Implantable medical device responsive to heart rate variability analysis

• US 6,571,121 B2
• Filed: 10/15/2001
• Issued: 05/27/2003
• Est. Priority Date: 12/11/1995
• Status: Expired due to Fees

• Current Assignee: Intermedics Incorporated
• Original Assignee: Intermedics Incorporated
• Inventors: Schroeppel, Edward A., Prutchi, David, Routh, André G.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/978,848
• Publication Number:
  US 20020072683A1
• Time in Patent Office: 589 Days
• Field of Search: 600/515, 600/516, 600/518, 607/4, 607/5, 607/6, 607/17, 607/25
• US Class Current: 600/515
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• 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 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A method and apparatus for evaluating heart rate variability of the heart of a person in order to forecast a cardiac event. A cardiac stimulator receives heart beat signals from the heart and determines a measurement of heart rate variability based on statistical data derived from the heart beat signals and sensing data derived from a sensor. This measurement of heart rate variability is compared with previously stored heart rate variability zones defining normal and abnormal heart rate variability. These zones are modifiable after the occurrence of a cardiac event. Once a cardiac event is detected, a pathway is computed which extends from a generally normal heart rate variability condition to an abnormal heart rate variability condition. Subsequent measurements of heart rate variability are compared with this pathway. Selective therapy regimes are initiated depending on the measurement of heart rate variability.

Claims

1. A method, comprising:

receiving heart beat signal;

analyzing the heart beat signals for an abnormal cardiac rhythm;

detecting the abnormal cardiac rhythm from the heart beat signals;

determining a variability in the heart beat signals that preceded the abnormal cardiac rhythm; and

classifying the variability in the heart beat signals that preceded the abnormal cardiac rhythm to a heart rate variability zone.

2. The method of claim 1, including establishing heart rate variability zones that define normal and abnormal cardiac sinus rhythm.

3. The method of claim 2, including classifying the variability in the heart beat signals to a heart rate variability zone that defines an abnormal cardiac sinus rhythm, and initiating a therapy regimen based on the classification of the variability in the heart beat signals.

4. The method of claim 2, including comparing the variability of received heart beat signals to the heart rate variability zones, and predicting an occurrence of an abnormal cardiac sinus rhythm based on the comparison.

5. The method of claim 2, including modifying one or more of the heart rate variability zones after the occurrence or non-occurrence of an abnormal cardiac rhythm.

6. The method of claim 1, wherein determining the variability in the heart beat signals includes computing time intervals occurring between successive heart beats and deriving a measurement of the variability from the computed time intervals.

7. The method of claim 6, including recording time intervals during a predetermined length of time.

8. The method of claim 1, including initiating a therapy regime when the measurement of heart rate variability is within the limits of the abnormal heart rate variability zone.

9. The method of claim 1, where classifying includes dividing the abnormal heart rate variability zone into a plurality of abnormal subzones, classifying the variability in the heart beat signals that preceded the abnormal cardiac rhythm to one of the plurality of abnormal subzones, and initiating a therapy regimen based on the classification of the variability in the heart beat signals.

10. A method implemented by a processor of an implantable medical device, the method comprising:

receiving heart beat signals for a first period;

determining a first period heart rate variability for the first period;

receiving heart beat signals for a second period subsequent to the first period;

detecting an abnormal heart beat signal within the second period;

determining a second period heart rate variability during the second period; and

classifying the second period heart rate variability.

11. The method of claim 10, wherein receiving heart beat signals includes receiving sensor data.

12. The method of claim 10, wherein receiving heart beat signals includes receiving statistical data.

13. The method of claim 10, wherein determining a first period heart rate variability includes determining a mean time between successive atrial depolarizations as measured from within the atrium (AA), a percentage of heart rate intervals having a duration longer than 50 ms (PNN50), a patient activity level, a mean absolute deviation (MAD) or a respiration rate.

14. The method of claim 10, wherein determining a first period heart rate variability includes determining a position within a three dimensional coordinate system.

15. The method of claim 10, wherein determining a first period heart rate variability includes classifying the first period heart rate variability as occurring within a zone of a plurality of heart rate variability zones.

16. The method of claim 10, wherein determining a second period heart rate variability includes determining a mean AA, a PNN50, a patient activity level, a MAD or a respiration rate.

17. The method of claim 10, wherein determining a second period heart rate variability includes determining a position within a three dimensional coordinate system.

18. The method of claim 10, wherein determining a first period heart rate variability includes determining a position defined by the variability within a three dimensional coordinate system defined by selected heart rate variability parameters.

19. The method of claim 10, wherein determining a first period heart rate variability includes determining a position defined by the variability within a three dimensional coordinate system defined by selected heart rate variability parameters selected from a group including PNN50, mean AA, activity, respiration and time of day.

20. The method of claim 10, wherein determining a second period heart rate variability includes determining a position defined by the variability within a three dimensional coordinate system defined by selected heart rate variability parameters.

21. The method of claim 10, wherein determining a second period heart rate variability includes determining a position within a three dimensional coordinate system defined by selected heart rate variability parameters selected from a group including PNN50, mean AA, activity, respiration and time of day.

22. A method implemented by a processor of an implantable medical device, the method comprising:

receiving heart beat signals for a first period and a second period, the second period subsequent to the first period;

determining a first period heart rate variability parameter for the first period and a second heart rate variability parameter during the second period;

detecting an abnormal heart beat signal within the second period;

classifying the first period heart rate variability parameter within a first zone of a plurality of heart rate variability zones, each zone of the plurality of heart rate variability zones having two or more dimensions;

classifying the second period heart rate variability parameter within a second zone of the plurality of heart rate variability zones, the second zone remote from the first zone; and

redefining the first zone to include a region encompassing the second period heart rate variability parameter.

23. The method of claim 22, wherein classifying includes locating a point within a three dimensional space.

24. The method of claim 22, wherein classifying includes locating a point within a three dimensional space wherein at least one dimension includes mean time between successive atrial depolarizations as measured from within the atrium (AA), percentage of heart rate intervals having a duration longer than 50 ms (PNN50), patient activity level, mean absolute deviation (MAD) or respiration rate.

25. The method of claim 22, wherein redefining the first zone includes defining a pathway between the first zone and the second period heart rate variability parameter as belonging to the first zone.

26. The method of claim 22, wherein classifying includes locating a point within a three dimensional space defined by the heart rate variability parameter.

27. The method of claim 22, wherein classifying includes locating a point within a three dimensional space defined by the heart rate variability parameter wherein coordinate axes for the three dimensional space represent selected heart rate variability parameters.

28. The method of claim 22, wherein classifying includes locating a point within a three dimensional space defined by the heart rate variability parameter wherein coordinate axes for the space represent selected heart rate variability parameters selected from the group including PNN50, mean AA, activity, respiration and time of day.