Coagulation Parameter Estimation Using Protein Concentrations
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Solution Overview
Problem
Current methods for managing anticoagulant treatment in patients at risk for thrombosis require discontinuation of medication before surgery, which can lead to increased bleeding risk, and existing clinical decision support systems require multiple input parameters to estimate coagulation system parameters, making them cumbersome and less effective.
Innovation Solution
A computer-implemented clinical decision method and device that estimates the time for a blood coagulation system to reach a state of coagulation after anticoagulant discontinuation using concentration levels of 5 or 6 coagulation proteins, reducing the need for input parameters and allowing for single-sample measurement, with the option for multiple samples for validation and using machine learning algorithms for accurate prediction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If multiple input parameters are used to estimate coagulation system parameters, then measurement precision is improved, but device complexity and ease of operation deteriorate
Solution Approach 1:
The patent extracts and identifies a minimal subset of 5-6 critical coagulation proteins (fibrinogen, factor V, factor VIII, factor IX, factor X, and factor VII) from the complete coagulation system. By focusing only on these essential proteins that most significantly influence coagulation status and INR values, the system achieves accurate parameter estimation while requiring far fewer measurements than comprehensive coagulation profiles, thus resolving the contradiction between precision and complexity.
Solution Approach 2:
The patent performs preliminary identification and selection of the most influential coagulation proteins before the actual estimation process. By pre-determining that these 5-6 specific proteins are sufficient for accurate coagulation parameter estimation, the system eliminates the need for patients and clinicians to manage multiple input parameters, thereby simplifying operation while maintaining measurement precision.
2Measurement precision
If multiple input parameters are used to estimate coagulation system parameters, then measurement precision is improved, but ease of operation deteriorates
Solution Approach 1:
The patent extracts and identifies a minimal subset of 5-6 critical coagulation proteins (fibrinogen, factor V, factor VIII, factor IX, factor X, and factor VII) from the complete coagulation system. By focusing only on these essential proteins that most significantly influence coagulation status and INR values, the system achieves accurate parameter estimation while requiring far fewer measurements than comprehensive coagulation profiles, thus resolving the contradiction between precision and complexity.
Solution Approach 2:
The patent performs preliminary identification and selection of the most influential coagulation proteins before the actual estimation process. By pre-determining that these 5-6 specific proteins are sufficient for accurate coagulation parameter estimation, the system eliminates the need for patients and clinicians to manage multiple input parameters, thereby simplifying operation while maintaining measurement precision.
3Object-affected harmful factors
If anticoagulant treatment is discontinued before surgery, then bleeding risk during surgery is reduced, but thrombosis risk increases
Solution Approach 1:
The patent implements a feedback mechanism by continuously monitoring the concentrations of 5-6 key coagulation proteins and using this real-time data to dynamically estimate coagulation parameters and predict when INR will fall below the 1.5 threshold. This feedback loop allows clinicians to make informed, personalized decisions about the optimal time to discontinue anticoagulant therapy, thereby minimizing both bleeding risk during surgery and thrombosis risk during the discontinuation period.
Solution Approach 2:
The patent changes the approach from using fixed, population-based discontinuation guidelines to dynamically adjusting the discontinuation timing based on individual patient coagulation protein concentrations and their rate of change. By monitoring parameter changes in coagulation protein levels over time, the system predicts the precise moment when safe surgery conditions will be met, allowing for optimized discontinuation timing that balances bleeding and thrombosis risks for each patient.
Data Source
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AI summary
The present invention relates to a method for estimating a value of a parameter of a blood coagulation system in a subject that is periodically supplied with an anticoagulant, wherein the parameter of the coagulation system is a time taken for the coagulation system to reach a state of coagulation after periodic supply of anticoagulant to the subject is discontinued. The value of the parameter of the coagulation system is estimated based on concentration levels of 5 or 6 coagulation proteins derived from the coagulation system at a predetermined point in time relative to a point in time of supply of a last dose of anticoagulant to the coagulation system. In one embodiment the 5 coagulation proteins are coagulation factor VII (F7), coagulation factor IX (F9), Anti-thrombin (AT), coagulation factor X (F10), and coagulation factor VIII (F8). Optionally the 6th coagulation protein is coagulation factor XI (F11).