Automatic adjustment of the control function for a rate adaptive pacemaker

• US 5,303,702 A
• Filed: 12/23/1991
• Issued: 04/19/1994
• Est. Priority Date: 12/27/1990
• Status: Expired due to Term

• Current Assignee: Ela Medical S.A. (LivaNova Plc)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Bonnet, Jean-Luc, Malherbe, Odile
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/813,204
• Time in Patent Office: 848 Days
• Field of Search: 128/419 PG
• US Class Current: 607/20
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585

Abstract

A cardiac pacemaker having a pacing rate responsive to a control function of a physiological parameter indicative of activity levels. The coefficients of the function are automatically calculated and modified in response to the trend of the measured physiological parameter in order to correspond to the patient real needs. For monitoring the physiological parameter minute ventilation (VE), the basic value VE low and maximum value VE max are calculated in order to vary the slope and intercept of the straight line representative of the control relation of the pacing rate FC by the minute volume VE.

Claims

1. A method for controlling a pacemaker having a control relation between the pacing rate (FC) and a monitored physiological parameter (X) of the patient, the control relation having coefficients defining the control relation of the pacing rate having a programmed minimum rate (FC low) and a programmed maximum rate (FC max), characterized by defining a linear control relation aX+b, calculating automatically a value X low and a value X max corresponding to a minimum activity and a maximum activity in response to a measure of the physiological parameter, and recalculating automatically the values X low and X max in response to a second obtained measure of the physiological parameter so that the control relation is a line intersecting two pairs of values (FC low, X low) and (FC max, X max) and corresponds to the real needs of the patient.

2. A method according to claim 1, characterized in that the physiological parameter (X) is the minute volume (VE) and further characterized by initializing the control relation by calculating the minimum parameter VE low to be the mean value taken over a plurality of breathing cycles of the patient at rest, the plurality being selected from between 4 and 16, and selecting the maximum parameter VE max to be equal to a number times VE low, the number being selected from between 5 and 7.

3. A method according to claim 2, further characterized by recalculating the control relation after each modification of VE max as soon as the heart rate of the patient is less than a threshold rate defined as close to the rate FC low.

4. A method according to claim 2, further characterized by calculating every M/2 breathing cycles a mean value VE/M of the measures of VE during M preceding cycles, M being selected from between 32 and 128, and comparing the mean value VE/M to an upper limit calculated as VE low+x% and to a lower limit VE low -x%, wherein x is selected from between 3 and 9;

reducing VE low by x% if VE/M is less than the lower limit, and increasing VE low by x% if VE/M is greater than the upper limit for more than a selected number of overshootings of the upper limit and VE low is not modified during those overshootings, the selected number being between 4 and 12.

5. A method according to claim 2, further characterized by calculating a limit value VE low/max as being equal to VE low/mean+y%, wherein VE low/mean is equal to the mean value of 256 values of VE low calculated every 96 breathing cycles, y being selected from between 10 and 30.

6. A method according to claim 2, further characterized by calculating the minute volume VE at each breathing cycle, calculating a mean value VE/N of the VE measures for the last N breathing cycles, N being selected from between 4 and 16, comparing the mean VE/N to the value of VE max, modifying VE max if VE/N is higher than VE max so that VE max will be equal to the smallest of the value of VE/N and Z(VE max), wherein Z is selected from between 1.03 and 1.12, and maintaining VE max the same if VE/N is less than VE max.

7. A method according to claim 6, further characterized by lowering the value of VE max on the order of 3% to 6% if the value of VE max has not been modified during a selected period on the order of 12 to 48 hours.

8. A method according to claim 6, further characterized by maintaining the modified value of VE max between an upper limit corresponding to a theoretical maximum value of the ventilation MVV calculated as a second number times VE low, the second number being greater than 10, and a lower limit corresponding to a minimum value calculated as Y(VE low), Y being selected from among the group consisting of 2, 3, 4, or 5.

