Temperature-based, rate-modulated cardiac therapy apparatus and method

• US 5,005,574 A
• Filed: 11/28/1989
• Issued: 04/09/1991
• Est. Priority Date: 11/28/1989
• Status: Expired due to Term

• Current Assignee: Medical Engineering And Development Institute Inc
• Original Assignee: Medical Engineering And Development Institute Inc
• Inventors: Evans, Merry L., Fearnot, Neal E.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/442,224
• Time in Patent Office: 497 Days
• Field of Search: 128/419 PG
• US Class Current: 607/21
• CPC Class Codes: A61N 1/3655 controlled by body or blood temperature

Abstract

A temperature-based, rate-modulated cardiac pacemaker having means for variably controlling the stimulation rate of the heart according to multiple temperature characteristics of the blood referenced to multiple moving baseline temperatures. A target rate is periodically calculated by obtaining a weighted sum of the following rate components: (1) the magnitude of a decrease in temperature below resting temperature, a first moving baseline, (2) the magnitude of an increase in temperature above a local minimum temperature, a second moving baseline, (3) the magnitude of an increase in the resting baseline above a daily minimum temperature, a third moving baseline, and (4) the absolute value of the rate of change of temperature. The resting temperature is preferably calculated over a longer interval than the local minimum temperature but a much shorter interval than the daily minimum temperature. A positive rate of change of temperature is distinguished from a negative rate of change of temperature and is used differently in the calculation of target rate. The target rate is not directly applied as the new pacing rate but is instead averaged with the previous rate in order to provide smoother transitions between pacing rates. An intermediate rate limit is included in addition to lower and upper rate limits, and rank filtering is employed in the determination of rate components.

Claims

1. A temperature-based, rate-modulated cardiac therapy device, comprising:

means for sensing central venous blood temperature; and

processing means coupled to said sensing means for calculating cardiac rate as a function of temperature conditions, one of said conditions including a dip in central venous blood temperature at the onset of exercise, said processing means including

means for calculating a first rate component proportional to the magnitude of said dip; and

means for increasing cardiac rate by said first rate component.

2. The cardiac therapy device of claim 1 wherein said processing means further includes

means for calculating a second rate component proportional to the absolute value of the rate of change of temperature;

and

means for increasing cardiac rate by said second rate component in addition to said first rate component.

3. The cardiac therapy device of claim 2 wherein said second rate component calculating means includes means for calculating said second rate component with one scale factor for a negative rate of change of temperature and with a greater scale factor for a positive rate of change of temperature.

4. The cardiac therapy device of claim 3 wherein said processing means further includes

means for deriving a local minimum temperature;

means for calculating a third rate component proportional to an increase in temperature above said local minimum temperature; and

means for increasing cardiac rate by said third rate component in addition to said first and second rate components.

5. The cardiac therapy device of claim 4 wherein said processing means further includes

means for deriving a resting temperature;

means for deriving a daily minimum temperature;

means for calculating a fourth rate component proportional to an increase in said resting temperature above said daily minimum temperature; and

means for increasing cardiac rate by said fourth rate component in addition to said first, second and third rate components.

6. The cardiac therapy device of claim 5 wherein said first rate component is proportional to said resting temperature minus current temperature;

said third rate component is proportional to current temperature minus said local minimum temperature;

said fourth rate component is proportional to said resting temperature minus said daily minimum temperature; and

wherein said processing means includes means for inhibiting response to negative values of said first, third and fourth rate components.

7. The cardiac therapy device of claim 6 further comprising smoothing means for limiting the rate of change of cardiac rate, said smoothing means including means for limiting the change in cardiac rate during a predetermined interval to a fraction of the cardiac rate change calculated by said processing means.

8. The cardiac therapy device of claim 7 further comprising rate limit means for limiting the cardiac rate increase in stages during calculation thereof.

9. The cardiac therapy device of claim 1 wherein said processing means further includes

means for deriving a local minimum temperature;

means for calculating a second rate component proportional to an increase in temperature above said local minimum temperature; and

means for increasing cardiac rate by said second rate component in addition to said first rate component.

10. The cardiac therapy device of claim 1 wherein said processing means further includes

means for deriving a resting temperature;

means for deriving a daily minimum temperature;

means for calculating a second rate component proportional to an increase in said resting temperature above said daily minimum temperature; and

means for increasing cardiac rate by said second rate component in addition to said first rate component.

11. The cardiac therapy device of claim 1 wherein said processing means further includes

means for deriving a resting temperature;

and

means for inhibiting response to a negative value of said first rate component;

wherein said first rate component is proportional to said resting temperature minus current temperature.

