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

VSEngineering 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

Engineering Contradiction:
Improveaccess to different lumensVSAvoidprocedural complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

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.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Ease of operation

If devices are exchanged to optimize maneuverability, then cannulation control improves, but procedural time and complexity increase

Engineering Contradiction:
Improvecannulation controlVSAvoidprocedural time
Core Design Contradiction:
Ease of operationVSLoss of time

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.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If multiple opening attempts are made, then successful cannulation is achieved, but tissue trauma increases

Engineering Contradiction:
Improvecannulation successVSAvoidtissue trauma
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

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.

Inventive Principle:
Principle #15Dynamics

4Ease of operation

If device manipulation is performed after cannulation, then cutting orientation is achieved, but additional procedural steps are required

Engineering Contradiction:
Improvecutting orientationVSAvoidprocedural steps
Core Design Contradiction:
Ease of operationVSDevice complexity

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.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS12508047B2Devices, systems, and methods for accessing a body lumen
Publication Date: 2025.12.30 BOSTON SCIENTIFIC SCIMED INC
  • US12508047B2 patent drawing
  • US12508047B2 patent drawing
  • US12508047B2 patent drawing

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.