9. In a pacemaker having a cardiac pacing rate that varies between a selected maximum rate and a selected minimum rate in response to a control function relating a monitored physiological parameter indicative of patient activity to a pacing rate, a method for adjusting the control function comprising:

(a) providing a minimum activity value for the physiological parameter corresponding to patient activity;

(b) calculating maximum activity value as a first function of the provided minimum activity value; and

(c) calibrating the control function so that the provided minimum activity value relates to the selected minimum pacing rate and the calculated maximum activity value relates to the selected maximum pacing rate.

10. The method of claim 9 further comprising;

(d) selecting the pacing rate in response to a measure of the physiological parameter using the calibrated control function.

11. The method of claim 10 further comprising:

modifying the maximum activity value in response to the trend of a first measure of the physiological parameter representative of maximum activity levels differing from the existing maximum activity value by more than a first threshold amount; and

recalibrating the control function using the modified value maximum activity.

12. The method of claim 11 further comprising:

modifying the minimum activity value in response to the trend of a second measure of the physiological parameter representative of minimum activity levels differing from the existing minimum activity value by more than a second threshold amount; and

recalibrating the control function using the modified maximum activity value.

13. The method of claim 10 further comprising, after step (d);

(e) obtaining a first activity value based on a first time measure of the physiological parameter corresponding to the patient'"'"'s average activity over a first time period;

(f) adjusting the maximum activity value in response to the first activity value being greater than the maximum activity value, so that the adjusted maximum activity value is the lesser of the first activity value and the preexisting maximum activity value times a first constant, the first constant being selected from between 1.03 and 1.12; and

(g) maintaining the maximum activity value unadjusted if it is greater than the first activity value.

14. A method of claim 13 wherein the physiological parameter is the minute volume and the control function is linear, providing the first function as a multiple on the order of 6 times the minimum activity level, wherein obtaining the first activity value further comprises averaging the minute volume measures obtained over the N most recent breathing cycles wherein N is selected from between 4 and 16.

15. The method of claim 13 further comprising:

(h) recalibrating the control function in response to the adjusted maximum activity value and the pacing rate decreasing below a selected rate threshold; and

thereafter

(i) selecting the pacing rate in response to a measure of the physiological parameter using the recalibrated control function.

16. The method of claim 15 wherein step (f) further comprises adjusting the maximum activity value in response to the maximum activity value not being adjusted during a third time period, the third time period being greater than the second time period, so that the adjusted value is the preexisting maximum activity value times a second constant selected from between 0.93 and 0.97.

17. The method of claim 16 wherein the physiological parameter is the minute volume and the control function is linear, providing the first function as a multiple on the order of 6 times the minimum activity level, wherein averaging the minute volume measures obtained over the last N number of breathing cycles wherein N is selected from between 4 and 16, and the third time period is selected from between 12 and 48 hours.

18. The method of claim 16 wherein step (f) further comprising:

providing an upper limit for the value of the maximum activity value as a second function of the minimum activity value;

providing a lower limit for the value of the maximum activity value as a third function of the minimum activity value; and

limiting the value of the maximum activity value to between the upper and lower limits.

19. The method of claim 18 wherein the second function is n times the minimum activity value, where n is selected to be greater than 10 and the third function is m times the minimum activity level, where m is selected from between 2 and 5.

20. The method of claim 18 further comprising;

(j) obtaining a second activity value based on a second time measure of the physiological parameter corresponding to the patient'"'"'s average activity over a second time period;

(k) adjusting the minimum activity value in response to the second activity value being less than the minimum activity value by more than a first percent, the first percent being selected from between 3 and 9 percent, so that the adjusted value of the minimum activity level is the preceding value reduced by the selected percent; and

(l) adjusting the minimum activity value in response to the second activity value being greater than the minimum activity value by more than a second selected percent for longer than a fourth period of time during which the minimum activity value is not adjusted, so that the adjusted value of the minimum activity value is the preceding value increased by the second percent, the second percent being selected from between 3 and 9 percent.

