Bile Duct Stent Mesh Valve for Durable Backflow Prevention

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Solution Overview

Problem

Conventional bile duct stents fail to effectively prevent backflow of food from the duodenum into the bile duct, leading to obstruction of bile flow and stent malfunction, and their durability is compromised due to resin material used in backflow prevention mechanisms.

Innovation Solution

A bile duct stent with a backflow-preventing pattern film formed using metal wires at the duodenum-side outlet, which includes various patterns woven with nylon threads or metal wires, providing durability and maintaining performance even with stent deformation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If resin material valves are used for backflow prevention, then backflow prevention function is provided, but durability is lowered due to film damage caused by bile

Engineering Contradiction:
Improvebackflow preventionVSAvoiddurability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent replaces durable metal components with a disposable resin film that can be safely discarded after a single use. The resin film is designed to perform its backflow prevention function effectively during the immediate post-operative period, after which it is removed or degraded, avoiding long-term exposure to bile damage while maintaining reliability during the critical initial phase.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent changes the material parameter from metal to resin, and changes the operational parameter from long-term permanent use to short-term temporary use. This parameter transformation allows the backflow prevention mechanism to achieve its function during the most critical period while avoiding the durability issues associated with resin material exposed to bile over extended periods.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If stent is expanded to maintain bile flow, then backflow prevention is improved, but diameter reduction for catheter loading becomes difficult

Engineering Contradiction:
Improvebackflow prevention performanceVSAvoidloading onto catheter
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent employs a dynamic structure where the stent transitions from a compressed state during catheter loading to an expanded state during implantation. The resin film is applied to the expanded stent structure, ensuring that the backflow prevention function is optimized for the operational (expanded) state while the dynamic compression capability is maintained for ease of loading onto the catheter.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent separates the loading function from the operational function by using a delivery catheter system. The stent is segmented into a compressed loadable form that fits within the catheter, and an expanded operational form that provides effective backflow prevention. The resin film is applied to the expanded form, allowing each stage to be optimized independently.

Inventive Principle:
Principle #1Segmentation

3Reliability

If metal wires are used for pattern member, then durability is secured, but manufacturing complexity increases

Engineering Contradiction:
ImprovedurabilityVSAvoidmanufacturing process
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent replaces complex mechanical weaving or assembly processes with a chemical coating process. Instead of mechanically constructing the pattern from metal wires through complex assembly, the resin film is applied as a coating that forms the protective pattern directly on the stent surface, significantly simplifying the manufacturing process while maintaining durability.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent creates a composite structure combining the stent base material with a resin film layer. This composite approach allows the underlying stent structure to provide mechanical strength and support, while the resin film provides the durable protective pattern, achieving both durability and manufacturing simplicity through material combination rather than complex mechanical assembly.

Inventive Principle:
Principle #40Composite materials

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 solution effectively prevents backflow of food into the bile duct, ensures durability, and facilitates easy loading onto a catheter by reducing the stent's diameter, while maintaining functionality despite pressure at the lesion site.

Implementation Method 1

by forming a radial backflow-preventing pattern film, which has a bent portion formed at the center, using metal wires having a self-expansile force, there is an effect of facilitating diameter reduction of the bile duct stent when loading the bile duct stent on a catheter

Methodology Applied
Scientific EffectSelf-expansile force: Elasticity

Data Source

PatentEP4137101B1Bile duct stent and manufacturing method thereof
Publication Date: 2024.11.27 THE ASAN FOUND
  • EP4137101B1 patent drawingFigure 1
  • EP4137101B1 patent drawingFigure 2
  • EP4137101B1 patent drawingFigure 3

AI summary

A bile duct stent and a method of manufacturing the same are disclosed. The bile duct stent having a backflow preventing means according to an embodiment of the present invention includes: a cylindrical body having a mesh structure formed by zigzagging metal wires of a shape memory alloy on a plurality of pins each disposed in a circumferential direction (X) and a longitudinal direction (Y) of a cylindrical jig; a film portion coated on cells of the metal wires of the mesh structure; and a backflow-preventing pattern film in which a hole is formed in the film portion of each cell formed at an outlet end of the cylindrical body and threads (Lasso) fixed by zigzagging to the cells of the metal wires in the circumferential direction by passing through any one hole (h) cross the outlet end one time or more to form a network structure.