Method and apparatus for controlling the base frequency of a cardiac pacemaker

• US 5,645,576 A
• Filed: 03/16/1995
• Issued: 07/08/1997
• Est. Priority Date: 03/16/1994
• Status: Expired due to Term

• Current Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Bouhour, Anne, Limousin, Marcel, Bonnet, Jean-Luc
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/405,286
• Time in Patent Office: 845 Days
• Field of Search: 607/19, 607/25
• US Class Current: 607/19
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

Process of control of the base frequency of a cardiac pacemaker having at least one sensor monitoring a physiological parameter. Rest phases and resumption of activity phases are detected to adapt automatically the base frequency of the pacemaker to the relative periods of rest and activity of the patient. Thus, the base frequency is allowed to decrease below the normally programmed base frequency in response to actual patient rest, to encourage a low spontaneous cardiac rhythm to inhibit pacing.

Claims

1. A process for controlling a base frequency of a cardiac pacemaker having a sensor monitoring a physiological parameter and circuits for monitoring stimulated and spontaneous cardiac events, the base frequency having a corresponding base interval, comprising the steps of:

(a) providing an initial programmed base frequency;

(b) monitoring an activity level of a patient;

(c) determining whether the patient activity level corresponds to one of a rest phase and an active phase; and

(d) adjusting the base frequency and corresponding base interval as a function of the determined rest phase to control the base frequency wherein the adjusted base frequency is variable relative to the initial programmed base frequency.

2. The process of claim 1, further comprising the step of controlling the pacemaker to have a stimulation frequency that is a function of the sensed physiological parameter independent of the current base interval.

3. The process of claim 1 wherein step (b) further comprises:

(i) monitoring a physiological parameter of a patient indicative of the patient'"'"'s level of activity;

(ii) analyzing the monitored parameter and identifying therefrom a sensor rest state corresponding to a patient activity level being in a rest state; and

(iii) monitoring patient cardiac activity including spontaneous and stimulated cardiac events and identifying therefrom a cardiac rest state corresponding to the patient cardiac activity level being in a rest state.

4. The process of claim 3 wherein step (c) further comprises determining that a rest phase exists by determining that one of a cardiac rest state and a sensor rest state exists.

5. The process of claim 3 wherein step (c) further comprises determining that a rest phase exists by determining that a cardiac rest state and a sensor rest state exist simultaneously.

6. The process of claim 5 wherein step (b)(iii) further comprises:

selecting sensed cardiac events for a plurality of cardiac cycles, identifying successive cardiac events that are similar in nature, and determining an interval between each said identified two similar successive cardiac events;

determining a percentage of the plurality of cardiac cycles for which the determined interval between said two identified consecutive similar cardiac events is greater than the base interval decreased by a threshold; and

determining that the cardiac activity level is in a rest state in response to the determined percentage being greater than a first value.

7. The process of claim 5 wherein step (b) (iii) further comprises:

selecting sensed cardiac events for a plurality of cardiac cycles, identifying successive cardiac events that are similar in nature, and determining an interval between each said identified two similar successive cardiac events; and

determining that the cardiac activity level is in a rest state in response to the determined interval between said two identified consecutive similar cardiac events being greater than the base interval decreased by a threshold.

8. The process of claim 5 wherein step (d) further comprises the steps of determining the end of a rest phase, and, in response thereto, increasing the base interval by an increment.

9. The process of claim 8 wherein increasing the base interval by an increment further comprises determining whether or not the base interval has reached a maximum interval limit corresponding to a minimal base frequency, and if it has, not further increasing the base interval.

10. The process of claim 3 wherein step (b)ii further comprises averaging monitored physiological parameters, determining an average value of the monitored physiological parameter for each of p samples and determining that the average is less than a predetermined sensor rest level for r out of p samples, wherein r≦

p.

11. The process of claim 10 wherein determining the average value further comprises providing a first duration and providing an average of the last information provided by the sensor during said first duration.

12. The process of claim 11 wherein monitoring the physiological parameter further comprises monitoring respiration, the method further comprising determining a respiratory cycle and providing said first duration as one of a first time interval and a first number of respiratory cycles.

13. The process of claim 12 wherein determining the average further comprises periodically calculating the average at regular intervals corresponding to a second duration, the second duration being one of a second time interval and a second number of respiratory cycles.

