Hypotonic Aqueous Composition for Amniotic Infusion

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Solution Overview

Problem

Current amniotic infusion methods for treating premature rupture of membranes (PPROM) face challenges such as rapid fluid loss from the uterus, high osmolarity and chloride ion concentrations that can harm fetal organs, and the risk of genetic contamination and infections from using animal-derived amniotic fluid, leading to health risks and ethical concerns.

Innovation Solution

A hypotonic aqueous composition with reduced chloride content and optional phospholipids, tailored to match the osmolarity and ion concentrations of human amniotic fluid, is used for amniotic infusion, which includes specific ion concentrations and surfactant components to promote lung maturation and reduce health risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If isotonic saline solution is used for amniotic infusion, then fluid volume is restored, but osmolarity and chloride ion concentration harm fetal organs

Engineering Contradiction:

Improveamniotic fluid volumeVSAvoidfetal organ damage from high osmolarity and chloride

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent changes the osmolarity parameter from isotonic (308 mosm/l) to hypotonic (240-290 mosm/l) and reduces chloride ion concentration from 154 mmol/l to 100-120 mmol/l, creating a composition that matches natural amniotic fluid parameters and eliminates fetal organ damage while maintaining fluid volume restoration

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent creates an artificial amniotic fluid composition that copies the biochemical parameters of natural amniotic fluid, including hypotonicity, reduced chloride content, and specific ion concentrations, thereby replicating the safe and beneficial properties of natural fluid without the harmful effects of saline solutions

Inventive Principle:

Principle #26Copying

2Quantity of substance

If animal-derived amniotic fluid is used for infusion, then fluid volume is restored, but genetic contamination and infection risks increase

Engineering Contradiction:

Improveamniotic fluid volumeVSAvoidrisk of genetic contamination and infections

Core Design Contradiction:

Quantity of substanceVSReliability

Solution Approach 1:

The patent uses synthetic, sterilizable composition that can be prepared fresh or stored safely, eliminating the biological contamination risks associated with animal-derived fluids while maintaining the therapeutic benefits of amniotic fluid replacement

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent introduces a synthetic composition as an intermediary that provides the necessary fluid replacement function without the biological hazards of animal-derived products, serving as a safe mediator between the need for fluid volume and the avoidance of contamination risks

Inventive Principle:

Principle #24Intermediary (Mediator)

3Productivity

If rapid fluid infusion is performed, then amniotic fluid volume is quickly restored, but fluid flows out of uterus quickly reducing treatment effect

Engineering Contradiction:

Improvefluid volume restoration speedVSAvoidamniotic fluid loss from uterus

Core Design Contradiction:

ProductivityVSLoss of substance

Solution Approach 1:

The patent changes the osmotic parameter to hypotonic, creating an osmotic gradient that promotes fluid retention in the amniotic cavity rather than rapid efflux, thereby maintaining treatment effectiveness while achieving quick volume restoration

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

Instead of using isotonic or hypertonic solutions that cause rapid fluid movement out of the uterus, the patent inverts the approach by using hypotonic solution that promotes fluid retention and absorption, reversing the harmful rapid efflux effect

Inventive Principle:

Principle #13The other way round (Inversion)

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 effectively reduces the risk of premature birth, promotes lung maturation, and minimizes damage to fetal organs, while being safe, cost-effective, and ethically sound, with a reduced risk of genetic contamination and infections.

Implementation Method 1

The osmolarity of this composition according to the invention is lower than that of physiological saline solution and thus less than 308.0 mosm/l

Methodology Applied

Scientific EffectOsmosis: Osmosis

Implementation Method 2

Studies on the composition of amniotic fluid have also been published. It is assumed that the phospholipids contained in human amniotic fluid are responsible for fetal lung maturation

Methodology Applied

Scientific EffectSurfactant: Surfactant

Data Source

PatentEP2661308B1Hypotonic aqueous composition with reduced chloride content, with or without phospholipids

Publication Date: 2019.05.08 PRENATAL INT GMBH

AI summary

The present invention relates to an aqueous composition for application in a method for surgical or therapeutic treatment of the human or animal body or in a diagnostic procedure which is practised on the human or animal body, the composition comprising osmotically active particles and containing less than 70 µl-1 of amniotic cells, the osmolarity of the composition being in the range from 240.0 mosm/l to less than 308.0 mosm/l, and the chloride ion concentration in the composition being not more than 130.0 mmol/l. The present invention further relates to an aqueous composition for application with an amniotic infusion, the composition containing less than 70 µl-1 of amniotic cells and comprising at least one surfactant.