Detection of apneae and hypopneae in an active implantable medical device

• US 7,848,792 B2
• Filed: 07/05/2006
• Issued: 12/07/2010
• Est. Priority Date: 07/05/2005
• Status: Active Grant

• Current Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Ela Medical SAS (MicroPort Scientific Corp.)
• Inventors: Vincent, Elodie, Vitali, Luca
• Primary Examiner(s): Getzow; Scott M
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US11/428,805
• Publication Number:
  US 20070156059A1
• Time in Patent Office: 1,616 Days
• Field of Search: 607/20, 600/509, 600/513, 600/514, 600/515, 600/527
• US Class Current: 600/509
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

An active implantable medical device for diagnosis and/or therapy that is able to detect the occurrence of apnea and hypopnea. The detection of an occurrence of respiratory apneae or hypopneae is performed by collecting the patient'"'"'s endocardial acceleration (EA), and determining at least one parameter, i.e., a peak acceleration, (PEA I, PEA II) that is a function of this collected endocardial acceleration. An apnea or hypopnea alert signal is then conditionally delivered as a function of the value taken by this (these) parameter(s).

Claims

1. An active implantable medical device for detection of the occurrence of apneae and hypopneae, comprising:

means for collecting endocardial acceleration (EA) signals from a patient implanted with the device using an endocardial lead implanted in the patient'"'"'s heart over at least two heart cycles;

means for determining from the endocardial acceleration signals the two endocardial acceleration peak values comprising a first peak value (PEA I) corresponding to the peak-to-peak value of the endocardial acceleration signals during an isovolumetric ventricular contraction phrase and a second peak value (PEA II) corresponding to the peak-to-peak value of the endocardial acceleration signal during the isovolumetric ventricular relaxation phase;

means for calculating a long-term average of at least one of the two endocardial acceleration peak values during a first number of cycles of the at least two heart cycles and a short-term average of the at least one of the two endocardial acceleration peak values during a second number of cycles of the at least two heart cycles;

means for determining a value as a function of the long-term average and the short-term average of the at least one of the two endocardial acceleration peak values; and

means for conditionally delivering an output signal representative of an apnea or a hypopnea alert state of the patient based on the value.

2. The device of claim 1, wherein said value is a function of:

(i) the variation, and/or

(ii) a difference or a ratio, of the long term average and the short term average of the at least one of the two endocardial acceleration peak values.

3. The device of claim 2, wherein:

said difference or ratio (R) is collected over a plurality of successive heart cycles,

said means for determining the value further comprises means for comparing said difference or ratio to a first threshold (S), and

said means for conditionally delivering delivers said output signal (ALM) in response to a crossing of said first threshold.

4. The device of claim 3, wherein the means for conditionally delivering delivers said output signal after crossing of said first threshold only if said first threshold remains crossed during one of a predetermined minimum duration and a predetermined minimum number of heart cycles.

5. The device of claim 3, wherein the means for determining the value further comprises means, responsive to the crossing of said first threshold, for detecting a reverse crossing of said first threshold followed by crossing of a second threshold, said second threshold being higher than the first threshold, and the means for delivering delivers a signal of confirmation of an apnea or hypopnea episode at the crossing of said second threshold.

6. The device of claim 5, wherein the means for delivering delivers said signal of confirmation of the apnea or hypopnea episode only if the crossing of said second threshold occurs during one of a predetermined maximum duration and a predetermined maximum number of heart cycles, following said reverse crossing of said first threshold.

7. The device of claim 1, wherein said value is further determined by an interval between a QRS complex and at least one of the two endocardial acceleration peak values, and/or the time interval between said first and second endocardial acceleration peak values.

8. The device of claim 1, wherein the means for determining the value further comprises means for comparing said value to a first threshold (S), wherein the means for conditionally delivering delivers said output signal (ALM) in response to a crossing of said first threshold.

9. The device of claim 1, wherein the means for determining the value further comprises a state machine or neuronal network that compares a plurality of said values to a plurality of thresholds, detects crossing of the different thresholds, analyzes the sequence of these crossings, and delivers said output signal upon detection of one or more predetermined sequence(s) of crossings.

10. The device of claim 1, wherein the means for determining the value further comprises means for applying to the two endocardial acceleration peak values, one of an autocorrelation processing, morphologic analysis, frequential analysis, and wavelet analysis.

11. The device of claim 1 further comprising means for collecting the patient'"'"'s heart rate, wherein the means for conditionally delivering delivers the alert output signal as a function of both patient'"'"'s heart rate and the value.

12. The device of claim 1 further comprising:

means for collecting respiratory activity; and

means for providing a signal of patient'"'"'s ventilatory activity,

wherein the means conditionally delivering delivers the output signal as a function of both the patient'"'"'s ventilatory activity signal and the value.

