Multi-parameter arrhythmia discrimination

• US 7,218,966 B2
• Filed: 03/19/2004
• Issued: 05/15/2007
• Est. Priority Date: 04/11/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Haefner, Paul
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US10/804,471
• Publication Number:
  US 20040230129A1
• Time in Patent Office: 1,152 Days
• Field of Search: None
• US Class Current: 607/17
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 : Pacing therapy

Abstract

An arrhythmia discrimination device and method involves receiving electrocardiogram signals and non-electrophysiologic signals at subcutaneous locations. Both the electrocardiogram-signals and non-electrophysiologic signals are used to discriminate between normal sinus rhythm and an arrhythmia. An arrhythmia may be detected using electrocardiogram signals, and verified using the non-electrophysiologic signals. A detection window may be initiated in response to receiving the electrocardiogram signal, and used to determine whether the non-electrophysiologic signal is received at a time falling within the detection window. Heart rates may be computed based on both the electrocardiogram signals and non-electrophysiologic signals. The rates may be used to discriminate between normal sinus rhythm and arrhythmia, and used to determining absence of an arrhythmia.

Claims

1. An arrhythmia discrimination method, comprising:

sensing electrocardiogram signals at a subcutaneous non-intrathoracic location;

receiving signals associated with a non-electrophysiological cardiac source, the received signals comprising at least one of heart sound signals, pulse oximetry signals, impedance signals indicative of cardiac activity, acoustic emission information, blood-flow information, and heart rate information;

verifying that the electrocardiogram signals comprise a cardiac signal using the non-electrophysiological signal;

discriminating, using the electrocardiogram signals and non-electrophysiologic signals, between a normal sinus rhythm and a cardiac arrhythmia; and

withholding delivery of subcutaneous non-intrathoracic cardiac stimulation therapy if the sensed electrocardiogram signals do not comprise the cardiac signal.

2. The method of claim 1, wherein discriminating between normal sinus rhythm and the arrhythmia comprises:

detecting the arrhythmia using the electrocardiogram signals; and

verifying presence of the arrhythmia using the non-electrophysiologic signals.

3. The method of claim 1, wherein discriminating between normal sinus rhythm and the arrhythmia comprises:

detecting the arrhythmia using the electrocardiogram signals;

determining temporal relationships between the electrocardiogram signals and non-electrophysiologic signals received while detecting the arrhythmia; and

verifying presence of the arrhythmia based on the temporal relationships between the electrocardiogram signals and non-electrophysiologic signals.

4. The method of claim 1, wherein discriminating between normal sinus rhythm and the arrhythmia comprises:

initiating a detection window in response to receiving each electrocardiogram signal of a succession of the electrocardiogram signals; and

determining whether each non-electrophysiologic signal of a succession of the non-electrophysiologic signals is received at a time falling within the detection window.

5. The method of claim 1, wherein discriminating between normal sinus rhythm and the arrhythmia comprises:

computing a first rate based on successive electrocardiogram signals;

computing a second rate based on successive non-electrophysiologic signals; and

discriminating between normal sinus rhythm and the arrhythmia using the first and second rates.

6. The method of claim 1, wherein discriminating between normal sinus rhythm and the arrhythmia comprises:

computing a first rate based on successive electrocardiogram signals;

computing a second rate based on successive non-electrophysiologic signals;

comparing the first rate with a first arrhythmia threshold;

comparing the second rate with a second arrhythmia threshold; and

determining presence of the arrhythmia in response to both the first and second rates exceeding the first and second arrhythmia thresholds, respectively.

7. The method of claim 1, wherein discriminating between normal sinus rhythm and the arrhythmia comprises:

computing a first rate based on successive electrocardiogram signals;

computing a second rate based on successive non-electrophysiologic signals;

comparing the first rate with a first arrhythmia threshold;

comparing the second rate with a second arrhythmia threshold; and

determining absence of the arrhythmia in response to the first rate exceeding the first arrhythmia threshold and the second rate failing to exceed the second arrhythmia threshold.

8. The method of claim 1, wherein discriminating between normal sinus rhythm and the arrhythmia comprises:

determining presence of the arrhythmia using a morphology of the electrocardiogram signals; and

verifying presence of the arrhythmia using the non-electrophysiologic signals.

9. The method of claim 1, wherein the non-electrophysiologic signals comprise subsonic acoustic signals indicative of cardiac activity.

