Dual-Guidewire Biliary Catheter for Accurate Duct Selection
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Solution Overview
Problem
Existing medical devices face challenges in efficiently accessing and maintaining access to the biliary tree, particularly the common bile duct and pancreatic duct, due to the technical difficulty of navigating the ampulla of Vater and the risk of inadvertently advancing guidewires or catheters into the wrong duct, necessitating repeated re-cannulation and potential complications.
Innovation Solution
A dual-wire catheter system with a guidewire lumen and an outer guidewire channel allows for simultaneous advancement of two guidewires, enabling the system to be repositioned to correctly access the desired duct by using one guidewire to block the unintended path, thereby reducing the need for re-cannulation and minimizing complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a single guidewire is used to access the biliary tree, then the device structure is simple, but the accuracy of duct selection is reduced and repeated re-cannulation is required
Solution Approach 1:
The catheter system is segmented into multiple functional channels: an inner lumen for passing a first guidewire and an outer channel for passing a second guidewire. This segmentation allows independent control of two guidewires, enabling one to block the unintended path while the other accesses the desired duct, thereby improving duct selection accuracy without requiring a completely new device architecture
Solution Approach 2:
The first guidewire is nested within the inner lumen of the catheter, while the second guidewire is nested within the outer channel. The catheter shaft itself is nested within the delivery system. This nested configuration allows multiple guidewires to be advanced simultaneously through different pathways while maintaining a relatively compact overall device structure, balancing complexity with functional capability
2Loss of time
If repeated re-cannulation is performed to access the correct duct, then device simplicity is maintained, but procedural time and potential complications increase
Solution Approach 1:
Two guidewires are prepared and positioned in advance through the catheter's dual channels before attempting duct access. The first guidewire can be positioned to block the unintended duct path, while the second guidewire is ready to access the desired duct. This preliminary positioning eliminates the need for repeated re-cannulation attempts, reducing procedural time and complexity
Solution Approach 2:
The catheter system acts as an intermediary device that coordinates the placement of multiple guidewires. By providing structured pathways (inner lumen and outer channel) for guidewire advancement, the catheter mediates the complex interaction between multiple guidewires and the biliary anatomy, making the procedure easier to control and execute
3Productivity
If a dual-wire system is implemented to improve duct access accuracy, then procedural efficiency is enhanced, but device complexity increases
Solution Approach 1:
Multiple functional elements (inner lumen, outer channel, first guidewire, second guidewire) are merged into a single integrated catheter assembly. The catheter shaft combines both pathways in one structure, allowing simultaneous advancement of two guidewires through a single device, thereby improving procedural efficiency without requiring multiple separate devices or complex coordination equipment
Data Source
AI summary
Medical devices and methods are disclosed. An example method for accessing a body lumen may include providing a catheter system. The catheter system may include a catheter shaft having a lumen defined therein and an outer wall surface having a channel formed therein. A first guidewire may be disposed in the channel and a second guidewire may be disposed in the lumen. The method may also include advancing the catheter system through a body lumen to a location where the body lumen splits into a first section and a second section, advancing the first guidewire into the first section, and advancing the second guidewire into the second section, and advancing the catheter shaft along the second guidewire and into the second section. Advancing the catheter shaft along the second guidewire and into the second section may remove at least a portion of the first guidewire from the channel.