12. The cardiac therapy device of claim 1 further comprising smoothing means for limiting the rate of change of cardiac rate, said smoothing means including means for limiting the change in cardiac rate to a fraction of the cardiac rate change calculated by said processing means.

13. A temperature-based, rate-modulated cardiac therapy device, comprising:

means for sensing blood temperature; and

processing means coupled to said sensing means for calculating cardiac rate, said processing means including means for increasing cardiac rate by an amount proportional to the magnitude of a dip in blood temperature.

14. The cardiac therapy device of claim 13 wherein said processing means further includes means for increasing cardiac rate by an amount proportional to the absolute value of the rate of change of temperature.

15. The cardiac therapy device of claim 14 wherein said processing means further includes means for calculating a cardiac rate increase with one scale factor for a negative rate of change of temperature and with a greater scale factor for a positive rate of change of temperature.

16. The cardiac therapy device of claim 15 wherein said processing means further includes

means for deriving a local minimum temperature;

and

means for increasing cardiac rate by an amount proportional to an increase in temperature above said local minimum temperature.

17. The cardiac therapy device of claim 16 wherein said processing means further includes

means for deriving a resting temperature;

means for deriving a daily minimum temperature; and

means for increasing cardiac rate by an amount proportional to an increase in said resting temperature above said daily minimum temperature.

18. The cardiac therapy device of claim 13 wherein said processing means further includes

means for deriving a local minimum temperature;

and

means for increasing cardiac rate by an amount proportional to an increase in temperature above said local minimum temperature.

19. The cardiac therapy device of claim 13 wherein said processing means further includes

means for deriving a resting temperature;

means for deriving a daily minimum temperature;

means for increasing cardiac rate by an amount proportional to an increase in said resting temperature above said daily minimum temperature.

20. The cardiac therapy device of claim 13 wherein said processing means further includes means for increasing cardiac rate by an amount proportional to a positive rate of change of temperature.

21. The cardiac therapy device of claim 20 wherein said processing means further includes means for increasing cardiac rate by an amount proportional to the additive inverse of a negative rate of change of temperature.

22. The cardiac therapy device of claim 21 wherein said processing means further includes

means for deriving a local minimum temperature;

and

means for increasing cardiac rate by an amount proportional to an increase in temperature above said local minimum temperature.

23. The cardiac therapy device of claim 22 wherein said processing means further includes

means for deriving a resting temperature;

means for deriving a daily minimum temperature; and

means for increasing cardiac rate by an amount proportional to an increase in said resting temperature above said daily minimum temperature.

24. A temperature-based, rate-modulated cardiac therapy device, comprising:

means for sensing blood temperature;

means coupled to said sensing means for determining first, second and third moving baseline temperatures; and

processing means coupled to said sensing means for calculating cardiac rate, said processing means including summing means for obtaining a weighted sum of a plurality of the following rate components;

the magnitude of a decrease in temperature below said first moving baseline temperature;

the magnitude of an increase in temperature above said second moving baseline temperature;

the magnitude of an increase in said first moving baseline temperature above said third moving baseline temperature; and

the absolute value of the rate of change of temperature.

25. The cardiac therapy device of claim 24 wherein said determining means includes means for calculating said first, second and third moving baseline temperatures periodically from temperature measurements taken over first, second and third intervals, respectively, said first interval exceeding said second interval in length, said third interval exceeding said first interval in length.

26. The cardiac therapy device of claim 25 wherein said determining means includes rank filter means for ranking multiple temperature values and selecting a value of predetermined rank therefrom.

27. The cardiac therapy device of claim 26 further comprising smoothing means for limiting the rate of change of cardiac rate, said smoothing means including means for limiting a change in cardiac rate during a predetermined interval to a fraction of the difference between current cardiac rate and a new cardiac rate calculated by said processing means.

28. The cardiac therapy device of claim 27 further comprising means for determining a lower rate limit, wherein said summing means includes means for adding said weighted sum to said lower rate limit.

29. A temperature-based, rate-modulated cardiac therapy device, comprising:

means for sensing venous blood temperature; and

processing means coupled to said sensing means for calculating cardiac rate, said processing means including

means for distinguishing between positive and negative rates of change of temperature;

means for calculating a first rate component proportional to the magnitude of a negative rate of change of temperature;

means for calculating a second rate component proportional to the magnitude of a positive rate of change of temperature; and

means for increasing cardiac rate by said first and second rate components.

