Multi-Layer Sterile Pouches With Inflatable Cushioning
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Solution Overview
Problem
Current sterilizable, flexible medical device pouches lack durability and provide insufficient protection during transport, handling, and storage, leading to potential breaches that compromise sterility and damage to medical devices.
Innovation Solution
The development of multi-layered, flexible medical device pouches with gas-impermeable and gas-permeable layers, where each layer can move independently, reducing the likelihood of breaches and incorporating gas-permeable pockets or perforations for sterilization, and inflatable cushions for enhanced protection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If single-layer pouches are used, then cost and simplicity are reduced, but durability and protection are insufficient
Solution Approach 1:
The pouch is divided into multiple independent layers (first layer, second layer, third layer) that are heat-sealed together. Each layer can move independently relative to the others, so that if one layer breaches during transport or handling, the other layers remain intact and continue to protect the medical device, thereby resolving the contradiction between manufacturing simplicity and durability.
Solution Approach 2:
The pouch combines multiple different materials with complementary properties: a gas-impermeable layer (such as foil or plastic) to prevent gas and moisture penetration, and gas-permeable layers (such as Tyvek) to allow sterilization gas passage while providing mechanical strength. This composite structure enhances overall pouch reliability without significantly complicating manufacturing.
2Device complexity
If single-layer pouches are used, then device complexity is reduced, but protection from damage is minimal
Solution Approach 1:
The pouch incorporates inflatable cushioning elements positioned between the layers that can be inflated before sterilization or transport. These cushions create a protective buffer zone that absorbs shocks and prevents direct contact between the medical device and the pouch walls, providing beforehand protection against damage during handling and transport while maintaining relatively simple pouch structure.
Solution Approach 2:
The pouch structure nests multiple layers within each other, with each layer providing a additional level of protection. The gas-impermeable layer is nested between gas-permeable layers, creating a nested configuration where each layer serves as a backup protection system, enhancing damage protection without requiring a completely complex structural design.
3Reliability
If gas-impermeable layers are added, then sterility maintenance is improved, but gas permeability for sterilization is reduced
Solution Approach 1:
The pouch is segmented into distinct functional layers: gas-permeable layers that allow sterilization gas to pass through during the sterilization process, and a gas-impermeable layer that prevents gas and moisture penetration after sterilization to maintain sterility. This segmentation allows the pouch to adapt to different requirements - gas permeability during sterilization and gas impermeability during storage and transport.
Solution Approach 2:
Different regions of the pouch have different gas permeability properties tailored to their specific functions. The outer layers are gas-permeable to facilitate sterilization, while the inner layer is gas-impermeable to maintain sterility. This local differentiation of material properties allows the pouch to simultaneously achieve both gas permeability for sterilization and gas impermeability for sterility maintenance.
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 multi-layered construction enhances durability, maintaining sterility and protecting medical devices from damage during transport, handling, and storage by minimizing the risk of breaches and providing additional cushioning.
Implementation Method 1
Each of the first, second and third layers may be formed of a gas-permeable material, such as a spun-bonded polyolefin... The first layer may be formed of a gas-impermeable material, such as a foil or plastic material
Implementation Method 2
An opening to access the pouch is left unsealed such that a medical device may be placed therein. Once the medical device is placed within the pouch, the opening is sealed with a heat sealing machine
Data Source
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AI summary
A flexible, sterilizable pouch (100) includes a first wall (118) coupled to a second wall (120) and a cavity (122) defined between the first wall (118) and the second wall (120). The cavity (122) is configured to receive a medical device (900), and the pouch (100) is configured to seal the medical device (900) within the cavity (122). At least one of the first wall (118) and the second wall (120) of the pouch includes two layers. Each layer is coupled to the adjacent layer such that a breach in any one layer of the multi-layered wall will not breach the seal of the pouch. A pocket may be formed between the layers of the multi-layered wall and may include a gas under pressure to inflate the corresponding wall to an inflated state.