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

• US 7,317,939 B2
• Filed: 04/24/2006
• Issued: 01/08/2008
• Est. Priority Date: 12/22/1999
• Status: Expired due to Fees

• Current Assignee: OrSense Ltd.
• Original Assignee: OrSense Ltd.
• Inventors: Shvartsman, Leonid, Fine, Ilya
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US11/409,034
• Publication Number:
  US 20060200014A1
• Time in Patent Office: 624 Days
• Field of Search: 600/310, 600/316, 600/322, 600/323, 600/324, 600/328, 600/335
• 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. An apparatus for use in non-invasive measurements on a patient'"'"'s body, the apparatus comprising:

a blood flow affecting unit configured and operable to create and maintain a state of blood flow cessation in a cessation location in the body for a predetermined time period;

an illumination/detection system configured and operable to carry out optical measurements with at least two selected different wavelengths of incident radiation on a measurement location, which is identical or adjacent to said cessation location, during at least said predetermined period of time, and generating measured data representative of light response of the measurement location to said incident radiation of at least two different wavelengths; and

a control unit connectable to the illumination/detection unit and preprogrammed to be responsive to the measured data for processing said data for determining a relation between time variations of the light response signals of said at least two different wavelengths for at least a certain time interval of said predetermined time period, analyzing said relation utilizing reference data based on a model corresponding to effects occurring before, during, and after the blood flow cessation state, and determining and displaying at least one of the following parameters of the patient blood or tissue;

concentration of glucose, concentration of hemoglobin, hematocrit, and oxygen saturation.

2. The apparatus according to claim 1, wherein said blood flow affecting unit comprises an occlusion assembly configured and operable to apply certain over-systolic pressure to the patient'"'"'s body to create the blood flow cessation state at the cessation location.

3. The apparatus according to claim 1, wherein the control unit is configured to operate the illumination/detection system and perform preliminary optical measurements for detecting the existence of the blood flow cessation state.

4. The apparatus according to claim 1, wherein the control unit is adapted to maintain said state of the blood flow cessation during the predetermined time period which is insufficient for irreversible changes to occur in the patient'"'"'s blood perfused fleshy medium.

5. The apparatus according to claim 4, wherein said predetermined time period is from one second to several minutes.

6. The apparatus according to claim 1, wherein the control unit is adapted to select for said processing the measured data corresponding to said preset time interval which is an initial time interval corresponding to relatively strong changes of the light response with time, as compared to a next, asymptotic time interval of said predetermined time period.

7. The apparatus according to claim 1, wherein the control unit is adapted to select for said processing the measured data corresponding to said preset time interval which is an asymptotic time interval corresponding to relatively slow changes of the light response with time, as comparedto an initial time interval of said predetermined time period.

8. The apparatus according to claim 1, wherein the control unit operates to process and analyze the measured data to determine a difference in the refractive indices of hemoglobin erythrocytes and plasma, (n_Hb−

n_pl).

9. The apparatus according to claim 1, wherein the control unit comprises a memory utility for storing reference data indicative of a parametric slope for said at least two time variations for said at least two selected wavelengths as a function of values of the desired parameter.

10. The apparatus according to claim 9, wherein the control unit is adapted to analyze the measured data by determining said parametric slope, and using said reference data to determine a corresponding value of the desired parameter.

11. The apparatus according to claim 10, wherein said control unit operates to determine the parametric slope by determining a function T_λ

2(T<sub>λ

1</sub>) for said at least a certain time interval of the predetermined time period, where T<sub>λ

2</sub> and T<sub>λ

1</sub> are the measured light responses for the wavelengths λ

₂ and λ

₁ of the incident radiation, respectively.

12. The apparatus according to claim 10, wherein said control unit operates to determine the parametric slope by determining a function log T_λ

2(log T<sub>λ

1</sub>) for said at least a certain time interval of the predetermined time period, wherein T<sub>λ

2</sub> and T<sub>λ

1</sub> are the measured light responses for the wavelengths λ

₂ and λ

₁ of the incident radiation, respectively.

13. The apparatus according to claim 1, wherein said illumination/detection assembly is configured for operating with the wavelengths of light in a range of 600-1600 nm.

14. The apparatus according to claim 13, wherein the at least two selected wavelengths are in the ranges of 600-1100 nm and 1100-1400 nm, respectively, thereby enabling determination of at least the concentration of hemoglobin.

15. The apparatus according to claim 13, wherein the at least two selected wavelengths are in the ranges of 600-930 nm and 940-980 nm, thereby enabling determination of at least the concentration of hemoglobin.

16. The apparatus according to claim 13, wherein the at least two selected wavelengths are in the ranges of 1500-1600 nm and 600-1300 nm, respectively, thereby enabling determination of at least the concentration of glucose.

