Prion Inactivation Assay via pH Neutralization and Thermal Detoxification

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Solution Overview

Problem

Current methods for inactivating unconventional transmissible agents like prions are inadequate, particularly in medical and surgical settings, as they are resistant to conventional disinfection methods and pose risks of secondary human-to-human transmission through contaminated equipment, with existing evaluation methods being complex and not representative of real-world scenarios.

Innovation Solution

A method involving incubation of prions with a liquid composition, followed by chemical and thermal detoxification, and subsequent measurement of inactivation using either in vitro or in vivo tests, which includes pH neutralization and heat treatment to ensure accurate assessment of inactivation without interfering with the prion's infectious capacity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If drastic treatments (soda, bleach, autoclaving at 134°C) are used to inactivate prions, then inactivation effectiveness is improved, but physical or chemical incompatibility with medical devices worsens

Engineering Contradiction:
Improveinactivation effectivenessVSAvoidphysical or chemical incompatibility
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies parameter changes by modifying the temperature and chemical concentration parameters of the inactivation treatment. Instead of using extreme conditions (134°C autoclaving, high-concentration bleach or soda), the patent uses milder parameters (lower temperature combined with specific chemical formulations) to achieve effective prion inactivation while preventing damage to medical devices.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If conventional inactivation methods are used, then ease of operation is improved, but inactivation effectiveness against prions worsens

Engineering Contradiction:
Improveease of operationVSAvoidinactivation effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent introduces a chemical intermediary substance that acts as a mediator between the conventional autoclaving process and the prion inactivation goal. This chemical formulation enhances the effectiveness of milder thermal treatments, allowing conventional equipment to achieve superior inactivation results without requiring extreme conditions.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Device complexity

If existing evaluation methods are used, then device complexity is reduced, but measurement precision of inactivation worsens

Engineering Contradiction:
Improveevaluation method complexityVSAvoidinactivation measurement precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent replaces complex mechanical evaluation systems with a simplified chemical-biological assay system. Instead of using intricate physical measurement devices, the patent employs a biochemical detection method that measures prion inactivation through chemical reactions and biological responses, achieving higher precision with lower complexity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 allows for reliable and reproducible measurement of prion inactivation, reducing experimental biases and ensuring the safety of medical devices and equipment by effectively neutralizing prions without altering their infectious characteristics, thus addressing the limitations of existing methods.

Implementation Method 1

step b1) of chemical detoxification of the mixture by neutralization of the pH

Methodology Applied
Scientific EffectpH neutralization:

Implementation Method 2

step b2) of thermal detoxification of the mixture at a temperature ranging from 60°C to 95°C

Methodology Applied
Scientific Effectthermal detoxification:

Implementation Method 3

a) incubate an ATNC with a composition to be tested

Methodology Applied
Scientific Effectchemical interaction:

Data Source

PatentEP2732827B1Method for determining the capability of a formulation to inactivate an non-conventional transmissible agent (NCTA)
Publication Date: 2015.09.16 FRANKLAB
  • EP2732827B1 patent drawingFigure 1~2

AI summary

The present invention relates to a method for measuring the ability of a liquid formulation to inactivate an Unconventional Transmissible Agent (UTA), in particular a prion.