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WO1993013706A2 - Procede optique de controle des hematocrites dans le sang arteriel - Google Patents

Procede optique de controle des hematocrites dans le sang arteriel Download PDF

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Publication number
WO1993013706A2
WO1993013706A2 PCT/US1993/000334 US9300334W WO9313706A2 WO 1993013706 A2 WO1993013706 A2 WO 1993013706A2 US 9300334 W US9300334 W US 9300334W WO 9313706 A2 WO9313706 A2 WO 9313706A2
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WO
WIPO (PCT)
Prior art keywords
blood
light
pulsatile
wavelengths
hematocrit
Prior art date
Application number
PCT/US1993/000334
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English (en)
Inventor
Joseph M. Schmitt
Original Assignee
The Government Of The United States Of America, As Represented By The Secretary Of The Department Of Health And Human Services
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Government Of The United States Of America, As Represented By The Secretary Of The Department Of Health And Human Services filed Critical The Government Of The United States Of America, As Represented By The Secretary Of The Department Of Health And Human Services
Publication of WO1993013706A2 publication Critical patent/WO1993013706A2/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/14535—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue for measuring haematocrit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/41—Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/414—Evaluating particular organs or parts of the immune or lymphatic systems
    • A61B5/417—Evaluating particular organs or parts of the immune or lymphatic systems the bone marrow

Definitions

  • the present invention relates to methods and apparatus for measuring blood hematocrit. More particularly, the present invention relates to non-
  • Anemia is associated with many pathological conditions that result in a loss or reduced production
  • red blood cells including renal failure, bone-marrow aplasia secondary to radiation therapy, and red-cell sickling. Although rarer, excessive production of red cells (polycythemia) is also seen clinically in patients with congenital heart disease and pulmonary emphysema.
  • PCV packed-cell volume
  • Another object of the present invention is to provide a method of measuring blood hematocrit. Another object of the present invention is to provide a non-invasive method of measuring blood hematocrit.
  • a further object of the present invention is to provide a method of simultaneously measuring oxygen saturation and hemoglobin concentration of blood.
  • An even further object of the present invention is to provide an apparatus for measuring blood hematocrit.
  • a still further object of the present invention is to provide an apparatus for non-invasively measuring blood hematocrit.
  • a still further object of the present invention is to provide a tissue phantom which simulates the optical properties of a perfused finger.
  • the present invention provides a method of measuring blood hematocrit which involves: directing first and second wavelengths of light through a blood sample; determining the ratio between pulsatile and non- pulsatile diffuse transmittances measured at each of the first and second wavelengths of light from the blood sample; and determining blood hematocrit of the blood sample from the ratio between pulsatile and non-pulsatile diffuse transmittances measured at each of the first and second wavelengths of light from the blood sample.
  • the present invention further provides an apparatus for measuring blood hematocrit which includes: a sample holder for receiving a blood sample; a first light generating means for generating light within the isobestic region of oxyhemoglobin: a second light generating means for generating light within the isobestic region of deoxyhemoglobin; means for directing light from the first and second light generating means to the sample holder; means for receiving light from the sample holder; means for measuring pulsatile and non-pulsatile diffuse transmittances from the sample holder; and means for determining ratios of the measured pulsatile and non-pulsatile diffuse transmittances from the sample holder.
  • the present invention also provides a tissue phantom for simulating optical properties of a perfused finger which includes two interwoven networks of randomly distributed tubes, wherein one of the tube networks is filled with a fixed volume of a blood standard and another of the tube networks is adapted to be injected with a blood standard to simulate a pulsatile increase in blood volume.
  • Figure 1 is an absorption spectra of water, deoxygenated red blood cells (Hb), and oxygenated red blood cells (Hb0 2 ) in the 700 nm to 1350 nm spectral region.
  • Figure 2 is a schematic diagram of an apparatus for measuring the hematocrit of blood according to one embodiment of the present invention.
  • Figure 3 is a schematic illustration of a tissue phantom which simulates the optical properties of a perfused finger according to one embodiment of the present invention.
