Claims Analysis
Total Claims: 29
Claim 1
Independent Claim
235 words
A method of determining one or more unknown values of known characteristics, such as the concentration of an analyte, of a biological fluid in a mammal, said method comprising: (a) irradiating said biological fluid having said unknown values of said known characteristics with infrared energy having at least several wavelengths so that there is differential absorption of at least some of said wavelengths by said biological fluid as a function of said wavelengths and said characteristics, said differential absorption causing intensity variations of said wavelengths incident from said biological fluid as a function of said wavelengths and said unknown values of said known characteristics, or as a function of said wavelengths and said characteristics, or as a function of said characteristics having unknown values; (b) measuring said intensity variations from said biological fluids; and (c) calculating said unknown values of said known characteristics in said biological fluid from said measured intensity variations utilizing an algorithm and a mathematical calibration model, said algorithm including all independent sources of intensity variations v. wavelength information obtained from irradiating a set of samples in which said values of said known characteristics are known, said algorithm also including more wavelengths than samples in said set of samples, said model being constructed from said set of samples and being a function of said known values and characteristics and said intensity variations v. wavelength information obtained from irradiating said set of samples.
Claim 2
Independent Claim
235 words
A method of determining one or more unknown values of known characteristics, such as the concentration of an analyte, of a biological fluid in a mammal, said method comprising: (a) irradiating said biological fluid having said unknown values of said known characteristics with infrared energy having at least several wavelengths so that there is differential absorption of at least some of said wavelengths by said biological fluid as a function of said wavelengths and said characteristics, said differential absorption causing intensity variations of said wavelengths incident from said biological fluid as a function of said wavelengths and said unknown values of said known characteristics, or as a function of said wavelengths and said characteristics, or as a function of said characteristics having unknown values; (b) measuring said intensity variations from said biological fluids; and (c) calculating said unknown values of said known characteristics in said biological fluid from said measured intensity variations utilizing an algorithm and a mathematical calibration model, said algorithm including all independent sources of intensity variations v. wavelength information obtained from irradiating a set of samples in which said values of said known characteristics are known, said algorithm also including more wavelengths than samples in said set of samples, said model being constructed from said set of samples and being a function of said known values and characteristics and said intensity variations v. wavelength information obtained from irradiating said set of samples.
Claim 3
Dependent Claim
14 words
The method of claim 1 wherein the fluid is irradiated in vivo and non-invasively.
Claim 4
Dependent Claim
14 words
The method of claim 1 wherein the fluid is irradiated in viva and invasively.
Claim 5
Dependent Claim
12 words
The method of claim 1 wherein the fluid is irradiated in vitro.
Claim 6
Independent Claim
15 words
The method in any of claims 1-4, wherein said infrared energy is near infrared energy.
Claim 7
Independent Claim
23 words
The method of any of claims 1-5, wherein said algorithm is selected from the group including, partial least squares and principle component regression.
Claim 8
Independent Claim
47 words
The method of either of claims 2 or 3, wherein said biological fluid is irradiated by directing said infrared energy so that it is incident on a portion of said mammal which includes said biological fluid, so that said biological fluid partially absorbs said incident infrared energy.
Claim 9
Dependent Claim
23 words
The method as set forth in claim 7, wherein said infrared energy incident on said portion of said mammal passes through said portion.
Claim 10
Dependent Claim
32 words
The method as set forth in claim 8, wherein said infrared energy incident on said portion of said mammal is partially absorbed by said portion and partially diffusely reflected from said portion.
Claim 11
Independent Claim
23 words
The method as set forth in any of claims 1-9, further including the step of detecting outlier samples in said set of samples.
Claim 12
Dependent Claim
66 words
The method as set forth in claim 10, wherein said detection of outlier samples in said set includes the step of comparing said intensity v. wavelength responses of each sample n said set to said model, and determining a measure of the magnitude of the difference between said intensity v. wavelength responses of each of said samples and said model in response to the comparing step.
Claim 13
Dependent Claim
82 words
The method as set forth in claim 11, wherein said detection of outlier samples in said set includes comparing said known values of said characteristics of each sample in said set to the calculated value of said characteristic, said calculated value being based on said model estimate of said value of said characteristic for each of said samples, and determining a measure of the magnitude of the difference between said known value of said characteristic and said calculated value of said characteristic.
Claim 14
Independent Claim
45 words
The method as set forth in either of claims 11 or 12, further comprising indicating the probability of said magnitude being caused by random chance by using a statistical test, and classifying as outliers said samples in said set having an excessively low determined probability.
