Method of optical measurements for determining various parameters of the patient's blood

• US 7,043,289 B2
• Filed: 03/22/2004
• Issued: 05/09/2006
• Est. Priority Date: 12/22/1999
• Status: Expired due to Term

• Current Assignee: OrSense Ltd.
• Original Assignee: OrSense Ltd.
• Inventors: Shvartsman, Leonid, Fine, Ilya
• Primary Examiner(s): Winakur, Eric F.
• Application Number:
  US10/805,416
• Publication Number:
  US 20040176671A1
• Time in Patent Office: 778 Days
• Field of Search: 600309-310, 600322-324, 600/335, 600/316
• US Class Current: 600/322
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: G01N 2015/0092 Monitoring flocculation or agglomeration
• CPC Class Codes: G01N 2015/012 Red blood cells

Abstract

A method for optical measurements of desired parameters of the patient'"'"'s blood is presented. A state of the blood flow cessation is provided within a measurement region and maintained during a predetermined time period. Measurement sessions are performed within this predetermined time period. Each measurement session includes at least two measurements with different wavelengths of incident light. Obtained measured data is representative of the time dependence of light response of the blood in the measurement region. The analyses of the measured data enables the determination of the desired blood parameters extracted from optical characteristics associated with the erythrocytes aggregation process during the state of the blood flow cessation.

Claims

1. A method for use in non-invasive measurements of chemical compositions of a patient'"'"'s blood, comprising:

creating a state of blood flow cessation of the patient'"'"'s blood within a measurement region of the patient'"'"'s body and maintaining the blood-flow cessation state during a predetermined time period which is insufficient for irreversible changes to occur in the body, thereby affecting an erythrocytes'"'"' aggregation process in the measurement location defining a change in characteristics of the patient'"'"'s blood;

applying an external electromagnetic field to the measurement region within said predetermined time period, and obtaining measured data representative of the time dependence of a response of the blood in the measurement region to said external electromagnetic field, the measured time dependence including an initial time period of the response variation and an asymptotic time period of relatively slow changes of the response as compared to the initial time period; and

analyzing the measured data for determining one or more parameters of the patient'"'"'s blood, including extracting characteristics associated with the erythrocytes aggregation process during the state of the blood flow cessation.

2. The method according to claim 1, wherein said state of the blood flow cessation in the measurement region is provided by applying an occlusion mode to the patient'"'"'s blood perfused fleshy medium.

3. The method according to claim 2, wherein the application of the occlusion mode comprises the application of over-systolic pressure to the patient'"'"'s blood perfused fleshy medium at a location upstream of said measurements region with respect to the direction of the normal blood flow in the patient'"'"'s body.

4. The method according to claim 3, and also comprising the step of preliminary optical measurements for detecting the existence of the blood flow cessation state.

5. The method according to claim 1, wherein said predetermined period of time is from one second to several minutes.

6. The method according to claim 1, wherein the analyzing of the measured data comprises the step of:

determining a Rouleaux Geometry Factor (RGF) characterizing the changes of the response of blood in the state of blood flow cessation, associated with the erythrocytes'"'"' aggregation process, as the function of time and wavelengths of the external electromagnetic field.

7. The method according to claim 6, wherein the determination of the RGF comprises:

determining a ratio Δ

(log T)/Δ

t as the function of wavelength λ

of the external electromagnetic field obtained from the several measurement sessions with different wavelengths, T being the measured response and Δ

t being a preset time interval of said predetermined period of time; and

determining a cut-off wavelength corresponding to the condition Δ

(log T)/Δ

t=0.

8. The method according to claim 7, wherein said preset time interval is the asymptotic time interval.

9. The method according to claim 7, wherein said desired parameter to be determined is an evaluated value of a parameter (n_Hb−

n_pl) for said patient, wherein n_Hb is the refraction index of hemoglobin in erythrocyte, and n_pl is the refraction index of plasma.

10. The method according to claim 9, wherein the evaluation of the parameter (n_Hb−

n_pl) comprises the utilization of theoretical data representative of a scattering function K(x(n_Hb−

n_pl)), wherein x=2π

a/λ

, a being the effective size of erythrocyte.

11. The method according to claim 6, wherein the determination of the RGF comprises:

determining a ratio or Δ

T/Δ

t as the function of wavelength λ

obtained from the several measurement sessions with different wavelengths, T being the measured response and Δ

t being a preset time interval of said predetermined period of time; and

determining a cut-off wavelength is that corresponding to the condition or Δ

T/Δ

t=0.

12. The method according to claim 1, wherein the application of measurements comprises optical measurements with at least two different wavelengths of the external illumination selected in accordance with at least one desired blood parameter to be determined, the analyzing of the measured data comprises:

determining a parametric slope, and using reference data in the form of a calibration curve of the parametric slope as a function of values of the desired parameter.

