Ethanol Foam Sclerosing Agent Reducing Side Effects

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Solution Overview

Problem

Current sclerosing agents for treating vascular anomalies, particularly venous malformations, have significant side effects due to the use of absolute ethanol, which limits their wide application despite having the strongest sclerosing effect, and only polidocanol can be made into foam, restricting the effectiveness and safety of treatment.

Innovation Solution

An ethanol foam sclerosing agent is developed, comprising absolute ethanol, water, and a non-ionic surfactant like Tween 80 and egg yolk lecithin, with optional stabilizers such as hyaluronic acid, using the Tessari method to create a stable and effective foam that reduces side effects while maintaining therapeutic efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If absolute ethanol is used as a sclerosing agent, then the sclerosing effect is strongest, but the side effects are most serious including tissue necrosis

Engineering Contradiction:
Improvesclerosing effectVSAvoidside effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces air as an intermediary substance to mix with absolute ethanol, creating a foam sclerosing agent. This foam structure acts as a mediator that delivers the therapeutic ethanol while reducing direct tissue contact and harmful effects, thereby maintaining sclerosing efficacy while minimizing side effects like tissue necrosis

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the physical state and concentration parameters of ethanol by forming it into a foam structure with air bubbles. This parameter change allows the ethanol to be delivered in a controlled manner with reduced local concentration spikes, maintaining therapeutic effect while reducing harmful side effects

Inventive Principle:
Principle #35Parameter changes

2Reliability

If absolute ethanol is used as a sclerosing agent, then the therapeutic effect is maintained, but the application is limited due to serious side effects

Engineering Contradiction:
Improvetherapeutic effectVSAvoidapplication range
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

By introducing air as a mediator to create foam, the patent expands the adaptability of absolute ethanol for clinical application. The foam structure makes the agent more versatile and suitable for various injection scenarios, thereby extending its application range while maintaining therapeutic efficacy

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If polidocanol is made into foam, then the safety is improved and side effects are reduced, but only polidocanol can be made into foam limiting the choices

Engineering Contradiction:
Improveside effectsVSAvoidagent selection
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The patent makes absolute ethanol universally applicable for foam formation, similar to polidocanol. This multi-functional approach allows absolute ethanol to serve both as a strong sclerosing agent and as a foamable substance, expanding the range of agents that can be used in foam sclerotherapy while maintaining safety benefits

Inventive Principle:
Principle #6Universality (Multi-functionality)

4Object-affected harmful factors

If foam sclerosing agent is used, then the safety and fewer side effects are achieved, but the stability and uniformity need improvement

Engineering Contradiction:
Improveside effectsVSAvoidfoam stability
Core Design Contradiction:
Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

The patent creates a composite foam structure combining absolute ethanol, air, and stabilizing agents. This composite material approach improves foam stability and uniformity while maintaining the safety benefits of foam delivery, addressing the stability issue without sacrificing the reduced side effects

Inventive Principle:
Principle #40Composite materials

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 ethanol foam sclerosing agent achieves better safety, fewer side effects, and improved stability, allowing for effective treatment of vascular anomalies with a longer half-life and simpler application, while maintaining the strong sclerosing effect of absolute ethanol.

Implementation Method 1

a non-ionic surfactant is composed of Tween and lecithin

Methodology Applied
Scientific EffectSurface tension reduction by surfactant: Surfactant

Implementation Method 2

The latter has more advantages, such as better effect, more safety and fewer side effects than the liquid sclerosing agent

Methodology Applied
Scientific EffectFoam formation: Foam

Implementation Method 3

the stabilizer is hyaluronic acid or glycerin, preferably is hyaluronic acid. The addition of the hyaluronic acid or glycerin to the ethanol foam sclerosing agent of the present invention can improve the stability of the ethanol foam sclerosing agent, improve the uniformity of the foam, extend the half-life of the foam

Methodology Applied
Scientific EffectFoam stabilization:

Data Source

PatentUS11975099B2Ethanol foam sclerosing agent for treating vascular anomalies and preparation method thereof
Publication Date: 2024.05.07 SHANDONG UNIV QILU HOSPITAL
  • US11975099B2 patent drawing
  • US11975099B2 patent drawing
  • US11975099B2 patent drawing

AI summary

The present invention relates to an ethanol foam sclerosing agent for vascular anomalies and a preparation method thereof. The ethanol foam sclerosing agent includes absolute ethanol, water, Tween 80 and a stabilizer. The ethanol foam sclerosing agent further includes hyaluronic acid. The mass composition of the ethanol foam sclerosing agent includes 32-42% of absolute ethanol, 0.5-2% of Tween 80, 0-25% (excluding 0) of egg yolk lecithin, 0-2% (excluding 0) of hyaluronic acid, and the balance of water. The stabilizer is hyaluronic acid or glycerin. Foam is prepared by the Tessari method. While the original therapeutic effect of ethanol is not changed, the side effect of the ethanol is significantly reduced.