METHOD OF SAMPLE CONTROL AND CALIBRATION ADJUSTMENT FOR USE WITH A NONINVASIVE ANALYZER
A method and apparatus for easing the use of an optically based noninvasive analyzer is presented. More particularly, a simplified algorithm is used that removes the daily requirement of collecting and using a noninvasive spectrum to update a calibration model. In another embodiment, a guide is used to substantially reduce variation in sample probe placement in relation to a skin tissue sampling site, resulting in the ability to maintain calibration performance with the use of a reference analyte concentration, with or without the use of a reference spectrum collected nearby in time.
1 . A noninvasive method for estimating a biological attribute concentration of human tissue of a tested subject, comprising the steps of:
providing an apparatus for measuring light throughput, said apparatus comprising an energy source emitting light at multiple wavelengths, an input element, an output element, and a spectrum analyzer;
irradiating said tissue through said input element with multiple wavelengths of said light with resulting absorption of at least some of said wavelengths;
prior to said step of irradiating, using light sensitive elements in mechanically positioning along x- and/or y-axes said input element relative to a position of the human tissue, wherein said step of mechanically positioning aligns said input element to a targeted tissue volume;
collecting at least a portion of non-absorbed light with said output element; determining the intensities of said collected light;
generating a model using calibration spectra and calibration reference concentrations;
adjusting said model with at least one direct reference measurement and a corresponding reference spectrum;
collecting at least one noninvasive prediction spectrum of said tissue of said tested subject;
estimating said biological attribute of said specific subject using said adjusted model; and
displaying said estimated biological attribute.
2 . The method of claim 1 , wherein said biological attribute comprises a glucose concentration.
3 . The method of claim 1 , wherein said light comprises wavelengths from 1100 to 1900 nm or at least one sub-range therein.
4 . The method of claim 1 , wherein said noninvasive calibration spectra comprise spectra from any of:
a single individual;
multiple individuals;
a single analyzer; and
multiple analyzers.
5 . The method of claim 1 , wherein said model comprises a multivariate analysis.
6 . The method of claim 5 , wherein said multivariate analysis comprises at least one of principal component regression and partial least squares.
7 . The method of claim 1 , wherein use of said adjusted model occurs for a time period comprising at least one of:
a fraction of a day;
a work day;
a waking portion of a day;
a week; and
a month.
8 . The method of claim 7 , wherein said direct reference measurement comprises any of:
a single reference glucose concentration;
a reference glucose concentration determined before or in time proximity to beginning of said time period;
the first n reference glucose concentrations of said time period; and
a set of at least two glucose concentrations.
9 . The method of claim 7 , wherein said reference spectrum comprises any of
a stored reference spectrum;
a first spectrum of said time period;
a spectrum of said specific subject;
an average of the first n spectra of said time period;
an average of the first n spectra of said specific subject;
a set of at least two spectra of said specific subject; and
a spectrum from a data base, wherein said spectrum is selected based upon at least one spectral feature.
10 . The method of claim 1 , wherein said sample side of said guide comprises at least one of:
a flat surface, and
a surface with a radius of curvature ranging from flat to 1.5 centimeters.
11 . The method of claim 1 , wherein said attachment side of said guide interfaces with at least one of:
a plug;
a photostimulator;
a sample module;
said input element; and
said output element.
12 . The method of claim 1 , further comprising the step of:
blowing air onto said fiber optic input element with a blower to evaporate moisture from said fiber optic input element.