Capillary tube hemoglobinometer and oximeter

• US 5,061,632 A
• Filed: 01/31/1989
• Issued: 10/29/1991
• Est. Priority Date: 01/31/1989
• Status: Expired due to Fees

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Steinke, John M., Shepherd, A. P.
• Primary Examiner(s): WARDEN, JILL ALICE
• Application Number:
  US07/304,744
• Time in Patent Office: 1,001 Days
• Field of Search: 422/73, 422/82.05, 436/66, 436/68, 436/69, 356/41, 356/339, 356/341
• US Class Current: 436/66
• CPC Class Codes: G01N 2021/3144 for oxymetry
• CPC Class Codes: G01N 2021/3155 Measuring in two spectral ranges, e.g. UV and visible
• CPC Class Codes: G01N 2021/3181 using LEDs
• CPC Class Codes: G01N 21/314 with comparison of measurements at specific and non-specific wavelengths dual wavelength spectrometry G01J3/427

Abstract

An oximeter that measures both the total hemoglobin concentration in whole, undiluted blood and the percentage of the hemoglobin saturated with oxygen. The oximeter uses red and infrared light-emitting diodes to illuminate a capillary tube filled with a sample of whole, undiluted blood. Light scattered by the blood travels a short distance down the length of the capillary tube and reaches a photodetector, the output of which is amplified, digitized, and fed to a microprocessor. The microprocessor computes the total hemoglobin concentration as a nonlinear monotonic function of the infrared light intensity. Oxyhemoglobin saturation is computed from the ratio of the logarithms of the intensities of red and infrared light. The invention provides a measurement of oxygen saturation without calibration shifts present in other oximeters due to fluctuations in total hemoglobin concentration. In addition, the present invention is accurate over a wide range of oxygen saturation, and the blood samples are not diluted or hemolyzed and can thus be preserved for further analysis.

Claims

1. Apparatus for measuring total hemoglobin concentration and percent oxygen saturation in a sample of whole, undiluted blood, comprising:

an elongated cuvette for holding a whole undiluted blood sample;

means for selectively illuminating said blood sample with infrared light and red light, the infrared light and red light entering the cuvette at predetermined locations along an axis of the cuvette;

means associated with said cuvette for sensing infrared light intensity, IR, and red light intensity, R, at a predetermined measuring location along the axis of the cuvette remote from said predetermined locations at which the infrared light and red light enter the cuvette, and for generating signals indicative of IR and R;

processing means for receiving said signals and for calculating total hemoglobin (Hb), and percent oxygen saturation, SO2, based on the signals, (Hb) being calculated as a first calibrated function of IR, SO2 being calculated as a second calibrated function of (LogR/LogIR), the second calibrated function being related to the calculated (Hb).

2. The apparatus of claim 1, further comprising a housing for holding the illuminating means and detecting means, said housing having a bore for selectively retaining the cuvette.

3. The apparatus of claim 2, wherein the housing comprises a cylindrical block including an axial bore for selectively retaining the cuvette and radial bores for housing the means for selectively illuminating and said means for sensing.

4. The apparatus of claim 1, wherein the illuminating means comprise:

an infrared light source for emitting infrared light oriented substantially perpendicular to a longitudinal axis of the cuvette; and

a red light source for emitting red light oriented substantially perpendicular to the longitudinal axis of the cuvette.

5. The apparatus of claim 4, further comprising means for directing light from the cuvette to the means for sensing substantially as an exit light beam oriented perpendicular to the longitudinal axis of the cuvette.

6. The apparatus of claim 5, wherein the infrared and red light sources and light directing means are oriented whereby the infrared light and red light are laterally offset at selected angles in relation to the exit light beam.

7. The apparatus of claim 1, wherein the first calibrated function is a monotonic function.

8. The apparatus of claim 7, wherein the first calibrated function is a polynomial function approximated by the equation:

space="preserve" listing-type="equation">(Hb)=A.sub.0 =A.sub.1 IR+... +A.sub.n IR.sup.n

wherein n is an integer greater than or equal to 2, and A₀, A₁, ..., A_n are n+1 calibration constants.

9. The apparatus of claim 8, wherein n is 2.

10. The apparatus of claim 8, wherein n is 3.

11. A method for measuring total hemoglobin concentration and percent oxygen saturation in a sample of whole, undiluted blood, comprising:

selectively scattering infrared and red light through a whole, undiluted blood sample;

measuring infrared light intensity, IR, and red light intensity, R, at a predetermined location, such that total hemoglobin concentration, (Hb), is a monotonic function of IR;

approximating the monotonic function with a first calibrated equation;

calculating (Hb) from IR based on the first calibrated equation; and

determining a second calibrated equation for calculating percent oxygen saturation, SO2, as a function of (LogR/LogIR) based on the calculated (Hb).

12. The method of claim 11, wherein the first calibrated equation is a polynomial equation.

13. The method of claim 11, wherein the second calibrated equation is linear.

14. The method of claim 13, wherein the second calibrated equation is determined by:

determining a first intermediate equation representing the logarithm of R divided by the logarithm of IR for 0% oxygen saturated blood, (LogR/LogIR)_0%, as a function of (Hb);

determining a second intermediate equation representing the logarithm of R divided by the logarithm of IR for 100% oxygen saturated blood, (LogR/LogIR)_100%, as a function of (Hb);

calculating (LogR/LogIR)_0% corresponding to the calculated (Hb) based on the first intermediate equation;

calculating (LogR/LogIR)_100% corresponding to the calculated (Hb) based on the second intermediate equation;

calculating SO2 from the second calibrated equation, the second calibrated equation being;

##EQU2##

15. The method of claim 14, wherein the first intermediate equation is:

space="preserve" listing-type="equation">(LogR/LogIR).sub.0% =C.sub.0 +C.sub.1 (Hb)+... +C.sub.n (Hb).sup.n

wherein n is an integer greater than or equal to 2 and C₀, C₁, ..., C_n are n+1 calibration constants.

16. The method of claim 15, wherein n is 3.

17. The method of claim 14, wherein the second intermediate equation is:

space="preserve" listing-type="equation">(LogR/LogIR).sub.100% =D.sub.0 +D.sub.1 (Hb)+... +D.sub.n (Hb).sup.n

wherein n is an integer greater than or equal to 2 and D₀, D₁, ..., D_n are n+1 calibration constants.

18. The method of claim 17, wherein n is 3.