Active implantable medical device having a control function responsive to at least one physiological parameter

• US 5,722,996 A
• Filed: 09/17/1996
• Issued: 03/03/1998
• Est. Priority Date: 06/30/1995
• 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, Geroux, Laurence
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US08/674,261
• Time in Patent Office: 532 Days
• Field of Search: 607/17, 607/18, 607/19, 607/20, 607/21, 607/22
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

An active implantable medical device, particularly a cardiac pacemaker, enslaved to at least one physiological parameter. The device is susceptible to function in an enslaved mode by controlling at least one function, particularly that of a cardiac stimulation frequency, based on at least one physiological parameter, and includes at least one effort sensor, measuring a predominantly physiological parameter and delivering an output signal that is a function of the effort developed by a patient bearing the device and at least one activity sensor, especially a sensor having a response time that is more rapid than the effort sensor, for measuring a predominantly physical parameter. The device also includes a selection means, functioning in response to at least one activity and at least one effort signal of each of the sensors, to analyze periodically the relative sequence of successive state changes of the sensors according to predetermined criteria intrinsic to the device, and to select one of the sensors for the enslavement function as a result of this analysis, in a manner to realize, at a given moment, an enslavement mode function respecting most nearly the physiology of the patient corresponding to the activity and effort level of the patient at the given moment.

Claims

1. An active implantable medical device having a control function that is enslaved to at least one physiological parameter, comprising:

at least one effort sensor, measuring a preponderantly physiological parameter and having an effort output signal corresponding to an effort developed by a patient bearing the device;

at least one activity sensor, measuring a preponderantly physical parameter, and having an activity output signal corresponding to the effort developed by said patient, said activity and effort sensors each having a response time, the activity sensor response time being faster than the effort sensor response time; and

selection means, functioning in response to each of the effort and activity sensors, for determining a state of each sensor, identifying a change in state of at least one sensor, periodically analyzing the relative sequence of successive state changes of the effort and activity sensors according to a predetermined criteria intrinsic to the device, and for selecting one of the effort and activity sensors as a function of the result of said periodic analysis, in a manner to realize, at a given instant, an enslavement respecting most nearly the physiology of the patient corresponding to his/her activity and effort level at said given instant.

2. The device of claim 1, in which each of the effort and activity sensors further comprises a state, the state being selectable from among at least three distinct states (REST, EXER, RECUP) determined as a function of the parameter measured by each sensor, the three states corresponding respectively to a phase of rest, a phase of exercise and a phase of recovery.

3. The device of claim 2, in which the sensor state comprises the state (REST) corresponding to the phase of rest in response to the measured parameter being less than a predetermined threshold.

4. The device of claim 2, in which the sensor state comprises the state (EXER) corresponding to the phase of exercise in response to the measured parameter being greater than the predetermined threshold and increasing or stable.

5. The device of claim 2, in which the sensor state comprises the state (RECUP) corresponding to the phase of recovery in response to the measured parameter being greater than the predetermined threshold and strictly decreasing.

6. The device of claim 1, in which the selection means operates to compare the states of the sensors during a given measurement cycle and associates with each possible combination of states a control value (Fconsig) to control the enslaved function of the device.

7. The device of claim 6, further comprising control means of crossed sensor indications, for comparing the state (EXER or RECUP) determined by the output signal of the activity sensor and this same state of activity determined by the output signal of the effort sensor, and terminating the functioning of the device in an enslaved mode in case of non-concordance.

8. The device of claim 7, further comprising a means for determining a time during which said non-concordance persists, wherein the control means of crossed indications operates to terminate the functioning of the device in said enslaved mode in response to said non-concordance persisting for at least a predetermined period, said period being one of a time greater than a predetermined duration, and a predetermined number of repetition of the step of comparison.

9. The device of claim 1, further comprising means of protection against gaps of information, to discriminate between a decline or end of activity and an intermittent decline of one of the sensor output signals that does not result from a decline of activity.

10. The device of claim 9, in which the protection means operates to maintain constant, in a case of a momentary activity decline, a value (Fasser) of the enslaved control function.

11. The device of claim 10, in which the protection means comprises a binary state variable determined by one of:

(i) the result of a comparison between the value (Fasser) and a control value (Fconsig);

(ii) a previous value of the state variable; and

(iii) the states of the two sensors.

12. The device of claim 1 wherein the effort sensor comprises a minute ventilation sensor and the effort output signal corresponds to a minute ventilation measurement.

13. The device of claim 12 wherein the activity sensor comprises an acceleration sensor and the activity output signal corresponds to an acceleration measurement of the patient.

14. The device of claim 1 wherein the activity sensor comprises an acceleration sensor and the activity output signal corresponds to an acceleration measurement of the patient.

