Perfusion Device Dynamic Coagulation Evaluation
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Solution Overview
Problem
Current methods for diagnosing coagulation deficits and monitoring pharmacological treatments for thrombotic and hemorrhagic diseases are inadequate, as they fail to provide a dynamic and multifactorial evaluation of blood coagulation processes, leading to difficulties in identifying potential risks and assessing treatment effectiveness.
Innovation Solution
A cartridge with perfusion chambers and software for digital image processing that allows for the dynamic ex-vivo evaluation of coagulation by measuring platelet and fibrin formation dynamics in a blood sample, using fluorescent probes and recalcification to simulate physiological conditions, enabling the analysis of platelet aggregation, adhesion, and thrombin generation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional coagulation analysis methods (PT, aPTT, aggregation tests) are used, then the diagnostic process is simple and quick, but the evaluation is static and incomplete, failing to capture the dynamic multifactorial nature of coagulation
Solution Approach 1:
The perfusion chamber is divided into multiple independent observation zones (first observation zone, second observation zone, third observation zone) that can simultaneously evaluate different aspects of coagulation (platelet adhesion, platelet aggregation, fibrin formation) using the same blood sample, enabling comprehensive dynamic assessment without requiring multiple separate tests
Solution Approach 2:
A single perfusion chamber system performs multiple diagnostic functions simultaneously: evaluating platelet adhesion to subendothelium, platelet aggregation dynamics, and fibrin formation, replacing multiple separate traditional tests with one integrated platform that provides comprehensive coagulation assessment
2Reliability
If dynamic ex-vivo evaluation with perfusion chambers is implemented, then comprehensive coagulation assessment is achieved, but the device complexity and operational requirements increase
Solution Approach 1:
The perfusion chamber is pre-coated with cytoadhesive substances (collagen, von Willebrand factor, fibronectin) before use, and the blood sample is pre-prepared with fluorescent probes for platelets and fibrin. This preliminary preparation ensures that when the blood flows through the chamber, coagulation processes occur naturally under controlled conditions, eliminating the need for complex real-time interventions during the test
Solution Approach 2:
The system uses the patient's own blood sample under physiological flow conditions to self-evaluate their coagulation status. The fluorescent probes automatically bind to platelets and fibrin as they form, and the digital imaging system automatically captures and analyzes the dynamic processes, reducing the need for manual intervention and interpretation
3Productivity
If multiple observation zones with different cytoadhesive substances are used, then platelet and fibrin formation dynamics can be simultaneously evaluated, but the manufacturing complexity increases
Solution Approach 1:
The perfusion chamber is divided into multiple independent observation zones, each coated with a specific cytoadhesive substance (collagen in the first zone, von Willebrand factor in the second zone, fibronectin in the third zone). This segmentation allows simultaneous evaluation of different coagulation aspects under physiologically relevant conditions, providing comprehensive data from a single test
Solution Approach 2:
Different portions of the perfusion chamber surface are selectively coated with different cytoadhesive substances to create locally optimized environments for specific coagulation evaluations. This local differentiation enables the system to assess various aspects of platelet adhesion and aggregation simultaneously while maintaining physiological relevance in each zone
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
This approach provides a comprehensive and dynamic assessment of coagulation processes, enabling the identification of coagulation defects and the evaluation of treatment effectiveness, thereby improving the monitoring of antiplatelet or anticoagulant therapies and risk assessment for thrombogenic disorders.
Implementation Method 1
treating the blood sample of step a) with a solution consisting of fluorescent probes for marking platelets and fibrin capable of binding more or less specifically to platelets and fibrin and emitting fluorescent light on two different emission frequencies
Implementation Method 2
the blood sample being made to flow into the perfusion chamber in known and measurable flow conditions
Implementation Method 3
treating the blood sample of step a) with a solution consisting of fluorescent probes for marking platelets and fibrin capable of binding more or less specifically to platelets and fibrin and emitting fluorescent light on two different emission frequencies and of a recalcification solution of the blood sample
Data Source
AI summary
A perfusion device is for evaluating the risk of thrombotic and hemorrhagic diseases linked to blood coagulation processes. In particular, a cartridge is for conducting a dynamic “ex-vivo” evaluation method of the coagulation process in a subjects blood sample, including at least one perfusion chamber, a well for loading the blood sample and reagents, an inclined ascending microchannel connecting the well to a first end of the perfusion chamber and an inclined descending microchannel placed at a second end. Preferably at least one perfusion chamber includes two half-channels of different width, placed in series or in parallel, or the cartridge includes at least two perfusion chambers placed in parallel. At least two of the perfusion chambers have a different width.