Control of an active implantable medical device

• US 5,522,860 A
• Filed: 12/23/1994
• Issued: 06/04/1996
• Est. Priority Date: 12/31/1993
• Status: Expired due to Term

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Paris, Catherine, Molin, Renzo D.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): HUANG, STEPHEN D
• Application Number:
  US08/363,748
• Time in Patent Office: 529 Days
• Field of Search: 607/9, 607/10, 607/11, 607/12, 607/13-17, 607/20, 128/708, 128/630, 128/632, 128/635, 128/731, 604/66
• US Class Current: 607/20
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

Process of control of an implantable active medical device. The device is under the responsive control of (enslavement to) a sensed physiological parameter. A representative magnitude of the physiological parameter is measured in the presence of a useful signal to determine a value of the parameter. Then, in the absence of the useful signal, another measure is made to determine the noise. The noise is compared to a threshold corresponding to an unacceptable level of noise. In case of crossing the noise threshold, this crossing is taken in account by a control device with a view to possible suspension of a function of the device if there is too much noise.

Claims

1. Process of control of an implantable active medical device comprising:

measuring a representative magnitude of a physiological parameter;

providing an enslavement function to enslave the operation of the implantable active medical device to the measured physiological parameter;

measuring a representative magnitude of a noise signal and determining a value of the noise;

comparing the value of the noise to a threshold; and

when the value of the noise exceeds the threshold, considering a possible suspension of the enslavement function in response thereto.

2. Process according to claim 1, wherein providing the enslavement function further comprises determining a cardiac stimulation frequency as a function of the measured physiological parameter.

3. Process according to claim 1, wherein the implantable active medical device has a case electrode and a pacemaking function, and measuring the physiological parameter further comprises sensing minute ventilation and measuring the representative magnitude further comprises sensing a voltage between a sensing electrode and the case electrode.

4. Process according to claim 3, wherein sensing the voltage further comprises:

measuring the voltage during an injection of current and determining a dynamic pulmonary impedance therefrom, and

measuring the voltage during an absence of a current injection and determining the noise therefrom.

5. Process according to claim 4, further comprising increasing a counter in response to a noise value crossing a noise threshold and suspending the enslavement function in response to the counter reaching a predetermined total.

6. Process according to claim 3, wherein sensing the voltage further comprises measuring the voltage during an injection of current for determining the a dynamic pulmonary impedance and outside of an injection of current for determining the noise value using the same electronic measuring circuit.

7. Process according to claim 6, further comprising:

determining a static pulmonary impedance by integrating preceding measures of dynamic pulmonary impedance; and

determining the dynamic pulmonary impedance by taking a difference between the sensed voltage and the static pulmonary impedance.

8. Process according to claim 1 wherein the measuring of the magnitude and determining a value of a noise signal is accomplished only when the measure of the representative magnitude of a physiological parameter exceeds a preselected threshold.

9. An implantable active medical device comprising an electronic circuit for measuring a representative magnitude of a physiological parameter, and a control device to insure an operation of the implantable active medical device as a function of the measured physiological parameter, wherein the electronic circuit further comprises an amplifier having a feedback signal input, an input corresponding to said measured magnitude, and an output, an analog-to-digital converter converting the amplifier output to a digital value, an integrator to integrate the digital values, and a digital-to-analog converter to convert the integrated values to said feedback signal.

10. The device according to claim 9, wherein the physiological parameter is minute ventilation and the control device is operable to produce a cardiac stimulation frequency as a function of the measured minute ventilation.

11. A method of controlling the operation of an implantable active medical device comprising the steps of:

a) sensing a first signal in response to a presence of a useful signal;

b) controlling the operation of the device in a first operating mode as a function of said first signal;

c) sensing a second signal in an absence of the useful signal;

d) determining whether or not the second signal corresponds to noise; and

e) considering whether or not to suspend operation in the first operating mode in response to determining that the second signal corresponds to noise.

