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

• US 9,314,636 B2
• Filed: 05/14/2014
• Issued: 04/19/2016
• 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:
  US14/277,552
• Publication Number:
  US 20140343619A1
• Time in Patent Office: 706 Days
• Field of Search: 607 4- 5, 607/17, 607/9, 607/28
• US Class Current: 1/1
• 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

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

using processing circuitry of the implantable medical device to detecting atrial and ventricular events;

using the processing circuitry to stimulate the right and left ventricles;

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

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

selectively operating the stimulation such that the device operates in either a right mode (RV only) wherein only the right ventricle is paced, or a left mode (LV only) wherein only the left ventricle is stimulated, or in a biventricular mode (BiV) wherein both ventricles are stimulated together with or without the application of a VVD;

using a sensor coupled to the processing circuitry to provide an endocardial acceleration signal EA;

extracting, from the EA signal, at least one predetermined characteristic EA parameter;

using the EA parameter to evaluate the biventricular stimulation, the evaluation comprising comparing the values of the EA parameter in biventricular mode to the values of the EA parameter in left only mode or right only mode and using the comparison to further compare to at least one threshold indicating 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; 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 parameter obtained in biventricular mode and in left mode comprises determining whether the difference between these values exceeds a first predetermined threshold.

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

4. The method of claim 3, wherein the assessment of the variability of the EA parameter as a function of the AVD in the left or right mode comprises:

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

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

5. The method of claim 4, wherein using the EA parameter to evaluate the biventricular stimulation comprises:

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

6. The method of claim 5, further comprising:

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

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

7. The method of claim 5, further comprising:

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

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

8. The method of claim 5, further comprising:

determine the occurrence of a loss of capture in the left cavity in response to the determination that the variation of the characteristic EA parameter for different AVD in left mode does not exceed the third threshold.

9. The method of claim 5, further comprising:

determining the occurrence of a loss of capture on the right cavity in response to the determination that the variation of the characteristic EA parameter for different AVD in right mode not exceed the fourth threshold.

10. The method of claim 5, further comprising:

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

11. The method of claim 5, wherein conducting the update comprises updating the stimulation energy of the left or right ventricle, in response to the determination of the occurrence of a loss of capture respectively in the left or in the right cavities.

12. The method of claim 5, wherein conducting the update comprises updating the stimulation energy of the left ventricle or for modifying the configuration of the pacing electrodes, in response to the determination of the presence of a phenomenon of anodal stimulation.

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

at least one sensor for detecting of atrial and ventricular events;

at least one electrode for stimulation of the right and left ventricles;

a processor that causes an atrioventricular delay AVD to be added to the stimulation, the AVD counted from the detection of a spontaneous or paced atrial event and at the end of which a right ventricular pacing is applied in the absence of detected spontaneous ventricular event, wherein the processor further causes an interventricular delay VVD between the respective times of stimulation of the left and right ventricles, wherein the processor is further configured to cause the device to selectively operate in either a right mode (RV only) wherein only the right ventricle is paced, or a left mode (LV only) wherein only the left ventricle is stimulated, or in a biventricular mode (BiV) wherein both ventricles are stimulated together with or without the application of a VVD;

a sensor to deliver an endocardial acceleration signal EA, wherein the processor extracts, from the EA signal, at least one predetermined characteristic EA parameter; and

wherein the processor comprises a plurality of executable computer code modules stored in memory, the modules comprising;

a first module configured to compare the values of the characteristic EA parameter obtained respectively in biventricular mode and in left mode and to determine whether the difference between these values exceeds a first predetermined threshold;

a second module configured to compare the values of the characteristic EA parameter obtained respectively in biventricular mode and in right mode and to determine if the difference between these values exceeds a second predetermined threshold;

a third module configured to determine whether the change in the characteristic EA parameter for different AVD in left mode exceeds a given third threshold;

a fourth module configured to determine if the change to the different characteristic EA parameter for different AVD exceeds a given fourth threshold;

a fifth module configured to compare the values of the characteristic EA parameter obtained in biventricular mode respectively with a negative or positive VVD and to determine if the difference between these values exceeds a predetermined fifth threshold; and

a sixth module configured to determine in response to the first, second, third, fourth and fifth means, the occurrence of a possible loss of capture in the left or right cavities, or the presence of a phenomenon of anodal stimulation.

14. The device of claim 13, wherein the memory is caused to test and store a plurality of different stimulation configurations with different VVD for a plurality of AVD;

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

15. The device of claim 13, wherein the third module executes in response to the determination by the second module that the difference between the values of the characteristic EA parameter obtained in biventricular mode and in right mode does not exceed the second threshold;

and

wherein the sixth module is configured to determine the occurrence of a loss of capture in the left cavity in response to the determination by the third module that the variation of the characteristic EA parameter for different AVD in left mode does not exceed the third threshold.

16. The device of claim 13, wherein the fourth module executes in response to the determination by the first module that the difference between the values of the characteristic EA parameter obtained in biventricular mode and in left mode does not exceed the first threshold;

and

wherein the sixth module is configured to determine the occurrence of a loss of capture on the right cavity in response to the determination by the fourth means that the variation of the characteristic EA parameter for different AVD in right mode not exceed the fourth threshold.

17. The device of claim 13, wherein the fourth module executes in response to the determination by the first means that the difference between the values of the characteristic EA parameter obtained in biventricular mode and in left mode does not exceed the first threshold;

the fifth module executes in response to the determination by the fourth means that the variation of the characteristic EA parameter for different AVD in right mode exceeds the fourth threshold; and

wherein the sixth module is configured to determine the presence of a phenomenon of anodal stimulation in response to the determination by the fifth means that the variation of the characteristic EA parameter for different VVD with stimulation of the left ventricle first, does not exceed the fifth threshold.

18. The device of claim 13, wherein the processor is configured to update the stimulation energy of the left or right ventricle, in response to the determination, by the sixth module, of the occurrence of a loss of capture respectively in the left or in the right cavities.

19. The device of claim 13, wherein the processor is configured to update the stimulation energy of the left ventricle or for modifying the configuration of the pacing electrodes, in response to the determination of the presence of a phenomenon of anodal stimulation by the sixth module.

20. An medical device for stimulating the heart using biventricular stimulation, comprising:

a sensor for detecting an endocardial acceleration parameter;

a processing circuit configured to receive the endocardial acceleration parameter;

stimulation electronics coupled to the processing circuit;

wherein the processing circuit is configured to use the EA parameter to evaluate the biventricular stimulation, the evaluation comprising 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 to further compare to at least one threshold indicating 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; and

wherein the processing circuit is further configured to conduct at least one update to operational parameters of the device based on the determined case.