Method and apparatus for determination of left ventricular stroke volume and cardiac output using the arteries of the forearm by means of integration technique
10524668 ยท 2020-01-07
Assignee
Inventors
Cpc classification
A63B71/0619
HUMAN NECESSITIES
A61B5/7239
HUMAN NECESSITIES
A61B5/0295
HUMAN NECESSITIES
A63B2225/50
HUMAN NECESSITIES
A63B22/0605
HUMAN NECESSITIES
A63B2230/04
HUMAN NECESSITIES
A63B2024/0065
HUMAN NECESSITIES
A61B5/029
HUMAN NECESSITIES
A61B5/02028
HUMAN NECESSITIES
A63B22/04
HUMAN NECESSITIES
A63B24/0062
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A63B71/06
HUMAN NECESSITIES
A61B5/02
HUMAN NECESSITIES
A63B22/04
HUMAN NECESSITIES
A61B5/0245
HUMAN NECESSITIES
A63B22/06
HUMAN NECESSITIES
Abstract
An apparatus a method for determining stroke volume by bioimpedance from a person having two or more spaced apart alternating current flow electrodes positionable on a person and two or more spaced apart voltage sensing electrodes positionable on the person and between the alternating current flow electrodes. A constant magnitude alternating current source is electrically connectable to the alternating current flow electrodes. A voltmeter is electrically connectable to the voltage sensing electrodes and configured to generate a voltage signal Z from a voltage sensed by the voltage sensing electrodes. A processing unit is electrically connectable with the voltmeter and configured to determine a stroke volume (SV) using the voltage signal Z and at least one of six equations.
Claims
1. An apparatus for determining stroke volume by bioimpedance from a person, comprising: two or more spaced apart alternating current flow electrodes positionable on a person; two or more spaced apart voltage sensing electrodes positionable on the person and between the alternating current flow electrodes; a constant magnitude alternating current source electrically connectable to the alternating current flow electrodes; a voltmeter electrically connectable to the voltage sensing electrodes and configured to generate a voltage signal Z from a voltage sensed by the voltage sensing electrodes; a processing unit electrically connectable with the voltmeter and configured to determine a stroke volume (SV) using the voltage signal Z and at least one of the following six equations:
2. The apparatus for determining stroke volume of claim 1, further comprising: a data input device in communication with the processing unit for receiving the person's weight W, wherein the processing unit is configured to determine the constant person-specific mass-based allometric equivalent of volume C using the following equation:
3. The apparatus for determining stroke volume of claim 2, wherein the constant k.sub.1.Math.k.sub.2 comprises: an impedance constant k.sub.1 at least 0.08 and no greater than 0.2, and a calibrating temporal constant k.sub.2 at least 0.5 and no greater than 1.5.
4. The apparatus for determining stroke volume of claim 1, wherein the processor is configured to: determine heart rate from the voltage signal; and determine cardiac output (CO) by using the following formula: CO=(heart rate)(SV).
5. The apparatus for determining stroke volume of claim 4, further comprising: a band configured to wrap around and secure to a person's wrist, wherein the processing unit is mounted to the band.
6. The apparatus for determining stroke volume of claim 5, further comprising: a display mounted to the band, wherein the display is electrically connected to the processing unit and configured to display at least one of the determined stroke volume and the determined cardiac output.
7. The apparatus for determining stroke volume of claim 4, further comprising: an exercise machine being one of a stationary bicycle, a treadmill, an elliptical pedaling device and a stair-climbing machine, wherein the exercise machine includes a display operatively connectable to the processing unit and configured to display at least one of the determined stroke volume and the determined cardiac output.
8. The apparatus for determining stroke volume of claim 7, wherein the operative connection between the display and the processing unit comprises a cable.
9. The apparatus for determining stroke volume of claim 7, wherein the operative connection between the display and the processing unit comprises a wireless connection.
