Apparatus and process for control of implantable rate-adaptive cardiac pacemaker

• US 5,645,574 A
• Filed: 11/29/1994
• Issued: 07/08/1997
• Est. Priority Date: 12/06/1993
• Status: Expired due to Term

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Legay, Thierry, Bouhour, Anne
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/346,027
• Time in Patent Office: 952 Days
• Field of Search: 607/19, 607/18, 607/17, 607/21
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585

Abstract

A rate-adaptive implantable cardiac pacemaker having a control parameter representative of the physical activity of the patient. The change of the stimulation frequency follows, in a manner to reproduce the natural change of the physiological cardiac rhythm, a non-linear mathematical function of time, e.g., of the type:

Fc(t)=A*(1-B*e.sup.-t/Tau)+C,

in which t is time, A, B, C and Tau are constants, and Fc(t) is the stimulation frequency as a function of time. Tau may be a different value for increasing and decreasing frequencies.

Claims

1. A method of controlling an implantable cardiac pacemaker having a stimulation frequency that is a function of at least a parameter representative of the physical activity of a patient, comprising adjusting the stimulation frequency to follow a time dependent non-linear mathematical function that is an approximation of the change of the physiological cardiac rhythm.

2. The process according to claim 1, characterized in that the mathematical function is of the type:

space="preserve" listing-type="equation">Fc(t)=A*(1-B*e.sup.-t/Tau)+C,

where Fc(t) is the stimulation frequency delivered by the pacemaker as a function of the time, t is the parameter of time, and A, B, C, and Tau are constants.

3. The process according to claim 2, characterized in that said mathematical function is approximated by a boundary limit.

4. The process according to claim 1, characterized in that the mathematical function is of the type:

space="preserve" listing-type="equation">Fc(t)=K-(Tau/t).

5.

5. The process according to claim 2, characterized in that the mathematical function is the type:

Fc(t)=(Fstart-Ftarget)*e^-t/Tau.sbsp.--^inc +Ftarget, to control an increase of the stimulation frequency, and

Fc(t)=(Fstart-Ftarget)*e^-t/Tau.sbsp.--^dec +Ftarget, to control a decrease of the stimulation frequency, where

Fstart is the cardiac stimulation frequency from which the increase or decrease of the stimulation frequency is measured,

Ftarget is the calculated, cardiac stimulation frequency that has to be reached based on the sensed value of one or more control parameters of the pacemaker,

Tau_-- inc is a control parameter of the increase of the stimulation frequency from Fstart to Ftarget; and

Tau_-- dec is a control parameter of the decrease of the stimulation frequency from Fstart to Ftarget.

6. The process according to claim 5, characterized in that said mathematical function is transformed to calculate cardiac escape intervals and to permit the calculation of the following escape interval by applying to the prior escape interval a variation:

space="preserve" listing-type="equation">dTc(t)=Tc.sup.3 (t)*[Fc(t)-Ftarget]/Tau,

where Tc(t)=1/Fc(t);

Tau=Tau_-- inc, for an increase of the stimulation frequency, and Tau=Tau_-- dec, for a decrease of the stimulation frequency.

7. The process according to claim 6, characterized in that the variation dTc(t) is not systematically applied to each escape interval but is applied to an escape interval every variable number (MULT) of escape intervals.

8. The process according to claim 7, characterized in that said variation dTc(t) applied on a variable number of escape intervals, is calculated as:

space="preserve" listing-type="equation">dTc(t)=Round(MULT*Tc.sup.3 (t)*[Fc(t)-Ftarget]/Tau),

where the factor MULT is obtained by an algorithm.

9. The process according to claim 8, characterized in that the factor MULT:

is incremented when variation applied to the preceding escape interval is null,

is reset to 1 as soon as the said variation is non null, and

is reset to 1 if Fc=Ftarget.

10. The process according to claim 9, characterized in that the permitted variation of the cardiac stimulation frequency from one cycle to the following cycle is limited to a maximal value, preferably equal to 6 mn^-1.

11. An implantable rate-adaptive cardiac pacemaker having a sensor detecting at least a parameter representative of the physical activity of a patient and a processor for determining, as a function of the detected parameter, a cardiac stimulation frequency which follows, in a manner to reproduce a change of a physiological cardiac rhythm, a mathematical function of the type:

space="preserve" listing-type="equation">Fc(t)=A*(1-B*e.sup.-t/Tau)+C,

where Fc(t) is the stimulation frequency output by the pacemaker as a function of time, t is the parameter of time, and A, B, C, and Tau are constants.

