Fibrinogen Sealant Stability via Factor XIa Segmentation
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Solution Overview
Problem
Existing fibrin sealant formulations require multiple components and are not storage-stable, leading to spontaneous coagulation issues when containing pure fibrinogen and calcium ions.
Innovation Solution
A single-component fibrinogen-based sealant formulation comprising a blood-derived fibrinogen concentrate, a divalent cation, and factor XIa, which is stable at temperatures between 20° C.-25° C. for at least 5 minutes, allowing for spontaneous coagulation upon contact with blood.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a two-component glue comprising fibrinogen and calcium ions is used, then coagulation ability is improved, but storage stability deteriorates due to spontaneous coagulation
Solution Approach 1:
The invention divides the traditional two-component system into three separate components: Component A contains fibrinogen and Factor XI, Component B contains Factor XIIa, and Component C contains calcium ions. This segmentation prevents spontaneous coagulation during storage by keeping the activation pathway separated, while enabling reliable coagulation when all components are combined at the application site.
Solution Approach 2:
The invention incorporates Factor XI and Factor XIIa into the sealant formulation in advance, preparing the coagulation cascade components for action. These factors are pre-positioned in Component A (Factors XI and XII) and Component B (Factor XIIa), ready to be activated by calcium ions upon application, ensuring rapid and reliable coagulation without premature activation during storage.
2Reliability
If multiple components are used to achieve coagulation, then clotting effectiveness is improved, but device complexity increases
Solution Approach 1:
The invention merges multiple coagulation factors into a single integrated three-component system. Component A combines fibrinogen and Factor XI, while Component B contains Factor XIIa. This merging approach maintains clotting effectiveness by including all necessary coagulation factors, while reducing complexity compared to traditional two-component systems by optimizing the factor combinations and adding calcium ions as a separate stable component.
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 formulation effectively promotes clot formation without spontaneous coagulation during storage, ensuring stability and efficient clotting when applied to wounds or physiological leaks, with a stable clotting time of less than 500 seconds.
Implementation Method 1
factor XIa...which, in aqueous solution does not coagulate spontaneously, and which is able to coagulate by adding a component containing calcium ions
Implementation Method 2
the combination of these ingredients, as a single component sealant, is storage stable and yet, upon contact with blood, it spontaneously coagulates
Implementation Method 3
able to coagulate by adding a component containing calcium ions
Data Source
AI summary
The invention relates to a storage-stable aqueous sealant formulation comprising a blood derived fibrinogen concentrate, a divalent cation and factor XIa.