10. The method of claim 1, wherein the non-electrophysiologic signals comprise pulse pressure signals.

11. The method of claim 1, further comprising declaring an arrhythmic episode in response to detecting the arrhythmia using the electrocardiogram signals and detecting the arrhythmia using the non-electrophysiologic signals.

12. The method of claim 1, further comprising enabling defibrillation therapy delivery in response to detecting the arrhythmia using the electrocardiogram signals and detecting the arrhythmia using the non-electrophysiologic signals.

13. The method of claim 1, further comprising inhibiting defibrillation therapy delivery in response to detecting the arrhythmia using the electrocardiogram signals but not detecting the arrhythmia using the non-electrophysiologic signals.

14. An arrhythmia discrimination method, comprising:

sensing an electrocardiogram signal at a subcutaneous non-intrathoracic location;

receiving a signal associated with a non-electrophysiological cardiac source;

verifying that the sensed electrocardiogram signal comprises a cardiac signal using the non-electrophysiological cardiac signal;

detecting a cardiac arrhythmia using one of the sensed electrocardiogram signal and the verified cardiac signal;

confirming the detection of the cardiac arrhythmia by performing a correlation between the electrocardiogram signal and the non-electrophysiological cardiac signal; and

withholding treatment of the cardiac arrhythmia if the sensed electrocardiogram signal does not comprise the cardiac signal.

15. The method of claim 14, further comprising:

defining a detection window with a start time associated with an inflection point of the electrocardiogram signal; and

evaluating the received non-electrophysiological cardiac signal within the detection window.

16. The method of claim 15, wherein the start time of the detection window is associated with a maxima or a minima of the electrocardiogram signal.

17. The method of claim 14, further comprising:

computing a first heart-rate based on intervals between successive electrocardiogram signals; and

computing a second heart-rate based on intervals between successive non-electrophysiological cardiac signals;

wherein confirming the detection of the cardiac arrhythmia comprises comparing the first heart-rate to the second heart-rate.

18. The method of claim 14, wherein the non-electrophysiological cardiac signal comprises acoustic emission information.

19. The method of claim 18, wherein the acoustic emission information comprises a temporal location of a peak heart-sound.

20. The method of claim 14, wherein the non-electrophysiological cardiac signal comprises cardiac acceleration information.

21. The method of claim 14, wherein the non-electrophysiological cardiac signal comprises pulse pressure information.

22. The method of claim 14, wherein the non-electrophysiological cardiac signal comprises blood-flow information.

23. The method of claim 14, wherein the non-electrophysiological cardiac signal comprises heart rate information.

24. The method of claim 14, wherein the non-electrophysiological cardiac signal comprises pulse oximetry information.

25. The method of claim 14, wherein detecting the cardiac arrhythmia comprises performing a rate based analysis of the electrocardiogram signal.

26. The method of claim 14, wherein detecting the cardiac arrhythmia comprises performing a morphology based analysis of the electrocardiogram signal.

27. The method of claim 14, further comprising delivering a cardiac therapy to treat the cardiac arrhythmia.

28. An implantable cardiac device, comprising:

an implantable housing;

an electrode arrangement configured for subcutaneous non-intrathoracic placement;

detection circuitry provided in the housing and coupled to the electrode arrangement, the detection circuitry configured to detect electrocardiogram signals;

a sensor configured to sense signals associated with a non-electrophysiological cardiac source, the sensor comprising at least one of a microphone, acoustic transducer, blood-flow transducer, pulse oximeter, and photoplethysmography circuitry;

energy delivery circuitry coupled to the electrode arrangement; and

a processor provided in the housing and coupled to the detection circuitry, sensor, and energy delivery circuitry, the processor using the non-electrophysiological signals to verify that the detected electrocardiogram signals comprise a cardiac signal, the processor withholding energy delivery if the detected electrocardiogram signals do not comprise the cardiac signal.

29. The device of claim 28, wherein the energy delivery circuitry comprises defibrillation therapy circuitry.

30. The device of claim 28, wherein the energy delivery circuitry comprises pacing therapy circuitry.

31. The device of claim 28, wherein the sensor is provided in or on the housing.

32. The device of claim 28, wherein the sensor is provided in or on a lead coupled to the housing.

33. The device of claim 28, wherein the sensor comprises an accelerometer.