Temperature responsive controller for cardiac pacer

• US 4,803,987 A
• Filed: 06/11/1986
• Issued: 02/14/1989
• Est. Priority Date: 06/11/1986
• Status: Expired due to Term

• Current Assignee: Eckhard Alt
• Original Assignee: Intermedics Incorporated (Boston Scientific Corporation)
• Inventors: Alt, Eckhard U., Baker, Ross G. Jr., Calfee, Richard V., Adkins, Robert A.
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): Manuel, George
• Application Number:
  US06/872,824
• Time in Patent Office: 979 Days
• Field of Search: 128/419 PG, 128/419 P
• US Class Current: 607/24
• CPC Class Codes: A61N 1/3655 controlled by body or blood temperature

Abstract

A controller for variably controlling the pacing rate of a cardiac pacer responsive to temperature which includes a logic and control unit, a parameter communication unit, an analog to digital converter and a temperature sensor. The temperature sensor in the right ventricle or atrium communicates a value related to blood temperature through the analog to digital converter to the logic and control unit. The logic and control unit operates under control of the rate algorithm to calculate a pacing rate value related to variations in the blood temperature. The pacing rate value is calculated as the sum of a reference rate, a natural rate response term, and a dynamic rate response term which contributes rate only in response to physical activity. A step rate response is also added to the calculated pacing rate when predetermined criteria related to the blood temperature and calculated pacing rate indicate the onset of physical activity. Under the control of the rate algorithm, the controller also maintains the level and rate of change of the calculated pacing rate within predetermined limits, and prevents the pacing rate from remaining at the maximum rate limit after physical activity has ceased.

Claims

1. A cardiac pacemaker adapted to vary its pacing rate according to the physiological state of the pacemaker patient, comprising:

means for detecting the patient'"'"'s central venous blood temperature; and

means responsive to the detected blood temperature for adjusting the pacing rate according to predetermined relationships between blood temperature and desired heart rate including non-exercise related and exercise related terms that depend upon variations in the blood temperature relative to a respective reference temperature, said adjusting means including means for determining a moving dynamic reference temperature that establishes a moving temperature reference value from which to measure the current change in blood temperature indicative of the metabolic need and means to adequately adjust the pacing rate accordingly.

2. The pacemaker of claim 1 wherein said means for determining said moving dynamic reference temperature comprises:

means for calculating said moving dynamic reference temperature as a value which is movable relative to the value of said detected blood temperature according to whether said detected blood temperature is changing at a rate greater than or less than a predetermined rate of change indicative of a predetermined level of exercise.

3. The pacemaker of claim 2 wherein said calculating means calculates a rapid decrease of the value of said moving dynamic reference temperature to the value of said detected blood temperature whenever said detected blood temperature falls below the moving dynamic reference temperature, whereby to avoid any contribution of said exercise related term to the adjustment of pacing rate during periods of non-exercise by the patient.

4. The pacemaker of claim 2 wherein said calculating means calculates a gradual increase of the value of said moving dynamic reference temperature toward the value of said detected blood temperature whenever said detected blood temperature is changing at a rate less than said predetermined rate of change, whereby to gradually reduce the relative contribution of the exercise related term to the adjustment of pacing rate upon cessation of exercises by the patient.

5. The pacemaker of claim 4 wherein said calculating means calculates the gradual increase of the value of said moving dynamic reference temperature in a stepwise manner.

6. The pacemaker of claim 1, further comprising means to limit the rate of change of said pacing rate during the adjustment thereof.

7. The pacemaker of claim 1, further comprising means to maintain the adjusted pacing rate within selected maximum and minimum rate limits.

8. The pacemaker of claim 7, further comprising means to prevent the adjusted pacing rate from remaining at said maximum rate limit after cessation of exercise by the patient.

9. A cardiac pacemaker having a stimulation rate which is adjusted according to variations of the blood temperature of the patient, comprising:

means for measuring the blood temperature;

means responsive to measurement of the blood temperature to detect a drop thereof for determining whether said detected temperature drop is indicative of the onset of exercise by the patient, said determining means being adapted to make said determination by applying criteria from the group consisting of (i) the relative difference between the value of the detected blood temperature and the value of a predetermined reference temperature, (ii) whether said relative difference has been less than a preselected value over a predetermined interval, (iii) the magnitude of the detected temperature drop, (iv) the rate of variation of the detected temperature drop, and (v) the present stimulation rate relative to a preselected reference rate; and

means responsive to a determination that the detected temperature drop is indicative of the onset of exercise for generating a stepped up stimulation rate.

10. The pacemaker of claim 9, wherein said means for determining initially determines whether said relative difference has been less than said preselected value over said interval, and then tests the other criteria only if that criterion is satisfied.

