Cardiac activation sequence monitoring for ischemia detection

• US 7,797,036 B2
• Filed: 03/14/2005
• Issued: 09/14/2010
• Est. Priority Date: 11/30/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hopper, Donald I., Meyer, Scott A., Stahmann, Jeffrey E., Zhang, Yi, McCabe, Aaron R., Yu, Yinghong, Ricci, Carlos Alberto, Brockway, Marina
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US11/079,744
• Publication Number:
  US 20060116593A1
• Time in Patent Office: 2,010 Days
• Field of Search: 600/509, 600/512, 600/515, 600/519, 600/521
• US Class Current: 600/512
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

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 to detect, monitor, track and/or trend ischemia using cardiac activation sequence information. Ischemia detection may involve sensing composite cardiac signals using implantable electrodes, and performing a signal separation that produces one or more cardiac activation signal vectors associated with one or more cardiac activation sequences. A change in the signal vector may be detected using subsequent separations. The change may be an elevation or depression of the ST segment of a cardiac cycle or other change indicative of myocardial ischemia, myocardial infarction, or other pathological change. The change may be used to predict, quantify, and/or qualify an event such as an arrhythmia, a myocardial infarction, or other pathologic change. Information associated with the vectors may be stored and used to track the vectors.

Claims

1. A method, comprising:

sensing a plurality of composite signals using a plurality of implantable electrodes over a plurality of cardiac cycles, each of the composite signals sensed within a window associated with a cardiac sequence feature that is opened for each cycle of the plurality of cardiac cycles, wherein the electrodes are distributed between a can and at least one lead, and the can and the lead are configured for implantation;

performing a source separation using the sensed plurality of composite signals, by which the sensed plurality of composite signals are separated according to their respective sources and one or more cardiac signal vectors are produced, each of the cardiac signal vectors representing angular orientation of a wavefront of the cardiac sequence feature of a respective cardiac cycle of the plurality of cardiac cycles;

determining a baseline angular orientation of the cardiac signal vectors for the plurality of cardiac cycles;

monitoring angular orientation of one or more additional cardiac signal vectors produced by source separation of subsequent composite signals sensed within one or more detection windows associated with the cardiac sequence feature, the subsequent composite signals sensed subsequent to the sensing of the plurality of composite signals; and

detecting a deviation in angular orientation of the one or more additional cardiac signal vectors from the baseline, wherein at least one of the steps of performing, determining, monitoring, and detecting is implemented at least in part by a circuit.

2. The method of claim 1, wherein the deviation is indicative of cardiac ischemia.

3. The method of claim 1, wherein the cardiac sequence feature is the ST segment of the cardiac cycles.

4. The method of claim 1, comprising predicting an arrhythmia or predicting an increased risk of arrhythmia using the detected deviation.

5. The method of claim 1, comprising predicting a myocardial infarction using the detected deviation.

6. The method of claim 1, wherein the cardiac sequence feature is the QRS complex of the cardiac cycles.

7. The method of claim 1, wherein the cardiac sequence feature is the P wave of the cardiac cycles.

8. The method of claim 1, wherein detecting the deviation comprises detecting a trend associated with the selected one or more vectors.

9. The method of claim 1, comprising transmitting information associated with the detected deviation to a patient-external device.

10. The method of claim 1, comprising confirming that the one or more vectors produced by the source separation comprises cardiac signal content.

11. The method of claim 1, comprising confirming that the one or more vectors produced by the source separation comprises cardiac signal content by repeating performance of the source separation to search for one or more additional vectors comprising the cardiac signal content until a predetermined termination criterion is reached.

12. The method of claim 1, comprising confirming that the one or more vectors produced by the source separation comprises cardiac signal content by performing an Independent Component Analysis to confirm that the one or more vectors produced by the source separation comprises cardiac signal content.

13. A system, comprising:

a plurality of implantable electrodes configured for sensing a plurality of composite signals, thereby providing a plurality of composite signals;

a housing configured for implantation in a patient;

a memory provided in the housing; and

a controller provided in the housing and coupled to the memory and the plurality of implantable electrodes, the controller configured to;

open a window associated with a cardiac sequence feature in which is sensed the plurality of composite signals for each of a plurality of cardiac cycles;

perform a source separation using the sensed plurality of composite signals by which the plurality of composite signals are separated according to their respective sources to produce cardiac signal vectors representing angular orientation of wavefronts of the cardiac sequence feature over the plurality of cardiac cycles;

determine a baseline angular orientation of the cardiac signal vectors for the plurality of cardiac cycles;

monitor angular orientation of one or more additional cardiac signal vectors produced by source separation of subsequent composite signals sensed within one or more detection windows associated with the cardiac sequence feature, the subsequent composite signals sensed subsequent to the sensing of the plurality of composite signals; and

detect a deviation in angular orientation of the one or more cardiac signal vectors from the baseline as an indication of ischemia.

