Process of controlling a dual chamber cardiac pacemaker

• US 5,713,928 A
• Filed: 07/25/1996
• Issued: 02/03/1998
• Est. Priority Date: 07/25/1995
• Status: Expired due to Term

• Current Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Bonnet, Jean Luc, Limousin, Marcel
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/693,533
• Time in Patent Office: 558 Days
• Field of Search: 607/9, 607/14, 607/25
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions

Abstract

A process for controlling a dual chamber cardiac pacemaker having a fallback mode of de-synchronization of the ventricular stimulation when the atrial rhythm exceeds an allowable level, and a mode of progressive re-synchronization in case of the return of the atrial rhythm to the allowable level. In the process:

(a) at each detection of an atrial depolarization, one defines a window of Detection of the Acceleration of the Atrial Rhythm (DAAR) whose duration is a function the preceding atrial rhythm, evaluated according to the duration of one or an average of several of preceding atrial intervals,

(b) at the detection of the next atrial depolarization, one starts an Atrial Escape Interval (AEI), and

(c) if this next atrial depolarization has occurred in the DAAR window, one commands if necessary a consecutive

atrial stimulation according to the AEI thus defined. According to the present invention, in step (a), one adapts the duration of the DAAR window as a function of the preceding atrial rhythm in a manner to define a first window for a determined rapid atrial rhythm and a second window for a determined slow atrial rhythm, which allows a discrimination between atrial extrasystoles (AES) and physiological accelerations of the atrial rhythm.

Claims

1. A process of controlling a dual chamber cardiac pacemaker operable to sense atrial and ventricular depolarizations, to stimulate an atrium and a ventricle, and to determine an atrial rhythm based on an interval between successive sensed atrial depolarizations and having a fallback mode of de-synchronization of a ventricular stimulation when the atrial rhythm exceeds an allowable level, and a mode of progressive re-synchronization in case of a return of the atrial rhythm to the allowable level comprising:

(a) sensing an atrial depolarization, defining a window of Detection of the Acceleration of the Atrial Rhythm (DAAR) in response to a sensed atrial depolarization, said DAAR having a duration that is a function of a preceding determined atrial rhythm, and further comprising at least one of the preceding intervals between successive sensed atrial depolarizations;

(b) sensing a next atrial depolarization, and in response thereto, starting a delay of an Atrial Escape Interval (AEI); and

(c) determining if said next sensed atrial depolarization has occurred in the defined DAAR window duration, and commanding if necessary a following atrial stimulation according to the started AEI delay,

wherein the method step (a) further comprises adapting the duration of the DAAR window as a function of the preceding atrial rhythm and selecting a first DAAR window duration for a rapid atrial rhythm and a second DAAR window duration for a slow atrial rhythm, and discriminating between atrial extrasystoles (AES) and a physiological acceleration of the atrial rhythm based on said selected DAAR window duration.

2. The process of claim 1 further comprising providing a threshold, comparing the atrial rhythm to the threshold and selecting the first DAAR window duration when the preceding atrial rhythm exceeds the threshold and the second DAAR window duration otherwise.

3. The process of claim 1, further comprising setting the duration of the DAAR window equal to a fraction of the interval separating two preceding successive physiological atrial depolarizations.

4. The process of claim 3, further comprising setting the fraction to approximately 62.5% when defining a second DAAR window duration and approximately 75% when defining a first DAAR window duration.

5. The process of claim 1, further comprising setting the duration of the DAAR window equal to a fraction of an average of a predetermined number of intervals separating two preceding successive physiological atrial depolarizations.

6. The process of claim 4, further comprising setting the fraction to approximately 62.5% when defining a second DAAR window duration and approximately 75% when defining a first DAAR window duration.

7. The process of claim 1, in which, in step (c), in response to determining that said next sensed atrial depolarization is inside the DAAR window:

if, inside the started AEI delay released by said next atrial depolarization, one does not detect another consecutive atrial depolarization;

(i) determining that there is an isolated atrial extra systole (AES), (ii) stimulating the atrium at the end of the AEI, and (iii) defining a long Atrio-Ventricular Delay (AVID); and

in the opposite case;

(i) determining that there is a suspicion of Trouble of the Atrial Rhythm (ToAR) condition, initiating a procedure of analysis of the atrial rhythm and confirmation/non-confirmation of the suspicion of ToAR condition, and (ii) defining a short AVD having a shorter duration than the long AVD.

8. The process of claim 7, further comprising determining a duration of the long AVD as a function of the preceding atrial rhythm.

9. The process of claim 7, further comprising providing a signal representative of a physiological parameter of a patient'"'"'s activity or effort and determining a duration of the long AVD as a function of the preceding atrial rhythm and the signal.

10. The process of claim 9, further comprising limiting the duration of the long AVD to a predetermined limit value.

11. The process of claim 7, further comprising determining a duration of the short AVD as a fixed duration corresponding to a minimal pre-programmed period of the ventricular stimulation.

