Thrombogenicity Testing Using Platelet-Rich Plasma
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Solution Overview
Problem
Current methods for testing the thrombogenicity of medical devices, such as stents, are unreliable and variable, particularly due to the measurement of weight gain in whole blood, which does not correlate well with thrombus size, making it difficult to compare results across different device sizes and types.
Innovation Solution
A method involving the deployment of medical devices in a testing device, exposure to platelet-rich plasma (PRP), and determining thrombogenicity based on indicators like LDH or D-dimer activity, allowing for a sensitive and reproducible assessment of thrombogenic potential.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If weight gain measurement in whole blood is used to evaluate thrombogenicity, then the testing method is simple to perform, but the measurement results are highly variable and do not reliably correlate with thrombus size
Solution Approach 1:
The patent introduces an intermediary substance (fibrinogen or other plasma proteins) that mediates the interaction between the medical device surface and platelets. This intermediary allows for more controlled and measurable thrombus formation compared to using whole blood directly, improving the reliability of thrombogenicity assessment while maintaining experimental feasibility
Solution Approach 2:
The patent changes the composition parameters of the testing medium from whole blood to plasma-based solutions with controlled fibrinogen concentrations. This parameter change eliminates variables present in whole blood (such as red blood cells and various plasma proteins) that contribute to measurement variability, thereby improving measurement precision while keeping the assay manageable
2Ease of operation
If weight gain measurement is used to assess thrombus size, then the measurement process is straightforward, but the results cannot be reliably compared across different device sizes and types
Solution Approach 1:
The patent creates a universal testing platform using plasma-based solutions that can be applied to evaluate thrombogenicity across different medical device types and sizes. The standardized plasma environment with controlled fibrinogen levels provides a consistent baseline that enables meaningful comparisons between devices, making the assay universally applicable while maintaining simplicity
Solution Approach 2:
By changing the testing medium from whole blood to standardized plasma solutions with controlled protein concentrations, the patent creates consistent measurement conditions across different device configurations. This parameter standardization allows results to be reliably compared across different device sizes and types, improving adaptability while keeping the measurement process straightforward
3Reliability
If platelet adhesion and fibrin deposition are measured in whole blood, then the test reflects in vivo conditions, but the results are confounded by multiple blood components and show high variability
Solution Approach 1:
The patent extracts the essential thrombogenic components (platelets and fibrinogen) from whole blood by using plasma-based solutions. This extraction removes confounding variables present in whole blood while retaining the core mechanisms of thrombus formation, thereby improving measurement consistency while still reflecting the fundamental in vivo thrombogenic process
Solution Approach 2:
The patent uses plasma proteins, particularly fibrinogen, as intermediaries to mediate platelet adhesion and aggregation on device surfaces. This intermediary approach simplifies the complex whole blood system while preserving the essential thrombogenic mechanisms, leading to more consistent and reliable measurements that still reflect in vivo conditions
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 reliable and reproducible method for evaluating the thrombogenicity of medical devices, enabling more accurate comparisons and improved safety by assessing thrombogenic potential through platelet adhesion and fibrin deposition in a controlled environment.
Implementation Method 1
contact with a foreign surface induces platelet activation. Activated platelets attach and detach and roll before ultimately forming stable adhesive interactions
Implementation Method 2
Activated platelets also bind soluble fibrinogen, which leads to platelet aggregation
Implementation Method 3
The deposition of insoluble fibrin results in more platelet adhesion, more fibrin deposition and growth of thrombus
Data Source
AI summary
A method of determining the thrombogenicity of an implantable medical device is disclosed. The implanted device is exposed in vitro to platelet rich plasma, the activity of an indicator is assayed, and the thrombogenicity is determined.