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

• US 9,943,693 B2
• Filed: 04/15/2016
• Issued: 04/17/2018
• 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): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US15/130,653
• Publication Number:
  US 20160228714A1
• Time in Patent Office: 732 Days
• Field of Search: 607 4- 5, 607 28
• 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. A method for an active implantable medical device that provides cardiac resynchronization by biventricular pacing, comprising:

detecting atrial and ventricular events;

stimulating a right ventricle and a left ventricle by;

selectively operating the stimulation in at least one of a right only mode wherein only the right ventricle is stimulated or a left only mode wherein only the left ventricle is stimulated; and

selectively operating the stimulation in a biventricular mode wherein both ventricles are stimulated together;

using a sensor coupled to processing circuitry to provide an endocardial acceleration (EA) signal in each of the biventricular mode and the at least one of the right only mode or the left only mode;

extracting, from the EA signal, at least one predetermined EA parameter in each of the biventricular mode and the at least one of the right only mode or the left only mode;

using the EA parameters to evaluate the biventricular mode stimulation, the evaluation comprising comparing values of the EA parameter in the biventricular mode to the values of the EA parameter in at least one of the left only mode or the right only 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; and

conducting at least one update to operational parameters of the device based on the determined case.

2. The method of claim 1, wherein comparing the values of the EA parameters obtained in the biventricular mode and in the left only mode comprises determining whether a difference between the values exceeds a first predetermined threshold.

3. The method of claim 2, wherein comparing the values of the EA parameters obtained in the biventricular mode and in the right only mode comprises determining whether the difference between the values exceeds a second predetermined threshold.

4. The method of claim 2, further comprising:

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

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 respective times of stimulation of the left ventricle and the right ventricle; and

using the comparison of the values of the EA parameter in the biventricular mode to the values of the EA parameter in the at least one of the left only mode or the right only mode to assess a variability of the EA parameter as a function of the AVD in the at least one of the left only mode or the right only mode to distinguish between the normal operation, the loss of the right ventricular capture or the left ventricular capture, and a possible anodal stimulation.

5. The method of claim 4, wherein the assessment of the variability of the EA parameter as the function of the AVD in the left only mode or the right only mode comprises:

determining whether the variability in the EA parameter for a different AVD in the left only mode exceeds a given third threshold; and

determining if the variability to the different EA parameter for another different AVD exceeds a given fourth threshold.

6. The method of claim 5, wherein using the EA parameter to evaluate the biventricular mode stimulation comprises:

comparing the values of the EA parameter obtained in the biventricular mode with a negative or positive VVD and determining if the difference between the values exceeds a predetermined fifth threshold.

7. The method of claim 6, further comprising:

recalling, from memory, a plurality of different stimulation configurations with different VVD for a plurality of AVD; and

selecting a predetermined EA parameter, for use in evaluation, among several possible EA parameters.

8. The method of claim 6, further comprising:

recalling, from a memory, a plurality of different stimulation configurations with different VVD for a plurality of AVD; and

determining the first predetermined threshold based on the recalled plurality of different stimulation configurations.

9. The method of claim 6, further comprising:

determine an occurrence of the loss of the left ventricle capture in response to the determination that the variability of the EA parameter for different AVD values in the left only mode does not exceed the third threshold.

10. The method of claim 6, further comprising:

determining an occurrence of the loss of the right ventricular capture in response to the determination that the variability of the EA parameter for different AVD values in the right only mode does not exceed the fourth threshold.

11. The method of claim 6, further comprising:

determining a presence of the anodal stimulation in response to the determination that the variability of the EA parameter for different VVD values with stimulation of the left ventricle first does not exceed the fifth threshold.

12. The method of claim 6, wherein conducting the update comprises updating an energy of the stimulation of the left or right ventricle in response to the determination of an occurrence of a loss of capture respectively in the left or in the right ventricles.

13. The method of claim 6, wherein conducting the update comprises updating an energy of the stimulation of the left ventricle or modifying a configuration of pacing electrodes in response to a determination of a presence of the anodal stimulation.