10. The apparatus for determining stroke volume of claim 7, wherein the alternating current source, a voltmeter and the processing unit are mounted to the exercise machine.
11. The apparatus for determining stroke volume of claim 1, further comprising: an exercise machine being one of a stationary bicycle, a treadmill, an elliptical pedaling device and a stair-climbing machine, wherein the exercise machine includes a display operatively connectable to the processing unit by a wireless connection and configured to display at least one of the determined stroke volume and the determined cardiac output.
12. The apparatus for determining stroke volume of claim 1, further comprising: an adhesive strip on which the two or more spaced apart alternating current flow electrodes and the two or more spaced apart voltage sensing electrodes are affixed.
13. A method of determining stroke volume by bioimpedance from a person, comprising: positioning two or more spaced apart alternating current flow electrodes on the forearm of a person; positioning two or more spaced apart voltage sensing electrodes on the forearm of the person and between the alternating current flow electrodes; providing a constant magnitude alternating current flow through the alternating current flow electrodes; measuring a voltage Z between the voltage sensing electrodes; determining a stroke volume (SV) using the measured voltage Z and at least one of the following six equations:
14. The method of claim 13, further comprising: determining the constant person-specific mass-based allometric equivalent of volume C using the following equation:
15. The method of claim 14, wherein the constant k1.Math.k2 comprises: an impedance constant k1 at least 0.08 and no greater than 0.2, and a calibrating temporal constant k2 at least 0.5 and no greater than 1.5.
16. The method of claim 13, wherein the positioning of the two or more spaced apart alternating current flow electrodes on the forearm of the person comprises: positioning a first of the two or more spaced apart alternating current flow electrodes proximal to the antecubital fossa of the person's forearm; and positioning a second of the two or more spaced apart alternating current flow electrodes proximal to the wrist of the person.
17. The method of claim 13, further comprising: determining heart rate from the measured voltage; and determining cardiac output (CO) by using the following formula:
CO=(heart rate)(SV).
18. The method of claim 17, further comprising: displaying at least one of the determined stroke volume (SV) and the determined cardiac output (CO) on a visual display.
19. The method of claim 17, further comprising: mounting the visual display to the person's wrist.
20. The method of claim 17, wherein the visual display is included as part of an exercise machine being one of a stationary bicycle, a treadmill, an elliptical pedaling device and a stair-climbing machine.
21. The method of claim 13, wherein the two or more spaced-apart alternating current flow electrodes and the two or more spaced-apart voltage sensing electrodes are affixed to an adhesive strip.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The drawings accompanying and forming part of this specification are included to depict certain aspects of the invention. A clearer concept of the invention and of the components of the operation of systems provided with the invention, will become more readily apparent by referring to the exemplary, and therefore nonlimiting, embodiments illustrated in the drawings, wherein identical reference numerals or letters (i.e. A, B, C, etc.) designate the same components. The invention may be better understood by reference to one or more of these drawings in conjunction with the description presented herein. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale.
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
DETAILED DESCRIPTION OF THE INVENTION
(11) An apparatus for determining stroke volume by bioimpedance from a person can include two or more spaced apart alternating current flow electrodes positionable on a person, two or more spaced apart voltage sensing electrodes positionable on the person and between the alternating current flow electrodes, an alternating current source electrically connectable to the alternating current flow electrodes, a voltmeter electrically connectable to the voltage sensing electrodes and configured to generate a voltage signal from a voltage sensed by the voltage sensing electrodes and a processing unit electrically connectable with the voltmeter and configured to determine a stroke volume (SV) using the voltage signal and at least one of the following equations specifically related to the acceleration curve dZ/dt of
(12)
The interval of +sin x is between /4 and 0 and the interval of |sin x| is between 0 and /6. Bracketed sin x is the absolute value of sin x, which is +sin x. If the absolute value of sin x was not applied, A would equal 0 (zero).