30. The cardiac therapy device of claim 29 further comprising means for storing first and second scale factors for said first and second rate component calculating means, respectively, said second scale factor being greater than said first scale factor.

31. The cardiac therapy device of claim 29 wherein said processing means further includes means for periodically executing a cardiac rate calculation;

and

wherein said means for increasing cardiac rate is responsive to only one of said first and second rate components during each cardiac rate calculation.

32. The cardiac therapy device of claim 31 wherein said means for increasing cardiac rate includes means for alternatively adding said first and second rate components to a subtotal of other rate components;

further comprising rate limit means for limiting the effect of said first and second rate components, said rate limit means including

means responsive to a negative rate of change of temperature for limiting the sum of said subtotal and said first rate component to a predetermined intermediate rate limit value; and

means responsive to a positive rate of change of temperature for limiting said subtotal to said intermediate rate limit value before said second rate component is added.

33. The cardiac therapy device of claim 29 wherein said means for increasing cardiac rate includes means for alternatively adding said first and second rate components to a subtotal of other rate components;

further comprising rate limit means for limiting the effect of said first and second rate components, said rate limit means including

means responsive to a negative rate of change of temperature for limiting the sum of said subtotal and said first rate component to a predetermined intermediate rate limit value; and

means responsive to a positive rate of change of temperature for limiting said subtotal to said intermediate rate limit value before said second rate component is added.

34. A temperature-based, rate-modulated cardiac therapy device, comprising:

means for sensing venous blood temperature, said sensing means including means for producing a plurality of temperature values per minute; and

processing means coupled to said sensing means for calculating cardiac rate in response to diurnal variations and deviations from resting temperature, said processing means including

means for deriving a daily minimum temperature from temperature values produced over a 24-hour period;

means for detecting temperature deviations from said daily minimum temperature;

means for deriving a resting temperature from temperature values produced over an interval less than approximately 12 hours;

means for detecting temperature deviations from said resting temperature; and

means for combining said temperature deviations.

35. The cardiac therapy device of claim 34 wherein said means for detecting temperature deviations from said daily minimum temperature includes means for detecting the magnitude of an increase in said resting temperature above said daily minimum temperature, and means for inhibiting response to a decrease in said resting temperature below said daily minimum temperature.

36. The cardiac therapy device of claim 35 further comprising:

means for deriving a local minimum temperature from temperature values produced over an interval less than the interval for said resting temperature; and

means for detecting the magnitude of an increase in temperature above said local minimum temperature, and means for inhibiting response to a decrease in temperature below said local minimum temperature;

wherein said means for detecting temperature deviations from said resting temperature includes means for detecting the magnitude of a decrease in temperature below said resting temperature, and means for inhibiting response to an increase in temperature above said resting temperature.

37. The cardiac therapy device of claim 36 wherein said means for deriving a resting temperature includes means for deriving a resting temperature from temperature values produced over an interval of between approximately 8 and 40 minutes.

38. The cardiac therapy device of claim 37 wherein said means for deriving a daily minimum temperature includes means for comparing different values of said resting temperature.

39. A temperature-based method of modulating cardiac rate, comprising the steps:

sensing blood temperature; and

calculating a new cardiac rate in response to sensed blood temperature, said calculating step including increasing cardiac rate by an amount proportional to the magnitude of a dip in blood temperature.

40. The method of claim 39 wherein said calculating step further includes increasing cardiac rate by an amount proportional to a positive rate of change of temperature.

41. The method of claim 40 wherein said calculating step further includes increasing cardiac rate by an amount proportional to the additive inverse of a negative rate of change of temperature.

42. The method of claim 41 wherein said calculating step further includes

deriving a local minimum temperature;

and

increasing cardiac rate by an amount proportional to an increase in temperature above said local minimum temperature.

43. The method of claim 42 wherein said calculating step further includes

deriving a resting temperature;

deriving a daily minimum temperature; and

increasing cardiac rate by an amount proportional to an increase in said resting temperature above said daily minimum temperature.

44. The method of claim 39 wherein said calculating step further includes

deriving a local minimum temperature;

and

increasing cardiac rate by an amount proportional to an increase in temperature above said local minimum temperature.

45. The method of claim 39 wherein said calculating step further includes

deriving a resting temperature;

deriving a daily minimum temperature; and

increasing cardiac rate by an amount proportional to an increase in said resting temperature above said daily minimum temperature.