14. The process of claim 3 further comprising step (e) determining that an active phase exists by determining that a cardiac rest state and a sensor rest state do not exist simultaneously;

wherein step (d) further comprises adjusting the base interval as a function of the determined rest and active phases.

15. The process of claim 14 wherein step (e) further comprises:

selecting sensed cardiac events for a plurality of cardiac cycles, identifying successive cardiac events that are similar in nature, and determining an interval between each said two identified similar successive cardiac events;

determining a percentage of the plurality of cardiac cycles for which the determined interval between said two identified consecutive similar cardiac events is less than or equal to the base interval decreased by a threshold; and

defining said cardiac active phase to exist in response to the determined percentage being less than or equal to a first value.

16. The process of claim 14 wherein step (e) further comprises:

selecting sensed cardiac events for a plurality of cardiac cycles, identifying successive cardiac events that are similar in nature, and determining an interval between each said two identified similar successive cardiac events; and

defining said cardiac active phase to exist in response to the determined interval between said two identified consecutive similar cardiac events being less than or equal to the base interval decreased by a threshold.

17. The process of claim 14 wherein step (d) further comprises the steps of determining the end of an active phase, and in response thereto decrementing the base interval by a decrement.

18. The process of claim 17 wherein decrementing the base interval by the decrement further comprises determining whether the base interval has reached a minimum interval limit corresponding to a second programmed base frequency, and if it has, not further decreasing the base interval.

19. The process of claim 14 further comprising:

selecting sensed cardiac events for a plurality of cardiac cycles, wherein the sensed cardiac events include at least one of atrial and ventricular extrasystole cardiac events;

counting the number of atrial and ventricular extrasystole cardiac events in said plurality of cardiac cycles; and

defining an extrasystole too important condition in response to the number of atrial and ventricular extrasystoles being greater than a first number.

20. The process of claim 19 wherein step (d) further comprises the step of decreasing the base interval in response to a defined extrasystole too important condition.

21. The process of claim 14 wherein step (e) further comprises determining an average value of the monitored parameter for each of p samples, and determining that the average is less than a predetermined sensor rest level for less than r out of p samples, wherein r≦

p.

22. The process of claim 21 wherein determining the average value further comprises providing a first duration and providing an average of the last information provided by the sensor during said first duration.

23. The process of claim 22 wherein monitoring the physiological parameter further comprises monitoring respiration, the method further comprising determining a respiratory cycle and providing a duration as one of a first time duration and a first number of respiratory cycles.

24. The process of claim 23 wherein determining the average further comprises periodically calculating the average at regular intervals corresponding to a second duration, the second duration being one of a second time interval and a second number of respiratory cycles.

25. An apparatus for controlling a base frequency of a cardiac pacemaker, the base frequency having a corresponding base interval, comprising:

an initial programmed base frequency;

first means for determining an activity level of the patient and determining whether the patient activity level corresponds to one of a rest phase and an active phase; and

means for automatically adjusting the base interval as a function of a determined rest phase wherein the adjusted base interval varies relative to the initial programmed base frequency.

26. The apparatus of claim 25 wherein said first determining means further comprises:

a sensor having an output signal corresponding to a physiological parameter of a patient indicative of the patient'"'"'s level of activity;

means for analyzing the sensor output signal and identifying therefrom a sensor rest state corresponding to a patient activity level in a rest state; and

means for processing the detected cardiac events and identifying therefrom a cardiac rest state corresponding to a patient cardiac activity level in a rest state.

27. The apparatus of claim 26 wherein the first determining means further comprises a second means for determining that a rest phase exists in response to the existence of one of an identified sensor rest state and an identified cardiac rest state.

28. The apparatus of claim 26 wherein the first determining means further comprises a second means for determining that a rest phase exists in response to a cardiac rest state and a sensor rest state existing simultaneously.

29. The apparatus of claim 26 wherein said processing means further comprises means for selecting the sensed cardiac events for a plurality of cardiac cycles, means for identifying two successive cardiac events that are similar in nature, means for determining an interval between each said identified two similar successive cardiac events, and means for determining a percentage of the plurality of cardiac cycles for which the determined interval between said two identified consecutive similar cardiac events is greater than the base interval decreased by a threshold, and means for determining that the cardiac activity level is in a rest state in response to the determined percentage being less than or equal to a first value.

