Method and system for non-invasive determination of the main cardiorespiratory parameters of the human body

• US 5,735,284 A
• Filed: 06/13/1995
• Issued: 04/07/1998
• Est. Priority Date: 06/24/1992
• Status: Expired due to Term

• Current Assignee: N.I. Medical Ltd.
• Original Assignee: N.I. Medical Ltd.
• Inventors: Frinerman, Efim, Tsoglin, Alexander
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/490,047
• Time in Patent Office: 1,029 Days
• Field of Search: 128/693, 128/695, 128/696, 128/723, 128/734, 364/413.02, 364/413.07
• US Class Current: 600/513
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• 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

Abstract

A method and a system for non-invasively determining at least one main cardiorespiratory parameter of an individual, such as the Stroke Volume, at least one parameter characterizing balance of the extracellular fluid in the body (such as the Index Balance), and for diagnostics of blood circulatory problems and/or failures of cardiac functions. The method for determining the main cardiorespiratory parameter comprises the steps of attaching at least two electrodes to the individual'"'"'s body in a manner enabling to obtain electrical bioimpedance measurements of the whole individual'"'"'s body, passing an alternating current with a stable and constant amplitude through the electrodes, measuring the integral bioimpedance as the result of the current flow; simultaneously separating an active component from the integral bioimpedance; calculating the cardiorespiratory parameter of the individual from the obtained active component, using an empiric formula applicable to integral bioimpedance measurements. The calculation is based on obtaining a number of values of the parameter for a number of cardia cycles during a respiratory cycle, and computing an average of the cardiorespiratory parameter during a single respiratory cycle.

Claims

1. A method for determining at least one main cardiorespiratory parameter of an individual, the method comprising the steps of:

attaching at least two electrodes to the body of an individual and providing a low impedance contact between the electrodes and a skin of the individual, and positioning the electrodes on at least one arm or at least one leg and at least another arm or at least another leg of the individual to enable current to pass between said at least two electrodes on said at least one arm or at least one leg to at least another arm or at least another leg of the individual;

passing an alternating current with a stable and constant amplitude through said at least two electrodes;

measuring, while passing said alternating current, a potential change as the result of a current flow to obtain a measurement of an electrical integral bioimpedance of the body of the individual from a measured potential between said at least two electrodes;

simultaneously separating an active component of the integral bioimpedance from measured integral bioimpedance;

calculating at least one of a cardio parameter and a respiratory parameter of the individual from the active component of said integral bioimpedance, using a semi-empiric formula applicable to integral bioimpedance measurements to obtain a number of values of said at least one parameter for a number of cardiac cycles during a respiratory cycle, and calculating an average of said at least one parameter during a single respiratory cycle; and

displaying said average of said at least one parameter thus obtained.

2. The method according to claim 1, wherein said cardiac parameter comprises a Stroke Volume (SV) parameter calculated substantially according to the following equation:

##EQU15## where;

Hct_corr. is a correcting factor depending from hematocrit, being 145+0.35 (Hct-40);

Hct is the hematocrit, obtained from analysis of the individual'"'"'s blood;

K(shape*sex*age) is a coefficient of the individual'"'"'s body, being;

4. A method according to claim 2, wherein the Index Balance is calculated based on the following formula:

space="preserve" listing-type="equation">R.sub.ind.prop /R.sub.measured

where

R measured is the measured resistive component of the individual'"'"'s bioimpedance, not including the individual'"'"'s skin resistance;

R_ind.prop. is a proper value of the resistive component of the individual'"'"'s bioimpedance being calculated according to the two following formulae;

##EQU18## where H is the individual'"'"'s height, and

W is the individual'"'"'s actual weight.

