Introducer Sheath Support Wire Against Distal Separation
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Solution Overview
Problem
Composite introducer sheaths, particularly those with an inner PTFE tube, a flat wire coil, and an outer nylon tube, can experience distal stretch separation breakage when placed in tension during withdrawal from a patient, due to differing elasticities of the layers.
Innovation Solution
Incorporating a withdrawal support wire that extends in parallel with the longitudinal axis between the outer nylon tube and the inner PTFE tube, attached to the distal end of the flat wire reinforcement, to absorb tension and prevent separation breakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a composite structure with inner PTFE tube, flat wire coil, and outer nylon tube is used, then flexibility and kink-resistance are improved, but distal stretch separation breakage occurs when placed in tension during withdrawal
Solution Approach 1:
A withdrawal support wire is introduced as an intermediary element between the inner PTFE tube and outer nylon tube. This wire extends parallel to the longitudinal axis and is attached to the distal end of the flat wire reinforcement, serving as a mediator that distributes tensile forces during withdrawal and prevents separation between the composite layers.
Solution Approach 2:
The patent enhances the composite structure by adding a withdrawal support wire component to the existing multi-layer construction. This creates a more complex composite system where the wire reinforces the bonding between PTFE and nylon layers, preventing delamination under tension while maintaining the flexible, kink-resistant properties of the original design.
2Ease of operation
If the outer nylon tube extends distally beyond the PTFE tube, then ease of insertion is improved, but the risk of distal stretch separation breakage increases when the sheath is placed in tension
Solution Approach 1:
The withdrawal support wire acts as an intermediary reinforcement element that spans the distal region where the nylon tube extends beyond the PTFE tube. This wire provides continuous support across the interface region, preventing separation breakage while allowing the nylon extension to maintain its ease of insertion benefit.
3Shape
If the flat wire coil is sandwiched between PTFE and nylon tubes, then flexibility is improved, but the differing elasticities cause separation breakage under tension
Solution Approach 1:
The withdrawal support wire serves as a mediator that bridges the inner PTFE tube and outer nylon tube, preventing separation between layers with different elasticities. The wire is positioned to work in conjunction with the flat wire coil, providing additional reinforcement that maintains layer bonding integrity while preserving the flexibility provided by the coil structure.
Data Source
AI summary
An introducer includes a dilator received in a lumen defined by an introducer sheath and including a dilation end extending distally beyond a distal end of the introducer sheath. The introducer sheath includes a flat wire reinforcement having a hollow cylindrical shape sandwiched between an inner PTFE tube and an outer nylon tube. The outer nylon tube includes a distal segment that extends distally beyond the PTFE tube, which extends distally beyond the PTFE tube, which extends distally beyond the flat wire reinforcement. A withdrawal support wire has a distal end attached to a distal end turn of the flat wire reinforcement and extends in a proximal direction in parallel with a longitudinal axis between an outer surface of the nylon tube and an inner surface of the PTFE tube. The withdrawal support wire is configured to be in tension when the sheath is placed in tension to inhibit distal stretch separation breakage.