12. The apparatus according to claim 11, characterized in that the mathematical function is of the type:

space="preserve" listing-type="equation">Fc(t)=(Fstart-Ftarget)*e.sup.-t/Tau.sbsp.--.sup.inc +Ftarget,

to control an increase of the stimulation frequency output, and

space="preserve" listing-type="equation">Fc(t)=(Fstart-Ftarget)*e.sup.-t/Tau.sbsp.--.sup.dec +Ftarget,

to control a decrease of the stimulation frequency output, where;

Fstart is the cardiac stimulation frequency from which the increase or the decrease of the stimulation frequency output begins,

Ftarget is the calculated cardiac stimulation frequency that has to be reached based on the sensed value of one or more control parameters of the pacemaker,

Tau_-- inc is a control parameter of the increase of the stimulation frequency output from Fstart to Ftarget,

Tau_-- dec is a control parameter of the decrease of the stimulation frequency output from Fstart to Ftarget.

13. The apparatus according to claim 12, characterized in that the mathematical function is transformed to calculate a cardiac escape interval and to permit the calculation of the following escape interval wherein the processor further comprises means for applying to the prior escape interval a variation:

space="preserve" listing-type="equation">dTc(t)=Tc.sup.3 (t)*[Fc(t)-Ftarget]/Tau,

where Tc(t)=1/Fc(t), Tau=Tau_-- inc, for the increase of the stimulation frequency output, and Tau=Tau_-- dec, for the decrease of the stimulation frequency output.

14. The apparatus according to claim 13, characterized in that the variation dTc(t) is not systematically applied to each escape interval but is applied to an escape interval every variable number (MULT) of escape intervals.

15. The apparatus according to claim 14, characterized in that variation dTc(t) applied every variable number of escape intervals is calculated as

16. The apparatus according to claim 15, characterized in that the factor MULT:

is incremented when the variation applied on the preceding escape interval is null,

is reset to 1 as soon as the variation is non null, and

is reset to 1 if Fc=Ftarget.

17. The apparatus according to claim 16, characterized in that the variation of the cardiac stimulation frequency from one cycle to the following cycle is limited to a maximal value, preferably equal to 6 mn^-1.

18. A method of controlling an implantable rate-adaptive cardiac pacemaker having a delivered stimulation frequency and a calculated stimulation frequency that is periodically calculated as a function of a sensed control parameter representative of the physical activity of a patient, comprising:

comparing an existing delivered stimulation frequency and a calculated stimulation frequency (Ftarget); and

controlling the delivered stimulation frequency to change between Fstart and Ftarget as a dependent non-linear mathematical function of time, wherein said function approximates a physiological cardiac rhythm change over time.

19. The method of claim 18 wherein the controlling step further comprises calculating the delivered stimulation frequency according to a mathematical function of the type:

space="preserve" listing-type="equation">Fc(t)=A*(1-B*e.sup.-t/Tau)+C,

where Fc(t) is the delivered stimulation frequency to be delivered by the pacemaker as a function of the time, t is the parameter of time, and A, B, C, and Tau are predetermined constants.

20. The method of claim 19, wherein the calculating step further comprises applying a boundary limit to said mathematical function.

21. The method of claim 18, wherein the controlling step further comprises calculating the delivered stimulation frequency according to a mathematical function of the type:

space="preserve" listing-type="equation">Fc(t)=K-(Tau/t).

22. The method of claim 19, wherein the comparing step further comprises determining whether the change from Fstart to Ftarget corresponds to an increasing frequency or a decreasing frequency, and wherein the controlling step further comprises calculating the delivered stimulation frequency by implementing a mathematical function of the type:

Fc(t)=(Fstart-Ftarget)*e^-t/Tau.sbsp.--^inc +Ftarget, for controlling a determined increasing frequency, and

Fc(t)=(Fstart-Ftarget)*e^-t/Tau.sbsp.--^dec +Ftarget for controlling a determined decreasing frequency, where

Tau_-- inc is a control parameter corresponding to an increasing frequency from Fstart to Ftarget; and

Tau_-- dec is a control parameter corresponding to a decreasing frequency from Fstart to Ftarget.

23. The method of claim 22, wherein the controlling step further comprises implementing said mathematical function to calculate cardiac escape intervals corresponding to the delivered stimulation frequency, and calculating a next escape interval by applying to an existing escape interval a variation:

space="preserve" listing-type="equation">dTc(t)=Tc.sup.3 (t)*[Fc(t)-Ftarget]/Tau,

where Tc(t)=1/Fc(t);

Tau=Tau_-- inc, for an increasing frequency, and Tau=Tau_-- dec, for a decreasing frequency.

24. The method of claim 23, further comprising applying the variation dTc(t) only to a variable number (MULT) of escape intervals.