6. The method according to claim 4, wherein said preliminary step of examination of the peripheral blood circulation comprises:

applying a pair of additional electrodes to two hips of the individual,

providing measurements of at least one of the parameters P, P₁ or P₂ between a distal part of each leg and a corresponding hip;

obtaining for each leg values of proper parameters P_proper, P_1prop. or P_2prop. for the individual, calculated according to the following formulae;

##EQU20## comparing the readings of at least one of the parameters P, P₁ or P₂ with the readings of the proper parameters P_prop, P_1prop or P_2prop for each leg, respectively,

and defining a pathologic leg if the readings related to a leg substantially differ from the proper parameters, and excluding said pathologic leg from the electrode attachment chosen for determining the main cardiorespiratory parameters.

8. The method according to claim 6, further comprising measuring Index Balance (IB) parameter;

diagnosing lung edema where the SV value measured in the arm-arm electrode attachment substantially differs from the SV value measured in the arm-leg electrode attachment, and the IB parameter is substantially higher than 1; and

diagnosing problems in lung blood circulation where the SV value measured in the arm-arm electrode attachment substantially exceeds the SV value measured in the arm-leg electrode attachment, and the IB equals to about 1.

10. The method according to claim 8, said step of measuring the Stroke Volume (SV) parameter including measuring the Stroke Volume (SV) both for the arm-arm electrode attachment, and for the arm-leg electrode attachment, the two arms and the leg chosen for measurement having no disturbance in blood circulation;

comparing the two measurements to each other; and

wherein

a left ventricle heart failure is diagnosed where the SV value measured in the arm-arm electrode attachment substantially exceeds the SV value measured in the arm-leg electrode attachment.

11. The method according to claim 1, said attaching step comprising attaching the electrodes to distal parts of the arms and legs of the individual.

12. The method according to claim 1, wherein the method is carried out in a bipolar mode, and said attaching step comprises attaching said at least two electrodes to the body of the individual with each electrode being used for both said passing current step and said measuring step.

13. The method according to claim 1, wherein the method is carried out in a tetrapolar mode, and said attaching step comprises attaching at least four electrodes to the body of the individual, of which at least two electrodes are used for said passing current step and at least two other different electrodes are used for said measuring step.

14. The method according to claim 12, said attaching step comprising attaching one of a first pair of electrodes and a second pair of electrodes to one arm or leg and another one of said first and second pair of electrodes to another arm or leg, passing the current between the first pair of electrodes, each electrode of the first pair being located on a different arm or leg and measuring the potential between the second pair of electrodes, different from that of the first.

15. The method according to claim 1, wherein said attaching step comprises:

attaching first basic pair of electrodes to the individual, by attaching one electrode of said pair on one arm or leg and another electrode of said pair on another arm or leg; and

attaching a pair of auxiliary electrodes by attaching each auxiliary electrode to one of the arms or legs to which the basic pair of electrodes are attached and positioning the auxiliary electrodes on a more distal portion of the arms or legs than the basic pair;

said measuring step comprises;

measuring impedance comprising a first step in which current is passed and potential is measured using the basic pair of electrodes, and a second step wherein current is passed through the auxiliary electrodes and potential measured through the basic electrodes, in a tetrapolar measurement mode;

calculating a difference between the potential measured in the first step and the potential measured in the second step to calculate resistance of the skin of the individual from said difference; and

continuously reducing the resistance of the skin of the individual in accordance with a value of said active component of the integral bioimpedance of the individual.

17. The system according to claim 15, comprising a plurality of electrodes for multi-channel bioimpedance measurement, said electrodes including four basic electrodes applied to distal parts of arms and legs, respectively, of the individual;

a pair of auxiliary electrodes for measuring a skin resistance of the individual and being applied to two of arms and legs of the individual and positioned more distal than corresponding basic electrodes;

four additional electrodes located one on each of a hip and a shoulder of the individual; and

automatic multiplexing means for performing said multi-channel bioimpedance measurements.

