Statistical mapping of the physiological state of the heart of a mammal

• US 6,246,903 B1
• Filed: 05/14/1999
• Issued: 06/12/2001
• Est. Priority Date: 11/15/1996
• Status: Expired due to Fees

• Current Assignee: Cardiosol, Ltd.
• Original Assignee: Cardiosol, Ltd.
• Inventors: Kletskin, Solomon
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/308,374
• Time in Patent Office: 760 Days
• Field of Search: 600/509, 600/517, 600/518, 600/515
• US Class Current: 600/509
• CPC Class Codes: A61B 5/35 by template matching
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives

Abstract

Providing an indication of the physiological state of the heart of a mammal by the steps of detecting periodic activity of internal heart organs in a sequence of heart cycles; observing a predetermined physical quantity characteristic of a selected activity; evaluating predetermined statistical parameters of the predetermined physical quantity for a selected number of the sequence of heart cycles; and comparing the evaluated statistical parameters with reference values thereby to provide an indication of the state of the selected activity.

Claims

1. A methods of providing an indication of the physiological state of the heart of a mammal by the following steps:

detecting periodic activity of internal heart organs in a sequence of heart cycles;

observing a predetermined physical quantity characteristic of a selected activity;

evaluating predetermined statistical parameters of the predetermined physical quantity for a selected number of the sequence of heart cycles; and

comparing the evaluated statistical parameters with reference values thereby to provide an indication of the state of the selected activity.

2. A method according to claim 1, wherein said step of observing includes the step of measuring the time period taken by each activity, and

said step of evaluating includes the step of evaluating predetermined statistical parameters of the time periods of a selected activity in a selected number of the sequence of heart cycles.

3. A method according to claim 2, wherein said step of evaluating includes evaluating a first statistical parameter indicating the state of the selected activity at the time of performing said step of detecting, and

said step of comparing includes comparing said evaluated first parameter with a reference range, and further includes the step of determining a relationship between said evaluated first statistical parameter and the reference range, thereby to also determine the physiological state of the mammal at the time of performing said step of detecting.

4. A method according to claim 3, wherein said step of evaluating also includes evaluating a second statistical parameter indicating a trend in the state of the selected activity, and

said step of comparing also includes comparing said evaluated second parameter with a reference range, and further includes the step of determining a relationship between said evaluated second statistical parameter and the reference range, thereby to also determine the trend in the state of the selected activity.

5. A method according to claim 4, wherein said step of comparing further includes the step of providing a visual reference system which includes first visual indications corresponding to said reference range, including a plurality of reference axes, each corresponding to a different predetermined heart activity, and

said step of determining a relationship includes the sub-steps of:

providing on said reference axes second visual indications corresponding to values of a predetermined statistical quantity for each said heart activity; and

visually comparing said second visual indications with said first visual indications, thereby to determine a relationship therebetween.

6. A method according to claim 5, wherein the reference system is a multi-axis reference system which has a plurality of axes radiating from an origin, wherein each axis defines a scale on which is indicated a range of possible values of said predetermined statistical quantities corresponding for a predetermined heart activity, and herein the first visual indications of the reference system are closed-shape line markings provided concentrically about the origin, thereby to define at least first and second reference regions, wherein visual indications within said first region indicate a first state of health of the heart of the mammal, and visual indications within said second region indicate a second state of heath of the heart of the mammal, different from said first state of health,

and wherein said step of comparing said second visual indications with said first visual indications comprises determining where said second visual indications fall relative to said reference regions, thereby to visually determine the state of health of the heart of the mammal.

7. A method according to claim 6, wherein said step of provided a reference system comprises the following steps:

detecting periodic activity of internal heart organs in a sequence of heart cycles for a statistically representative number of subjects each having a similar physiological conditions;

observing a plurality of predetermined physical quantities each characteristic of a known heart activity;

evaluating selected statistical parameters of each of the predetermined physical quantities for a selected number of the sequence of heart cycles for each of the subjects;

determining minimum and maximum values for each of said selected statistical parameters, thereby to define a range of values for each said parameter for subjects having said physiological condition; and

plotting said range of values on said multi-axis reference system, thereby to indicate visually said minimum and maximum values for each said statistical parameter for each said heart activity.

