Methods and devices for monitoring myocardial mechanical stability

• US 7,620,448 B1
• Filed: 06/02/2006
• Issued: 11/17/2009
• Est. Priority Date: 06/02/2006
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Farazi, Taraneh Ghaffari, Park, Euljoon
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Dinga; Roland
• Application Number:
  US11/421,915
• Time in Patent Office: 1,264 Days
• Field of Search: 600508-519, 607/9
• US Class Current: 600/515
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 7/023 for introduction into the body, e.g. into the oesophagus oesophageal ECG probes A61B5/285
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

Embodiments of the present invention relate to implantable systems, and methods for use therewith, for monitoring myocardial mechanical stability based on a signal that is indicative of mechanical functioning of a patient'"'"'s heart for a plurality of consecutive beats. Certain embodiments use time domain techniques, while other embodiments use frequency domain techniques, to monitor myocardial mechanical stability. In certain embodiments the patient'"'"'s heart is paced using a patterned pacing sequence that repeats every N beats. In other embodiments, the patient'"'"'s heart need not be paced. This abstract is not intended to be a complete description of, or limit the scope of, the invention.

Claims

1. In an implantable system, a method for monitoring myocardial mechanical stability, comprising:

(a) obtaining a signal that is indicative of mechanical functioning of a patient'"'"'s heart for a plurality of consecutive beats;

(b) determining a metric of the signal for each of the plurality of consecutive beats;

(c) dividing the plurality of consecutive beats into a plurality of sets of N consecutive beats, wherein N is an integer that is at least 2;

(d) determining, for each of the plurality of sets of N consecutive beats, one or more pairwise combination of the metrics for consecutive pairs of beats;

(e) cumulative averaging or cumulative summing corresponding pairwise combinations determined for the plurality of sets of N consecutive beats to thereby produce a plurality of cumulative values; and

(f) monitoring myocardial mechanical stability based on the cumulative values.

2. The method of claim 1, further comprising pacing the patient'"'"'s heart for a period of time using a patterned pacing sequence that repeats every N beats;

and wherein the signal obtained at step (a) is indicative of mechanical functioning of the patient'"'"'s heart for a plurality of consecutive beats while the patient'"'"'s heart is being paced using the patterned pacing sequence that repeats every N beats.

3. The method of claim 1, wherein N is an integer that is at least 3.

4. The method of claim 1, wherein step (f) comprises determining, based on the cumulative values, whether mechanical alternans are present.

5. The method of claim 4, wherein:

step (e) comprises cumulative averaging corresponding pairwise differences determined for the plurality of sets of N consecutive beats to thereby produce the plurality of cumulative values; and

step (f) comprises determining that mechanical alternans are present when the cumulative values exceed a specified threshold.

6. The method of claim 4, wherein:

step (e) comprises cumulative summing corresponding pairwise differences determined for the plurality of sets of N consecutive beats to thereby produce the plurality of cumulative values; and

step (f) comprises determining that mechanical alternans are present when a slope of the cumulative values exceeds a specified slope threshold.

7. The method of claim 1, wherein step (f) comprises tracking changes in myocardial mechanical stability as steps (a) through (g) are repeated over time.

8. The method of claim 1, further comprising bounding the pairwise combinations determined at step (d) prior to the cumulative averaging or cumulative summing performed at step (e).

9. The method of claim 1, further comprising:

detecting disruptive beats, if they exist, based on the cumulative values determined at step (e); and

if one or more disruptive beats are detected, compensating for the disruptive beats, and performing steps (c), (d) and (e) again before monitoring myocardial mechanical stability at step (f).

10. The method of claim 9, wherein:

step (d) comprises cumulative averaging corresponding pairwise differences determined for the plurality of sets of N consecutive beats to thereby produce the plurality of cumulative values; and

the detecting disruptive beats step comprises detecting a disruptive beat if the cumulative values continually stay within a range and then suddenly go outside the range and continually stay within a further range.

11. The method of claim 9, wherein:

step (d) comprises cumulative summing corresponding pairwise differences determined for the plurality of sets of N consecutive beats to thereby produce the plurality of cumulative values; and

the detecting disruptive beats step comprises detecting a disruptive beat if the cumulative values continually increase and then suddenly continually decrease.

12. The method of claim 1, wherein step (a) comprises obtaining a signal selected from the group consisting of:

a signal is representative of ventricular pressure obtained from a pressure transducer within a ventricle;

a signal representative of contraction strength obtained from an accelerometer;

a signal representative of blood flow rate obtained from a blood flow transducer;

a signal representative of heart rate sounds obtained from a microphone or an accelerometer that responds to acoustic vibrations transmitted through body fluids;

a signal representative of blood volume obtained using an impedance measuring circuit;

a signal representative of pulse pressure obtained using a photo-plethysmography sensor; and

a signal representative of venous oxygen saturation obtained using an SVO2 sensor.

13. An implantable system for monitoring myocardial mechanical stability, comprising:

one or more sensor configured to obtain a signal that is indicative of mechanical functioning of the patient'"'"'s heart for a plurality of consecutive beats;

a measuring means configured to determine a metric of the signal for each of the plurality of consecutive beats; and

a controller configured to

divide the plurality of consecutive beats into a plurality of sets of N consecutive beats;

determine, for each of the plurality of sets of N consecutive beats, one or more pairwise combination of the metrics for consecutive pairs of beats;

cumulative average or cumulative sum corresponding pairwise combinations determined for the plurality of sets of N consecutive beats to thereby produce a plurality of cumulative values; and

monitor myocardial mechanical stability based on the cumulative values.

14. The system of claim 13, further comprising one or more pulse generator configured to pace a patient'"'"'s heart for a period of time using a patterned pacing sequence that repeats every N beats, where N is an integer that is at least 2;

and wherein the one or more sensor obtains the signal that is indicative of mechanical functioning of the patient'"'"'s heart for a plurality of consecutive beats while the patient'"'"'s heart is being paced using the patterned pacing sequence that repeats every N beats.

15. The system of claim 13, wherein N is an integer that is at least 3.

16. The implantable system of claim 13, wherein the one or more sensor is selected from the group consisting of:

a pressure transducer configured to be placed within a ventricle to obtain a signal representative of ventricular pressure;

an accelerometer configured to obtain a signal representative of contraction strength;

a blood flow transducer configured to obtain a signal representative of blood flow rate;

a microphone configured to obtain a signal representative of heart rate sounds;

an accelerometer, that responds to acoustic vibrations transmitted through body fluids, configured to obtain a signal representative of heart rate sounds;

an impedance measuring circuit configured to obtain a signal representative of blood volume;

a photo-plethysmography sensor configured to obtain a signal representative of pulse pressure; and

an SVO2 sensor configured to obtain a signal representative of venous oxygen saturation.