Method and system for use in non-invasive optical measurements of blood parameters

• US 6,993,372 B2
• Filed: 06/03/2003
• Issued: 01/31/2006
• Est. Priority Date: 06/03/2003
• Status: Active Grant

• Current Assignee: OrSense Ltd.
• Original Assignee: OrSense Ltd.
• Inventors: Fine, Ilya, Finarov, Alexander
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US10/452,932
• Publication Number:
  US 20040249252A1
• Time in Patent Office: 973 Days
• Field of Search: 600309-310, 600322-323, 600334-335
• US Class Current: 600/335
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips

Abstract

A method and device are presented for use in non-invasive optical measurements of at least one desired characteristic of patient'"'"'s blood. A condition of artificial blood kinetics is created at a measurement location in a patient'"'"'s blood perfused fleshy medium and maintained for a certain time period. This condition is altered over a predetermined time interval within said certain time period so as to modulate scattering properties of blood. Optical measurements are applied to the measurement location by illuminating it with incident light beams of at least two different wavelengths in a range where the scattering properties of blood are sensitive to light radiation, detecting light responses of the medium, and generating measured data indicative of time evolutions of the light responses of the medium for said at least two different wavelengths, respectively, over at least a part of said predetermined time interval.

Claims

1. A method for use in non-invasive optical measurements in a patient'"'"'s body, the method comprising:

(a) creating a condition of artificial blood kinetics at a measurement location in a patient'"'"'s blood perfused fleshy medium and maintaining this condition for a certain time period, the creation of the artificial blood kinetics comprising applying primary over-systolic pressure to achieve a state of temporary blood flow cessation in the medium at the measurement location, the primary over-systolic pressure being applied either to a certain location upstream of the measurement location with respect to a normal blood flow direction in the medium or to the vicinity of the measurement location;

(b) altering said condition of artificial blood kinetics at the measurement location over a predetermined time interval within said certain time period so as to modulate an optical response by changing scattering properties of blood, said altering of the condition of artificial blood kinetics including applying a perturbation to the medium by at least one secondary pressure pulse of a predetermined value over said predetermined time interval; and

(c) applying optical measurements to the measurement location by illuminating the measurement location with incident light beams of at least two different wavelengths in a range where the light radiation is sensitive to scattering properties of blood, detecting light responses of the medium, and generating measured data indicative of time evolutions of the light responses of the medium for said at least two different wavelengths, respectively, over at least a part of said predetermined time interval.

2. The method of claim 1, comprising:

analyzing the measured data for determining a parameter derived from scattering spectral features of the medium as a relation between the different time evolutions of the light responses of the medium; and

utilizing the calculated parameter and predetermined reference data, created during a calibration procedure and being indicative of a desired blood characteristic as a function of the parameter derived from scattering spectral features of the medium, thereby enabling a determination of a value of the desired blood characteristic.

3. The method of claim 2 wherein said reference data is a calibration curve defining a dependence of the parameter on the desired blood characteristic.

4. The method of claim 2 wherein said parameter is a parametric slope defined as a ratio between a first function depending on a light response of the medium corresponding to one wavelength and a second function depending on the light response of the medium corresponding to another wavelength, said one wavelength and another wavelength being selected from said at least two different wavelengths.

5. The method of claim 4 wherein said first and second functions are logarithmic functions of the light response corresponding to said at least two different wavelengths, respectively.

6. The method of claim 4 wherein said first and second functions are a time rate of the changes of light response signal.

7. The method of claim 1, wherein said certain time period is insufficient for irreversible changes in the fleshy medium.

8. The method of claim 1 wherein the predetermined value of the secondary pressure is in the range from zero to an over-systolic pressure higher than said primary over-systolic pressure value.

9. The method of claim 1 wherein the predetermined value of the secondary pressure is in a range over said primary over-systolic pressure value.

10. The method of claim 1 wherein said altering of the conditions of artificial blood kinetics includes applying perturbations to the medium by secondary pressure of a predetermined cyclic pattern over said predetermined time interval.

11. A method for use in non-invasive optical measurements of at least one desired characteristic of patient'"'"'s blood, the method comprising:

(a) creating a condition of artificial blood kinetics at a measurement location in a patient'"'"'s blood perfused fleshy medium and maintaining this condition for a certain time period, the creation of the artificial blood kinetics comprising applying primary over-systolic pressure to achieve a state of temporary blood flow cessation in the medium at the measurement location, the primary over-systolic pressure being applied either to a certain location upstream of the measurement location with respect to a normal blood flow direction in the medium or to the vicinity of the measurement location;

(b) altering said condition of artificial blood kinetics at the measurement location over a predetermined time interval within said certain time period so as to modulate scattering properties of blood, said altering of the condition of artificial blood kinetics including applying perturbations to the medium by secondary pressure of a predetermined cyclic pattern over said predetermined time interval; and

(c) applying optical measurements to the measurement location by illuminating the measurement location with incident light beams of at least two different wavelengths in a range where the light radiation is sensitive to scattering properties of blood, detecting light responses of the medium, and generating measured data indicative of time evolutions of the light responses of the medium for said at least two different wavelengths, respectively, over at least a part of said predetermined time interval.

