Method for non-invasively determining the concentration of an analyte by compensating for the effect of tissue hydration

• US 6,635,491 B1
• Filed: 07/28/2000
• Issued: 10/21/2003
• Est. Priority Date: 07/28/2000
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Kanger, Johannes Sake, de Mul, Frits Frans Maria, Bolt, Rene′ Alexander, Khalil, Omar S.
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): GAKH, YELENA G
• Application Number:
  US09/627,859
• Time in Patent Office: 1,180 Days
• Field of Search: 436/95, 436/164, 436/171, 422/55, 422/68.1, 422/82.05, 422/82.09
• US Class Current: 436/95
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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: G01N 2021/3133 with selection of wavelengths before the sample
• CPC Class Codes: G01N 2021/3155 Measuring in two spectral ranges, e.g. UV and visible
• CPC Class Codes: G01N 2021/3174 Filter wheel
• CPC Class Codes: G01N 21/31 Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry G01N21/72 takes precedence
• CPC Class Codes: G01N 21/314 with comparison of measurements at specific and non-specific wavelengths dual wavelength spectrometry G01J3/427
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/49 within a body or fluid
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A method for determining the concentration of an analyte in tissues. The method involves compensating for a change in the value of an optical property of the tissues, such as, for example, the scattering coefficient, resulting from a change in the hydration status of the tissues. The method comprises the steps of:

(a) measuring at least one optical property of a tissue sample at at least one wavelength at an initial time;

(b) calculating the absorption coefficient and the scattering coefficient of the tissue sample at the initial time;

(c) repeating the measurement of the at least one optical property of the tissue sample at at least a later time at the at least one wavelength;

(d) calculating the absorption coefficient and scattering coefficient of the tissue sample at at least the later time;

(e) calculating the change in the value of the absorption coefficient at the at least one wavelength to indicate the change in the water content of the tissue sample and the change in the value of the scattering coefficient to indicate both the change in the water content of the tissue sample and the change in concentration of an analyte in the tissue sample;

(f) correcting the value of the scattering coefficient to account for the effect of the change in the water content of the tissue sample; and

(g) calculating the concentration of the analyte by means of the corrected value of the scattering coefficient.

Claims

1. A method for determining the concentration of an analyte in a sample of intact tissue, said method comprising the steps of:

(a) measuring at least one optical property of said sample of intact tissue at at least one wavelength at an initial time, said at least one wavelength being in the range of from 550 nm to 1450 nm;

(b) calculating the absorption coefficient and the reduced scattering coefficient of said sample of intact tissue at said initial time;

(c) repeating the measurement of said at least one optical property of said sample of intact tissue at at least a later time at said at least one wavelength;

(d) calculating the absorption coefficient and reduced scattering coefficient of said sample of intact tissue at at least said later time;

(e) calculating the change in the value of the absorption coefficient at said at least one wavelength to indicate the change in the water content of said sample of intact tissue and the change in the value of the reduced scattering coefficient to indicate both the change in the water content of said sample of intact tissue and the change in concentration of an analyte in said sample of intact tissue;

(f) correcting the value of the reduced scattering coefficient to account for the effect of the change in the water content of said sample of intact tissue; and

(g) calculating the concentration of said analyte by means of the corrected value of the reduced scattering coefficient, wherein said light wavelengths at which said absorption coefficient is determined correspond to wavelengths of maximum absorption of a compound that is found in the sample of intact tissue.

2. The method of claim 1, wherein said compound has a substantially high absorptivity.

3. The method of claim 1, wherein said compound is hemoglobin.

4. The method of claim 1, wherein said spectral range of the measurement is between 550 nm and 1100 nm.

5. The method of claim 1, wherein the spectral range of the measurement is between about 500 nm and 1500 nm.

6. The method of claim 1, wherein said light wavelengths at which the reduced scattering coefficient is determined are selected close to the wavelengths at which the absorption coefficients are determined to assure that the light penetrates to the same depth in the sample of intact tissue.

7. The method of claim 1, wherein said analyte is glucose.

8. The method of claim 1, wherein said analyte is urea.