(13) More specifically for area (A) integration of a biphasic sinusoidal curve, such as dZ/dt, the following example pertains:
A=.sub.a.sup.bf(x)dx+.sub.b.sup.c|f(x)|dxEquation 2
where f(x) is the positive concave downward curve above the baseline is added positively to the absolute value of f(x), the concave upward portion of the dZ/dt curve. It should be understood that to solve the solution for SV, several integrative steps are required. They are analogous and consistent with abstractions of the physics of motion, extrapolated for use in cardiovascular dynamics. Consider the following: if interrogating the behavior of blood flowing through the area of an orifice, such as the aortic valve, and the radius r remains constant through the whole ejection phase, the following equations pertain:
Acceleration of blood flow {umlaut over (Q)} is given as follows:
(14)
Where v=velocity (cm.Math.s.sup.1) dv(t)/dt=acceleration (cm.Math.s.sup.2) s=distance (cm) d.sup.2S/dt.sup.2=acceleration (cm.Math.s.sup.2) r.sup.2=aortic valve cross-sectional area (cm.sup.2) mL.Math.s.sup.2 indicates the units are milliliters per seconds squared
Blood flow velocity (mL.Math.s.sup.1)Q is the integral of blood flow acceleration {umlaut over (Q)} (mL.Math.s.sup.2):
(15)
Equivalently,
(16)
Stroke volume (SV) Q is the integral of velocity of flow, or rate of change of distance:
(17)
The integrals within equation 5 represent time velocity integrals, otherwise known as systolic velocity integrals (S, cm) in the techniques of both Doppler velocimetry and electromagnetic flowmetry (Bernstein D P. Impedance cardiography: pulsatile blood flow and the biophysical and electrodynamic basis for the stroke volume equations. Journal of Electrical Bioimpedance. vol 1, pp 2-17, 2010).
(18) Here, avo is equal to aortic valve opening and avc is equal to aortic valve closure, and the time interval between the two fiducial landmarks is known as left ventricular ejection time (LVET, s)), hereafter, for this technique, is designated as systolic flow time (SFT).
(19) The apparatus can calculate the following equations, which represent an extrapolation of the classical physics of motion (vide supra) for determining SV as per iterative equations 9 through 14 (vide infra).
(20) Referring to
(21)
(22) For all +dZ/dt, the area bounded by the +perimeter of the superior impedance envelope and baseline Z.sub.0, +dZ/dt may be the absolute value of dZ/dt. For all absolute values of dZ/dt, the area bounded by the perimeter of the inferior impedance envelope and baseline, Z.sub.0, the absolute value of dZ/dt may be +dZ/dt.
(23) For
{umlaut over (Q)}.sub.Z=mL.Math.s.sup.2Equation 7
where: {umlaut over (Q)}.sub.Z=Impedance-derived acceleration of blood flow (in units of mL/s.sup.2) C=A constant person-specific mass-based (kg) allometric equivalent of volume (mL)
(24)
And simplifying,
(25)
(26) For equations 1 and 2 and all subsequent equations 6 through 12, the positive (+) and negative () signs denote the superior (concave downward) and inferior (concave upward) areas of the sinusoidal curves, respectively. Reiterating, the following equations containing a dZ/dt term will be added as +dZ/dt. The apparatus can therefore calculate the velocity of blood flow, {dot over (Q)}, by the following method,
(27)
where: {dot over (Q)}.sub.Z=Impedance-derived velocity of blood flow (with mLs.sup.1 indicating the units are in milliliters per second =definite integral of area bounded within the impedance curve and Z.sub.0 over time intervals t.sub.B to t.sub.0 and t.sub.0 to t.sub.X
And simplifying,
(28)
where, dZ(t) represents the velocity of blood flow, which is analogous to dv(t) of equations 3 and 3a.
(29)
(30) The apparatus can calculate SV, which is the integral of flow, by the following method:
(31)
where C.Math.Z.sub.total/Z.sub.0 is analogous and equivalent to r.sup.2S of the right hand side of equation 5.
