Method for non-invasive blood analyte measurement with improved optical interface

• US 6,152,876 A
• Filed: 10/19/1998
• Issued: 11/28/2000
• Est. Priority Date: 04/18/1997
• Status: Expired due to Term

• Current Assignee: Rio Grande Medical Technologies Incorporated
• Original Assignee: Rio Grande Medical Technologies Incorporated
• Inventors: Robinson, Mark Ries, Messerschmidt, Robert G.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/174,812
• Time in Patent Office: 771 Days
• Field of Search: 600/310, 600/322, 600/323, 600/473, 356/39-41, 514/744, 514/937, 514/941, 252/408.1, 252/582
• US Class Current: 600/322
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters

Abstract

A method for non-invasively measuring the concentration of an analyte, particularly blood analyte in blood. The method utilizes spectrographic techniques in conjunction with an improved optical interface between a sensor probe and a skin surface or tissue surface of the body containing the blood to be analyzed. An index-matching medium is disclosed to improve the interface between the sensor probe and skin surface during spectrographic analysis. In a preferred embodiment, the blood analyte concentration in blood is quantified utilizing a partial squares analysis relative to a model incorporating analysis of plural known blood samples.

Claims

1. A non-invasive method for measuring the concentration of blood analyte in human tissue comprising the steps of:

providing an apparatus for measuring infrared absorption, said apparatus including an energy source emitting infrared energy at multiple wavelengths, including selected wavelengths relevant to analyte concentration due to absorption by said analyte, operatively connected to an input element, said apparatus further including an output element operatively connected to a spectrum analyzer;

providing an index-matching medium, said index-matching medium having minimal absorption of infrared energy at said selected wavelengths and a refractive index of between about 1.30 and 1.45, and disposing a quantity of said medium between said human tissue and said input element and output element to couple said elements to said analyte-containing tissue through said index-matching medium; and

,

irradiating said tissue through said input element with said multiple wavelengths of infrared energy so that there is differential absorption of at least some of said wavelengths; and

,

collecting at least a portion of the non-absorbed infrared energy with said output element for analysis of absorption with subsequent calculation of blood analyte concentration utilizing an algorithm and a model.

2. The method of claim 1, wherein said input element and output element are incorporated into a single sensor element.

3. The method of claim 1, wherein said index-matching medium has a refractive index closely matched to that of the tissue being irradiated.

4. The method of claim 1, wherein said index-matching medium further comprises a diagnostic additive dispersed therein.

5. The method of claim 4, wherein said diagnostic additive is a spectrographically active agent showing sharp absorbance at a wavelength other than said selected wavelengths.

6. The method of claim 4, wherein said diagnostic additive is selected from the group consisting of:

perfluoro-2-butyltetrahydrofuran, perfluorosuccinyl chloride and mixtures thereof.

7. The method of claim 1, wherein said index-matching medium further comprises a physiological additive.

8. The method of claim 7, wherein said physiological additive is a vasodilating agent.

9. The method of claim 8, wherein said agent is selected from the group consisting of:

methyl nicotinate, minoxidil, nitroglycerin, histamine, menthol, capsaicin and mixtures thereof.

10. A non-invasive method for measuring the concentration of blood analyte in human tissue comprising the steps of:

providing an apparatus for measuring infrared absorption, said apparatus including an energy source emitting infrared energy at multiple wavelengths, including selected wavelengths relevant to analyte concentration due to absorption by said analyte, operatively connected to an input element, said apparatus further including an output element operatively connected to a spectrum analyzer;

providing an index-matching medium, said index-matching medium including a chlorofluorocarbon polymer, and disposing a quantity of said medium between said human tissue and said input element and output element to couple said elements to said analyte-containing tissue through said index-matching medium; and

,

irradiating said tissue through said input element with said multiple wavelengths of infrared energy so that there is differential absorption of at least some of said wavelengths; and

,

collecting at least a portion of the non-absorbed infrared energy with said output element for analysis of absorption with subsequent calculation of blood analyte concentration utilizing an algorithm and a model.

11. The method of claim 10, wherein said input element and output element are incorporated into a single sensor element.

12. The method of claim 10, wherein said index-matching medium has a refractive index closely matched to that of the tissue being irradiated.

13. The method of claim 10, wherein said index-matching medium further comprises a diagnostic additive dispersed therein.

14. The method of claim 13, wherein said diagnostic additive is a spectrographically active agent showing sharp absorbance at a wavelength other than said selected wavelengths.

15. The method of claim 13, wherein said diagnostic additive is selected from the group consisting of:

perfluoro-2-butyltetrahydrofuran, perfluorosuccinyl chloride and mixtures thereof.

