Multi-Lumen Catheter Articulation for Difficult Body Lumen Access
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Solution Overview
Problem
Accessing and navigating a body lumen, such as during endoscopic cannulation procedures, is challenging due to tortuous anatomies, difficult angles, small or sealed openings, and blockages, leading to potential tissue trauma and procedural complications.
Innovation Solution
The catheter design includes a shaft with multiple lumens and reinforcing filaments or tubular members that enhance maneuverability and control, allowing for precise articulation and manipulation, enabling efficient access and enlargement of the lumen without the need for device exchange.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple devices are exchanged to access body lumens, then access to different lumens is achieved, but procedural complexity and time increase
Solution Approach 1:
The catheter shaft integrates multiple lumens (first lumen for guidewire, second lumen for articulation wire, third lumen for cutting wire) within a single device structure, enabling multiple functions (cannulation, articulation, cutting) to be performed without exchanging devices. This multi-functional design directly resolves the contradiction by providing versatility while maintaining procedural simplicity.
2Ease of operation
If devices are exchanged to optimize maneuverability, then cannulation control improves, but procedural time and complexity increase
Solution Approach 1:
The catheter is pre-configured with multiple wires (articulation wire in second lumen, cutting wire in third lumen) and reinforcing filaments positioned to provide immediate maneuverability and control upon insertion. The articulation wire can be activated to bend the shaft tip, and the cutting wire is pre-positioned for immediate use, eliminating the need for sequential device exchanges and reducing procedural time while maintaining optimal control.
3Reliability
If multiple opening attempts are made, then successful cannulation is achieved, but tissue trauma increases
Solution Approach 1:
The catheter incorporates an articulation mechanism where translation of the articulation wire within the second lumen dynamically changes the bend angle of the shaft tip. This dynamic articulation capability allows the operator to adjust the distal tip orientation in real-time to match the target lumen angle on the first attempt, reducing the need for multiple opening attempts and minimizing tissue trauma. The reinforcing filaments provide structural support while allowing controlled flexibility.
4Ease of operation
If device manipulation is performed after cannulation, then cutting orientation is achieved, but additional procedural steps are required
Solution Approach 1:
The catheter design merges the articulation function and cutting function into a single integrated device. The articulation wire (second lumen) and cutting wire (third lumen) are both present simultaneously, allowing the operator to first articulate the shaft tip for cannulation and then activate the cutting wire for orientation and cutting without removing or exchanging the catheter. This combination eliminates additional procedural steps while maintaining ease of operation for both articulation and cutting.
Data Source
AI summary
The disclosure relates generally to the field of medical devices for accessing body lumens. In an embodiment, a catheter may include a shaft having a proximal end, a distal end, and a length along a longitudinal axis extending through the shaft. A plurality of lumens may extend along the length of the shaft. At least one reinforcing filament may extend along the length of the shaft and between at least two of the plurality of lumens.