13. The method according to claim 12, wherein the determination of the parametric slope comprises the determination of a function T_λ

2(T<sub>λ

1</sub>), wherein T<sub>λ

2</sub> and T<sub>λ

1</sub> are the measured data corresponding to the wavelengths λ

₂ and λ

₁ of the incident radiation, respectively, the function T<sub>λ

2</sub>(T<sub>λ

1</sub>) being determined for a preset time interval of said predetermined time period.

14. The method according to claim 13, wherein said preset time interval is the initial time interval.

15. The method according to claim 13, wherein said preset time interval is the asymptotic time interval.

16. The method according to claim 12, wherein the determination of the parametric slope comprises the determination of a function log T_λ

2(log T<sub>λ

1</sub>), wherein T<sub>λ

2</sub> and T<sub>λ

1</sub> are the measured data corresponding to the wavelengths λ

₂ and λ

₁ of the incident radiation, respectively, the function T<sub>λ

2</sub>(T<sub>λ

1</sub>) being determined for a preset time interval of said predetermined time period.

17. The method according to 12, wherein said desired parameter is the concentration of a certain substance in blood.

18. The method according to claim 17, wherein said calibration curve is determined from values of the parametric slope and values of the concentration obtained for different patients.

19. The method according to claim 17, wherein said substance is hemoglobin, the at least two wavelengths being in the ranges of about 600–

1100 nm and about 1100–

1400 nm.

20. The method according to claim 17, wherein said substance is glucose, the at least two wavelengths being in the ranges of 1500–

1600 nm and 600–

1300 nm.

21. The method according to claim 12, wherein said desired parameter is oxygen saturation.

22. The method according to claim 21, wherein the at least two wavelengths are in the ranges of about 600–

780 nm and about 820–

980 nm.

23. The method according to claim 21, wherein the determination of said calibration curve comprises at least one of the following:

the calibration curve is determined from values of the parametric slope and values of the oxygen saturation obtained for different patients; and

the calibration curve is plotted by applying to the patient'"'"'s blood in the measurement region at least two multiple-occlusion measurement sessions with the at least two wavelengths, determining the parametric slope values for each occlusion, and concurrently determining the oxygen saturation in the blood perfused fleshy medium of said patient outside said measurement region.

24. The method according to claim 1, wherein the analyzing of the measured data comprises the determination of Erythrocyte Aggregation Rate, as Δ

T/Δ

t, where T is the measured light response for the external illumination of a certain wavelength and Δ

t is a preset time interval of said predetermined period of time.

25. The method according to claim 24, wherein Δ

t is within the initial time interval or asymptotic time interval.

26. The method according to claim 1, wherein said desired parameter is the concentration of a certain substance in blood.

27. The method according to claim 26, wherein said substance is hemoglobin.

28. The method according to claim 26, wherein said substance is glucose.

29. The method according to claim 1, wherein said desired parameter is oxygen saturation.

30. A method of non-invasive optical measurements in a patient'"'"'s body, the method comprising:

creating a state of blood flow cessation of the patient'"'"'s blood within a measurement region of the patient'"'"'s body and maintaining the blood-flow cessation state during a predetermined time period being insufficient for irreversible changes to occur in the body, thereby affecting an erythrocytes'"'"' aggregation process in the measurement location defining optical characteristics of blood;

applying measurements to the measurement region within said predetermined time period, and obtaining measured data representative of the time dependence of a light response of the blood in the measurement region to incident light of one or more wavelengths, the measured time dependence including an initial time period of the light response variation and an asymptotic time period of relatively slow charges of the light response as compared to the initial time period;

analyzing the measured data for determining one or more chemical compositions of the patient'"'"'s blood, extracted from optical characteristics associated with the erythrocytes aggregation process during the state of the blood flow cessation.

31. An apparatus for non-invasive optical measurements of chemical compositions of the patient'"'"'s blood, the apparatus comprising:

an occlusion assembly adapted for applying pressure to the patient'"'"'s body, so as to create a state of the blood flow cessation in a measurement region in the body for a predetermined time period;

illumination/detection assembly for applying optical measurements with at least two different wavelengths of incident radiation to said measurement region during said predetermined period of time, and generating data representative of light response signals; and

a control unit configured to be responsive to the generated data and preprogrammed for carrying out the following;

determining, from said generated data, measured data in the form of time variations of the light response signals;

utilizing optical characteristics associated with erythrocytes aggregation process during the state of the blood flow cessation to analyze the measured data from within a preset time interval of said predetermined period of time and determine one or more chemical compositions of the patient'"'"'s blood.