3. 3-(3.1*(Actual Age-20)), for men younger than 20 years old;

527.3, for men from 20 to 40 years old;

527.3+(3.1*(Actual Age-40)), for men older than 40 years old;

587.6-(2.9*(Actual Age-18)), for women younger than 18 years old;

587.6, for women from 18 to 50 years old;

587.6+(2.9*(Actual Age-50)), for women older than 50 years old;

δ

r is the amplitude value of the change of the individual'"'"'s basic body resistance R at the anacrotic (systolic) portion of a cardiac cycle;

R is the individual average basic body resistance during one cardiac cycle;

H_corr. is a corrected height of the individual, given by;

##EQU16## α

+β

is duration of a cardiac cycle, being a sum of its anacrotic and catacrotic portion;

β

is duration of the catacrotic portion of a cardiac cycle;

Kel is a coefficient dependent on ion concentration in the individual'"'"'s blood plasma, calculated based on the blood analysis and being given by;

a) for an individual exposed to a hemodialysis Kel=sum of the blood concentrations at ##EQU17## b) for other individuals Kel=blood concentration of Na⁺ /142;

K_w is a weight coefficient, being a ratio Actual weight,/Ideal weight

where Ideal weight being obtained from International Tables of ideal weights;

IB is an Index Balance, reflecting ratio between the measured volume of extracellular fluids and the individual'"'"'s proper volume of extracellular fluids.

5. The method according to claim 3, further comprising a preliminary step of examination of a peripheral blood circulation of the individual, said preliminary step including:

measuring at least one of parameters P, P₁, P₂ or P₃ between the individual'"'"'s two arms having an arm-arm electrode attachment, between the individual'"'"'s arm and leg having an arm-leg electrode attachment, and between the individual'"'"'s two legs having an leg-leg electrode attachment;

said parameters being calculated substantially by the following formulae;

##EQU19## comparing readings obtained in said leg-leg electrode attachment with readings obtained in said arm-arm and said arm-leg electrode attachment, and

diagnosing peripheral circulatory disturbances at least in one of the legs of the individual based on a difference in readings obtained in the leg-leg electrode attachment compared to other attachments.

7. The method according to claim 5, wherein the Stroke Volume (SV) parameter is measured both for the arm-arm electrode attachment, and for the arm-leg electrode attachment, the two arms and the leg chosen for measurement having no disturbance in blood circulation;

and wherein the two measurements are compared to each other; and

and wherein a left ventricle heart failure is diagnosed where the SV value measured in the arm-arm electrode attachment substantially exceeds the SV value measured in the arm-leg electrode attachment.

9. The method according to claim 3, comprising applying four additional electrodes, one to each of shoulders and hips of the individual, and a preliminary step of revealing disturbances in a peripheral blood circulation of the individual;

said preliminary step including determining of at least one of parameters P, P₁ or P₂ between a distal part of each of the arms and legs and a corresponding additional electrode;

said parameters being calculated substantially by the following formulae;

##EQU21## obtaining for each arm and leg values of proper parameters P_prop, P_1prop or P_2prop of the individual values calculated substantially according to the following formulae;

##EQU22## comparing at least one of the parameters P, P₁ or P₂ with a corresponding proper parameter P_prop, P_1prop or P_2prop for each arm and leg;

and defining at least one pathologic arm or leg if the readings of the parameters P, P₁ or P₂ related to said at least one arm or leg substantially differ from the values of the corresponding proper parameters P_prop, P_1prop or P_2prop, and excluding said at least one pathologic arm or leg from the electrode attachment chosen for determining the main cardiorespiratory parameters.

16. A non-invasive medical system for accurately determining at least one cardiorespiratory parameter of the human body, the system comprising:

at last two electrodes,

an electrical integral bioimpedance measuring unit for measuring integral bioimpedance of a human body, coupled to the electrodes and including a high stability amplitude alternating current source and an electronic circuit for automatic derivation of an active component of the integral bioimpedance; and

a computer coupled to the electrical integral bioimpedance measuring unit for calculating an average value measured cardio parameter or a respiratory parameter of the individual, the average value being of a number of values of said parameter for a number of cardiac cycles during a respiratory cycle, each parameter being calculated from said active component using a semi-empiric formula applicable to integral bioimpedance measurements, the computer being further coupled to a display for displaying said average value.