Automatic capture verification using electrocardiograms sensed from multiple implanted electrodes

• US 8,116,871 B2
• Filed: 03/23/2009
• Issued: 02/14/2012
• Est. Priority Date: 05/09/2005
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Zhang, Yi, Ding, Jiang, McCabe, Aaron, Meyer, Scott A.
• Primary Examiner(s): Layno, Carl H.
• Assistant Examiner(s): Heller, Tammie K.
• Application Number:
  US12/409,348
• Publication Number:
  US 20090198301A1
• Time in Patent Office: 1,058 Days
• Field of Search: 607/11, 607/28, 600/512
• US Class Current: 607/28
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

Cardiac monitoring and/or stimulation methods and systems that provide one or more of monitoring, diagnosing, defibrillation, and pacing. Cardiac signal separation is employed for automatic capture verification using cardiac activation sequence information. Devices and methods sense composite cardiac signals using implantable electrodes. A source separation is performed using the composite signals. One or more signal vectors are produced that are associated with all or a portion of one or more cardiac activation sequences based on the source separation. A cardiac response to the pacing pulses is classified using characteristics associated with cardiac signal vectors and the signals associated with the vectors. Further embodiments may involve classifying the cardiac response as capture or non-capture, fusion or intrinsic cardiac activity. The characteristics may include an angle or an angle change of the cardiac signal vectors, such as a predetermined range of angles of the one or more cardiac signal vectors.

Claims

1. A method of classifying a cardiac response to a pacing pulse, comprising:

delivering, from within a patient, a cardiac pacing pulse;

sensing one or more composite cardiac signals following delivery of the cardiac pacing pulse using at least three spatially distributed implantable electrodes;

performing source separation using the sensed one or more composite cardiac signals, the source separation algorithmically separating one or more components of the sensed composite cardiac signals according to correlation between components of cardiac origin;

producing one or more cardiac signal vectors representative of all or a portion of one or more cardiac activation sequences based on the separated one or more components of the sensed composite cardiac signals;

comparing an orientation of the one or more cardiac signal vectors with predetermined vector orientation criteria comprising at least a capture vector orientation criterion and a fusion vector orientation criterion; and

classifying the cardiac response to the pacing pulse as one of capture and fusion based on the comparison.

2. The method of claim 1, wherein each of the capture and fusion vector orientation criteria comprises a predefined range of vector orientation based at least in part on patient population data.

3. The method of claim 1, wherein each of the capture and fusion vector orientation criteria comprises a predefined range of vector orientation based at least in part on a patient'"'"'s baseline data.

4. The method of claim 1, wherein the capture vector orientation criteria comprises a criterion for bi-ventricular capture vector orientation.

5. The method of claim 1, wherein the capture vector orientation criteria comprises a criterion for bi-ventricular capture vector orientation and one or both of a criterion for left ventricular vector orientation and a criterion for right ventricular vector orientation.

6. The method of claim 1, wherein:

the predetermined vector orientation criteria comprises an intrinsic vector orientation criterion;

comparing the orientation comprises comparing the orientation of the one or more cardiac signal vectors with at least the capture vector orientation criterion, the fusion vector orientation criterion, and the intrinsic vector orientation criterion; and

classifying the cardiac response to the pacing pulse comprises classifying the cardiac response as one of capture, fusion, and intrinsic based on the comparison.

7. The method of claim 6, wherein:

the predetermined vector orientation criteria comprises a non-capture vector orientation criterion;

comparing the orientation comprises comparing the orientation of the one or more cardiac signal vectors with at least the capture vector orientation criterion, the fusion vector orientation criterion, the intrinsic vector orientation criterion, and the non-capture vector orientation criterion; and

classifying the cardiac response to the pacing pulse comprises classifying the cardiac response as one of capture, fusion, intrinsic, and non-capture based on the comparison.