11. The pacemaker of claim 9, further comprising means responsive to the level of the stepped up stimulation rate relative to a preselected maximum stimulation rate for limiting said stepped up rate not to exceed said preselected maximum rate.

12. The pacemaker of claim 9, further comprising means responsive to variations in the measured blood temperature commensurate with exercise by the patient for calculating a smoothly varying stimulation rate, and means for gradually reducing said stepped up rate after a selected interval in favor of adjustment of stimulation rate according to said calculated rate.

13. A stimulus generator for variably controlling the stimulation rate of a cardiac pacer according to variations of the patient'"'"'s blood temperature, comprising:

means for sensing the blood temperature;

means for determining a moving dynamic variable reference temperature having an instantaneous value related to variations of the sensed blood temperature relative to a preselected rate of variation of the blood temperature;

means responsive to the sensed blood temperature and to the relative value of the determined dynamic reference temperature for calculating a dynamic hear rate response related to variations in said sensed blood temperature relative to said dynamic reference temperature attributable to exercise by the patient; and

means for combining said dynamic heart rate response with a predetermined bas rate to obtain a desired stimulation rate for said stimulus generator.

14. The stimulus generator of claim 13, further comprising:

means for establishing a relatively static reference temperature;

means responsive to the sensed blood temperature and to said static reference temperature for calculating a natural heart rate response related to non-exercise related variations in said sensed blood temperature relative to said static reference temperature; and

means for combining said natural heart rate response with said dynamic heart rate response and said base rate to obtain said desired stimulation rate.

15. The stimulus generator of claim 14 wherein said establishing means includes means for periodically recalculating said static reference temperature as a long-term weighted average temperature over a selectable interval.

16. The stimulus generator of claim 13, further comprising:

means responsive to a variation of the sensed blood temperature indicative of the onset of exercise by the patient for calculating a step rate response; and

means for combining said step rate response with said dynamic rate response and said base rate to obtain said desired stimulation rate.

17. The stimulus generator of claim 16 wherein said step rate response calculating means comprises means for testing selected criteria related to the magnitude and slope of downward variations in said blood temperature to determine whether any such variation is indicative of the onset of exercise.

18. The stimulus generator of claim 17 wherein said testing means further tests selected criteria related to the present stimulation rate and to the relative difference between said blood temperature and said dynamic reference temperature during a predetermined interval preceding the calculation of said step response.

19. The stimulus generator of claim 13 wherein said means for sensing blood temperature comprises:

thermistor means for generating an analog signal indicative of said blood temperature; and

analog-to-digital converter means for converting each value of said generated analog signal to a respective digital value.

20. The stimulus generator of claim 19 wherein said converter means further comprises:

input means for detecting a digital value; and

comparator means for comparing the detected digital value with said generated analog signal and providing an indication of correspondence therebetweeen.

21. The stimulus generator of claim 20 wherein said converter means further comprises adjustment means for selectively altering the correspondence between digital values and analog signals.

22. The stimulus generator of claim 13, further comprising means to limit the rate of change of the stimulation rate while combining the responses to obtain a desired rate.

23. The stimulus generator of claim 13, further comprising means to maintain the obtained stimulation rate within selected maximum and minimum rate limits.

24. The stimulus generator of claim 23, further comprising means to reduce the obtained stimulation rate from said maximum rate limit after cessation of exercise by the patient.

25. A pulse generator controller for variably controlling the pacing rate of a cardiac pacer, comprising:

means for detecting the central venous blood temperature of the pacer patient;

means for calculating components of the desired pacing rate related to the detected blood temperature, a moving dynamic reference temperature having a changing value dependent on rate of variation of the detected blood temperature relative to a preselected rate of variation, and a static reference temperature, said components consisting of (i) a predetermined reference rate related to a baseline value of the blood temperature, (ii) a natural rate response related to variations of the blood temperature with the patient'"'"'s circadian rhythm and other non-exercise phenomena relative to the static reference temperature, (iii) a dynamic rate response related to variations of the blood temperature with patient exercise relative to the moving dynamic reference temperature, and (iv) a step rate response related to variations of the blood temperature with onset of patient exercise; and

means for combining the calculated components to establish a physiologically appropriate pacing rate, with the contributions of components (ii), (iii) and (iv) being based on the recited variations of the blood temperature.

26. In a stimulus generator for varying the pacing rate of a cardiac pacer according to the physiological state of the patient, wherein said pacer is of the type responsive to variations in the detected blood temperature with respect to a reference temperature, the improvement comprising means for periodically recalculating said reference temperature as a long term weighted average over a selectable interval.

