Non-invasive sensor having controllable temperature feature

• US 6,662,030 B2
• Filed: 05/18/1998
• Issued: 12/09/2003
• Est. Priority Date: 05/18/1998
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Stalder, Arnold F., Kanger, Johannes S., Bolt, René A., de Mul, Frits F. M., Khalil, Omar S., Lowery, Michael G., Hanna, Charles F., Yeh, Shu-jen, Wu, Xiaomao
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/080,470
• Publication Number:
  US 20020026106A1
• Time in Patent Office: 2,031 Days
• Field of Search: 600/310, 600/322, 600/323, 600/334, 600/316, 600/473, 600/476
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/0242 for varying or adjusting the optical path length in the tissue
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/1491 Heated applicators
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: G01N 21/4795 spatially resolved investigating of object in scattering medium in vivo A61B

Abstract

Devices and methods for non-invasively measuring at least one parameter of a sample, such as the presence or concentration of an analyte, in a body part wherein the temperature is controlled. The present invention measures light that is reflected, scattered, absorbed, or emitted by the sample from an average sampling depth, d_av, that is confined within a temperature controlled region in the tissue. This average sampling depth is preferably less than 2 mm, and more preferably less than 1 mm. Confining the sampling depth into the tissue is achieved by appropriate selection of the separation between the source and the detector and the illumination wavelengths. In another aspect, the invention involves a method and apparatus for non-invasively measuring at least one parameter of a body part with temperature stepping. In another aspect, the invention involves a method and apparatus for non-invasively measuring at least one parameter of a body part with temperature modulation. In another aspect, the invention provides an improved method of measuring at least one parameter of a tissue sample comprising the steps of:

(a) lowering the temperature of said tissue sample to a temperature that is lower than the normal physiological temperature of the body; and

(b) determining at least one optical property of said tissue sample.

Claims

1. A method of determining at least one parameter of a region of tissue of a body having a temperature, said method comprising the steps of:

(a) modulating said temperature of said region of tissue of said body part between at least two values of temperature, whereby temperature of said region of tissue of said body part is controlled;

(b) introducing light at at least one wavelength into said region of tissue of said body part at a surface of said body part and measuring light that is reflected, scattered, absorbed, or emitted by said region of tissue of said body part from an average sampling depth that is confined within said temperature controlled region of tissue of said body part, said average sampling depth not exceeding about 2 mm;

(c) measuring at least one optical property of said region of tissue of said body part, at at least on wavelength, as a function of temperature, to obtain an optical, measurement; and

(d) analyzing the optical measurement of (c) to obtain a determination of said at least one parameter of said region of tissue of said body part, wherein said at least one parameter is the presence or concentration of glucose in said region of tissue of said body part.

2. The method of claim 1 wherein said at least one parameter is the presence of a tissue heterogeneity that has thermal properties different from those of adjacent tissue.

3. The method of claim 1, wherein said at least one parameter is a change in blood circulation.

4. The method of claim 1, wherein said at least one optical property is a scattering coefficient.

5. The method of claim 1, wherein said at least one optical property is an absorption coefficient.

6. The method of claim 1, wherein said optical measurement is performed at two or more wavelengths.

7. The method of claim 1, wherein the area of the body part subject to temperature control is at least two times the area of the body part being optically sampled.

8. The method of claim 1, wherein the area of the body part subject to temperature control is at least five times the area of the body part being optically sampled.

9. The method of claim 1, wherein said at least one wavelength is between 400 nm and 2500 nm, inclusive.

10. The method of claim 1, wherein said at least one wavelength is between 400 nm and 2500 nm, inclusive.

11. The method of claim 1, further comprising the step of correlating the measured optical property with the concentration of glucose in the region of tissue of said body part, said concentration determined by a method independent of steps (a), (b), (c), and (d).

12. The method of claim 11, wherein said step of correlating involves a method selected from the group consisting of least squares, partial least squares, and neural networks.

13. The method of claim 1, wherein said at least one optical property is reflectance.

14. The method of claim 1, wherein said at least one optical property is mean free path.

15. The method of claim 1, wherein said at least one optical property is effective attenuation coefficient.

16. The method of claim 1, wherein said at least one optical property is light penetration depth in tissue.

35. The method of claim 1, wherein said at least one wavelength is between 400 nm and 2500 nm, inclusive.

17. A method of measuring at least one parameter of a region of tissue of a body part at a give temperature, said method comprising the steps of:

(a) decreasing the temperature of said region of tissue of said body part to a temperature that is at or below the normal physiological temperature of said region of tissue of said body part, whereby temperature of said region of tissue of said body part is controlled;

(b) introducing light at at least one wavelength into said region of tissue of said body part at a surface of said body part and measuring light that is reflected, scattered, absorbed, or emitted by said body part from an average sampling depth that is confined within said temperature controlled region of tissue of said body part, said average sampling depth not exceeding about 2 mm;

(c) determining at least one optical property of said region of tissue of said body part at said decreased temperature of step (a);

(d) introducing light at at least one wavelength into said region of tissue of said body part at a surface of said body part and measuring light that is reflected, scattered, absorbed, or emitted by said body part from an average sampling depth that is confined within said temperature controlled region of tissue of said body part;

(e) increasing the temperature of said region of tissue of said body part to a temperature above the normal physiological temperature of said region of tissue of said body part, whereby temperature of said region of tissue of said body part is controlled;

(f) determining at least one optical property of said region of tissue of said body part at said increased temperature of step (e); and

(g) analyzing the optical properties determined in steps (c) and (f) to obtain a measurement of said at least one parameter of said region of tissue of said body part, wherein said at least one parameter is the presence or concentration of glucose in said region of tissue of said body part.