12. The method of claim 11 wherein said predetermined cyclic pattern is in the form of secondary pressure pulses having amplitudes in the range from zero to an over-systolic pressure higher than said primary over-systolic pressure.

13. The method of claim 11 wherein said predetermined cyclic pattern is in the form of secondary pressure pulses having amplitudes in a range over said primary over-systolic pressure.

14. The method of claim 11, wherein said at least two different wavelengths are in the red-NIR range.

15. The method according to claim 11, wherein said at least one desired characteristic of patient'"'"'s blood is selected from the following:

concentration of a substance in patient'"'"'s blood, oxygen saturation, Erythrocyte Sedimentation Rate (ESR) and Erythrocyte Aggregation Rate (EAR).

16. The method according to claim 15 wherein said substance is selected from glucose and hemoglobin.

17. The method of claim 11 wherein said altering of the condition of artificial blood kinetics includes applying the perturbation to the medium by at least one secondary pressure pulse of a predetermined value over said predetermined time interval.

18. The method of claim 11, comprising:

analyzing the measured data for determining a parameter derived from scattering spectral features of the medium as a relation between the different time evolutions of the light responses of the medium; and

utilizing the calculated parameter and predetermined reference data, created during a calibration procedure and being indicative of the desired blood characteristic as a function of the parameter derived from scattering spectral features of the medium, thereby enabling determining a value of the desired blood characteristic.

19. The method of claim 18 wherein said reference data is a calibration curve defining a dependence of the parameter on the desired blood characteristic.

20. The method of claim 11, comprising:

analyzing the measured data for determining a parameter derived from scattering spectral features of the medium as a relation between the different time evolutions of the light responses of the medium; and

utilizing the calculated parameter and predetermined reference data, sensitive to patient individuality, and indicative of the desired blood characteristic as a function of the parameter derived from scattering spectral features of the medium, for determining a value of the desired blood characteristic of the patient.

21. The method of claim 20, wherein said reference data is a calibration curve defining a dependence of the parameter on the desired blood characteristic.

22. The method of claim 18 wherein said parameter is a parametric slope defined as a ratio between a first function depending on a light response of the medium corresponding to one wavelength and a second function depending on the light response of the medium corresponding to another wavelength, said one wavelength and another wavelength being selected from said at least two different wavelengths.

23. The method of claim 22 wherein said first and second functions are logarithmic functions of the light response corresponding to said at least two different wavelengths, respectively.

24. The method of claim 22 wherein said first and second functions are a time rate of changes of light response signal.

25. The method of claim 18, wherein said parameter is a time dependent function of a parametric slope, which is defined as a ratio between a first function depending on a light response of the medium corresponding to one wavelength and a second function depending on the light response of the medium corresponding to another wavelength, said one wavelength and another wavelength being selected from said at least two different wavelengths.

26. The method of claim 11 wherein said certain time period is insufficient for irreversible changes in the fleshy medium.

27. The method of claim 11 wherein said at least two different wavelengths are in the red-NIR range.

28. The method of claim 11 wherein said at least one desired characteristic of patient'"'"'s blood is selected from the following:

concentration of a substance in patient'"'"'s blood, oxygen saturation, Erythrocyte Sedimentation Rate (ESR) and Erythrocyte Aggregation Rate (EAR).

29. The method of claim 28, wherein said substance is selected from glucose and hemoglobin.

30. A method for use in non-invasive optical measurements in a human body, the method comprising:

applying a primary over-systolic pressure to a patient'"'"'s blood perfused fleshy medium at a location in vicinity of a measurement location to thereby create a condition of artificial blood kinetics at the measurement location, and maintaining this condition for a certain time period;

varying the over-systolic pressure in the vicinity of the measurement location by applying, over a predetermined time interval, a perturbation to the medium by at least one secondary pressure pulse of a predetermined profile, starting from said primary over-systolic pressure value, thereby altering said condition of artificial blood kinetics at the measurement location over said predetermined time interval within said certain time period so as to modulate scattering properties of blood; and

applying optical measurements to the measurement location by illuminating the measurement location with incident light beams of at least two different wavelengths in a range where the light radiation is sensitive to scattering properties of blood detecting light responses of the medium, and generating measured data indicative of time evolutions of the light responses of the medium for said at least two different wavelengths, respectively, over at least a part of said predetermined time interval.

