Cold Sterilizer for Endoscopes with Pressure-Controlled Chemical Circulation

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Solution Overview

Problem

Current sterilization systems for medical devices, particularly rigid and flexible endoscopes, are inadequate as they are complex, non-versatile, and unsafe due to the handling of chemical agents, and none can concurrently sterilize both types of endoscopes at lower temperatures without damaging flexible ones.

Innovation Solution

A cold sterilizer with a chamber for chemical agents, a container for flexible devices, compartments for rigid devices, and means for agent circulation, pressure control, and safe collection, using agents like peracetic acid and 5,7-diphenyl-1,3-diazoadamantan-6-one within the 20-35°C range, allowing simultaneous sterilization of both types.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional sterilization systems (steam autoclaves, plasma gas autoclaves, ethylene oxide autoclaves) are used, then sterilization is achieved, but temperatures exceed 50°C which damages flexible endoscopes

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidtemperature damage to flexible endoscopes
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention changes the temperature parameter from conventional high-temperature sterilization (>50°C) to cold sterilization (20-35°C) by using chemical sterilizing agents instead of thermal methods, thereby eliminating temperature damage to flexible endoscopes while maintaining sterilization effectiveness

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention replaces mechanical/thermal sterilization systems (steam autoclaves, plasma gas autoclaves) with a chemical-based cold sterilization system that uses circulating chemical agents to achieve sterilization without thermal damage

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

2Reliability

If dedicated separate sterilizers are used for rigid and flexible endoscopes, then sterilization safety is improved, but device complexity and space requirements increase

Engineering Contradiction:
Improvesterilization safetyVSAvoidsystem structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention creates a universal sterilization system that can simultaneously process both rigid endoscopes in compartments and flexible endoscopes in the container using the same cold sterilization chemistry, eliminating the need for separate dedicated sterilizers while maintaining safety through controlled chemical circulation and pressure management

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The invention merges the sterilization functions for rigid and flexible endoscopes into a single integrated system with shared chemical circulation infrastructure, control systems, and safety mechanisms, reducing overall system complexity and space requirements compared to separate dedicated systems

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If chemical agents are manually handled for sterilization, then sterilization process is simple, but safety hazards increase for operators

Engineering Contradiction:
Improveoperation simplicityVSAvoidchemical agent hazards to operators
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The system performs self-service through automatic circulation of chemical sterilizing agents via pumps and filters, automated pressure control, and computer-controlled monitoring, eliminating the need for manual chemical handling by operators while maintaining simple operation through automated workflows

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention introduces an intermediary automated chemical circulation system with sealed containers, filters, and pressure-controlled distribution networks that mediates between the sterilizing chemicals and operators, allowing effective sterilization while protecting operators from direct chemical exposure through automated containment and handling

Inventive Principle:
Principle #24Intermediary (Mediator)

4Object-affected harmful factors

If cold sterilization is implemented, then flexible endoscope safety is improved, but sterilization effectiveness may be compromised compared to high-temperature methods

Engineering Contradiction:
Improvedamage to flexible endoscopesVSAvoidsterilization effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The invention changes the sterilization parameters from high temperature to low temperature (20-35°C) while compensating for reduced thermal energy through extended exposure time, enhanced chemical agent concentration and circulation, and pressurized delivery systems to maintain sterilization effectiveness without thermal damage

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system ensures continuous and thorough sterilization through constant circulation of chemical agents through all endoscope channels and surfaces, maintaining sustained contact between sterilizing agents and contaminated surfaces throughout the treatment period to achieve complete sterilization at low temperatures

Inventive Principle:
Principle #20Continuity of useful 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

Enables safe and efficient concurrent sterilization of rigid and flexible endoscopes at lower temperatures, ensuring complete safety and reliability in the handling of chemical agents, addressing the limitations of existing systems.

Implementation Method 1

means for the circulation of the above chemical agents, among the tanks (1), the container (3), the casings (7) and the medical devices contained therein

Methodology Applied
Scientific EffectFluid circulation: Convection

Implementation Method 2

means for assuring the circulation under pressure of said chemical agents

Methodology Applied
Scientific EffectPressure-driven flow: Pressure Gradient

Data Source

PatentUS8980197B2Cold sterilizer
Publication Date: 2015.03.17 IMS SPA
  • US8980197B2 patent drawing
  • US8980197B2 patent drawing
  • US8980197B2 patent drawing

AI summary

A cold sterilizer, for deterging/decontaminating, sterilizing, drying and storing until the time of use medical devices, optionally the thermo-labile ones, in particular flexible and rigid endoscopes for surgical and diagnostic use, suitable for operating with sterilizing agents effective in the range 20-35° C., including the following parts in combination, a chamber, containing the tanks for deterging and sterilizing chemical agents, with closure means thereof; a room—which is or contains the container for flexible devices—equipped with optionally see-through closure means; a plurality of compartments substantially parallel thereamong and arranged substantially parallel to the side walls and to the support base, equipped with individual or common closure means and containing the casings in which the rigid devices are stored; means for the circulation of the above chemical agents among the tanks, the container, the casings and the medical devices contained therein; means for the automatic collection of the deterging and sterilizing chemical agents; means for assuring the circulation under pressure of said agents; means for detecting and controlling in real time the pressures exerted on the channels of the fluxed medical devices; means for allowing the purging of the channels of said medical devices; hydraulic and electrical connections; optionally, means for recording and printing the reprocessing data; optionally, means for facilitating the access to the mechanics thereof. FIG. 1 shows an embodiment of the cold sterilizer according to the invention.