Stabilized Free Radical Polymers for Sterilization and ROS Generation

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Solution Overview

Problem

Current methods for sterilizing medical devices using ionizing radiation can cause degradation of polymers and limit the availability of reactive oxidative species (ROS) for therapeutic applications due to their short existence and difficulty in delivering them to treatment sites effectively.

Innovation Solution

Development of biocompatible, semi-crystalline, hydrolytically degradable polymers that are subjected to ionizing radiation to stabilize free radicals, which generate ROS when exposed to an oxygen-containing aqueous environment, allowing for extended ROS production at treatment sites.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ionizing radiation is applied to sterilize medical devices, then sterilization is achieved, but polymer degradation occurs

Engineering Contradiction:
Improvesterilization efficacyVSAvoidpolymer degradation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies ionizing radiation at controlled doses (25-50 kGy) to generate stabilized free radicals in semi-crystalline hydrolytically degradable polymers. By carefully controlling the radiation dose parameters and the crystalline structure, the patent achieves sterilization while preserving polymer integrity and creating therapeutic ROS-generating materials.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent converts the harmful effect of ionizing radiation (which typically causes polymer degradation) into a beneficial therapeutic mechanism. The radiation-generated free radicals are stabilized within the crystalline polymer structure and subsequently generate reactive oxidative species (ROS) that provide therapeutic benefits for treating conditions like cancer and restenosis.

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

2Reliability

If free radicals are generated in polymers through ionizing radiation, then sterilization is achieved, but free radicals rapidly react or recombine reducing their therapeutic availability

Engineering Contradiction:
ImprovesterilizationVSAvoidfree radical availability
Core Design Contradiction:
ReliabilityVSDuration of action of moving object

Solution Approach 1:

The patent changes the physical state and chemical environment of free radicals by stabilizing them within the crystalline structure of semi-crystalline polymers. This stabilization extends the lifetime of free radicals from brief moments to prolonged periods, enabling therapeutic ROS generation over extended durations.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates localized stabilization of free radicals within the crystalline regions of the polymer, while amorphous regions remain more reactive. This spatial differentiation allows free radicals to be stabilized where needed for therapeutic effect while maintaining overall polymer functionality.

Inventive Principle:
Principle #3Local quality

3Reliability

If high doses of ionizing radiation are applied to ensure sterilization, then sterilization efficacy is improved, but device degradation increases

Engineering Contradiction:
Improvesterilization efficacyVSAvoiddevice integrity
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent optimizes the radiation dose parameter to a specific range (25-50 kGy) that is sufficient for sterilization while minimizing polymer degradation. This precise parameter control allows achievement of sterilization efficacy without excessive device degradation.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent exploits the different responses of crystalline and amorphous regions to radiation. The crystalline regions provide stabilization for free radicals while being more resistant to degradation, allowing selective preservation of structural integrity in critical areas.

Inventive Principle:
Principle #3Local quality

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 stabilized free radical-containing materials enable controlled and prolonged generation of ROS, enhancing their availability for therapeutic applications, such as inhibiting cellular proliferation and treating conditions like stenosis and restenosis, while minimizing polymer degradation.

Implementation Method 1

subjected to ionizing radiation at a dose rate less than 50 kGy

Methodology Applied
Scientific EffectIonizing radiation: Radiation

Implementation Method 2

If the free radical formed on the irradiated polymer chain combines with another element such as, but not limited to, oxygen, it may result in a degradation reaction and possibly a decrease in overall polymer molecular weight. In either case, the free radical reaction rate is typically very fast once the necessary conditions exist. Where the free radicals react with an oxygen molecule, reactive oxidative species (ROS) may be generated.

Methodology Applied
Scientific EffectFree radical reaction: Oxidation

Data Source

PatentEP2890407B1Reactive oxidative species generating materials and methods of use
Publication Date: 2018.07.11 WL GORE & ASSOC INC
  • EP2890407B1 patent drawingFigure 1
  • EP2890407B1 patent drawingFigure 2
  • EP2890407B1 patent drawingFigure 3

AI summary

Materials capable of delivering stabilized free radicals to targeted treatment sites. The materials comprise semi-crystalline, hydrolytically degradable polymers that are subjected to ionizing radiation to create stabilized free radicals therein. Upon exposure to oxygen containing aqueous media, the materials generate reactive oxidative species which are useful in biological processes.