Micro-scale Coagulation Assay via Automated Imaging
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Solution Overview
Problem
Current methods for monitoring blood coagulation parameters require large volumes of blood or plasma and are not easily accessible for point-of-service use, making them cumbersome and difficult to manage, especially for patients on anticoagulant therapy.
Innovation Solution
A method and device for measuring coagulation time using a small volume of blood (as little as 20 μL) that involves initiating a coagulation reaction, capturing images of the reaction, and analyzing these images to determine coagulation time, allowing for point-of-service monitoring and adjustment of medication dosage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If conventional coagulation assay methods are used, then measurement accuracy is maintained, but large volumes of blood (5 mL) are required which complicates point-of-service use
Solution Approach 1:
The patent segments the coagulation assay into a micro-scale reaction system that can be performed in small volumes (20-100 μL) while maintaining measurement accuracy through optimized reagent concentrations and detection sensitivity
Solution Approach 2:
The patent replaces conventional mechanical mixing and manual observation methods with automated imaging systems that capture and analyze coagulation dynamics, enabling point-of-service performance without requiring skilled operators
2Ease of operation
If conventional coagulation assays are performed, then coagulation parameters can be measured, but the procedures are cumbersome and require skilled operators
Solution Approach 1:
The patent implements self-service capabilities where the system automatically performs sample handling, reagent addition, reaction monitoring, and data analysis without requiring skilled operators, while the automated imaging and analysis components maintain the necessary measurement precision
Solution Approach 2:
The patent changes key parameters including reducing blood volume from 5 mL to 20-100 μL, shortening assay time to under 1 hour, and automating the measurement process to eliminate skilled operator requirements while maintaining clinical accuracy
3Productivity
If large volumes of blood are used for coagulation monitoring, then accurate measurements can be obtained, but patient monitoring becomes more complex and less frequent
Solution Approach 1:
The patent enables multiple coagulation parameters to be measured from a single small blood sample (20-100 μL) by segmenting the assay into parallel micro-reactions, allowing frequent monitoring without increasing total blood consumption
Solution Approach 2:
The patent creates a universal assay platform that can measure multiple coagulation parameters (PT, aPTT, fibrinogen, factor levels) from a single small blood sample, maximizing the utility of each sample and enabling more frequent monitoring
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 rapid and accurate measurement of coagulation parameters using minimal blood samples, facilitating timely adjustments in medication and improving the management of blood coagulation disorders.
Implementation Method 1
initiating a coagulation reaction of the blood sample of the subject
Implementation Method 2
obtaining a set of more than one image of said coagulation reaction
Data Source
AI summary
Compositions and methods for measuring coagulation parameters using very small volumes of blood are provided. Advantageously, the methods described herein can be performed from a single drop of blood (about 20 μL) while generally leaving enough sample to perform other measurements, optionally in a multiplexed format. The methods and devices do not require a skilled operator and can be performed at the point of service, which can be an important feature for managing blood coagulation disorders and treatments thereof.