Catheter Sheath Assembly for Sterile, Low-Trauma Insertion
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Solution Overview
Problem
Existing sheath assemblies for inserting catheters into patients fail to effectively prevent bacterial penetration and bodily fluid leakage while minimizing trauma and ensuring sterility during the insertion process.
Innovation Solution
A sheath assembly comprising an introducer sheath and an auxiliary sheath with detachable fastening mechanisms and integrated flushing devices to maintain sterility and minimize diameter differences, allowing for two-stage compression of the catheter to prevent damage and bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If an auxiliary sheath is used to hold and insert the catheter into the introducer sheath, then the catheter can be properly positioned and protected during insertion, but the complexity of the sheath assembly increases and the risk of bacterial penetration and fluid leakage increases
Solution Approach 1:
The auxiliary sheath is inserted into the introducer sheath, creating a nested configuration where the auxiliary sheath resides within the introducer sheath. This nesting arrangement allows the catheter to be held and inserted through the auxiliary sheath while the introducer sheath provides an outer protective layer, enabling proper catheter positioning and protection without requiring separate handling of multiple sheaths.
Solution Approach 2:
The auxiliary sheath acts as an intermediary component between the catheter and the introducer sheath. It provides a interface that facilitates catheter insertion while maintaining the integrity of the introducer sheath system, thereby managing the complexity by distributing functions across multiple components rather than requiring a single complex sheath structure.
2Ease of operation
If the outer diameter of the introducer sheath is increased to accommodate the auxiliary sheath and catheter, then insertion is facilitated, but trauma to the patient increases
Solution Approach 1:
The sheath system is segmented into multiple components: the introducer sheath and the auxiliary sheath. This segmentation allows each sheath to have a optimized diameter for its specific function, with the auxiliary sheath having a smaller diameter than the introducer sheath. The catheter is further segmented into sections that can be compressed to fit through the sheaths, enabling insertion without requiring an excessively large introducer sheath diameter that would cause patient trauma.
Solution Approach 2:
The diameter parameter of the sheaths and catheter is dynamically adjusted during the insertion process. The catheter is compressed to a reduced diameter to fit through the auxiliary sheath, which itself is inserted into the introducer sheath. This parameter change allows the system to achieve proper insertion capability while maintaining the introducer sheath outer diameter at a level that minimizes patient trauma.
3Ease of operation
If detachable fastening means are used to connect the auxiliary sheath to the introducer sheath, then ease of assembly and disassembly is improved, but the reliability of the connection and risk of accidental separation increases
Solution Approach 1:
The detachable fastening means are designed to be engaged in advance during the assembly process, before the sheaths are inserted into the patient's body. This preliminary engagement ensures that the connection is established under controlled conditions, allowing for easy assembly and disassembly during the procedure while maintaining reliable connection during use. The fastening mechanism is prepared and secured before critical insertion steps, preventing accidental separation during the procedure.
4Reliability
If flushing devices are integrated into both sheaths, then sterility is better maintained, but the device complexity and risk of contamination increases
Solution Approach 1:
Flushing devices are integrated locally into specific regions of the sheaths where contamination risk is highest. The introducer sheath has a flushing device at its proximal end, and the auxiliary sheath has a flushing device at its distal end. This localized placement of flushing capability allows sterility to be maintained at critical interfaces without requiring flushing systems throughout the entire length of both sheaths, thereby managing device complexity while ensuring sterility where it is most needed.
Data Source
AI summary
Sheath assembly for the insertion of a cord-shaped element, comprising an introducer sheath, and an auxiliary sheath for insertion into the introducer sheath together with the cord-shaped element. In some examples, the auxiliary sheath has a housing configured to detachably couple to the introducer sheath housing, and to detachably fasten the cord-shaped element with respect to the auxiliary sheath housing.