Freeze-Dried Platelets for Blood Coagulation Diagnostics
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Solution Overview
Problem
Current methods for detecting and monitoring blood clotting disorders are often insensitive and unreliable, relying on artificial systems that do not accurately reflect a patient's thrombotic potential, and require multiple blood samples, making them cumbersome and potentially inaccurate.
Innovation Solution
Development of freeze-dried platelets that retain all relevant surface markers and can rapidly respond to platelet agonists, allowing for superior detection of platelet activation functions and aggregation, which can be used as control reagents for diagnostic tests and to monitor blood clotting ability over time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional coagulation assays (ACT, PT, PTT, APTT) are used to evaluate blood clotting, then the coagulation pathways can be assessed, but the results are potentially unreliable as they are end-point tests based on artificial systems that do not reflect the patient's thrombotic potential
Solution Approach 1:
The patent uses freeze-dried platelets as a standardized control reagent that replicates normal platelet function. These freeze-dried platelets serve as a reference copy of healthy platelet behavior, allowing comparison with patient samples to assess thrombotic potential more accurately than artificial coagulation assays
Solution Approach 2:
The patent introduces light transmission aggregometry as an intermediary measurement method. Instead of directly measuring clot formation time endpoints, the aggregometer measures platelet aggregation in real-time using light transmission, providing a more reliable indicator of thrombotic potential that bridges the gap between artificial assays and actual physiological function
2Measurement precision
If multiple blood samples are drawn for coagulation assays, then comprehensive evaluation of clotting pathways is possible, but the process becomes cumbersome and potentially inaccurate
Solution Approach 1:
The freeze-dried platelets serve multiple functions: they act as a control reagent, a calibration standard, and a reference for normal platelet function all in one standardized product. This multi-functionality eliminates the need for multiple separate blood samples and assays, simplifying the testing procedure while maintaining comprehensive evaluation capability
Solution Approach 2:
The platelets are freeze-dried and standardized in advance, with their aggregation characteristics pre-established. This preliminary preparation allows the control reagent to be ready for immediate use without requiring fresh blood samples for each test, making the procedure more convenient while maintaining evaluation comprehensiveness
3Measurement precision
If platelet function assays are performed on freshly drawn blood, then accurate assessment of platelet function is possible, but the process requires numerous assays and is not highly sensitive to slight perturbations
Solution Approach 1:
The patent replaces the mechanical process of performing numerous separate assays on fresh blood with an automated light transmission aggregometry system. The aggregometer automatically measures platelet aggregation in real-time, substituting multiple manual assays with a single automated measurement process that is both efficient and sensitive to subtle functional changes
Solution Approach 2:
The freeze-dried platelets provide a standardized reference model of normal platelet function. By comparing patient platelet aggregation against this standardized copy of normal function, the system can detect slight perturbations more efficiently than by performing numerous assays on fresh blood without a reference standard
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
The freeze-dried platelets provide a more sensitive and accurate means to diagnose and monitor blood clotting disorders, maintaining functional integrity during storage and reconstitution, enabling quicker detection of clotting issues and improved calibration of diagnostic instruments.
Implementation Method 1
The platelets can be reconstituted by exposure to water or aqueous solution
Implementation Method 2
Freeze-dried platelets, method of making and method of use as a diagnostic agent
Data Source
AI summary
The present invention provides freeze-dried platelets and compositions comprising freeze-dried platelets for use as a diagnostic and calibration reagent for blood coagulation function. The invention also provides methods of diagnosing or monitoring blood coagulation function, including diagnosing or monitoring blood coagulation diseases and disorders. Kits for performing the methods of the invention are also included.