Implantable cardiac resynchronizer with biventricular pacing and detection of loss of capture and anodal stimulation

• US 10,441,797 B2
• Filed: 04/16/2018
• Issued: 10/15/2019
• Est. Priority Date: 05/14/2013
• Status: Active Grant

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Inventors: Ziglio, Filippo, Renesto, Fabrizio
• Primary Examiner(s): Morales, Jon Eric C
• Application Number:
  US15/954,255
• Publication Number:
  US 20180296844A1
• Time in Patent Office: 547 Days
• Field of Search: 607 9
• 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 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay
• 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 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/3714 Atrial capture

Abstract

A medical device for stimulating the heart using biventricular stimulation. The device includes a sensor for detecting an endocardial acceleration parameter and a processing circuit configured to receive the endocardial acceleration parameter. The device further includes stimulation electronics coupled to the processing circuit. The processing circuit is configured to use the EA parameter to evaluate the biventricular stimulation. The evaluation includes comparing the value of the EA parameter in biventricular mode to the value of the EA parameter in left only mode or right only mode, and using the comparison and an assessment of the variability of the EA parameter as a function of the AVD in the left or right mode to distinguish between cases comprising: (a) normal operation, (b) a loss of RV or LV capture, (c) possible anodal stimulation. The processing circuit is further configured to conduct at least one update to operational parameters of the device based on the determined case.

Claims

1. An active implantable medical device that provides cardiac resynchronization by biventricular pacing, comprising:

a memory storing a plurality of executable instructions; and

a processor configured to execute the instructions to;

selectively operate a stimulation in a first mode and a second mode, the first mode comprising a right only mode wherein a right ventricle is stimulated and a left ventricle is not stimulated or a left only mode wherein the left ventricle is stimulated and the right ventricle is not stimulated, the second mode comprising a biventricular mode in which both the left ventricle and the right ventricle are stimulated;

receive, from an endocardial acceleration sensor, an endocardial acceleration (EA) signal in each of the first mode and the second mode;

extract, from the EA signal, an EA parameter in each of the first mode and the second mode;

use the extracted EA parameters to evaluate the stimulation in the second mode, the evaluation comprising comparing values of the EA parameter in the second mode to the values of the EA parameter in the first mode to distinguish between;

(a) normal operation, (b) a loss of a right ventricular capture or a left ventricular capture, and (c) possible anodal stimulation.

2. The device of claim 1, further comprising:

a sensor configured to detect atrial and ventricular events; and

at least one electrode configured to stimulate the right and left ventricles.

3. The device of claim 1, wherein the processor is further configured to execute the instructions to conduct at least one update to operational parameters of the device based on the determined case.

4. The device of claim 1, wherein the processor is further configured to determine whether a difference between the values of the EA parameter in first mode and the second mode exceeds a first predetermined threshold.

5. The device of claim 4, wherein the processor is further configured to determine whether a difference between the values of the EA parameter in the first mode and the second mode exceeds a second predetermined threshold.

6. The device of claim 5, wherein the processor is further configured to execute the instructions to:

apply an atrioventricular delay (AVD) counted from a detection of a spontaneous or paced atrial event;

apply a right ventricular pacing at an end of the AVD in absence of a detected spontaneous ventricular event;

apply an intreventricular delay (VVD) between respective times of stimulation of the left ventricle and the right ventricle; and

use the comparison of the values of the EA parameter in the second mode to the values of the EA parameter in the first mode to assess a variability of the EA parameter as a function of the AVD in the first mode to distinguish between the normal operation, the loss of the right ventricular capture or the left ventricular capture, and a possible anodal stimulation.

7. The device of claim 5, wherein in response to determining the difference between the values of the EA parameter in the first mode and the second mode exceeds the first threshold, the processor is further configured to:

determine whether the variability in the EA parameter for a different AVD in the first mode exceeds a predetermined third threshold; and

in response to determining the variability of the EA parameter for a different AVD in the first mode exceeds the third threshold, classify the stimulation as (c) possible anodal stimulation.

8. The device of claim 5, wherein in response to determining the difference between the values of the EA parameter in the first mode and the second mode exceeds the second threshold, the processor is further configured to:

determine whether the variability of the EA parameter for another different AVD in the first mode exceeds a given fourth threshold; and

in response to determining the variability of the EA parameter for another different AVD in the first mode exceeds the fourth threshold, classify the stimulation as (b) a loss of a right ventricular capture or a left ventricular capture.

