Medical instrument for noninvasive measurement of cardiovascular characteristics

• US 4,519,395 A
• Filed: 12/15/1982
• Issued: 05/28/1985
• Est. Priority Date: 12/15/1982
• Status: Expired due to Term

• Current Assignee: William J.M. Hrushesky
• Original Assignee: William J.M. Hrushesky
• Inventors: Hrushesky, William J. M.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/450,066
• Time in Patent Office: 895 Days
• Field of Search: 128/670-671, 128/687-690, 128/905, 128/700
• US Class Current: 600/484
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: Y10S 128/905 Feedback to patient of biological signal other than brain electric signal

Abstract

A medical instrument includes a noninvasive pulse transducer which senses heart beats of a human subject. Based upon pulse signals from the transducer, the instrument provides visual stimulae which allow the human subject to voluntarily synchronize the subject'"'"'s respiration cycles with the subject'"'"'s heart beats. At the same time, the instrument determines and stores the instantaneous beat-to-beat heart rate for each beat of the respiratory cycles. After a predetermined number of synchronized respiratory cycles have been completed, the instrument performs both classical statistical and rhythmometric analyses utilizing the stored instantaneous heart rates. The instrument determines from these analyses mean and standard error values for each beat of the respiratory cycle; an analysis of variance of the mean value; a rhythm qualified mean heart rate value; an amplitude value; a timing value (which indicates the location of the peak of the cosine curve best fitting the heart rate data within the respiratory cycle), and a percent rhythm value (which indicates the quality of the fit with the cosine curve to the stored instantaneous heart rates). The amplitude value provides an indication of the physiological (as opposed to chronological) cardiovascular age of the human subject, since it indicates the compliance of the heart tissue. The effect of cardiotoxins, cardiac drugs, other substances, as well as altered physiologic states upon a subject'"'"'s heart tissue compliance also can be monitored using the amplitude, mean and peak timing values produced by the instrument. The instrument provides a displayed and/or printed output so that the subject or his or her physician has a simple yet accurate indication of heart condition which may be evaluated periodically and followed over time.

Claims

1. An apparatus for noninvasive quantitative measurement of characteristics of a cardiovascular system of a human object, the instrument comprising:

noninvasive pulse transducer means for providing signal pulses representative of sensed heart beats of the human subject;

voluntary cardiorespiratory synchronization means responsive to the signal pulses for providing stimulae which permit the human subject to voluntarily synchronize the subject'"'"'s respiratory cycles with the subject'"'"'s heart beats;

instantaneous heart rate measurement means responsive to the signal pulses for providing digital data representative of instantaneous heart rate at each heart beat of a plurality of N-beat voluntarily synchronized respiratory cycles;

data sorting means for sorting the digital data by each of N-beat categories;

data analysis means for analyzing the sorted digital data to derive a digital value indicative of a characteristic of the subject'"'"'s cardiovascular system; and

output means for providing a human perceivable output as a function of the derived digital value.

2. The apparatus of claim 1 wherein the data analysis means comprises:

means for computing a mean and a standard error digital value for each beat category based upon the sorted digital data.

3. The apparatus of claim 2 wherein the data analysis means further comprises:

means for computing a digital value for each beat category representative of variance of the main.

4. The apparatus of claim 2 wherein the data analysis means further comprises:

means for computing an index representative of a characteristic of the subject'"'"'s cardiovascular system based upon the mean digital values.

5. The apparatus of claim 4 and further comprising:

input means for providing an input signal indicative of chronologic age of the subject;

means for deriving a digital value representative of physiologic age of the subject'"'"'s cardiovascular system based upon the index and the input signal; and

wherein the output means provides a human perceivable output repesentative of the derived physiologic age.

6. The apparatus of claim 1 wherein the data analysis means comprises:

means for deriving a cosine curve which best fits the sorted digital data;

means for determining rhythm parameter values based upon the cosine curve; and

wherein the output means provides the human perceivable output as a function of the rhythm parameter values.

7. The apparatus of claim 6 wherein the output means provides a reconstructed visual representation of the cosine curve based upon the rhythm parameter values.

8. The apparatus of claim 7 wherein the rhythm parameter values include confidence intervals, and wherein the reconstructed visual representation of the cosine curve includes a representation of the confidence intervals.

9. The apparatus of claim 6 wherein the rhythm parameter values include an amplitude value.

10. The apparatus of claim 9 wherein the rhythm parameter values include a mean instantaneous heart rate value.

11. The apparatus of claim 10 wherein the rhythm parameter values include a timing value representative of a location of a peak of the cosine curve.

12. The apparatus of claim 6 and further comprising:

means for computing an index representative of a characteristic of the subject'"'"'s cardiovascular system based upon the rhythm parameter values; and

wherein the output means provides a human perceivable output as a function of the index.

13. The apparatus of claim 6 and further comprising:

input means for providing an input signal indicative of chronologic age of the subject; and

means for deriving a digital value representative of physiologic age of the subject'"'"'s cardiovascular system as a function of the input signal and a rhythm parameter value.

14. The apparatus of claim 1 wherein the data analysis means derives a plurality of digital values, and wherein the apparatus further comprises:

means for selecting at least one of the plurality of digital values as the digital value upon which the human perceivable output is based.

