Active implantable medical device for detecting a remodeling or reverse remodeling phenomenon of the patient

• US 9,757,566 B2
• Filed: 04/15/2016
• Issued: 09/12/2017
• Est. Priority Date: 04/17/2015
• Status: Active Grant

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Inventors: Milpied, Paola, Euzen, Marie-Anne
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US15/130,540
• Publication Number:
  US 20160303372A1
• Time in Patent Office: 515 Days
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/341 Vectorcardiography [VCG]
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

According to some embodiments, a device operates by comparative morphological analysis of depolarization signals collected in spontaneous rhythm on separate respective channels, with two temporal components combined into a single 2D parametric VGM vectogram characteristic. Similarity quantification methods evaluate a variation over time of a descriptor parameter of a current VGM compared to a stored previous reference VGM. This variation is compared with predetermined thresholds to diagnose an occurrence of remodeling or reverse remodeling in a patient, and/or to detect a lead failure or an occurrence of ischemia. The descriptor parameter is a function of a velocity vector of the VGM, a comparison relating to a correlation coefficient between respective magnitudes of a current VGM velocity vector and of a reference VGM velocity vector, and an average angle between these respective velocity vectors.

Claims

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

a processor configured to;

control stimulation of the heart;

detect at least one of a ventricular depolarization signal or an atrial depolarization signal on a channel at a plurality of distinct instants; and

perform a morphological analysis in which the at least one of the ventricular depolarization signal or the atrial depolarization signal at the distinct instants are compared, wherein the processor is configured to perform the morphological analysis by;

inhibiting the controlled stimulation;

collecting at least two EGM signals of endocardial electrogram during a spontaneous rhythm cardiac cycle, wherein the EGM signals are collected concurrently on a plurality of separate respective channels, wherein the at least two EGM signals collected concurrently on separate respective channels include a unipolar EGM far-field signal and a near-field EGM bipolar signal;

deriving at least two respective distinct temporal components from the at least two EGM signals;

combining the at least two temporal components into at least one parametric 2D characteristic representative of the cardiac cycle, from the variations of one of the temporal components as a function of the other temporal component;

analyzing the 2D characteristic by deriving, from the 2D characteristic or from an average of the 2D characteristics collected over successive cardiac cycles, at least one intrinsic descriptor parameter representative of the 2D characteristic;

periodically performing a historical analysis by evaluating a variation over time of the at least one intrinsic descriptor parameter of a current 2D characteristic with respect to a previous reference 2D characteristic stored by the device;

comparing the variation assessed by the historical analysis to a predetermined threshold; and

selectively triggering an alert based on the result of the comparison.

2. The device of claim 1, wherein the processor is configured to perform the historical analysis by evaluating the daily variation over time of the at least one intrinsic descriptor parameter.

3. The device of claim 1, wherein the at least one intrinsic descriptor parameter is a function of a velocity vector of the 2D characteristic, considered in a plurality of respective points of the 2D characteristic.

4. The device of claim 3, wherein the function of the velocity vector comprises a magnitude of the velocity vector.

5. The device of claim 4, wherein the processor is configured to perform the historical analysis by calculating a correlation coefficient between the magnitudes of respective velocity vectors of the current 2D characteristic and of the reference 2D characteristic.

6. The device of claim 5, wherein the function of the velocity vector comprises an orientation of a speed vector.

7. The device of claim 6, wherein the processor is configured to perform the historical analysis by calculating an average angle between respective velocity vectors of the current 2D characteristic and of the reference 2D characteristic.

8. The device of claim 7, wherein the comparison comprises:

comparing the average angle between velocity vectors to a first threshold;

the correlation coefficient between the magnitudes of velocity vectors to a second threshold; and

selectively triggering the alert occurs in response to at least one of the average angle between velocity vectors exceeding the first threshold or when the correlation coefficient between the magnitudes of velocity vectors is lower than the second threshold.

9. The device of claim 1, wherein the processor is configured to perform the morphological analysis further by updating the at least one intrinsic descriptor parameter of the reference 2D characteristic when the alert is not triggered by the comparison.

