Biocompatible Hose Assembly With Overmolded Opening Seal
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Solution Overview
Problem
Manufacturing issues such as burr formation, material deformation, and bubble formation at the mouth opening of hose assemblies, particularly during injection molding or pressing processes, hinder the production of biocompatible and food-safe hose assemblies that meet regulatory standards like ISO 10993, FDA, and KTW guidelines.
Innovation Solution
Incorporating a mouth sealing body with a sleeve section along one hose section and a further sealing body section that follows the other hose section, made of silicone with a Shore hardness greater than 60 Shore-A, to facilitate improved force distribution and stability, and using a die with a mouth sealing body that is overmolded with the hose sections to avoid manufacturing errors and ensure biocompatibility and food safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If injection molding or pressing process is used to manufacture hose assembly, then production efficiency is improved, but manufacturing defects such as burr formation, material deformation, and bubble formation occur at the mouth opening
Solution Approach 1:
A mouth sealing body made of silicone material is introduced as an intermediary component between the hose sections. This sealing body has a sleeve section that fits over one hose section and a further sealing body section that follows the other hose section, creating a stable forming core during injection molding that prevents burr formation and material deformation at the mouth opening while allowing efficient production
Solution Approach 2:
The patent specifies that the silicone material of the mouth sealing body should have a Shore hardness greater than 60 Shore-A. This parameter change in material hardness provides sufficient stability during the injection molding process to prevent manufacturing defects while maintaining flexibility for proper sealing and connection
2Device complexity
If mouth opening is formed without mouth sealing body, then device complexity is reduced, but manufacturing defects and instability occur
Solution Approach 1:
The mouth sealing body serves as a temporary intermediary forming core during manufacturing that ensures reliable production of the mouth opening. After the hose sections are molded over it, the die is drawn and only the die is removed, leaving the mouth sealing body integrated into the final product as a functional sealing component rather than a manufacturing aid
Solution Approach 2:
The mouth sealing body is prepared in advance with specific geometric features (sleeve section and further sealing body section) that pre-define the desired mouth opening geometry. This preliminary preparation ensures that when the hose sections are molded over it, the mouth opening is formed correctly without defects, improving manufacturing reliability
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 mouth sealing body enhances the stability and biocompatibility of the hose assembly, preventing undesirable deformation and burr formation, while ensuring compliance with regulatory standards, and simplifies the manufacturing process by reducing molding errors and material usage.
Implementation Method 1
The mouth sealing body can also ensure better force distribution in the tube assembly in the area of the mouth opening. This results in increased stability of the tube assembly.
Implementation Method 2
Material deformation, particularly expansion of the tube sections in the area of the mouth opening, can also be avoided.
Data Source
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AI summary
A biocompatible and/or food-grade hose assembly (1) serves to connect at least three hose connections (A, B, C). A first hose section (2) connects two (A, B) of the at least three hose connections (A, B, C). A second hose section (3) opens into the first hose section (2) via an opening (4) in a shell wall (5). An opening seal (8) seals the opening (4) against the inner lumen of the first hose section (2) and the inner lumen of the second hose section (3). The first hose section (2) and the second hose section (3) are injection-molded onto the opening seal (8) using a die (10). This results in a biocompatible and/or food-grade hose assembly that avoids manufacturing problems.