Perfluorocarbon Sclerosing Foam for Vascular Interventions
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Solution Overview
Problem
Current treatments for venous malformations, such as sclerotherapy, face challenges with the stability and safety of sclerosing foams, particularly due to the risk of pulmonary embolism and stroke associated with air-based foams, and the limited effectiveness of foams made with polidocanol, which cannot form foam directly with air.
Innovation Solution
Development of an embolic or sclerosing foam comprising a liquid phase with a sclerosing agent and a gas phase predominantly composed of perfluorocarbon gases like C2F6, C3F8, and C4F10, which enhances stability and reduces bubble size, along with the inclusion of anionic surfactants and radio-opaque agents to improve safety and efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If air is used as the gas phase in sclerosing foam, then the foam is less stable and reduces embolization risk, but the treatment effectiveness is reduced
Solution Approach 1:
The patent changes the gas phase composition from air to perfluorocarbon gases (C2F6, C3F8, C4F10), which fundamentally alters the foam's stability characteristics. This parameter change allows the foam to maintain stability for extended periods (hours to days) while still enabling controlled dissolution in the bloodstream, thus resolving the contradiction between stability and safety.
Solution Approach 2:
The invention creates a composite foam structure combining perfluorocarbon gas bubbles with liquid sclerosing agent (polidocanol or absolute ethanol) and surfactant. This composite formulation achieves synergistic effects: the perfluorocarbon provides stability, the surfactant controls surface tension and bubble size, and the sclerosing agent provides therapeutic effect, simultaneously addressing stability and safety requirements.
2Stability of the object's composition
If perfluorocarbon gas is used in the foam, then the foam stability is enhanced, but the risk of pulmonary embolism and stroke increases
Solution Approach 1:
The patent applies local quality by creating foam with controlled bubble size distribution and spatial characteristics. The small bubble size (achieved through surfactant addition) and localized dissolution properties allow the stable foam to be effectively trapped and dissolved in target veins, preventing systemic embolization while maintaining local stability for sustained therapeutic effect.
Solution Approach 2:
The surfactant acts as an intermediary substance that mediates between the perfluorocarbon gas and the liquid phase, controlling bubble formation, size, and dissolution rate. This intermediary enables the foam to maintain stability during injection and distribution while facilitating controlled breakdown in the target vasculature, thus reducing embolization risk.
3Ease of manufacture
If polidocanol is used as the sclerosing agent, then the foam can be formed with air, but the therapeutic effect is weaker compared to anhydrous ethanol
Solution Approach 1:
The patent changes the gas phase parameter from air to perfluorocarbon, which enables the use of absolute ethanol as the sclerosing agent. This parameter change allows the formulation to achieve both strong therapeutic effect (from ethanol) and stable foam formation (from perfluorocarbon), resolving the contradiction between ease of manufacture and therapeutic effectiveness.
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 foam exhibits enhanced stability and smaller bubble sizes, reducing the risk of complications and improving treatment outcomes by maintaining therapeutic effectiveness while minimizing side effects, with tunable stability from minutes to days.
Implementation Method 1
The gas phase comprises at least about 50% by volume of a perfluorocarbon gas, such as C2F6, C3F8, and/or C4F10
Implementation Method 2
The anionic surfactant can include at least one of sodium tetradecyl sulfate (STS), polidocanol, ethanolamine oleate, sodium morrhuate, or an analogue thereof
Data Source
AI summary
A sclerosing foam includes a liquid phase and a gas phase, wherein the liquid phase comprises at least one sclerosing agent and the gas phase comprises at least about 50% by volume of a pefluorocarbon gas.