18. The method of claim 17, wherein said at least one optical parameter is scattering coefficient.

19. The method of claim 17, wherein said at least one optical parameter is absorption coefficient.

20. The method of claim 17, further comprising the step of correlating the measured optical property with concentration of an analyte in the body, said concentration determined by a method independent of steps (a), (b), (c), (d), and (e).

21. The method of claim 20, wherein said step of correlating involves a method selected from the group consisting of least squares, partial least squares, and neural networks.

22. The method of claim 17 wherein said parameter is the presence of a tissue heterogeneity that has thermal properties different from those of adjacent tissue.

23. The method of claim 17, wherein said parameter is the presence of a blood circulation change.

24. The method of claim 17, further comprising the step of correlating the measured optical property with concentration of an analyte in the region of tissue in said body part, said concentration determined by a method independent of steps (a), (b), (c), (d), (e), (f), and (g).

25. The method of claim 24, wherein said step of correlating involves a method selected from the group consisting of least squares, partial least squares, and neural networks.

26. The method of claim 17, wherein said at least one optical parameter is reflectance.

27. The method of claim 17, wherein said at least one optical parameter is mean free path.

28. The method of claim 17, wherein said at least one optical parameter is effective attenuation coefficient.

29. The method of claim 17, wherein said at least one optical parameter is light penetration depth in tissue.

30. A method of measuring at least one parameter of a region of tissue of a body part, said method comprising the steps of:

(a) adjusting the temperature of said region of tissue of said body part to a temperature that is substantially the same as the normal core temperature of said body part, whereby temperature of said region of tissue of said body part is controlled;

(b) introducing light at at least one wavelength into said region of tissue of said body part at a surface of said body part and measuring light that is reflected, scattered, absorbed, or emitted by said region of tissue of said body part from an average sampling depth that is confined within said temperature controlled region of tissue of said body part, said average sampling depth not exceeding about 2 mm;

(c) determining at least one optical property of said region of tissue of said body part at said temperature of step (a);

(d) decreasing the temperature of said region of tissue of said body part to a temperature that is at least five degrees lower than the core temperature of said body part;

(e) determining at least one optical property of said region of tissue of said body part at said decreased temperature of step (d);

(f) increasing the temperature of said region of tissue of said body part to a temperature that is above the normal core temperature of said body part;

(g) determining at least one optical property of said region of tissue of said body part at said increased temperature of step (f); and

(h) analyzing the measurements of steps (c), (e), and (g) to obtain a measurement of said at least one parameter of said region of tissue of said body part, wherein said at least one parameter is the presence or concentration of glucose in said region of tissue of said body part.

31. The method of claim 30, wherein said parameter is the presence of a tissue heterogeneity that has thermal properties different from those of adjacent tissue.

32. The method of claim 30, wherein said parameter is the presence of a vascular change.

33. The method of claim 30, wherein the area of the body part subject to temperature control is at least two times the area of the body part being optically sampled.

34. The method of claim 30, wherein the area of the body part subject to temperature control is at least five times the area of the body part being optically sampled.

36. The method of claim 30, wherein said at least one optical parameter is reflectance.

37. The method of claim 30, wherein said at least one optical parameter is mean free path.

38. The method of claim 30, wherein said at least one optical parameter is effective attenuation coefficient.

39. The method of claim 30, wherein said at least one optical parameter is light penetration depth in tissue.

40. An apparatus for measuring concentration of glucose in a region of tissue of a body part comprising:

(a) a temperature controlling element adapted to conform to the surface of said body part, said temperature controlling element capable of controlling the temperature of said region of tissue of said body part;

(b) at least one light transmitting element and at least one light collecting element located within said temperature controlling element (a), said at lest one light transmitting element and said at lest one light collecting element positioned so that light that is measured is reflected, scattered, absorbed, or emitted by said region of tissue of said body part from an average sampling depth that is confined within said temperature controlled region of said body part, said average sampling depth not exceeding about 2 mm;

(c) at least one light source for providing light to said at least one light transmitting element to illuminate said region of tissue of said body part subject to temperature control and at least one detector to measure intensity of light collected from said at least one light collecting element; and

(d) a signal processor to determine an optical property of said region of tissue of said body part, said temperature controlling element capable of controlling the temperature of an area of the body part that is larger than the area of the body part being sampled by the at least one light source and at least one detector.

41. The apparatus of claim 40 where the distance of the at least one light transmitting element from the at least one light collecting element and the wavelengths of the source are selected to limit the depth of penetration in the tissue to that wherein the temperature is being controlled.

42. The apparatus of claim 41, wherein said at least one wavelength is between 400 nm and 2500 nm, inclusive.

43. The apparatus of claim 42, wherein said at least one wavelength is between 600 nm and 1300 nm, inclusive.

44. The apparatus of claim 42, wherein the separation distance between the center of said at least one light transmitting element and the center of said at least one light collecting element is no more than 6 mm.