Single-layer microfluidic device and methods of manufacture and use thereof
Inventors
Assignees
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Publication Number
US-11642669-B2
Publication Date
2023-05-09
Expiration Date
Abstract
The disclosure relates to methods of manufacturing and using a single layer microfluidic for detecting target analytes, including obtaining a single layer sheet of paper; depositing wax boundaries onto the paper in a plurality of patterns including a main channel, fluid transfer channels, and an independent diagnostic area corresponding to each fluid transfer channel; melting the wax through the paper; depositing diagnostic components onto the diagnostic areas; depositing a continuous wax backing; and cutting devices from the paper. The disclosure also relates to a method of capturing an image of the micro fluidic device to generate diagnostic results corresponding to the diagnostic components by: identifying at least two panels from the image; and determining a color for each panel of the at least two panels; and generating for display, using the computing device, a graphical user-interface including at least one component visualizing the diagnostic results.
Core Innovation
The invention relates to a method of manufacturing a single layer microfluidic device using a single layer sheet of hydrophilic, porous paper having a front and a back. At least two patterns of wax boundaries are printed onto the front of the paper, where each pattern corresponds to a single device. Each device includes a main channel, at least two fluid transfer channels, and an independent diagnostic area corresponding to each fluid transfer channel.
In the disclosed device design, the main channel is in fluid communication with each of the fluid transfer channels, while the fluid transfer channels are independent of each other and in fluid communication with their corresponding diagnostic areas. The method includes heating the paper after wax-boundary printing to melt the wax deposited through the thickness of the paper and then cooling to room temperature. After melting the wax, a wax barrier is printed onto the back of the paper so that it covers all of the back of the paper.
After the wax barrier is printed on the back, the method includes sequentially printing a first reagent on each diagnostic area, then printing a dye after at least 10 minutes, and then printing a stabilizer onto at least one diagnostic area after at least 10 minutes. Individual devices are cut out from the paper, and for each device a paper filter is attached to an inlet of the main channel at a position upstream of the main channel. The described diagnostic framework supports multi-analyte detection using sample flow and colorimetric/fluorometric visual indicators, together with an imaging and compute workflow to determine colors and map results.
Claims Coverage
The independent claim is a manufacturing method that includes multiple inventive features spanning wax-boundary patterning, independent diagnostic area layout, melt-through wax processing, back-side wax barrier formation, timed sequential deposition of diagnostic components, device singulation, and upstream paper filter attachment. The dependent claims further specify identifying indicia outside assay regions (QR code, bar code, or calibration region) and refine certain material/attachment details (filter paper, adhesive attachment).
Wax-boundary patterning for a main channel and independent diagnostic areas
Printing at least two patterns of wax boundaries onto the front of the paper, wherein each pattern corresponds to a single device comprising a main channel, at least two fluid transfer channels, and an independent diagnostic area corresponding to each fluid transfer channel, wherein the main channel is in fluid communication with each of the fluid transfer channels, and wherein the fluid transfer channels are independent of each other and in fluid communication with their corresponding diagnostic areas.
Melt-through heating of wax in hydrophilic porous paper
Heating the paper of step (b) at a temperature of about 120 C to about 150 C to melt the wax deposited in step (b) through the thickness of the paper, and then cooling the paper to room temperature.
Back-side wax barrier covering the rear of the device sheet
After step (c), printing a wax barrier onto the back of the paper such that the wax barrier has a thickness of 50-100 μm and covers all of the back of the paper.
Timed sequential printing of reagent, dye, and stabilizer on diagnostic areas
Directly after the wax barrier is printed in step (d), printing a first reagent onto each diagnostic area of the paper, and then, after at least 10 minutes, printing a dye onto each diagnostic area of the paper, and then, after at least 10 minutes, printing a stabilizer onto at least one diagnostic area of the paper.
Cutting out individual devices from the wax-patterned paper
Cutting out individual devices from the paper.
Upstream attachment of a paper filter to the main channel inlet
For each device, attaching a paper filter to an inlet of the main channel at a position upstream of the main channel.
Identifying indicia outside fluidic and diagnostic regions
Depositing at least one identifying indicator onto the paper outside of the main channel, fluid transfer channels, and diagnostic areas before step (f).
QR code or bar code identifying indicator
At least one identifying indicator is a QR code or bar code.
Calibration region identifying indicator
At least one identifying indicator is a calibration region.
Filter paper as the hydrophilic porous paper
Using hydrophilic porous paper in the form of filter paper.
Adhesive attachment of an inlet paper filter
Attaching a paper filter to the inlet of the main channel using an adhesive.
Across the independent claim, the core inventive coverage is wax-boundary patterning that yields a main channel with independent fluid transfer channels and corresponding diagnostic areas, followed by melt-through wax heating, back-side wax barrier printing, timed sequential deposition of reagent/dye/stabilizer on diagnostic areas, cutting individual devices, and attaching a paper filter upstream of the main channel inlet. The dependent claims add identifying indicia outside assay zones (QR code, bar code, or calibration region), refine the paper to filter paper, and specify adhesive-based inlet filter attachment.
Stated Advantages
Enables multi-analyte detection using sample flow and colorimetric/fluorometric visual indicators.
Supports imaging-based identification and color determination using a computing workflow that determines colors and maps results.
Documented Applications
Multi-analyte detection using sample flow and colorimetric/fluorometric visual indicators on the manufactured single-layer microfluidic device.
An imaging and compute workflow that captures device images, identifies panels, and determines colors for result mapping using a graphical user interface and computing device/mobile device.
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