Iodine Antiseptic Self-Sterilization via Elemental Iodine Generation

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Solution Overview

Problem

Current sterilization methods for antiseptic solutions, particularly iodine-based products, are inefficient and create impurities, making them unsuitable for mass production and prone to contamination, which can lead to clinical infections and regulatory issues due to degradation of active ingredients and unsuitable for all types of packaging.

Innovation Solution

A self-sterilization process using a closed container system heated to low temperatures (60-100°C) under high pressure to generate free elemental iodine, which diffuses and reacts to kill bacteria and viruses, maintaining solution purity and preventing contamination without creating new impurities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sterilization methods (heat sterilization, ethylene oxide sterilization, gamma radiation sterilization) are used on antiseptic solutions, then sterilization is achieved, but the antimicrobial molecules degrade creating impurities and lowering active drug concentration

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidimpurity concentration
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent applies self-service by allowing the iodine-containing solution to sterilize itself through controlled decomposition. The solution is heated to 40-100°C to promote decomposition of excess iodine into elemental iodine, which then acts as the sterilizing agent. This eliminates the need for external sterilization methods that would degrade the active ingredients.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent changes physical parameters (temperature and pressure) to control the sterilization process. By heating to 40-100°C and applying pressure of 1-10 atm, the solution undergoes controlled decomposition and sterilization without the harsh conditions of conventional methods. This parameter control prevents degradation while achieving sterilization.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If gamma radiation sterilization is used on antiseptic products, then sterilization is effective, but it breaks down chemical components and active ingredients requiring lengthy FDA approval process

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidmanufacturing approval time
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent replaces the mechanical/radiation-based sterilization system (gamma radiation) with a thermal-chemical system. Instead of using high-energy radiation that breaks down molecular bonds, the invention uses controlled heating to promote beneficial decomposition reactions that produce sterilizing elemental iodine without degrading the active ingredients.

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

3Reliability

If ethylene oxide sterilization is used on antiseptic solutions, then sterilization is achieved, but it cannot permeate through thick plastic packaging or rigid closed containers

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidpackaging compatibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent uses heat as an intermediary that can penetrate packaging materials to transfer energy to the solution inside. The thermal energy passes through the container walls to heat the solution, enabling sterilization without requiring the sterilizing agent to permeate the packaging. This allows sterilization of solutions in various packaging types including thick plastic and rigid containers.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If autoclave sterilization is used on iodine solutions, then sterilization is achieved, but it requires high temperature and pressure degrading packaging materials and suitable only for small batches

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidsterilization temperature
Core Design Contradiction:
ReliabilityVSTemperature

Solution Approach 1:

The patent applies partial action by using only the temperature range necessary to promote iodine decomposition (40-100°C) rather than the excessive temperatures of autoclaving (121°C or higher). This partial heating is sufficient to generate sterilizing elemental iodine while avoiding degradation of packaging materials and enabling mass production.

Inventive Principle:
Principle #16Partial or excessive action

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 method effectively sterilizes iodine solutions within a short time frame, ensuring compliance with regulatory standards, preventing Hospital-Acquired Infections, and maintaining the integrity of iodine-based products without degrading packaging materials.

Implementation Method 1

heating the iodine-containing solution to a temperature sufficient to promote decomposition of the iodine-containing solution

Methodology Applied
Scientific EffectHeating: Heating

Implementation Method 2

promote decomposition of the iodine-containing solution and generate free elemental iodine

Methodology Applied
Scientific EffectDecomposition: Decomposition (biological)

Implementation Method 3

The free elemental iodine kills bacteria and viruses in the solution and on the surface of the container

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS20230390397A1System, method and process for self-sterilization of iodine-containing devices
Publication Date: 2023.12.07 HDR LLC
  • US20230390397A1 patent drawing
  • US20230390397A1 patent drawing
  • US20230390397A1 patent drawing

AI summary

A method and system for sterilizing an iodine antiseptic solution is disclosed. The iodine antiseptic solution can comprise iodine crystals and/or povidone-iodine (PVP-I). The method includes providing the iodine antiseptic solution to a closed container. And during a sterilization cycle, the method further includes heating the iodine antiseptic solution in the closed container to a sterilization temperature sufficient to generate free elemental iodine in the closed container. The method further includes applying a positive pressure in the closed container to pressurize the free elemental iodine to produce sterilized iodine within the closed container.