  • Figure 4 is a schematic diagram of an apparatus for measuring the hematocrit of blood according to another embodiment of the present invention.
  • Figure 5a is a graph of optical transmissions of whole blood at 800 nm and 1300 nm at various hemoglobin concentrations.
  • Figure 5b is a graph of the ratio between the optical densities of Fig. 5a at various hemoglobin concentrations.
  • Figure 6 is a graph which compares theoretical predictions of measurements of blood hematocrit with experimental test results.
  • Blood hematocrit is routinely determined in clinics by analysis of blood samples.
  • the present invention provides a non-invasive method for measuring arterial blood hematocrit which, when combined with pulse oximetry, enables simultaneous monitoring of hemoglobin concentration and oxygen saturation.
  • the present invention is based on the same principles underlying pulse oximetry, except according to the present invention, two light sources which emit close to isobestic wavelengths of oxy/deoxyhemoglobin in the near-infrared band are employed.
  • hematocrit is related to the ratios of the pulsatile and non-pulsatile components of the diffuse intensity transmitted through a blood-perfused tissue at isobestic wavelengths of oxy/deoxyhemoglobin in the near-infrared band. Based upon the inventor's discovery, an apparatus as described below has been developed for non-invasively measuring hemoglobin concentration and oxygen saturation.
  • the optical density of whole blood has a strong dependence on the density of red cells in the blood and on the concentration and oxygenation state of the hemoglobin contained in the cells.
  • the optical density of whole blood is altered as a result of changes in both scattering and absorption.
  • the macroscopic absorption and transport-corrected scattering coefficients of whole blood can be related to hematocrit as follows:
  • H blood hematocrit (assumed to be equal to the volume fraction of red blood cells, neglecting the small fraction of white cells and other formed • elements) ;
  • i volume of a red blood cell ( ⁇ m );
  • S hemoglobin oxygen saturation;
  • ⁇ 2 absorption cross-section of an oxygenated red cell ( ⁇ m 2 ) ;
  • C__ m , a nd e a nd _ are the mi l limo lar extinction coeffic °ients (mM ⁇ ?_. • L -1 • cm -1 ) of oxyhemoglobin and deoxyhemoglobin , respectively , and ⁇ - ⁇ rbc is the
  • the optical-density ratio has, in general, a more complicated dependence on d and H than that given by Eq. (8). Nonetheless , as shown below, the optical-density ratio has been observed to maintain its linear dependence on hematocrit provided that d is less than a few millimeters.
  • the technique of pulse oximetry has been shown to provide a satisfactory solution to the challenging problem of measuring changes in the optical absorption of blood contained in highly scattering skin tissues (Yoshiya, Vol. 18, supra; Tremper, Vol. 70, supra ) .
  • the pulsatile optical signals measured by a pulse oximeter result from changes in the bulk absorption coefficient of the skin induced by a transient increase in blood volume during cardiac systole.
  • the blood-perfused tissue is treated as a homogeneous mixture of blood and bloodless skin tissues through which photons diffuse. Changes in the intensity measured by sources and detectors placed on the skin are calculated using a simple photon-diffusion theory. In earlier studies, this approach has proven useful in the analysis of multiple scattering effects on pulse oximetry (Schmitt, "A simple Photon Diffusion Analysis of the Effects of Multiple Scattering on Pulse Oximetry", IEEE Trans. Biomed. Eng., Vol. 88 (1991), pages 1194-1203) .
  • k 2 -k 1 ⁇ [exp(- ⁇ t d)-exp(o_d)]/[exp(-o_d)-exp(ad)] ⁇ (lib)
  • the diffuse intensity, I received by a collimated detector located on the opposite side of the tissue slab can then be obtained as follows:
  • ⁇ can be obtained by adding the absorption coefficients of the individual absorbers in the tissue, which mainly comprise hemoglobin, water, and assorted pigment chromophores. By limiting interest to intensities measured at isobestic wavelengths, it is unnecessary to distinguish the volume fractions of venous and arterial blood. With these assumptions, the total absorption coefficient is simply
  • V, and V are the volume fractions of blood and water
  • ⁇ C a L g represents absorption by other unspecified substances.
