Sterile Syringe Packaging With Deformable Ejection Projection
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Solution Overview
Problem
Existing medical device packaging, particularly for pre-filled syringes, requires direct handling which can lead to contamination and compromise sterility, especially for ophthalmic syringes, and affects dose accuracy.
Innovation Solution
A packaging design featuring a deformable projection, such as a dome-shaped feature, that allows the syringe to be ejected without direct user contact by flexing the packaging, using a tray with cavities and a removable cover permeable to sterilants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If direct handling is used to remove syringe from packaging, then ease of operation is improved, but sterility and contamination risk are worsened
Solution Approach 1:
A deformable projection is introduced as an intermediary element between the user and the syringe. The projection extends through the packaging to contact the syringe, allowing the user to manipulate the syringe through the packaging material without direct hand contact. This mediator transfers the user's action to the syringe while maintaining a sterile barrier.
Solution Approach 2:
The packaging incorporates a deformable projection made of flexible material that can be compressed through the packaging wall. This flexible element allows the syringe to be ejected and manipulated through the packaging barrier, enabling ease of operation while maintaining sterility through the thin film/packaging barrier.
2Ease of operation
If direct handling is used during removal, then ease of operation is improved, but dose accuracy is worsened
Solution Approach 1:
The deformable projection serves as a mediator that transmits force from the user to the syringe plunger through the packaging barrier. This allows precise control of the plunger movement for dose accuracy while the user only needs to compress the projection, not directly handle the syringe components that would risk displacement or contamination.
3Object-affected harmful factors
If packaging structure is added to enable projection ejection, then sterility is improved, but device complexity is worsened
Solution Approach 1:
Instead of adding complex rigid structures, the packaging uses a deformable projection made of flexible material that can be compressed through the existing packaging wall. This flexible approach maintains sterility through the packaging barrier while avoiding the need for complex mechanical ejection mechanisms.
Solution Approach 2:
The projection is designed to be dynamic and deformable rather than static and rigid. It can be compressed by user finger pressure to eject the syringe, then returns to its original shape. This dynamic behavior enables simple operation without complex mechanical linkages or multiple moving parts.
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
Reduces contamination risk and maintains sterility, ensuring accurate dose delivery by minimizing direct handling during removal, thereby decreasing the likelihood of infections and medication loss.
Implementation Method 1
A projection may be associated with the base of the cavity and may extend away from the base of the cavity in a direction opposite to the opening of the cavity. The projection may be made of a deformable material.
Data Source
AI summary
According to one aspect of the disclosure, packaging for a sterile syringe having a nominal size of less than 1 mL may include a flexible tray having a cavity for containing the syringe. The cavity may include an opening, one or more sidewalls, and a base. A lip may surround the opening, may extend radially outward from the cavity, and may define a periphery of the tray. A removable cover may have a periphery that is adhered to the lip, and the removable cover may be permeable to a gaseous sterilant, including one or more of vaporized hydrogen peroxide or ethylene oxide. A projection may be associated with the base of the cavity and may extend away from the base of the cavity in a direction opposite to the opening of the cavity.