Implantable devices, and methods for use therewith, for monitoring sympathetic and parasympathetic influences on the heart

• US 7,711,415 B1
• Filed: 11/08/2006
• Issued: 05/04/2010
• Est. Priority Date: 11/08/2006
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kroll, Mark W., Jurkowski, Kevin S., Bornzin, Gene A., Farazi, Taraneh Ghaffari, Benser, Michael E.
• Primary Examiner(s): Manuel; George
• Assistant Examiner(s): Wieland; Robert N
• Application Number:
  US11/557,814
• Time in Patent Office: 1,273 Days
• Field of Search: 600/509, 600/485, 600/515, 600/519, 607/9, 607/14, 607/17, 607/25
• US Class Current: 600/509
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: G06F 2218/08 Feature extraction

Abstract

Provided herein are implantable devices, and methods for use therewith, that independently monitor levels of parasympathetic and sympathetic tone of a patient. In accordance with an embodiment, a cardiac electrogram (EGM) signal is sensed using implanted electrodes, cardiac intervals are measured within a portion of the sensed EGM signal, and levels of parasympathetic tone and sympathetic tone are independently assessed based on the measured cardiac intervals. This abstract is not intended to describe all of the various embodiments of the present invention.

Claims

1. For use with an implantable device, a method for independently monitoring levels of parasympathetic and sympathetic tone of a patient, comprising:

(a) sensing a cardiac electrogram (EGM) signal using implanted electrodes;

(b) measuring cardiac intervals within a portion of the sensed EGM signal; and

(c) independently assessing levels of parasympathetic tone and sympathetic tone based on the measured cardiac intervals, wherein step (c) comprises;

(c.1) assessing the level of parasympathetic tone in one of the following manners;

(c.1.i) determining the patient'"'"'s diurnal variation of cardiac intervals based on the measured cardiac intervals, wherein diurnal variation of cardiac intervals is a measurement of change in cardiac intervals over the course of a day, and assessing the level of parasympathetic tone based on the diurnal variation of cardiac intervals;

(c.1.ii) determining the patient'"'"'s diurnal variation of heart rate based on the measured cardiac intervals, wherein diurnal variation of heart rate is a measurement of change in heart rate over the course of a day, and assessing the level of parasympathetic tone based on the diurnal variation of heart rate; and

(c.1.iii) identifying each said cardiac interval that is longer than the immediately preceding cardiac interval as being indicative of cardiac deceleration, and assessing the level of parasympathetic tone based on the cardiac intervals that are identified as being indicative of cardiac deceleration; and

(c.2) assessing the patient'"'"'s level of sympathetic tone in one of the following manners

(c.2.i) determining the patient'"'"'s average cardiac interval based on the measured cardiac intervals, and assessing the level of sympathetic tone based on the determined average cardiac interval;

(c.2.ii) determining the patient'"'"'s average heart rate based on the measured cardiac intervals, and assessing the level of sympathetic tone based on the determined average heart rate; and

(c.2.iii) identifying each said cardiac interval that is shorter than the immediately preceding cardiac interval as being indicative of cardiac acceleration, and assessing the level of sympathetic tone based on the cardiac intervals that are identified as being indicative of cardiac acceleration.

14. The method of claim 1, further comprising:

comparing the assessed levels of parasympathetic and sympathetic tone for the patient with previously assessed levels parasympathetic and sympathetic tone for the patient to monitor changes in the patient'"'"'s levels of parasympathetic and sympathetic tone.

15. The method of claim 1, comprising repeating steps (a) through (c) over time to monitor changes in the patient'"'"'s levels of parasympathetic and sympathetic tone.

16. The method of claim 1, wherein step (c) comprises determining the patient'"'"'s diurnal variation of cardiac intervals based on the measured cardiac intervals, and assessing the level of parasympathetic tone based on the diurnal variation of cardiac intervals.

17. The method of claim 1, wherein step (c) comprises determining the patient'"'"'s diurnal variation of heart rate based on the measured cardiac intervals, and assessing the level of parasympathetic tone based on the diurnal variation of heart rate.

