Pacemaker with optimized rate responsiveness and method of rate control

• US 5,065,759 A
• Filed: 08/30/1990
• Issued: 11/19/1991
• Est. Priority Date: 08/30/1990
• Status: Expired due to Term

• Current Assignee: Vitatron Medical BV
• Original Assignee: Vitatron Medical BV
• Inventors: de Vries, Bernhard, Begemann, Malcolm J. S., van der Veen, Johannes S.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/575,289
• Time in Patent Office: 446 Days
• Field of Search: 128/419 PG, 128/707
• US Class Current: 607/18
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

A pacemaker system is provided for rate responsive pacing, wherein rate is controlled as a function of two or more sensor inputs, each sensor providing a signal representing a respective different control parameter. Preferably a first sensor signal represents a physiologically accurate although slow response signal such as OT interval, and a second sensor represents a relatively fast response such as activity. The two parameter signals are processed so that they are directly comparable and can be compared as indicators of pacing rate throughout the desired pacing range. The algorithm utilizes a parameter control reference curve for each respective parameter, such reference curve representing the desired correlation between pacing rate and the parameter signal. Rate control is accomplished by determining the difference between each processed parameter signal and its corresponding reference point for the current pacing interval, and logically analyzing the two differences to determine which is used to indicate change in pacing rate. Each parameter reference curve is automatically adjustable to correspond to patient conditions. Automatic drift correction of the fast response parameter, such as activity, is used to compensate for conditions where the fast response signal is not likely to be physiologically reflective of the patient condition.

Claims

1. A pacing system having rate controllable pulse generator means for generating pacing pulses, first sensor means for developing first signals indicating a first pacing rate, second sensor means for developing second signals indicating a second pacing rate, and rate control means for determining desired pacing rate and controlling the rate of said pulse generator means, said rate means further comprising algorithm means for determining (a) from each of said first and second sensor means signals a respective indicated direction of rate change and amount of rate change, and (b) for determining said desired pacing rate as a function of said directions and amounts.

2. The pacing system as described in claim 1, comprising a lead having a first end with an electrode adapted for placement in the patient'"'"'s ventricle, the other end being electrically connected to said pulse generator means, said first sensor means including said lead and comprising means for detecting the QT interval, and wherein said second sensor means provides an output indicative of the patient'"'"'s physical activity.

3. The pacing system as described in claim 1, wherein said first signals indicate a physiological rate reflective of the physiological state of said patient, and wherein said second signals indicate a fast rate reflective of a relatively fast response to patient conditions compared to said physiological rate.

4. The pacing system as described in claim 1, wherein said second sensor means has a relatively fast response to patient conditions compared to the response of said first sensor means.

5. The pacing system as described in claim 3, wherein said algorithm means comprises means for comparing said physiological and fast rates, means for deriving a rate difference indication therefrom, and means for determining pacing rate as the physiological rate plus an increment of rate which is a function of said rate difference.

6. The pacing system as described in claim 1, wherein said algorithm means provides a signal for changing pacing rate by a predetermined step when both said first and second sensor signals indicate a rate change in the same direction.

7. The pacing system as described in claim 6, wherein said algorithm determining means has means for comparing said amount indications when said rate change directions are opposite, and means for choosing the direction of rate change on the basis of said amounts comparison.

8. The pacing system as described in claim 1, comprising means for generating first reference data for correlating said first signals and desired pacing rate and second reference data for correlating said second signals and desired pacing rate, and wherein said algorithm means comprises

means for comparing said first signals with said first reference data to provide a first difference;

means for comparing said second signals with said reference data to provide a second difference; and

means for comparing said first and second differences to determine said desired pacing rate.

9. The pacing system as described in claim 1, comprising means for automatically adjusting said second signals to indicate a pacing rate closer to that indicated by said first signals.

10. The pacing system as described in claim 1, wherein said algorithm means comprises means for comparing the respective indicated directions of rate change and the indicated amounts of rate change, and further comprises means for reducing the indicated amount of change determined from said second signals relative to said first signals.

11. The pacing system as described in claim 1, wherein each pacing cycle said algorithm means selects which of said sensor signals indicates a preferred rate change, and determines rate change in accordance with the selected rate change.

12. A pacemaker system adapted for implantation in the body of a patient, comprising:

pulse generator means adapted to be rate controlled for generating pacing stimulus pulses;

at least first and second sensor means for generating respective first and second pacing rate signals correlative of desired pacing rates;

indicator means for deriving from each of said pacing rate signals an indication for direction of desired change of pacing rate and an indication of amount of desired change of pacing rate;

rate determining means for determining pacing rate as a predetermined function of said direction and amount indications of each respective sensor means; and

rate control means for controlling said pulse generator means in accordance with said determined pacing rate.

