Calibration technique for non-invasive medical devices
First Claim
1. A method of calibrating a non-invasive sensor for a first physiologic parameter in tissue, comprising:
- (a) non-invasively measuring first values of the first physiologic parameter and of a second physiologic parameter in the tissue, a known relationship existing between the first and second physiologic parameters;
(b) acting on the tissue so as to change the first and second physiologic parameters;
(c) non-invasively measuring second values of the first physiologic parameter and of the second physiologic parameter in the tissue, the measurements of the first and second values of the second physiologic parameter being absolutely calibrated; and
(d) determining a calibrated value for at least one of the first and second values of the first physiologic parameter from the first and second values of both the first and second physiologic parameters.
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Abstract
There is a need for a non-invasive method of calibrating medical devices at the point of care, where the calibration is performed without the removal of blood or bodily fluids. The invention is directed to an approach for calibrating a first non-invasive sensor in which the tissue being measured is modulated in some way so as to after the value of the parameter being measured by the first optical sensor. A second sensor detects another parameter that also changes with the modulation. The second sensor is absolutely calibrated. Where there is a known relationship between the first and second parameters, a calibration may be derived for the first sensor. Such a technique is applicable to calibrating non-invasive sensors for monitoring a wide variety of physiologic parameters including, inter alia, glucose, blood gases, blood electrolytes and blood pH.
316 Citations
44 Claims
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1. A method of calibrating a non-invasive sensor for a first physiologic parameter in tissue, comprising:
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(a) non-invasively measuring first values of the first physiologic parameter and of a second physiologic parameter in the tissue, a known relationship existing between the first and second physiologic parameters;
(b) acting on the tissue so as to change the first and second physiologic parameters;
(c) non-invasively measuring second values of the first physiologic parameter and of the second physiologic parameter in the tissue, the measurements of the first and second values of the second physiologic parameter being absolutely calibrated; and
(d) determining a calibrated value for at least one of the first and second values of the first physiologic parameter from the first and second values of both the first and second physiologic parameters. - 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)
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27. A system for determining a value of a first physiologic parameter within tissue, comprising:
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first measuring means for non-invasively measuring first and second values of the first physiologic parameter in the tissue;
second measuring means for non-invasively measuring first and second values of a second physiologic parameter in the tissue, a known relationship existing between the first and second physiologic parameters, the second measuring means being absolutely calibrated;
means for acting on the body so as to change the first and second physiologic parameters; and
means for determining a calibrated value for at least one of the first and second values of the first physiologic parameter from the first and second values of both the first and second physiologic parameters.
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28. An apparatus for determining a value of a first physiologic parameter within tissue, comprising:
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an uncalibrated, first non-invasive sensor for measuring the first physiologic parameter of the tissue;
a calibrated, second non-invasive sensor for measuring a second physiologic parameter of the tissue; and
a processor coupled to receive first and second signals from each of the first and second non-invasive sensors, and to calculate calibrated values for the first physiologic parameter from the first and second signals from each of the first and second non-invasive sensors when a characteristic of the tissue is modulated between the first and second signals. - View Dependent Claims (29, 30, 31, 32, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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- 33. An apparatus as recited in claim 33, wherein the pH sensor emits excitation light in the wavelength range 300 nm-400 nm.
Specification