Non-invasive detection of the occurrence of apneae or hypopneae in a patient

• US 7,613,507 B2
• Filed: 07/05/2006
• Issued: 11/03/2009
• 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): Bockelman; Mark W
• Assistant Examiner(s): So; Elizabeth K
• Application Number:
  US11/428,798
• Publication Number:
  US 20070167851A1
• Time in Patent Office: 1,217 Days
• Field of Search: 600/509, 600/513, 600/595
• 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 5/1126 using a particular sensing technique
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

A device for the non-invasive detection of apneae or hypopneae in a patient. This apparatus collects the patient'"'"'s endocardial acceleration using an external acceleration sensor (12) able to be maintained in contact with the patient'"'"'s thoracic wall (10). An analysis is made to determine at least one parameter that is function of collected endocardial acceleration and to conditionally deliver an apnea or hypopnea alert signal as a function of the value taken by this parameter. This parameter can notably be a function of one and/or the other of the two endocardial acceleration peaks over one given heart cycle, the first peak (PEA I) corresponding to the ventricular isovolumetric contraction phase and the second peak (PEA II) to the ventricular isovolumetric relaxation phase.

Claims

1. A device for non-invasive detection of the occurrence of apnea or hypopnea in a patient, comprising:

means for collecting the patient'"'"'s endocardial acceleration, comprising an external acceleration sensor able to maintain contact with the patient'"'"'s thoracic wall, and

means for analysis, able to;

determine at least one parameter value by evaluating a function of a ratio of a long term average of the values of the endocardial acceleration peaks to a short term average of the values of endocardial acceleration peaks collected over a plurality of successive cycles;

compare the at least one parameter value to a first predetermined threshold; and

deliver an apnea or hypopnea alert signal in response to the at least one parameter value crossing the first predetermined threshold.

2. The device of claim 1, wherein said at least one parameter value is function of at least one of a first endocardial acceleration peak (PEA I) during the isovolumetric ventricular contraction phase and a second endocardial acceleration peak (PEA II) during the isovolumetric ventricular relaxation phase.

3. The device of claim 2, further comprising means for non-invasively detecting the patient'"'"'s electrocardiogram wave form including a QRS complex wherein said function of said at least one parameter is an interval between a QRS complex and at least one of the two endocardial acceleration peaks, and/or the time interval between said first and second endocardial acceleration peaks.

4. The device of claim 1, wherein the means for analysis can deliver said alert 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 1, wherein the means for analysis further comprises means able, after crossing of said first threshold, to detect a reverse crossing of said first threshold followed by crossing of a second threshold, said second threshold being higher than the first threshold, and to deliver a signal of confirmation of the apnea or hypopnea episode at the crossing of this second threshold.

6. The device of claim 5, wherein the means for analysis can deliver said signal of confirmation of 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 the means for analysis further comprises a state machine or neuronal network able to compare a plurality of said parameters to a plurality of predetermined thresholds, to detect the crossing of the predetermined thresholds, to analyze the sequence of the crossings and deliver an alert signal upon detection of a predetermined sequence of crossings.

8. The device of claim 1, wherein the means for analysis comprises means able to apply an autocorrelation processing, a morphologic analysis, a frequential analysis, a wavelet analysis and/or a principal components analysis to an endocardial acceleration.

9. The device of claim 1, further comprising means for collecting at least one physiologic data among:

heart rate, nasal pressure and/or blood oxygen saturation of the patient, and in which the means for analysis are means able to conditionally deliver the alert signal as a function of both said at least one physiologic data and the value taken by said at least one parameter.

10. A device for non-invasive detection of the occurrence of apnea or hypopnea in a patient, comprising:

means for collecting the patient'"'"'s endocardial acceleration comprising an external acceleration sensor able to maintain contact with the patient'"'"'s thoracic wall;

means for determining at least one parameter value by evaluating a function of a ratio between a long term average of the values of the endocardial acceleration peaks to a short term average of the values of endocardial acceleration peaks collected over a plurality of successive cycles;

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

means for delivering an alert signal corresponding to an apnea or a hypopnea in response to the at least one parameter value crossing the first predetermined threshold.

11. The device of claim 10 wherein said function further comprises an average of said at least one parameter value over a plurality of successive cycles.

12. The device of claim 10 wherein said function further comprises a variation of said at least one parameter value over a plurality of successive cycles.

13. The device of claim 10 wherein said at least one parameter value is a function of an endocardial acceleration peak (PEA I) measured during the isovolumetric ventricular contraction phase.

14. The device of claim 10 further comprising means for non-invasively detecting a QRS complex in said patient'"'"'s electrocardiogram, wherein said at least one parameter value is a function of an interval between a QRS complex and said endocardial acceleration peaks.

15. The device of claim 10 wherein said at least one parameter value is a function of an endocardial acceleration peak (PEA II) measured during the isovolumetric ventricular relaxation phase.

16. The device of claim 15 further comprising means for non-invasively detecting a QRS complex in said patient'"'"'s electrocardiogram wherein said at least one parameter value is a function of an interval between a QRS complex and said endocardial acceleration peaks.

17. The device of claim 10 wherein said at least one parameter is a function of a time interval between a first endocardial acceleration peak measured during the isovolumetric ventricular contraction phase and a second endocardial acceleration peak measured during the isovolumetric relaxation phase.

18. The device of claim 10, wherein the means for delivering said alert signal further comprises means for delivering said alert signal in response to said first threshold remaining crossed during a predetermined minimum duration, or over a predetermined minimum number of heart cycles.

19. The device of claim 10, wherein the means for delivering an alert 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.

20. The device of claim 19, 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.

21. The device of claim 10, further comprising means for non-invasively collecting the patient'"'"'s heart rate, wherein said means for delivering said alert signal is able to conditionally deliver said alert signal as a function of both the patient'"'"'s heart rate and at least one parameter value.

22. The device of claim 10 further comprising means for non-invasively collecting the respiratory activity, able to provide a signal of said patient'"'"'s ventilatory activity, and wherein said means for delivering said alert signal is as a function of both the patient'"'"'s ventilatory activity signal and the at least one parameter value.

23. The device of claim 10 further comprising means for detecting at least one phase of exercise and/or sleep, and providing a signal corresponding to the patient'"'"'s status indicative of whether the patient is in a sleep phase or an exercise phase, and the means for delivering said alert signal is able to conditionally deliver the alert signal as a function of both the patient'"'"'s status signal and the at least one parameter value.

24. The device of claim 10, 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 able to compare said plurality of said parameters values to said plurality of predetermined thresholds, to detect the crossing of the different thresholds, to analyze any sequence of these crossings and to deliver said alert signal upon detection of one or more predetermined sequence(s) of crossings.