Plasma-Supplemented Fibrinogen Formulation for Tissue Sealant Stability
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Fibrinogen formulations used in fibrin sealants often lack essential plasma proteins due to production processes, leading to instability and reduced effectiveness in tissue sealing applications.
Innovation Solution
A method of preparing plasma-supplemented fibrinogen formulations by mixing a concentrated fibrinogen preparation with a blood plasma source, enhancing the stability and protein content of the final product.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If fibrinogen is concentrated through production processes, then fibrinogen concentration is improved, but plasma protein content deteriorates
Solution Approach 1:
The patent extracts only the fibrinogen component through concentration processes, separating it from the plasma proteins. This extraction achieves high fibrinogen concentration (improving quantity) but results in loss of plasma proteins (worsening composition precision).
Solution Approach 2:
The production process changes the concentration parameter of fibrinogen to achieve therapeutic levels, but this parameter change inadvertently alters the plasma protein content parameter, causing depletion of essential proteins needed for stability and effectiveness.
2Manufacturing precision
If plasma proteins are removed during production, then purity is improved, but stability deteriorates
Solution Approach 1:
The production process extracts and removes plasma proteins to achieve high purity fibrinogen formulations. However, this extraction simultaneously removes stabilizing proteins, causing the formulation to become unstable and less effective in tissue sealing applications.
Solution Approach 2:
The patent recognizes that while plasma protein removal achieves purity, it creates instability. The solution converts this harmful effect by deliberately re-introducing plasma proteins back into the concentrated fibrinogen formulation, thus transforming the purity-stability trade-off into a beneficial multi-component formulation.
3Productivity
If fibrinogen is concentrated to high levels, then productivity is improved, but reconstitution difficulty worsens
Solution Approach 1:
The production process changes the concentration parameter to achieve high productivity and efficient storage. However, this high concentration parameter creates operational difficulties during reconstitution, requiring specialized techniques and equipment to properly dissolve and administer the fibrinogen.
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 plasma-supplemented fibrinogen formulations exhibit improved stability and enhanced healing properties, with increased levels of anti-B19 specific antibodies, making them more effective for tissue sealing and hemostasis.
Implementation Method 1
The thrombin converts the fibrinogen to fibrin by enzymatic action at a rate determined by the thrombin concentration
Implementation Method 2
thrombin cleaves fibrinogen thus allowing the latter to polymerize into fibrin and generate the sealant
Implementation Method 3
Factor XIII, an enzyme of the blood coagulation system, cross-links and stabilizes the fibrin clot
Implementation Method 4
mixing a concentrated fibrinogen preparation and a blood plasma source... enhancing the stability and protein content of the final product
Data Source
AI summary
Provided herein is a plasma-supplemented fibrinogen and/or fibrin formulation, method for the preparation and use thereof.