Fluidic Junctions for Simultaneous Coagulation Assays
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Solution Overview
Problem
Existing point of care assay systems struggle to integrate multiple coagulation tests on a single cartridge due to cross-activation of coagulation cascade pathways, requiring improved design for efficient mixing and separation of reagents and substrates.
Innovation Solution
A sample analysis cartridge with fluidic junctions and micro-environment sensors that separate and analyze biological samples by splitting them into segments, using fluidic lock valves and conduits with immobilized reagents and substrates to prevent cross-activation, allowing for simultaneous performance of PT and aPTT tests.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple coagulation tests are integrated on a single cartridge, then device versatility is improved, but cross-activation of coagulation cascade pathways occurs causing interference between tests
Solution Approach 1:
The cartridge is divided into separate test chambers (first test chamber and second test chamber) with isolated fluidic pathways. Each chamber contains specific reagents for different coagulation tests (PT and aPTT), preventing cross-activation while allowing both tests to be performed on a single cartridge. The sample is split into separate streams that flow through distinct conduits to each chamber.
Solution Approach 2:
A fluidic junction acts as an intermediary component that receives the biological sample and divides it into separate segments. This junction includes a first segment that flows to the first test chamber and a second segment that flows to the second test chamber, enabling simultaneous independent testing without interference.
2Measurement precision
If reagents and substrates are mixed efficiently, then assay sensitivity is improved, but cross-contamination between different test pathways occurs
Solution Approach 1:
The fluidic system is segmented into separate conduits for each test pathway. The first conduit contains reagents for the extrinsic pathway test while the second conduit contains reagents for the intrinsic pathway test. This physical segmentation allows efficient mixing within each pathway while preventing cross-contamination between pathways.
Solution Approach 2:
Each test chamber is designed with localized reagent zones and substrate regions. The first test chamber has specific reagents for extrinsic pathway activation while the second test chamber has reagents for intrinsic pathway activation. This local differentiation ensures that each test receives appropriate reagents without interference from the other pathway's reagents.
3Device complexity
If a single cartridge design is used for multiple tests, then device simplicity is improved, but test interference occurs
Solution Approach 1:
The cartridge is designed as a multi-functional device that can perform both PT and aPTT tests simultaneously on a single sample. The universal cartridge structure includes multiple test chambers, separate fluidic conduits, and integrated pumping mechanisms that enable both tests without requiring separate cartridges for each assay type.
Solution Approach 2:
Within the universal cartridge design, internal segmentation is used to separate the PT and aPTT test pathways. The cartridge includes a first test chamber for PT testing and a second test chamber for aPTT testing, with isolated fluidic connections. This internal segmentation maintains overall device simplicity while preventing test interference through physical separation.
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
Enables efficient and precise simultaneous analysis of coagulation tests on a single cartridge by preventing cross-activation and optimizing reagent-substrate interaction, improving analytical precision and reducing interference.
Implementation Method 1
push the first segment over the first sensor region to the first fluidic lock valve such that the first segment is locked within the second conduit, and push the second segment over the second sensor region to the second fluidic lock valve such that the second segment is locked within the third conduit
Implementation Method 2
a pump configured to push the first segment over the first sensor region to the first fluidic lock valve such that the first segment is locked within the second conduit, and push the second segment over the second sensor region to the second fluidic lock valve such that the second segment is locked within the third conduit
Implementation Method 3
The coagulation cascade leading to active thrombin consists of two pathways, the extrinsic and the intrinsic pathways, which converge into a common pathway that includes active thrombin catalyzing the conversion of fibrinogen to fibrin
Implementation Method 4
The enzyme catalyzing this reaction is thrombin, which does not permanently circulate in the blood in an active form but exists as prothrombin, the inactive precursor of thrombin
Implementation Method 5
a first sensor region, a second sensor region... configured to operate in a localized manner and are capable of determining one or more diagnostic clotting times
Data Source
AI summary
The present invention relates to analytical testing devices comprising fluidic junctions and methods for assaying coagulation in a fluid sample received within the fluidic junctions. For example, the present invention may be directed to a sample analysis cartridge including an inlet chamber, a first conduit comprising a first junction configured to split a biological sample into at least first and second segments, a second conduit comprising a first reagent, a first sensor region, and a first fluidic lock valve, and a third conduit comprising a second reagent, a second sensor region, and a second fluidic lock valve. The sample analysis cartridge further includes a pump configured to push the first segment over the first sensor region to the first fluidic lock valve, and push the second segment over the second sensor region to the second fluidic lock valve.