System and method for automatically determining the slope of a transfer function for a rate-responsive cardiac pacemaker

• US 5,514,162 A
• Filed: 06/07/1994
• Issued: 05/07/1996
• Est. Priority Date: 06/07/1994
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Arambula, Elia R., Florio, Joseph J., Bornzin, Gene A.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/255,194
• Time in Patent Office: 700 Days
• Field of Search: 607/17-26, 607/30
• US Class Current: 607/19
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

A rate-responsive pacemaker measures a patient'"'"'s level of activity and stores the results in an activity level histogram. The patient'"'"'s average level of activity is maintained as a running average. Based on a prescribed base pacing rate, a prescribed maximum pacing rate, the average level of activity, and the measured levels of activity stored in the activity level histogram, the rate-responsive pacemaker automatically calculates the slope of the pacemaker transfer function. An activity deviation histogram is also maintained. Analysis of the activity deviation histogram allows the pacemaker to determine if the patient was usually inactive for an extended period of time, and to inhibit an automatic slope calculation under such conditions. If a patient desires to reach a prescribed target heart rate during exercise, the slope may be calculated using the target heart rate and a prescribed fraction of time each week that the patient devotes to exercise.

Claims

1. A rate-responsive pacemaker for administering pacing pulses to a patient'"'"'s heart in accordance with a predetermined transfer function that correlates sensor measurements representative of the patient'"'"'s level of metabolic need to heart rate, the transfer function being having a base pacing rate, a maximum pacing rate, and a slope 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 function;

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

a memory for storing the predetermined transfer function, and for storing selected sensor measurements as a first histogram, the first histogram representing a profile of the patient'"'"'s level of metabolic need over a predetermined period of time, the first histogram defining a frequency distribution of sensor measurements for a plurality of amplitudes; and

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

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

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

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

(d) means for selecting sensor measurements for storage in the first histogram; and

(e) means for deriving the slope of the transfer function as a function of the patient'"'"'s profile of metabolic need as represented by the first histogram containing the selected sensor measurements stored over the predetermined period of time.

2. The pacemaker of claim 1, wherein:

the memory further includes means for storing the base pacing rate and the maximum pacing rate;

the processor includes means for maintaining a running average of the sensor measurements in the memory; and

the processor includes means for determining the slope of the transfer function in accordance with the base pacing rate, the maximum pacing rate, the running average, and the patient'"'"'s profile of metabolic need as represented by the first histogram containing the selected sensor measurements stored over the predetermined period of time.

3. The pacemaker of claim 2, wherein the means for maintaining the running average includes means for digitally filtering the sensor measurements using a time constant of about 18 hours.

4. The pacemaker of claim 2, wherein:

the memory includes means for storing the first histogram using a plurality of storage locations corresponding to a plurality of bins, each bin associated with a different sensor measurement; and

the processor includes means for incrementing a count associated with a particular bin when the sensor measurement to be stored in the first histogram corresponds to the particular bin.

5. The pacemaker of claim 4, wherein the processor includes means for deriving the slope of the transfer function in accordance with the relationship:

##EQU6## wherein;

MPR represents the maximum pacing rate;

BPR represents the base pacing rate;

Act_-- Avg represents the running average of the sensor measurements;

x% represents a percentage of total counts stored in the first histogram, which is preprogrammed into the memory;

Act_-- x% represents a bin of the first histogram corresponding to a sensor measurement that is exceeded by no more than a percentage designated by x% of the sensor measurements stored as counts in the first histogram over the predetermined period of time; and

c is an empirically derived constant, preprogrammed into the memory, that defines a heart rate as a percentage of the difference between the maximum pacing rate and the base pacing rate, added to the base pacing rate, that should be achieved when the patient is experiencing a level of metabolic need defined by a sensor measurement designated by Act_-- x%.

6. The pacemaker of claim 5, wherein the processing means further includes means for deriving the slope using:

x% equal to about one percent; and

c equal to about 0.25.

7. The pacemaker of claim 1, wherein the processor includes means for deriving the slope of the transfer function in accordance with the patient'"'"'s regular exercise routine.

8. The pacemaker of claim 7, wherein:

the memory further includes means for storing the base pacing rate, and a target heart rate that is appropriate when the patient is engaged in exercise;

the processor includes means for maintaining a running average of the sensor measurements in the memory; and

the processor includes means for deriving the slope of the transfer function in accordance with the base pacing rate, the target heart rate, the running average, and the patient'"'"'s profile of metabolic need as represented by the first histogram containing the selected sensor measurements stored over the predetermined period of time.