18. The method of claim 15, further comprising:

(d) monitoring for diabetic autonomic neuropathy based on the patient'"'"'s levels of parasympathetic and sympathetic tone.

2. For use with an implantable device, a method for independently monitoring levels of parasympathetic and sympathetic tone of a patient, comprising:

(a) sensing a cardiac electrogram (EGM) signal using implanted electrodes;

(b) measuring cardiac intervals within a portion of the sensed EGM signal; and

(c) independently assessing levels of parasympathetic tone and sympathetic tone based on the measured cardiac intervals, wherein step (c) includes;

(c.1) identifying each said cardiac interval that is longer than the immediately preceding cardiac interval as being indicative of cardiac deceleration; and

(c.2) assessing the level of parasympathetic tone based on the cardiac intervals that are identified as being indicative of cardiac deceleration.

3. The method of claim 2, wherein step (c) further includes:

(c.3) identifying each said cardiac interval that is shorter than the immediately preceding cardiac interval as being indicative of cardiac acceleration; and

(c.4) assessing the level of sympathetic tone based on the cardiac intervals that are identified as being indicative of cardiac acceleration.

4. For use with an implantable device, a method for independently monitoring levels of parasympathetic and sympathetic tone of a patient, comprising:

(a) sensing a cardiac electrogram (EGM) signal using implanted electrodes;

(b) measuring cardiac intervals within a portion of the sensed EGM signal; and

(c) independently assessing levels of parasympathetic tone and sympathetic tone based on the measured cardiac intervals, wherein step (c) includes;

(c.1) identifying each said cardiac interval that is longer than the immediately preceding cardiac interval as a positive anchor point;

(c.2) defining for each identified positive anchor point a segment of at least three consecutive said cardiac intervals that is generally centered about the positive anchor point;

(c.3) averaging the segments defined for the positive anchor points to produce an average deceleration segment; and

(c.4) assessing a level of parasympathetic tone based on the average deceleration segment.

5. The method of claim 4, wherein step (c) further includes:

(c.5) identifying each said cardiac interval that is shorter than the immediately preceding cardiac interval as a negative anchor point;

(c.6) defining for each identified negative anchor point a segment of at least three consecutive said cardiac intervals that is generally centered about the negative anchor point;

(c.7) averaging the segments defined for the negative anchor points to produce an average acceleration segment; and

(c.8) assessing the level of sympathetic tone based on the average acceleration segment.

6. The method of claim 5, wherein:

step (c.4) includes

determining a metric indicative of an amplitude of a parasympathetic central wavelet of the average deceleration segment; and

assessing the level of parasympathetic tone based on the metric of the parasympathetic central wavelet; and

step (c.8) includes

determining a metric indicative of an amplitude of a sympathetic central wavelet of the average acceleration segment; and

assessing the level of sympathetic tone based on the metric of the sympathetic central wavelet.

7. The method of claim 6, wherein:

step (c.4) further includes

recognizing a decrease in the metric of the parasympathetic central wavelet of the average deceleration segment as being indicative of a decrease in parasympathetic tone; and

recognizing an increase in the metric of the parasympathetic central wavelet of the average deceleration segment as being indicative of an increase in parasympathetic tone; and

step (c.8) further includes

recognizing a decrease in the metric of the sympathetic central wavelet of the average acceleration segment as being indicative of a decrease in sympathetic tone; and

recognizing an increase in the metric of the sympathetic central wavelet of the average acceleration segment as being indicative of an increase in sympathetic tone.

8. The method of claim 5, wherein:

step (c.4) includes

determining a time constant of the average deceleration segment; and

assessing the level of parasympathetic tone based on the time constant of the average deceleration segment; and

step (c.8) includes

determining a time constant of the average acceleration segment; and

assessing the level of sympathetic tone based on the time constant of the average acceleration segment.