8. A method according to claim 1, wherein said step of detecting periodic activity of internal heart organs includes:

sensing at the body surface of a mammal electrical potentials produced by heart activity thereof, during a predetermined minimum number of consecutive heart cycles;

providing an analog output signal corresponding to the sensed electrical potentials;

sampling said analog output signal at a high frequency sampling rate, so as to convert said analog output signal into digital signals which retain substantially all the information contained in the sensed electrical potentials;

storing said digital signals signals as input data in an initial input file; and

providing a high resolution output waveform corresponding to said input data in which substantially only information concerning heart activity is represented, which includes;

determining waveform characteristic points,

superposing said characteristic points on said output waveform, thereby to divide said waveform into a plurality of waveform cycles each corresponding to a single heart cycle, and also so as to divide each said waveform into a plurality of waveform portions each being located between two selected characteristic points, and being defined by a plurality of points;

selecting a waveform portion alignment point;

aligning with each other all corresponding portions of said waveform cycles along said selected alignment point; and

averaging the ordinates of all said points of all said aligned waveform portions, thereby to reduce the effects of non-useful information and thus to produce a signal waveform which is characteristic of the heart activity of the mammal.

9. A method according to claim 8, wherein said step of sampling is performed at a rate of greater that 500 times per second.

10. A method according to claim 9, wherein said step of sampling is performed at a rate of at least 750 times per second.

11. A method according to claim 10, wherein said step of sampling is performed at a rate of at least 5,290 times per second.

12. A method according to claim 8, wherein said step of providing a high resolution output waveform includes the step of visually displaying said waveform.

13. A method according to claim 12, wherein said step of visually displaying includes provision of visual indications corresponding to activity of individual internal heart organs.

14. A method according to claim 8, wherein said step of determining waveform characteristic points includes determining Q, R and S points, and includes the following sub-steps:

identifying maxima on the output waveform, thereby to determine R peaks of all intervals thereof;

determining a minimum point Q immediately preceding the R peak; and

approximating a minimum point S′

immediately succeeding the R peak.

15. A method according to claim 14, wherein said step of determining the minimum point Q includes the sub-step of obtaining a first derivation of the output waveform along the portion thereof immediately preceding R, and said step of approximating the S minimum points comprises the sub-step of obtaining a first derivative of the waveform along the portion thereof immediately succeeding R.

16. A method according to claim 14, and also including the steps, after said step of approximating, of:

determining a P wave portion preceding the Q point and bounded by points P1 and P2, and

determining a T wave portion succeeding the S point and bounded by points T1 and T2.

17. A method according to claim 16, wherein said step of determining a P wave portion includes approximating the P-wave by applying the exponential expression

18. A method according to claim 17, wherein, said step of determining the P wave also includes the steps of:

determining the distance between P1 and P2 by applying the function k(λ

,A)×

λ

, and

determining the locations of points P1 and P2;

and wherein, said step of determining the T wave also includes the steps of;

determining the distance between T1 and T2 by applying the function k(λ

A)×

λ

, and

determining the locations of points T1 and T2.

19. A method according to claim 18, said step of determining the P wave also includes the step of performing a third order polynomial approximation of the P wave, wherein P1 and P2 are two of the roots of said approximation, and the third root thereof is P, and said step of determining the T wave also includes the step of performing a third order polynomial approximation of the T wave, wherein T1 and T2 are two of the roots of said approximation, and the third root thereof is T.

20. A method according to claim 19, and further including the following steps:

constructing a seventh order polynomial for the Q→

T1 waveform portion;

performing a second approximation of the point S″

, and determining the point S″

, as the root of said seventh order polynomial immediately succeeding R.

21. A system for providing an indication of the physiological state of the heart of a mammal which includes:

apparatus for detecting periodic activity of internal heart organs in a sequence of heart cycles and for providing output signals corresponding thereto;

apparatus associated with said apparatus for detecting, for receiving said output signals and for determining in accordance therewith a predetermined physical quantity characteristic of an activity;

apparatus for evaluating predetermined statistical parameters of the predetermined physical quantity for a selected number of the sequence of heart cycles; and

apparatus for comparing the evaluated statistical parameters with reference values thereby to provide an indication of the state of the selected activity.

22. A system according to claim 21, wherein said apparatus for receiving and determining includes apparatus for determining the time period taken by each activity, and

said apparatus for evaluating includes apparatus for evaluating predetermined statistical parameters of the time periods of a selected activity in a selected number of the sequence of heart cycles.

23. A system according to claim 22 wherein said apparatus for evaluating includes apparatus for evaluating a first statistical parameter indicating the state of the selected activity during operation of said apparatus for detecting, and

said apparatus for comparing includes;

apparatus for comparing the evaluated first parameter with a reference range corresponding to a state of health of the mammal, and

apparatus for visually displaying said reference range and the evaluated first parameter, thereby to provide an indication of the state of health of the mammal.