9. The pacemaker of claim 8, wherein the means for maintaining the running average includes means for digitally filtering the sensor measurements using a time constant of about 18 hours.

10. The pacemaker of claim 8, wherein:

the first histogram comprises a plurality of bins, each bin associated with a different sensor measurement; and

the processor includes means for incrementing a count associated with a particular bin when the sensor measurement to be stored in the first histogram corresponds to the particular bin.

11. The pacemaker of claim 10, wherein the processor includes means for deriving the slope of the transfer function in accordance with the relationship:

##EQU7## wherein;

THR represents the target heart rate;

BPR represents the base pacing rate;

Act_-- Avg represents the running average of the sensor measurements;

Ex% represents a percentage of the predetermined period of time that the patient engages in exercise, which is preprogrammed into the memory; and

Act_-- Ex% represents a bin of the first histogram corresponding to a sensor measurement that is exceeded by no more than a percentage designated by Ex% of the sensor measurements stored as counts in the first histogram over the predetermined period of time.

12. The pacemaker of claim 1, wherein the processor includes means for inhibiting the derivation of the slope of the transfer function when the patient'"'"'s level of metabolic need is below a threshold level over the predetermined period of time.

13. The pacemaker of claim 12, wherein:

the memory further includes means for storing sensor measurement deviation values as a second histogram over the predetermined period of time, the second histogram having a dominant mode and a median; and

the processor includes means for inhibiting the derivation of the slope of the transfer function when the median is less than about 2.5 times the mode after the predetermined period of time has elapsed.

14. The pacemaker of claim 13, wherein the processor includes means for deriving each sensor measurement deviation value by taking an absolute value of a difference between a current sensor measurement and an earlier sensor measurement.

15. The pacemaker of claim 14, wherein the processor includes means for deriving the current sensor measurement about 26 seconds after the the earlier sensor measurement.

16. The pacemaker of claim 1, wherein the processor includes means for periodically deriving the slope of the transfer function.

17. The pacemaker of claim 1, wherein the memory for storing the selected sensor measurements over a predetermined period of time includes means for storing the selected sensor measurements over about one week.

18. 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.

19. The pacemaker of claim 1, wherein:

the memory further includes means for storing a slope offset value; and

the processor includes means for adding the slope offset value to the derived slope.

20. The pacemaker of claim 1, wherein the base pacing rate and the maximum pacing rate have a minimum and a maximum sensor threshold associated therewith, respectively, the first histogram further being characterized as having a mode with a first amplitude value associated therewith corresponding to the patient'"'"'s average metabolic need, and a second amplitude value at the upper end of the first histogram corresponding to an upper value for the patient'"'"'s metabolic need, further comprising:

means for adjusting the minimum sensor threshold to the first amplitude value; and

means for adjusting the maximum sensor threshold to the second amplitude value.

21. A rate-responsive pacemaker comprising:

pulse generating means for generating pacing pulses at a selectable rate;

physiological sensing means for sensing a patient'"'"'s level of metabolic need;

rate selecting means for selecting the rate at which the pulse generating means generates pacing pulses based on the sensed level of metabolic need and the corresponding heart rate defined by a transfer function that correlates metabolic need to heart rate, the transfer function comprising a slope that defines pacing rates between a minimum pacing rate and a maximum pacing rate;

slope adjusting means for automatically adjusting the slope of the transfer function in accordance with the level of metabolic need sensed over a predetermined period of time; and

inhibiting means for inhibiting the slope adjusting means from automatically adjusting the slope of the transfer function when the patient'"'"'s level of metabolic need over the predetermined period of time is below a threshold level.

22. The pacemaker of claim 21 further comprising:

memory means for storing sensor deviation values as a histogram over the predetermined period of time, the histogram having a dominant mode and a mean; and

sensor deviation deriving means for deriving the sensor deviation values at predetermined intervals;

wherein the inhibiting means inhibits the slope adjusting means from adjusting the slope of the transfer function when the median is less than about 2.5 times the mode after the predetermined period of time has elapsed.

23. The pacemaker of claim 22, wherein the sensor deviation deriving means includes:

means for deriving each sensor deviation value by taking an absolute value of a difference between a current level of metabolic need sensed by the physiological sensing means and an earlier level of metabolic need sensed by the physiological sensing means.