9. The method of claim 8, wherein:

step (c.4) further includes

recognizing a decrease in the time constant of the average deceleration segment as being indicative of a decrease in parasympathetic tone; and

recognizing an increase in the time constant of the average deceleration segment as being indicative of an increase in parasympathetic tone; and

step (c.8) further includes

recognizing a decrease in the time constant of the average acceleration segment as being indicative of an increase in sympathetic tone; and

recognizing an increase in the time constant of the average acceleration segment as being indicative of a decrease in sympathetic tone.

10. The method of claim 5, wherein:

step (c.4) includes

determining a slope of the average deceleration segment, and

assessing the level of parasympathetic tone based on the slope of the average deceleration segment; and

step (c.8) includes

determining a slope of the average acceleration segment; and

assessing the level of sympathetic tone based on the slope of the average acceleration segment.

11. The method of claim 10, wherein:

step (c.4) further includes

recognizing a decrease in the slope of the average deceleration segment as being indicative of an increase in parasympathetic tone; and

recognizing an increase in the slope of the average deceleration segment as being indicative of a decrease in parasympathetic tone; and

step (c.8) further includes

recognizing a decrease in the slope of the average acceleration segment as being indicative of a decrease in sympathetic tone; and

recognizing an increase in the slope of the average acceleration segment as being indicative of an increase in sympathetic tone.

12. The method of claim 5, wherein step (c) includes:

producing a measurement of the average deceleration segment and a measurement of the average acceleration segment;

normalizing the measurement of the average deceleration segment and the measurement of the average acceleration segment; and

assessing the level of parasympathetic tone based on the normalized measure of the average deceleration segment, and assessing the level of sympathetic tone based on the normalized measure of the average acceleration segment.

13. The method of claim 12, further comprising producing an autonomic nervous system index (ANSi) value based on the normalized measure of the average deceleration segment and the normalized measure of the average acceleration segment.

19. An implantable device for assessing levels of parasympathetic and sympathetic tone of a patient, comprising:

implantable electrodes for sensing a cardiac electrogram (EGM) signal;

means for measuring cardiac intervals within a portion of the sensed EGM signal;

means for independently assessing levels of parasympathetic tone and sympathetic tone based on the measured cardiac intervals, wherein the means for independently assessing levels of parasympathetic tone and sympathetic tone comprises one or more processor, and

wherein the one or more processor assesses the level of parasympathetic tone in one of the following manners;

determining the patient'"'"'s diurnal variation of cardiac intervals based on the measured cardiac intervals, wherein diurnal variation of cardiac intervals is a measurement of change in cardiac intervals over the course of a day, and assessing the level of parasympathetic tone based on the diurnal variation of cardiac intervals;

determining the patient'"'"'s diurnal variation of heart rate based on the measured cardiac intervals, wherein diurnal variation of heart rate is a measurement of change in heart rate over the course of a day, and assessing the level of parasympathetic tone based on the diurnal variation of heart rate; and

identifying each said cardiac interval that is longer than the immediately preceding cardiac interval as being indicative of cardiac deceleration, and assessing the level of parasympathetic tone based on the cardiac intervals that are identified as being indicative of cardiac deceleration; and

wherein the one or more processor assesses the level of sympathetic tone in one of the following manners

determining the patient'"'"'s average cardiac interval based on the measured cardiac intervals, and assessing the level of sympathetic tone based on the determined average cardiac interval;

determining the patient'"'"'s average heart rate based on the measured cardiac intervals, and assessing the level of sympathetic tone based on the determined average heart rate; and

identifying each said cardiac interval that is shorter than the immediately preceding cardiac interval as being indicative of cardiac acceleration, and assessing the level of sympathetic tone based on the cardiac intervals that are identified as being indicative of cardiac acceleration.

20. The device of claim 19, further comprising:

means for comparing the assessed levels of parasympathetic and sympathetic tone for the patient with previously assessed levels parasympathetic and sympathetic tone for the patient to monitor changes in the patient'"'"'s levels of parasympathetic and sympathetic tone.