Platelet Function Test System for Aspirin Resistance Detection
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Solution Overview
Problem
Current methods fail to effectively identify patients at increased risk of adverse cardiovascular events while undergoing aspirin antiplatelet therapy, as aspirin reduces ischemic vascular events by only about 22%, and there is a need to determine poor responsiveness to aspirin therapy to focus preventive measures on high-risk individuals.
Innovation Solution
A method involving a platelet-containing sample from a patient being evaluated for platelet hyperactivity under high shear conditions using a capillary with a membrane containing a platelet aggregation stimulator, where the time to platelet plug formation is measured and compared to a predetermined time to assess the risk of adverse cardiovascular events.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If aspirin antiplatelet therapy is administered to reduce ischemic vascular events, then the risk of cardiovascular events is reduced by about 22%, but the majority of patients (78%) still experience events indicating insufficient protection
Solution Approach 1:
The invention changes the parameter of platelet function assessment by measuring platelet plug formation time under high shear conditions in patients undergoing aspirin therapy. This allows identification of patients with poor aspirin responsiveness (platelet hyperactivity) who may require alternative or additional antiplatelet agents, thereby improving the overall reliability of cardiovascular protection.
2Measurement precision
If platelet plug formation time is measured as an indicator of platelet hyperactivity, then patients with increased risk of adverse cardiovascular events can be identified, but current methods lack the precision to effectively differentiate high-risk from low-risk patients
Solution Approach 1:
The invention applies local quality by creating specific local conditions (high shear stress environment) in the test system that mimic physiological conditions. The test cartridge contains a membrane with specific apertures and platelet aggregation stimulators positioned to create localized high shear zones, enabling precise measurement of platelet plug formation time and improving both measurement precision and risk stratification reliability.
3Ease of operation
If a simple test method is used to assess platelet function, then the testing process is easier to perform, but the test may not provide sufficient information to accurately identify high-risk patients
Solution Approach 1:
The invention employs self-service by using the patient's own blood sample under vacuum-driven flow conditions to automatically create the high shear environment needed for testing. The system requires minimal manual intervention - the vacuum pump automatically draws blood through the test cartridge, and the platelet plug formation is measured automatically, providing both ease of operation and precise measurement of platelet hyperactivity.
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 method allows for the identification of patients with increased risk of adverse cardiovascular events, indicating a four to seven times higher likelihood of future events if platelet plug formation time is less than 90 seconds, enabling targeted preventive measures.
Implementation Method 1
A platelet-containing sample from the patient is drawn under vacuum through a capillary so that it contacts a membrane comprising an aperture and platelets in the sample are activated by means of shear force
Implementation Method 2
The time to formation of a platelet plug that blocks the aperture of the membrane is determined and the time to formation of a platelet plug is related to the patient's risk of an adverse cardiovascular event
Data Source
AI summary
Methods, compositions and kits are disclosed for identifying patients with an increased risk of experiencing an adverse cardiovascular event where the patient is undergoing aspirin antiplatelet therapy. A platelet-containing sample from the patient is evaluated for platelet hyperactivity and platelet hyperactivity in the sample is related to the patient's risk of an adverse cardiovascular event. In some embodiments the evaluation for platelet hyperactivity is carried out by assessing the function of platelets in the sample using a high shear platelet function test.