Specimen Collection Device with Light Pipe Sufficiency Indicator
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Solution Overview
Problem
Current methods for collecting and testing bodily fluids, such as saliva, face challenges in ensuring sample integrity and efficiency, particularly in point-of-care settings, where contamination risks and the need for rapid, accurate results are high, and existing devices often require additional filtration or centrifugation steps, are not user-friendly, and lack integrated solutions for sample volume adequacy assessment.
Innovation Solution
A specimen sample collection device with a handle, absorbent pad, and pad compression tube that includes a sufficiency indicator and unidirectional locking teeth, allowing for split collection and direct fluid communication with multiple chambers, enabling simultaneous collection and testing without separate filtration or centrifugation, and providing a mechanism for determining sample volume adequacy through a light pipe indicator.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional blood collection methods are used in laboratories, then accurate diagnostic results can be obtained, but the process requires trained phlebotomists, laboratory equipment, and significant time for sample processing and transport
Solution Approach 1:
The device segments the collection and testing process into distinct functional zones within a single integrated unit: the collection chamber for sample acquisition, the filtration zone with integrated filters, the testing chamber with test strips, and the confirmation chamber. This segmentation allows complex functions to be distributed across modular components that work together in sequence, eliminating the need for separate laboratory equipment and trained personnel while maintaining diagnostic accuracy.
Solution Approach 2:
The invention merges multiple previously separate functions into a single integrated device: sample collection, filtration, testing, and confirmation are all combined in one handheld unit. The collection device integrates absorbent pads, filtration membranes, test strips, and confirmation mechanisms into a unified system that performs laboratory-grade testing at the point of care, dramatically reducing device complexity requirements.
2Reliability
If duplicate samples are collected for confirmation testing, then sample integrity and chain-of-custody can be ensured, but the collection process becomes more time-consuming and requires additional handling steps
Solution Approach 1:
The device performs preliminary filtration and sample preparation actions automatically as the sample flows through the integrated system. The filtration zone with its multiple filters prepares the sample in advance, and the split absorbent pads simultaneously create both the initial test sample and the confirmation sample, eliminating the need for separate collection and preparation steps for duplicate samples.
Solution Approach 2:
The integrated collection device acts as an intermediary that automatically manages the creation, separation, and protection of duplicate samples. The device's internal mechanisms automatically split the sample into two sealed chambers, maintaining chain-of-custody and integrity without requiring manual handling or additional processing time from the user.
3Measurement precision
If filtration and centrifugation steps are added to improve sample quality, then testing accuracy increases, but the device complexity and procedural steps increase significantly
Solution Approach 1:
The invention extracts the complex centrifugation and filtration equipment from the point-of-care device and replaces it with integrated filtration membranes and absorbent pads that perform the same sample preparation functions passively. The filtration zone contains multiple filters that automatically remove particulates as sample flows through, eliminating the need for external centrifuges or complex filtration apparatus while maintaining testing accuracy.
4Measurement precision
If multiple separate devices are used for collection, filtration, and testing, then each function can be optimized independently, but the overall process requires more handling and increases contamination risk
Solution Approach 1:
The invention merges collection, filtration, and testing functions into a single integrated device with continuous enclosed sample flow paths. The sample remains contained within the device from collection through to testing, eliminating exposure to the external environment and reducing contamination risk. The test strips are pre-installed within the device, and results are read through windows in the device housing, maintaining a closed system throughout the entire process.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device ensures efficient, contamination-free collection and testing of bodily fluids, allowing for immediate analysis or storage, with reduced risk of misdiagnosis and tampering, and provides rapid test results without the need for additional equipment or complex procedures.
Implementation Method 1
an absorbent pad partially contained within the handle
Implementation Method 2
a sufficiency indicator made up of a light pipe indicator window
Data Source
AI summary
A specimen sample collection device and test system includes a handle with a sufficiency indicator and locking teeth, an absorbent pad partially contained within the handle; a pad compression tube with outlet ports and locking holes insertable over the pad and handle; one or more collection tubes attachable to the pad compression tube outlet ports. The apparatus may include a light pipe sufficiency indicator with a spring compressor to force the absorbent pad into contact with the light pipe. The apparatus may include a collector dam. The apparatus may include a secondary seal. The apparatus may include a cylindrically shaped absorbent pad and a wrap-around light pipe sufficiency indicator with vent grooves. The apparatus may include a pad seat with buffer material disposed within the pad compression tube. The apparatus may include an absorbent pad split and divided into two lengths connected at a base. The apparatus may include a bar code identification. The apparatus may include a lock and key securing mechanism. The apparatus may include a handle containing one or more analyte test strips The apparatus may include a first absorbent pad in fluid communication with a sample adequacy indicator, which is in parallel with a second absorbent pad in fluid communication with a lateral flow analyte test strip. The apparatus ma include a first absorbent pad in fluid communication with a sample adequacy indicator, which is in parallel with a second absorbent pad in fluid communication with a lateral flow analyte test strip, with an impermeable membrane separating the first and second absorbent pads.