System for non-invasive measurement of glucose in humans
First Claim
1. An apparatus for non-invasive measurement of glucose in human tissue by quantitative near infrared spectroscopy comprising:
- an illumination subsystem which generates near infrared light;
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;
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;
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 an electrical representation;
a data acquisition subsystem which receives the electrical representation of the interferogram, said data acquisition subsystem including means for amplifying and filtering said electrical representation and converting a resulting electrical signal to its digital representation; and
a computing subsystem for receiving said digital representation and further including means for determining glucose concentration in human tissue from said digital representation, wherein in combination said subsystems provide a clinically relevant level of glucose measurement precision and accuracy.
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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
50 Claims
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1. An apparatus for non-invasive measurement of glucose in human tissue by quantitative near infrared spectroscopy comprising:
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an illumination subsystem which generates near infrared light;
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;
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;
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 an electrical representation;
a data acquisition subsystem which receives the electrical representation of the interferogram, said data acquisition subsystem including means for amplifying and filtering said electrical representation and converting a resulting electrical signal to its digital representation; and
a computing subsystem for receiving said digital representation and further including means for determining glucose concentration in human tissue from said digital representation, wherein in combination said subsystems provide a clinically relevant level of glucose measurement precision and accuracy. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. An apparatus for non-invasive measurement of glucose in human tissue by quantitative near infrared spectroscopy comprising:
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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;
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;
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 an electrical representation;
a data acquisition subsystem which receives the electrical representation of the interferogram, said data acquisition subsystem including means for amplifying and filtering said electrical representation and converting a resulting electrical signal to its digital representation; and
a computing subsystem for receiving said digital representation and further including means for determining glucose concentration in human tissue from said digital representation, wherein in combination said subsystems provide a clinically relevant level of glucose prediction precision and accuracy. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
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37. An apparatus for non-invasive measurement of glucose in human tissue by quantitative near infrared spectroscopy comprising:
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an illumination subsystem which generates near infrared light including means for angularly and spatially homogenizing at least a portion of said light;
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;
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;
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 an electrical representation, said detector that is sensitive to light in the 1.2 to 2.5 μ
m region of the spectrum;
a data acquisition subsystem with a minimum SNR of 100 dbc which receives the electrical representation of the interferogram, said data acquisition subsystem including means for amplifying and filtering said electrical representation and an analog-to-digital converter for converting the resulting electrical signal to its digital representation; and
a computing subsystem for receiving said digital representation and further including means for determining glucose concentration in human tissue from said digital representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy. - View Dependent Claims (38, 39, 40, 41, 42, 43, 44, 45, 46)
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47. An apparatus for non-invasive measurement of glucose in human tissue by quantitative near-infrared spectroscopy comprising:
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an illumination subsystem which generates near-infrared light;
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;
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 an electrical representation, said detector that is sensitive to light in the 1.2 to 2.5 μ
m region of the spectrum;
a data acquisition subsystem which receives the electrical representation of the interferogram, said data acquisition subsystem including means for amplifying and filtering said electrical representation and converting a resulting electrical signal to its digital representation; and
a computing subsystem for receiving said digital representation and further including means for determining glucose concentration in human tissue from said digital representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy. - View Dependent Claims (48, 49)
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50. An apparatus for non-invasive measurement of glucose in human tissue by quantitative near-infrared spectroscopy comprising:
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an illumination subsystem which generates near-infrared light;
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;
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 an electrical representation;
a data acquisition subsystem with a minimum SNR of 100 dbc which receives the electrical representation of the interferogram, said data acquisition subsystem including means for amplifying and filtering said electrical representation and converting a resulting electrical signal to its digital representation and an analog-to-digital converter for converting a resulting electrical signal to its digital representation; and
a computing subsystem for receiving said digital representation and further including means for determining glucose concentration in human tissue from said digital representation, wherein in combination said subsystems provide a clinically relevant level of precision and accuracy.
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Specification