21. The method of claim 20 wherein step (k) further comprises:

calculating an average of the minimum activity value values over a fifth period of time; and

providing an upper limit for the minimum activity value as a fourth function of the calculated average minimum activity level.

22. The method of claim 20 wherein the physiological parameter is the minute volume and the control function is linear, providing the first function as a multiple on the order of 6 times the minimum activity level, wherein obtaining the first activity value further comprises averaging the minute volume measures obtained over the last N number of breathing cycles N being selected from between 4 and 16, the third time period being selected from between 12 and 48 hours, and wherein providing the second activity value further comprises calculating every M number of breathing cycles a mean value of the preceding minimum activity values during a T number of preceding breathing cycles, wherein M is selected from between 16 and 64 and T is selected from between 34 and 128.

23. The method of claim 21 wherein the fourth function is 1 times the calculated average minimum activity level, 1 being selected from between 1.1 and 1.3.

24. The method of claim 21 wherein the physiological parameter is the minute volume and the control function is linear, providing the first function as a multiple on the order of 6 times the minimum activity level, wherein obtaining the first activity value further comprises averaging the minute volume measures obtained over the last N breathing cycles, N being selected from between 4 and 16, the third time period being selected from between 12 and 48 hours, wherein obtaining the second activity value further comprises calculating every M number of breathing cycles a mean value of the preceding minimum activity values during a T number of preceding breathing cycles, wherein M is selected from between 16 and 64 and T is selected from between 34 and 128, and wherein calculating the average of the minimum activity value over the fifth period of time further comprises calculating the mean value of the minimum activity value every U number of breathing cycles, wherein U is selected from between 48 and 192.

25. The method of claim 9 wherein step (a) further comprises obtaining a first activity value based on a first time measure of the physiological parameter corresponding to the patient being in a rest activity level and, setting the minimum activity value to be the first activity value.

26. The method of claim 25 wherein the physiological parameter is the minute volume and the control function is linear, wherein obtaining the first activity value further comprises averaging a first plurality of minute volume measures obtained over a corresponding plurality of breathing cycles, the first being selected from between 16 and 64, and providing the first function as a multiple on the order of 6 times the minimum activity value.

27. A pacemaker having a programmed minimum pacing rate (FC low) and a programmed maximum pacing rate (FC max), comprising:

a sensor for monitoring a physiological parameter (X) indicative of patient activity;

means for providing a linear control relation for providing a selected pacing rate in response to a measure of the physiological parameter having as coefficients FC low and FC max;

first means for calculating automatically a value X low and a value X max in response to an obtained measure of the physiological parameter corresponding to patient minimum and maximum activity levels, respectively, said first means recalculating automatically the values X low and X max in response to a second obtained measure of the physiological parameter; and

means for adjusting the linear control relation to intersect two pairs of values (FC low, X low) and (FC max, X max) to correspond to the real needs of the patient.

28. The pacemaker of claim 27 wherein the physiological parameter (X) is the minute volume (VE) measured over a breathing cycle and the first calculating means further comprises means for receiving an initial minimum parameter VE low based on a mean minute volume value taken over a plurality of breathing cycles of the patient at rest, the plurality being selected from between 4 and 16, and means for determining an initial maximum parameter VE max to be equal to a number times the initial VE low, the number being selected from between 5 and 7, the first calculating means thereafter calculating the minimum and maximum values of VE low and VE max based on subsequently obtained measures of minute volume.

29. The apparatus of claim 28 further comprising means for recalculating the control relation after each modification of VE max as soon as the heart rate of the patient is less than a threshold rate defined as close to the rate FC low.

30. The pacemaker of claim 28 wherein the first calculating means further comprises a second means for calculating every M/2 breathing cycles a mean value VE/M of the measures of VE during M preceding cycles, M being selected from between 32 and 128, and means for comparing the mean value VE/M to an upper limit calculated as VE low+x% and to a lower limit VE low-x%, wherein x is selected from between 3 and 9;

means for reducing VE low by x% if VE/M is less than the lower limit, and means for increasing VE low by x% if VE/M is greater than the upper limit for more than a selected number of overshootings of the upper limit and VE low is not modified during those overshootings, the selected number being between 4 and 12.

