Sterilizable Pouch With Permeable Header And Sealed Cavity

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Solution Overview

Problem

Current sterilizable medical device pouches face challenges in being gas-permeable during sterilization while maintaining sterility and becoming gas-impermeable post-sterilization, often requiring additional oxygen absorbers or complex processes.

Innovation Solution

A flexible pouch design comprising a gas-impermeable web, a gas-permeable web, and a longer gas-impermeable web, where the gas-permeable web allows sterilizing gases to reach the medical device and is sealed to form a gas-impermeable cavity post-sterilization, enabling easy removal of the header and ensuring the pouch remains impermeable.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a gas-permeable web is used to allow sterilizing gases to penetrate the pouch, then sterilization effectiveness is improved, but the pouch becomes permeable to oxygen and other gases after sterilization, compromising sterility

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidgas permeability after sterilization

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The pouch is divided into two distinct functional zones: a header region containing the gas-permeable web for sterilization access, and a cavity region sealed with gas-impermeable material for sterility maintenance. This segmentation allows each zone to perform its specific function without compromising the other.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The gas-permeable web is extracted and confined to a specific header region, separated from the main cavity that requires gas-impermeability. This extraction allows the pouch to have both permeable and impermeable characteristics in different locations, resolving the contradiction between sterilization access and sterility maintenance.

Inventive Principle:

Principle #2Taking out (Extraction)

2Object-affected harmful factors

If oxygen absorbers and desiccants are added to make the pouch gas-impermeable after sterilization, then sterility is maintained, but cost and complexity increase

Engineering Contradiction:

Improvegas impermeabilityVSAvoidpouch structure complexity

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

Different regions of the pouch are assigned different gas permeability properties: the header region uses gas-permeable material for sterilization, while the cavity region uses gas-impermeable material for sterility. This local differentiation eliminates the need for additional oxygen absorbers and desiccants.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The pouch employs a composite structure combining gas-permeable web material in the header with gas-impermeable sealing material in the cavity. This composite approach achieves both gas permeability for sterilization and gas impermeability for sterility maintenance without requiring additional chemical absorbers.

Inventive Principle:

Principle #40Composite materials

3Object-affected harmful factors

If the pouch is made completely gas-impermeable to maintain sterility, then sterility is preserved, but sterilizing gases cannot penetrate to reach the medical device

Engineering Contradiction:

Improvegas impermeabilityVSAvoidsterilization effectiveness

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The pouch is segmented into a header zone with gas-permeable properties for sterilization gas penetration and a cavity zone with gas-impermeable properties for sterility maintenance. This segmentation resolves the contradiction by allowing gas permeability where needed and gas impermeability where required.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The gas-permeable web acts as an intermediary structure that allows sterilizing gases to pass through to reach the medical device, while the gas-impermeable sealing prevents external gases from contaminating the sterile cavity. This intermediary approach enables both functions to coexist.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 design effectively allows sterilizing gases to penetrate during sterilization and seals the pouch to prevent gas entry post-sterilization, reducing costs and complexity while maintaining sterility, enhancing the pouch's functionality and efficiency.

Implementation Method 1

a second gas-permeable web... wherein the second web allows passage of a sterilizing gas therethrough

Methodology Applied

Scientific EffectGas permeation: Permeation

Implementation Method 2

a first gas-impermeable web... and a third gas-impermeable web... wherein a cavity is formed between the first and third webs

Methodology Applied

Scientific EffectGas impermeability:

Data Source

PatentUS11691797B2Sterilizable pouches for medical devices

Publication Date: 2023.07.04 MEDTRONIC VASCULAR INC

AI summary

A flexible, sterilizable pouch includes a first gas-impermeable web, a second gas-permeable web, and the third gas-impermeable web. The webs are arranged and sealed to form a cavity portion of the pouch and a header portion of the pouch. The header portion of the pouch is gas-permeable through the second gas-permeable web. The cavity portion of the pouch is configured to hold a medical device for sterilization and is configured to be sealed from the header portion after sterilization, thereby making the cavity portion gas-impermeable. The header is also configured to be removed from the pouch, leaving the cavity portion.