Pre-assembled Introducer Assembly with Compressed Hemostatic Valve
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Solution Overview
Problem
Current introducer assemblies for medical catheters face challenges with leakage resistance and require assembly at the treatment site, which can lead to invasiveness and inefficiency.
Innovation Solution
An introducer assembly with an integrated sheath and dilator, featuring a hemostatic valve that is compressed by a deforming member to enhance leakage resistance, allowing the assembly to be pre-assembled and reducing the need for on-site assembly, thereby improving handling and reducing invasiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the hemostatic valve is left open to allow easy passage of the dilator tube, then the ease of operation is improved, but the leakage resistance deteriorates
Solution Approach 1:
The hemostatic valve is designed to dynamically change its state between open and closed positions. During insertion, the valve remains open to facilitate easy passage of the dilator tube. After insertion, a compression member compresses the valve to close the passage, preventing leakage. This dynamic state change resolves the contradiction between ease of operation and leakage resistance.
2Productivity
If the assembly is pre-assembled to reduce on-site assembly steps, then the productivity is improved, but the device complexity increases
Solution Approach 1:
The introducer sheath and dilator tube are pre-assembled into an integrated unit before sterilization and packaging. The compression member is also pre-positioned within the assembly. This merging of components into a single pre-assembled unit eliminates on-site assembly steps, improving productivity while the modular design keeps the added complexity manageable.
3Reliability
If the dilator tube is reduced in diameter to fit through the compressed hemostatic valve, then the leakage resistance is improved, but the strength of the dilator tube deteriorates
Solution Approach 1:
The compression member is designed to compress the hemostatic valve only after the dilator tube has been inserted into the introducer sheath. During the insertion process, the valve remains uncompressed and open, allowing the dilator tube to pass through without encountering resistance or requiring diameter reduction. This preliminary action sequence protects the dilator tube strength while achieving leakage resistance after insertion.
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 integrated design improves leakage resistance and reduces the need for on-site assembly, enhancing the hemostatic function of the valve and minimizing invasiveness during medical procedures.
Implementation Method 1
the deforming member presses the hemostatic valve and gives a compressive force to the hemostatic valve in such a direction as to close the passage
Implementation Method 2
the hemostatic valve fully exhibits its hemostatic function even after the dilator Lube has been pulled out
Data Source
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AI summary
[Object] An introducer assembly composed of an introducer sheath and a dilator which has been previously integrated with each other is provided. It permits the hemostatic valve to exhibit its hemostatic function over a long period of time without adversely affecting the inherent function of the dilator tube. [Solving Means] A introducer assembly has a dilator tube (50) passing through a passage (41) of a hemostatic valve (40) and it also has an introducer sheath (11) and a dilator (13) previously integrated with each other. The introducer assembly has a deforming member (90) arranged between the hemostatic valve and a cap (12). As the cap is pushed toward the proximal end surface of a sheath hub (30) for engagement with the sheath hub, the cap presses the hemostatic valve and applies a compressive force to the hemostatic valve in such a direction as to close the passage.