Method and apparatus for capture verification and threshold determination

• US 7,177,689 B2
• Filed: 10/26/2001
• Issued: 02/13/2007
• Est. Priority Date: 10/26/2001
• Status: Expired due to Term

• 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): Pezzuto; Robert E.
• Assistant Examiner(s): Oropeza; Frances P.
• Application Number:
  US10/003,718
• Publication Number:
  US 20030083710A1
• Time in Patent Office: 1,936 Days
• Field of Search: 600/373, 600/374, 600/393, 600/509, 600/519, 607/4, 607/5, 607/7, 607/9, 607/11, 607/20, 607/30, 607/32, 607/119, 607/28, 128/903
• US Class Current: 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 1/3684 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

Abstract

An apparatus and method for verifying capture by a pacing pulse in which a test depolarization waveform recorded during a pacing event is compared with a template waveform representing capture by the pacing pulse. Capture verification in this manner may be used in pacemakers having multiple pacing channels for the atrial and/or ventricles where the multiple paces can interfere with conventional sensing of evoked responses in order to verify capture.

Claims

1. A system for determining capture thresholds for a multi-site cardiac pacemaker, comprising:

a pacemaker having;

(a) first and second pacing channels with each such channel comprising an electrode for disposing new a chamber of the heart, a pulse generator for outputting pacing pulses, and a channel interface for adjusting the pacing pulse energy, (b) a controller for controlling the operation of the pulse generators in accordance with a programmed pacing mode such that first and second pacing pulses are delivered from the first and second pacing channels, respectively, to one or both of the paired atria or to one or both of the paired ventricles during a cardiac cycle, and (c) a telemetry interface for communicating with an external programmer;

an external programmer having a controller for processing data received from the pacemaker, wherein the controller is programmed to;

generate a dual-channel capture template by recording a depolarization waveform produced when first and second pacing pulses are delivered from the first and second pacing channels at an energy sufficient to achieve capture by each of the first and second pacing pulses,

generate a first channel capture template by recording a depolarization waveform produced when first pacing pulses are delivered from the first pacing channel at an energy sufficient to achieve capture by the first pacing pulses with no pacing pulses delivered by the second pacing channel,

generate a second channel capture template by recording a depolarization waveform produced when second pacing pulses are delivered from the second pacing channel at an energy sufficient to achieve capture by the second pacing pulses with no pacing pulses delivered by the first pacing channel,

record a test depolarization waveform when pacing pulses are delivered from the first and second pacing channels,

compare the test depolarization waveform to the dual-channel capture template, the first channel capture template, and the second channel capture template,

determine that both the first and second pacing channels have achieved capture if the test depolarization waveform matches the dual-channel capture template;

determine that the first pacing channel has failed to achieve capture if the test depolarization waveform does not match the dual-channel capture template but matches the second channel capture template,

determine that the second pacing channel has failed to achieve capture if the test depolarization waveform does not match the dual-channel capture template but matches the first channel capture template, and

determine that neither the first nor the second pacing channel has achieved capture if the test depolarization waveform matches neither the dual-channel capture template, the first channel capture template, nor the second channel capture template.

2. The system of claim 1 further comprising an evoked response sensing channel in the pacemaker comprising an electrode and a sense amplifier for sensing an evoked response generated after a pacing pulse and wherein the test waveform is an electrogram from the evoked response sensing channel and transmitted to the external programmer.

3. The system of claim 1 wherein the test waveform is a surface electrocardiogram.

4. The system of claim 1 wherein the controller of the external programmer is programmed to compare the test and template waveforms by performing a time-domain cross-correlation.

5. The system of claim 1 wherein the external programmer 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 system of claim 5 wherein the external programmer 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 system of claim 6 wherein the external programmer 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 waveform no longer matches a template waveform representing capture by both of the first and second pacing pulses.

8. The system of claim 6 wherein the external programmer 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 waveform matches a template waveform representing capture by the second pacing pulse but not by the first pacing pulse; and

,

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

9. The system of claim 6 wherein the external programmer controller is programmed to:

lower the pacing energy of the first and second pacing channels simultaneously until the test waveform no longer matches a template waveform representing capture by both of the first and second pacing pulses;

compare the test waveform to a template waveform representing capture by a pacing pulse delivered only from the first pacing channel and to a template waveform representing capture by a pacing pulse delivered only from the second pacing channel to determine the capture threshold of the pacing channel or channels that failed to capture in the previous step; and

,

determine the capture threshold of a pacing channel that succeeded in capturing in the previous step by lowering the pacing energy of that channel until the test waveform no longer matches a template waveform representing capture by a pacing pulse delivered individually from that channel.

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

11. A method for determining capture thresholds for a multi-site cardiac pacemaker, comprising:

delivering first and second pacing pulses through first and second pacing channels, respectively, to either the atria or the ventricles during a cardiac cycle in accordance with a programmed pacing mode;

generating a dual-channel capture template by recording a depolarization waveform produced when first and second pacing pulses are delivered from the first and second pacing channels at an energy sufficient to achieve capture by each of the first and second pacing pulses,

generating a first channel capture template by recording a depolarization waveform produced when first pacing pulses are delivered from the first pacing channel at an energy sufficient to achieve capture by the first pacing pulses with no pacing pulses delivered by the second pacing channel,

generating a second channel capture template by recording a depolarization waveform produced when second pacing pulses are delivered from the second pacing channel at an energy sufficient to achieve capture by the second pacing pulses with no pacing pulses delivered by the first pacing channel,

recording a test depolarization waveform when pacing pulses are delivered from the first and second pacing channels,

comparing the test depolarization waveform to the dual-channel capture template, the first channel capture template, and the second channel capture template,

determining that both the first and second pacing channels have achieved capture if the test depolarization waveform matches the dual-channel capture template;

determining that the first pacing channel has failed to achieve capture if the test depolarization waveform does not match the dual-channel capture template but matches the second channel capture template,

determining that the second pacing channel has failed to achieve capture if the test depolarization waveform does not match the dual-channel capture template but matches the first channel capture template, and;

determining that neither the first nor the second pacing channel has achieved capture if the test depolarization waveform matches neither the dual-channel capture template, the first channel capture template, nor the second channel capture template.

12. The method of claim 11 wherein the comparison between the test and template waveforms is performed with a time-domain cross-correlation.

13. The method of claim 11 wherein the test waveform is a surface electrocardiogram.

14. The method of claim 11 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 further comprising lowering 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 waveform no longer matches a template waveform 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 waveform matches a template waveform representing capture by the second pacing pulse but not by the first pacing pulse; and

,

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

18. The method of claim 15 further comprising adjusting the pacing pulse energy of a pacing channel in accordance with the results of the capture threshold determination.

19. The method of claim 15 further comprising:

lowering the pacing energy of the first and second pacing channels simultaneously until the test waveform no longer matches a template waveform representing capture by both of the first and second pacing pulses;

comparing the test waveform to a template waveform representing capture by a pacing pulse delivered only from the first pacing channel and to a template waveform representing capture by a pacing pulse delivered only from the second pacing channel to determine the capture threshold of the pacing channel or channels that failed to capture in the previous step; and

,

determining the capture threshold of a pacing channel that succeeded in capturing in the previous step by lowering the pacing energy of that channel until the test waveform no longer matches a template waveform representing capture by a pacing pulse delivered individually from that channel.