Elastomeric Sealing Part for Medical Container Insertion
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Solution Overview
Problem
Containers made by the Blow-Fill-Seal method for medical applications face challenges in achieving low insertion force while maintaining high retraction force, as existing designs either require high insertion force or lead to leakage, violating standards such as EN ISO 8536-4.
Innovation Solution
A container design featuring a cap part with a sealing part made of elastomeric material, which creates a radial distance and friction zone during retraction, forming an annular duct that increases retraction force without raising insertion force, using a removable strap for secure storage and multiple sealing elements for adaptability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If high retaining force is provided by accepting high insertion force, then the retraction force is improved, but the ease of operation deteriorates because high insertion forces cannot be achieved by nursing staff
Solution Approach 1:
The sealing part is divided into two functional zones: a first sealing zone that provides low insertion force through its geometry, and a second sealing zone that provides high retraction force through its geometry. This segmentation allows each zone to be optimized for its specific function, resolving the contradiction between easy insertion and secure retention.
Solution Approach 2:
Different regions of the sealing part are given different local qualities through their respective geometries. The first sealing zone has a geometry optimized for low-resistance insertion, while the second sealing zone has a geometry optimized for high-retention force. This local differentiation allows the single sealing part to simultaneously satisfy both insertion ease and retention strength requirements.
2Force
If arrow-shaped insertion parts with undercuts or barbs are used to increase retaining force, then the retraction force is improved, but the reliability deteriorates due to leakage of the sealing part
Solution Approach 1:
The sealing part is segmented into two distinct sealing zones with different geometries: the first sealing zone ensures reliable sealing during insertion without undercuts or barbs that could cause leakage, while the second sealing zone provides retention force through its geometric configuration. This segmentation allows the sealing function and retention function to be independently optimized without compromising either.
Solution Approach 2:
The first sealing zone is designed with local geometric qualities that prioritize sealing reliability and prevent leakage, while the second sealing zone is designed with local geometric qualities that prioritize retention force. This local quality differentiation resolves the contradiction by ensuring that the sealing function remains reliable while the retention function is sufficiently strong.
3Ease of operation
If known sealing caps with hollow stoppers are used to make tapping easier, then the insertion force is reduced, but the retraction force is not sufficiently increased
Solution Approach 1:
The sealing part is segmented into two functional zones: the first sealing zone provides easy insertion with low force requirements, while the second sealing zone provides high retraction force. This segmentation resolves the limitation of hollow stopper designs by adding a second functional zone that actively increases retention force without compromising insertion ease.
Solution Approach 2:
The sealing part is designed to be dynamically adaptable during the insertion and retraction processes. During insertion, the first sealing zone deforms to provide low resistance. During retraction, the second sealing zone engages to provide high retention force. This dynamic behavior allows the sealing part to optimize its performance for each operational phase, resolving the contradiction between easy insertion and strong retention.
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 design effectively increases retraction force to prevent accidental removal of the insertion part while keeping insertion force low, ensuring secure and safe infusion processes in medical applications.
Implementation Method 1
the radial distance is at least partially packed by the sealing part, which is a further component of the device and which applies at least an increased frictional force on the insertion part, at least in certain sections, during its retraction from the container
Implementation Method 2
Through the displacement of the sealing part material caused by the retraction movement and the filling of the radial distance, a friction and compression zone is formed at the through-hole in the cap part, which impedes the retraction movement
Data Source
AI summary
A container has an at least partially filled container body and at least one cap part (10). The cap part has at least one sealing part (16) that, for removal of the container contents, can be penetrated by a hollow-spike-shaped insertion part (22) from the outside, with a predeterminable actuating force, in an introduction direction. The insertion part can be removed from the container again, with a predeterminable pull-out force, in an oppositely directed pull-out direction. A device (16, 18) makes it difficult for the insertion part (22) to be removed with the pull-out force being increased such that unintentional removal of the insertion part (22) is at least made difficult.