25. The method of claim 24, wherein the step of applying the variation dTc(t) to a variable number (MULT) of escape intervals, further comprises calculating the variation as:

space="preserve" listing-type="equation">dTc(t)=Round(MULT*Tc.sup.3 (t)*[Fc(t)-Ftarget]/Tau,

and providing the factor MULT based on an algorithm for selecting which of said escape intervals is to be changed by said variation.

26. The method of claim 25, wherein providing the factor MULT based on said algorithm further comprises:

incrementing the factor MULT when said variation applied to the preceding escape interval is null,

resetting the factor MULT to 1 as soon as the said variation is non null, and

resetting the factor MULT to 1 if the calculated stimulation frequency equals Ftarget.

27. The method of claim 26 further comprising limiting the variation of the controlled delivered stimulation frequency from one cycle to the following cycle to a maximal value.

28. The method of claim 26 further comprising limiting the variation of the controlled delivered stimulation frequency from one cycle to the following cycle to a maximal value of approximately 6 mn^-1.

29. In an implantable rate-adaptive cardiac pacemaker having a delivered stimulation frequency and a sensor to detect a control parameter representative of the physical activity of a patient, apparatus for controlling the delivered stimulation frequency comprising:

means for calculating a stimulation frequency corresponding to said sensed control parameter;

means for comparing an existing delivered stimulation frequency (Fstart) and a calculated stimulation frequency (Ftarget); and

means for controlling the delivered stimulation frequency to change between Fstart and Ftarget as a dependent non-linear mathematical function of time that approximates a physiological cardiac rhythm change over time.

30. The apparatus of claim 29 wherein the controlling means further comprises means for calculating the delivered stimulation frequency as a mathematical function of the type:

space="preserve" listing-type="equation">Fc(t)=A*(1-B*e.sup.-t/Tau)+C,

where Fc(t) is the delivered stimulation frequency to be delivered by the pacemaker as a function of the time, t is the parameter of time, and A, B, C, and Tau are predetermined constants.

31. The method of claim 30, wherein the calculating means further comprises a boundary limit to said mathematical function.

32. The method of claim 29, wherein the controlling means further comprises means for calculating the delivered stimulation frequency as a mathematical function of the type:

space="preserve" listing-type="equation">Fc(t)=K-(Tau/t).

33. The apparatus of claim 30, wherein the comparing means further comprises means for determining whether the change from Fstart to Ftarget corresponds to an increasing frequency or a decreasing frequency, and wherein the controlling means further comprises means for calculating the delivered stimulation frequency as a mathematical function of the type:

Fc(t)=(Fstart-Ftarget)*e^-t/Tau.sbsp.--^inc +Ftarget, for a determined increasing frequency, and

Fc(t)=(Fstart-Ftarget)*e^-t/Tau.sbsp.--^dec +Ftarget for a determined decreasing frequency, where

Tau_-- inc is a control parameter corresponding to an increasing frequency from Fstart to Ftarget; and

Tau_-- dec is a control parameter corresponding to a decreasing frequency from Fstart to Ftarget.

34. The method of claim 33, wherein the controlling means further comprises means for calculating successive cardiac escape intervals wherein a next escape interval is calculated by applying to an existing escape interval a variation:

space="preserve" listing-type="equation">dTc(t)=Tc.sup.3 (t)*[Fc(t)-Ftarget]/Tau,

where Tc(t)=1/Fc(t);

Tau=Tau_-- inc, for an increasing frequency, and Tau=Tau_-- dec, for a decreasing frequency.

35. The apparatus of claim 34, wherein the escape interval calculating means operates to further add the variation dTc(t) only to a variable number (MULT) of escape intervals.

36. The apparatus of claim 35, wherein the escape interval calculating means operates to calculate the variation as:

space="preserve" listing-type="equation">dTc(t)=Round(MULT*Tc.sup.3 (t)*[Fc(t)-Ftarget]/Tau),

wherein the factor MULT has a value based on an algorithm for selecting which of said escape intervals is to be changed by said variation.

37. The method of claim 36, wherein said algorithm further comprises the operations of:

incrementing the factor MULT when said variation applied to the preceding escape interval is null,

resetting the factor MULT to 1 as soon as the said variation is non null, and

resetting the factor MULT to 1 if the calculated stimulation frequency equals Ftarget.

38. The apparatus of claim 37 further comprising means for limiting the variation of the controlled delivered stimulation frequency from one cycle to the following cycle to a maximal value.

39. The apparatus of claim 37 further comprising means for limiting the variation of the controlled delivered stimulation frequency from one cycle to the following cycle to a maximal value of approximately 6 mn^-1.