Injectable Fibrin Void Filler with Elastomeric Particles
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Solution Overview
Problem
Current soft tissue void fillers lack mechanical stability and control over water uptake, swelling, and bioactive molecule release, limiting their effectiveness in soft tissue applications such as occlusion, augmentation, and filling lumens and voids.
Innovation Solution
A multi-component injectable soft tissue void filler composition comprising fibrinogen, thrombin, a biodegradable plasticizer, and particles, which allows for fine-tuning of mechanical properties and bioactive molecule release, including the use of iodinated contrast agents and calcium phosphate particles to enhance elastomeric behavior and visibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If fibrin alone is used as a soft tissue void filler, then it is biocompatible and easy to use, but it lacks mechanical stability and elastomeric properties
Solution Approach 1:
The patent combines fibrin with elastomeric particles (such as polyethylene glycol diacrylate crosslinked with calcium chloride) to create a composite material that exhibits both biocompatibility and elastomeric mechanical properties. The composite composition includes fibrinogen, thrombin, elastomeric particles, and a plasticizer, where the particles provide mechanical stability and the fibrin matrix provides biocompatibility and degradability.
2Stability of the object's composition
If the fibrin composition is made more complex with additional components, then mechanical stability improves, but the ease of use and simplicity deteriorates
Solution Approach 1:
The composition is divided into separate components that are mixed immediately before use: Component A contains fibrinogen, elastomeric particles, and plasticizer, while Component B contains thrombin. This segmentation allows each component to be prepared and stored separately with optimized properties, then combined to achieve the desired mechanical stability and elastomeric behavior while maintaining ease of clinical application.
3Reliability
If there is no control over water uptake and swelling, then the composition is simpler, but the effectiveness in soft tissue applications is limited
Solution Approach 1:
The patent controls water uptake and swelling by adjusting the plasticizer content (10-50% by weight) and elastomeric particle concentration in the composition. The plasticizer (such as glycerol or propylene glycol) and elastomeric particles work together to regulate the composition's interaction with water, enabling controlled swelling that enhances effectiveness in soft tissue applications while maintaining compositional simplicity.
4Object-affected harmful factors
If the composition is fully resorbable with low toxicity, then safety improves, but mechanical stability and durability may be compromised
Solution Approach 1:
The fibrin-based composition utilizes the body's natural fibrinolytic system to degrade and resorb the material after it has fulfilled its mechanical support function. The elastomeric particles provide temporary mechanical stability and elastomeric properties, while the fibrin matrix is naturally degraded by plasmin, ensuring complete resorbability and low toxicity without requiring external intervention.
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 composition provides superior mechanical stability, controlled bioactive molecule release, and visibility, making it suitable for minimally invasive treatments of soft tissue indications like fistulae, urinary incontinence, and vascular occlusion, with the ability to be tailored for specific applications.
Implementation Method 1
component (a) comprising fibrinogen; component (b) comprising thrombin
Implementation Method 2
exhibits elastomeric mechanical behavior making it mechanically superior to fibrin alone
Implementation Method 3
Alteration of the fibrin modifier (plasticizer) and or particulate component can allow for fine control of water uptake, swelling
Data Source
AI summary
The present invention teaches a micro-porous injectable, soft elastic, fully resorbable fibrin-based composition for use as a soft tissue lumen and void filler. The composition of the present application exhibits physical characteristics, such as mechanical properties, typically seen in elastomers and mechanical stability, which is superior to fibrin alone. A variety of properties of the composition of the present invention can be effectively fine-tuned and altered by adjusting type and content of the particles as well as of the plasticizer contained in the void filler composition.