Noninvasive transdermal systems for detecting an analyte in a biological fluid and methods
First Claim
1. A noninvasive transdermal system for detecting an analyte in interstitial fluid extracted from or underneath the skin of a subject, said noninvasive transdermal system comprising:
- (a) a noninvasive transdermal patch comprising a target surface having a dry chemistry component for interacting with the analyte to generate color or shade of color at said target surface, said dry chemistry component having a sensitivity which enables it to detect the analyte extracted from interstitial fluid, anda wet chemistry component for transferring the analyte from the interstitial fluid in or underneath the skin to said dry chemistry component in an amount sufficient so that said dry chemistry component can detect the analyte; and
(b) a reflectometer comprisinga modulated light source for emitting light to illuminate said target surface which possesses a certain color and shade of color following interaction with the analyte;
an optical detector for detecting light that is reflected from said target surface and generating a first output indicative of detected light;
means for processing the first output to generate a feedback signal for application to the optical detector to compensate for any shift in the first output resulting from the detection of ambient light by the optical detector, and differentially amplify the first output to generate a second output; and
a detector for synchronously demodulating the second output to generate a substantially steady DC output voltage that is indicative of the color or shade of color at said target surface.
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Abstract
The present invention relates to noninvasive transdermal systems comprised of a noninvasive transdermal patch and a reflectometer. The noninvasive transdermal patches are comprised of a wet chemistry component and a dry chemistry component. The wet chemistry component is a liquid transfer medium in the form of a gel layer for the extraction and liquid bridge transfer of the analyte of interest from the biological fluid within or beneath the skin to the dry chemistry component. The dry chemistry component is a reagent system for interacting with the analyte of interest (glucose) to generate a color change. The reflectometers include a modulated light source for emitting light to illuminate a target surface which possesses a certain color and shade of color for detection by an optical detector. The output signal is processed for determining a corresponding quantity or quality measurement.
70 Citations
72 Claims
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1. A noninvasive transdermal system for detecting an analyte in interstitial fluid extracted from or underneath the skin of a subject, said noninvasive transdermal system comprising:
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(a) a noninvasive transdermal patch comprising a target surface having a dry chemistry component for interacting with the analyte to generate color or shade of color at said target surface, said dry chemistry component having a sensitivity which enables it to detect the analyte extracted from interstitial fluid, and a wet chemistry component for transferring the analyte from the interstitial fluid in or underneath the skin to said dry chemistry component in an amount sufficient so that said dry chemistry component can detect the analyte; and (b) a reflectometer comprising a modulated light source for emitting light to illuminate said target surface which possesses a certain color and shade of color following interaction with the analyte; an optical detector for detecting light that is reflected from said target surface and generating a first output indicative of detected light; means for processing the first output to generate a feedback signal for application to the optical detector to compensate for any shift in the first output resulting from the detection of ambient light by the optical detector, and differentially amplify the first output to generate a second output; and a detector for synchronously demodulating the second output to generate a substantially steady DC output voltage that is indicative of the color or shade of color at said target surface. - 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, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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45. A noninvasive transdermal system for detecting an analyte in a biological fluid extracted from or underneath the skin of a subject, said noninvasive transdermal system comprising:
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(a) a noninvasive transdermal patch comprising a target surface having a dry chemistry component for interacting with the analyte to generate color or shade of color at said target surface, a dry chemistry component for interacting with the analyte to detect the analyte, said dry chemistry component having a sensitivity which enables it to detect the analyte extracted from interstitial fluid, and a wet chemistry component for transferring in about 15 minutes or less the analyte from the interstitial fluid in or underneath the skin to said dry chemistry component in an amount sufficient, so that said dry chemistry component can interact with the analyte to generate color or shade of color at said target surface for detecting the analyte, said wet chemistry component consisting essentially of a gel and a skin permeate enhancer; (b) a reflectometer comprising a light source for emitting light to illuminate said target surface which possesses a certain color and shade of color; an optical detector circuit for detecting light that is reflected from the target surface and generating a substantially steady DC output voltage that is indicative of the color or shade of color at said target surface; a stored look-up table or mathematical formula correlating steady DC voltage values to corresponding quantity or quality measurements for each one of a plurality of different tests; and a processor for consulting the stored look-up table or mathematical formula for a certain test being performed, and converting the steady DC voltage indicative of the color or shade of color at said target surface into a corresponding quantity or quality measurement in accordance with that certain test; and
wherein the light source is a modulated light source and wherein the optical detector circuit comprises;an optical detector for detecting light that is reflected from the target surface and generating a first output indicative of detected light; means for processing the first output to generate a feedback signal for application to the optical detector to compensate for any shift in the first output resulting from the detection of ambient light by the optical detector, and differentially amplify the first output to generate a second output; and a detector for synchronously demodulating the second output to generate the substantially steady DC output voltage that is indicative of the color or shade of color at the target surface. - View Dependent Claims (46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72)
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Specification