Skin Packaging With Nested Protective Sheath for Sterility
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Solution Overview
Problem
Existing medical device packaging is bulky, complex, and inefficient in maintaining sterility while requiring significant material and storage space, with product information integration being cumbersome.
Innovation Solution
A package assembly comprising a sterile pouch with a sheath and an outer enclosure, featuring perforations and pull tabs for easy retrieval, along with a radio frequency identification (RFID) tag for efficient information transmission, reduces material use and simplifies retrieval by using a combination of materials with varying rigidity and transparency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional packaging components and layers are used to maintain sterility and protection, then device protection and sterility are ensured, but packaging volume and material consumption increase significantly
Solution Approach 1:
The sheath is nested within the sterile pouch, and both are contained within the outer enclosure. This nested arrangement allows the protective sheath to be integrated into the sterile barrier packaging without requiring separate external protective structures, thereby reducing overall packaging volume while maintaining both protection and sterility functions
Solution Approach 2:
The sterile pouch serves multiple functions simultaneously: it provides the sterile barrier, contains the sheath, and acts as the outer protective enclosure. This multi-functionality eliminates the need for separate packaging components, reducing material consumption and packaging volume while ensuring device protection and sterility
2Reliability
If multiple packaging components are used to provide protection and sterility, then device protection is improved, but device complexity and material consumption increase
Solution Approach 1:
The sterile pouch combines multiple protective functions into a single integrated component. The pouch material provides both sterile barrier properties and mechanical protection, while the sheath integration further consolidates protective functions. This merging reduces packaging complexity compared to separate components for each function
Solution Approach 2:
The packaging system uses composite material structures where the sterile pouch material and sheath material work together as a composite protective system. This composite approach provides enhanced protection while reducing the number of separate components needed, thereby reducing overall packaging complexity
3Reliability
If bulky packaging components are used to ensure protection and sterility, then device protection is maintained, but ease of retrieval and storage efficiency deteriorate
Solution Approach 1:
The packaging is segmented into functional layers (sterile pouch, sheath, outer enclosure) that can be independently accessed and removed. The sheath can be removed from the pouch through defined openings, and the pouch can be opened through pull tabs, enabling easy retrieval of the device while maintaining the protective barrier until needed
4Reliability
If traditional packaging materials are used to provide protective layers, then device protection is ensured, but sustainability and material efficiency worsen
Solution Approach 1:
The sterile pouch and sheath utilize thin film materials that provide adequate protective and sterile barrier functions with minimal material consumption. These thin films are sufficient to protect the device while reducing material waste compared to traditional bulky packaging materials
Solution Approach 2:
The packaging design optimizes material parameters such as thickness and material composition to achieve the minimum necessary protective performance. By carefully selecting material properties and thickness parameters, the design ensures adequate protection while minimizing material consumption and waste
Data Source
AI summary
A package assembly including a sheath, a pouch, and an outer enclosure. The sheath includes perforations that extend across the sheath along an orientation that is transverse to an elongate dimension of the sheath. The sheath is configured to receive and enclose an implant or a surgical instrument. The pouch has an inner volume that receives the sheath, the inner volume of the pouch being configured to be vacuum sealed. The outer enclosure is designed to receive the pouch. The sheath is made of a material with greater rigidity than the pouch.


