Non-invasive measurement of blood glucose
First Claim
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1. A near-infrared quantitative analysis instrument for non-invasive measurement of blood glucose in blood present in a body part of a subject, comprising:
- (a) introducing means including a near infrared energy source for introducing near-infrared energy into blood present in a body part of a subject wherein said introducing means introduces near-infrared energy of between about 600 and 1100 nanometers;
(b) detecting means for detecting near-infrared energy emerging from the body part;
(c) positioning means for positioning both the near-infrared introducing means and the detecting means closely adjacent to the body part; and
(d) processing means for processing a first electrical signal produced by the detector means into a second signal indicative of the quantity of glucose present in the blood of the subject.
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Abstract
Near-infrared quantitative analysis instruments and methods non-invasively measure blood glucose by analyzing near-infrared energy following interactance with venous or arterial blood, or transmisison through a blood containing body part. The instruments and methods are accurate and readily lend themselves to at-home testing by diabetics.
588 Citations
43 Claims
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1. A near-infrared quantitative analysis instrument for non-invasive measurement of blood glucose in blood present in a body part of a subject, comprising:
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(a) introducing means including a near infrared energy source for introducing near-infrared energy into blood present in a body part of a subject wherein said introducing means introduces near-infrared energy of between about 600 and 1100 nanometers; (b) detecting means for detecting near-infrared energy emerging from the body part; (c) positioning means for positioning both the near-infrared introducing means and the detecting means closely adjacent to the body part; and (d) processing means for processing a first electrical signal produced by the detector means into a second signal indicative of the quantity of glucose present in the blood of the subject. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 27, 28, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39)
- 18. The analysis instrument of claim 1 wherein the signal processing means processes the first signal according to the formula
- space="preserve" listing-type="equation">C=K.sub.0 +K.sub.1 [log 1/I.sub.A -2*log 1/I.sub.B +log 1/I.sub.C ]+K.sub.2 T.sub.1
wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K3 is line slope of
space="preserve" listing-type="equation">[log 1/I.sub.A -2*log 1/I.sub.B +1/I.sub.C ]K2 is a calibration constant, log 1/IA, log 1/IB, and log 1/IC each represent an optical density value at corresponding wavelengths A, B and C, and TS represents the local surface temperature of said body part.
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19. The analysis instrument of claim 1 wherein the signal processing means processes the signal according to the formula ##EQU2## wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K1 is the line slope of ##EQU3## K2 is a calibration constant, log 1/IA, log 1/IB, log 1/ID and log 1/IK each represent an optical density value at corresponding wavelengths A, B, D and E and TS represents the local surface temperature of said body part.
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20. The analysis instrument of claim 1 wherein the signal processing means processes the signal according to the formula ##EQU4## wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K1 is the line slope of ##EQU5## K2 is a calibration constant, log 1/IA, log 1/IB, log 1/IC, log 1/ID, log 1/IE, and log 1/IF each represent an optical density value at corresponding wavelengths A, B, C, D, E and F, and TS represents the local surface the temperature of said body part.
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27. The analysis instrument of claim 1 wherein the first signal processing means processes the signal according to the formula ##EQU10## wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K1 is the line slope of ##EQU11## K2 and K3 are calibration constants, log 1/IA, log 1/IB, log 1/ID and log 1/IE each represent an optical density value at corresponding wavelengths A, B, D and E, TS represents the local surface temperature of said body part and TA represents the ambient air temperature of said instrument.
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28. The analysis instrument of claim 1 wherein the first signal processing means processes the signal according to the formula ##EQU12## wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K1 is the line slope of ##EQU13## K2 and K3 are calibration constants, log 1/IA, log 1/IB, log 1/IC, log 1/ID, log 1/IE, and log 1/IF each represent an optical density value at corresponding wavelengths A, B, C, D, E and F, TS represents the local surface the temperature of said body part and TA represents the ambient temperature of said instrument.
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30. The analysis instrument of any of claims 17-20, 27 or 28 wherein the corresponding wavelengths are between about 600 and about 1100 nanometers.
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31. The analysis instrument of claim 30 wherein said corresponding wavelength A is between about 780 and about 810 nanometers and said corresponding wavelength B is between about 1070 and about 1090 nanometers.
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32. The analysis instrument of claim 30 wherein said wavelength A is about 771 nanometers, said wavelength B is about 791 nanometers, said wavelength D is about 1070 nanometers, and said wavelength E is about 1080 nanometers.
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33. The analysis instrument of claim 1 wherein said energy source comprises means for emitting near-infrared energy at a plurality of center wavelengths, said plurality of center wavelengths being separated by a constant wavelength, said introducing means further comprising control means for powering said energy source such that near-infrared energy at each said center wavelength is sequentially introduced into said body part.
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34. The analysis instrument of claim 33 wherein said energy source comprises a plurality of infrared emitting diodes and wherein said control means sequentially powers each said plurality of infrared emitting diodes.
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35. The analysis instrument of claim 33 further comprising means for identifying which two of said center wavelengths provide the a maximum difference when said subject is measured at a time of low glucose level and at a time of higher glucose level.