  • a pulsatile (“ac”) variation is superimposed on the time- averaged ("dc") intensity received by the detector. The ratio of the pulsatile to the average intensity is then,
  • the quantity (3 ⁇ ⁇ * /2 s ⁇ a ⁇ )1 at a particular wave _length can be obtained by fitting the slope of the In [ r I ( r ) ] - vs - r surface-reemittance curve .
  • a single photodiode 6 e.g., an InGaAs photodiode
  • This optical configuration was chosen to approximate the plane-parallel conditions under which the photon- diffusion model discussed above was desired.
  • Voltages proportional to scattered intensities at both wavelengths of each laser diode were measured simultaneously by a pair of lock- in amplifiers 8a, 8b, each referenced to the modulation frequency of one of the laser diodes by reference oscillators 9a and 9b.
  • the tissue model or phantom shown in Fig. 3 was designed to simulate the optical properties of a moderately-perfused finger.
  • the tissue phantom consisted of two interweaved networks of randomly distributed plastic tubes (0.25 mm ID) embedded in a liquid scattering medium.
  • One network 10 was composed of rigid polystyrene tubing occupying about 2% of the total scattering volume; the other network 11, which occupied about 1% of the scattering volume, was composed of soft silastic tubing.
  • the rigid tubing 10 was filled with a fixed volume of whole blood which simulated the reservoir of non-pulsatile blood in the skin. To simulate a small pulsatile increase in the blood volume, whole blood was injected into the network of silastic tubing.
  • the intensity recorded before injection represented the non-pulsatile component (I, ) and the difference between the intensity recorded before and after injection represented the pulsatile component of the diffuse intensity (I ).
  • Blood samples having a known hematocrit were prepared by mixing packed human red cells and plasma obtained from the blood bank. Before mixing, the initial hematocrit of the packed cells was determined by measuring the cell volume fraction in centrifuged capillary-tube samples.
  • the scattering liquid in which the tubing networks were e bedded consisted of a mixture of 0.99- ⁇ m-diameter polystyrene spheres 12 (Polyscience, Inc.), water, and glycerol in a glass-walled sample chamber (5.9 mm thickness).
  • 1.3 vol.% of spheres were used in a 1:1 mixture of glycerol and water to obtain a transport-corrected scattering coefficient equal to 1.73 mm “ and 1.26 mm “ at 800 and 1300 nm, respectively (values were calculated using Mie scattering theory; the calculated anisotropy parameter of the spheres in the mixture was 0.91 at 820 nm and 0.83 at 1300 nm) .
  • Glycerol which has a lower absorption coefficient than water at 1300 nm (0.044 mm " vs. 0.14 mm- ), was added to reduce the absorption coefficient of the mixture at 1300 nm to about 0.092 mm " .
  • the absorption coefficient of the water/glycerol mixture was very small ( ⁇ 0.003 mm ); therefore, absorption at this wavelength was mainly determined by the volume of blood in the tubing network.
  • FIG. 2 To obtain reemittance measurements from live human skin, the instrumentation shown in Fig. 2 was modified slightly. As shown in Fig. 4, the fiber bundles 2 were replaced by a single optic fiber 13 and the light from both laser diodes la and lb was focused on an end of optic fiber 13. An identical optic fiber 14 was attached to the photodiode 6. To adjust the distance between the source and detector fibers (13 and 14), a calibrated position was used. Figure 4 shows a human finger 15 positioned between optical fibers 13 and 14.
  • Photoplethysmograms were recorded holding the tip of the optic fiber 13 against the top surface of the index finger 15. A photodiode 6 contacted the bottom surface of the finger 15 via optic fiber 14. In another embodiment, optical fiber 14 was eliminated and the lower surface of finger 15 rested on photodiode 6.