31. An optical system for use in non-invasive optical measurements in a human body, the system comprising:

(A) a probe including;

(i) two substantially U-shaped portions configured for enclosing and holding a portion of the patient'"'"'s flesh medium therebetween and carrying an optical measuring unit operable for illuminating a measurement location on a patient'"'"'s blood perfused flesh medium with different wavelengths of incident light, detecting light responses of the medium, and generating measured data indicative of time evolutions of the light responses of the medium corresponding to the different wavelengths of incident light, respectively; and

(ii) a pressurizing assembly operable for applying pressure to the patient'"'"'s fleshy medium, the pressurizing assembly comprising a drive assembly operable to move the U-shaped portions towards one another, and thereby apply the primary and secondary pressure to the portion of the medium enclosed therebetween;

(B) a control unit connectable to said measuring unit and said pressurizing assembly for synchronizing the operation thereof so as to apply a primary over-systolic pressure to a certain location on the medium to create a condition of artificial blood kinetics in the medium at the measurement location and maintain this condition for a certain time period, to apply a secondary controllably varying pressure to the fleshy medium in the vicinity of the measurement location so as to alter said condition of artificial blood kinetics over a predetermined time interval within said certain time period thereby modulating scattering properties of blood, and to apply the optical measurements while altering the condition of the artificial blood kinetics, the control unit comprising;

(a) a memory for storing reference data sensitive to patient individuality and indicative of a desired blood characteristic as a function of a parameter derived from scattering spectral features of the medium, and (b) a data acquisition and processing utility coupled to output of the measuring unit for receiving and analyzing the measured data to utilize the reference data and determine said at least one desired blood characteristic.

32. The system of claim 31 wherein said pressurizing assembly includes:

a primary occlusion cuff for applying said primary over-systolic pressure to the fleshy medium at a first location upstream of the measurement location with respect to the normal blood flow direction in the medium,

a secondary occlusion cuff for applying the secondary pressure to the flesh medium at a second location, said secondary pressure being controllably variable up to over-systolic pressure values, and

a pressure driver assembly actuated by the control unit for operating the primary and secondary occlusion cuffs.

33. The system of claim 31 wherein said reference data is a calibration curve defining a dependence of the parameter on the desired blood characteristic.

34. The system of claim 33 wherein said parameter is a parametric slope defined as a ratio between a first function depending on a light response of the medium corresponding to one wavelength and a second function depending on the light response of the medium corresponding to another wavelength, said one wavelength and another wavelength are selected from said at least two different wavelengths.

35. The system of claim 31 wherein dimensions of the U-shaped portions are such that one of them can enter into the other onto a predetermined distance.

36. The system of claim 31, wherein the pressurizing assembly includes an air cushion mounted on an inner side of at least one of the U-shaped portions and connected to the driver operable by the control unit to apply a controllable variable pressure to the portion of the medium enclosed between the two U-shaped portions.

37. The system of claim 31 wherein the measuring unit is operable in a transmission mode.

38. The system of claim 31 wherein the measuring unit is operable in a reflection mode.

39. The system of claim 31, wherein said parameter is a time dependent function of a parametric slope, which is defined as a ratio between a first function depending on a light response of the medium corresponding to one wavelength and a second function depending on the light response of the medium corresponding to another wavelength, said one wavelength and another wavelength being selected from said at least two different wavelengths.

40. A probe for use in non-invasive optical measurements in a human body, the probe including:

(a) two substantially U-shaped portions configured for enclosing and holding a portion of a patient'"'"'s blood perfused flesh medium therebetween and being driven to move one towards the other,

(B) a measuring unit operable for illuminating a measurement location on the portion of the medium with different wavelengths of incident light beams, detecting light responses of the medium, and generating measured data indicative of time evolutions of the light responses of the medium corresponding to the different wavelengths of incident light, respectively; and

(C) a pressurizing assembly associated with at least one of the U-shaped portions and operable for moving the U-shaped portion one towards the other to thereby apply a primary over-systolic pressure to the fleshy medium so as to create a condition of artificial blood kinetics in the fleshy medium and maintain this condition for a certain time period and to apply a secondary controllably varying over-systolic pressure to the fleshy medium, so as to alter said condition of artificial blood kinetics over a predetermined time interval within said certain time period, thereby to modulate scattering properties of blood.

41. The probe of claim 40 wherein said measuring unit includes:

an illumination assembly providing unobstructed optical transmission to the portion of the medium via a first aperture arranged in one of the U-shaped portions; and

a light detection assembly configured for receiving the light radiation transmitted through the medium via a second aperture configured in the other U-shaped portion.

42. The probe of claim 40 wherein the measuring unit is operable in a transmission mode.

43. The probe of claim 40 wherein the measuring unit is operable in the reflection mode.