And finally, simplifying the LHS of equation 12, SV is thus given as;
(32)
where Z.sub.total is the aggregate sum of the numerator of equation 12. More specifically, where total means the aggregate flow from the positive sinusoid above Z.sub.0, and the negative sinusoid below Z.sub.0.
(33) Referring to
(34) Alternatively, and referring to
(35)
(36) In order to determine the person-specific volumetric constant C (which is indicative of the person's volume), the apparatus can calculate SV by means of the following equation from U.S. Pat. No. 9,451,888 B1, which is incorporated solely to calibrate person-specific volumetric constant C:
(37)
where dZ(t)/dt.sub.max is the peak rate of change of the cardiogenically-induced transradioulnar impedance pulse variation (.Math.s.sup.2). The term a is at least 5 and no greater than 10, n is at least 2 and no greater than 4, W is the person's weight, b is at least 1 and no greater than 2, k.sub.1.Math.k.sub.2 collectively are a dimensionless constant at least 0.04 and no greater than 0.3, dZ/dt.sub.max is a peak time rate of change of a transradioulnar impedance pulse variation, Z.sub.0 is a transradioulnar quasi-static base impedance, T.sub.SF is a systolic flow time, and a.sup.nW.sup.b is a volumetric personal constant.
(38) A further description of variables for equation 16 are defined as disclosed in U.S. Pat. No. 9,451,888 B1, which is incorporated herein by reference for all purposes.
(39) The apparatus can calculate C, the person-specific volumetric constant, which is a function of a person's body mass, and is given as follows;
(40)
where the numerator of equation 17 is as disclosed in U.S. Pat. No. 9,451,888 B1. For Systolic flow time (SFT), point B to point X, for equation 15, SFT is preferably measured from the point B to point X of the lower acceleration waveform, dZ/dt in
(41) It should be appreciated that the stroke volume equations 10-15 are an improvement to the stroke volume equation 16. However, stroke volume equation 16 is useful in determining the person-specific volumetric constant C, which is then used to determine a more accurate stroke volume using equations 10-15. For determining constant C, alternative stroke volume SV equations and techniques can be substituted for equation 16 and thus the numerator of equation 17. Such SV equations may be other impedance-derived SV equations, such as those implemented by means of the transthoracic and transbrachial methods, as well as SV methods using Doppler velocimetry and echo-imaging of the aortic valve. Other noninvasive SV methods, including rebreathing of inert gases, noninvasive pressure pulse contour methods, or even magnetic resonance imaging may be implemented, the results of which can be used as the numerator of equation 17.
(42) Rationale for integrating the waveforms from the aggregate radial (and ulnar) arteries derive from the observation that trivial diameter change (approximately 1.5%) occurs over a wide range of blood pressures in normotensives and hypertensives (Arterioscler Thromb 1994; 14:1223-1231), which implies that the impedance change, dZ(t) is virtually a pure velocity induced change in blood resistivity with trivial luminal volumetric expansion (D, diameter). Evaluating the following equation,
(43)
The differential of Equation 18 is given below:
(44)
(45) If L (the distance between the voltage-sensing electrodes) remains constant, and if V, vessel diameter, cross-sectional area and volume are virtually constant (i.e. dV(t).fwdarw.0), then dZ(t) and dZ(t)/dt vary uniquely with d.sub.b(t) the blood resistivity change and its rate of change of d.sub.b(t)/dt, respectively. If d.sub.b(t) and d.sub.b(t)/dt are the sole variables, then dZ(t) and dZ(t)/dt are purely a function of the velocity-induced blood resistivity change and rate of change, respectively.
