Coagulation Test Device for Individualized Hemostasis Management
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Solution Overview
Problem
Current coagulation tests provide insufficient information about the underlying cause of bleeding abnormalities, leading to a one-size-fits-all approach in managing bleeding patients, which can result in inappropriate therapy and thromboembolic events.
Innovation Solution
A point-of-care device that measures clotting time and clot characteristics of whole blood under different hemostatic conditions, requiring little-to-no laboratory skills, and allows for in-vitro testing of therapeutic agents to determine the underlying cause of coagulopathy and prevent thromboembolic events.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If traditional coagulation tests are used, then bleeding abnormalities can be diagnosed, but insufficient information is provided regarding the underlying cause of bleeding
Solution Approach 1:
The device divides the coagulation testing process into multiple parallel test channels, each evaluating different aspects of coagulation function. This segmentation allows simultaneous assessment of multiple coagulation parameters, providing comprehensive information about the underlying cause of bleeding without requiring sequential complex procedures.
Solution Approach 2:
The coagulation test device is designed to perform multiple functions within a single system, including measuring various coagulation parameters, evaluating response to different hemostatic agents, and providing diagnostic information about different types of coagulopathy. This multi-functionality eliminates the need for separate specialized tests while maintaining comprehensive diagnostic capability.
2Adaptability or versatility
If Massive Transfusion Protocols are used for all bleeding patients, then a standardized approach is provided, but individualized treatment based on underlying etiologies is not achieved
Solution Approach 1:
The device provides immediate feedback on the patient's specific coagulation profile and response to different hemostatic agents. This feedback enables physicians to tailor transfusion protocols to the individual patient's underlying etiology rather than applying standardized Massive Transfusion Protocols to all patients, thereby achieving individualized treatment while simplifying the decision-making process through objective test results.
3Measurement precision
If laboratory tests for factor levels or visco-elastic tests are performed, then detailed coagulation information is obtained, but time and skilled technical staff are required
Solution Approach 1:
The coagulation test device is designed for self-service operation with automated sample processing, reagent delivery, and result calculation. The system automatically performs measurements across multiple test channels and provides interpreted results without requiring skilled technical staff for execution, thereby maintaining high measurement precision while dramatically reducing the time and expertise required compared to traditional laboratory tests.
4Reliability
If hemostatic agents are administered without testing, then rapid treatment is provided, but thromboembolic events may occur due to inappropriate therapy
Solution Approach 1:
The device enables preliminary testing of hemostatic agents in vitro before actual administration to the patient. By pre-testing which agents are most likely to be effective based on the patient's specific coagulopathy type, the system ensures safer treatment selection while maintaining rapid response capability. This preliminary assessment prevents inappropriate therapy that could lead to thromboembolic events.
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 provides individualized, evidence-based results within 15 minutes, aiding in treatment decisions and reducing the risk of thromboembolic events by determining the specific etiology of coagulopathy and optimizing hemostatic agent administration.
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
Data Source
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.