Dual Compartment Pouch With Breathable Membrane For Sterilization
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Solution Overview
Problem
Conventional packaging systems for drug-coated stents lack sufficient control over gases, leading to reduced drug efficacy, increased material usage, and labor-intensive processes, with multiple steps and separate bags required for sterilization.
Innovation Solution
A sterilizable multicompartment pouch with an impervious inner sheet featuring a breathable membrane that allows sterilizing gases to pass between compartments, minimizing moisture vapor ingress and using absorbent packets to remove gases without direct contact, thereby maintaining drug integrity and simplifying the packaging process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional packaging systems are used for drug-coated stents, then sterilization can be achieved, but gas control is insufficient leading to reduced drug efficacy
Solution Approach 1:
The packaging system is divided into two separate compartments: a first compartment for the drug-coated stent and a second compartment for the absorbent material. This segmentation allows independent control of the stent environment and the absorbent material, enabling effective gas control while maintaining drug integrity. The barrier sheet separating the compartments prevents direct contact between the drug and absorbent material while allowing gas management.
Solution Approach 2:
An intermediary barrier sheet with selective permeability is introduced between the stent compartment and the absorbent material compartment. This barrier sheet allows certain gases to pass through while blocking others, acting as a mediator that controls gas transfer between compartments. The barrier sheet enables the absorbent material to manage gases without directly contacting the drug-coated stent, thus maintaining drug efficacy while achieving gas control.
2Reliability
If multiple separate packaging bags are used for sterilization, then sterilization effectiveness is improved, but device complexity and material usage increase
Solution Approach 1:
The packaging system merges multiple functions into a single integrated pouch structure. The outer packaging bag contains both compartments (first compartment for stent, second compartment for absorbent material) within one sealed unit. This merging eliminates the need for multiple separate packaging bags while maintaining sterilization effectiveness, as the entire structure can be sterilized together and provides both drug protection and gas control in one system.
Solution Approach 2:
The single packaging pouch performs multiple functions simultaneously: it provides sterilization containment, separates the drug from absorbent material, controls gas transfer, and protects the drug-coated stent. The barrier sheet with selective permeability adds multi-functionality by enabling both gas control and physical separation within the same structure, reducing overall packaging complexity while maintaining effectiveness.
3Reliability
If conventional packaging is used, then sterilization can be performed, but labor intensity and handling time increase
Solution Approach 1:
The packaging system combines the stent packaging and absorbent material containment into a single pre-assembled unit. This merging eliminates the need for separate handling of multiple bags and reduces the number of sealing and assembly steps required during packaging operations. The integrated structure allows for simpler loading and handling while maintaining sterilization capabilities.
4Object-affected harmful factors
If absorbent material is placed in direct contact with the stent, then gas absorption is improved, but drug integrity may be compromised
Solution Approach 1:
The packaging is segmented into two distinct compartments: the first compartment contains the drug-coated stent while the second compartment contains the absorbent material. This segmentation prevents direct contact between the drug and absorbent material, protecting drug integrity while still allowing the absorbent material to perform its gas absorption function in its own compartment.
Solution Approach 2:
A barrier sheet with selective permeability acts as an intermediary between the stent compartment and the absorbent material compartment. This barrier sheet allows gases to pass through from the stent compartment to the absorbent material compartment for absorption, while preventing direct contact between the drug-coated stent and the absorbent material. Thus, gas absorption is maintained while drug integrity is protected.
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 solution effectively maintains drug efficacy by controlling gases, reduces material usage and handling time, and simplifies the packaging process by integrating sterilization and gas control within a single, dual-compartment pouch.
Implementation Method 1
The breathable membrane comprises a breathable material that is pervious to moisture and gases
Implementation Method 2
The breathable membrane allows moisture and gases within the pouch to be absorbed by the absorbent packet
Data Source
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AI summary
The invention provides a dual compartment pouch having first and second compartments that are separated from each other by an impervious inner sheet having a breathable membrane. The breathable membrane comprises a breathable material that is pervious to moisture and gases, and impervious to liquids as well as microorganisms. The breathable membrane allows a sterilizing gas to be introduced between the first and second compartments. The front and back sheets are sealed to the inner sheet to define the first and second compartments in which the inner sheet forms a common wall between the compartments. The breathable membrane is disposed towards a central portion of the inner sheet and is spaced apart from the seams joing the front and back sheets to the inner sheet. In one embodiment, a sterilized article is disposed in one compartment, and an absorbent packets are disposed in the other compartment.