12. The process of claim 1, in which:

in step (c), in response to sensing said next atrial depolarization inside the selected DAAR window duration, and in response to sensing at least one other consecutive atrial depolarization inside the AEI started by said next sensed atrial depolarization, considering that there is a suspicion of Trouble of the Atrial Rhythm (ToAR) condition, and releasing a procedure of analysis of the atrial rhythm and confirmation/non-confirmation of the suspicion of ToAR, counting, in response to the released analysis procedure of the atrial rhythm, a number of cardiac cycles, and determining whether or not there exists one of a majority proportion of x₁ % of the cardiac cycles on M₁ successive cycles verifying the suspicion of ToAR, and a majority proportion of x₂ % of the cardiac cycles on M₂ successive cycles verifying the suspicion of ToAR, with M₂ >

M₁ and x₂ <

x₁ ;

confirming the presence of a ToAR condition in response to said determining step; and

,

commuting the pacemaker to a mode of de-synchronized ventricular stimulation in response to said confirmed ToAR condition.

13. The process of claim 12, further comprising selecting M₂ 32 2*M₁.

14. The process of claim 13, wherein M₁ =32 and M₂ =64, and x₁ %=87.5% and x₂ %=56% approximately.

15. The process of claim 1 further comprising providing said pacemaker with a dual chamber stimulation mode, in which:

in step (c), in response to detecting said next sensed atrial depolarization inside the selected DAAR window duration and in response to detecting at least one other consecutive atrial depolarization inside the AEI started by said next sensed atrial depolarization, considering that there is a suspicion of Trouble of the Atrial Rhythm (ToAR) condition and releasing a procedure of analysis of the atrial rhythm and confirmation/non-confirmation of the suspicion of ToAR condition;

in response to the released procedure of analysis, confirming the maintenance of a ToAR condition, commuting the pacemaker to operating in a mode of de-synchronized ventricular stimulation in response to a confirmed maintenance of a ToAR condition, and releasing a procedure of analysis of the atrial rhythm for maintenance of the ToAR condition;

detecting a disappearance of the ToAR condition, in response to the released procedure of analysis of the atrial rhythm for the maintenance of the ToAR condition, commuting the pacemaker to operate in a mode of progressive re-synchronization of the ventricular stimulation to a synchronized stimulation, and releasing a procedure of ventricular and atrial rhythm analysis and confirmation of the disappearance of the ToAR condition;

confirming a disappearance of the ToAR condition in response to said released procedure of ventricular and atrial rhythm analysis, and commuting the pacemaker to operate in a mode synchronized with the dual chamber stimulation mode.

16. A method for controlling a dual chamber pacemaker having atrial and ventricular depolarization monitoring circuits and atrial and ventricular stimulating circuits and a fallback operating mode in which the stimulation of the ventricles is desynchronized from an atrial rhythm comprising:

a. monitoring the spontaneous and stimulated atrial depolarization events as p waves;

b. monitoring stimulated and spontaneous ventricular depolarization events;

c. determining a ventricular rhythm from the monitored ventricular depolarization events;

d. detecting a first spontaneous P wave;

e. determining an atrial rhythm as a function of a pair of consecutive P waves;

f. selecting, in response to said detected first spontaneous P wave, a duration as a window of Detection of Acceleration of the Atrial Rhythm (DAAR), said selected duration being one of a first duration corresponding to said determined atrial rhythm preceding said detected first spontaneous P wave representing a fast atrial rhythm and a second duration corresponding to said determined atrial rhythm preceding said detected first spontaneous P wave representing a slow atrial rhythm;

g. initiating, in response to the detection of said first spontaneous P wave, the selected DAAR window;

h. detecting a next spontaneous P wave subsequent to said detected first spontaneous P wave;

i. initiating an atrial escape interval (AEI) in response to said detected next spontaneous P wave,

j. determining whether or not the detected next spontaneous P wave is detected during the initiated selected DAAR window; and

k. in response to said detected next spontaneous P wave being detected during said DAAR window, stimulating if necessary the ventricle at the end of the AEI.

17. The process of claim 16 further comprising providing a threshold wherein step f of further comprises:

comparing the determined atrial rhythm to the threshold;

providing the first duration in response to the determined atrial rhythm being greater than the threshold; and

providing the second duration in response to the determined atrial rhythm not being greater than the threshold.

18. The process of claim 17 wherein providing the first duration further comprises selecting the first duration as a fraction of said determined atrial rhythm.

19. The process of claim 17 wherein:

comparing the determined atrial rhythm to the threshold further comprises determining an average atrial rhythm for a predetermined number of intervals separating two preceding successive spontaneous atrial depolarizations; and

providing the first duration further comprises selecting the first duration as a fraction of said determined average atrial rhythm.

