Instrument for 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 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;
(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;
(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;
(e) a housing means for housing said introducing means, said detecting means and said processing means; and
(f) a replaceable cartridge means engaging said housing means comprising a memory means for storing data comprising said second signal.
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Abstract
Near-infrared quantitative analysis instruments non-invasively measure blood glucose by analyzing near-infrared energy following interactance with venous or arterial blood, or transmission through a blood containing body part. A replaceable cartridge stores data unique to an individual patient/user. The analysis instruments are accurate and readily lend themselves to at-home testing by diabetics.
825 Citations
27 Claims
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1. A near-infrared quantitative analysis instrument for non-invasive measurement of 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; (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; (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; (e) a housing means for housing said introducing means, said detecting means and said processing means; and (f) a replaceable cartridge means engaging said housing means comprising a memory means for storing data comprising said second signal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
- 19. An 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 [log1/I.sub.A -2*log1/I.sub.B +log1/I.sub.c ]+K.sub.2 T.sub.1
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">[log1/I.sub.A -2*log1I.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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20. An 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/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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21. An 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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22. An analysis instrument of claim 1 wherein the first 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, K1 is the line slope of ##EQU7## K2 and K3 are calibration constants, log 1/IA, log 1/IB, and 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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23. An analysis instrument of claim 1 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 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, T. represents the local surface the temperature of said body part and TA represents the ambient temperature of said instrument.
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24. An analytical instrument of claim 1 further comprising protection means for requiring that said cartridge which is custom calibrated for an individual be used in a specific analytical instrument.
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25. An analytical instrument of claim 24 wherein said protection means comprises storing at least one calibration constant in each said specific analytical instrument and said cartridge which must be matched before the analytical instrument will operate.
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26. An analytical instrument of claim 1 further comprising speech synthesizer means for providing audio operational instructions and audio output corresponding to said second signal.
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27. An analytical instrument of claim 1 wherein said processor means further comprises means for automatically correcting for bias drift in said second signal.
Specification