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

a first sensor configured to detect atrial and ventricular events;

at least one electrode for stimulation of a right ventricle and a left ventricle;

a second sensor configured to deliver an endocardial acceleration (EA) signal;

a memory storing a plurality of executable instructions; and

a processor configured to execute the instructions to;

cause an atrioventricular delay (AVD) to be added to the stimulation, the AVD counted from a detection of a spontaneous or paced atrial event and at an end of which a right ventricular pacing is applied in an absence of detected spontaneous ventricular event;

cause an interventricular delay (VVD) between the respective times of stimulation of the left and right ventricles;

selectively operate in either a right only mode wherein only the right ventricle is paced, or a left only mode wherein only the left ventricle is stimulated, or in a biventricular mode wherein both ventricles are stimulated together;

compare values of at least one predetermined EA parameter obtained respectively in the biventricular mode and in the left only mode;

determine whether a difference between these values exceeds a first predetermined threshold;

compare the values of the EA parameter obtained respectively in the biventricular mode and in the right only mode;

determine if the difference between these values exceeds a second predetermined threshold; and

determine in response to the first and second, third, fourth and fifth threshold comparisons, an occurrence of a possible loss of capture in the left or right ventricles, or a presence of a phenomenon of anodal stimulation.

15. The device of claim 14, wherein the memory tests and stores a plurality of different stimulation configurations with different VVD for a plurality of AVD;

and wherein the processor is further configured to set the first threshold, based on results produced by prior testing of the plurality of configurations.

16. The device of claim 14, wherein the processor is further configured to:

determine whether a variability in the EA parameter for different AVD in the left only mode exceeds a given third threshold;

determine if the variability to the different EA parameter for different AVD exceeds a given fourth threshold;

compare the values of the EA parameter obtained in the biventricular mode respectively with a negative or positive VVD;

determine if the difference between these values exceeds the fifth threshold; and

determine in response to the first, second, third, fourth and fifth threshold comparisons, the occurrence of the possible loss of capture in the left or right ventricles, or the presence of the phenomenon of anodal stimulation.

17. The device of claim 16, wherein determining whether the variability in the EA parameter for different AVD in the left only mode exceeds the given third threshold occurs in response to the determination that the difference between the values of the EA parameter obtained in the biventricular mode and in the right only mode does not exceed the second threshold;

and

wherein determining the occurrence of the loss of capture in the left ventricle occurs in response to the determination that the variability of the EA parameter for different AVD in the left only mode does not exceed the third threshold.

18. The device of claim 16, wherein the determining if the variability to the different EA parameter for different AVD exceeds the fourth threshold occurs in response to the determination that the difference between the values of the EA parameter obtained in the biventricular mode and in the left only mode does not exceed the first threshold;

and

wherein determining the occurrence of the loss of capture on the right ventricle occurs in response to the determination that the variability of the EA parameter for different AVD in the right only mode not exceed the fourth threshold.

19. The device of claim 16, wherein determining if the variability to the different EA parameter for different AVD exceeds the fourth threshold occurs in response to the determination that the difference between the values of the EA parameter obtained in the biventricular mode and in the left only mode does not exceed the first threshold;

comparing the values of the EA parameter obtained in the biventricular mode respectively with a negative or positive VVD occurs in response to the determination that the variability of the EA parameter for different AVD in right mode exceeds the fourth threshold; and

wherein determining the presence of the phenomenon of anodal stimulation occurs in response to the determination that the variability of the EA parameter for different VVD with stimulation of the left ventricle first, does not exceed the fifth threshold.

20. The device of claim 16, wherein the processor is configured to execute the instructions to update the stimulation energy of the left or right ventricle, in response to the determination of the occurrence of the loss of capture respectively in the left or in the right ventricle.

21. The device of claim 16, wherein the processor is configured to execute the instruction to perform operations further comprising updating the stimulation energy of the left ventricle or for modifying a configuration of pacing electrodes, in response to the determination of the presence of the phenomenon of anodal stimulation.

22. A medical device for stimulating a heart using a biventricular stimulation, comprising:

a sensor that detects endocardial acceleration (EA) parameters;

stimulation electronics coupled to a processor for the biventricular stimulation of a right ventricle and a left ventricle and for the stimulation of only the right ventricle or for the stimulation of only the left ventricle;

a memory storing a plurality of executable instructions; and

wherein the processor is configured to execute the instructions to;

receive the endocardial acceleration parameters;

use the EA parameters to evaluate the biventricular stimulation, the evaluation comprising;

comparing a value of the EA parameter in biventricular mode to the value of the EA parameter in a right only mode wherein only the right ventricle is stimulated, or a left only mode wherein only the left ventricle is stimulated; and

using the comparison to further compare to at least one threshold indicating an assessment of a 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 right ventricle or left ventricle capture, (c) possible anodal stimulation; and

conduct at least one update to operational parameters of the device based on the determined case.