Non-DEHP Blood Storage Containers With Alternative Plasticizers

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Solution Overview

Problem

Existing blood storage containers made from PVC-DEHP materials leach phthalates, posing health risks, especially for sensitive individuals like pregnant women and neonates, and complicating the goal of providing DEHP-free or phthalate-free blood products.

Innovation Solution

Development of containers with walls comprising layers of polymeric materials, such as PVC, combined with extractable agents like terephthalate esters, cyclohexane dicarboxylic acid esters, citrate esters, and polyol esters, which reduce the phthalate content to less than 3% (w/w), thereby minimizing leaching and enhancing blood component quality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If PVC-DEHP materials are used for blood storage containers, then flexibility and softness of the container are ensured, but phthalates leach into blood products causing health risks

Engineering Contradiction:

Improveflexibility and softnessVSAvoidphthalate leaching

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent removes DEHP plasticizer from the container system entirely, replacing it with alternative materials or plasticizers that do not leach harmful phthalates into blood products, thereby extracting the harmful substance while maintaining container functionality

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent employs composite material solutions, including PVC combined with alternative plasticizers or different polymeric materials, to maintain the required flexibility and softness while eliminating DEHP-related health risks

Inventive Principle:

Principle #40Composite materials

2Reliability

If DEHP plasticizer is used in PVC containers, then hemolysis of red blood cells is reduced during storage, but exposure to phthalates increases for sensitive individuals

Engineering Contradiction:

Improvehemolysis reductionVSAvoidphthalate exposure

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent addresses the dual nature of DEHP by seeking alternative plasticizers that can provide the beneficial hemolysis reduction effect without the harmful phthalate exposure, effectively converting the harmful substance's protective function into a safe alternative

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The patent changes the chemical parameters of the plasticizer substance, transitioning from DEHP to alternative plasticizers with different chemical structures that do not belong to the phthalate family, thereby maintaining protective functions while eliminating harmful effects

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS20250049637A1Medical Containers And System Components With Non-Dehp Plasticizers For Storing Red Blood Cell Products, Plasma And Platelets

Publication Date: 2025.02.13 FRESENIUS KABI DEUTSCHLAND GMBH

AI summary

A container for blood or a blood component is provided, the container comprising one or more container walls defining an interior chamber, the container walls comprising one or more layers, the layers comprising or consisting of a composition comprising one or more polymeric materials and at least one extractable agent selected from the group consisting of a terephthalate ester, a cyclohexane dicarboxylic acid ester, a citrate ester, and a polyol ester, wherein the container further comprises one or more additional components, wherein the container comprises less than about 3% (w/w) of di-2-ethylhexyl phthalate (DEHP), preferably wherein the container comprises less than about 3% (w/w) of phthalates. Thereby, improved blood products are provided in which the DEHP or overall phthalate content is reduced.