24. The pacemaker of claim 23, wherein the processor includes means for deriving the current level of metabolic need about 26 seconds after the earlier level of metabolic need.

25. The pacemaker of claim 21, wherein the slope adjusting means includes means for periodically adjusting the slope of the transfer function.

26. The pacemaker of claim 21, wherein the memory for storing the selected sensor measurements over a predetermined period of time includes means for storing the selected sensor measurements over about one week.

27. The pacemaker of claim 21, wherein the physiological sensing means comprises activity sensing means for generating signals representative of levels of physical activity, the levels of physical activity being indicative of the levels of metabolic need.

28. A method of providing rate-responsive pacing therapy to a patient'"'"'s heart in accordance with a transfer function that correlates sensor measurements representative of the patient'"'"'s metabolic need to heart rate, the transfer function being having a base pacing rate, a maximum pacing rate, and a slope 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;

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

processing the raw sensor signals to derive sensor measurements;

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

selecting sensor measurements for storage in the first histogram;

storing the selected sensor measurements as a first histogram, the first histogram representing a profile of the patient'"'"'s metabolic need over a predetermined period of time, the first histogram defining a frequency distribution of sensor measurements for a plurality of amplitudes; and

deriving the slope of the transfer function as a function of the patient'"'"'s profile of metabolic need as represented by the first histogram containing the selected sensor measurements stored over the predetermined period of time.

29. The method of claim 28, wherein:

the method further comprises the step of maintaining a running average of the sensor measurements; and

the deriving step comprises the step of deriving the slope of the transfer function in accordance with the base pacing rate, the maximum pacing rate, the running average, and the patient'"'"'s profile of metabolic need as represented by the first histogram containing the selected sensor measurements stored over the predetermined period of time.

30. The method of claim 29, wherein maintaining step comprises the step of digitally filtering the sensor measurements using a time constant of about 18 hours.

31. The method of claim 29, wherein:

the memory includes means for storing the first histogram using a plurality of storage locations corresponding to a plurality of bins, each bin associated with a different sensor measurement; and

the storing step comprises the step of incrementing a count associated with a particular bin when the sensor measurement to be stored in the first histogram corresponds to the particular bin.

32. The method of claim 31, wherein the deriving step comprises the step of deriving the slope of the transfer function in accordance with the relationship:

##EQU8## wherein;

MPR represents the maximum pacing rate;

BPR represents the base pacing rate;

Act_-- Avg represents the running average of the sensor measurements;

x% represents a predetermined percentage of total counts stored in the first histogram;

Act_-- x% represents a bin of the first histogram corresponding to a sensor measurement that is exceeded by no more than a percentage designated by x% of the sensor measurements stored as counts in the first histogram over the predetermined period of time; and

c is a predetermined, empirically derived constant that defines a heart rate as a percentage of the difference between the maximum pacing rate and the base pacing rate, added to the base pacing rate, that should be achieved when the patient is experiencing a level of metabolic need defined by a sensor measurement designated by Act_-- x%.

33. The method of claim 32, wherein the step of deriving the slope further comprises the steps of:

defining x% equal to about one percent; and

defining c equal to about 0.25.

34. The method of claim 28, wherein the deriving step comprises the step of:

deriving the slope of the transfer function in accordance with the patient'"'"'s regular exercise routine, whereby pacing therapy is administered such that during periods of exercise, the patient'"'"'s heart rate is maintained at a predetermined target heart rate.

35. The method of claim 34, wherein:

the method further comprises the step of maintaining a running average of the sensor measurements; and

the deriving step comprises the step of deriving the slope of the transfer function in accordance with the base pacing rate, the target heart rate, the running average, and the patient'"'"'s profile of metabolic need as represented by the first histogram containing the selected sensor measurements stored over the predetermined period of time.

36. The method of claim 35, wherein the step of maintaining the running average comprises the step of:

digitally filtering the sensor measurements using a time constant of about 18 hours.

37. The method of claim 35, wherein:

the first histogram comprises a plurality of bins, each bin associated with a different sensor measurement; and

the storing step comprises the step of incrementing a count associated with a particular bin when the sensor measurement to be stored in the first histogram corresponds to the particular bin.

