Dilatation Balloon for Biliary Stricture Management
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Solution Overview
Problem
Current biliary stricture management protocols using traditional percutaneous biliary drains are inefficient, causing discomfort, frequent exchanges, and increased healthcare costs due to their small diameter, which limits quality of life and is associated with complications like pain, skin irritation, and leakage.
Innovation Solution
A dilatable biliary drain system with a balloon mounted on a segment of the drain that crosses the stricture, allowing for prolonged and sustained dilatation to a normal bile duct diameter, featuring a hybrid balloon with varying diameters to prevent migration and a wire access area for targeted balloon deflation, enabling early drain removal and improved luminal gain.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If traditional percutaneous biliary drains with small diameter are used, then the drain can be inserted through the skin and liver, but the drain causes discomfort, frequent exchanges, and complications due to limited diameter
Solution Approach 1:
The drain incorporates a balloon that can be inflated to expand the drain diameter in situ. The balloon transforms the drain from a small-diameter catheter to a large-diameter drainage device without requiring insertion of a large catheter through the skin and liver, thus avoiding the discomfort and complications associated with large-bore percutaneous drains while achieving adequate drainage lumen size
Solution Approach 2:
The balloon is mounted on the drain in a nested configuration where the balloon can be collapsed within the drain during insertion, then expanded at the target site. This nesting principle allows the large-diameter balloon to pass through the small-diameter insertion path through skin and liver, then expand to provide large-diameter drainage without the initial trauma of large-bore insertion
2Productivity
If a large diameter drain is used to improve drainage, then drainage efficiency improves, but insertion through skin and liver becomes difficult and traumatic
Solution Approach 1:
The drain system dynamically changes diameter through balloon inflation. During insertion, the balloon remains deflated allowing easy passage through skin and liver tract. Once positioned, the balloon inflates to expand the drainage lumen to large diameter, achieving high drainage efficiency without the insertion trauma associated with permanent large-bore drains
Solution Approach 2:
The balloon acts as an intermediary mechanism that decouples the insertion process from the final drainage function. The small-diameter deflated balloon facilitates easy insertion, while the large-diameter inflated balloon provides efficient drainage. This intermediary structure resolves the contradiction between insertion ease and drainage efficiency
3Ease of manufacture
If the balloon has uniform diameter, then manufacturing is simple, but the balloon may migrate along the drain
Solution Approach 1:
The balloon incorporates asymmetric diameter variation with enlarged ends and a narrowed center portion. This asymmetric geometry creates mechanical engagement with the drain and surrounding tissue that prevents longitudinal migration. The larger ends act as stops that engage the drain edges or tissue, while the narrowed center allows passage through the stricture, providing stable positioning without complex manufacturing
Solution Approach 2:
Different portions of the balloon have different diameters optimized for different functions: the enlarged ends provide anchoring and prevent migration, the narrowed center portion facilitates passage through the stricture and engages the drain, and the overall balloon provides dilation. This local differentiation of balloon quality achieves stable positioning while maintaining manufacturing simplicity
4Reliability
If the drain remains in place for prolonged periods to maintain stricture dilation, then stricture patency is maintained, but patient quality of life decreases due to prolonged foreign body presence
Solution Approach 1:
The balloon provides self-sustaining stricture dilation through its inflated state, maintaining patency without requiring continuous external intervention. The balloon's position stability features prevent migration, and the sustained inflation maintains stricture dilation over time, allowing the drain to serve itself in maintaining patency rather than requiring frequent medical intervention or patient management
Solution Approach 2:
The balloon performs preliminary and sustained dilation of the stricture during the drain placement period. By maintaining dilation throughout the drain residence time, the balloon prepares the stricture for eventual drain removal while maintaining patency. This preliminary action of sustained dilation allows for shorter overall drain placement duration compared to traditional methods that require prolonged presence to maintain patency
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 dilatable biliary drain system effectively dilates strictures to a normal diameter, reducing the need for prolonged drain placement, decreasing complications, and improving patient quality of life by allowing early drain removal and minimizing the number of procedures required.
Implementation Method 1
A dilatable biliary drain system with a balloon mounted on a segment of the drain that crosses the stricture, allowing for prolonged and sustained dilatation
Data Source
AI summary
A biliary drain system includes a drain having a first end and a second end. The drain also includes a lumen that connects the first end to the second end. The system also includes a balloon mounted to the drain and configured to mount within a stricture of a bile duct of a patient. The balloon includes a first end, a second end, and a center portion. A size of the first end of the balloon is greater than a size of the center portion of the balloon.