Prion Deactivating Composition Using Copper Chelators and Subtilisin

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Solution Overview

Problem

Prion diseases pose a transmission risk through medical devices, particularly neurosurgical and ophthalmological instruments, due to the difficulty in deactivating prions using conventional decontamination methods, which are often damaging to these devices and ineffective at low pH levels.

Innovation Solution

A prion deactivating composition comprising copper (II) complexing agents and subtilisin, which can be used to denature prions, is applied to contaminated surfaces or articles, followed by a sterilization medium to ensure effective deactivation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional decontamination methods (autoclaving, chemical sterilants) are used to deactivate prions, then prion deactivation is achieved, but the medical devices are damaged or the methods are incompatible with device materials

Engineering Contradiction:

Improveprion deactivation effectivenessVSAvoiddamage to medical devices

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the chemical parameters of the decontamination process by using a proteolytic enzyme (subtilisin) that functions effectively at neutral to alkaline pH levels, avoiding the need for extreme heat or harsh chemicals that damage devices. The enzyme-based approach allows deactivation at moderate temperatures and neutral pH, compatible with sensitive medical device materials

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces mechanical/thermal sterilization methods (autoclaving at high temperatures) with a biochemical approach using proteolytic enzymes. This substitution allows prion deactivation through protein digestion rather than thermal stress, preserving device integrity while achieving complete deactivation

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If high pH levels are used to enhance prion deactivation, then deactivation effectiveness improves, but compatibility with medical device materials deteriorates

Engineering Contradiction:

Improveprion deactivation effectivenessVSAvoidcompatibility with medical device materials

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent optimizes the pH parameter to work at neutral to alkaline levels (pH 7-11) rather than requiring extreme pH values. This optimized parameter range maintains effectiveness against prions while being compatible with a broader range of medical device materials, including plastics and metals that can be damaged by strong acids or bases

Inventive Principle:

Principle #35Parameter changes

3Reliability

If proteolytic enzymes are used to denature prions, then deactivation effectiveness improves, but the enzymes may be inhibited by copper ions present in prion proteins

Engineering Contradiction:

Improveprion deactivation effectivenessVSAvoidenzyme inhibition by copper ions

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent introduces chelating agents as intermediary substances that bind to copper ions in the prion protein. These chelators act as mediators that remove or sequester the copper ions, preventing them from inhibiting the proteolytic enzyme while allowing the enzyme to continue effectively deactivating the prion

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent converts the harmful copper ions into a beneficial component by using chelating agents to bind them. The copper ions, which would normally inhibit the enzyme, are instead captured by the chelators and removed from the active site, transforming a harmful factor into a controlled element that can be managed

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 composition effectively denatures prions, reducing their infectivity and ability to replicate, while being compatible with medical device materials, even at low pH levels, thus enhancing the safety of surgical procedures.

Implementation Method 1

prion denaturing agent which is at least one copper (II) complexing agent selected from the group consisting of ethylendiamintetraacetic acid (EDTA), benzotriazole, tolyltriazole, trisodiummethylglycinediacetic acid (Trilon M), 6,6'6"-(1,3,5-triazine-2,4,6-triyltriimino) tris(hexanoic acid) (Irgacor L190), ethanol-2,2'-[[methyl-1H-benzotriazol-1-yl]methyl]imino]bis- (Irgamet 42), and didecyldimethylammonium bicarbonate/carbonate (CarboShield 1000)

Methodology Applied

Scientific EffectComplexation:

Implementation Method 2

prion deactivating enzyme which is at least one protease selected from the group consisting of subtilisin, thermolysin, bacterial protease, and a combination of two or more thereof

Methodology Applied

Scientific EffectProteolytic hydrolysis: Hydrolysis

Data Source

PatentEP2219687B1Prion deactivating composition and methods of using same

Publication Date: 2017.03.08 AMERICAN STERILIZER CO

AI summary

The disclosed invention relates to prion deactivating compositions and methods for using the same. The prion deactivating composition may comprise at least one prion denaturing agent and at least one prion deactivating enzyme. The invention relates to a method of cleaning and/or sterilizing a material contaminated with infectious proteins.