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

• US 5,655,530 A
• Filed: 08/09/1995
• Issued: 08/12/1997
• Est. Priority Date: 08/09/1995
• Status: Expired due to Term

• Current Assignee: Rio Grande Medical Technologies Incorporated
• Original Assignee: Rio Grande Medical Technologies Incorporated
• Inventors: Messerschmidt, Robert G.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Winakur, Eric F.
• Application Number:
  US08/512,940
• Time in Patent Office: 734 Days
• Field of Search: 128/633, 128/664, 356/39-41
• US Class Current: 600/366
• 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
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes

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 a blood analyte in human tissue comprising the steps of:

(a) providing an apparatus for measuring infrared absorption, said apparatus including an energy source emitting infrared energy at multiple wavelengths operatively connected to an input element of a sensor element, said apparatus further including an output element within said sensor element operatively connected to a spectrum analyzer;

(b) selecting a sample area on a skin surface of an analyte-containing human tissue;

(c) providing an index-matching medium and disposing a quantity of said medium between said sensor element and said sample area, wherein said index-matching medium comprises a mixture of perfluorocarbons and chlorofluorocarbons;

(d) placing said input element and said output element in contact with said quantity of index-matching medium to couple said sensor element with said analyte-containing tissue through said index-matching medium; and

(e) irradiating said analyte-containing tissue through said input element so that there is differential absorption of at least some of said wavelengths and measuring said differential absorption of said wavelengths through said output element connected to said spectrum analyzer.

2. The method of claim 1, further comprising the step of calculating a concentration of said blood analyte in said analyte-containing tissue with said spectrum analyzer by comparing said differential absorption to a model including differential absorption data on plural known analyte-containing tissue samples.

3. The method of claim 2, wherein a partial least squares analysis is utilized to compare said differential absorption of said analyte-containing tissue to said model.

4. The method of claim 1, wherein said input element and said output element include optical lenses.

5. The method of claim 1, wherein said sample area is a skin surface on an underside of a forearm of a patient.

6. The method of claim 1, wherein said index-matching medium has a refractive index of about 1.30 to about 1.40.

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

(a) providing an apparatus for measuring infrared absorption, said apparatus including an energy source emitting infrared energy at multiple wavelengths operatively connected to an input element of a sensor element, said apparatus further including an output element within said sensor element operatively connected to a spectrum analyzer;

(b) selecting a sample area on a skin surface of an analyte-containing human tissue;

(c) providing an index-matching medium and disposing a first quantity of said medium between said input element and said sample area and a second quantity of index-matching medium between said output element and an opposing surface of said sample area, wherein said index-matching medium comprises a mixture of perfluorocarbons and chlorofluorocarbons;

(d) placing said input element in contact with said first quantity of index-matching medium and said output element in contact with said second quantity of index-matching medium to couple said sensor element with said analyte-containing tissue through said first and said second quantity of index-matching medium; and

,

(e) irradiating said analyte-containing tissue through said input element so that there is differential absorption of at least some of said wavelengths and measuring said differential absorption by transmittance of a portion of said wavelengths through said analyte-containing tissue to said output element connected to said spectrum analyzer.

8. The method of claim 7, further comprising the step of calculating a concentration of said blood analyte in said analyte-containing tissue with said spectrum analyzer by comparing said differential absorption to a model including differential absorption data on plural known analyte-containing tissue samples.

9. The method of claim 8, wherein a partial least squares analysis is utilized to compare said differential absorption of said analyte-containing tissue to said model.

10. The method of claim 7, wherein said input element and said output element include optical lenses.

11. The method of claim 7, wherein said sample area is a skin surface on an underside of a forearm of a patient.

12. The method of claim 7, wherein said index-matching medium has a refractive index of about 1.30 to about 1.40.