13. The device of claim 1 further comprising;

means for detecting at least one phase of exercise and/or sleep; and

means for providing a signal of patient'"'"'s status,

wherein the means conditionally delivering delivers the output signal as a function of both the patient'"'"'s status signal and the value.

14. An active implantable medical device for detecting apneae and hypopneae, comprising:

means for collecting endocardial acceleration (EA) signals from a patient implanted with the device using an endocardial lead implanted in the patient'"'"'s heart over at least two heart cycles;

means for determining from the endocardial acceleration signals two endocardial acceleration peak values comprising a first peak value (PEA I) corresponding to the peak-to-peak value of the endocardial acceleration signals during an isovolumetric ventricular contraction phase and a second peak value (PEA II) corresponding to the peak-to-peak value of the endocardial acceleration signal during an isovolumetric ventricular relaxation phase;

means for calculating a long-term average of at least one of the two endocardial acceleration peak values during a first number of cycles of the at least two heart cycles and a short-term average of the at least one of the two endocardial acceleration peak values during a second number of cycles of the at least two heart cycles;

means for determining at least one parameter value as a function of the long-term average and the short-term average of the at least one of the two endocardial acceleration peak values;

means for comparing said at least one parameter value to a first threshold; and

means for delivering an output signal representative of an alert state corresponding to an apnea or a hypopnea in response to said at least one parameter value crossing said first threshold.

15. The device of claim 14 wherein said at least one parameter value is averaged over a plurality of successive heart cycles.

16. The device of claim 14 wherein said long-term average and/or said short-term average are determined by a variation of said at least one parameter value over a plurality of successive heart cycles.

17. The device of claim 14 wherein said second number of cycles is less than said first number of cycles.

18. The device of claim 14 wherein said at least one parameter value is further determined by the first peak value (PEA I) measured during the isovolumetric ventricular contraction phase.

19. The device of claim 18 further comprising means for detecting a QRS complex in said patient'"'"'s electrogram, wherein said at least one parameter value is further determined by an interval between a QRS complex and said endocardial acceleration peak values.

20. The device of claim 14 wherein said at least one parameter value is further determined by the second peak value (PEA II) measured during the isovolumetric ventricular relaxation phase.

21. The device of claim 20 further comprising means for detecting a QRS complex in said patient'"'"'s electrogram wherein said at least one parameter value is further determined by an interval between a QRS complex and said endocardial acceleration peak values.

22. The device of claim 15 wherein said at least one parameter is further determined by a time interval between the first peak value, measured during the isovolumetric ventricular contraction phase and the second peak value measured during the isovolumetric relaxation phase.

23. The device of claim 14, wherein a difference or a ratio (R) of the long-term average and the short-term average is collected over a plurality of successive heart cycles.

24. The device of claim 15, wherein the means for delivering said output signal further comprises means for delivering said output signal in response to said first threshold remaining crossed during a predetermined minimum duration, or over a predetermined minimum number of heart cycles.

25. The device of claim 14, wherein the means for delivering said output signal further comprises means for detecting, after crossing of said first threshold, a reverse crossing of said first threshold followed by crossing of a second threshold, higher than said first threshold, and means for delivering a signal of confirmation of an apnea or hypopnea episode in response to said crossing of this second threshold.

26. The device of claim 25, wherein the means for delivering said signal of confirmation operates only if the crossing of said second threshold occurs during one of a predetermined maximum duration and a predetermined maximum number of heart cycles, following said reverse crossing of the first threshold.

27. The device of claim 14, further comprising means for collecting the patient'"'"'s heart rate, wherein said means for delivering said output signal conditionally delivers said output signal as a function of both the patient'"'"'s heart rate and at least one parameter value.

28. The device of claim 14 further comprising:

means for collecting respiratory activity of the patient; and

means for providing a signal of said patient'"'"'s ventilatory activity,

wherein said means for delivering said output signal is as a function of both the patient'"'"'s ventilatory activity signal and the at least one parameter value.

29. The device of claim 15 further comprising:

means for detecting at least one phase of exercise and/or sleep; and

means for providing a signal corresponding to the patient'"'"'s status indicative of whether the patient is in a sleep phase or an exercise phase,

wherein the means for delivering said output signal conditionally delivers the output signal as a function of both the patient'"'"'s status signal and the at least one parameter value.

30. The device of claim 14, wherein the at least one parameter value further comprises a plurality of parameters values, and said threshold further comprises a plurality of predetermined thresholds, said device further comprising a state machine or neuronal network for comparing said plurality of said parameters values to said plurality of predetermined thresholds, for detecting the crossing of the different thresholds, wherein said means for determining determines any sequence of these crossings and said means for delivering delivers said output signal upon detection of one or more predetermined sequence(s) of crossings.