30. The apparatus of claim 26 wherein said processing means further comprises means for selecting the sensed cardiac events for a plurality of cardiac cycles, means for identifying two successive cardiac events that are similar in nature, means for determining an interval between each said identified two similar successive cardiac events, and means for determining a cardiac activity level that is in a rest state in response to the determined interval between said two identified consecutive similar cardiac events being greater than the base interval decreased by a threshold for said plurality of cardiac cycles.

31. The apparatus of claim 26, further comprising a pacemaker having said base interval and means for detecting cardiac events and producing a stimulation frequency that is a function of the sensed physiological parameter independent of the automatically adjusted base interval.

32. The apparatus of claim 26 wherein said adjusting means further comprises means for determining an end of a rest phase, and in response thereto increasing the base interval by an increment.

33. The apparatus of claim 32 wherein the adjusting means further comprises means for not increasing the base interval above a maximum interval limit corresponding to a minimal base frequency.

34. The apparatus of claim 26 wherein said analyzing means further comprises means for determining an average value of the sensor output signal for each of a number p of samples, and means for determining that a sensor rest state exists in response to said average value being less than a predetermined sensor rest level during a number r of the p samples, wherein r≦

p.

35. The apparatus of claim 34 further comprising a first duration wherein said average comprises an average of the last information provided by the sensor during said first duration.

36. The apparatus of claim 35 wherein the monitored parameter comprises respiration, the analyzing means further comprises means for determining a respiratory cycle, and said first duration comprises one of a first time interval and a first number of respiratory cycles.

37. The apparatus of claim 36 wherein said analyzing means further comprises means for calculating said average value at regular intervals having a second duration, the second duration being one of a second time interval and a second number of respiratory cycles.

38. The apparatus of claim 26 further comprising second means for determining that an active phase exists in response to a cardiac rest state and a sensor rest state not existing simultaneously;

and wherein said adjusting means function further comprises a function of said determined rest and active phases of the patient.

39. The apparatus of claim 38 wherein said processing means further comprises means for selecting the sensed cardiac events for a plurality of cardiac cycles, means for identifying two successive cardiac events that are similar in nature, means for determining an interval between each said identified two similar successive cardiac events, and means for determining a percentage of the plurality of cardiac cycles for which the determined interval between said two identified consecutive similar cardiac events is greater than the base interval decreased by a first threshold, and means for determining a cardiac active phase to exist in response to the determined percentage being greater than a first value.

40. The apparatus of claim 38 further comprising:

third means for determining whether a sensed cardiac event is one of an atrial extrasystole and a ventricular extrasystole;

means for counting the number of determined extrasystoles in a plurality of cardiac cycles; and

means for defining an extrasystole too important condition in response to the number of atrial and ventricular extrasystoles being greater than a first number.

41. The apparatus of claim 38 wherein said processing means further comprises means for selecting the sensed cardiac events for a plurality of cardiac cycles, means for identifying successive cardiac events that are similar in nature, means for determining an interval between each said identified two similar successive cardiac events, and means for determining a cardiac activity level that is in an active state in response to the determined interval between said two identified consecutive similar cardiac events being less than or equal to the base interval decreased by a threshold for said plurality of cardiac cycles.

42. The apparatus of claim 38 wherein said adjusting means further comprises means for determining an end of an activity phase, and in response thereto, further comprises means for decrementing the base interval by a decrement.

43. The apparatus of claim 42 wherein the adjusting means further comprising means for not decrementing the base interval below a minimum interval limit corresponding to a second programmed base frequency.

44. The apparatus of claim 43 wherein the adjusting means further comprises means for decreasing the base interval in response to a defined extrasystole too important condition.

45. The apparatus of claim 38 wherein said analyzing means further comprises means for determining an average value of the sensor output signal for each of a number p of samples and means for determining that a sensor active state exists in response to said average value being less than a predetermined sensor rest level during a number r of the p samples of events, wherein r≦

p.

46. The apparatus of claim 45 further comprising a first duration wherein said average value comprises an average of the last information provided by the sensor during said first duration.

47. The apparatus of claim 46 wherein the monitored parameter comprises respiration, the analyzing means further comprises means for determining a respiratory cycle, and said first duration comprises one of a first time interval and a first number of respiratory cycles.

48. The apparatus of claim 47 wherein said analyzing means further comprises means for determining said average value at regular intervals having a second duration, the second duration being one of a second time interval and a second number of respiratory cycles.