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A fluidic medical diagnostic device permits measurement of analyte concentration or a property of a biological fluid, particularly the coagulation time of blood. The device has at one end a sample port for introducing a sample and at the other end a bladder for drawing the sample to a measurement ar

A fluidic medical diagnostic device permits measurement of analyte concentration or a property of a biological fluid, particularly the coagulation time of blood. The device has at one end a sample port for introducing a sample and at the other end a bladder for drawing the sample to a measurement area. A first channel carries the sample from the sample port to the measurement area, and a stop junction, between the measurement area and bladder, halts the sample flow. A second channel, which runs from the first channel to an edge of the device, determines whether the sample volume is sufficient to permit an accurate measurement. The desired measurement can be made by placing the device into a meter, which measures a physical property of the sample, typically optical transmittance, after it has interacted with one or more reagents on the device.

대표청구항 ▼

[ What is claimed is:] [1.]1. A fluidic diagnostic device for measuring an analyte concentration or property of a biological fluid, comprisinga first layer and second layer, at least one of which has a resilient region over at least a part of its area, separated by an intermediate layer, in which cu

[ What is claimed is:] [1.]1. A fluidic diagnostic device for measuring an analyte concentration or property of a biological fluid, comprisinga first layer and second layer, at least one of which has a resilient region over at least a part of its area, separated by an intermediate layer, in which cutouts in the intermediate layer form, with the first and second layers,a) a sample port for introducing a sample of the biological fluid into the device;b) a measurement area in which a physical parameter of the sample is measured and related to the analyte concentration or property of the fluid;c) a first channel, having a first end and a second end, to provide a fluidic path from the sample port at the first end through the measurement area;d) a bladder, at the second end of the first channel, comprising at least a part of the resilient region in at least the first or second layer and having a volume that is at least about equal to the combined volume of the measurement area and first channel;e) a stop junction in the first channel between the measurement area and bladder that comprises a co-aligned through-hole in at least the first or second layer, the through-hole being overlaid with a third layer; andf) a second channel having a first end in fluid communication with the first channel at a first point between the sample port and measurement area and a second end vented, in which(i) at least the first or second layer has a transparent section at a predetermined second point adjoining the second channel and(ii) the volume of the part of the second channel lying between the first and second points is at least about equal to the volume of the measurement area.