Tracheal Intubation Stylet Sheath Moulding
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Solution Overview
Problem
Current methods for manufacturing tracheal intubation stylets with plastic coverings are costly and inefficient, particularly in achieving a smooth and even thickness, and none have successfully utilized injection moulding effectively.
Innovation Solution
A method involving a first and second injection moulding tool with sheath projections to accurately position and mould a sheath around a malleable insert, ensuring a smooth exterior and reducing the risk of trauma during intubation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If traditional methods (extrusion, dipping, spraying, compression moulding) are used to cover the stylet rod, then the plastic covering can be applied, but the manufacturing process is costly and inefficient, and achieving even thickness and smooth surface is difficult
Solution Approach 1:
The injection moulding tool is segmented into multiple components including a fixed component, a movable component, and a core component that can be independently positioned. This segmentation allows precise control of the moulding cavity geometry, enabling production of sheaths with uniform wall thickness and smooth surfaces while maintaining manufacturing efficiency through the injection moulding process
Solution Approach 2:
The invention introduces a third dimensional aspect by using a movable component that can be positioned at different locations within the moulding cavity. This allows dynamic control of the sheath formation process, enabling even thickness distribution and smooth surface finish that were not achievable with traditional single-step methods
2Productivity
If injection moulding is used to manufacture the sheath, then manufacturing efficiency and cost-effectiveness improve, but achieving accurate positioning of the insert and even thickness of the sheath has been unsuccessful in prior art
Solution Approach 1:
The core component is pre-positioned within the moulding cavity before the injection process begins. This preliminary positioning ensures that the sheath material will be deposited uniformly around the insert from the start of the process, achieving both accurate insert positioning and even sheath thickness in a single injection moulding operation
Solution Approach 2:
The movable component acts as an intermediary element between the fixed component and the insert. It facilitates precise positioning of the insert and controls the flow of sheath material, enabling the injection moulding process to achieve both high productivity and high precision simultaneously
3Measurement precision
If the sheath has openings from support projections, then the insert can be positioned, but the exterior surface is not smooth and may catch on patient anatomy causing trauma
Solution Approach 1:
The harmful feature (openings in the sheath surface) is extracted and removed by designing the movable component to fill these openings during the injection moulding process. The result is a sheath with a completely smooth exterior surface that eliminates the risk of catching on patient anatomy, while the insert positioning function is maintained through the core component
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
This method provides a more accurate and cost-effective manufacturing process for tracheal intubation devices with a smooth exterior, reducing the risk of trauma and kinks, and enabling the use of both stylet and bougie functions.
Implementation Method 1
injection moulding a second sheath about the inner sheath body and the at least one insert
Implementation Method 2
injection moulding a second sheath about the inner sheath body and the at least one insert
Data Source
Figure 1~4
Figure 5~6(d)
AI summary
Improvements relating to the Manufacture of Medical Devices The present invention relates to medical devices and methods of manufacturing medical devices. The application describes method of manufacturing a medical device where at least one insert (20,22) is provided with a first sheath including an inner sheath body (24) and one or more sheath projections (26), such that the insert (20,22) and the first sheath can be supported by the one or more sheath projections (24) within a mould chamber, and a second sheath (28) is injection moulded about the inner sheath body (24) and the at least one insert (20,22), between the one or more sheath projections (26).