(46) Others (Wallace et al. Endotracheal Cardiac Output Monitor. Anesthesiology 2000; 92:178-189) have proposed integrating the dZ(t) waveform from the tracheal mucosa. The integration of dZ(t) proposed to obtain SV is given by the following equation:
SV.sub.shmulewitz=m.sub.BET.sup.EETDZdtEquation 20
where m is constant of proportionality, BET=point B, EET=point X, DZdtdZ(t)dt. The Shmulewitz equation, without definition of m, however, does not lead directly to SV. It is noted that the integral results in an ohmic dimension of Z. When Z is multiplied by m, the following results:
SV.sub.shmulewitz=m.Math.ZEquation 21
As discussed by Wallace et al., m takes the form of the Nyboer-Kubicek or Bernstein-Sramek volume conductors, which results by rearrangement in the following:
(47)
(48) Other assumptions of the Shmulewitz method require comment. The assumption that dZ, (i.e. Z(t), dZ(t)), is generated purely by volumetric (i.e. plethysmographic) changes of the aorta and aortic arch is probably an oversimplification. Many studies have shown that impedance changes of the ascending aorta and the arch also comprise a significant change in velocity-induced blood resistivity. The velocity component probably contributes up to 50% of the dZ signal (Sakamoto K, Kanai H. Electrical properties of flowing blood. IEEE Trans Biomed Eng. 1979; 26:686-689; Kosicki et al. Contributions of the impedance cardiogram waveform. Ann Biomed Eng. 1986; 14:67-80; Visser K R. Electric properties of flowing blood and impedance cardiography. 1989; 17:463-473; Visser K R et al. Investigation of the origin of the impedance cardiogram by means of exchange transfusion with stroma-free haemoglobin solution in the dog. Cardiovasc Res. 1990; 24:24-32). Therefore, depending on the compliance of the aorta, the ratio of volumetric (plethysmographic) to blood resistivity changes is not a constant and unknown. Therefore, integrating the area beneath the aortic arch dZ(t) waveform may not consistently yield ohmic equivalents of true rate of change of volume (i.e. aortic flow). Other assumptions, such as modeling m after the Nyboer/Kubicek or Bernstein/Sramek methods, may not yield physiologically valid results, because they are purely empiric constructs, derived from basic laws of electricity. These inconsistencies contribute to the generally poor results in humans reported in the medical literature for endotracheal bioimpedance SV and CO (Moller-Sorensen H et al. Lack of agreement and trending ability of the endotracheal cardiac output monitor, compared to thermodilution. Acta Anaesthesiol Scand. 2012; 56:433-440; Maus T M et al. Cardiac output determination from endotracheal cardiac output monitor. J Cardiothorac Vasc Anesth. 2011; 25:770-775; Maass S W et al. Cardiac output measurement by bioimpedance and noninvasive pulse contour analysis compared with pulmonary artery thermodilution technique. J Cardiothorac Vasc Anesth. 2014; 28:534-539; Fellahi J L et al. A comparison of endotracheal bioimpedance cardiography and transpulmonary thermodilution in cardiac surgery patients. J Cardiothorac Vasc Anesth. 2012; 26:217-222; Ball T R et al. Comparison of the endotracheal cardiac output monitor to thermodilution in cardiac surgery patients. J Cardothorac Vasc Anesth. 2010; 24:762-766).
(49) A method of determining stroke volume by bioimpedance from a person can include positioning two or more spaced apart alternating current flow electrodes on the forearm of a person, positioning two or more spaced apart voltage sensing electrodes on the forearm of the person and between the alternating current flow electrodes, providing a constant magnitude alternating current flow through the alternating current flow electrodes, measuring a voltage between the voltage sensing electrodes, and determining a stroke volume (SV) using the measured voltage and the above described equations.
(50) The invention and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known starting materials, processing techniques, components, and equipment are omitted so as not to unnecessarily obscure the invention in detail. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the invention, are given by way of illustrations only and not by way of limitation. Various substitutions, modifications, additions an/or rearrangements within the spirit and/or scope of the underlying inventive concept will become apparent to those skilled in the art from this disclosure.
