System and method for complexity analysis-based cardiac tachyarrhythmia detection

• US 6,490,478 B1
• Filed: 09/25/2000
• Issued: 12/03/2002
• Est. Priority Date: 09/25/2000
• Status: Expired due to Term

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Inventors: Lin, Dongping, Zhang, Xu-Sheng
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/669,020
• Time in Patent Office: 799 Days
• Field of Search: 607/4, 607/5, 607/14, 600/515, 600/518, 600/517
• US Class Current: 600/518
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A system and method based on electrocardiogram (ECG) complexity analysis for real-time detecting shockable ventricular fibrillation (VF) and ventricular tachycardia (VT), and discriminating them from non-shockable tachyarrhythmia (e.g. supraventricular tachycardia (SVT) and atrial fibrillation (AF)) and high-frequency noise. In the disclosed invention, complexity measure CM (0 to 100), quantitatively characterizing the complexity nature of the non-linear dynamics underlying cardiac arrhythmia, is extracted from the sensed patient ECG signal using ECG complexity analysis. From the calculated complexity measure, by three thresholds (low complexity threshold (LCT), mediate complexity threshold (MCT), and high complexity threshold (HCT)), different kinds of tachyarrhythmia (i.e. heart rate (HR) above a preset rate threshold) and high-frequency noise are discriminated from each other: for non-shockable tachyarrhythmia, CM≦LCT; for VT, LCT<CM≦MCT; for VF, MCT<CM≦HCT; and for high-frequency noise, HCT<CM. The disclosed system and method can be used as a primary cardiac tachyarrhythmia detection scheme or as a backup system to reconfirm arrhythmia detection using conventional techniques.

Claims

1. A system for detecting cardiac arrhythmia comprising:

a sensor that senses an intrinsic signal indicative of cardiac activity;

a signal processor receiving said intrinsic signal and transforming said intrinsic signal into a sequence S indicative of non-linear characteristics of said cardiac activity;

a calculator arranged to operate on said signal S to determine a complexity measure CM indicative of the complexity of a dynamic behavior of said cardiac activity; and

a complexity analyzer that analyzes said complexity measure CM to derive a current condition of the heart and generates a corresponding output, wherein said complexity analyzer includes a first comparator that compares said complexity measure CM to a first threshold TDR to detect a non-shockable rhythm and a second comparator that compares said complexity measure CM to a second threshold HCT to detect a high frequency noise;

said complexity analyzer being adapted to distinguish between cardiac classifications of the heart including a nonshockable rhythm, ventricular tachycardia and ventricular fibrillation.

2. The system of claim 1 wherein said signal processor includes a comparator that compares magnitudes of said intrinsic signal to a threshold Td and generates said sequence S based on said comparison.

3. The system of claim 2 further comprising a pattern recognition element arranged to receive said sequence S and to recognize repetitive sub-sequences in said sequence S.

4. The system of claim 3 wherein said calculator further comprises a counter arranged to count said sub-sequences, wherein each counted sub-sequence is unique in that said sub-sequence does not contain any of the previous sub-sequences, said counter generating a count that is used by said calculator in determining said complexity measure CM.

5. The system of claim 4 wherein said calculator further includes a normalizer adapted to normalize said count to be used by said calculator in generating said complexity measure CM.

7. The system of claim 1 wherein said sensor is arranged to sense a plurality of ECG signals over a predetermined time period, said ECG signals including a plurality of peaks.

8. The system of claim 7 further comprising a buffer that stores a magnitude of said peaks and a threshold calculator adapted to determine a threshold Td based on said magnitudes.

9. The system of claim 8 wherein said buffer stores peak magnitudes of positive and negative peaks, and further comprising a second buffer adapted to store a mean value related to said peaks, and a threshold Td being related to said mean value.

10. The system of claim 1 further comprising a third comparator that compares said complexity measure CM to a third threshold LCT to detect a non-shockable tachycardia.

11. The system of claim 10 further comprising a fourth comparator that compares said complexity measure CM to a fourth threshold MCT to differentiate between ventricular tachycardia and ventricular fibrillation.