  • the output signals from the lock-in amplifiers were band ⁇ pass filtered (0.5 - 10 Hz) to separate the ac and dc intensity signals, which were subsequently processed using a microcomputer-based data acquisition system (not shown) .
  • Fig. 3a The intensity of light transmitted through a 1.85 mm thick sample of fresh, fully oxygenated whole blood at 800 nm and 1300 nm is shown in Fig. 3a as a function of blood hematocrit.
  • the photon path lengths in skin tissue at 800 nm and 1300 nm are not well-defined; they depend on the concentration of the absorbing substances (mainly water and hemoglobin) and scatterers in the skin, as well as the dimensions of the illuminated volume.
  • the blood absorption values were calculated according to Eqs. (3) and (4) , using the measured absorption data plotted in Fig. 1; the scattering coefficient of blood was calculated by Mie theory (Bonner, Vol. 4, supra ..
  • the scattering coefficients shown in Table 1 were estimated using the surface-ree ittance measurement technique discussed above. According to the Table 1 values, the optical coefficients of the in vitro model used in the present experiments corresponded to those of a 10 mm-thick finger containing 1-3 vol.% of blood and 65 vol.% of water.
  • the ratio varied by a factor of about 2.5 over the range of hematocrits between 15% and 60%.
  • the volume of blood in the rigid tubing network (denoted as "V, " in the figure) , which mainly affected the background absorption at 830 nm, did not appear to have a strong effect on the R vs. H relationship.
  • the theoretical curves shown in the figure, which were obtained using the photon-diffusion theory discussed above fit the experimental data well.
  • the ac-dc intensity ratio at each wavelength was calculated using Eq. (14), with 1. given by Eq. (12).
  • the total absorption coefficient of the experimental scattering medium was calculated by adding the absorption coefficients of the water/glycerol mixture and blood (Table 1), according to Eq. (13), and the total scattering coefficient was assumed to be equal to that of the polystyrene spheres in the water/glycerol mixture.
  • the present invention provides a method and apparatus which can be used to non-invasively measure blood hematocrit by dual- wavelength, near-infrared photoplethysmography.

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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Appareil et procédé de mesure des hématocrites sanguins consistant à faire passer une première et une seconde longueurs d'ondes de lumière à travers un échantillon sanguin, à déterminer le rapport entre des facteurs de transmissions diffuses pulsatiles et non pulsalites mesurés à chacune des première et seconde longueurs d'ondes de lumière provenant de l'échantillon sanguin, et à déterminer les hématocrites sanguins de l'échantillon sanguin à partir du rapport entre les facteurs de transmissions diffuses pulsatiles et non pulsatiles mesurés à chacune des première et seconde longueurs d'ondes de lumière provenant de l'échantillon sanguin. L'une des première et seconde longueurs d'ondes de lumière se trouve à l'intérieur de la région isobestique d'oxyhémoglobine et l'autre se trouve à l'intérieur de la région isobestique de désoxyhémoglobine. Un tissu fantôme de simulation des propriétés optiques d'un doigt perfusé est utilisé pour tester le procédé et l'appareil.
PCT/US1993/000334 1992-01-17 1993-01-15 Procede optique de controle des hematocrites dans le sang arteriel WO1993013706A2 (fr)

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EP0693900A4 (fr) * 1993-04-12 1997-05-07 Noninvasive Medical Technology Systeme et procede de surveillance non invasive de l'hematocrite
EP0648085A4 (fr) * 1993-05-07 1997-02-12 Biotek Instr Inc Simulation pour oxymetre par impulsions.
US5791345A (en) * 1993-09-03 1998-08-11 Toa Medical Electronics Co., Ltd. Non-invasive blood analyzer
US5598842A (en) * 1993-09-03 1997-02-04 Toa Medical Electronics Co., Ltd. Non-invasive blood analyzer and method using the same
WO1995020757A1 (fr) * 1994-01-31 1995-08-03 Minnesota Mining And Manufacturing Company Procede et appareil de prediction non sanglante d'hematocrite
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