17. The apparatus according to claim 13, wherein said at least two wavelengths are in the ranges of 600-780 nm and 820-980 nm, respectively, thereby enabling determination of at least the oxygen saturation.

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

creating a state of blood flow cessation of the patient'"'"'s blood within a cessation location, and maintaining said state during a predetermined time period;

performing optical measurements on a measurement location, which is identical or adjacent to said cessation location, during at least said predetermined time period with at least two different wavelengths, and generating measured data indicative of time variations of at least two light responses from the measurement location for said at least two different wavelengths, respectively;

analyzing the measured data, utilizing reference data based on a model corresponding to effects occurring before, during, and after the blood flow cessation state, for determining a relation between said at least two time variations for at least a certain time interval of said predetermined time period, to determine and display at least one of the following parameters of the patient'"'"'s blood or tissue;

concentration of glucose, concentration of hemoglobin, hematocrit, an oxygen saturation.

19. The method according to claim 18, wherein said creating of the state of the blood flow cessation in the cessation location comprises applying an occlusion mode to the patient'"'"'s blood perfused fleshy medium.

20. The method according to claim 19, wherein said applying of the occlusion mode comprises applying over-systolic pressure to the patient'"'"'s blood perfused fleshy medium.

21. The method according to claim 20, comprising performing preliminary optical measurements for detecting the existence of the blood flow cessation state.

22. The method according to claim 18, wherein said predetermined time period is insufficient for irreversible changes to occur in the patient'"'"'s blood perfused fleshy medium.

23. The method according to claim 22, wherein said predetermined time period is from one second to several minutes.

24. The method according to claim 18, wherein said preset time interval is an initial time interval corresponding to relatively strong changes of the light response with time, as compared to a next, asymptotic time interval of said predetermined time period.

25. The method according to claim 18, wherein said preset time interval is an asymptotic time interval corresponding to relatively slow changes of the light response with time, as compared to an initial time interval of said predetermined time period.

26. The method according to claim 18, wherein the at least two different wavelengths are in a range of 600-1600 nm.

27. The method according to claim 18, comprising determining a difference in the refractive indices of hemoglobin erythrocytes and plasma, (n_Hb−

n_pl).

28. The method according to claim 18, wherein the analyzing of the measured data comprises:

determining a parametric slope for said at least two time variations for said at least two wavelengths selected in accordance with the desired parameter to be determined; and

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

29. The method according to claim 28, wherein said determining of the parametric slope comprises determining a function T_λ

2(T<sub>λ

1</sub>) for said at least a certain time interval of the predetermined time period, where T<sub>λ

2</sub> and T<sub>λ

1</sub> are the measured light responses for the wavelengths λ

₂ and λ

₁ of the incident radiation, respectively.

30. The method according to claim 29, wherein said preset time interval is an initial time interval corresponding to relatively strong changes of the light response with time, as compared to a next, asymptotic time interval of said predetermined time period.

31. The method according to claim 29, wherein said preset time interval is an asymptotic time interval corresponding to relatively slow changes of the light response with time, as compared to an initial time interval of said predetermined time period.

32. The method according to claim 28, wherein said determining of the parametric slope comprises determining a function log T_λ

2(log T<sub>λ

1</sub>) for said at least a certain time interval of the predetermined time period, wherein T<sub>λ

2</sub> and T<sub>λ

1</sub> are the measured light responses for the wavelengths λ

₂ and λ

₁ of the incident radiation, respectively.

33. The method according to claim 30, wherein said preset time interval is an initial time interval corresponding to relatively strong changes of the light response with time, as compared to a next, asymptotic time interval of said predetermined time period.

34. The method according to claim 30, wherein said preset time interval is an asymptotic time interval corresponding to relatively slow changes of the light response with time, as compared to an initial time interval of said predetermined time period.

35. The method according to claim 28, wherein said calibration curve is determined from values of the parametric slope and values of the desired parameter obtained for different patients.

36. The method according to claim 35, comprising plotting said calibration curve by performing multiple-occlusion measurement sessions on the measurement location with the at least two selected different wavelengths, determining the parametric slope values for each occlusion measurement session, and determining the oxygen saturation in the blood perfused fleshy medium of said patient outside the measurement location.

37. The method according to claim 18, wherein the at least two selected wavelengths are in the ranges of 600-1100 nm and 1100-1400 nm, respectively, thereby enabling determination of the concentration of hemoglobin.

38. The method according to claim 18, wherein the at least two selected wavelengths are in the ranges of 600-930 nm and 940-980 nm, thereby enabling determination of the concentration of hemoglobin.

39. The method according to claim 18, wherein the at least two selected wavelengths are in the ranges of 1500-1600 nm and 600-1300 nm, respectively, thereby enabling determination of the concentration of glucose.

40. The method according to claim 18, wherein said at least two wavelengths are in the ranges of 600-780 nm and 820-980 nm, respectively, thereby enabling determination of oxygen saturation.