System for non-invasive measurement of glucose in humans
First Claim
1. An apparatus for non-invasive determination of an attribute of human tissue by quantitative near infrared spectroscopy comprising:
- a. an illumination subsystem which generates near infrared light;
b. a tissue sampling subsystem, in optical communication with and receiving light from said illumination subsystem, including means for irradiating human tissue with at least a portion of said received light and collecting at least a portion of said light diffusely reflected from said human tissue;
c. a calibration maintenance subsystem selectively optically coupled to said tissue sampling subsystem for receiving at least a portion of said light and diffusely reflecting a portion thereof;
d. an FTIR spectrometer subsystem selectively optically coupled to (i) said tissue sampling subsystem to receive at least a portion of said light diffusely reflected from said tissue, or (ii) selectively optically coupled to said calibration maintenance subsystem to receive at least a portion of said infrared light diffusely reflected therefrom, or (iii) a combination thereof, said FTIR spectrometer subsystem including a spectrometer that creates an interferogram, said FTIR spectrometer subsystem further including a detector which receives the interferogram and converts said interferogram to a communicable representation;
e. a data acquisition subsystem which receives the communicable representation of the interferogram, said data acquisition subsystem including means for modifying said communicable representation and producing an analyzable representation thereof; and
f. a computing subsystem for receiving said analyzable representation and further including means for determining the attribute from said analyzable representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy.
1 Assignment
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Accused Products
Abstract
An apparatus and method for non-invasive measurement of glucose in human tissue by quantitative infrared spectroscopy to clinically relevant levels of precision and accuracy. The system includes six subsystems optimized to contend with the complexities of the tissue spectrum, high signal-to-noise ratio and photometric accuracy requirements, tissue sampling errors, calibration maintenance problems, and calibration transfer problems. The six subsystems include an illumination subsystem, a tissue sampling subsystem, a calibration maintenance subsystem, an FTIR spectrometer subsystem, a data acquisition subsystem, and a computing subsystem.
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Citations
49 Claims
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1. An apparatus for non-invasive determination of an attribute of human tissue by quantitative near infrared spectroscopy comprising:
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a. an illumination subsystem which generates near infrared light;
b. a tissue sampling subsystem, in optical communication with and receiving light from said illumination subsystem, including means for irradiating human tissue with at least a portion of said received light and collecting at least a portion of said light diffusely reflected from said human tissue;
c. a calibration maintenance subsystem selectively optically coupled to said tissue sampling subsystem for receiving at least a portion of said light and diffusely reflecting a portion thereof;
d. an FTIR spectrometer subsystem selectively optically coupled to (i) said tissue sampling subsystem to receive at least a portion of said light diffusely reflected from said tissue, or (ii) selectively optically coupled to said calibration maintenance subsystem to receive at least a portion of said infrared light diffusely reflected therefrom, or (iii) a combination thereof, said FTIR spectrometer subsystem including a spectrometer that creates an interferogram, said FTIR spectrometer subsystem further including a detector which receives the interferogram and converts said interferogram to a communicable representation;
e. a data acquisition subsystem which receives the communicable representation of the interferogram, said data acquisition subsystem including means for modifying said communicable representation and producing an analyzable representation thereof; and
f. a computing subsystem for receiving said analyzable representation and further including means for determining the attribute from said analyzable representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. An apparatus for non-invasive determination of an attribute of human tissue by quantitative near infrared spectroscopy comprising:
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a. an illumination subsystem which generates near infrared light;
b. a tissue sampling subsystem, in optical communication with and receiving light from said illumination subsystem, including means for irradiating human tissue with at least a portion of said received light and collecting at least a portion of said light diffusely reflected from said human tissue;
c. a calibration maintenance subsystem selectively optically coupled to said tissue sampling subsystem for receiving at least a portion of said light and diffusely reflecting a portion thereof;
d. an FTIR spectrometer subsystem selectively optically coupled to (i) said tissue sampling subsystem to receive at least a portion of said light diffusely reflected from said tissue, or (ii) selectively optically coupled to said calibration maintenance subsystem to receive at least a portion of said infrared light diffusely reflected therefrom, or (iii) a combination thereof, said FTIR spectrometer subsystem including a spectrometer that creates an interferogram, said FTIR spectrometer subsystem further including a detector which receives the interferogram and converts said interferogram to a communicable representation;
e. a data acquisition subsystem which receives the communicable representation of the interferogram, said data acquisition subsystem including means for modifying said communicable representation and producing an analyzable representation thereof; and
f. a computing subsystem for receiving said analyzable representation and further including means for determining the attribute from said analyzable representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy;
wherein said calibration maintenance subsystem comprises a reference sample which receives a portion of said infrared light and produces a spectrum similar to a representative human tissue sample, and wherein the reference sample comprises a gelling agent, a scattering agent, and water. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23)
