Coagulation Factor Activity Scoring for Hemophilia Dosing
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Solution Overview
Problem
Current methods for managing bleeding disorders lack the ability to provide real-time coagulation factor level information, leading to inadequate treatment dosing and increased risks of bleeding or clotting complications, especially outside specialized clinical laboratories.
Innovation Solution
A method and system for determining coagulation factor activity scores using data from patient samples, incorporating baseline levels, drug coagulation factor levels, and activity ratios to calculate a score indicative of clotting status, enabling real-time therapeutic decision-making and dosing adjustments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current standard testing methods are used, then treatment dosing can be determined, but real-time coagulation factor level information is not available leading to inadequate dosing adjustments
Solution Approach 1:
The patent performs preliminary calculations of expected coagulation factor levels based on drug dosing history and pharmacokinetic parameters before actual bleeding events occur. This allows the system to have dosing recommendations ready in advance, reducing the time needed for treatment adjustments when bleeding occurs.
Solution Approach 2:
The patent introduces an intermediary computational model that translates drug dosing information and pharmacokinetic parameters into predicted coagulation factor levels. This intermediary system bridges the gap between drug administration and clinical decision-making, providing real-time information without requiring immediate laboratory testing.
2Ease of operation
If historical factor activity levels are used for dosing, then treatment can be simplified, but dosing accuracy does not reflect real-time coagulation factor levels
Solution Approach 1:
The patent implements a feedback mechanism where predicted coagulation factor levels from the pharmacokinetic model are continuously updated based on actual measured levels when available. This feedback loop maintains dosing regimen simplicity while progressively improving dosing accuracy through learned adjustments.
Solution Approach 2:
The patent dynamically adjusts pharmacokinetic parameters such as half-life and volume of distribution based on individual patient responses and measured factor levels. This allows the system to maintain operational simplicity while adapting to real-time patient-specific variations in drug metabolism and response.
3Measurement precision
If specialized clinical laboratory testing is performed, then accurate coagulation factor levels can be obtained, but testing is not accessible outside specialized facilities
Solution Approach 1:
The patent creates a computational copy of the specialized laboratory testing capability through a pharmacokinetic model that runs on standard computing devices. This virtual copy replicates the accuracy of specialized laboratory analysis without requiring physical presence at specialized facilities, making accurate coagulation factor level assessment accessible anywhere with internet connectivity.
4Productivity
If empirical dosing adjustments are made after adverse outcomes, then treatment can be initiated, but bleeding or clotting complications increase before adjustment
Solution Approach 1:
The patent applies preliminary anti-action by predicting coagulation factor levels and providing dosing recommendations before adverse bleeding or clotting events occur. The system proactively prevents complications by suggesting dose adjustments based on predicted factor levels, rather than reacting after adverse outcomes have already manifested.
Data Source
AI summary
Compositions and methods useful for point of care testing for hemophilia by measuring coagulation factor levels are provided.