Method and system for non-invasive determination of blood-related parameters

• US 7,020,506 B2
• Filed: 11/06/2003
• Issued: 03/28/2006
• Est. Priority Date: 11/06/2003
• Status: Active Grant

• Current Assignee: OrSense Ltd.
• Original Assignee: OrSense Ltd.
• Inventors: Fine, Ilya, Gandelman, Iosef, Fikhte, Boris, Finarov, Alexander
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/702,044
• Publication Number:
  US 20050101846A1
• Time in Patent Office: 873 Days
• Field of Search: 600309-310, 600/335, 600/316, 600/547, 600/322
• US Class Current: 600/316
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/0095 by applying light and detecting acoustic waves, i.e. photoacoustic measurements
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01N 2291/02466 Biological material, e.g. blood
• CPC Class Codes: G01N 29/2418 using optoacoustic interaction with the material, e.g. laser radiation, photoacoustics photoacoustic cells G01N21/1702; measuring characteristics of vibrations by using radiation-sensitive means G01H9/00; acousto-optical conversion techniques for short-range imaging G01S15/8965; sound-producing devices using laser bundle G10K15/046

Abstract

A method and system for measuring time variations of a response of a blood perfused fleshy medium to an external electromagnetic field is provided. The response of the medium to the external electromagnetic field can be a photo-acoustic signal, obtained in response to the exciting light, and/or impedance of the medium, in response to the applied ac electromagnetic field. Measurements of the time variations of the response of the medium are carried out when the condition of artificial kinetics is created and maintained over a certain time period by applying primary over-systolic pressure to a certain location at the medium with normal blood flow, so as to achieve a state of temporary blood flow cessation at the medium downstream of the certain location. When required, the control of the condition of the artificial kinetics can be further achieved by applying a perturbation of secondary pressure to the fleshy medium.

Claims

1. A non-invasive method for use in determining at least one desired characteristic of blood of a patient, 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;

(b) applying an external electromagnetic field to the measurement location;

(c) detecting a time response of the medium from at least a portion of the measurement location to said external electromagnetic field, the response including at least one of an acoustic response to illuminating incident light having a wavelength in a range where the scattering properties of blood are sensitive to light radiation or an impedance of the portion of the medium;

(d) generating measured data indicative of time evolutions of the response of the medium over at least a part of said certain time period;

(e) analyzing said measured data for determining at least one characteristic parameter derived from said time response of the medium, the characteristic parameter including at least one of an actual value of the time response at a certain moment, during said certain time period, chosen when the response attains its near asymptotic magnitude; and

a parametric slope defined as a ratio between a first function depending on a time response of the medium corresponding to a first frequency of the external electromagnetic field or a second function depending on the time response of the medium corresponding to a second frequency;

(f) providing predetermined reference data sensitive to patient individuality and indicative of the desired blood characteristic obtained by other independent method as a function of said at least one characteristic parameter; and

(g) utilizing the determined characteristic parameter derived from said time response of the medium and said predetermined reference data for obtaining a value of the desired blood characteristic.

2. The method of claim 1 further comprising:

altering said condition of the artificial blood kinetics at the measurement location over a predetermined time interval within said certain time period so as to modulate properties of the blood affecting said time response.

3. The method of claim 2 wherein said altering of the condition of artificial blood kinetics includes applying a perturbation to the medium by at least one secondary pressure pulse of a predetermined value over said predetermined time interval.

4. The method of claim 3 wherein the predetermined value of the secondary pressure is in the range of about 0–

300 mmHg.

5. The method of claim 2 wherein said altering of the condition of artificial blood kinetics includes applying a perturbation to the medium by secondary pressure of a predetermined cyclic pattern over said predetermined time interval.

6. The method of claim 5 wherein said predetermined cyclic pattern is in the form of secondary pressure pulses having amplitudes in the range of about 0–

300 mmHg.

7. The method of claim 1, wherein said reference data is a calibration curve defining a dependence of the characteristic parameter on the desired blood characteristic.

8. The method of claim 1, wherein said first and second functions are logarithmic functions of the response corresponding to the first and second frequencies, respectively.

9. The method of claim 1, wherein said first and second functions are a time rate of the changes of the response corresponding to the first and second frequencies, respectively.

10. The method of claim 1 wherein said creating of the condition of artificial kinetics includes applying primary over-systolic pressure to a certain location at the medium with a normal blood flow upstream of the measurement location so as to achieve a state of temporary blood flow cessation in the medium at the measurement location.

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

12. The method of claim 1 wherein said at least one desired characteristic of the patient'"'"'s blood is a concentration of glucose therein.