10. The device of claim 1, wherein the processor is further configured to perform diagnostics of remodeling or of reverse remodeling using the morphological analysis, the alert triggered by the comparison being an alert of an occurrence of remodeling or of an occurrence of reverse remodeling in patients.

11. The device of claim 1, wherein the processor is further configured to perform at least one of detecting breakage of a lead or diagnosing ischemia using the morphological analysis, the alert triggered by the comparison being an alert of at least one of a lead break or of an ischemia occurrence in the patient.

12. The device of claim 1, wherein the unipolar EGM far-field signal is collected between a first location comprising at least one of a proximal electrode, a distal electrode, an intermediate electrode, or a defibrillation coil electrode of a ventricular lead and a second location comprising a metal housing generator of the device.

13. The device of claim 1, wherein the unipolar EGM far-field signal is collected between a first location comprising at least one of a first proximal electrode, a first distal electrode, or a first defibrillation coil electrode of a first ventricular lead and a second location comprising at least one of a second proximal electrode, a second distal electrode, an intermediate electrode or a second defibrillation coil electrode of a second ventricular lead, wherein both the first and the second ventricular leads are located in a single ventricle.

14. The device of claim 1, wherein the unipolar EGM far-field signal is collected between a first location comprising at least one of a first proximal electrode, a first distal electrode, or a first defibrillation coil electrode of a first ventricular lead and a second location comprising at least one of a second proximal electrode, a second distal electrode, or an intermediate electrode of a second ventricular lead, wherein the first ventricular lead is located in the right ventricle and the second ventricular lead is located in the left ventricle.

15. The device of claim 1, wherein the near-field EGM bipolar signal is collected between at least one of:

a distal electrode and a proximal electrode of a ventricular lead;

a defibrillation coil and at least one of the proximal electrode or the distal electrode of the ventricular lead;

a distal electrode and an intermediate electrode of a left ventricular lead;

a proximal electrode and the intermediate electrode of the left ventricular lead;

or

a first intermediate electrode and a second intermediate electrode of the left ventricular lead.

16. The device of claim 1, wherein the unipolar EGM far-field signal is collected between a first electrode and a housing of the implantable medical device and the near-field EGM bipolar signal is collected between the first electrode and a second electrode, the first electrode and the second electrode located on a ventricular lead.

17. A method comprising:

controlling, by an implantable medical device, stimulation of a heart;

detecting, by the implantable medical device, at least one of a ventricular depolarization signal or an atrial depolarization signal on a channel at a plurality of times; and

performing, by the implantable medical device, a morphological analysis in which the at least one of the ventricular depolarization signal or the atrial depolarization signal at two or more of the plurality of times are compared, performing the morphological analysis comprising;

inhibiting the controlled stimulation;

collecting at least two EGM signals of endocardial electrogram during a spontaneous rhythm cardiac cycle, wherein the EGM signals are collected concurrently on a plurality of separate respective channels, wherein the at least two EGM signals collected concurrently on separate respective channels include a unipolar EGM far-field signal and a near-field EGM bipolar signal;

deriving at least two respective distinct temporal components from the at least two EGM signals;

combining the at least two temporal components into at least one parametric 2D characteristic representative of the cardiac cycle, from the variations of one of the temporal components as a function of the other temporal component;

analyzing the 2D characteristic by deriving, from the 2D characteristic or from an average of the 2D characteristics collected over successive cardiac cycles, at least one intrinsic descriptor parameter representative of the 2D characteristic;

performing a historical analysis by evaluating a variation over time of the at least one intrinsic descriptor parameter of a current 2D characteristic with respect to a previous reference 2D characteristic stored by the device;

comparing the variation assessed by the historical analysis to a predetermined threshold; and

selectively triggering an alert based on the result of the comparison.

18. The method of claim 17, wherein performing the historical analysis comprises evaluating a daily variation over time of the at least one intrinsic descriptor parameter.

19. The method of claim 17, wherein the at least one intrinsic descriptor parameter is a function of a velocity vector of the 2D characteristic, considered in a plurality of respective points of the 2D characteristic.

20. The method of claim 19, wherein the function of the velocity vector comprises at least one of a magnitude or an orientation of the velocity vector.