Splittable Catheter Shaft for Wire Guide Uncoupling
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Solution Overview
Problem
Current short-wire systems for exchanging medical devices in the biliary system lack compatibility with long wire methods, result in loss of wire guide access, and are inefficient due to friction and incompatibility with smaller-diameter wire guides, leading to complications in procedures like stent placement and recannulation.
Innovation Solution
The ultra-short wire technique allows for remote uncoupling of medical devices within the work site, using a shorter wire guide that does not require external exchange, with an optional coupling mechanism for longer wire compatibility, and includes alignment indicators for precise control and confirmation of uncoupling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a long wire guide is used for over-the-wire exchange, then device exchange is enabled, but wire guide control is lost and assistant intervention is required
Solution Approach 1:
The catheter is divided into two segments: a proximal portion that remains external to the patient and a distal portion that is introduced over the wire guide into the patient. The wire guide exits through a side port of the proximal catheter portion, separating the wire guide path from the catheter lumen and enabling independent control of each component.
Solution Approach 2:
The wire guide is extracted from the catheter lumen and routed through a side port of the proximal catheter portion. This extraction allows the wire guide to be controlled independently by the physician while the catheter can be managed separately, eliminating the need for assistant intervention in wire management.
2Ease of operation
If a short wire guide is used for rapid exchange, then physician control is improved, but compatibility with long wire methods is lost and wire guide access is lost
Solution Approach 1:
The catheter design serves multiple functions: it can be used with both long wire and short wire techniques, and it can be exchanged with both over-the-wire and rapid exchange methods. The side port configuration allows the wire guide to be routed externally, maintaining compatibility across different exchange methodologies while preserving physician control.
3Strength
If the catheter wall is made integral and non-splittable, then structural integrity is maintained, but friction increases during device exchange
Solution Approach 1:
The catheter wall is segmented into a proximal portion and a distal portion that can be separated. The distal portion can be peeled away from the proximal portion during exchange, reducing friction between the catheter and wire guide while maintaining structural integrity of the proximal portion that remains external to the patient.
4Productivity
If external exchange is performed, then device exchange is enabled, but procedural complexity increases and access is lost
Solution Approach 1:
The wire guide is extracted from the catheter lumen and routed through a side port, allowing the catheter to be exchanged without requiring external manipulation. The physician can control the wire guide externally through the side port while the catheter is exchanged internally, simplifying the procedure and maintaining continuous access.
Data Source
AI summary
A method and apparatus for uncoupling a wire guide from and elongate medical device comprising a catheter shaft having a wire guide lumen extending there through, wherein the material surrounding the wire guide lumen is selected or adapted to facilitate splittability for removal of the wire guide. The catheter shaft is coextruded and comprises a plurality of materials. The portion of the shaft adjacent the wire guide lumen is formed from a first material and the balance of the shaft is formed from a second material. The first material is selected or adapted to facilitate splittability as compared to the second material. The first material may have a lower durometer than the second material. A peel tool for separating the wire guide from the catheter shaft is also provided.