12. The method of claim 11 wherein steps c) and d) further comprise measuring an amplitude of the second signal, comparing the measured amplitude to a predetermined threshold, and determining that the second signal corresponds to noise when the measured amplitude exceeds the predetermined threshold.

13. The method of claim 12 wherein step d) further comprises adjusting the predetermined threshold to select for an allowable level of noise.

14. The method of claim 12 wherein step e) further comprises counting number of times the measured amplitude exceeds the predetermined threshold, comparing the counted number to a count threshold, and suspending operation in the first operating mode in response to the counted number exceeding the count threshold.

15. The method of claim 14 wherein step e) further comprises counting the number of times the measured amplitude exceeds the predetermined threshold during a preset time interval, comparing the counted number to a count threshold, and suspending operation in the first operating mode in response to the counted number exceeding the count threshold.

16. A method of controlling an operation of an implantable active cardiac control device comprising the steps of:

a) sensing a first signal amplitude corresponding to a presence of a useful signal and representative of a physiological parameter;

b) operating said device in a first operating mode as a function of said sensed first signal amplitude;

c) sensing a second signal amplitude corresponding to an absence of said useful signal and representative of noise;

d) determining whether or not the sensed second signal amplitude corresponds to an unacceptable level of noise; and

e) considering whether or not to suspend operation in the first operating mode in response to determining that the second signal corresponds to an unacceptable level of noise.

17. The method of claim 16 wherein step d) further comprises comparing the second signal amplitude to a predetermined threshold, and determining that the second signal amplitude corresponds to an unacceptable level of noise when the sensed second signal amplitude exceeds the predetermined threshold.

18. The method of claim 17 wherein step d) further comprises adjusting the predetermined threshold to select the unacceptable level of noise and operating in the first operating mode until said second signal amplitude exceeds the predetermined threshold.

19. The method of claim 17 wherein step e) further comprises counting a number of times the sensed second signal amplitude exceeds the predetermined threshold, comparing the counted number to a count threshold, and suspending operation in the first operating mode in response to the counted number exceeding the count threshold.

20. The method of claim 19 wherein step e) further comprises comparing the counted number to the count threshold periodically and restarting the counting step at zero thereafter.

21. The method of claim 16 wherein step b) further comprises providing a cardiac stimulation frequency that is a function of the physiological parameter.

22. The method of claim 21 wherein step a) further comprises providing said device with an electronic measuring circuit for sensing the first signal amplitude as a voltage between a sensing electrode and a reference electrode corresponding to minute ventilation.

23. The method of claim 22 wherein:

step a) further comprises measuring said voltage during an injection of current and determining a dynamic pulmonary impedance therefrom; and

step c) further comprises measuring said second signal amplitude during an absence of an injection of current for determining noise therefrom.

24. The method of claim 23 wherein step c) further comprises measuring said second signal amplitude as said voltage during the absence of an injection of current using said electronic measuring circuit.

25. The method of claim 23 wherein step d) further comprises comparing the second signal amplitude to a predetermined threshold, and determining that the second signal amplitude corresponds to said unacceptable level of noise when the sensed second signal amplitude exceeds the predetermined threshold.

26. The method of claim 25 wherein step e) further comprises counting a number of times the second signal amplitude exceeds a predetermined threshold, comparing the counted number to a count threshold, and suspending operation in the first operating mode in response to the counted number exceeding the counted threshold.

27. The method of claim 26 wherein step e) further comprises comparing the count number to the count threshold periodically and restarting the counting step at zero thereafter.

28. The method of claim 16 further comprising the step of:

f) determining when the sensed first signal corresponds to a physiological parameter value corresponding to rest activity state, and in response thereto not performing c, d, and e.

29. The method of claim 28 wherein step f) further comprises comparing the sensed first signal to a threshold corresponding to a rest activity level, and determining when the sensed first signal is below said threshold.