27. A method for variably controlling the pacing rate of a cardiac pacer comprising the steps of:

detecting the patient'"'"'s central venous blood temperature;

determining a moving dynamic reference temperature that establishes a moving temperature reference value from which to measure that current change in blood temperature indicative of the metabolic need and means to adequately adjust the pacing rate accordingly;

calculating a dynamic heart rate response related to variations in said detected blood temperature relative to said dynamic reference temperature, attributable to patient exercise; and

combining said dynamic rate response with a predetermined base rate to obtain a desired pacing rate.

28. The method defined in claim 27, further including the steps of

establishing a relatively static reference temperature;

calculating a natural heart rate response related to non-exercise related variations in said detected blood temperature relative to said static reference temperature; and

combining said natural rate response with said dynamic rate response and said base rate to obtain said desired pacing rate.

29. The method defined in claim 28, further including the step of periodically recalculating said static reference temperature as a long-term weighted average temperature over a selectable interval.

30. The method defined in claim 27, further including the steps of:

calculating a step rate response;

determining whether preselected criteria indicative of the onset of patient exercise are satisfied; and

if said criteria are satisfied, combining said step rate response with said dynamic rate response and said base rate to obtain said desired pacing rate.

31. The method defined in claim 30 wherein said preselected criteria include criteria related to the magnitude and slope of a detected drop in said blood temperature.

32. The method defined in claim 30 wherein said preselected criteria include criteria related to the present pacing rate, and to the relative difference between said blood temperature and said dynamic reference temperature during a predetermined interval preceding the calculation of said step rate response.

33. The method defined in claim 27, further including the step of limiting the rate of change of the pacing rate obtained from said combining step.

34. The method defined in claim 27, further including the step of maintaining the pacing rate obtained from the combining step within selected maximum and minimum rate limits.

35. The method defined in claim 34, further including the step of the obtained pacing rate from said maximum rate limit after cessation of exercise by the patient.

36. A stimulus generator for a rate adaptive cardiac pacemaker, comprising

means for detecting a physiological parameter of a pacemaker patient uniquely indicative of either patient exercise or non-exercise,

means responsive to said parameter for processing thereof according to a first algorithm in which heart rate is a function of said parameter under conditions of exercise by a healthy person with a normally functioning heart,

means responsive to said parameter for processing thereof according to a second algorithm in which heart rate is a function of said parameter under conditions of non-exercise by a healthy person with a normally functioning heart,

means for generating electrical stimuli at a controllably variable rate, and

means responsive to said detected parameter for selectively combining said first and second algorithms to control the rate at which stimuli are generated by said generating means, said combining means including means for selectively determining the contribution of each of said first and second algorithms to control the stimulation rate.

37. The stimulus generator of claim 36, further comprising

means responsive to said detected parameter for determining the onset of patient exercise, and means responsive to that determination for stepping up the rate at which stimuli are generated by said generating means.

38. The stimulus generator of claim 36, wherein said parameter is blood temperature variation relative to a reference temperature.

39. The stimulus generator of claim 38, wherein the processing means for the first algorithm includes means for developing a variable reference temperature having an instantaneous value dependent on detected blood temperature and the variation thereof relative to a predetermined rate of variation.

40. The stimulus generator of claim 39, wherein said contribution determining means utilizes the instantaneous value of said variable reference temperature relative to the detected blood temperature to selectively determine the contribution of the first and second algorithms to the rate control.

41. The stimulus generator of claim 39 wherein said combining means further includes means for rapidly adjusting the variable reference temperature to track detected blood temperature to lower value, and for gradually adjusting the variable reference temperature toward detected blood temperature of higher value when the detected blood temperature variation is below said predetermined rate of variation.

42. The stimulus generator of claim 38 wherein the processing means for the second algorithm includes means for establishing a relatively static reference temperature against which variations of the detected blood temperature are to be measured.

43. The stimulus generator of claim 42 wherein said establishing means periodically recalculates said static reference temperature as a long-term weighted average over a programmable interval.

44. The stimulus generator of claim 36 wherein said contribution determining means designates a contribution of said first algorithm to the rate control only if the detected parameter is indicative of patient exercise.

45. An exercise responsive cardiac pacemaker, comprising

means for detecting the commencement and continuation of patient exercise by monitoring the timely course o a physiological parameter,

means for generating electrical stimuli at a controllable rate,

means responsive to said detection for controlling the rate at which stimuli are generated by said generating means according to a physiological function representing a combination of an initial temporary increase in heart rate from a non-exercise related heart rate at the moment of detection of commencement of exercise, with selectively variable contributions to rate control attributable to exercise related and non-exercise related components in which heart rate is a function of said physiological parameter in the manner experienced by a healthy person with a normal functioning heart, throughout the detected exercises, and

means for selectively varying the contributions of said exercise related and non-exercise related heart rate components to the rate control.