12. The system of claim 1 wherein said complexity analyzer determines a patient'"'"'s heart condition by determining whether said complexity measure is within a predetermined range.

13. The system of claim 1 further comprising a heart rate detector coupled to said sensor and arranged to detect a heart rate HR for the patient based on said intrinsic signal.

14. The system of claim 3 further comprising a timer and wherein said heart rate detector detects a current heart rate of the patient based on time-dependent measurements determined by said timer.

15. The system of claim 1 wherein the cardiac activity exhibits non-linear dynamic behavior and wherein said wherein said calculator is adapted to generate said complexity measure CM as a parameter indicative of said non-linear dynamic behaviour.

16. A cardiac device incorporating the system of claim 1 and adapted to provide one of an indication of a patient'"'"'s cardiac condition and antiarrhythmia therapy based on said complexity measure.

17. The cardiac device of claim 16 wherein said device includes therapy means to provide antitachycardia therapy based on said output.

18. The cardiac device of claim 16 wherein said device includes therapy means arranged to provide defibrillation therapy based on said output.

19. The cardiac device of claim 16 wherein said device includes therapy means arranged to provide cardioversion therapy based on said output.

20. The cardiac device of claim 16 wherein said device includes means to provide antibradicardia therapy based on said output.

21. The cardiac device of claim 16 wherein said device includes an implantable housing and wherein said system is disposed in said implantable housing.

22. The cardiac device of claim 16 wherein said device includes an external device and wherein said system is disposed within said external device.

23. A device incorporating the system of claim 1 further comprising an indicating means adapted to provide an indication of a patient'"'"'s condition based on said complexity measure CM.

6. The system of 5 claim wherein said normalizer is adapted to normalize said count to limit said complexity measure to a predetermined range.

24. A device for applying antitachyarrhythmic therapy to a patient'"'"'s heart comprising:

a sensor that senses an intrinsic signal indicative of cardiac activity of the patient, said cardiac activity exhibiting a non-linear dynamic behavior;

a complexity calculator adapted to determine a complexity measure indicative of the complexity of said intrinsic signal;

a complexity analyzer adapted to analyze the condition of the heart by determining if said complexity measure CM is characteristic of treatable and non-shockable tachyarrhythmia, wherein said complexity analyzer includes a first comparator that compares said complexity measure CM to a first threshold TDR to detect a non-shockable tachyarrhythmia and a second comparator that compares said complexity measure CM to a second threshold HCT to detect a high frequency noise;

a conventional cardiac detector adapted to generate a cardiac signal using conventional techniques; and

a controller adapted to receive said CM and said cardiac signal and to generate commands defining cardiac therapy based on both said CM and said cardiac signal if said CM is in a range characteristic of treatable tachyarrhythmia.

25. The device of claim 24 wherein said controller is adapted to generate defibrillation commands defining defibrillation shocks, said defibrillation commands being generated only if said CM parameter is indicative of a VF condition in the patient'"'"'s heart.

26. The system of claim 24 further comprising a third comparator that compares said complexity measure CM to a third threshold LCT to detect a non-shockable tachycardia.

27. The system of claim 26 further comprising a fourth comparator that compares said complexity measure CM to a fourth threshold MCT to differentiate between ventricular tachycardia and ventricular fibrillation.

28. The system of claim 24 further comprising a heart rate detector coupled to said sensor and arranged to detect a heart rate HR for the patient based on said intrinsic signal.

29. The system of claim 28 further comprising a timer and wherein said detector detects a current heart rate of the patient based on time-dependent measurements by said timer of said intrinsic signal.

30. The system of claim 24 wherein the cardiac activity exhibits non-linear dynamic behavior and wherein said wherein said calculator is adapted to generate said complexity measure CM as a parameter indicative of said non-linear dynamic behaviour.

31. The system of claim 24 further comprising a transforming element adapted to transform said intrinsic signal into a signal S indicative of non-linear dynamic characteristics of the heart, wherein said complexity analyzer derives said complexity measure from said signal S.