Devices and formulations for detecting, screening and monitoring levels of certain constituents in bodily fluids and method
Inventors
Altschul, Randice Lisa • Rapkin, Myron • O'Brien, Rebecca
Assignees
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Publication Number
US-8431386-B2
Publication Date
2013-04-30
Expiration Date
Abstract
A device is disclosed for conducting a non-invasive analysis of a bodily fluid to determine the presence and level of a certain constituent carried by the bodily fluid. An indicator formulation of the device changes color in response to exposure to the constituent to provide a visible indication of the presence and level of the constituent carried by the bodily fluid. A carrier substrate of the device is constructed of a material having voids providing a high void volume within the substrate. The device is made by applying a chromagen to the carrier substrate to create a chromagen-laden carrier member. Then, a selected reagent having a particular constituent-specific formulation is applied to the chromagen-laden member. The selected reagent then combines with the chromagen, thereby establishing the indicator formulation within the carrier substrate in place for reception of a sample of the bodily fluid.
Core Innovation
A device is provided for conducting a non-invasive analysis of a bodily fluid to determine the presence and the level of a certain constituent carried by the bodily fluid. The device includes a target area on a carrier substrate of a fibrous material having fibers and voids establishing a high void volume, about eight to twelve percent of the total volume of the carrier substrate, in juxtaposition with the target area. The voids establish communication between fibers and ambient air.
An indicator formulation changing color in response to exposure to the certain constituent is carried by the fibers so that the indicator formulation is placed in juxtaposition with voids in the carrier substrate and within the target area. Communication with ambient air in the juxtaposed voids enables reaction after a sample of the bodily fluid is later placed upon the target area and in communication with ambient air within the voids. This provides a visible indication of the presence and the level of the certain constituent as the certain constituent reacts with the indicator formulation.
The indicator formulation consists essentially of a chromagen formulation and a constituent-specific formulation selected from formulations responsive to levels of any one of a plurality of different certain constituents. The fibrous, high-void-volume approach supports multiple constituent targets including glucose, cholesterol, ethanol, uric acid, and galactose, using constituent-specific formulations. A two-step approach is described in which the chromagen formulation is impregnated into fibers/pores for later combination with a constituent-specific reagent to form a color-changing indicator responsive to constituent levels.
Claims Coverage
The independent claim set is led by one independent claim, which includes two main inventive aspects: the fibrous carrier substrate with high-void-volume target area communicating with ambient air, and the indicator formulation carried in the fibers that changes color in response to the certain constituent after exposure in communication with ambient air. Dependent claims refine this by specifying particular carrier materials and by defining constituent-specific chromagen and reagent formulations.
High-void-volume fibrous target area with ambient air communication
A target area on a carrier substrate of a fibrous material having fibers and voids establishing a high void volume within a range of about eight to twelve percent of the total volume of the carrier substrate in juxtaposition with the target area and with fibers within the carrier substrate, with voids establishing communication between fibers and ambient air.
Fiber-carried ambient-air-responsive color-changing indicator formulation
An indicator formulation changing color in response to exposure to the certain constituent in the presence of ambient air to provide a visible indication of the presence and the level of the certain constituent carried by the bodily fluid, the indicator formulation being carried by the fibers of the carrier substrate such that the indicator formulation is placed in juxtaposition with voids in the carrier substrate and within the target area for enabling communication with ambient air within the voids and reception of a sample of the bodily fluid later placed upon the target area of the carrier substrate and in communication with ambient air within the voids for enabling reaction with the indicator formulation on the fibers, with the sample exposed to ambient air present in the juxtaposed voids as the certain constituent in the sample reacts with the indicator formulation.
Chromagen plus constituent-specific formulation selected across a plurality of constituents
The indicator formulation consisting essentially of a chromagen formulation and a constituent-specific formulation selected from formulations responsive to levels of any one of a plurality of different certain constituents.
Non-woven synthetic polymeric carrier substrate material
The device of claim 1 is characterized in that the carrier substrate material is a non-woven synthetic polymeric material.
Chromagen formulation with approximately equal parts MBTH and DMAB
The chromagen formulation consists essentially of approximately equal parts of 0.05 to 0.5 M 3-methyl-2-benzothiazolinone hydrazone and 0.05 to 0.5 M dimethylaminobenzoic acid.
Glucose-specific formulation with glucose oxidase and peroxidase plus HEPES, surface active agents, and stabilizer
The glucose-specific formulation consists essentially of approximately equal amounts of glucose oxidase and peroxidase with approximately equal amounts of 0.05 to 0.5 M HEPES, a blend of surface active agents, and a stabilizer.
Cholesterol-specific formulation with cholesterol esterase, peroxidase, and cholesterol oxidase plus HEPES, surface active agents, and stabilizer
The cholesterol-specific formulation consists essentially of a selected amount of cholesterol esterase, the same selected amount of peroxidase, and twice the selected amount of cholesterol oxidase, in the presence of approximately equal amounts of 0.05 to 0.5 M HEPES, a blend of surface active agents, and a stabilizer.
Ethanol formulation with PVP K30, ethoxylated surfactant, phosphate buffer, alcohol oxidase, and peroxidase
The ethanol formulation consists essentially of approximately equal selected amounts of about 1% to 20% PVP K30, about 0.5% to 5.0% ethoxylated surfactant, and about 0.05 to 0.5 M phosphate buffer at pH 8.5, with one-half the selected amount of alcohol oxidase and one-quarter the selected amount of peroxidase.
Overall, the claim coverage centers on a high-void-volume fibrous carrier substrate whose voids communicate with ambient air and on a color-changing indicator formulation carried in the fibers that reacts after sample placement in communication with ambient air. The claims further require that the indicator formulation consists essentially of a chromagen formulation plus a constituent-specific formulation responsive to different constituents, with dependent claims refining carrier material type and defining specific chromagen and constituent-specific formulations.
Stated Advantages
Provides a visible indication of the presence and the level of the certain constituent carried by the bodily fluid.
Enables non-invasive analysis of a bodily fluid to determine presence and level of a constituent.
Documented Applications
Color gauge disk and reader variants intended for weight/glycemic control monitoring, including an advanceable coiled strip/digital readout with a used portion advanced and discarded.
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