Radiopaque Insert Septum Manufacturing Efficiency
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Solution Overview
Problem
The existing manufacturing process for implantable medical device septums with embedded radiopaque indicia is time-consuming and inefficient, requiring the injection and curing of fluidized radiopaque material, which limits production capacity and quality control.
Innovation Solution
The process involves molding a solid radiopaque insert with the same configuration as the septum depression and mounting it onto the septum base, followed by a silicone layer application, eliminating the need for fluid injection and curing, and using a one-piece combination insert and top layer with impregnated radiopaque material for improved visual representation under imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If fluidized radiopaque material is injected into the depression and cured, then the indicia is embedded in the septum, but the manufacturing process is time-consuming and production efficiency is low
Solution Approach 1:
The patent changes the physical state of the radiopaque material from fluidized (requiring injection and curing) to solid pre-formed inserts. This parameter change eliminates the time-consuming injection and curing steps while maintaining the embedded indicia functionality, directly resolving the contradiction between manufacturing precision and productivity
Solution Approach 2:
The radiopaque inserts are pre-formed with the indicia configuration before being mounted to the septum base. This preliminary action of creating the indicia structure in advance eliminates the need for in-situ material injection and curing during assembly, significantly improving production efficiency while preserving indicia quality
2Manufacturing precision
If fluidized radiopaque material is injected into each depression, then the indicia is formed, but the process requires waiting for curing and hardening
Solution Approach 1:
The patent changes the physical state of the radiopaque material from fluidized to solid pre-formed inserts. This eliminates the curing and hardening waiting time completely, as the inserts are already in their final solid state with the indicia configuration, resolving the time loss issue while maintaining precise indicia formation
Solution Approach 2:
The indicia structure is formed in advance during the insert manufacturing process rather than during assembly. The radiopaque inserts are pre-formed with the exact indicia configuration needed, eliminating the time-consuming in-situ formation process and its associated curing等待 time
3Measurement precision
If the radiopaque material is compacted during molding, then the visual representation under radiographic imaging is improved, but the manufacturing process complexity increases
Solution Approach 1:
The patent separates the indicia formation process into a distinct insert manufacturing step, which is then mounted to the septum base. The compacting of radiopaque material occurs during this separate insert molding process, allowing for optimized compaction to improve radiographic visual representation without complicating the overall assembly process
Solution Approach 2:
The radiopaque insert with compacted material for improved radiographic representation is manufactured in advance as a separate component. This preliminary action allows the insert to be optimized for imaging quality independently, then simply mounted to the septum, avoiding the need for complex integrated molding processes
Data Source
AI summary
An information bearing septum viewable under radiographic imaging is formed by molding a septum base to have a depression with a given configuration and molding a one-piece solid radiopaque material insert having the same given configuration. The radiopaque insert is mounted to the cavity formed by the depression at the septum base. The top of the septum is then covered by a silicone layer that bonds to the septum. The finished septum is adapted to be fitted to a reservoir housing of a subcutaneous implantable portal. In place of the solid insert, the septum may be formed by placing on top of the septum base a one-piece top layer impregnated with a radiopaque material that has an integral hanging insert that fittingly mounts into the cavity formed by the depression at the septum base.