VENTRICULAR CAPTURE TESTING BY ANALYSIS OF AN ENDOCARDIAL ACCELERATION SIGNAL IN AN ACTIVE IMPLANTABLE MEDICAL DEVICE

• US 20120022607A1
• Filed: 07/26/2011
• Published: 01/26/2012
• Est. Priority Date: 07/26/2010
• Status: Active Grant

• Current Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Inventors: Amblard, Amel, GIORGIS, Lionel
• Granted Patent: US 8,489,188 B2
• Time in Patent Office: Days
• US Class Current: 607/4
• CPC Class Codes: A61N 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: G06F 2218/12 Classification; Matching

Abstract

An active implantable medical device such as a cardiac prosthesis, including ventricular capture testing by analysis of an endocardial acceleration signal. The device isolates in an endocardial acceleration (“EA”) signal an EA component, extracts from it, n representative indicators (PEA_i, LEA_i), and forms a vector EA (X_i) from these indicators. A classifier allows acquiring reference EA signals at a stimulation energy level sufficient to cause a capture, and in spontaneous rhythm in the absence of ventricular pacing and forms a corresponding plurality of first reference EA vectors. The n-dimensional space of the EA vectors is partitioned into two corresponding subspaces. The presence or absence of a capture is discriminated based on the position of the current EA vector (X_i) in one or other of these two sub-spaces. The representative indicators may be: the value of peak to peak amplitude, the width, the moment of occurrence of the peak, the starting time and the ending time of the EA1 and/or EA2 components, the signal to noise ratio (SNR), the contrast value, the entropy value, and the cumulative energy of the EA1 and/or EA2 component, or the value of the peak-to-peak amplitude of the EA 4 component.

Claims

1. An active implantable medical device for cardiac pacing, resynchronization and/or defibrillation, comprising:

ventricular pacing means for delivering stimulation pulses of low energy to be applied to an electrode implanted in the right and/or left ventricular cavity of a patient and

means for testing ventricular capture, for detecting the onset of ventricular contraction resulting from delivery of a stimulation pulse, comprising;

an acceleration sensor having as an output an EA signal representative of a patient'"'"'s endocardiac acceleration; and

means for analyzing the EA signal for determining a presence and an absence of a ventricular capture,

Wherein;

the means for analyzing the EA signal comprises means for;

isolating in the EA signal at least one EA component of endocardial acceleration corresponding to a first major noise of the heart, and at least one EA component describing the continuous variation of said EA signal in a bounded temporal window corresponding to a fraction of a cardiac cycle;

extracting from said at least one EA component n indicators (PEA_i, LEA_i), with n≧

2, representative of the EA signal, and

forming a vector EA (X_i) of dimension n from the n indicators thus extracted;

the device further comprising a classifier means for, during a preliminary phase;

acquiring a plurality of EA signals at a stimulation energy level high enough to cause a capture and forming a corresponding plurality of first reference EA vectors (X_capt_ref_p);

acquiring a plurality of EA signals in a spontaneous rhythm of the patient in the absence of ventricular pacing and forming a corresponding plurality of second reference EA vectors (X_spont_ref_p) and

from the first and second vectors thus acquired, partitioning the n-dimensional space of the EA vectors into two subspaces corresponding respectively to the presence and absence of a capture; and

wherein the means for testing ventricular capture further comprises means for;

acquiring at least one EA signal at a current level of stimulation energy, and forming at least one corresponding current EA vector (X_i), and

discriminating the presence or absence of ventricular capture based on the position of the current EA vector in one of said two sub-spaces of said n-dimensional space of EA vectors.

2. The device of claim 1, wherein the n representative indicators of the EA signal are selected from among the group consisting of:

the value of the peak-to-peak amplitude (PEA), the width (LEA), the timing of occurrence of the peak (t_m, t_M), the start time of the peak (t_start), and the ending time (t_end), of the EA component.

3. The device of claim 2, wherein said at least one EA component further comprises an EA1 component corresponding to an S1 noise of the heart and/or an EA2 component corresponding to an S2 noise of the heart, and/or an EA3 component corresponding to an S3 noise of the heart, and/or an EA4 component corresponding to an S4 noise of the heart.

4. The device of claim 3, wherein said at least one EA component comprises a first indicator for an EA1 component and a second indicator for an EA2 component.

8. The device of claim 2, wherein the n representative indicators of the EA signal indicators are selected from among the group consisting of:

the value of the peak-to-peak amplitude, the width, the timing of occurrence the peak, the starting time and the ending time of the EA1 and/or EA2 components and at least one of value of the peak-to-peak amplitude of an EA 4 component.

9. The device of claim 1, wherein n=2 and the two representative indicators of the EA signal comprise the value of the peak-to-peak amplitude (PEA) and the width (LEA) of the EA component, where the EA component is one of an EA1 component and an EA2 component.

10. The device of claim 1, wherein the means for testing ventricular capture comprise means for forming a plurality of current EA vectors, and for discriminating the presence or absence of a capture by application of a majority.

11. The device of claim 1, wherein the means for partitioning the n-dimensional space of EA vectors into two subspaces comprise means for applying a threshold criterion separately to each of the indicators of the EA vectors.

12. The device of claim 1, wherein the means for partitioning the n-dimensional space of the EA vectors into two sub-spaces comprise means for implementing a classification algorithm selected from among the group consisting of:

K-nearest neighbors, neural network, and linear classification by estimation of the pseudo-inverse matrix.

13. The device of claim 1, wherein the classifier means further comprise means for evaluating a distance between classes and for verification of a minimum distance.

14. The device of claim 1, further comprising means for stimulating a patient'"'"'s atrium activated at a predetermined fixed stimulation frequency during an implementation of the classifier means and the means for testing ventricular capture.

15. The device of claim 1, further comprising means for searching the threshold of ventricular capture, for iteratively modifying the energy level of the stimulation pulse, and for testing each time for a presence or absence a capture.

16. The device of claim 1, wherein:

the device comprises means for joint stimulation of both left and right ventricles, with application of an interventricular delay between the respective moments of stimulation of the left and right ventricles;

the means for testing ventricular capture further comprises means for detecting the presence of a capture on the left and the right ventricles, and

the device further comprises means for activating the means for testing ventricular capture in response to an adjustment of the interventricular delay.

17. The device of claim 1, wherein the acceleration sensor comprises a sensor selected from among the group consisting of:

endocardial sensor, epicardial sensor, external sensor.

5. The device of claim 5, wherein the n representative indicators of the EA signal further comprise morphology indicators chosen from among the group consisting of:

the SNR, the contrast value, the value of entropy, and the cumulative energy, of the EA component.

6. The device of claim 5, wherein said at least one EA component further comprises an EA1 component corresponding to an S1 noise of the heart and/or an EA2 component corresponding to an S2 noise of the heart, and/or an EA3 component corresponding to an S3 noise of the heart, and/or an EA4 component corresponding to an S4 noise of the heart.

7. The device of claim 6, wherein said at least one EA component comprises a first indicator for an EA1 component and a second indicator for an EA2 component.