"'s level of metabolic need.

14. The pacemaker of claim 13, wherein:

the memory further includes means for storing an activity slope that defines the transition segment of the transfer function; and

the processor includes means for deriving the appropriate heart rate by increasing the heart rate from the base pacing rate by an amount defined by the product of the activity slope and the second variance measurements.

15. The pacemaker of claim 13, wherein the first variance measurement exhibit less variation over time than the second variance measurements.

16. The pacemaker of claim 1, wherein:

the physiological sensor comprises an activity sensor; and

the sensor measurements derived by the processor represent levels of physical activity, the levels of physical activity being indicative of the levels of metabolic need.

17. A method of providing rate-responsive pacing therapy to a patient'"'"'s heart in an implantable stimulation device, the implantable stimulation device including memory means for storing a predetermine transfer function that correlates sensor measurements representative of the patient'"'"'s metabolic need to heart rate, the predetermine transfer function being characterized by a base pacing rate, a maximum pacing rate, and a transition segment defining pacing rates between the base pacing rate and the maximum pacing rate, the method comprising the steps of:

generating pacing pulses at a selectable rate between the base pacing rate and the maximum pacing rate in accordance with the predetermined transfer curve;

sensing the patient'"'"'s level of metabolic need and generating raw sensor signals representative thereof;

processing the raw sensor signals to derive the sensor measurements;

determining the rate at which pacing pulses are generated based on the sensor measurements and the predetermined transfer function;

processing the sensor measurements to derive first variance measurements, the first variance measurements being based on the difference between a current sensor measurement and at least one previous sensor measurement; and

modulating the base pacing rate to a lower pacing rate in accordance with the first variance measurements.

18. The method of claim 17, wherein the step of modulating the base pacing rate comprises modulating the base pacing rate between a prescribed resting rate and a prescribed sleeping rate that is below the resting rate.

19. The method of claim 18, wherein the step of modulating the base pacing rate further comprises setting the base pacing rate to the sleeping rate when a current sensor measurement is below a sensor measurement threshold and a current first variance measurement is below a variance measurement threshold.

20. The method of claim 19, wherein the step of modulating the base pacing rate further comprises setting the base pacing rate to the resting rate when either the current sensor measurement meets or exceeds the sensor measurement threshold, or the current first variance measurement meets or exceeds the variance measurement threshold.

21. The method of claim 19 further comprising the step of maintaining a running average of the sensor measurements, the running average defining the sensor measurement threshold.

22. The method of claim 21, wherein the step of maintaining the running average comprises digitally filtering the sensor measurements using a time constant of about 18 hours.

23. The method of claim 19 further comprising the steps of:

storing first variance measurements derived during a predetermined period of time as a histogram, the histogram including a plurality of bins ranging from a lowest bin to a highest bin, each bin being associated with a different first variance measurement value; and

deriving the variance measurement threshold by determining a bin associated with the highest first variance measurement derived while the patient was sleeping.

24. The method of claim 23, wherein the step of deriving the variance measurement threshold comprises:

estimating a number of first variance measurements that were derived while the patient was sleeping during the predetermined period of time in accordance with a prescribed fraction of time that the patient sleeps each day and a total number of first variance measurements stored in the histogram during the predetermined period of time; and

counting the first variance measurements stored in the histogram, starting with the lowest bin and proceeding through successively higher bins until the estimated number of first variance measurements that were derived while the patient was sleeping have been counted, the bin associated with the last count defining the highest first variance measurement derived while the patient was sleeping.

25. The method of claim 23, wherein the predetermined period of time is about one week.

26. The method of claim 17, wherein the step of processing the sensor measurements to derive the first variance measurements comprises taking an absolute value of a difference between a current sensor measurement and an earlier sensor measurement, and filtering the result with a recursive, low pass digital filter.

27. The method of claim 26, wherein the current sensor measurement is derived about 26 seconds after the earlier sensor measurement.