15. An implantable cardiac pacemaker having an enslaved operating mode in which a cardiac stimulation frequency is determined as a function of at least one physiological parameter of a patient bearing the device in an enslaved operating mode, comprising:

a first sensor, responsive to a physiological parameter of the patient, having an effort output signal corresponding to an effort developed by said patient;

a second sensor, responsive to a physical parameter of the patient, having an activity output signal corresponding to the effort developed by said patient, said first and second sensors each having a response time, the second sensor response time being faster than the first sensor response time;

a signal processor having an input to receive each of the first and second output signals sensors, and operate on said signals to periodically analyze said received effort and activity output signals, determine a state of at least one of said first and second sensors at a given time and determine whether said at least one sensor state has changed from a first state determined at a first time to a second state determined at a second time, and analyze a relative sequence of successive state changes of the first and second sensors according to a predetermined criteria intrinsic to the device; and

means for selecting one of the first and second sensors as a function of the result of said periodic analysis, wherein the cardiac stimulation frequency is determined in response to the one selected sensor output signal.

16. The device of claim 15, wherein the signal processor determines for said at least one of the first and second sensors, whether said one sensor is in one of at least a REST state, EXER state, and RECUP state corresponding respectively to a phase of rest, a phase of exercise and a phase of recovery.

17. The device of claim 16 wherein the signal processor determines the state of said first sensor and whether the determined state of said first sensor has changed prior to determining the state of the second sensor.

18. The device of claim 17, wherein the signal processor operates to compare the determined states of the first and second sensors during a given measurement cycle, and said predetermined criteria associates with each possible combination of determined states a control value to control the cardiac stimulation frequency.

19. The device of claim 18 wherein the associated control value is selected from among the group consisting of a base pacing frequency, a first enslaved cardiac stimulation frequency responsive to the effort output signal, and a second enslaved cardiac stimulation frequency responsive to the activity output signal.

20. The device of claim 18, further comprising means for comparing the determined states of the first sensor and the second sensor, determining if said determined states are in non-concordance, and terminating the enslaved operating mode in response to a determined non-concordance.

21. The device of claim 20, further comprising a surveillance duration selected from one of a predetermined time duration, and a predetermined number of comparisons by the comparing means, wherein the comparing means terminates the functioning of the device in said enslaved operating mode in response to a determined non-concordance persisting for said surveillance duration.

22. The device of claim 15, further comprising means for discriminating between a decline or end of activity and an intermittent decline of one of the sensor output signals that does not result from a decline of activity, and, in response to a discriminated momentary activity decline, maintaining constant said enslaved cardiac stimulation frequency.

23. The device of claim 15 wherein the first sensor further comprises a minute ventilation sensor and the second sensor further comprises an acceleration sensor.

24. A method for determining a control function output enslaved to at least a physiological parameter comprising:

(a) monitoring a physiological parameter of a patient corresponding to an effort developed by the patient;

(b) monitoring a physical parameter of said patient corresponding to said effort developed by the patient;

(c) determining a physiological state as a function of the monitored physiological parameter, the physiological state being one of a rest state, an activity state, and a recovery state;

(d) determining a physical state as a function of the monitored physical parameter, the physical state being one of a rest state, an activity state, and a recovery state;

(e) selecting one of said monitored physiological parameter and said monitored physical parameter and determining said control function output as one of a first function of said monitored physiological parameter and a second function of said monitored physical parameter, wherein step (e) further comprises;

(i) determining a first physiological state in response to said monitored physiological parameter sample at a first time;

(ii) determining whether the determined first physiological state is different from a determined physiological state in response to a monitored physiological parameter at a second time prior to said first time;

(iii) in response to said step (e)(ii) not determining a difference in said physiological state, determining a first physical state in response to a first monitored physical parameter at a third time; and

(iv) selecting said control function output to be one of the first function and the second function according to a predetermined set of criteria relating the determined effort state and the determined activity state.

25. The method of claim 24 wherein step (e)(iv) further comprises selecting the control function to be one of the first function in response to the monitored physiological parameter at said first time and the second function in response to the monitored physical parameter at said third time.

26. The method of claim 24 wherein steps (c) and (e) are periodically reported having a measurement cycle, and further comprising

(e)(v) comparing the determined physiological state and the determined physical state;

(e)(vi) determining whether said compared states are in a non-concordance; and

(e)(vii) terminating an operation of the enslaved control function in response to said non-concordance persisting for a predetermined surveillance period.

27. The method of claim 24 further comprising:

(f) identifying a change in the selected one of the monitored physiological parameter and the monitored physical parameter corresponding to a diminution in magnitude, (ii) discriminating an identified diminution in magnitude corresponding to a gap in said monitored parameter from an identified diminution in magnitude corresponding to an end of or decline in said phase of activity, and (iii) maintaining the control function output constant in response to said identified diminution corresponding to a gap.