Apparatus and method for determining analyte concentrations

• US 7,884,933 B1
• Filed: 08/20/2010
• Issued: 02/08/2011
• Est. Priority Date: 05/05/2010
• Status: Expired due to Fees

• Current Assignee: Revolutionary Business Concepts, Inc.
• Original Assignee: Revolutionary Business Concepts, Inc.
• Inventors: Seyl, Craig, Mayer, Carl, Ellenz, John, Kashyap, Dheerendra
• Primary Examiner(s): Toatley; Gregory J
• Assistant Examiner(s): Underwood; Jarreas C
• Application Number:
  US12/860,569
• Time in Patent Office: 172 Days
• Field of Search: 3562371-2416, 3562421-2438, 356426-431, 356600-640
• US Class Current: 356/338
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: G01N 2021/4742 comprising optical fibres
• CPC Class Codes: G01N 21/474 Details of optical heads therefor, e.g. using optical fibres

Abstract

An apparatus and method for determining an analyte concentration of a sample, such as a tissue sample. The apparatus may comprise an emitter, close proximity detectors laterally located less than about 2 mm away from the emitter, and far away detectors laterally located greater than about 0.5 cm away from the emitter. A plurality of wavelengths may be sent from the emitter to the sample, reflected off of the sample, and received by the detectors. The reflectance value measured by the close proximity detectors may be used to calculate one or more scattering coefficients. The reflectance value measured by the far away detectors may be compared with a reflectance value calculated using the scattering coefficients in a numerical inversion of a diffusion model to determine the analyte concentration of the sample.

Claims

1. A method to determine the concentration of analytes in tissues and samples, the method comprising:

a. illuminating a tissue or a sample with a plurality of light wavelengths with one or more light emitters;

b. measuring intensity values of light propagated from the tissue or sample at a plurality of distances from the one or more light emitters with at least one detector configured for detecting light, wherein light is measured at a first lateral distance and at a second lateral distance, wherein the first lateral distance is smaller than the second lateral distance;

c. calculating one or more scattering coefficients μ

_s′

for the plurality of light wavelengths based on the light intensity values measured at the first lateral distance independent of light intensity values measured at the second lateral distance; and

d. calculating analyte concentrations using one or more of the scattering coefficients μ

_s′ and

using the intensity values at the plurality of light wavelengths measured at the second lateral distance without calculating scattering coefficients for the plurality of wavelengths based on the light intensity values measured at the second lateral distance.

2. The method of claim 1, wherein the light wavelengths are in the range of about 500-1350 nm.

3. The method of claim 1, wherein the scattering coefficients are determined in the continuous domain.

4. The method of claim 1, wherein step d comprises calculating a numerical inversion of a diffusion model with the scattering coefficients calculated in step c and the propagated light intensity measured at the second lateral distance at the plurality of wavelengths.

5. The method of claim 4, wherein absorption coefficients μ

_a of the tissue or sample are calculated using an approximation of analyte concentrations.

6. The method of claim 5, further comprising:

using the scattering coefficients μ

_s′ and

the absorption coefficients μ

_a in the diffusion model to determine one or more calculated intensity values of propagated light;

comparing the calculated intensity values of propagated light with the measured intensity values of propagated light measured at the second lateral distance; and

iteratively updating the approximation of analyte concentrations and determining the calculated intensity values of propagated light using the updated approximation of analyte concentrations until the calculated intensity values are within a specified range of the measured intensity values.

7. The method of claim 6, outputting a current value of the approximation of analyte concentrations once the calculated intensity values are within the specified range of the measured intensity values measured at the second lateral distance.

8. The method of claim 1, wherein the first distance is equal to or less than about 2 mm and the second distance is equal to or greater than about 0.5 cm.

9. The method of claim 1, further comprising calculating arterial and venous blood oxygen saturations using the estimated scattering coefficients at the plurality of wavelengths and the calculated analyte concentrations.