16. The method of claim 10, wherein said index-matching medium further comprises a physiological additive.

17. The method of claim 16, wherein said physiological additive is a vasodilating agent.

18. The method of claim 17, wherein said agent is selected from the group consisting of methyl nicotinate, minoxidil, nitroglycerin, histamine, menthol, capsaicin and mixtures thereof.

19. A non-invasive method for measuring the concentration of blood analyte in human tissue comprising the steps of:

providing an apparatus for measuring infrared absorption, said apparatus including an energy source emitting infrared energy at multiple wavelengths, including selected wavelengths relevant to analyte concentration due to absorption by said analyte, operatively connected to an input element, said apparatus further including an output element operatively connected to a spectrum analyzer;

providing an index-matching medium, said index-matching medium including a chlorofluorocarbon polymer which is substantially spectroscopically inactive at said selected wavelengths, and disposing a quantity of said medium between said human tissue and said input element and output element to couple said elements to said analyte-containing tissue through said index-matching medium; and

,

irradiating said tissue through said input element with said multiple wavelengths of infrared energy so that there is differential absorption of at least some of said wavelengths; and

,

collecting at least a portion of the non-absorbed infrared energy with said output element followed by calculation of blood analyte concentration utilizing an algorithm and a model.

20. The method of claim 19, wherein said input element and output element are incorporated into a single sensor element.

21. The method of claim 19, wherein said index-matching medium has a refractive index closely matched to that of the tissue being irradiated.

22. The method of claim 19, wherein said index-matching medium further comprises a diagnostic additive dispersed therein.

23. The method of claim 22, wherein said diagnostic additive is a spectrographically active agent showing sharp absorbance at a wavelength other than said selected wavelengths.

24. The method of claim 22, wherein said diagnostic additive is selected from the group consisting of:

perfluoro-2-butyltetrahydrofuran, perfluorosuccinyl chloride and mixtures thereof.

25. The method of claim 19, wherein said index-matching medium further comprises a physiological additive.

26. The method of claim 25, wherein said physiological additive is a vasodilating agent.

27. The method of claim 26, wherein said agent is selected from the group consisting of methyl nicotinate, minoxidil, nitroglycerin, histamine, menthol, capsaicin and mixtures thereof.

28. A fluid composition for providing an optical interface between a skin surface on a body and a spectrographic sensor element when measuring the absorption of infrared energy by constituents under said skin surface within said body at selected multiple wavelengths, said fluid composition comprising:

a non-toxic fluid having a refractive index greater than 1.0; and

an effective amount of diagnostic additive.

29. The fluid composition of claim 28, wherein said diagnostic additive is a spectrographically active agent showing sharp absorbance at a wavelength other than said selected wavelengths.

30. The fluid composition of claim 29, wherein said diagnostic additive is selected from the group consisting of:

perfluoro-2-butyltetrahydrofuran, perfluorosuccinyl chloride and mixtures thereof.

31. A fluid composition for providing an optical interface between a skin surface on a body and a spectrographic sensor element when measuring the absorption of infrared energy by constituents under said skin surface within said body at multiple wavelengths, said fluid composition comprising:

a non-toxic fluid having a refractive index greater than 1.0; and

an effective amount of physiological additive.

32. The fluid composition of claim 31, wherein said physiological additive is a vasodilating agent.

33. The fluid composition claim 32, wherein said agent is selected from the group consisting of:

methyl nicotinate, minoxidil, nitroglycerin, histamine, menthol, capsaicin and mixtures thereof.

34. A fluid composition for providing an optical interface between a skin surface on a body and a spectrographic sensor element when measuring the absorption of infrared energy by constituents under said skin surface within said body at selected multiple wavelengths, said fluid composition comprising:

about 80% to about 99.8% of a chlorofluorocarbon polymer; and

about 0.2% to about 20% of a diagnostic additive.

35. The fluid composition of claim 34, wherein said diagnostic additive is a spectrographically active agent showing sharp absorbance at a wavelength other than said selected wavelengths.

36. The fluid composition of claim 35, wherein said diagnostic additive is selected from the group consisting of:

perfluoro-2-butyltetrahydrofuran, perfluorosuccinyl chloride and mixtures thereof.

37. A fluid composition for providing an optical interface between a skin surface on a body and a spectrographic sensor element when measuring the absorption of infrared energy by constituents under said skin surface within said body at multiple wavelengths, said fluid composition comprising:

about 80% to about 99.8% of a chlorofluorocarbon polymer; and

about 0.2% to about 20% of a physiological additive.

38. The fluid composition of claim 37, wherein said physiological additive is a vasodilating agent.

39. The fluid composition claim 38, wherein said agent is selected from the group consisting of:

methyl nicotinamide, minoxidil, nitroglycerin, histamine, menthol, capsaicin and mixtures thereof.