Blood Coagulation Analysis via Dielectric Measurement and Drug Correction
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Solution Overview
Problem
Current methods for evaluating blood coagulation capacity are inadequate for accurately assessing coagulation status, particularly in perioperative settings, due to artifacts from drug concentrations and the inability to account for non-spherical cell shapes and agglutination in blood samples, leading to inconsistent and unreliable results.
Innovation Solution
A blood state analysis device and method that includes a correction unit to account for drug concentrations in plasma, a correlation detection unit to determine drug-plasma correlations, and a blood coagulation evaluation unit using dielectric constant measurements to assess coagulation capacity, along with a plasma internal drug concentration calculation and erythrocyte quantitative evaluation units to provide accurate hematocrit and hemoglobin values.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional coagulation tests (PT, APTT) are used to analyze plasma proteins, then the test procedures are well-established and technically mature, but cell components (platelets and erythrocytes) are removed by centrifugation causing test results to differ from actual clinical pathologic conditions
Solution Approach 1:
The invention extracts and removes the centrifugation step from the conventional coagulation test procedure. By eliminating the centrifugation process that separates plasma from cell components, the test directly analyzes whole blood, thereby retaining platelets and erythrocytes that are essential for accurate coagulation assessment in clinical settings.
Solution Approach 2:
The invention introduces an automated analysis system as an intermediary between the blood sample and the coagulation assessment. This automated system processes whole blood samples without manual centrifugation, using computational algorithms to analyze coagulation parameters while preserving the natural interactions between blood components.
2Measurement precision
If PT and APTT tests are used to assess bleeding tendency, then they can detect bleeding disorders, but they cannot sensitively detect thrombus tendency which varies throughout the perioperative period
Solution Approach 1:
The invention creates a universal coagulation analysis system that can detect both bleeding tendency and thrombus tendency through a single test methodology. By analyzing whole blood without centrifugation and using comprehensive parameter assessment, the system provides multi-functional capability to evaluate opposite coagulation states (bleeding and thrombus) throughout the perioperative period.
Solution Approach 2:
The invention implements dynamic monitoring capability that can track changes in coagulation status throughout the perioperative period. The automated system continuously assesses coagulation parameters and can detect transitions between bleeding tendency and thrombus tendency, providing real-time adaptive information for clinical decision-making.
3Extent of automation
If thromboelastometry (TEG, ROTEM) is used for comprehensive coagulation testing, then it can assess both bleeding and thrombus tendencies, but measurements are not automated and depend on measuring person's procedure
Solution Approach 1:
The invention implements a self-service automated analysis system that independently processes blood samples without human intervention. The system automatically performs measurements, analyzes data using predefined algorithms, and generates coagulation assessments, thereby eliminating dependence on individual measuring persons' procedures and ensuring consistent, reliable results.
Solution Approach 2:
The invention incorporates feedback mechanisms where the automated system uses measured parameters to adjust and refine its analysis. The system continuously monitors measurement data and applies computational algorithms to interpret results, providing consistent feedback-based assessment that eliminates variability introduced by manual measurement procedures.
4Reliability
If manual thromboelastometry measurements are performed, then comprehensive coagulation assessment is possible, but the quality control procedure is complex and reagent for QC is expensive
Solution Approach 1:
The invention employs disposable test elements or cartridges that integrate the measurement and quality control functions. These single-use components eliminate the need for complex, reusable equipment requiring elaborate quality control procedures and expensive reagents, while maintaining measurement accuracy through built-in calibration and validation mechanisms.
5Measurement precision
If conventional methods use electric conductivity of solvent without cells to calculate cell volume fraction, then calculations can be performed using Formula (1) or (2), but it is difficult to obtain volume fraction from suspension data alone and cells must be dispersed without agglutination
Solution Approach 1:
The invention extracts and eliminates the sample preparation step requiring cell dispersion in solvent. By directly measuring whole blood without removing cells or requiring them to be dispersed in a solvent, the method obtains accurate cell volume fraction and coagulation parameters from the native blood sample, avoiding agglutination issues entirely.
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
Enables accurate and handy evaluation of blood coagulation capacity by correcting for drug concentrations and accounting for non-spherical cell shapes and agglutination, reducing analysis costs and time while improving the reliability of coagulation assessments.
Implementation Method 1
a measuring unit that measures electric characteristics of the blood sample
Data Source
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AI summary
A blood state analysis device (1) that analyzes a state of a blood sample, as used for clotting time testing, said blood samlple comprising a plasma and at least one reagent, including a correction unit (11) configured to correct a measured blood coagulation evaluation result of the blood sample based on a relation between reference concentrations of the at least one reagent in plasma and reference blood coagulation evaluation results, the at least one reagent is an anticoagulation treatment releasing agent, a coagulation activator, an anticoagulant, a platelet activator, an antiplatelet drug, or a combination thereof and is present in the blood sample.For instance, such device (1) allows to correct blood clotting time resutls with respect to concentrations of an anti-coagulant drug present in the blood sample.