15. The apparatus of claim 14 wherein the data analysis means comprises:

statistical analysis means for deriving a plurality of statistical values based upon the sorted digital data; and

rhythmometric analysis means for deriving a plurality of rhythm parameter values based upon the sorted digital data.

16. The apparatus of claim 15 wherein the data analysis means further comprises:

arithmetic analysis means for deriving an index value based upon a plurality of the derived values.

17. The apparatus of claim 1 and further comprising:

data storage means for storing data representative of previous testing; and

wherein the data analysis means analyzes the sorted digital data and the stored data to produce the digital value indicative of the characteristic of the subject'"'"'s cardiovascular system, and wherein the digital value is representative of a comparison of a current state of the subject'"'"'s cardiovascular system with results of the previous testing.

18. The apparatus of claim 17 wherein the data stored by the data storage means is representative of previous testing of the subject.

19. The apparatus of claim 17 wherein the data stored by the data storage means is representative of previous testing of a subset of subjects having a characteristic in common with the subject.

20. An apparatus for noninvasive quantitative measurement of characteristics of a cardiovascular system of a human subject, the apparatus comprising:

noninvasive pulse transducer means for providing signal pulses representative of sensed heart beats of the human subject;

voluntary cardiorespiratory synchronization means responsive to the signal pulses for providing stimulae which permit the human subject to voluntarily synchronize the subject'"'"'s respiratory cycles with the subject'"'"'s heart beats so that each respiratory cycle has a period corresponding to a predetermined number N of heart beats;

instantaneous heart rate measurement means for providing digital data representative of instantaneous heart rate at each sensed heart beat based upon the signal pulses;

means for storing the digital data for each sensed heart beat during a plurality of N-beat voluntarily synchronized respiratory cycles;

statistical analysis means for deriving a plurality of digital statistical values based upon the digital data;

rhythmometric analysis means for deriving a plurality of digital rhythm parameter values based upon the digital data; and

means for providing an output signal based upon at least one digital value derived from the digital data.

21. The apparatus of claim 20 and further comprising:

data sorting means for sorting the digital data by each beat of the N-beat respiratory cycles; and

wherein the statistical analysis means and the rhythmometric means derive the digital values as a function of the sorted digital data.

22. The apparatus of claim 21 wherein the statistical analysis means derives a mean and standard error value for each of the N beats as a function of the sorted digital data.

23. The apparatus of claim 22 wherein the statistical analysis means also derives a digital value representative of variance of the mean for each of the N beats.

24. The apparatus of claim 20 wherein the rhythmometric analysis means derives a cosine curve which best fits the digital data and determines the rhythm parameter values from the derived cosine curve.

25. The apparatus of claim 24 wherein the rhythm parameter values include an amplitude value, a mean instantaneous heart rate value and a timing value.

26. The apparatus of claim 20 and further comprising:

display means for displaying a visual output as a function of the output signal.

27. The apparatus of claim 20 and further comprising:

data storage means for storing previous test data representative of results of previous testing; and

means for providing a digital value representative of a comparison of the previous test data and digital data corresponding to a current measurement of the subject.

28. The apparatus of claim 27 wherein the previous test data is representative of previous testing of the subject.

29. The apparatus of claim 27 wherein the previous test data is representative of previous testing of a subset of subjects having a characteristic in common with the subject.

30. A noninvasive method of measuring condition of the cardiovascular system of a human subject, the method comprising:

providing a signal pulse in response to each sensed heart beat of the human subject;

providing stimulae to the human subject, as a function of the signal pulses, which stimulae permit the human subject to voluntarily synchronize the subject'"'"'s respiratory cycles with the subject'"'"'s sensed heart beats, so that a first number N1 of heart beats occur during an inhalation portion of each N-beat respiratory cycle and a second number N2 of heart beats occur during an expiration portion of each N-beat respiratory cycle;

determining, based upon time intervals between the signal pulses, instantaneous heart rates for each sensed heart beat during a plurality of voluntarily synchronized N-beat respiratory cycles;

deriving a cosine curve which best characterizes the instantaneous heart rates during the voluntarily synchronized N-beat cycles; and

providing an output signal based upon the derived cosine curve.

31. The method of claim 30 wherein providing an output comprises:

determining an amplitude value as a function of a minimum and a maximum of the cosine curve; and

providing the output signal as a function of the amplitude value.

32. The method of claim 30 wherein providing the output signal comprises:

determining a timing value representative of a location of a peak of the cosine curve; and

providing the output signal as a function of the timing value.

33. The method of claim 30 wherein providing the output signal comprises:

determining a mean instantaneous heart rate value for the N-beat respiratory cycle; and

providing the output signal as a function of the mean instantaneous heart rate value.

34. The method of claim 30 wherein deriving a cosine curve comprises:

sorting the instantaneous heart rates by each beat of the N-beat respiratory cycles;

performing a cosinor rhythmometric analysis of the sorted instantaneous heart rates to derive a cosine curve which best fits the sorted instantaneous heart rates.

35. The method of claim 30 and further comprising:

determining for each beat of the N-beat respiratory cycle a mean instantaneous heart rate value and a standard error value based upon the instantaneous heart rates corresponding to that beat; and

providing an output signal which is a function of the mean instantaneous heart rate values and the standard error values.