Multiple Entry Dilator Sheath for Cardiovascular Tracking
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Solution Overview
Problem
Current delivery sheath-dilator assemblies face difficulties in tracking over complex paths and sharp bends in the cardiovascular system, particularly in the main pulmonary artery and its branches, due to insufficient support from single guide wires, leading to system memory and failure to reach desired destinations.
Innovation Solution
A multiple entry, single lumen dilator with a sheath assembly featuring multiple holes at the distal end for accommodating multiple guide wires, which provides extra support and allows for variable orientation to overcome system memory and facilitate tracking over complex paths.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single guide wire is used to support the delivery sheath-dilator assembly, then the system structure remains simple, but the ability to track complex paths and sharp bends deteriorates due to insufficient support
Solution Approach 1:
The single guide wire is segmented into multiple guide wires (typically 2-4 wires) that enter through multiple holes in the dilator and converge to a single exit point. This segmentation distributes the mechanical load across multiple wires, providing enhanced support for tracking complex paths and sharp bends while maintaining operational simplicity through the single exit configuration.
2Ease of operation
If a very stiff guide wire is used to push the dilator-sheath assembly forward, then tracking capability improves, but the ability to overcome system memory deteriorates
Solution Approach 1:
Multiple guide wires with varying stiffness characteristics are merged into a unified support system that converges at a single exit point. This combination allows the ensemble to provide both the pushing force needed for tracking and the adaptability to overcome system memory, as the distributed wire configuration can better accommodate the delivery system's elastic recovery.
3Ease of operation
If multiple guide wires are used to support the delivery system, then tracking capability over complex paths improves, but the device complexity increases
Solution Approach 1:
The multiple guide wires are nested within the dilator structure, with each wire passing through its own hole in the dilator body. The wires are contained within the dilator-sheath assembly, creating a compact integrated structure that provides enhanced tracking capability without proportionally increasing external device complexity.
Solution Approach 2:
The dilator with multiple entry holes serves multiple functions: it provides structural support for multiple guide wires, maintains their parallel alignment, facilitates their convergence to a single exit point, and enables the delivery system to track complex paths. This multi-functionality reduces the need for additional separate components.
Data Source
AI summary
A single lumen, multiple entry dilator sheath assembly is provided for delivering medical devices in different parts of cardiovascular system. The multiple holes allow multiple guidewires to enter the dilator-delivery sheath system distally and exit from a single lumen proximally thereby providing extra support to the delivery system while tracking over complex paths. Such a multi guide wire system has a definite advantage even over a two-wire system because, although two wire system may offer better support as compared to single wire, it will not be as good as a four wire system. Also, in two wire system the wires are fixed in their position and therefore overcoming the memory of sheath and dilator system will not be as good as with multi-wire system because of the ability to use the multiple entry holes in various permutations and combinations.