10. The method of claim 4, wherein step c of calculating the scattering coefficients μ

_s′

further comprises fitting a line through the scattering coefficients μ

_s′

calculated from the intensity values measured at the first lateral distance at the plurality of wavelengths and restricting all of the scattering coefficients μ

_s′

within a range of plus or minus approximately 1 cm<sup>−

1</sup> or approximately 10% from the line.

11. The method of claim 1, wherein a plurality of intensity measurements are used to calculate the one or more scattering coefficients μ

_s′ and

the plurality of intensity measurements are obtained at several different locations relative to the one or more emitters with each of the several different locations spaced the first lateral distance away from the one or more emitters.

12. A method to determine the concentration of analytes in tissues and samples, the method comprising:

a. illuminating a tissue or a sample with a plurality of light wavelengths in the range of 500-1350 nm with one or more light emitters;

b. measuring intensity values of light propagated from the tissue or sample at a plurality of distances from the one or more light emitters with one or more light detectors, wherein light is measured at a first lateral distance and at a second lateral distance, wherein the first lateral distance is smaller than the second lateral distance;

c. calculating one or more scattering coefficients μ

_s′

for the plurality of wavelengths using the intensity values measured at the first lateral distance; and

d. calculating a numerical inversion of a diffusion model using one or more of the scattering coefficients μ

_s′ and

the measured intensity values of propagated light measured at the second lateral distance to determine the concentration of analytes in the tissue or sample.

13. The method of claim 12, wherein the first lateral distance is less than about 2 mm and the second lateral distance is greater than about 0.5 cm.

14. The method of claim 12, wherein the first lateral distance is less than about 1.3 mm and the second lateral distance is greater than 0.7 cm.

15. The method of claim 12, further comprising evaluating differential path length factors using the scattering coefficients μ

_s′ and

absorption coefficients calculated using the analyte concentrations and comprising computing SpO₂ and SaO₂ based on the differential path length factors.

16. The method of claim 12, further comprising using the analyte concentrations to determine at least one of Hb, HbO, HbAlc, StO₂, and H₂O.

17. The method of claim 12, wherein the detectors measure the propagated light in the continuous domain and determine the scattering coefficients μ

_s′

using continuous domain measurements.

18. The method of claim 12, wherein calculating the numerical inversion of the diffusion model comprises:

using one or more of the scattering coefficients μ

_s′ and

an initial approximation of analyte concentrations as factors in one or more diffusion model equations to determine one or more calculated intensity values of propagated light;

iteratively updating the initial approximation of analyte concentrations and recalculating the calculated intensity values until the calculated intensity values and the measured intensity values measured at the second lateral distance are within a pre-determined range of each other; and

outputting a current updated value of the initial approximation of analyte concentrations when the calculated intensity values are within the predetermined range of the measured intensity values measured at the second lateral distance.

19. A method to determine analyte concentrations in a tissue or sample, the method comprising:

a. illuminating the tissue or sample with a plurality of light wavelengths in the range of 500-1350 nm with one or more light emitters;

b. measuring intensity values of propagated light from the tissue or sample at a plurality of lateral distances from the one or more emitters with one or more light detectors, wherein at least one of the distances is less than about 2 mm and at least one of the distances is greater than about 1 cm;

c. calculating one or more scattering coefficients μ

_s′

at the plurality of wavelengths determined from the intensity values measured at less than about 2 mm; and

d. calculating analyte concentrations using one or more of the scattering coefficient μ

_s′ and

using the intensity values measured for the plurality of wavelengths at a distance greater than about 1 cm.

20. The method of claim 19, wherein the detectors comprise one or more photo detectors located away from the tissue or sample and light reflected from the tissue or sample is collected through one or more optical fibers and transmitted to the one or more photo detectors, wherein each end of the optical fibers is laterally located at less than 2 mm from the one or more light emitters or greater than 1 cm from the one or more light emitters.