20. The process of claim 17 wherein providing the second duration further comprises selecting the second duration as a fraction of said determined atrial rhythm.

21. The process of claim 17 wherein:

comparing the determined atrial rhythm to the threshold further comprises determining an average atrial rhythm for a predetermined number of intervals separating two preceding successive spontaneous atrial depolarizations; and

providing the second duration further comprises selecting the second duration as a fraction of said determined average atrial rhythm.

22. The process of claim 17 wherein:

providing the first duration further comprises selecting the first duration as a first fraction of said determined atrial rhythm; and

providing the second duration further comprises selecting the second duration as a second fraction of said determined atrial rhythm, wherein the first fraction is greater than the second fraction.

23. The process of claim 22 further comprising selecting the first fraction to be approximately 75% and selecting the second fraction to be approximately 62.5%.

24. The process of claim 17 wherein:

comparing the determined atrial rhythm to the threshold further comprises determining an average atrial rhythm for a predetermined number of intervals separating two preceding successive spontaneous atrial depolarizations;

providing the first duration further comprises selecting the first duration as a first fraction of said determined average atrial rhythm; and

providing the second duration further comprises selecting the second duration as a second fraction of said determined average atrial rhythm, the second fraction being greater than the first fraction.

25. The process of claim 24 further comprising selecting the first fraction to be approximately 75% and selecting the second fraction to be approximately 62.5%.

26. The process of claim 16 further comprising:

1. in response to said detected next spontaneous P wave not being detected during said DAAR window;

i) determining that said detected next spontaneous P wave is an isolated atrial extrasystoles (AES),

ii) stimulating the atrium in response to the end of the AEI, and

iii) establishing a first atrio-ventricular delay (AVD); and

wherein step k further comprises;

declaring a suspicion of trouble of atrial rhythm (ToAR) condition,

initiating an analysis of the atrial rhythm to confirm or not the ToAR condition, and

establishing a second atrio-ventricular delay (AVD), the second AVD being shorter than the first AVD.

27. The process of claim 26 further comprising determining the first AVD as a function of a determined cardiac rhythm.

28. The process of claim 26 further comprising sensing a physiological parameter of a patient corresponding to at least one of activity and effort of the patient, determining a rate responsive pacing rhythm from said sensed physiological parameter, and determining the first AVD as a function of a determined cardiac rhythm and the determined rate responsive rhythm.

29. The process of claim 28 further comprising limiting the first AVD to a preselected maximum period.

30. The process of claim 26 further comprising sensing successive ventricular stimulations and setting the second AVD to a predetermined period corresponding to a minimal interval between said successive ventricular stimulations.

31. The process of claim 16 further comprising:

1. in response to the next spontaneous P wave being detected during the DAAR window, the steps of;

detecting a third spontaneous P wave during said AEI initiated in step i,

declaring a suspicion of a ToAR condition, and

analyzing the atrial rhythm over a time period to confirm or not confirm the suspected ToAR condition.

32. The process of claim 31, wherein the analyzing step of step 1. further comprises:

i) monitoring a number M1 of successive (atrial) cardiac cycles according to steps e-1 and determining whether or not each of said M1 successive atrial cycles is declared a suspicion of a ToAR condition;

ii) determining a first number of said M1 cardiac cycles satisfying the suspected ToAR condition;

iii) monitoring a number M2 of successive cardiac cycles according to steps e-1 and determining whether or not each of said M2 successive cardiac cycles is declared a suspicion of a ToAR condition,

iv) determining a second number of said M2 cardiac cycles satisfying the suspected ToAR condition, M2 being greater than M1,

v) determining that the suspected ToAR condition is confirmed in response to one of;

1) the first number being a first majority percentage x₁ % of the number M1 successive cardiac cycles, and

2) the second number being a second majority percentage x₂ % of the number M2 successive cardiac cycles, the x₂ % being less than the x₁ %, and

vi) in response to a confirmed ToAR condition, operating the pacemaker in the fallback mode, wherein the ventricular stimulation is desynchronized to the atrial rhythm.

33. The process of claim 32 further comprising selecting M2 to be twice as large as M1, x₁ % to be approximately 87.5 percent, and x₂ % to be approximately 56 percent.

34. The process of claim 31, wherein in response to the analyzing step of step 1 confirming a ToAR condition, said method further comprises:

desynchronizing the ventricular stimulation from the atrial rhythm;

analyzing the atrial rhythm and determining whether or not the ToAR condition is maintained; and

in response to determining that the ToAR condition is not maintained;

commuting the pacemaker to operate in a mode of progressive resynchronization of the ventricular stimulation with the atrial rhythm,

initiating an analysis of the ventricular rhythm and atrial rhythm and confirmation of the disappearance of the ToAR condition, and

in response to the confirmation of the disappearance of the ToAR condition, commuting the pacemaker to operate in a synchronized dual chamber pacing mode.