Multi-lumen Balloon Catheter for Bile Duct Stone Removal
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Solution Overview
Problem
The management of choledocholithiasis, or stones in the common bile duct, poses logistical and therapeutic challenges due to the high learning curve and perceived hurdles in laparoscopic common bile duct exploration (LCBDE) techniques, leading to a decline in its adoption despite its safety and cost-effectiveness compared to endoscopic retrograde cholangiopancreatography (ERCP).
Innovation Solution
A multi-lumen catheter with longitudinally spaced expandable members for dilating the Sphincter of Oddi and anchoring in the biliary tree, allowing for efficient gallstone removal through fluid flushing and dilation, facilitating a one-step procedure that can be performed with a single intrabody insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If LCBDE is performed with traditional multi-device approaches, then complete bile duct exploration and stone removal can be achieved, but the procedure complexity and learning curve increase significantly
Solution Approach 1:
The patent combines multiple previously separate devices and functions into a single integrated catheter system. The catheter integrates the distal seal balloon, proximal dilating balloon, and flushing/lumen functions into one device that can be inserted through a single access point, eliminating the need for multiple device exchanges and reducing procedural complexity while maintaining stone removal effectiveness
Solution Approach 2:
The catheter is designed with multi-functionality to perform multiple tasks: the distal expandable member creates seals in the biliary tree, the proximal expandable member dilates the Sphincter of Oddi, and the lumens deliver flushing fluids and contrast dye. This universal design allows one device to replace multiple specialized devices, simplifying the overall procedure
2Adaptability or versatility
If multiple device exchanges are performed during the procedure, then different functions (sealing, dilation, flushing) can be achieved, but the procedure time and number of intrabody insertions increase
Solution Approach 1:
The catheter merges sealing, dilation, and flushing functions into a single integrated device that remains in place throughout the procedure. The distal balloon provides sealing, the proximal balloon provides dilation, and the lumens provide flushing capabilities all simultaneously, eliminating the need for sequential device exchanges and reducing procedure time
Solution Approach 2:
The catheter is pre-configured with all necessary components (multiple expandable members, multiple lumens, valves) before insertion. The expandable members are positioned and can be independently controlled, allowing all necessary functions to be performed without removing or exchanging the catheter, thus reducing procedure time while maintaining functional versatility
3Reliability
If traditional ERCP is used for choledocholithiasis management, then stone removal can be achieved, but hospital costs and length of stay increase compared to LCBDE
Solution Approach 1:
The catheter employs segmented expandable members with independent control valves that can be selectively inflated and deflated. The distal seal balloon and proximal dilating balloon can be controlled independently, allowing precise control of sealing and dilation functions to optimize stone removal while minimizing resource requirements and enabling a more cost-effective LCBDE procedure
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The multi-lumen catheter enables efficient and simple intervention for choledocholithiasis management, potentially increasing the adoption of LCBDE by simplifying the procedure and reducing hospital costs and length of stay, while allowing for effective stone clearance without the need for multiple device exchanges.
Implementation Method 1
a first expandable member on the distal end portion... sized and configured for dilating the Sphincter of Oddi and a second expandable member on the distal end portion... sized and configured for anchoring the catheter anywhere in the biliary tree to create different size seals
Implementation Method 2
at least one additional lumen in fluid communication with the first and second expandable members to controllably inflate and deflate the first and second expandable members
Data Source
AI summary
Multi-lumen catheters with first and second expandable members are configured so that one expandable member dilates the Sphincter of Oddi and the second anchors within the biliary duct distal to the Common Bile Duct/Cystic Duct junction or within the cystic duct. The multi-lumen catheters include a primary lumen sized and configured for delivering a flushing agent to remove gallstones together or separately with a dye to complete a Cholangiogram and also include at least one lumen in fluid communication with the first and second expandable members.