24. A system according to claim 23, wherein said apparatus for evaluating also includes apparatus for evaluating a second statistical parameter indicating a trend in the state of the selected activity, and

said apparatus for comparing includes;

apparatus for comparing the evaluated second parameter with a reference range corresponding to a trend in the state of health of heart of the mammal, and

apparatus for visually displaying said reference range and the evaluated second parameter, thereby to provide an indication of a trend in the state of health of the heart of the mammal.

25. A system according to claim 22, wherein said apparatus for comparing includes,

a multi-axis visual reference system which includes:

a plurality of axes radiating from an origin, wherein each axis defines a scale on which is indicated a range of possible values of said predetermined statistical quantities corresponding to a predetermined heart activity,

a plurality of closed-shape line markings provided concentrically about said origin, thereby to define at least first and second reference regions, wherein visual indications within said first region indicate a first state of health of the heart of the mammal, and visual indications within said second region indicate a second state of health of the heart of the mammal, different from said first state of health.

26. A system according to claim 22, wherein said apparatus for detecting period activity includes:

electrode apparatus for sensing at the body surface of a mammal electrical potentials produced by heart activity thereof, during a predetermined minimum number of consecutive heart cycles, and for providing an analog output signal corresponding to the sensed electrical potentials;

sampling apparatus for sampling said analog output signal at a high frequency sampling rate, and for converting said analog output signal into digital signals which retain substantially all the information contained in the sensed electrical potentials;

memory apparatus for storing said digital signals as input data in an initial input file; and

processing apparatus for providing a high resolution output waveform corresponding to said input data in which substantially only information concerning heart activity is represented; and

which includes;

apparatus for determining waveform characteristic points,

apparatus for superposing said characteristic points on said output waveform, thereby to divide said waveform into a plurality of waveform cycles each corresponding to a single heart cycle, and also so as to divide each said waveform cycle into a plurality of waveform portions each being located between two selected characteristic points, and being defined by a plurality of points;

apparatus for selecting a waveform portion alignment point;

apparatus for aligning with each other all corresponding portions of said waveform cycles along said selected alignment point; and

apparatus for averaging the ordinates of all said points of all said aligned waveform portions, thereby to reduce the effects of non-useful information and thus to produce a single waveform which is characteristic of the heart activity of the mammal.

27. A system according to claim 26, wherein said sampling apparatus is operative to sample said analog output signal at a rate exceeding 500 times per second.

28. A system according to claim 27, and also including apparatus associated with said processing apparatus, for visually displaying said waveform.

29. A system according to claim 28, wherein said display apparatus includes apparatus for displaying visual indications corresponding to activity of individual internal heart organs.

30. A system according to claim 27, wherein said processing apparatus further comprises apparatus for stabilizing said output waveform, which includes:

adaptive high pass filtering apparatus for the digital signals at a threshold preselected in accordance with the heart rate of a subject so as to provide an adjusted waveform;

apparatus for determining an ordinates histogram of said adjusted waveform;

apparatus for determining the modal value of said histogram;

apparatus for determining a baseline for said adjusted waveform corresponding to said modal value of said histogram; and

apparatus for combining said baseline and said adjusted waveform so as to provide a stabilized waveform.

31. A system according to claim 26, wherein said sampling apparatus is operative to sample said analog output signal at a rate exceeding 750 times per second.

32. A system according to claim 26, wherein said sampling apparatus is operative to sample said analog output signal at a rate exceeding 5,290 times per second.

33. A multi-axis visual reference system for indicating the state of health of the heart of a mammal, which includes:

a plurality of axes radiating from an origin, wherein each axis defines a scale on which is indicated a range of possible values of a predetermined statistical quantity corresponding to a predetermined heart activity, and

a plurality of closed-shape line markings provided concentrically about said origin, thereby to define at least first and second reference regions, wherein visual indications within said first region indicate a first state of health of the heart of the mammal, and visual indications within said second region indicate a second state of health of the heart of the mammal, different from said first state of health.

34. A reference system according to claim 33, wherein said first region indicates a first range of values defining a statistically determined healthy range for the predetermined heart activity, and said second region indicates a second range of values beyond said first range, thereby to indicate an unhealthy range vis-a-vis the predetermined activity.

35. A reference system according to claim 34, and also comprising a third region which indicates a third range of values defining a statistically determined diseased range for the predetermined heart activity, wherein said second region indicates a range of values between said first and third ranges, thereby to indicate a statistically determined intermediate health range for the predetermined heart activity.

36. A reference system according to claim 34, wherein said visual indications within said at least first and second reference regions correspond to the state of health of the heart of the mammal at the time at which heart activity of the mammal is sampled.

37. A reference system according to claim 34, wherein said visual indications within said at least first and second reference regions correspond to a statistically determined trend in the state of health of the heart of the mammal subsequent to the time at which heart activity of the mammal is sampled.