13. A system for non-invasive determination of at least one desired characteristic of blood of a patient, the system comprising:

(i) a pressurizing assembly arranged for creating a condition of artificial blood kinetics at a measurement location in a patient'"'"'s blood perfused fleshy medium and at least maintaining this condition for a certain time period, the pressurizing assembly comprising a primary occlusion cuff for applying a primary over-systolic pressure to the fleshy medium at a primary pressure location, and a secondary occlusion cuff for applying a secondary pressure to the flesh medium at a secondary pressure location, thereby altering the condition of the artificial blood kinetics at said secondary pressure location over a predetermined time interval within said certain time period so as to modulate properties of the blood affecting said time response;

(ii) a measuring probe including

a source of an external electromagnetic field configured for applying said external electromagnetic field to said measurement location, and

a detecting module configured for detecting a time response of the medium from at least a portion of the measurement location to said external electromagnetic field; and

(iii) a control unit electrically coupled to said pressurizing assembly, said control unit including;

a memory for storing reference data sensitive to patient individuality and indicative of the desired blood characteristic as a function of a characteristic parameter derived from said time response; and

a data acquisition and processing utility coupled to the detecting module for receiving and analyzing measured data therefrom and configured to utilize the reference data and determine said at least one desired blood characteristic.

14. The system of claim 13 wherein said primary pressure location is selected upstream of the secondary pressure location with respect to the normal blood flow direction in the medium, said secondary pressure location being in the vicinity of the measurement location.

15. The system of claim 13 wherein said measuring probe includes a photo-acoustic system, where said source of the external electromagnetic field being configured for generating a light beam in the wavelength range where the scattering or absorbing properties of the patients blood are sensitive to provide an acoustic response, and where said detecting module is an acoustic detector.

16. The system of claim 13 wherein said measuring probe includes a system for measuring impedance of at least a portion of the medium at the measurement location.

17. The system of claim 13 wherein said reference data is a calibration curve defining a dependence of the characteristic parameter on the desired blood characteristic.

18. The system of claim 17 wherein said at least one characteristic parameter is an actual value of the time response at a certain moment during said certain time period.

19. The system of claim 18 wherein said certain moment is chosen when the response attains its near asymptotic magnitude.

20. The system of claim 13 wherein said characteristic parameter is a parametric slope defined as a ratio between a first function depending on a time response of the medium corresponding to a first frequency of the external electromagnetic field and a second function depending on the time response of the medium corresponding to a second frequency.

21. The system of claim 20 wherein said first and second functions are logarithmic functions of the response corresponding to the first and second frequencies, respectively.

22. The system of claim 20 wherein said first and second functions are a time rate of the changes of the response corresponding to the first and second frequencies, respectively.

23. The system of claim 13 wherein said at least one desired characteristic of the patient'"'"'s blood is a concentration of glucose therein.

24. A system for non-invasive determination of at least one desired characteristic of blood of a patient, the system comprising:

(i) a pressurizing assembly arranged for creating a condition of artificial blood kinetics at a measurement location in a patient'"'"'s blood perfused fleshy medium and at least maintaining this condition for a certain time period;

(ii) a measuring probe comprising

a source of an external electromagnetic field configured for applying said external electromagnetic field to said measurement location, said source of the external electromagnetic field being configured for generating a light beam in the wavelength range where the scattering or absorbing properties of the patients blood are sensitive to provide an acoustic response, and

a detecting module comprising an acoustic detector configured for detecting a time response of the medium from at least a portion of the measurement location to said external electromagnetic field; and

(iii) a control unit electrically coupled to said pressurizing assembly, said control unit comprising

a memory for storing reference data sensitive to patient individuality and indicative of the desired blood characteristic as a function of a characteristic parameter derived from said time response; and

a data acquisition and processing utility coupled to the detecting module for receiving and analyzing measured data therefrom and configured to utilize the reference data and determine said at least one desired blood characteristic.

25. The system of claim 24 wherein said pressurizing assembly includes a primary occlusion cuff for applying a primary over-systolic pressure to the fleshy medium at a primary pressure location.

26. The system of claim 25 wherein said pressurizing assembly further includes a secondary occlusion cuff for applying a secondary pressure to the flesh medium at a secondary pressure location, thereby altering said condition of the artificial blood kinetics at said secondary pressure location over a predetermined time interval within said certain time period so as to modulate properties of the blood affecting said time response.

27. The system of claim 26 wherein said primary pressure location is selected upstream of the secondary pressure location with respect to the normal blood flow direction in the medium, said secondary pressure location being in the vicinity of the measurement location.

28. The system of claim 24 wherein said measuring probe includes a system for measuring impedance of at least a portion of the medium at the measurement location.

29. The system of claim 24 wherein said reference data is a calibration curve defining a dependence of the characteristic parameter on the desired blood characteristic.

30. The system of claim 29 wherein said at least one characteristic parameter is an actual value of the time response at a certain moment during said certain time period.

31. The system of claim 30 wherein said certain moment is chosen when the response attains its near asymptotic magnitude.

32. The system of claim 24 wherein said characteristic parameter is a parametric slope defined as a ratio between a first function depending on a time response of the medium corresponding to a first frequency of the external electromagnetic field and a second function depending on the time response of the medium corresponding to a second frequency.

33. The system of claim 32 wherein said first and second functions are logarithmic functions of the response corresponding to the first and second frequencies, respectively.

34. The system of claim 32 wherein said first and second functions are a time rate of the changes of the response corresponding to the first and second frequencies, respectively.

35. The system of claim 24 wherein said at least one desired characteristic of the patient'"'"'s blood is a concentration of glucose therein.