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36. The analysis instrument of claim 33 wherein said constant wavelength is approximately 10 nanometers.
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37. The analysis instrument of claim 17 wherein said energy source comprises a plurality of near-infrared emitting diodes.
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38. The analysis instrument of claim 37 wherein said plurality of near-infrared emitting diodes comprises six near-infrared emitting diodes.
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39. The analysis instrument of claim 37 wherein optical filters corresponding to optimum wavelength values for A and B for a given subject are installed in said instrument.
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21. A non-invasive method for quantitatively analyzing blood glucose in blood of a subject, comprising:
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(a) introducing at least one pair of wavelengths of near-infrared energy from a near-infrared energy source into blood within a body part of the subject, said pair of wave lengths being within the range of about 600 to about 1100 nanometers; (b) detecting near-infrared energy emerging from the subject with a detector which provides a signal upon detecting energy emerging from the subject; and (c) processing the signal to provide a second signal indicative of the amount of glucose present in the body of the subject. - View Dependent Claims (22, 23, 24, 25, 26, 29, 40)
- 24. The method of claim 21 wherein the first signal processing means processes the signal according to the formula
- space="preserve" listing-type="equation">C=K.sub.0 +K.sub.1 [log 1/I.sub.A -2*log 1/I.sub.B +log 1/I.sub.C ]+K.sub.2 T.sub.S
wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K1 is line slope of
space="preserve" listing-type="equation">[log 1/I.sub.A -2*log 1/I.sub.B +1/I.sub.C ]K2 is a calibration constant, log 1/IA, log 1/IB, and log 1/IC each represent an optical density value at corresponding wavelengths A, B and C, and TS represents the local surface temperature of said body part.
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25. The method of claim 21 wherein the signal processing means processes the signal according to the formula ##EQU6## wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K0 is the line slope of ##EQU7## K2 is a calibration constant, log 1/IA, log 1/IB, log 1/ID and log 1/IE each represent an optical density value at corresponding wavelengths A, B, D and E and TS represents the local surface temperature of said body part.
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26. The method of claim 21 wherein the first signal processing means processes the signal according to the formula ##EQU8## wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K1 is the line slope of ##EQU9## K2 is a calibration constant, log 1/IA, log 1/IB, log 1/IC, log 1/ID, log 1/IE, and log 1/IF each represent an optical density value at corresponding wavelengths A, B, C, D, E and F, and TS represents the local surface temperature of said body part.
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29. The method of claim 21 wherein the first signal processing means processes the signal according to the formula ##EQU14## wherein C is concentration of glucose present in the blood, K0 is an intercept constant, K1 is the line slope of ##EQU15## K2 and K3 are calibration constants, log 1/IA, log 1/IB, log 1/ID and log 1/IE each represent an optical density value at corresponding wavelengths A, B, D and E, TS represents the local surface temperature of said body part and TA represents the ambient temperature of said instrument.
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40. The method of claim 21 wherein said at least one pair of wavelengths is individually selected for a subject by the following:
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(a) sequentially introducing near-infrared energy into said body part of a subject at a plurality of center wavelengths, said plurality of center wavelengths being separated by a constant wavelength; (b) measuring a glucose level of said subject at a time of low glucose level and measuring a glucose of said subject level at a time of higher glucose level; and (c) determining from the measuring step which center wavelengths provide the maximum difference and using the determined wavelengths in subsequent measurements for said subject.
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41. A near-infrared quantitative analysis instrument for non-invasive measurement of blood glucose levels in blood present in a body part of a subject, comprising:
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(a) introducing means including a near infrared energy source for introducing near-infrared energy of between about 600 to about 850 nanometers and between about 850 and 1100 nanometers into blood present in a body part of a subject; (b) detecting means for detecting near-infrared energy emerging from the body part; and (c) processing means for processing a first electrical signal produced by the detector means into a second signal indicative of the quantity of glucose present in the blood of the subject.
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42. A near-infrared quantitative analysis instrument for non-invasive measurement of the concentration of a blood analyte in a body part of a subject comprising:
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(a) introducing means for introducing near-infrared energy into blood present in a body part of a subject wherein said introducing means introduces near-infrared energy of between about 600 and 1100 nanometers; (b) detecting means for detecting near-infrared energy emerging from the body part of the subject; (c) positioning means for positioning both the near-infrared introducing means and the detecting means closely adjacent to the body part; and (d) processing means for processing a first electrical signal produced by the detector means into a second signal indicative of the analyte concentration in the blood of the subject.
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43. A non-invasive method for quantitatively analyzing the concentration of a blood analyte in a body part of a subject, comprising:
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(a) introducing near-infrared energy from a near-infrared energy source into blood within a body part of the subject, said near-infrared energy being within the range of about 600 to about 1100 nanometers; (b) detecting near-infrared energy emerging from the subject with a detector which provides a signal upon detecting energy emerging from the subject; and (c) processing the signal to provide a second signal indicative of the analyte concentration in the blood of said subject.
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Specification