13. A method of pacing utilizing a rate responsive pacing system adapted to provide stimulus pulses to a patient'"'"'s heart at a rate within a predetermined range which is responsive to one or both of a first physiological control parameter and a second fast response control parameter, said system having means for periodically obtaining signals reflective of said control parameters and correlating means for correlating each parameter to a respective indication of desired pacing rate, comprising:

a) correlating one of said parameter signals so as to adjust its influence relative to the other control parameter signal, whereby pacing rate is primarily determined by said first parameter signal; and

b) comparing said respective pacing rate indications and determining pacing rate as a function of said comparison each pacing cycle.

14. The method as described in claim 13, wherein said comparing step comprises establishing a parameter control reference point for each respective parameter each time said control parameters are obtained, each reference point representing pacing rate as a function of the respective parameter signal.

15. The method as described in claim 14, comprising comparing for each pacing cycle each control parameter with the reference point established during the prior cycle, and establishing a difference value therefrom, and said comparing step comprises comparing the difference values so obtained for the two respective parameters.

16. The method as described in claim 15, comprising automatically introducing a correction factor to said second control parameter whenever there is a difference between such control parameter and its corresponding reference point.

17. The method as described in claim 14, comprising generating said parameter control reference points in accordance with a predetermined reference curve for each respective parameter, and adjusting each said reference curve when a predetermined condition exists at at least one pacing rate within said range.

18. The method of claim 13, comprising obtaining QT interval as said first parameter and an activity count as said second parameter.

19. The method of claim 13, comprising sensing patient heartbeat, and obtaining both said first and second parameters from the sensed heartbeat.

20. The method of claim 19, comprising obtaining QT interval as said first parameter and T wave amplitude as said second parameter.

21. A pacing system having pulse generator means for delivering stimulus pulses and rate adjusting means for adjusting the rate of delivery of said stimulus pulses, slow physiological sensor means for generating a relatively slow response signal representative of desired physiological pacing rate and at least a second fast sensor means for generating a fast response signal having a faster response than said physiological signal to changing patient circumstances such as activity and the like and which is representative of pacing rate, said pacing system being characterized by:

slow means for deriving a physiological rate indication from said slow signal;

fast means for deriving a fast rate indication from said fast signal;

means for comparing said physiological and fast rate indications;

means for determining a rate factor as a function of said comparing;

means for determining desired pacing rate as said physiological rate indication modified by said rate factor; and

means for causing said rate factor to move in a direction so as to reduce its modifying effect.

22. The pacing system as described in claim 21 wherein said fast sensor means comprises an activity sensor, and said slow sensor means comprises means for obtaining QT interval.

23. The pacing system as described in claim 21, wherein both said slow means and said fast means comprise means for obtaining patient heartbeat signals and means for deriving signals representative of desired pacing rate from said heartbeat signals.

24. A pacemaker system adapted to continuously vary the rate of generated pacing pulses as a function of sensed patient conditions, and having at least first and second sensors for obtaining signal indications of pacing rate, said sensors having relatively high and low respective rates of response to changing patient conditions, the system having rate determining means characterized by:

reference means for determining a sensor rate reference for each of said sensors corresponding to each pacing interval at which stimulus pulses are generated;

difference means for determining a difference value for each sensor for each pacing interval, each said difference value reflecting the signal of each said sensor compared to the corresponding sensor rate reference for the prior interval;

comparing rate means for comparing the difference values of each of said sensors; and

rate means for determining rate change as a function of said comparison of difference values.

25. The pacemaker system of claim 24, comprising means for coupling said sensor rate references within a predetermined rate range.

26. The pacemaker system of claim 25, comprising means for setting the maximum output of each of said sensor to be produced at the upper limit of said rate range (URL) and at about maximum patient exercise and stress.

27. The pacemaker system of claim 24, comprising means of adjusting the relative influence of the signals of said sensors in determining rate change.

28. The pacemaker system of claim 24, wherein said rate means comprises step means for determining the step size of said rate change, said step size being variable with pacing interval.

29. The pacemaker system of claim 24, comprising means for periodically adjusting the fast rate response signal when at least a predetermined difference value exists between said fast signal and its corresponding reference value.

30. The pacemaker system of claim 24, wherein said reference means comprises adjustment means operative under predetermined patient conditions for adjusting the determined references for at least one of said sensors.

