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

• US 10,420,945 B2
• Filed: 09/11/2017
• Issued: 09/24/2019
• Est. Priority Date: 04/17/2015
• Status: Active Grant

• Current Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Inventors: Milpied, Paola, Euzen, Marie-Anne
• Primary Examiner(s): Manuel, George
• Application Number:
  US15/701,249
• Publication Number:
  US 20170368349A1
• Time in Patent Office: 743 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 implantable medical device comprising:

a processor configured to;

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

collect two endocardial electrogram (EGM) signals during a spontaneous rhythm cardiac cycle, wherein the EGM signals are collected on a plurality of separate channels, wherein the EGM signals include a unipolar far-field EGM signal and a near-field EGM signal;

derive a temporal component from each of the EGM signals;

combine the two temporal components into a parametric 2D characteristic representative of the cardiac cycle based on the variations of one of the temporal components as a function of the other temporal component;

analyze the 2D characteristic by deriving, from the 2D characteristic or from an average of a plurality of the 2D characteristics collected over successive cardiac cycles, an intrinsic descriptor parameter representative of the 2D characteristic;

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

compare the variation to a predetermined threshold; and

trigger an alert in response to determining the variation exceeds the predetermined threshold.

2. The device of claim 1, wherein the EGM signals collected on a plurality of separate channels are collected concurrently.

3. The device of claim 1, wherein the historical analysis is performed periodically.

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

5. The device of claim 1, wherein the 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.

6. The device of claim 5, wherein the function of the velocity vector comprises a magnitude of the velocity vector.

7. The device of claim 6, 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 the reference 2D characteristic.

8. The device of claim 7, wherein the function of the velocity vector comprises an orientation of a speed vector.

9. The device of claim 8, wherein the processor is configured to perform the historical analysis by calculating an average angle between velocity vectors of the current 2D characteristic and of the reference 2D characteristic.

10. The device of claim 9, wherein the comparison comprises:

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

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

selectively triggering the alert when the average angle between velocity vectors exceeds the first threshold or the correlation coefficient between the magnitudes of velocity vectors is lower than the second threshold.

11. The device of claim 1, wherein the processor is configured to update the intrinsic descriptor parameter of the reference 2D characteristic when the alert is not triggered by the comparison.

12. The device of claim 1, wherein the processor is further configured to perform diagnostics of remodeling or of reverse remodeling, wherein the alert triggered by the comparison is an alert of an occurrence of remodeling or of an occurrence of reverse remodeling in a patient.

13. The device of claim 1, wherein the processor is further configured to detect at least one of a breakage of a lead or to diagnose ischemia, wherein the alert triggered by the comparison is an alert of at least one of a lead break or of an ischemia occurrence in the patient.

14. The device of claim 1, wherein the unipolar EGM far-field signal is collected between a first location comprising one or more 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.

15. The device of claim 1, wherein the unipolar EGM far-field signal is collected between a first location comprising one or more 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 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.

16. The device of claim 1, wherein the unipolar EGM far-field signal is collected between a first location comprising one or more 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.

17. 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.

18. A method comprising:

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

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

deriving a temporal component from each of the EGM signals;

combining the two temporal components into a parametric 2D characteristic representative of the cardiac cycle based on 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 a plurality of the 2D characteristics collected over successive cardiac cycles, an intrinsic descriptor parameter representative of the 2D characteristic;

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

comparing the variation to a predetermined threshold; and

triggering an alert in response to determining the variation exceeds the predetermined threshold.

19. The method of claim 18, wherein the EGM signals collected on a plurality of separate channels are collected concurrently.

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