9. A method for an active implantable medical device that provides cardiac resynchronization by biventricular pacing, comprising:

receiving, from an endocardial acceleration sensor, an endocardial acceleration (EA) signal in a first mode, wherein only one of a left ventricle and a right ventricle are stimulated and a second mode, wherein both of a left ventricle and a right ventricle are stimulated,

extracting, from the EA signal, an EA parameter in each of the first mode and the second mode; and

comparing values of the EA parameter of the first mode to the values of the EA parameter of the second mode to distinguish between a plurality of operating conditions of the active implantable medical device; and

updating an operational parameter of the device based on the comparison of the values of the EA parameter in the first mode to the values of the EA parameter in the second mode.

10. The method of claim 9, wherein the plurality of operating conditions include (a) normal operation, (b) a loss of a right ventricular capture or a left ventricular capture, and (c) possible anodal stimulation.

11. The method of claim 9, wherein updating the operational parameter of the device based on the comparison of the values of the EA parameter in the first mode to the values of the EA parameter in the second mode comprises updating the operational parameter based on the determined operating condition.

12. The method of claim 9, wherein comparing the values of the EA parameters obtained in the first mode and the second mode comprises determining whether a difference between the values exceeds a first predetermined threshold.

13. The method of claim 12, wherein comparing the values of the EA parameters obtained in the first mode and the second mode comprises determining whether a difference between the values exceeds a second predetermined threshold.

14. The method of claim 13, further comprising:

applying an atrioventricular delay (AVD);

applying a right ventricular pacing at an end of the AVD in absence of a detected spontaneous ventricular event;

applying an interventricular delay (VVD) between times of stimulation of the left ventricle and the right ventricle; and

using the comparison of the values of the EA parameter in the first mode to the values of the EA parameter in the second mode to assess a variability of the EA parameter as a function of the AVD in the second mode to distinguish between the plurality of operating conditions.

15. The method of claim 14, further comprising:

in response to determining the difference between the values of the EA parameter in the first mode and the second mode exceeds the first threshold, determining whether the variability of the EA parameter for a different AVD in the first mode exceeds a predetermined third threshold; and

in response to determining the variability of the EA parameter for a different AVD in the first mode exceeds the third threshold, classifying the stimulation as (c) possible anodal stimulation.

16. The method of claim 14, further comprising:

in response to determining the difference between the values of the EA parameter in the first mode and the second mode exceeds the second threshold, determining whether the variability of the EA parameter for another different AVD in the first mode exceeds a given fourth threshold; and

in response to determining the variability of the EA parameter for another different AVD in the first mode exceeds the fourth threshold, classifying the stimulation as (b) a loss of a right ventricular capture or a left ventricular capture.

17. An active implantable medical device that provides cardiac resynchronization by biventricular pacing, comprising:

a sensor configured to generate an endocardial acceleration (EA) signal in a first mode, wherein only one of a left ventricle and a right ventricle are stimulated, and a second mode, wherein both of a left ventricle and a right ventricle are stimulated; and

processing electronics configured to;

receive the EA signal;

extract, from the EA signal, an EA parameter in each of the first mode and the second mode; and

compare values of the EA parameter of the first mode to the values of the EA parameter of the second mode to distinguish between a plurality of operating conditions of the active implantable medical device; and

update an operational parameter of the device based on the comparison of the values of the EA parameter in the first mode to the values of the EA parameter in the second mode.

18. The device of claim 17, wherein the plurality of operating conditions include (a) normal operation, (b) a loss of a right ventricular capture or a left ventricular capture, and (c) possible anodal stimulation.

19. The device of claim 17, wherein the processing electronics are further configured to:

apply an atrioventricular delay (AVD);

apply a right ventricular pacing at an end of the AVD in absence of a detected spontaneous ventricular event;

apply an interventricular delay (VVD) between times of stimulation of the left ventricle and the right ventricle; and

use the comparison of the values of the EA parameter in the first mode to the values of the EA parameter in the second mode to assess a variability of the EA parameter as a function of the AVD in the second mode to distinguish between the plurality of operating conditions.

20. The device of claim 19, further comprising a memory configured to:

test and store a plurality of different stimulation configurations with different VVD for a plurality of AVD.