8. The method of claim 7, wherein:

the predetermined vector orientation criteria comprises a pseudofusion vector orientation criterion;

comparing the orientation comprises comparing the orientation of the one or more cardiac signal vectors with at least the capture vector orientation criterion, the fusion vector orientation criterion, the intrinsic vector orientation criterion, the non-capture vector orientation criterion, and the pseudofusion vector orientation criterion; and

classifying the cardiac response to the pacing pulse comprises classifying the cardiac response as one of capture, fusion, intrinsic, non-capture, and pseudofusion based on the comparison.

9. A method of classifying a cardiac response to a pacing pulse, comprising:

delivering, from within a patient, a cardiac pacing pulse;

sensing one or more composite cardiac signals following delivery of the cardiac pacing pulse using at least three spatially distributed implantable electrodes;

performing source separation using the sensed one or more composite cardiac signals, the source separation algorithmically separating one or more components of the sensed composite cardiac signals according to correlation between components of cardiac origin;

producing one or more cardiac signal vectors representative of all or a portion of one or more cardiac activation sequences based on the separated one or more components of the sensed composite cardiac signal;

comparing an orientation of the one or more cardiac signal vectors with predetermined vector orientation criteria comprising at least a criterion for bi-ventricular capture vector orientation and a criterion for single ventricular chamber capture vector orientation; and

classifying a cardiac response to the pacing pulse as one of bi-ventricular capture and single ventricular chamber capture based on the comparison.

10. The method of claim 9, wherein each of the bi-ventricular and single ventricular chamber capture vector orientation criteria comprises a predefined range of vector orientation based at least in part on patient population data.

11. The method of claim 9, wherein each of the bi-ventricular and single ventricular chamber capture vector orientation criteria comprises a predefined range of vector orientation based at least in part on a patient'"'"'s baseline data.

12. The method of claim 9, wherein the predetermined vector orientation criteria comprises the criterion for bi-ventricular capture vector orientation and a criterion for left ventricular vector orientation.

13. The method of claim 9, wherein the predetermined vector orientation criteria comprises the criterion for bi-ventricular capture vector orientation, a criterion for left ventricular vector orientation, and a criterion for right ventricular vector orientation.

14. The method of claim 13, wherein classifying the cardiac response comprises discriminating between left ventricular non-capture and right ventricular non-capture in response to delivery of bi-ventricular pacing pulses.

15. The method of claim 9, comprising implementing the method during beat-to-beat or periodic capture verification.

16. An implantable cardiac electrical stimulation system, comprising:

a pulse generator configured to generate pacing pulses;

at least three implantable electrodes coupled to the pulse generator;

sensing circuitry coupled to the at least three electrodes and configured for sensing cardiac electrical activity following delivery of a pacing pulse by the pulse generator, thereby providing one or more composite cardiac signals;

a control system coupled to the pulse generator and the sensing circuitry, the control system comprising a signal processor; and

the signal processor configured to execute stored program instructions to cause the system to;

perform source separation using the one or more composite cardiac signals, the source separation performed by the signal processor algorithmically separating one or more components of the composite cardiac signals according to correlation between components of cardiac origin;

produce one or more cardiac signal vectors representative of all or a portion of one or more cardiac activation sequences based on the separated one or more components of the composite cardiac signals;

compare an orientation of the one or more cardiac signal vectors with predetermined vector orientation criteria comprising at least a capture vector orientation criterion and a fusion vector orientation criterion; and

classify the cardiac response to the pacing pulse as one of capture and fusion based on the comparison.

17. The system of claim 16, wherein the capture vector orientation criteria comprises a criterion for bi-ventricular capture vector orientation.

18. The system of claim 16, wherein the capture vector orientation criteria comprises a criterion for bi-ventricular capture vector orientation and one or both of a criterion for left ventricular vector orientation and a criterion for right ventricular vector orientation.

19. The system of claim 16, wherein the predetermined vector orientation criteria comprises an intrinsic vector orientation criterion, and the signal processor is configured to execute stored program instructions to cause the system to:

compare the orientation of the one or more cardiac signal vectors with at least the capture vector orientation criterion, the fusion vector orientation criterion, and the intrinsic vector orientation criterion; and

classify the cardiac response to the pacing pulse as one of capture, fusion, and intrinsic based on the comparison.