14. The system of claim 13, wherein the controller predicts one or both of myocardial infarction and cardiac arrhythmia based on the detected deviation.

15. The system of claim 13, wherein the cardiac sequence feature is the QRS complex of the cardiac cycles.

16. The system of claim 13, wherein the cardiac sequence feature is the ST segment of the cardiac cycles.

17. The system of claim 13, comprising a signal processor provided in a patient-external device or system, the signal processor and the controller coupled to respective communication devices to facilitate wireless communication between the signal processor and controller.

18. The system of claim 13, comprising a signal processor provided in a network server system, the signal processor and the controller coupled to respective communication devices to facilitate wireless communication between the signal processor and controller.

19. The system of claim 13, further comprising a lead configured for subcutaneous non-intrathoracic placement in a patient and coupled to the controller, wherein at least one of the plurality of implantable electrodes is supported by the lead.

24. The system of claim 13, wherein the controller is configured to confirm that the one or more vectors produced by the source separation comprises the cardiac signal content.

25. The system of claim 13, wherein the controller is configured to confirm that the one or more vectors produced by the source separation comprises cardiac signal content by repeating performance of the source separation to search for one or more additional vectors comprising cardiac signal content until a predetermined termination criterion is reached.

26. The system of claim 13, wherein the controller is configured to confirm that the one or more vectors produced by the source separation comprises cardiac signal content by performing an Independent Component Analysis to confirm that the one or more additional vectors produced by the source separation comprises cardiac signal content.

20. An implantable cardiac device, comprising:

means for implantably sensing a plurality of composite signals over a plurality of cardiac cycles, each of the composite signals sensed within a window associated with a cardiac sequence feature that is opened for each cycle of the plurality of cardiac cycles;

means for performing a source separation using the sensed plurality of composite signals by which the sensed plurality of composite signals are separated according to their respective sources, the source separation producing one or more cardiac signal vectors, each of the cardiac signal vectors representing angular orientation of a wavefront of the cardiac sequence feature of a respective cardiac cycle of the plurality of cardiac cycles;

means for determining a baseline angular orientation of the cardiac signal vectors for the plurality of cardiac cycles;

means for monitoring angular orientation of one or more additional cardiac signal vectors produced by source separation of subsequent composite signals sensed within one or more detection windows associated with the cardiac sequence feature, the subsequent composite signals sensed subsequent to the sensing of the plurality of composite signals; and

means for detecting ischemia based on a deviation in angular orientation of the one or more additional cardiac signal vectors from the baseline.

21. The device of claim 20, wherein the cardiac signal feature is the ST segment of the cardiac cycles.

22. The device of claim 20, further comprising means for predicting one or both of myocardial infarction and cardiac arrhythmia based on the deviation.

23. The device of claim 20, further comprising means for communicating information associated with one or both of the one or more cardiac signal vectors and the one or more cardiac activation sequences to a patient-external device.

27. A method, comprising:

sensing a plurality of composite signals using a plurality of implantable electrodes over a plurality of cardiac cycles, each of the composite signals sensed within a window associated with a cardiac sequence feature that is opened for each cycle of the plurality of cardiac cycles;

performing a source separation using the sensed plurality of composite signals, by which the sensed plurality of composite signals are separated according to their respective sources to produce one or more cardiac signal vectors, each of the cardiac signal vectors representing angular orientation of a wavefront of the cardiac sequence feature of a respective cardiac cycle of the plurality of cardiac cycles;

determining a baseline angular orientation of the cardiac signal vectors for the plurality of cardiac cycles;

monitoring angular orientation of one or more additional cardiac signal vectors produced by source separation of subsequent composite signals sensed within one or more detection windows associated with the cardiac sequence feature, the subsequent composite signals sensed subsequent to the sensing of the plurality of composite signals; and

detecting a change in angular orientation of the one or more additional cardiac signal vectors relative to the baseline, wherein at least one of the steps of performing, determining, monitoring, and detecting is implemented at least in part by a circuit.

28. The method of claim 27, wherein the change is indicative of cardiac ischemia.

29. The method of claim 27, wherein the cardiac sequence feature comprises an ST segment and the detected change comprises an elevation or depression of the ST segment.