Perforating Needles Sliding Mechanism for Medical Container Sealing
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Solution Overview
Problem
Existing devices for filling containers with radioactive pharmaceuticals are difficult to use, prone to membrane perforation issues leading to leaks, and risk accidental detachment of piping connections, making them impractical and costly.
Innovation Solution
A device with a sliding mechanism allowing needles to be parallel and easily accessible for membrane perforation, featuring a thrust surface for effortless operation within a flexible pack, ensuring correct sealing and reducing the risk of connection detachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the needles are arranged tilted to accommodate Luer-lock connection and air filter, then the connections can be positioned with larger dimensions, but the membrane perforation becomes incorrect causing oval holes and sealing failures
Solution Approach 1:
The patent introduces a movable support structure that allows the needles to approach the membrane from a different spatial dimension (perpendicular approach), separating the connection positioning function from the perforation function. This enables correct circular perforation holes while maintaining the ability to accommodate Luer-lock connections and air filters with larger dimensions.
Solution Approach 2:
The device is divided into separate functional components: a movable support structure for needle positioning, a fixed connection structure for Luer-lock and air filter mounting, and the membrane assembly. This segmentation allows each component to optimize its function independently - needles can approach perpendicular to the membrane while connections are positioned at appropriate angles and locations.
2Force
If the operator applies pressure on the bottom of the container to perforate the membrane, then the membrane can be perforated, but it is difficult to apply sufficient force because the thrust surface is limited and the upper portion is occupied by needles
Solution Approach 1:
Instead of having the operator push from the bottom of the container, the patent inverts the approach by having the operator push on a thrust surface located on the support structure above the membrane. This reverses the direction of force application and provides adequate leverage and thrust surface area for easy operation.
Solution Approach 2:
The support structure acts as an intermediary between the operator's force and the membrane. The thrust surface on the support structure transmits the operator's pressure to the needles, which then perforate the membrane. This intermediary provides mechanical advantage and distributes the force effectively.
3Reliability
If the device is maintained inside a flexible pack to protect sterility, then sterility is preserved, but the operator cannot easily apply force to perforate the membrane
Solution Approach 1:
The support structure is designed to be movable relative to the container, allowing it to be positioned in different configurations. When inside the flexible pack, the structure can be configured to allow easy access for force application. During operation, the support structure moves to position the needles correctly for membrane perforation while maintaining sterility protection.
4Adaptability or versatility
If the needles are arranged tilted for connection positioning, then Luer-lock connection and air filter can be accommodated, but the holes obtained have oval conformation causing incorrect seal and risk of pharmaceutical product leakage
Solution Approach 1:
The patent inverts the needle arrangement from tilted to perpendicular orientation relative to the membrane. This inversion ensures that the needles create circular holes that provide correct sealing, while the connection components (Luer-lock and air filter) are accommodated through the movable support structure that positions the needles independently of the connection geometry.
Data Source
AI summary
The device (1) for the filling of containers (C) for medical use having a closing membrane (M) which can be perforated, comprises an element for feeding (2) a pharmaceutical product which can be fitted to a container (C) and having at least a pair of needles (3, 4) suitable for perforating the membrane (M) of the container itself, where such element for feeding (2) comprises a first portion (5) which can be associated with the container (C) and at least a second portion (6), supporting the needles (3, 4), associated mobile with the first portion (5) between an idle position and a work position, removable fastening means (17) of the first portion (5) to the container (C), identification means (20a, 20b, 21) for identifying the position of the second portion (6) with respect to the first portion (5) suitable for making them reciprocally integral in a removable way, and where the second portion (6) has at least an abutment element (26) defining an abutment surface (26a) arranged facing a reference surface (28) defined by the first portion (5) to define a housing area (29) placed in between them for inserting grip means suitable for separating the element for feeding (2) from the container (C).