31. The pacemaker of claim 28 wherein the first means for calculating further comprises a second means for calculating the minute volume VE at each breathing cycle;

a third means for calculating a mean value VE/N of the VE measures for the last N breathing cycles, N being selected from between 4 and 16;

means for comparing the mean VE/N to the value of VE max;

means for modifying VE max if VE/N is higher than VE max so that VE max, will be equal to the smallest of the value of VE/N and Z(VE max), wherein Z is selected from between 1.03 and 1.12; and

first means for maintaining VE max the same if VE/N is less than VE max.

32. The pacemaker of claim 31 wherein the first calculating means further comprises means for lowering the value of VE max on the order of 3% to 6% if the value of VE max has not been modified during a selected period on the order of 12 to 48 hours.

33. The pacemaker of claim 32 wherein the lowering means and the modifying means further comprise a second means for maintaining the modified value of VE max between an upper limit corresponding to a theoretical maximum value of the ventilation MVV calculated as a second number times VE low, the second number being greater than 10, and a lower limit corresponding to a minimum value calculated as Y(VE low), Y being selected from between 2 and 5.

34. A method for controlling a pacemaker having a control relation between the pacing rate (FC) and a monitored minute volume (VE) of a patient, the control relation having coefficients defining the control relation of the pacing rate having a programmed minimum rate (FC low) and a programmed maximum rate (FC max), characterized by:

defining a linear control relation a(VE)+b;

initializing the control relation by calculating a minimum parameter VE low to be the mean value taken over a plurality of breathing cycles of the patient at rest, the plurality being selected from between 4 and 16, and providing a maximum parameter VE max;

calculating automatically thereafter a value VE low and a value VE max corresponding to a minimum activity and a maximum activity in response to measures of the minute volume; and

maintaining the control relation as a line intersecting two pairs of values (FC low, VE low) and (FC max, VE max) to correspond to the real needs of the patient.

35. A method according to claim 34, further characterized by calculating the minute volume VE at each breathing cycle, calculating a mean value VE/N of the VE measures for the last N breathing cycles, N being selected from between 4 and 16, comparing the mean VE/N to the value of VE max, modifying VE max if VE/N is higher than VE max so that VE max will be equal to the smallest of the value of VE/N and Z(VE max), wherein Z is selected from between 1.03 and 1.12, and maintaining VE max the same if VE/N is less than VE max.

36. A method according to claim 35, further characterized by lowering the value of VE max on the order of 3% to 6% if the value of VE max has not been modified during a selected period on the order of 12 to 48 hours.

37. A method according to claim 35, further characterized by maintaining the modified value of VE max between an upper limit corresponding to a theoretical maximum value of the ventilation MVV calculated as a second number times VE low, the second number being greater than 10, and a lower limit corresponding to a minimum value calculated as Y(VE low), Y being selected from among the group consisting of 2, 3, 4, or 5.

38. A method according to claim 34, further characterized by recalculating the control relation after each modification of VE max as soon as the heart rate of the patient is less than a threshold rate defined as close to the rate FC low.

39. A method according to claim 34, further characterized by calculating every M/2 breathing cycles a mean value VE/M of the measures of VE during M preceding cycles, M being selected from between 32 and 128, and comparing the mean value VE/M to an upper limit calculated as VE low+x% and to a lower limit VE low-x%, wherein x is selected from between 3 and 9;

reducing VE low by x% if VE/M is less than the lower limit, and increasing VE low by x% if VE/M is greater than the upper limit for more than a selected number of overshootings of the upper limit and VE low is not modified during those overshootings, the selected number being between 4 and 12.

