Method and system for cardiovascular system diagnosis

• US 20070021673A1
• Filed: 07/20/2006
• Published: 01/25/2007
• Est. Priority Date: 01/27/2004
• Status: Abandoned Application

• Current Assignee: Spirocor Ltd.
• Original Assignee: CardioMeter Ltd.
• Inventors: Tal, Yoram, Arbel, Ronen, Ortenberg, Michael
• Application Number:
  US11/489,721
• Publication Number:
  US 20070021673A1
• Time in Patent Office: Days
• US Class Current: 600/500
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02116 of pulse wave amplitude A61B5/02225 takes precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/726 using Wavelet transforms

Abstract

The present invention is directed to a method and system for monitoring function and/or diagnosing dysfunction of the cardiovascular system of a human subject. The method comprise measuring pulse wave signals of the subject during rapid excitation of the cardiovascular system, analyzing the measured signals and computing indicators reflecting a response to said excitation. The cardiovascular excitation preferably comprise a controlled breathing protocol characterized by a predefined frequency of breaths (e.g., about 0.1 Hz).

Claims

1. A method for monitoring function and/or diagnosing dysfunction of the cardiovascular system of a human subject, comprising measuring pulse wave signals of said subject during rapid excitation of said cardiovascular system, analyzing said signals and computing indicators reflecting a response to said excitation.

2. The method of claim 1, wherein the excitation of the cardiovascular system is provided by the use of controlled breathing characterized by a predefined frequency of breaths.

3. The method of claim 2, wherein the predefined frequency of breaths is about 0.1 Hz.

4. The method of claim 1, further comprising segmenting the measured pulse wave signals into distinct pulse waves.

5. The method of claim 4, wherein the segmentation is carried out by performing the following steps:

finding a dominant frequency from the measured signals when transformed into the frequency domain;

defining a scan window according to said dominant frequency;

partitioning said PW signals into consecutive portions, the size of each is determined according to said scan window;

finding a maximal value of said PW signals within each one of said portions; and

finding a minimal value between pairs of consecutive maximal values found.

6. The method of claim 5, further comprising computing beat rate values by calculating the inverse of the time difference between consecutive maximal values.

7. The method of claim 1, further comprising performing time domain analysis, frequency domain analysis, and/or pulse wave morphology analysis to the measured signal in order to determine the response to excitation.

8. The method of claim 1, wherein the signals are measured in a region selected from the group consisting of a finger, ear, wrist, ankle, toe, neck, chest, of the subject.

9. The method of claim 1, wherein the signals are measured invasively.

10. The method of claim 1, further comprising comparing the signals measured during the excitation, and/or indicators computed therefore, to the subject'"'"'s normal pulse wave signals, and/or indicators computed therefore.

11. The method of claim 4, further comprising computing one or more indicators selected from the group consisting of PWA Range, Al, Pulse Period Range, HF integral, LF integral, BPM STDEV, pNN50, and BPM range, wherein said indicators are computed using signals obtained during the excitation and for normal pulse wave signals.

12. The method of claim 1, further comprising computing arterial flow, arterial stiffness, and ANS function, scores for indicating physiological functions, by calculating a weighted summation of the indicators.

13. The method of claim 12, further comprising, computing a total score, wherein said total score is the linear combination of the scores for indicating physiological functions.

14. The method of claim 13, further comprising manipulating the scores for obtaining risk evaluations for one or more of the following cardiovascular events:

acute coronary syndrome;

sudden cardiac death;

arrhythmia;

stroke; and

myocardial infarction.

15. The method of claim 1, further comprising extracting a Peripheral Flow Reserve (PFR) indicator by computing the ratio between averaged amplitude of the pulse wave signal measured during the excitation and the averaged amplitude of normal pulse wave signals of the subject.

16. The method of claim 2, further comprising extracting a Respiratory Modulation Response (RMR) indicator by computing the ratio between a first and a second areas defined under the curve of the frequency domain representation of the PW signal, wherein said areas are defined under said curve in a region defined by two adjacent minimal values adjacently located on the two sides of the breath frequency, and wherein a first area is defined to be the area under said curve between said minimal values and a second area is defined to be the subtraction of the area under the line connecting said minimal values and said first area.

