Microvesicle Size Control via Gas Solubility Mixture

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Solution Overview

Problem

Conventional methods for preparing size-controlled gas-filled microvesicles result in high polydispersity index (PDI) and foaming phenomena, which are undesirable for ultrasound imaging and therapeutic applications, especially when using gases with low aqueous solubility.

Innovation Solution

A method involving a mixture of gases with low and high water solubility, where the volume percentage of the low solubility gas is 15% or lower, and the highly soluble gas is 60% or higher in the final stabilized microvesicles, is used in a microfluidic flow-focusing process to stabilize microvesicles rapidly and reduce PDI and foaming.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional methods are used to prepare gas-filled microvesicles, then the preparation process is simple, but the polydispersity index (PDI) is high and foaming phenomena occur

Engineering Contradiction:
Improvepolydispersity index (PDI)VSAvoidpreparation method complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by controlling the gas composition (using mixtures of perfluorocarbon gas with other gases), temperature (maintaining 20-40°C during preparation and storage), and flow rates in the microfluidic device to achieve monodisperse microvesicles with PDI < 10%, resolving the contradiction between manufacturing precision and process complexity

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses an intermediary approach by introducing a stabilizing envelope comprising phospholipids and proteins that form a protective layer around the gas-filled microvesicles, preventing coalescence and foaming while maintaining size control, thus improving manufacturing precision without excessive complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

2Duration of action of stationary object

If gases with low aqueous solubility are used to improve persistence, then the persistence of microvesicles is enhanced, but foaming phenomena and PDI increase occur

Engineering Contradiction:
Improvepersistence of microvesiclesVSAvoidfoaming phenomena
Core Design Contradiction:
Duration of action of stationary objectVSObject-generated harmful factors

Solution Approach 1:

The patent applies local quality by creating a stabilizing envelope with specific composition (phospholipids and proteins) that localizes at the gas-liquid interface of each microvesicle, providing localized stabilization that prevents foaming while allowing the use of low-solubility gases for enhanced persistence

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent uses composite materials by combining perfluorocarbon gas (for persistence) with other gases, and combining phospholipids with proteins in the stabilizing envelope, creating a composite system that achieves both long persistence and prevents foaming phenomena

Inventive Principle:
Principle #40Composite materials

3Stability of the object's composition

If temperature is increased to limit coalescence, then coalescence is reduced, but microvesicle stability decreases over time

Engineering Contradiction:
Improveresistance to coalescenceVSAvoidlong-term stability
Core Design Contradiction:
Stability of the object's compositionVSDuration of action of stationary object

Solution Approach 1:

The patent applies preliminary action by forming a complete stabilizing envelope comprising both phospholipids and proteins around the microvesicles during the preparation process itself, rather than relying on post-formation stabilization. This preliminary protective layer prevents both coalescence during formation and maintains stability over time

Inventive Principle:
Principle #10Preliminary action

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

This approach significantly reduces PDI and foaming, stabilizing microvesicles quickly, ensuring consistent size distribution and preventing the formation of large microvesicles, thus enhancing their suitability for imaging and therapeutic applications.

Implementation Method 1

a flow of a gas component is focused by a flow of a liquid component through a narrow orifice

Methodology Applied
Scientific EffectFlow-focusing: Focusing

Implementation Method 2

the liquid component comprises an envelope forming material (typically surfactants such as lipids, including phospholipids and/or fatty acids), which entraps the gaseous component to form the desired gas-filled microvesicles, which are stabilized against coalescence and dissolution by said envelope forming material

Methodology Applied
Scientific EffectEntrapment: Physical Containment

Implementation Method 3

aqueous suspensions of gas-filled microvesicles where the bubbles of gas are bounded, at the gas/liquid interface, by a very thin envelope (film) involving a stabilizing amphiphilic material (typically a phospholipid) disposed at the gas to liquid interface

Methodology Applied
Scientific EffectAmphiphilic stabilization: Amphiphiles

Implementation Method 4

A method involving a mixture of gases with low and high water solubility, where the volume percentage of the low solubility gas is 15% or lower, and the highly soluble gas is 60% or higher in the final stabilized microvesicles

Methodology Applied
Scientific EffectGas solubility differentiation: Absorption (physical)

Data Source

PatentEP3762041B1Preparation of size-controlled microvesicles
Publication Date: 2024.10.02 BRACCO SUISSE SA
  • EP3762041B1 patent drawingFigure 1
  • EP3762041B1 patent drawingFigure 2~3
  • EP3762041B1 patent drawingFigure 4~5

AI summary

A method for preparing a suspension of "size-controlled" gas-filled microvesicles by microfluidic manufacturing techniques, which comprises using a gaseous flow comprising a first gas having high solubility in water and a second gas having low 5 solubility in water.