(51) As used herein, the terms comprises, comprising, includes, including, has, having or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements no expressly listed or inherent to such process, method, article, or apparatus. Further, unless expressly stated to the contrary, or refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by any one of the following: A is true (or present) and B is false (or not present) and B is true (or present), and both A and B are true (or present).
(52) Also, use of the a or an are employed to describe elements and components of the invention. This is done merely for convenience and to give a general sense of the invention. This description should be read to include one or at least one and the singular also includes the pleural unless it is obvious that it is meant otherwise.
(53) Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.
(54)
(55)
(56)
(57)
(58)
(59)
(60)
(61)
(62)
(63) The present invention is a method and apparatus for the determination of stroke volume (SV) and cardiac output (CO) by transradioulnar electrical bioimpedance velocimetry, wherein the signal sources are the radial and ulnar arteries of the forearm. SV and CO, while not sensitive indices of the overall intrinsic force generation capacity or contractility of the heart muscle, are the best indicators of the overall performance of the heart considered as a muscular pump. The apparatus and method disclosed involve the application of a constant magnitude alternating current of high frequency and small amplitude across a segment of a person's lower arm (forearm) of the upper extremity to interrogate both the radial and ulnar arteries, considered in the aggregate. The present invention may also provide a method to determine a stroke volume equation, including a method for calibration of the transradioulnar person-specific constant C. Thus, in contradistinction to the generally accepted transthoracic bioimpedance method for SV/CO determination, the present invention relates to the acquisition and signal processing of the cardiogenically induced, pulsatile transradioulnar bioimpedance signal for the purpose of SV/CO determination.
(64) Advantages of the transradioulnar method include: 1. Stroke volume (SV) and cardiac output (CO) values are not corrupted by excess extravascular, intrathoracic liquids; namely pulmonary edema fluid. 2. Baseline transradioulnar quasi-static base impedance, Z.sub.0, is not substantially affected by pulmonary (lung) ventilation, thereby obviating the necessity the necessity for sophisticated stabilizing adaptive filtering techniques to obtain a steady baseline for measurement of the cardiac-induced transradioulnar impedance change, Z(t), and the magnitudes and fiducial landmarks on its first time-derivative transradioulnar dZ/dt. 3. The cumbersome and user-unfriendly transthoracic electrode montage, and the difficult self-application of the transbrachial electrode configuration, is replaced with a user-friendly 4 spot-electrode montage affixed to an adhesive strip, the adhesive strip affixed to the ventral (volar) aspect of the forearm. 4. With the arm at rest, or the arm stabilized by handle bars of a stationary exercise machine, including a bicycle, treadmill, stair-climb, or elliptical pedaling device, motion artifact is limited and is easily filtered by the signal processing module located on the wrist or exercise machine and/or with an integrated tri-axial accelerometer. 5. The bioimpedance signal obtained from the forearm is unaffected by the presence of electronic or metallic devices located on the surface of the chest, or within the chest cavity. 6. Without the perturbing influence of multiple pulsating blood vessels, both arterial and venous, and motion of the heart and chest wall, the signal-to-noise ratio (S/N) of the arterial pulsations of the forearm are enhanced over the various transthoracic bioimpedance methods. 7. The radial and ulnar arteries are more rigid than either the vessels of the chest cavity, including the thoracic aorta, or the brachial artery, thereby yielding a pulsatile velocimetric bioimpedance waveform without the perturbation of vessel volume changes over the cardiac cycle. 8. Fiducial landmarks, point B and point X are more easily identified from the biphasic dZ/dt curve. 9. The integration of dZ(t) and dZ(t)/dt provide a biophysically coherent explanation for the legitimacy of the impedance method for determination of SV and CO.