46. A temperature-based method of modulating cardiac rate, comprising the steps:

sensing blood temperature;

determining first, second and third moving baseline temperatures; and

calculating a new cardiac rate in response to sensed blood temperature, said calculating step including obtaining a weighted sum of a plurality of the following rate components;

the magnitude of a decrease in temperature below said first moving baseline temperature;

the magnitude of an increase in temperature above said second moving baseline temperature;

the magnitude of an increase in said first moving baseline temperature above said third moving baseline temperature; and

the absolute value of the rate of change of temperature.

47. The method of claim 46 wherein said determining step includes calculating said first, second and third moving baseline temperatures periodically from temperature measurements taken over first, second and third intervals, respectively, said first interval exceeding said second interval in length, said third interval exceeding said first interval in length.

48. The method of claim 47 wherein said determining step includes ranking multiple temperature values and selecting a value of predetermined rank therefrom.

49. The method of claim 48 further comprising the step of limiting the rate of change of cardiac rate, said limiting step including limiting a change in cardiac rate during a predetermined interval to a fraction of the difference between current cardiac rate and a new cardiac rate calculated in said calculating step.

50. The method of claim 49 further comprising the step of determining a lower rate limit, wherein said calculating step includes adding said weighted sum to said lower rate limit.

51. A temperature-based, rate-modulated cardiac therapy device, comprising:

sensing means for sensing central venous blood temperature;

sampling means coupled to said sensing means for periodically creating indicia of central venous blood temperature;

at least one buffer means for storing a plurality of said indicia of central venous blood temperature;

processing means coupled to said at least one buffer

means for determining a cardiac pacing rate including a first rate component which is a function of the dip in central venous blood temperature which occurs at the onset of exercise, said processing means including

means for calculating said first rate component such that it is proportional to the magnitude of said dip in central venous blood temperature; and

means for increasing the cardiac pacing rate by said at least one rate component.

52. The cardiac therapy device of claim 51, wherein said at least one buffer means stores a first predetermined number of indicia of central venous blood temperature during a first time period of a first predetermined duration, and a second predetermined number of indicia of central venous blood temperature during a second time period of a second predetermined duration, said first time period immediately preceding in time said second time period, said processing means including means for determining, based on the indicia stored in said first and said second time periods, a second rate component which is proportional to the absolute value of the rate of change of central venous blood temperature;

and

means for increasing cardiac rate by both of said first second rate components.

53. The cardiac therapy device of claim 52, wherein said second rate component which is proportional to the absolute value of the rate of change of central venous blood temperature is proportionally greater for a positive rate of change than for a negative rate of change.

54. The cardiac therapy device of claim 52, having a second buffer means, said second buffer means storing a plurality of said indicia of central venous blood temperature, said indicia being selected for storage in said second buffer means from said second predetermined number of indicia at a first periodic interval which is representative of a predetermined minimum value of said second predetermined number of indicia stored in said at least one buffer at the time said indicia is selected, one of said indicia stored in said second buffer being selected to represent a local minimum central venous blood temperature, said processing means including means for determining, based on said indicia representing a local minimum central venous blood temperature and on the indicia most recently selected for storage in said second buffer, a third rate component which is proportional to an increase in temperature above ,said local minimum central venous blood temperature, and

means for increasing cardiac rate by said third rate component in addition to said first and second rate components.

55. The cardiac therapy device of claim 54, wherein said indicia selected for storage in said second buffer means from said second predetermined number of indicia, is the indicia representative of the second lowest central venous blood temperature, and said indicia stored in said second buffer selected to represent a local minimum temperature is the indicia representing the lowest central venous blood temperature.

56. The cardiac therapy device of claim 54, wherein said sampling means creates an indicia of central venous blood temperature at approximately ten second intervals, said first and second time periods are each of approximately one minute duration, and said first periodic interval is of from one to five minutes duration.

57. The cardiac therapy device of claim 56, wherein said second buffer means stores six of said indicia of central venous blood temperature.

58. The cardiac therapy device of claim 54, having a third buffer means and a fourth buffer means, said third buffer means storing a plurality of indicia representative of the average value of the indicia stored in said first buffer means during said second time period at a second periodic interval which is greater in duration than said first time period, one of said indicia stored in said third buffer means being selected to represent a resting central venous blood temperature, said fourth buffer means storing an indicia representative of the daily minimum central venous blood temperature, said indicia selected for storage in said fourth buffer being the indicia representing the lowest resting central venous temperature occurring during a third periodic interval of approximately twenty-four hours duration, the indicia stored in said fourth buffer at the end of said third period being used to represent the daily minimum central venous blood temperature for the next twenty-four hour period, said processing means including means for determining, based on said indicia representing the daily minimum central venous blood temperature and on said indicia representing the resting central venous blood temperature, a fourth rate component which is proportional to an increase in resting temperature above, said daily minimum central venous blood temperature, and

means for increasing cardiac rate by said fourth rate component in addition to said first, second, and third rate components.

