Ultrasound Endoscope Access Pipe for Bile Leakage Control

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Solution Overview

Problem

Conventional biliary drainage procedures face challenges with bile leakage into the abdominal cavity during the expansion of the hole for stent insertion, leading to potential complications.

Innovation Solution

An access device with a piercer and access pipe configured for endoscopic use, allowing switching between piercing and non-piercing modes, and featuring a treatment tool for controlled introduction into hollow organs, utilizing energy application for precise tissue penetration and minimizing bile leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a needle and guidewire are used to pierce the bile duct followed by balloon dilation, then access to the bile duct is achieved, but bile leakage into the abdominal cavity occurs during the expansion process

Engineering Contradiction:

Improveaccess stabilityVSAvoidbile leakage

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The device is divided into distinct functional segments: a piercing needle for initial access, a guidewire for pathway establishment, and a self-expanding access device that maintains the opening. This segmentation allows each component to perform its specific function without causing bile leakage, as the access device continuously seals the puncture site throughout the procedure.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The piercing needle creates the initial access channel before the access device is deployed. This preliminary action establishes a controlled pathway that guides subsequent components through the tissue, ensuring precise placement and minimizing uncontrolled bile leakage during the procedure.

Inventive Principle:

Principle #10Preliminary action

2Adaptability or versatility

If multiple separate devices (needle, guidewire, balloon dilator, stent) are used sequentially, then the bile duct can be accessed and treated, but the procedure becomes complex and time-consuming

Engineering Contradiction:

Improvetreatment capabilityVSAvoidprocedure steps

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

Multiple functions previously requiring separate devices are merged into a single integrated access device. The device combines the piercing function, guidewire delivery, dilation capability, and stent delivery system into one unified structure, reducing the number of procedural steps and minimizing bile leakage risks associated with multiple device insertions and removals.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The access device is designed as a multi-functional universal tool that can perform piercing, guide wire delivery, dilation, and stent deployment. This universality eliminates the need for multiple specialized devices while maintaining full treatment capability, thereby simplifying the overall procedure.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Ease of operation

If the needle is removed after piercing but before stent insertion, then the needle can be drawn out of the patient's body, but the opening must be expanded separately which increases the risk of bile leakage

Engineering Contradiction:

Improveneedle removalVSAvoidbile leakage during expansion

Core Design Contradiction:

Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The access device serves as an intermediary structure that remains in place after needle removal. Instead of directly expanding the opening with a balloon dilator (which risks bile leakage), the access device is deployed through the needle tract and gradually expanded to maintain a sealed pathway, preventing bile leakage while enabling subsequent stent insertion.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The access device maintains continuous sealing of the puncture site from needle removal through stent insertion. Unlike the conventional approach where the opening is temporarily open during expansion, this device continuously closes the pathway around the working components, preventing bile leakage throughout the entire procedure.

Inventive Principle:

Principle #20Continuity of useful action

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 device effectively pierces and secures access to hollow organs while preventing bile leakage, enabling safe and controlled treatment procedures by maintaining a stable pathway for treatment tools.

Implementation Method 1

The piercer includes an energy device configured to apply energy

Methodology Applied

Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS12533157B2Treatment method and device with ultrasound endoscope

Publication Date: 2026.01.27 OLYMPUS CORPORATION(JP)

AI summary

An access device used with an endoscope includes an access pipe configured to be inserted into a sheath of the endoscope, a piercer disposed on a distal end portion of the access pipe and configured to pierce into a hollow organ through a digestive tract of a patient, and a treatment tool configured to be inserted into the access pipe and to be introduced into the hollow organ by the piercer. The access device is switchable between a first configuration and a second configuration. In the first configuration, a piercing function of the piercer is switched on, so that the piercer pierces the digestive tract and the hollow organ to enter into an interior of the hollow organ, and in the second configuration, the piercing function of the piercer is switched off, the piercer is kept connected to the interior of the hollow organ.