Template-based capture verification for multi-site pacing

• US 8,406,880 B2
• Filed: 05/29/2007
• Issued: 03/26/2013
• Est. Priority Date: 10/26/2001
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Yonce, David J., Ternes, David
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): OROPEZA, FRANCES P
• Application Number:
  US11/754,496
• Publication Number:
  US 20070219593A1
• Time in Patent Office: 2,128 Days
• Field of Search: 600/372, 600/373, 600/374, 600/377, 600/393, 600/509, 607/4, 607/5, 607/9, 607/28, 607/116, 607/119, 607/122, 607/123
• US Class Current: 607/28
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• 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 1/3682 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 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

An apparatus and method for verifying capture by first and second pacing pulses in which an evoked response waveform recorded during a pacing event is compared with template waveforms representing capture by the first, second, and both pacing pulses. The evoked response is then classified as representing a type of capture represented by a template waveform if the evoked response waveform highly correlates with one template waveform and has correlation values with the other template waveforms within specified bounds.

Claims

1. A cardiac pacemaker, comprising:

pulse generators for incorporating into first and second pacing channels;

a controller for controlling the operation of the pulse generators and programmed to deliver pacing pulses to either both of the ventricles or both of the atria through the first and second pacing channels in accordance with a programmed pacing mode;

a sense amplifier for incorporating into an evoked response sensing channel for sensing an evoked response generated after a pacing pulse; and

,

wherein the controller is programmed to;

deliver first and second pacing pulses from the first and second pacing channels, respectively, during a cardiac cycle;

record a test electrogram from the evoked response sensing channel during delivery of the first and second pacing pulses;

compare the test electrogram with a template representing capture by both the first and second pacing channels, a template representing capture by the first pacing channel only, and a template representing capture by the second channel only;

classify the test electrogram as representing the type of capture represented the template electrogram to which the test electrogram is most similar;

wherein the controller is programmed to measure a parameter related to the signal energy of the test electrogram, classify the test electrogram as representing asystole if the measured parameter is below a specified threshold, and classify the test electrogram as representing a fusion beat if the test electrogram fails to correlate with any of the templates to specified extents and is not classified as representing asystole.

2. The pacemaker of claim 1 wherein the first and second pacing channels are configurable as right and left ventricular pacing channels, the evoked response sensing channel is configurable with an electrode disposed near the right ventricle, and wherein the controller is programmed to classify the test electrogram as representing right ventricular (RV) capture, left ventricular (LV) capture, or biventricular (BiV) capture based upon a comparison of the test electrogram with RV, LV, and BiV templates representing RV, LV, and BiV capture, respectively, and to further distinguish between RV capture and BiV capture based upon the value of the parameter related to the signal energy of the test electrogram and the value of similar parameters for the BiV and RV templates.

3. The pacemaker of claim 1 wherein the first and second pacing channels are configurable as right and left ventricular pacing channels, the evoked response sensing channel is configurable with an electrode disposed near the left ventricle, and wherein the controller is programmed to classify the test electrogram as representing right ventricular (RV) capture, left ventricular (LV) capture, or biventricular (BiV) capture based upon a comparison of the test electrogram with RV, LV, and BiV templates representing RV, LV, and BiV capture, respectively, and to further distinguish between LV capture and BiV capture based upon the value of the parameter related to the signal energy of the test electrogram and the value of similar parameters for the BiV and LV templates.

4. The pacemaker of claim 1 wherein the parameter related to the signal energy of a test electrogram is the signal energy during a sub-window interval of 200-300 ms following the pace.

5. The pacemaker of claim 1 wherein the controller is further programmed to vary the pulse energy of the pacing pulses in order to determine a capture threshold for a pacing channel.

6. The pacemaker of claim 5 wherein the controller is further programmed to lower the pacing pulse energy of a pacing channel until capture is no longer achieved by that channel in order to determine the capture threshold.

7. The pacemaker of claim 6 wherein the controller is programmed to determine a capture threshold for each of the first and second pacing channels by lowering the pacing energy of each pacing channel separately until the test electrogram no longer matches the template electrogram representing capture by both of the first and second pacing pulses.