(65) As disclosed above, the present invention relates to the measurement of stroke volume (SV) and cardiac output (CO) by means of the transradioulnar method, using the radial and ulnar arteries, in the aggregate, as the cardiogenically induced signal source. Methodologically, the transradioulnar method is similar to the transthoracic and transbrachial techniques for determining SV. However, in the transthoracic technique, signal acquisition is effected over a segment of the thorax (U.S. Pat. No. 7,806,830 B2, FIG. 7) and the transbrachial technique over a segment of the brachium (upper arm) (U.S. Pat. Nos. 7,261,697 B2, 7,740,590 B2 7,806,830 B2, all three of these patents are incorporated herein by reference for all purposes. In contrast, the transradioulnar technique uses a segment of the lower arm, namely the forearm, for signal acquisition.
(66)
(67) With the current field thus generated, the potential difference between the current injecting electrodes (AKA alternating current flow electrodes) 108,110 is measured by a voltmeter 120 connected to voltage-sensing wires 116, 118, which are connected, respectively, to voltage sensing electrodes 112 proximal and distal to 108 and 114 placed proximal and cephalad to 110 within the current field. The voltage then passes through differential amplifier 122, then through voltage demodulator 124 whereupon the demodulated voltage undergoes phase adjustment 126. After phase adjustment, and to increase the signal to noise ratio (S/N), the signal is denoised by passage through a first low pass filter 128 (30 Hz). The denoised signal then passes through a high pass filter 130 (0.1 Hz) yielding oscillating signal Z 132, followed by passage through a second low pass filter (10 Hz) 134, yielding quasi-static base impedance signal Z.sub.0 136. Both 132, 136 are then fed into an analog to digital converter (A to D) 138, whereupon the A to D conversion is fed into the signal (micro) processing unit (SMU, SPU) 140 wherein the Z(t) 132 signal is electronically differentiated into its first time-derivative, transradioulnar d(Z(t))/dt, hereafter simply designated as dZ/dt (.Math.s.sup.2), where its peak systolic magnitude is thus designated as dZ/dt.sub.max 142. The SPU can also effect integration of area beneath the initial concave downward impedance envelope (+dZ/dt) as well as the area within the impedance concave upward envelope bounded by point 0, dZ/dt and point X 145. Systolic flow time (T.sub.SF, s) 144 is calculated and a volume conductor, personal constant C 146 is calculated based on person's body weight (kg). For the purposes of the invention disclosed herein, dZ/dt.sub.max (.Math.s.sup.2) is equivalent to the nadir, or peak negative value of the rate of change of the impedance pulse variation, dZ/dt.sub.max (i.e. dZ/dt.sub.mm) where the absolute value of dZ/dt.sub.max=+dZ/dt.sub.max=dZ/dt.sub.min.
(68) In the embodiments of
(69) C is a person-specific volumetric constant based on allometric equivalents of body mass (kg). Person-specific constant C can be calculated as follows. First, per U.S. Pat. No. 9,451,888 B1, SV can be calculated thusly:
(70)
where dZ(t)/dtmax is the peak rate of change of the cardiogenically-induced transradioulnar impedance pulse variation (/s.sup.2). The aforementioned equation is used solely to calculate the person-specific constant C, the definition of terms of which are disclosed in U.S. Pat. No. 9,451,888 B1. Therefore, the person specific weight-based constant C is calibrated thusly:
(71)
(72) Using equations 9 through 15 to determine SV 148, cardiac output (CO) 150 is determined by the product of 148 and heart rate (HR) 152. An accelerometer 154 within the SMU 140 is implemented to detect and stabilize motion artifacts in Z.sub.0 136 and Z and dZ/dt 132.
(73) Many different methods of applying the electrodes or electrode arrays to the forearm are envisioned, such as spot electrodes, arm bands, both circumferential and non-circumferential, adhesive strips, or other attachment means known to the art. In the preferred embodiment, however, four (4) spot-electrodes are affixed to the forearm by means of attachment to an adhesive carrier strip (see
(74) To better understand the biological electronic circuitry, a second embodiment of the invention
I(t).Math.[(Z.sub.tZ.sub.bZ.sub.w)Z.sub.b(t)]=U.sub.0U.sub.b(t)=I(t).Math.[Z.sub.0Z(t)]=U.sub.0U.sub.b(t)Equation 25
(75) In a third embodiment,
(76) Male: T.sub.SF=0.0017.Math.HR+0.413, and
(77) Female: T.sub.SF=0.0016.Math.HR+0.418.
