Sterilizable Dual Compartment Pouch Seal Design
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Solution Overview
Problem
Existing pouch-type packaging for medical devices struggles with maintaining a sterile environment while allowing for oxygen ingress, as breathable layers can lead to excess oxygen ingress unless the sealing is continuously effective, and double-sealing methods require extra manufacturing steps and increase the risk of ingress.
Innovation Solution
A dual compartment pouch with five separate layers, featuring a primary seal that adheres the base and top layers along the periphery and a secondary seal that captures the breathable webs between the outer layers, allowing for a single, continuous peripheral seal that maintains sterility and allows oxygen ingress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If breathable layers are utilized to allow sterilization gas ingress, then the package is sterilized and breathable, but excess oxygen ingress may still occur unless the sealing is ongoingly effective
Solution Approach 1:
The pouch is divided into multiple functional layers including breathable webs and impermeable barriers. The breathable layers allow sterilization gas to pass through while the impermeable layers block excess oxygen and moisture, creating a segmented defense system that addresses both sterilization requirements and prevention of harmful gas ingress
Solution Approach 2:
The pouch employs a composite structure combining different material properties - breathable materials for sterilization and impermeable materials for protection. This composite approach allows the package to simultaneously achieve breathability for sterilization and barrier properties to prevent excess oxygen ingress
2Strength
If double-sealing the layers at the peripheral edges is used to increase seal integrity, then the seal strength is improved, but extra manufacturing steps are required and the probability of ingress increases
Solution Approach 1:
The patent combines multiple sealing functions into a single integrated seal structure. The peripheral seal simultaneously seals multiple layers together and incorporates breathable and impermeable materials in one continuous sealing process, eliminating the need for separate double-sealing steps while maintaining seal integrity
Solution Approach 2:
The peripheral seal serves multiple functions simultaneously - it seals the package, allows sterilization gas to pass through, and prevents excess oxygen ingress. This multi-functional seal reduces manufacturing complexity by consolidating what would otherwise require multiple separate sealing operations
3Strength
If double-sealing is used to improve seal integrity, then the seal strength is improved, but the seals do not entirely overlap across all of the lengths
Solution Approach 1:
The seal structure is designed in advance to ensure complete overlap across the entire length of the pouch. The peripheral seal is configured to extend continuously along all edges, with breathable and impermeable materials positioned to guarantee overlapping coverage that prevents any gaps or discontinuities in the seal
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 seals the breathable material at the outer edges in a single step, encapsulating all layers in one continuous seal, thereby enhancing the efficacy and strength of the peripheral seal, reducing the risk of ingress, and maintaining a sterile environment for medical devices.
Implementation Method 1
A peripheral seal of the pouch includes direct adherence of impermeable outer layers across a first part of its width to help maintain seal strength to resist egress while also capturing one or more webs of a breathable material between those two outer layers across a second part of that same peripheral seal's width
Data Source
AI summary
A pouch for holding a medical device. A base layer has a base periphery, a base back end and opposing base outer edges. A breathable first web is on the base layer and adapted to permit a sterilization gas to pass therethrough. A non-breathable middle film is adhered to the first web. A breathable second web is attached to the middle film, and a non-breathable top layer is over the base layer, thereby the pouch includes five layers. A primary seal adheres the base layer and the top layer. Then a secondary seal adheres the middle film and the second web to the base layer. The secondary seal is coextensive with the primary seal but then extends a partial width of the primary seal to thereby form a setback, wherein the setback allows the first web, the middle film and the second web to be formed in a single sealing step.