40. A method according to claim 34, further characterized by calculating a limit value VE low/max as being equal to VE low/mean+y%, wherein VE low/mean is equal to the mean value of 256 values of VE low calculated every 96 breathing cycles, y being selected from between 10 and 30.

41. In a pacemaker having a cardiac pacing rate that varies between a selected maximum rate and a selected minimum rate in response to a control function relating a monitored physiological parameter indicative of patient activity to a pacing rate, a method for adjusting the control function comprising:

(a) providing a minimum activity value for the physiological parameter corresponding to patient activity;

(b) providing a maximum activity value;

(c) calibrating the control function so that the provided minimum activity value relates to the selected minimum pacing rate and the provided maximum activity value relates to the selected maximum pacing rate;

(d) selecting the pacing rate in response to a measure of the physiological parameter using the calibrated control function;

(e) obtaining a first activity value based on a first time measure of the physiological parameter corresponding to the patient'"'"'s average activity over a first time period;

(f) adjusting the maximum activity value in response to the first activity value being greater than the maximum activity value, so that the adjusted maximum activity value is the lesser of the first activity value and the preexisting maximum activity value times a first constant, the first constant being selected from between 1.03 and 1.12; and

(g) maintaining the maximum activity value unadjusted if it is greater than the first activity value.

42. The method of claim 41 further comprising:

(h) recalibrating the control function in response to the adjusted maximum activity value and the pacing rate decreasing below a selected rate threshold; and

thereafter

(i) selecting the pacing rate in response to a measure of the physiological parameter using the recalibrated control function.

43. The method of claim 42 wherein step (f) further comprises adjusting the maximum activity value in response to the maximum activity value not being adjusted during a third time period, the third time period being greater than the second time period, so that the adjusted value is the preexisting maximum activity value times a second constant selected from between 0.93 and 0.97.

44. The method of claim 43 wherein step (f) further comprising:

providing an upper limit for the value of the maximum activity value as a second function of the minimum activity value;

providing a lower limit for the value of the maximum activity value as a third function of the minimum activity value; and

limiting the value of the maximum activity value to between the upper and lower limits.

45. The method of claim 44 wherein the second function is n times the minimum activity value, where n is selected to be greater than 10 and the third function is m times the minimum activity level, where m is selected from between 2 and 5.

46. The method of claim 44 further comprising;

(j) obtaining a second activity value based on a second time measure of the physiological parameter corresponding to the patient'"'"'s average activity over a second time period;

(k) adjusting the minimum activity value in response to the second activity value being less than the minimum activity value by more than a first percent, the first percent being selected from between 3 and 9 percent, so that the adjusted value of the minimum activity level is the preceding value reduced by the selected percent; and

(l) adjusting the minimum activity value in response to the second activity value being greater than the minimum activity value by more than a second selected percent for longer than a fourth period of time during which the minimum activity value is not adjusted, so that the adjusted value of the minimum activity value is the preceding value increased by the second percent, the second percent being selected from between 3 and 9 percent.

47. The method of claim 46 wherein step (k) further comprises:

calculating an average of the minimum activity value values over a fifth period of time; and

providing an upper limit for the minimum activity value as a fourth function of the calculated average minimum activity level.

48. The method of claim 47 wherein the fourth function is 1 times the calculated average minimum activity level, 1 being selected from between 1.1 and 1.3.

49. The method of claim 46 wherein the physiological parameter is the minute volume and the control function is linear, wherein obtaining the first activity value further comprises averaging the minute volume measures obtained over the last N number of breathing cycles N being selected from between 4 and 16, the third time period being selected from between 12 and 48 hours, and wherein providing the second activity value further comprises calculating every M number of breathing cycles a mean value of the preceding minimum activity values during a T number of preceding breathing cycles, wherein M is selected from between 16 and 64 and T is selected from between 34 and 128.

50. The method of claim 41 wherein step (a) further comprises obtaining a first activity value based on a first time measure of the physiological parameter corresponding to the patient being in a rest activity level and, setting the minimum activity value to be the first activity value.

