Implantable medical device responsive to heart rate variability analysis

• US 6,571,122 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: Routh, André G., Schroeppel, Edward A., Prutchi, David
• Primary Examiner(s): JASTRZAB, JEFFREY R
• Application Number:
  US09/978,855
• Publication Number:
  US 20020068875A1
• 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. An implantable medical device, comprising:

at least one electrode for detecting a series of heart beat signals;

memory to store one or more heart rate variability zones; and

control circuitry connected to the at least one electrode and memory, where the control circuitry analyzes the heart beat signals for an abnormal cardiac rhythm, determines a variability in the heart beat signals that preceded a detected abnormal cardiac rhythm, and classifies the variability in the heart beat signals that preceded the abnormal cardiac rhythm to a heart rate variability zone of the one or more heart rate variability zones.

2. The implantable medical device of claim 1, wherein the memory stores heart rate variability zones that define normal and abnormal cardiac sinus rhythm.

3. The implantable medical device of claim 2, wherein the control circuitry classifies the variability in the heart beat signals to a heart rate variability zone that defines an abnormal cardiac sinus rhythm, and initiates a therapy regimen based on the classification of the variability in the heart beat signals.

4. The implantable medical device of claim 2, wherein the control circuitry compares the variability of received heart beat signals to the heart rate variability zones, and predicts an occurrence of an abnormal cardiac sinus rhythm based on the comparison.

5. The implantable medical device of claim 2, wherein the control circuitry modifies one or more of the heart rate variability zones in the memory after the occurrence or non-occurrence of an abnormal cardiac rhythm.

6. The implantable medical device of claim 1, wherein the control circuitry computes time intervals occurring between successive heart beats and derives a measurement of the variability from the computed time intervals.

7. The implantable medical device of claim 6, wherein the control circuitry records time intervals during a predetermined length of time.

8. The implantable medical device of claim 1, wherein the control circuitry initiates a therapy regime when the measurement of heart rate variability is within the limits of an abnormal heart rate variability zone.

9. The implantable medical device of claim 1, wherein the control circuitry divides the abnormal heart rate variability zone into a plurality of abnormal subzones, classifies the variability in the heart beat signals that preceded the abnormal cardiac rhythm to one of the plurality of abnormal subzones, and initiates a therapy regimen based on the classification of the variability in the heart beat signals.

10. An implantable device comprising:

an electrode adapted to receive heart signals;

a processor coupled to the electrode;

a therapy delivery circuit coupled to the microprocessor;

a memory coupled to the processor; and

a program stored in the memory, the program adapted to determine a first measure of heart rate variability for a particular first period, classify the first measure as normal or abnormal based on comparing the first measure with a stored definition, detect a cardiac event during a second period subsequent to the first period, determine a second measure of heart rate variability during the second period and modify the stored definition based on the second measure.

11. The device of claim 10, wherein the memory is adapted to store a definition for normal and the program is adapted to modify the stored definition for normal.

12. The device of claim 10, wherein the memory is adapted to store a definition for abnormal and the program is adapted to modify the stored definition for abnormal.

13. The device of claim 10, wherein the therapy delivery circuit is adapted to deliver therapy based on an instruction from the processor.

14. The device of claim 10, wherein the memory includes storage for a plurality of definitions.

15. The device of claim 14, wherein the program is adapted to cause the processor to instruct the therapy delivery circuit to operate in one mode of a plurality of modes selected based on the first measure of heart rate variability.

16. The device of claim 10, wherein the program is adapted to cause the processor to receive heart signals according to one mode of a plurality of modes selected based on the first measure of heart rate variability.

17. The device of claim 10, wherein the program is adapted to modify a stored definition of normal if a cardiac event is detected during the second period.

18. The device of claim 10, wherein the program is adapted to modify a definition by adding a pathway to the cardiac event.

19. The device of claim 10, wherein the program is adapted to determine the first measure of heart rate variability based on time intervals between successive heart beats.

20. The device of claim 10, wherein the memory is adapted to store a definition having two parameters.

21. The device of claim 10, wherein the memory is adapted to store a definition having three or more parameters.