Epsilon Polylysine Contact Lens Packaging for Microbial Protection

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Solution Overview

Problem

Microbial contamination of contact lenses during handling is a significant public health concern, particularly for daily disposable wearers due to non-compliant storage and reuse, leading to increased incidence of ocular infiltrates and infections.

Innovation Solution

A sealed, autoclaved contact lens package containing a sterile, unworn contact lens and a contact lens packaging solution with epsilon polylysine (εPLL) that reduces microbial contamination by at least one microbe, such as Pseudomonas aeruginosa, during lens removal, as determined by a log kill test after 24 hours incubation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If contact lenses are packaged in sterile solution without additional antimicrobial agents, then the packaging solution maintains simplicity and compatibility with lens materials, but the lenses become susceptible to microbial contamination during handling and removal from packaging

Engineering Contradiction:
Improveprotection against microbial contaminationVSAvoidcomplexity of packaging solution composition
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by incorporating epsilon polylysine into the packaging solution before the lens is packaged. This pre-established antimicrobial environment protects the lens during storage and handling, preventing microbial contamination before it can occur during lens removal and wear.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses epsilon polylysine as an intermediary substance between the lens and potential microbial contaminants. This polypeptide acts as a protective mediator that neutralizes or prevents microbial adhesion to the lens surface during handling, without directly contacting the eye with harsh disinfectants.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If strong antimicrobial agents are used in the packaging solution, then microbial contamination is effectively prevented, but the risk of ocular irritation and damage to lens materials increases

Engineering Contradiction:
Improveprotection against microbial contaminationVSAvoidocular irritation and lens material damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the parameter of antimicrobial agent selection by using epsilon polylysine, a naturally occurring polypeptide with mild properties. This polypeptide provides effective antimicrobial activity through its cationic charge that interacts with microbial cell membranes, while maintaining biocompatibility and avoiding the harsh effects of traditional disinfectants like peroxide or chlorhexidine.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent leverages the mechanism of epsilon polylysine which acts as a natural antimicrobial agent that disrupts microbial cell membranes through electrostatic interactions and oxidative stress, providing effective pathogen control without requiring strong chemical oxidants that could damage lens materials or irritate the eye.

Inventive Principle:
Principle #38Strong oxidants (Accelerated oxidation)

3Reliability

If epsilon polylysine is added to the packaging solution to reduce microbial contamination, then lens handling safety is improved, but the cost of manufacturing and complexity of solution formulation increase

Engineering Contradiction:
Improvereduced microbial contamination during handlingVSAvoidmanufacturing complexity and cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent optimizes the concentration of epsilon polylysine in the packaging solution to achieve effective antimicrobial protection at minimal doses. By carefully controlling the polypeptide concentration and formulation pH, the patent reduces manufacturing costs while maintaining efficacy against common ocular pathogens.

Inventive Principle:
Principle #35Parameter changes

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 use of epsilon polylysine in the packaging solution effectively reduces microbial contamination by achieving less than a two log kill of Pseudomonas aeruginosa compared to control lenses, providing protection against microbial keratitis and ocular infiltrates, and is applicable to various contact lens materials and wear modalities.

Implementation Method 1

ε-polylysine is a homopolymer of about 25-35 residues of L-lysine in which the epsilon-amino and carboxyl groups of L-Lysine are linked. It is a naturally-occurring polymer produced by Streptomyces species. It has broad-spectrum antimicrobial activity

Methodology Applied
Scientific EffectAntimicrobial activity:

Data Source

PatentEP3157582B1Protection of contact lenses from microbial contamination caused by handling
Publication Date: 2023.02.15 COOPERVISION INT LTD
  • EP3157582B1 patent drawing

AI summary

A sealed contact lens package contains a sterile, unworn contact lens and a contact lens packaging solution comprising epsilon polylysine (εPLL). The εPLL protects the contact lens from microbial contamination caused by handling the lens when it is removed from its package.