59. The cardiac therapy device of claim 58, wherein said first rate component is proportional to said resting central venous blood temperature minus said current central venous blood temperature, said third rate component is proportional to said current central venous blood temperature minus said local minimum central venous blood temperature, said fourth rate component is proportional to said resting central venous blood temperature minus said daily minimum central venous blood temperature, and said processing means includes means for inhibiting response to negative values of said first, said third, and said fourth rate components.

60. The cardiac therapy device of claim 59, wherein said processing means includes smoothing means for limiting the rate of change of cardiac rate, said smoothing means including means for limiting the change in cardiac rate during a fourth periodic interval to a portion of the cardiac rate change represented by the total of said first, second, third and fourth rate components.

61. The cardiac therapy device of claim 60, wherein said processing means includes rate limiting means, which limits the cardiac pacing rate to rates between a lower base pacing rate and an upper maximum pacing rate.

62. The cardiac therapy device of claim 58, wherein said processing means includes smoothing means for limiting the rate of change of cardiac rate, said smoothing means including means for limiting the change in cardiac rate during a fourth periodic interval to a portion of the cardiac rate change represented by the total of said first, second, third and fourth rate components.

63. The cardiac therapy device of claim 62, wherein said processing means includes rate limiting means, which limits the cardiac pacing rate to rates between a lower base pacing rate and an upper maximum pacing rate.

64. The cardiac therapy device of claim 58, wherein said processing means includes intermediate rate limiting means which limits the increase in cardiac rate due to said first, second, and fourth rate components to an intermediate rate for negative rates of change of central venous blood temperature, such that said cardiac rate is limited to said intermediate rate plus said third rate component.

65. The cardiac therapy device of claim 64, wherein said processing means includes smoothing means for limiting the rate of change of cardiac rate, said smoothing means including means for limiting the change in cardiac rate during a fourth periodic interval to a portion of the cardiac rate change represented by the total of said first, second, third and fourth rate components.

66. The cardiac therapy device of claim 65, wherein said processing means includes rate limiting means, which limits the cardiac pacing rate to rates between a lower base pacing rate and an upper maximum pacing rate.

67. The cardiac therapy device of claim 58, wherein said processing means includes intermediate rate limiting means which limits the increase in cardiac rate due to said first and fourth rate components to an intermediate rate for positive rates of change of central venous blood temperature, such that said cardiac rate is limited to said intermediate rate plus said second and third rate components.

68. The cardiac therapy device of claim 67, wherein said processing means includes smoothing means for limiting the rate of change of cardiac rate, said smoothing means including means for limiting the change in cardiac rate during a fourth periodic interval to a portion of the cardiac rate change represented by the total of said first, second, third and fourth rate components.

69. The cardiac therapy device of claim 68, wherein said processing means includes rate limiting means, which limits the cardiac pacing rate to rates between a lower base pacing rate and an upper maximum pacing rate.

70. The cardiac therapy device of claim 52, wherein said sampling means creates indicia of central venous blood temperature at approximately ten second intervals, and said first and second time periods are each of approximately one minute duration.

71. A temperature-based, rate-modulated cardiac therapy device, comprising:

means for sensing venous blood temperature, said sensing means including means for producing a plurality of temperature values per minute; and

processing means coupled to said sensing means for calculating cardiac rate in response to deviations between diurnal and resting temperatures, said processing means including

means for deriving a daily minimum temperature from temperature values produced over a 24-hour period;

means for deriving a resting temperature from temperature values produced over an interval less than approximately 12 hours; and

means for deriving deviations between said daily minimum temperature and said resting temperature.

72. A temperature-based, rate-modulated cardiac therapy device, comprising:

first sensing means for sensing a physiological state, said first sensing means including second sensing means for sensing venous blood temperature;

sampling means coupled to said first sensing means for periodically creating indicia of said blood temperature;

at least one buffer means for storing a plurality of said indicia of said blood temperature;

processing means coupled to said at least one buffer means for determining a cardiac therapy including a first rate component which is proportional to the magnitude of a dip in said blood temperature.

73. The device of claim 72 wherein said processing means include means for deriving a second rate component which is a function of at least one of a plurality of factors including a daily minimum temperature, a resting temperature, a rate of change of temperature, an absolute value of said rate of change of temperature, a local minimum temperature, and a weighted sum of a number of factors.