38. The method of claim 37, wherein the deriving step comprises the step of:

deriving the slope of the transfer function in accordance with the relationship;

##EQU9## wherein;

THR represents the target heart rate;

BPR represents the base pacing rate;

Act_-- Avg represents the running average of the sensor measurements;

Ex% represents a predetermined percentage of the predetermined period of time that the patient engages in exercise; and

Act_-- Ex% represents a bin of the first histogram corresponding to a sensor measurement that is exceeded by no more than a percentage designated by Ex% of the sensor measurements stored as counts in the first histogram over the predetermined period of time.

39. The method of claim 28, further comprising the step of inhibiting derivation of the slope of the transfer function when the patient'"'"'s level of metabolic need is below a threshold level over the predetermined period of time.

40. The method of claim 39, wherein:

the storing step comprises the step of storing sensor measurement deviation values as a second histogram over the predetermined period of time, the second histogram having a dominant mode and a mean; and

the inhibiting step comprises the step of inhibiting derivation of the slope of the transfer function when the median is less than about 2.5 times the mode after the predetermined period of time has elapsed.

41. The method of claim 40, wherein the processing step comprises the step of:

deriving each sensor measurement deviation value by taking an absolute value of a difference between a current sensor measurement selected for storage in the first histogram and an earlier sensor measurement previously stored in the first histogram.

42. The method of claim 41, wherein the current sensor measurement is derived about 26 seconds after the earlier sensor measurement is derived.

43. The method of claim 28, wherein the deriving step is performed on a periodic basis.

44. The method of claim 28, wherein the predetermined period of time is about one week.

45. The method of claim 28, wherein the sensing step comprises the step of:

sensing levels of physical activity, the levels of physical activity being indicative of the levels of metabolic need.

46. A method of providing rate-responsive pacing therapy, comprising the steps of:

generating pacing pulses at a selectable rate;

sensing a patient'"'"'s level of metabolic need;

selecting the rate at which pacing pulses are generated based on the sensed level of metabolic need and the corresponding heart rate defined by a transfer function that correlates metabolic need to heart rate, the transfer function comprising a slope that defines pacing rates between a minimum pacing rate and a maximum pacing rate;

automatically adjusting the slope of the transfer function in accordance with the level of metabolic need sensed over a predetermined period of time; and

inhibiting automatic slope adjustment when the patient'"'"'s level of metabolic need over the predetermined period of time is below a threshold level.

47. The method of claim 46, further comprising the steps of:

deriving sensor deviation values at predetermined intervals; and

storing the sensor deviation values as a histogram over the predetermined period of time, the histogram having a dominant mode and a mean;

wherein the inhibiting step comprises inhibiting slope adjustment when the mean is less than about 2.5 times the mode after the predetermined period of time has elapsed.

48. The method of claim 47, wherein the deriving step comprises the step of:

deriving each sensor deviation value by taking an absolute value of a difference between a sensed current level of metabolic need and an earlier sensed level of metabolic need.

49. The method of claim 48, wherein the step of deriving each sensor deviation value comprises the steps of:

sensing the level of metabolic need about every 26 seconds; and

defining the earlier sensed level of metabolic need as the level of metabolic need sensed about 26 seconds prior to the current level of metabolic need.

50. The method of claim 46, wherein further comprising:

defining the predetermined period of time equal to about one week.

51. The method of claim 46, wherein the sensing step comprises the step of:

sensing levels of physical activity, the levels of physical activity being indicative of the levels of metabolic need.

52. A rate-responsive pacemaker comprising:

pulse generating means for generating pacing pulses at a selectable rate;

physiological sensing means for sensing a patient'"'"'s level of metabolic need;

rate selecting means for selecting the rate at which the pulse generating means generates pacing pulses by applying the sensed level of metabolic need to a transfer function that correlates metabolic need to heart rate, the transfer function comprising a slope that defines pacing rates between a minimum pacing rate and a maximum pacing rate, the minimum pacing rate and the maximum pacing rate have a minimum sensor threshold and a maximum sensor threshold associated therewith, respectively;

a memory for storing sensor measurements as a first histogram, the first histogram defining a frequency distribution of sensor measurements for a plurality of amplitudes, the first histogram further having a mode with a first amplitude value associated therewith corresponding to the patient'"'"'s average metabolic need, and a second amplitude value at an upper end of the first histogram corresponding to an upper value for the patient'"'"'s metabolic need;

means for adjusting the minimum sensor threshold to the first amplitude value; and

means for adjusting the maximum sensor threshold to the second amplitude value.