Microfluidic Hemostasis Assay With Real-Time Platelet and Fibrin Analysis
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Solution Overview
Problem
Traditional systems for assessing bleeding and clotting risk in critical care environments fail to replicate human body clotting physiology, lack specific functional data on key components of hemostasis, and cannot provide timely results for critical decision-making.
Innovation Solution
A system comprising a microfluidic device, reagents, imaging instrument, and software that measures both platelet and fibrin accumulation to determine hemostatic function, using fluorescent intensity analysis to compare against a healthy population average, allowing real-time clinical feedback.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional systems are used for assessing bleeding and clotting risk, then the assessment can be performed with simple equipment, but the systems cannot provide timely results for critical care decision-making
Solution Approach 1:
The system divides the hemostasis assessment into separate functional modules: a microfluidic device for clot formation, an imaging instrument for data collection, and software for analysis. This segmentation allows each component to be optimized independently while working together to provide rapid results.
Solution Approach 2:
The patent replaces traditional mechanical clotting tests with an optical imaging system that uses fluorescent labels to detect and quantify platelet and fibrin accumulation in real-time, enabling faster and more precise measurements.
2Reliability
If traditional systems are used, then the equipment and procedures are simple, but the systems are generally unable to create a testing environment that is analogous to the blood clotting physiology found in the human body
Solution Approach 1:
The microfluidic device is designed to replicate physiological parameters including blood flow dynamics, shear stress, and temperature. By controlling these parameters, the system creates a testing environment that accurately mimics human blood clotting physiology.
Solution Approach 2:
The patent introduces fluorescently labeled fibrinogen as an intermediary that binds to forming clots, allowing indirect visualization and quantification of clot formation processes that would otherwise be invisible, thereby enhancing physiological relevance.
3Loss of information
If traditional systems are used, then the procedures are straightforward, but the systems do not provide specific functional data on the key components of hemostasis (platelets and coagulation)
Solution Approach 1:
The system uses fluorescently labeled fibrinogen that emits specific wavelengths of light when bound to forming clots. This optical signal allows differentiation and quantification of fibrin versus platelet contributions to clot formation, providing specific functional data on each hemostatic component.
Solution Approach 2:
The patent adds the dimension of optical detection to traditional clotting assays. By measuring fluorescent intensity across different wavelengths and time points, the system extracts multiple parameters including clot formation rate, platelet function, and coagulation factor activity from a single test.
4Loss of time
If traditional systems are used, then the procedures are simple, but the systems cannot provide results in a timeframe required for critical care decision making in emergent situations
Solution Approach 1:
The imaging instrument continuously captures images of clot formation in real-time without requiring interruption or manual sampling. This continuous monitoring allows rapid acquisition of kinetic data and immediate generation of clinical results.
Solution Approach 2:
The system performs preliminary data processing and analysis during the clot formation process itself. The software continuously analyzes incoming images and provides preliminary results as the assay progresses, reducing post-test processing time.
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
Provides accurate, real-time assessment of hemostatic function, enabling early detection of abnormal clotting or bleeding risks, and allowing for immediate clinical intervention.
Implementation Method 1
The device allows blood flow under physiological conditions, enabling platelet and fibrin accumulation at a reaction zone
Implementation Method 2
A fluorescent label on the fibrinogen allows for detection of fibrin signals
Implementation Method 3
using fluorescent intensity analysis to compare against a healthy population average
Data Source
AI summary
A system for detecting and quantifying platelet function and coagulation function within a biological sample is provided. The system includes a detection instrument with computing capability. The system includes an assay device capable of receiving a biological sample. Introduction of the biological sample into the assay device results in a biological process by which fibrin and platelets may accumulate at a reaction zone of the assay device. The assay device is capable of receiving one or more chemical reagents compatible with the biological sample and usable for detecting the accumulation of the fibrin and platelets within the reaction zone. The fibrin and platelets, and their associated signals, accumulated at the reaction zone of the assay device are usable to determine at least one of a platelet function, a coagulation function, platelet normalcy, fibrin normalcy, platelet response to a drug, and coagulation response to a drug, within the biological sample.