Biliary Access Sheath Self-Expanding Distal Anchor

Solution Overview

Problem

Current endoscopic procedures for accessing biliary and pancreatic ducts are hindered by the difficulty in navigating larger fiber optic scopes with greater than 1.2 mm working channels through smaller mother scopes, requiring expensive 'mother-baby' systems and risking scope withdrawal during manipulation, especially in direct peroral cholangioscopy.

Innovation Solution

A biliary access sheath with a self-expanding distal portion, constraining during introduction and expanding to anchor within the biliary tree, allowing for efficient navigation and retention of ultra-slim endoscopes with a 2 mm accessory channel, compatible with standard endoscopes and reducing procedural costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a larger fiber optic scope with greater than 1.2 mm working channel is used, then diagnostic and therapeutic options are improved, but the difficulty of navigating through a mother scope increases

Engineering Contradiction:
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The scope system is divided into two independent components: a standard duodenoscope for access and a separate ultra-slim intraductal endoscope for intraductal procedures. This segmentation allows each component to be optimized independently - the duodenoscope provides robust access capabilities while the ultra-slim scope (with 2 mm accessory channel) provides enhanced diagnostic and therapeutic options without the navigation difficulties of forcing a large scope through a mother scope.

Inventive Principle:
Principle #1Segmentation

2Reliability

If a mother-baby scope system is used, then access to biliary and pancreatic ducts is achieved, but procedural cost increases

Engineering Contradiction:
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The ultra-slim intraductal endoscope is designed with a 2 mm accessory channel that can accommodate various therapeutic devices including baskets, balloons, and stents, making it a universal platform for multiple biliary and pancreatic procedures. This eliminates the need for separate mother-baby scope configurations and allows a single scope to perform multiple functions, thereby reducing procedural costs while maintaining reliable access.

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

3Productivity

If an ultra-slim scope is directed into a bile duct without a mother scope, then procedural efficiency is improved, but the risk of scope withdrawal during manipulation increases

Engineering Contradiction:
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

A specialized delivery catheter serves as an intermediary device that facilitates the introduction of the ultra-slim intraductal endoscope into the biliary tree. The delivery catheter provides a tracking mechanism and initial support, allowing the ultra-slim scope to be navigated efficiently without requiring a mother scope. Once positioned, the scope is secured within the biliary duct, eliminating the risk of withdrawal while maintaining procedural efficiency.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Enables efficient and cost-effective navigation and retention of ultra-slim endoscopes within the biliary tree, reducing the need for expensive 'mother-baby' systems and minimizing scope withdrawal risks, while providing superior image quality and expanded diagnostic and therapeutic options.

Implementation Method 1

The distal tube portion (106) is configured as a self-expanding tube, similar to a self-expanding stent construction, being constrained during introduction into a proximal portion of the biliary tree, and released to anchor the distal sheath portion (106) therein.

Methodology Applied
Scientific EffectSelf-expanding: Elasticity

Data Source

PatentEP2568872B1Biliary access sheath
Publication Date: 2017.09.06
  • EP2568872B1 patent drawingFigure 1~2A
  • EP2568872B1 patent drawingFigure 3~3A
  • EP2568872B1 patent drawingFigure 4~4B

AI summary

A biliary access sheath may include an elongate proximal tube portion having a fixed outer diameter and permanently attached to a distal tube portion having an outer diameter that may be constricted and expanded. The distal portion may be configured as a self-expanding tube similar to a self-expanding stent construction, being constrained during introduction into a proximal portion of the biliary tree, and released to anchor the distal sheath portion therein. In another aspect, a method for introducing an intra-ductal endoscope may use a biliary access sheath as herein described.