51. The method of claim 50 wherein the physiological parameter is the minute volume and the control function is linear, wherein obtaining the first activity value further comprises averaging a first plurality of minute volume measures obtained over a corresponding plurality of breathing cycles, the first being selected from between 16 and 64, and providing the maximum activity value for initializing further comprises calculating the maximum activity value as a multiple on the order of 6 times the minimum activity value.

52. A method of claim 41 wherein the physiological parameter is the minute volume and the control function is linear, providing the maximum activity value for initializing further comprises calculating the maximum activity value as a multiple on the order of 6 times the minimum activity level, wherein obtaining the first activity value further comprises averaging the minute volume measures obtained over the N most recent breathing cycles wherein N is selected from between 4 and 16.

53. The method of claim 41 further comprising:

modifying the maximum activity value in response to the trend of a first measure of the physiological parameter representative of maximum activity levels differing from the existing maximum activity value by more than a first threshold amount; and

recalibrating the control function using the modified value maximum activity.

54. The method of claim 53 further comprising:

modifying the minimum activity value in response to the trend of a second measure of the physiological parameter representative of minimum activity levels differing from the existing minimum activity value by more than a second threshold amount; and

recalibrating the control function using the modified maximum activity value.

55. In a pacemaker having a control relation between the pacing rate (FC) and a monitored minute volume physiological parameter (VE) measured over a breathing cycle of the patient indicative of patient activity, the control relation having coefficients defining a programmed minimum rate (FC low) and a programmed maximum rate (FC max), apparatus for adjusting a control relation, comprising:

means for receiving an initial minimum parameter VE low based on a mean minute volume value taken over a plurality of breathing cycles of the patient at rest, the plurality being selected from between 4 and 16;

means for receiving an initial maximum parameter VE max;

first means for calculating automatically a value VE low and a value VE max in response to subsequently obtained measures of the minute volume corresponding to patient maximum and minimum activity levels, respectively; and

means for adjusting the control relation to intersect two pairs of values (FC low, VE low) and (FC max, VE max) to correspond to the real needs of the patient.

56. The apparatus of claim 55 wherein the first means for calculating further comprises a second means for calculating the minute volume VE at each breathing cycle;

a third means for calculating a mean value VE/N of the VE measures for the last N breathing cycles, N being selected from between 4 and 16;

means for comparing the mean VE/N to the value of VE max;

means for modifying VE max if VE/N is higher than VE max so that VE max, will be equal to the smallest of the value of VE/N and Z(VE max), wherein Z is selected from between 1.03 and 1.12; and

first means for maintaining VE max the same if VE/N is less than VE max.

57. The apparatus of claim 56 wherein the first calculating means further comprises means for lowering the value of VE max on the order of 3% to 6% if the value of VE max has not been modified during a selected period on the order of 12 to 48 hours.

58. The apparatus of claim 57 wherein the lowering means and the modifying means further comprise a second means for maintaining the modified value of VE max between an upper limit corresponding to a theoretical maximum value of the ventilation MVV calculated as a second number times VE low, the second number being greater than 10, and a lower limit corresponding to a minimum value calculated as Y(VE low), Y being selected from between 2 and 5.

59. The apparatus of claim 55 further comprising means for recalculating the control relation after each modification of VE max as soon as the heart rate of the patient is less than a threshold rate defined as close to the rate FC low.

60. The apparatus of claim 55 wherein the first calculating means further comprises a second means for calculating every M/2 breathing cycles a mean value VE/M of the measures of VE during M preceding cycles, M being selected from between 32 and 128, and means for comparing the mean value VE/M to an upper limit calculated as VE low+x% and to a lower limit VE low-x%, wherein x is selected from between 3 and 9;

means for reducing VE low by x% if VE/M is less than the lower limit, and means for increasing VE low by x% if VE/M is greater than the upper limit for more than a selected number of overshootings of the upper limit and VE low is not modified during those overshootings, the selected number being between 4 and 12.