8. The pacemaker of claim 6 wherein the controller is programmed to determine a capture threshold of the first and second pacing channels by:

lowering the pacing energy of the first pacing channel until the test electrogram matches the template electrogram representing capture by the second pacing pulse but does not match the template electrogram representing capture by the first pacing pulse; and

,

lowering the pacing energy of the second pacing channel until the test electrogram matches a template electrogram representing capture by the first pacing pulse but does not match the template electrogram representing capture by the second pacing pulse.

9. The pacemaker of claim 5 wherein the controller is further programmed to adjust the pacing pulse energy of a pacing channel in accordance with the results of the capture threshold determination.

10. A method for operating a cardiac pacemaker, comprising:

delivering first and second pacing pulses during a cardiac cycle to electrodes disposed for pacing each of the paired atria or each of the paired ventricles in accordance with a programmed pacing mode;

sensing an evoked response generated after a pacing pulse;

recording a test electrogram from the evoked response sensing channel during delivery of the first and second pacing pulses;

comparing the test electrogram with a template representing capture by both the first and second pacing channels, a template representing capture by the first pacing channel only, and a template representing capture by the second channel only and

classifying the test electrogram as representing the type of capture represented the template electrogram to which the test electrogram is most similar;

wherein the controller is programmed to measure a parameter related to the signal energy of the test electrogram, classify the test electrogram as representing asystole if the measured parameter is below a specified threshold, and classify the test electrogram as representing a fusion beat if the test electrogram fails to correlate with any of the templates to specified extents and is not classified as representing asystole.

11. The method of claim 10 wherein the first and second pacing channels are configured as right and left ventricular pacing channels, the evoked response sensing channel is configured with an electrode disposed near the right ventricle, and further comprising classifying the test electrogram as representing right ventricular (RV) capture, left ventricular (LV) capture, or biventricular (BiV) capture based upon a comparison of the test electrogram with RV, LV, and BiV templates representing RV, LV, and BiV capture, respectively, and further distinguishing between RV capture and BiV capture based upon the value of the parameter related to the signal energy of the test electrogram and the value of similar parameters for the BiV and RV templates.

12. The method of claim 10 wherein the first and second pacing channels are configured as right and left ventricular pacing channels, the evoked response sensing channel is configured with an electrode disposed near the left ventricle, and further comprising classifying the test electrogram as representing right ventricular (RV) capture, left ventricular (LV) capture, or biventricular (BiV) capture based upon a comparison of the test electrogram with RV, LV, and BiV templates representing RV, LV, and BiV capture, respectively, and further distinguishing between LV capture and BiV capture based upon the value of the parameter related to the signal energy of the test electrogram and the value of similar parameters for the BiV and LV templates.

13. The method of claim 10 wherein the parameter related to the signal energy of a test electrogram is the signal energy during a sub-window interval of 200-300 ms following the pace.

14. The method of claim 10 further comprising varying the pulse energy of the pacing pulses in order to determine a capture threshold for a pacing channel.

15. The method of claim 14 wherein the controller is further programmed to lower the pacing pulse energy of a pacing channel until capture is no longer achieved by that channel in order to determine the capture threshold.

16. The method of claim 15 further comprising determining a capture threshold for each of the first and second pacing channels by lowering the pacing energy of each pacing channel separately until the test electrogram no longer matches the template electrogram representing capture by both of the first and second pacing pulses.

17. The method of claim 15 further comprising determining a capture threshold of the first and second pacing channels by:

lowering the pacing energy of the first pacing channel until the test electrogram matches the template electrogram representing capture by the second pacing pulse but does not match the template electrogram representing capture by the first pacing pulse; and

,

lowering the pacing energy of the second pacing channel until the test electrogram matches a template electrogram representing capture by the first pacing pulse but does not match the template electrogram representing capture by the second pacing pulse.

18. The method of claim 16 further comprising adjusting the pacing pulse energy of a pacing channel in accordance with the results of the capture threshold determination.