(78) (Weissler et al. Systolic time intervals in heart failure in man. Circulation 1968; 37:149.)
(79) In a fourth embodiment of the invention,
(80) In a fifth embodiment,
(81) In a sixth embodiment,
(82) In a seventh embodiment,
(83) In an eighth embodiment,
(84) In the ninth embodiment,
(85) In a tenth and final embodiment, heart rate HR can be determined by the following means: The SPU can receive, detect and process ECG signals and, 1. Measure the RR time intervals of an ECG over a given period of time t, 2. Divide 60 seconds by the average of the RR time intervals over t. 3. Examples: a. If the average RR time interval is 0.5 seconds over one minute t (60 s), then t/RR=60/0.5=120 beats per minute (BPM). b. If the average RR time interval is 0.5 seconds over t 15 seconds, then
HR=60/tt/0.5=60/1515/0.5=120 BPM. c. If the average RR time interval is 2 seconds over one minute t (60 s), then the heart rate=60/2=30 BPM. d. If the average RR time interval is 2 seconds over t15 seconds, then
HR=60/tt/2=60/1515/2=30 BPM. The SPU can receive, detect and process ECG signals and, 1. Measure the number of ECG R wave spikes over a stipulated period of time t. 2. Multiply number of R spikes60/t. 3. Examples: a. If 20 R wave spikes occur in 15 seconds, then 2060/15=204=80 BPM. b. If 30 R wave spikes occur in 15 seconds, then 3060/15=304=120 BPM. The SPU can receive, detect and process SpO.sub.2 signals and: 1. Determine the first time-derivative of SpO.sub.2, d(SpO.sub.2)/dt, 2. The first and largest spike of the derivatized waveform d(SpO.sub.2)/dt.sub.max can be treated as per the methods outlined and disclosed in U.S. Pat. Nos. 7,261,697 B2, 7,740,590 B2 and 7,806,830 B2 and treated as in methods using ECG or d(SpO.sub.2)/dt. 3. The second time-derivative, d.sup.2(SpO.sub.2)/dt.sup.2 can be used as per methods for d(SpO.sub.2)/dt or ECG to determine HR (d(SpO.sub.2)/dt.sub.max to d(SpO.sub.2)/dt.sub.max time interval). The SPU can receive, detect, and process the first or second time derivatives of Z and: 1. The maximum of dZ/dt or d.sup.2Z/dt.sup.2, which are dZ/dt.sub.max or d.sup.2Z/dt.sup.2.sub.max, respectively, can be treated as per the method using ECG or d(SpO.sub.2)/dt to determine HR. 2. Specifically, the time interval between the maximum systolic peaks (dZ/dt.sub.max to dZ/dt.sub.max) can be treated as per the methods delineated in treatment of ECG or SpO.sub.2 signals.
(86) It is to be understood that the present invention is not limited to the embodiment(s) described above and illustrated herein, but encompasses any and all variations falling within the scope of the appended claims. For example, references to the present invention herein are not intended to limit the scope of any claim or claim term, but instead merely make reference to one or more features that may be covered by one or more of the claims. Materials, processes and numerical examples described above are exemplary only, and should not be deemed to limit the claims. Further, as is apparent from the claims and specification, not all method steps need be performed in the exact order illustrated or claimed.
(87) Hardware, software and/or firmware can be used to implement the logic steps and/or processes of the invention. It should further be appreciated that such logic steps or process can be implemented as computer-executable instructions stored on a non-transitory computer readable medium, such a CD or DVD (including re-writable CDs and DVDs), flash or other non-volatile memory, ROM, EEPROM, disc drive, solid state drive, etc.