28. The method of claim 17, wherein the step of modulating the base pacing rate comprises increasing the base pacing rate from a prescribed sleeping rate that defines a minimum maintained heart rate by an amount defined by the product of a prescribed base rate slope and the first variance measurements.

29. The method of claim 28, wherein:

the step of processing the sensor signals to derive sensor measurements comprises deriving second variance measurements; and

the step of applying the sensor measurements to the transfer function comprises the step of applying the second variance measurements to the transition segment of the transfer function to derive the appropriate heart rate for the patient'"'"'s level of metabolic need.

30. The method of claim 29, wherein the step of applying the second variance measurements to the transition segment comprises increasing the heart rate from the base pacing rate by an amount defined by the product of a prescribed activity slope and the second variance measurements.

31. The method of claim 29, wherein the first variance measurements exhibit less variation over time than the second variance measurements.

32. The method of claim 17, wherein the step of sensing the patient'"'"'s level of metabolic need comprises sensing levels of physical activity, the levels of physical activity being indicative of the levels of metabolic need.

33. A rate-responsive pacemaker for administering pacing pulses to a patient'"'"'s heart, comprising:

a pulse generator for generating pacing pulses at a rate between a variable base rate and a maximum pacing rate;

an activity sensor for generating raw sensor signals indicative of the patient'"'"'s activity level;

control means for determining the rate of pacing pulses generated by the pulse generator, the control means including;

(a) processing means for processing the raw sensor signals to determine activity measurements;

(b) detecting means for detecting when a patient is asleep based on the activity measurements; and

(c) modulating means for varying the base pacing rate between a resting rate and a sleeping rate when the patient is asleep.

34. The pacemaker of claim 33, wherein:

the processing means comprises means for processing the raw sensor measurements to determine activity level measurements and activity variance measurements, the activity variance measurements being based on the difference between a current activity level measurement and at least one earlier activity level measurement; and

the detecting means comprises means for detecting when a patient is asleep based on the activity variance measurements.

35. The pacemaker of claim 34, wherein the detecting means further comprises:

threshold determining means for determining an activity variance threshold based on the activity variance measurements, the patient being awake when a current activity variance measurement has a value above the activity variance threshold and asleep when the current activity variance measurement has a value below the activity variance threshold.

36. The pacemaker of claim 35, further comprising:

memory means for storing activity variance measurements derived during a predetermined period of time as a histogram, the histogram including a plurality of bins ranging from a lowest bin to a highest bin, each bin being associated with a different activity variance measurement value, the histogram being bimodal with a dominant mode corresponding to a time period when the patient was sleeping; and

wherein the threshold determining means includes means for deriving the activity variance threshold based on a distribution of the dominant mode of the histogram.

37. The pacemaker of claim 35, wherein the modulating means comprises:

means for setting the base pacing rate to the resting rate when either the current activity level measurement meets or exceeds the activity level measurement threshold, or the current activity variance measurement meets or exceeds the activity variance threshold.

38. The pacemaker of claim 35, wherein the modulating means comprises:

means for setting the base pacing rate to the sleeping rate when a current sensor measurement is below the sensor measurement threshold and a current first variance measurement is below the activity variance threshold.

39. The pacemaker of claim 34, further comprising:

memory means for storing a base rate slope; and

wherein the modulating means includes means for modulating the base pacing rate by increasing the base pacing rate from the sleeping rate by an amount defined by the product of the base rate slope and the activity variance measurements.

40. A rate-responsive pacemaker for administering pacing pulses to a patient'"'"'s heart, comprising:

a pulse generator for generating pacing pulses at a rate between a base rate and a maximum pacing rate;

an activity sensor for generating raw sensor signals indicative of the patient'"'"'s activity level; and

control means for determining the rate of pacing pulses generated by the pulse generator, the control means including;

processing means for processing the raw sensor signals to determine activity measurements; and

modulating means for continuously adjusting the base pacing rate based on the activity measurements.