Multi-Reagent Coagulation Testing for Etiology-Specific Treatment
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Solution Overview
Problem
Existing coagulation tests, both point-of-care and laboratory-based, provide insufficient information regarding the underlying cause of bleeding and often rely on a one-size-fits-all approach in managing bleeding patients, which can lead to inappropriate treatment strategies and potential thromboembolic events.
Innovation Solution
A point-of-care coagulation test device that requires minimal laboratory skills and provides individualized, evidence-based results within 15 minutes, allowing for in-vitro testing of therapeutic agents to determine the underlying cause of coagulopathy and prevent thromboembolic events by measuring clotting time and clot characteristics under different hemostatic conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional laboratory coagulation tests are used, then diagnostic information can be obtained, but the tests require skilled technical staff and time to execute
Solution Approach 1:
The invention uses a disposable cartridge containing pre-loaded reagents and a test chamber with a spherical member. The entire testing system is designed as a single-use unit that is discarded after one test, eliminating the need for skilled technical staff to perform complex procedures and ensuring consistent results without requiring expert operation.
Solution Approach 2:
The cartridge is designed to automatically mix blood samples with reagents and monitor coagulation through a spherical member that naturally settles as clotting occurs. The system performs self-diagnosis by detecting the position of the spherical member, eliminating the need for skilled technical intervention in the testing process.
2Productivity
If a one-size-fits-all transfusion protocol is used, then management of bleeding patients can be standardized, but underlying etiologies of coagulopathy are not addressed
Solution Approach 1:
The invention segments the coagulation testing into multiple separate test chambers, each containing different reagents that test specific aspects of coagulation function. This allows simultaneous evaluation of different coagulation pathways and provides detailed information about the specific etiology of coagulopathy, enabling personalized treatment rather than standardized protocols.
Solution Approach 2:
The system changes testing parameters by using multiple different reagents in separate chambers, each designed to detect specific coagulation factors or pathways. By measuring clotting time under different chemical conditions, the system identifies the specific underlying cause of coagulopathy, providing etiology-specific information that guides personalized treatment decisions.
3Speed
If hemostatic agents are administered without testing, then bleeding can be treated quickly, but thromboembolic events may occur
Solution Approach 1:
The invention performs preliminary testing by measuring clotting time in multiple test chambers with different reagents before administering hemostatic agents. This preliminary assessment identifies the specific coagulopathy etiology and predicts which agents will be effective, allowing rapid administration of the correct treatment while avoiding agents that could cause thromboembolic events.
Solution Approach 2:
The system provides immediate feedback on coagulation status by measuring clotting time and interpreting results to identify the underlying etiology. This feedback loop enables clinicians to select appropriate hemostatic agents based on actual test results rather than empirical protocols, reducing the risk of thromboembolic events while maintaining rapid treatment capability.
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 device offers personalized clinical guidance for managing coagulopathy by comparing the effects of hemostatic agents on whole blood clotting time, thereby aiding in appropriate treatment decisions and reducing the risk of adverse events.
Implementation Method 1
a vacuum source coupled to the cartridge... activate the vacuum source to move the whole blood sample from a container into a plurality of channels in the cartridge
Implementation Method 2
receive signals from a plurality of sensors, each sensor associated with one of the test chambers, where the signals are based on the presence of a spherical member within a magnetic field generated by a magnet positioned adjacent to each of the test chambers
Implementation Method 3
an actuator linked to the cartridge to agitate the cartridge... activate the actuator to agitate the cartridge
Implementation Method 4
coagulation test device... for measuring clotting time and clot characteristics of a whole blood sample... determine whether coagulopathy is present
Data Source
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AI summary
A coagulation test device for measuring clotting time and clot characteristics of a whole blood sample under different hemostatic conditions. Results of the test are used as an aid in management of patients with coagulopathy of unknown etiology in order to help the physician determine appropriate clinical action to arrest bleeding in a patient.