Claim 15
Independent Claim
19 words
The method as set forth in claims 12 or 13 wherein the statistical test is the F ratio test.
Claim 16
Dependent Claim
221 words
Apparatus for determining at least one unknown value of a known characteristic, such as the concentration of an analyte, in a biological fluid, said apparatus comprising: (A) a source of infrared energy having at least several wavelengths (B) means for coupling said at least several wavelengths of said infrared energy to said biological fluid to enable said biological fluid to differentially absorb at least some of said wavelengths, said differential absorption causing intensity variations of said infrared energy incident from said biological fluid as a function of said at least several wavelengths of said energy and said unknown value of said known characteristics; (C) means for measuring said intensity variations; and (D) computer means including: i. a stored model constructed from a set of samples in which the values of said known characteristic are known, said model being a function of said known values from said set of samples and intensity v. wavelength information obtained from said set of samples, and ii. an algorithm for utilizing (a) all independent sources of said intensity variations v. said wavelengths information from both said set of samples and said biological fluid and (b) more wavelengths than samples, said algorithm utilizing said model for calculating said unknown value of said known characteristic of said biological fluid from said measured intensity variations from said biological fluid.
Claim 17
Dependent Claim
221 words
Apparatus for determining at least one unknown value of a known characteristic, such as the concentration of an analyte, in a biological fluid, said apparatus comprising: (A) a source of infrared energy having at least several wavelengths (B) means for coupling said at least several wavelengths of said infrared energy to said biological fluid to enable said biological fluid to differentially absorb at least some of said wavelengths, said differential absorption causing intensity variations of said infrared energy incident from said biological fluid as a function of said at least several wavelengths of said energy and said unknown value of said known characteristics; (C) means for measuring said intensity variations; and (D) computer means including: i. a stored model constructed from a set of samples in which the values of said known characteristic are known, said model being a function of said known values from said set of samples and intensity v. wavelength information obtained from said set of samples, and ii. an algorithm for utilizing (a) all independent sources of said intensity variations v. said wavelengths information from both said set of samples and said biological fluid and (b) more wavelengths than samples, said algorithm utilizing said model for calculating said unknown value of said known characteristic of said biological fluid from said measured intensity variations from said biological fluid.
Claim 18
Dependent Claim
30 words
The apparatus as set forth in claim 15, further including means for determining whether said intensity variations v. wavelength of said known characteristic in said biological fluid is an outlier.
Claim 19
Dependent Claim
23 words
The apparatus as set forth in either claim 15 or 16, wherein said means for coupling includes an attenuated total reflectance (ATR) device.
Claim 20
Dependent Claim
25 words
The apparatus as set forth in claim 17, further including a flow cell, said ATR device being positioned in said cell for in vitro sampling.
Claim 21
Dependent Claim
40 words
The apparatus as set forth in claim 17, wherein said ATR crystal has a biocompatible coating on at least a portion thereof whereby said portion of said ATR device can be placed in contact with said biological fluid in vivo.
Claim 22
Dependent Claim
21 words
The apparatus as set forth in either claim 15 or 16, wherein said means for coupling includes a fiber optic device.
Claim 23
Dependent Claim
20 words
The apparatus as set forth in claim 20, wherein a portion of said fiber optic device forms an ATR device.
Claim 24
Dependent Claim
41 words
The apparatus as set forth in claim 20, wherein said fiber optic device includes a portion for transmitting said infrared energy to said biological fluid and a separate portion for transmitting said infrared energy from said biological fluid to said apparatus.
Claim 25
Independent Claim
53 words
The apparatus as set forth in either of claims 15 or 16, wherein said apparatus includes a first portion which can be positioned on one side of an in vivo source of biological fluid and a second portion which can be positioned on another side of said in vivo source of biological fluid.
Claim 26
Independent Claim
45 words
The apparatus as set forth in either of claims 15 or 16, wherein said means for coupling includes means for transmitting said infrared energy to an in vivo source of said biological fluid and means for measuring diffuse infrared reflection from said in vivo source.
Claim 27
Independent Claim
33 words
The apparatus as set forth in either of claims 15 or 16, further including means for transmitting signals from said computer means to a means for changing said value of said known characteristic.
Claim 28
Dependent Claim
17 words
The apparatus as set forth in claim 25, wherein said means for changing is an insulin pump.
Claim 29
Dependent Claim
65 words
The apparatus of claim 15 or 16, wherein said means for measuring said intensity variations includes an array of infrared sensors, means for frequency dispersing said intensity variations of said at least several wavelengths onto said sensors, different ones of said sensors being provided for different ones of said at least several wavelengths, so that said different ones of said sensors derive different electric signals.