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

• US 6,622,032 B1
• Filed: 09/28/2000
• Issued: 09/16/2003
• Est. Priority Date: 08/09/1995
• Status: Expired due to Fees

• Current Assignee: Inlight Solutions, Inc.
• Original Assignee: Inlight Solutions, Inc.
• Inventors: Messerschmidt, Robert G., Robinson, Mark Ries
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/672,373
• Time in Patent Office: 1,083 Days
• Field of Search: 600/310, 600/322, 600/323, 600/473, 514/744, 514/937, 514/941, 252/408.1, 252/582
• US Class Current: 600/310
• 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 method for evaluating the separation of a sensor element for spectrographic analysis relative to tissue under analysis comprising the steps of:

providing an apparatus for spectrographic analysis, said apparatus including an energy source emitting energy at multiple wavelengths, including selected wavelengths relevant to measuring an attribute of interest in said tissue, an input element, an output element, and a spectrum analyzer;

providing a medium, said medium having a known spectral absorbance, and disposing a quantity of said medium between said tissue and said input element and output element to couple said elements to said tissue through said medium;

irradiating said tissue through said input element with said multiple wavelengths of energy; and

collecting at least a portion of said energy with said output element and evaluating the separation of the sensor element based on the spectral absorbance of the medium.

2. The method of claim 1, wherein evaluating the separation of the sensor element based on the spectral absorbance of the medium comprises evaluating the distance between the tissue and the sensor element.

3. The method of claim 1, further comprising the step of deriving a pathlength correction for the analysis based on the evaluated separation of the sensor element.

4. The method of claim 1, wherein said medium is a fluid composition comprising about 0.2% to about 20% of a compound having a known spectral absorbance.

5. The method of claim 1, further comprising the step of determining the attribute of the interest only when proper coupling is confirmed.

6. A method for evaluating instrument calibration during non-invasive determination of an attribute of tissue comprising the steps of:

providing an apparatus for spectrographic analysis of tissue, said apparatus including an energy source emitting energy at multiple wavelengths, including selected wavelengths relevant to said attribute of tissue, an input element, said apparatus further including an output element and a spectrum analyzer;

providing a medium, said medium having known spectral absorbance, and disposing a quantity of said medium between said tissue and said input element and output element to couple said elements to said tissue through said medium;

irradiating said tissue through said input element; and

collecting at least a portion of the energy with said output element and evaluating instrument calibration utilizing the spectral absorbance of said medium.

7. The method of claim 6, further comprising the step of determining said attribute of tissue only after instrument calibration is confirmed.

8. The method of claim 6, wherein said medium is a fluid composition comprising about 0.2% to about 20% of a compound having said spectral absorbance.

9. The method of claim 6, wherein substantially all of said medium comprises a compound having said known spectral absorbance.