Polysulfone Blood Membrane with Hydroxy Polymer

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Solution Overview

Problem

Existing blood processing separation membranes face challenges with decreased performance and blood compatibility due to chemical changes caused by oxygen, temperature, and light exposure during storage and sterilization, leading to protein adsorption and elution of decomposition products.

Innovation Solution

Incorporating a polymer with a hydroxy group in the side chain, such as poly(hydroxypropyl methacrylate) or poly(hydroxyethyl methacrylate), into the polysulfone-based separation membrane to enhance stability and prevent radical-induced decomposition, ensuring high blood compatibility and storage stability even after irradiation sterilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a polysulfone polymer is used as a base material for the separation membrane, then membrane-formability, biological safety, and chemical stability are improved, but hydrophobicity increases leading to poor blood compatibility and protein adsorption

Engineering Contradiction:
Improvemembrane-formability and chemical stabilityVSAvoidhydrophobicity causing protein adsorption
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines polysulfone polymer with hydrophilic polymers (polyvinylpyrrolidone, polyvinyl alcohol, or polyethylene glycol) to create a composite membrane structure. The hydrophilic polymer component (0.1-10 mass%) modifies the surface properties to reduce hydrophobicity and prevent protein adsorption, while the polysulfone base maintains structural integrity and chemical stability.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the chemical composition parameters of the membrane by incorporating hydrophilic polymers in specific concentrations (0.1-10 mass%). This parameter change transforms the surface energy characteristics from hydrophobic to hydrophilic, improving blood compatibility while maintaining the underlying polysulfone structure's reliability.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If a hydrophilic polymer is added to improve blood compatibility, then protein adsorption is suppressed, but the membrane becomes more susceptible to chemical changes during storage and sterilization

Engineering Contradiction:
Improveprotein adsorption suppressionVSAvoidchemical stability during storage
Core Design Contradiction:
Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

The patent uses specific hydrophilic polymers (polyvinylpyrrolidone, polyvinyl alcohol, or polyethylene glycol) as intermediary substances that mediate between the hydrophobic polysulfone base and the blood environment. These intermediaries provide blood compatibility while their molecular structures resist oxidation and degradation during storage and sterilization processes.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent optimizes the concentration range of hydrophilic polymers (0.1-10 mass%) to achieve the right balance between blood compatibility and storage stability. This parameter optimization ensures sufficient hydrophilicity for protein adsorption prevention while maintaining adequate chemical stability during storage and sterilization.

Inventive Principle:
Principle #35Parameter changes

3Loss of time

If the separation membrane is stored for a long period, then availability is improved, but chemical changes occur leading to reduced blood compatibility and increased elution of decomposition products

Engineering Contradiction:
Improvestorage durationVSAvoidblood compatibility maintenance
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent incorporates antioxidants (0.01-5 mass% of vitamin E, vitamin C, or butylated hydroxytoluene) as protective agents that preemptively counteract oxidative degradation during storage. These antioxidants act as cushions against chemical changes, preserving the membrane's blood compatibility and preventing decomposition product formation during long-term storage.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The patent creates a multi-component composite system combining polysulfone polymer, hydrophilic polymer, and antioxidant. This composite structure provides synergistic effects where the antioxidant protects the hydrophilic polymer from degradation during storage, maintaining blood compatibility over extended periods.

Inventive Principle:
Principle #40Composite materials

4Object-affected harmful factors

If irradiation sterilization is applied to ensure sterility, then infection risk is reduced, but the hydrophilic polymer decomposes leading to increased elution of decomposition products

Engineering Contradiction:
Improveinfection riskVSAvoidhydrophilic polymer decomposition
Core Design Contradiction:
Object-affected harmful factorsVSLoss of substance

Solution Approach 1:

The patent incorporates antioxidants (0.01-5 mass% of vitamin E, vitamin C, or butylated hydroxytoluene) that provide beforehand protection against radiation-induced oxidation. These antioxidants absorb free radicals generated during irradiation sterilization, cushioning the hydrophilic polymer from decomposition and preventing elution of decomposition products.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The patent converts the harmful effect of irradiation (free radical generation causing polymer degradation) into a beneficial outcome by using antioxidants that scavenge these radicals. The irradiation sterilization process, when combined with antioxidant protection, achieves both sterility and preservation of the hydrophilic polymer structure.

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

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 membrane maintains excellent blood compatibility and storage stability, with satisfactory air-bleeding during priming, effectively preventing protein adsorption and elution of decomposition products, thus ensuring reliable performance in blood processing applications.

Implementation Method 1

Incorporating a polymer with a hydroxy group in the side chain, such as poly(hydroxypropyl methacrylate) or poly(hydroxyethyl methacrylate), into the polysulfone-based separation membrane to enhance stability and prevent radical-induced decomposition

Methodology Applied
Scientific EffectAntioxidant: Oxidation

Implementation Method 2

incorporating such a hydrophilic polymer in the membrane hydrophilizes the surface of the membrane and provide an effect of suppressing adsorption of proteins to the membrane

Methodology Applied
Scientific EffectHydrophilicity: Hydrophile

Implementation Method 3

a separation membrane for blood processing is a separation membrane to be charged in a blood processing apparatus

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentEP2774635B1Separation membrane for use in treatment of blood, and blood treatment device having said membrane integrated therein
Publication Date: 2020.09.09 ASAHI KASEI MEDICAL CO LTD
  • EP2774635B1 patent drawing
  • EP2774635B1 patent drawing
  • EP2774635B1 patent drawing

AI summary

An object of the present invention is to provide a separation membrane for blood processing having high blood compatibility and storage stability and membrane performance that rarely deteriorates even if irradiation sterilization treatment is applied, and provide a blood processing apparatus having the membrane installed therein. The present invention is also directed to providing a separation membrane for blood processing having satisfactory air-bleeding during priming treatment of the blood processing membrane, and providing a blood processing apparatus having the membrane installed therein. The present invention provides a separation membrane for blood processing, comprising a polysulfone polymer, a hydrophilic polymer and a polymer having a hydroxy group in a side chain and having a solubility of 0.5 g or less in water (100 g) at 20°C, in which the content of the polymer falls within a specific range, and a blood processing apparatus having the membrane installed therein.