30. Apparatus for controlling operation of an implantable active cardiac control device comprising:

a first electronic measuring circuit sensing a first signal amplitude corresponding to a presence of a useful signal and representative of a physiological parameter;

a data processor operating said device in one of a first operating mode performing cardiac control as a function of the sensed first signal amplitude, and a second operating mode performing cardiac control other than as a function of the sensed first signal amplitude;

a second electronic measuring circuit sensing a second signal amplitude during an absence of said useful signal and corresponding to a suspected noise signal; and

means for determining whether or not the sensed second signal corresponds to an unacceptable level of noise;

wherein said data processor further comprises operating means for considering whether or not to suspend operation of said device in the first operating mode in response to determining that the sensed second signal corresponds to an unacceptable level of noise.

31. The apparatus of claim 30 wherein said determining means and operating means further comprise:

a comparator having a first input receiving the first signal amplitude and a second input receiving a predetermined threshold, and an output signal having a first state indicating that the sensed second signal amplitude has exceeded the determined threshold and corresponds to said unacceptable level of noise.

32. The apparatus of claim 31 further comprising means for adjusting the predetermined threshold to select said unacceptable level of noise.

33. The apparatus of claim 31 wherein said operating means further comprises:

a counter to count a number of times the second signal amplitude has exceeded the predetermined threshold;

a second comparator to compare the counted number to a count threshold; and

means for suspending operation in the first operating mode in response to the counter count exceeding the count threshold.

34. The apparatus of claim 33 wherein the data processor further comprises an analog-to-digital converter, a microprocessor, wherein the comparators and counter are implemented in software, and the cardiac control function is a control algorithm relating the sensed first signal to a cardiac control event.

35. The apparatus of claim 33 further comprising means for resetting the counter to zero periodically.

36. The apparatus of claim 30 wherein said data processor first operating mode function further comprises a control algorithm calculating a cardiac stimulation frequency as a function of the sensed first signal representative of a physiological parameter.

37. The apparatus of claim 36 wherein the first electronic circuit further comprises a sensing electrode and a reference electrode, the first sensed signal amplitude is a voltage between the sensing and reference electrodes, and the physiological parameter is a minute ventilation.

38. The apparatus of claim 37 wherein said useful signal is an injection of current and said first electronic circuit determines a dynamic pulmonary impedance from said sensed first signal amplitude;

and

said second electronic measuring circuit measures said second signal amplitude during an absence of an injection of current for determining noise therefrom.

39. The apparatus of claim 38 wherein said second electronic measuring circuit is said first electronic measuring circuit and measures said second signal amplitude as said voltage between said sensing and reference electrodes during the absence of an injection of current.

40. The apparatus of claim 38 wherein said operating means further comprises:

a first comparator having a first input receiving the sensed second signal amplitude and a second input receiving a predetermined threshold, and an output signal having a first state indicating that the second signal amplitude has exceeded the predetermined threshold and corresponds to said unacceptable level of noise.

41. The apparatus of claim 40 further comprising means for adjusting the predetermined threshold to select said unacceptable level of noise.

42. The apparatus of claim 40 wherein said operating means further comprises a counter to count a number of times the second signal amplitude has exceeded the predetermined threshold, a second comparator to compare the counter count number to a count threshold, wherein said data processor suspends operation in the first operating mode in response to the counted number exceeding the count threshold.

43. The apparatus of claim 42 wherein the data processor further comprises a microprocessor having said first operating mode and said second operating mode.

44. The apparatus of claim 30 wherein said data processor further comprises second means for determining whether the sensed first signal corresponds to a physiological parameter value corresponding to a rest activity state, wherein said second electronic measuring circuit and determining means are responsive to said second determining means for not sensing said second signal in response to the sensed first signal corresponding to a rest activity state.

45. The apparatus of claim 44 wherein said second determining means further comprises a comparator having the sensed first signal as an input and an activity threshold as an input, a first output corresponding to an activity state when the first signal is above the threshold and a second output corresponding to a rest state when the first signal is below the threshold, the second electronic measuring circuit being responsive to said second output.