Compact apparatus for noninvasive measurement of glucose through near-infrared spectroscopy

• US 20060116562A1
• Filed: 01/18/2006
• Published: 06/01/2006
• Est. Priority Date: 03/08/2002
• Status: Abandoned Application

• Current Assignee: George M. Acosta, James R. Henderson, Kevin H. Hazen, N. Alan Abul Haj, Stephen L. Monfre, Thomas B. Blank, Timothy L Ruchti
• Original Assignee: George M. Acosta, James R. Henderson, Kevin H. Hazen, N. Alan Abul Haj, Stephen L. Monfre, Thomas B. Blank, Timothy L Ruchti
• Inventors: Henderson, James R., Ruchti, Timothy L., Abul Haj, N. Alan, Acosta, George M., Monfre, Stephen L., Hazen, Kevin H., Blank, Thomas B.
• Application Number:
  US11/335,067
• Publication Number:
  US 20060116562A1
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 2562/0242 for varying or adjusting the optical path length in the tissue
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 2562/227 Sensors with electrical connectors
• CPC Class Codes: A61B 2562/228 Sensors with optical connectors
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• 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
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/49 within a body or fluid

Abstract

The invention involves the monitoring of a biological parameter through a compact analyzer. The preferred apparatus is a spectrometer based system that is attached continuously or semi-continuously to a human subject and collects spectral measurements that are used to determine a biological parameter in the sampled tissue. The preferred target analyte is glucose. The preferred analyzer is a near-IR based glucose analyzer for determining the glucose concentration in the body.

Claims

1. An apparatus for noninvasive measurement of an analyte property using spectroscopy, comprising:

a sample module;

that is positioned proximate to a sample site during collection of a sample spectrum;

a base module, physically separated from said sample module, said base module and said sample module each comprising a wireless communication system for communication there between; and

a source located in said sample module;

said base module comprising means for any of generating said analyte property using said spectrum and recording said analyte property generated from said sample spectrum.

2. The apparatus of claim 1, said wireless communication system comprising a two-way wireless communication system.

3. The apparatus of claim 2, wherein said base module is worn by a person.

4. The apparatus of claim 3, said base module comprising a remote display and receiving unit.

5. The apparatus of claim 4, said base module comprising a data processing system.

6. The apparatus of claim 1, said sample module comprising a data collection system.

7. The apparatus of claim 6, said sample module further comprising:

an optic that is positioned in close proximity to said sample site to reduce specular reflectance.

8. The apparatus of claim 7, said sample module further comprising:

a detector array.

9. The apparatus of claim 8, further comprising:

a first optic located in an optical train after said source to remove photonic heat from said optical train; and

a second optic located in said optical train after said first optic and before a sample site.

10. The apparatus of claim 9, wherein at least one of said first optic and said second optic removes source light otherwise detected by said detector as second order light from said grating.

11. The apparatus of claim 8, wherein said detector array is optically coupled to a wavelength separation device.

12. The apparatus of claim 1, said analyte property comprising:

glucose concentration.

13. The apparatus of claim 12, said analyzer either continuously or semi-continuously monitoring said glucose concentration.

14. The apparatus of claim 13, further comprising:

means for enhancing equilibration in glucose concentration between said sample site and finger blood glucose concentration.

15. The apparatus of claim 13, further comprising:

means for bias correcting at least one of spectra (X) and glucose concentration data (Y).

16. The apparatus of claim 1, said sample module either continuously or semi-continuously samples said sample site in an automated fashion, wherein time between sampling comprises any of about:

seconds;

one minute;

five minutes;

ten minutes;

twenty minutes;

a half hour; and

one hour.

17. The apparatus of claim 1, said source comprising an incandescent lamp.

18. The apparatus of claim 1, said source comprising at least one light emitting diode.

19. The apparatus of claim 1, further comprising:

means for automated delivery of a coupling fluid to said sample site prior to sampling.

20. The apparatus of claim 1, further comprising:

means for optically detecting proximate contact of said sample module with said sample site.

21. The apparatus of claim 1, further comprising:

means for performing an indirect determination of said analyte property using said sample spectrum.

22. The apparatus of claim 1, further comprising:

means for measuring a reference spectrum and a wavelength standardization spectrum through spectroscopic measurement of a minimally absorbing substance and a material with known and immutable spectral absorbance bands.

23. The apparatus of claim 1, said base module further comprising:

means for calibrating to an individual or a group of individuals based upon a calibration data set comprised of paired data points of processed spectral measurements and reference biological parameter values.

24. The apparatus of claim 1, wherein said sample module is replaceably attached to a docking station:

wherein said docking station comprises a computer and an analyte property management center; and

wherein said analyte property management center keeps track of events occurring over time.

25. The apparatus of claim 1, further comprising:

means for taking any of continuous and semi-continuous measurements when said sample module is in proximate contact with said sample site.

26. The apparatus of claim 1, wherein said sample module is supported by said sample site during collection of said sample spectrum.

27. The apparatus of claim 1, said spectroscopy comprising near-infrared spectroscopy.

28. The apparatus of claim 1, said sample module further comprising:

a Fabry-Perot interferometer.

29. A method for noninvasive measurement of an analyte property using near-infrared spectroscopy, comprising the steps of:

providing an analyzer for collecting a near-infrared spectrum of a human tissue sample site; and

estimating said analyte property through application of a multivariate calibration model on said spectrum;

wherein the step of providing said analyzer comprises the steps of;

providing a base module and a sample module that is positioned proximate a sample site during collection of a sample spectrum, and;

that is physically separated from said base module, said base module and said sample module each comprise a wireless communication system for communication there between; and

providing a source located in said sample module;

said base module either of generating said analyte property using said spectrum and recording said analyte property generated from said sample spectrum.