20. The system of claim 19, wherein the predetermined vector orientation criteria comprises a non-capture vector orientation criterion, and the signal processor is configured to execute stored program instructions to cause the system to:

compare the orientation of the one or more cardiac signal vectors with at least the capture vector orientation criterion, the fusion vector orientation criterion, the intrinsic vector orientation criterion, and the non-capture vector orientation criterion; and

classify the cardiac response to the pacing pulse as one of capture, fusion, intrinsic, and non-capture based on the comparison.

21. The system of claim 20, wherein the predetermined vector orientation criteria comprises a pseudofusion vector orientation criterion, and the signal processor is configured to execute stored program instructions to cause the system to:

compare the orientation of the one or more cardiac signal vectors with at least the capture vector orientation criterion, the fusion vector orientation criterion, the intrinsic vector orientation criterion, the non-capture vector orientation criterion, and the pseudofusion vector orientation criterion; and

classify the cardiac response to the pacing pulse as one of capture, fusion, intrinsic, non-capture, and pseudofusion based on the comparison.

22. An implantable cardiac electrical stimulation system, comprising:

a pulse generator configured to generate pacing pulses;

at least three implantable electrodes coupled to the pulse generator;

sensing circuitry coupled to the at least three electrodes and configured for sensing cardiac electrical activity following delivery of a pacing pulse by the pulse generator, thereby providing one or more composite cardiac signals;

a control system coupled to the pulse generator and the sensing circuitry, the control system comprising a signal processor; and

the signal processor configured to execute stored program instructions to cause the system to;

perform source separation using the one or more composite cardiac signals, the source separation performed by the signal processor algorithmically separating one or more components of the composite cardiac signals according to correlation between components of cardiac origin;

produce one or more cardiac signal vectors representative of all or a portion of one or more cardiac activation sequences based on the separated one or more components of the composite cardiac signals;

compare an orientation of the one or more cardiac signal vectors with predetermined vector orientation criteria comprising at least a criterion for bi-ventricular capture vector orientation and a criterion for single ventricular chamber capture vector orientation; and

classify a cardiac response to the pacing pulse as one of bi-ventricular capture and single ventricular chamber capture based on the comparison.

23. The system of claim 22, wherein each of the bi-ventricular and single ventricular chamber capture vector orientation criteria comprises a predefined range of vector orientation based at least in part on patient population data or a patient'"'"'s baseline data.

24. The system of claim 22, wherein:

the predetermined vector orientation criteria comprises the criterion for bi-ventricular capture vector orientation and a criterion for left ventricular capture vector orientation; and

the signal processor is configured to execute stored program instructions to cause the system to;

compare the orientation of the one or more cardiac signal vectors with the criterion for bi-ventricular capture vector orientation and the criterion for left ventricular capture vector orientation; and

classify the cardiac response as one of bi-ventricular capture and left ventricular capture based on the comparison.

25. The system of claim 22, wherein:

the predetermined vector orientation criteria comprises the criterion for bi-ventricular capture vector orientation, a criterion for left ventricular capture vector orientation, and a criterion for right ventricular capture vector orientation; and

the signal processor is configured to execute stored program instructions to cause the system to;

compare the orientation of the one or more cardiac signal vectors with the criterion for bi-ventricular capture vector orientation, the criterion for left ventricular capture vector orientation, and the criterion for right ventricular capture vector orientation; and

classify the cardiac response as one of bi-ventricular capture, left ventricular capture, and right ventricular capture based on the comparison.

26. The system of claim 22, wherein:

the predetermined vector orientation criteria comprises the criterion for bi-ventricular capture vector orientation, a criterion for left ventricular capture vector orientation, and a criterion for right ventricular capture vector orientation; and

the signal processor is configured to execute stored program instructions to cause the system to;

compare the orientation of the one or more cardiac signal vectors with the criterion for bi-ventricular capture vector orientation, the criterion for left ventricular capture vector orientation, and the criterion for right ventricular capture vector orientation; and

discriminate between left ventricular non-capture and right ventricular non-capture in response to delivery of bi-ventricular pacing pulses by the pulse Generator.