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24. An apparatus for non-invasive determination of an attribute of human tissue by quantitative near infrared spectroscopy comprising:
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a. an illumination subsystem which generates near infrared light, said illumination subsystem including a light homogenizer positioned to receive at least a portion of said infrared light;
b. a tissue sampling subsystem optically coupled to said illumination subsystem which receives at least a portion of said infrared light exiting said light homogenizer, said tissue sampling subsystem including means for irradiating human tissue with at least a portion of said received infrared light and collecting at least a portion of said light diffusely reflected from human tissue;
c. an FTIR spectrometer subsystem selectively optically coupled to said tissue sampling subsystem to receive at least a portion of said light diffusely reflected from said tissue, said FTIR spectrometer subsystem including a spectrometer that creates an interferogram, said FTIR spectrometer subsystem further including a detector which receives the interferogram and converts said interferogram to a communicable representation;
d. a data acquisition subsystem which receives the communicable representation of the interferogram, said data acquisition subsystem including means for modifying said communicable representation and producing an analyzable representation thereof; and
e. a computing subsystem for receiving said analyzable representation and further including means for determining the attribute of human tissue from said analyzable representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
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40. An apparatus for non-invasive determination of an attribute of human tissue by quantitative near infrared spectroscopy comprising:
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a. an illumination subsystem which generates near infrared light including means for angularly and spatially homogenizing at least a portion of said light;
b. a tissue sampling subsystem optically coupled to said illumination subsystem which receives at least a portion of said infrared light, said tissue sampling subsystem including means for irradiating human tissue with at least a portion of said received infrared light and collecting at least a portion of said light diffusely reflected from said human tissue, said tissue sampling subsystem including at least one input element which transfers said light to said human tissue and at least one output element which receives light from said tissue, wherein said input element and said output element are spaced apart by a gap of about 100 μ
m or greater;
c. a calibration maintenance subsystem selectively optically coupled to said tissue sampling subsystem for receiving at least a portion of said infrared light and diffusely reflecting a portion thereof, said calibration maintenance subsystem including a reference sample having optical properties similar to a representative human tissue sample;
d. an FTIR spectrometer subsystem selectively optically coupled to said tissue sampling subsystem to receive at least a portion of said light diffusely reflected from said tissue or selectively optically coupled to said calibration maintenance subsystem to receive at least a portion of said infrared light diffusely reflected therefrom, said FTIR spectrometer subsystem including a spectrometer that creates an interferogram, said FTIR spectrometer subsystem further including a detector which receives the interferogram and converts said interferogram to a communicable representation, said detector that is sensitive to light in the 1.2 to 2.5 μ
m region of the spectrum;
e. a data acquisition subsystem with a minimum SNR of 100 dbc which receives the communicable representation of the interferogram, said data acquisition subsystem including means for modifying said communicable representation and an analog-to-digital converter for converting a resulting electrical signal to its digital representation; and
f. a computing subsystem for receiving said digital representation and further including means for determining the attribute from said digital representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48)
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49. An apparatus for non-invasive determination of an attribute of human tissue by quantitative near-infrared spectroscopy comprising:
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a. an illumination subsystem which generates near-infrared light;
b. a tissue sampling subsystem optically coupled to said illumination subsystem which receives at least a portion of said infrared light generated by said illumination subsystem, said tissue sampling subsystem including means for irradiating human tissue with at least a portion of said received infrared light and collecting at least a portion of said light diffusely reflected from human tissue, said means for irradiating human tissue including at least one input element which transfers said light to said human tissue and at least one output element which receives light from said tissue;
c. an FTIR spectrometer subsystem selectively optically coupled to said tissue sampling subsystem to receive at least a portion of said light diffusely reflected from said tissue, said FTIR spectrometer subsystem including a spectrometer that creates an interferogram, said FTIR spectrometer subsystem further including a detector which receives the interferogram and converts said interferogram to a communicable representation, said detector that is sensitive to light in the 1.2 to 2.5 μ
m region of the spectrum;
d. a data acquisition subsystem which receives the communicable representation of the interferogram, said data acquisition subsystem including means for modifying said communicable representation and producing an analyzable representation thereof; and
e. a computing subsystem for receiving said analyzable representation and further including means for determining the attribute from said analyzable representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy;
wherein said detector is a thermoelectrically cooled, extended range InGaAs detector that is sensitive to light in the 1.2 to 2.5 mm region of the spectrum.
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Specification