17. The method of claim 1, used for one or more of the following applications:

cardiovascular risk screening and assessment;

cardiovascular intervention monitoring such as stenting and bypass surgery;

cardiovascular intervention follow-up;

therapeutic strategy monitoring such as medications;

monitoring of life style changes such as diet and sports.

adjunctive tool to existing diagnostic procedures, including;

CT Angio, SPECT, PET, ECG, Stress ECG, Calcium Scoring, Echo.

18. The method of claim 1, wherein one or more of the following cardiovascular dysfunctions are monitored or diagnosed:

cardiac Ischemia;

endothelial dysfunction;

coronary artery disease;

coronary artery occlusion;

arterial stiffness;

autonomic nervous system function;

myocardial infarction;

angina pectoris;

atherosclerosis.

19. The method of claim 1, further comprising extracting a responsive augmentation index ratio indicator by computing the ratio between the Al indicator of the subject'"'"'s normal blood PW signals and the Al indicator of the subject'"'"'s responsive to the excitation.

20. A system for monitoring function and/or diagnosing dysfunction of the cardiovascular system of a human subject, comprising a sensor for measuring pulse wave signals of a human subject, means for converting said signals into a data format, and a means for processing and analyzing the converted signals and extracting diagnostic indicators therefrom, wherein said signals are measured during rapid excitation of the cardiovascular system of said subject.

21. The system of claim 20, wherein the excitation of the cardiovascular system is provided by the use of controlled breathing characterized by a predefined frequency of breaths.

22. The system of claim 21, wherein the predefined frequency of breaths is about 0.1 Hz.

23. The system of claim 20, further comprising a low pass filter for separating breath offsetting components from the converted signals, and means for subtracting said components from said converted signal.

24. The system of claim 23, further comprising an additional low pass filter for filtering out high frequency noise and an upsampler for interpolating the signal and thereby adding data thereto.

25. The system of claim 20, further comprising means for comparing the signals measured during the excitation with the subject'"'"'s normal pulse wave signals, and for outputting corresponding indications.

26. The system of claim 20, wherein the processing mean is adapted to compute one or more of the following indicators:

PWA range, Al, Pulse Period Range, LF integral, BPM STDEV, pNN50, and BPM range, during the excitation and for normal pulse wave signals.

27. The system of claim 20, used for one or more of the following applications:

cardiovascular risk screening and assessment;

cardiovascular intervention monitoring such as stenting and bypass surgery;

cardiovascular intervention follow-up;

therapeutic strategy monitoring such as medications; and

life style changes such as diet and sports.

28. The system of claim 20, wherein one or more of the following cardiovascular dysfunctions are monitored or diagnosed:

cardiac ischemia, endothelial dysfunction, coronary artery disease, coronary artery occlusion, arterial stiffness, autonomic nervous system, myocardial infarction, angina pectoris, and atherosclerosis.

29. The system of claim 21, wherein the processing mean is adapted to compute a respiratory modulation response indicator by computing the ratio between a first and a second areas defined under the curve of the frequency domain representation of the PW signal, wherein said areas are defined under said curve in a region defined by two adjacent minimal values adjacently located on the two sides of the breath frequency, and wherein a first area is defined to be the area under said curve between said minimal values and a second area is defined to be the subtraction of the area under the line connecting said minimal values and said first area.

30. The system of claim 21, wherein the processing mean is adapted to compute a responsive augmentation index ratio indicator by computing the ratio between the Al indicator of the subject'"'"'s normal pulse rate signals and the Al indicator of the subject'"'"'s responsive to the excitation.

31. The system of claim 20, wherein the processing mean is adapted to compute a peripheral flow reserve indicator by computing the ratio between averaged amplitude of the pulse wave signal measured during the excitation and the averaged amplitude of normal pulse wave signals of the subject.

32. The system of claim 20, wherein the sensor is selected from the group consisting of a Photoplethysmograph sensor;

flow sensor;

mechanical sensors;

optical sensors, ultrasonic sensors;

electrical impedance sensor, capillary (skin) blood flow sensor.