31. A pacemaker system adapted to continuously vary the rate of generated pacing pulses as a function of sensed patient conditions, having rate means for controlling pacing rate over a predetermined range of rates in response to a determination of rate change, said means for controlling comprising:

first means for developing a first indicator of pacing rate based on a first sensed parameter;

second means for developing a second indicator of pacing rate based on a second sensed parameter which is a relatively faster-response parameter compared to said first parameter;

said second means having conversion means for converting said second indicator so that it has a proportionately lesser influence relative to said first indicator; and

algorithm means for comparing said first indicator and said converted second indicator and for determining change in pacing rate as function of said comparing.

32. The pacemaker system as described in claim 31, wherein said algorithm means is operative each pacing cycle and further comprises means for determining the amount of rate change indicated by each of said indicators.

33. The pacemaker system as described in claim 31, wherein said first means comprises means for developing a signal representative of a QT time interval, and said second means comprises means for developing a signal representative of patient activity, and wherein said conversion means converts said activity signals so that said second indicator is representative of a time interval comparable to said QT interval.

34. The pacemaker system as described in claim 31, wherein said algorithm means comprises means for comparing the magnitudes of said first indicator and said converted second indicator, and comprises logic means for determining the direction of rate increase as a function of said compared magnitudes when said indicators indicate respective different directions of rate change.

35. The pacemaker system as described in claim 31, wherein said algorithm means performs said comparing periodically, and comprises means for incrementing or decrementing rate by a selected predetermined amount.

36. The pacemaker system as described in claim 31, wherein said first parameter provides a relatively slow physiological response to patient conditions and said second parameter provides a relatively fast response to patient conditions.

37. The pacemaker system as described in claim 36, wherein said first parameter is QT interval, and said second parameter is activity.

38. The pacemaker system as described in claim 36, wherein said second parameter is derived from the patient T wave.

39. The pacing system as described in claim 31, wherein said conversion means converts said second indicator to have a lesser influence relative to said first indicator throughout said predetermined range.

40. The pacing system as described in claim 31, wherein said conversion means performs the function of converting said second rate indicator generally to a lower rate than the rate indicated by said first rate indicator.

41. A pacemaker having pulse generator means for delivering stimulus pulses and rate adjusting means for adjusting the rate of delivery of said pulses, first sensor means for generating a first response signal representative of desired pacing rate and at least a second sensor means for generating a second response signal representative of the desired pacing rate, said pacemaker being characterized by:

a) first rate means for deriving a first rate change indication from said first response signal;

second rate means for deriving a second rate change indication from said second response signal; and

b) algorithm means operative each pacing cycle for comparing said rate change indications and for selecting one of said rate change indications, and rate means for incrementing or decrementing rate as a predetermined function of said selected rate indication.

42. The pacemaker as described in claim 41, wherein said algorithm means is further characterized by having means for automatically decreasing rate changes indicated by said first response signal.

43. The pacing system as described in claim 41, wherein one of said rate means comprises influence means for adjusting its rate change indication relative to the other rate change indication, whereby one of said response signals normally has greater influence than the other on determining rate changes.

44. A pacing system having pulse generator means for delivering stimulus pulses and rate adjusting means for adjusting the rate of delivery of said stimulus pulses, first sensor means for generating a first signal representative of a first desired pacing rate and at least a second sensor means for generating a second signal representative of a second pacing rate, said pacing system being characterized by:

first rate indication means for deriving a first rate indication from said first signal;

second rate indication means for deriving a second rate indication from said second signal;

said rate adjusting means having comparing means for comparing said first rate indication and said second rate indication to provide a rate control signal for control of said rate adjusting; and

drift means for changing said second rate indication in a direction to reduce its influence relative to said first rate indication in said comparison.

45. The pacing system as described in claim 44, wherein said first sensor means generates a relatively slow response signal representative of a physiological pacing rate and said second sensor means generates a fast response signal having a faster response than said physiological signal.

46. The pacing system as described in claim 45, wherein said drift means changes said second rate indication by a fixed amount once every predetermined time period.

47. The pacing system as described in claim 46, wherein said drift means changes only a second rate indication which is false positive compared to said first rate indication.

48. The pacing system as described in claim 46, wherein said drift means corrects for second rate indications which are false negatives compared to said first rate indications.

49. A pacemaker system having means for providing stimulus pulses to a patient'"'"'s heart at a rate which is responsive to one or both of a first physiological parameter and a second relatively faster-response parameter, said system having sensor means for obtaining signals reflective of said parameters and correlation means for correlating each of said parameters with a respective correlation function to respective first and second indications of pacing rate, said correlation means further comprising influence means for setting the influence of said parameter signals relative to each other so that pacing rate is primarily determined by said physiological signal, and having comparing means for comparing said first and second pacing rate indications and means for determining pacing rate as a function of said comparison.