Medical Device Package with Antibacterial Air-Permeable Sealing
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Solution Overview
Problem
Existing medical device packaging methods, particularly sterilized bags, are prone to breakage and contamination, leading to inefficiencies in high-speed drug filling processes due to creases, wrinkles, and poor handleability by machines, which results in reduced productivity and the need for irradiation sterilization.
Innovation Solution
A medical device package comprising a storage container with a shape-retaining property and a sheet-shaped second sealing member that is antibacterial and air-permeable, allowing for reliable handling and sterilization without irradiation, featuring a medical device container with a nest holding multiple devices and a removable first sealing member for filling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a thin resin film sterilized bag is used to maintain sterility, then the outer surface of the tab can be kept sterile, but the bag is vulnerable to breakage and likely to cause pinholes and contamination
Solution Approach 1:
The patent employs a nested structure with an inner sterilized bag containing the tab and an outer sterilized bag surrounding it. The inner bag maintains sterility while the outer bag provides additional mechanical protection. This nested configuration allows the system to achieve both high sterility reliability and improved structural strength by combining multiple protective layers.
2Reliability
If irradiation sterilization is performed before and after opening the sterilized bag, then sterility can be maintained, but a considerable amount of irradiation time is required which slows down processing speed
Solution Approach 1:
The sterilization process is performed in advance during manufacturing, and the sterilized bags are sealed and stored in a sterile state before use. This preliminary sterilization action eliminates the need for time-consuming irradiation sterilization at the point of use, thereby maintaining high sterility reliability while significantly improving processing speed and productivity.
3Reliability
If the inner sterilized bag is stored in the outer sterilized bag, then sterility can be maintained, but creases and wrinkles are inevitably generated and the shape is not constant, causing suction errors and gripping failures
Solution Approach 1:
The nested bag structure is designed with sufficient internal space and appropriate dimensional relationships between the inner and outer bags. This allows the inner bag to maintain a relatively stable shape even when nested, reducing excessive folding and wrinkling. The structured nesting approach balances sterility maintenance with improved machine handleability.
4Reliability
If a sterile environment is maintained in the drug filling device, then product contamination is prevented, but the handling of the inner sterilized bag becomes difficult causing positioning errors and device stoppage
Solution Approach 1:
The inner sterilized bag is prepared and sealed in a sterile state during manufacturing before being transferred to the filling device. This preliminary sterilization and sealing action maintains the sterile environment requirement while simplifying the handling process in the filling device, as the pre-sealed bag requires minimal manipulation, thereby preventing device stoppage and maintaining high filling efficiency.
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 maintains sterility of the outer surface, prevents contamination, and enhances machine handleability, enabling high-speed drug filling without irradiation sterilization, thus improving productivity and processing speed.
Implementation Method 1
a sheet-shaped second sealing member sealing the through opening at the one end of the storage container main body, with the sheet-shaped second sealing member having an antibacterial property and air permeability
Data Source
AI summary
A medical device package includes: a medical device container including a nest which holds a plurality of medical devices (syringes) to be filled with medicine to be aligned in a predetermined direction, a medical device container main body which accommodates the nest, and a sheet-shaped first sealing member which seals the medical device container main body; and a storage container for packing with an outer peripheral surface of the medical device container maintained in a sterile state. The storage container is formed of a storage container main body accommodating the medical device container and having a shape-retaining property, and seals a transfer opening at an upper end of the storage container main body with a sheet-shaped second sealing member having an antibacterial property and air permeability.