Ultrasound Endoscope Access Pipe for Leak-Limited Biliary Entry
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Solution Overview
Problem
Conventional biliary drainage methods using ultrasound endoscopes face issues with bile leakage during the expansion of the hole for stent insertion, leading to potential complications.
Innovation Solution
An access device with a piercer and access pipe system for an endoscope that allows controlled piercing and energy application, enabling safe introduction of a treatment tool into hollow organs, with switchable configurations for piercing and tool delivery.
Engineering Contradictions & Design Principles
Engineering 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 occurs during the expansion phase leading to complications
Solution Approach 1:
The patent applies preliminary action by pre-forming a puncture channel through the digestive tract wall and hollow organ wall using a piercer with stylet before introducing the treatment tool. The stylet creates a controlled trajectory that maintains structural integrity during the procedure, preventing bile leakage that would occur with conventional balloon dilation methods.
Solution Approach 2:
The patent uses a guidewire as an intermediary element that is introduced through the puncture channel created by the piercer. The guidewire serves as a mediator that maintains the patency of the access channel and guides subsequent treatment tools while preventing bile leakage, eliminating the need for balloon dilation that causes the harmful effect.
2Reliability
If multiple separate tools (needle, guidewire, balloon dilator, stent) are used sequentially, then bile duct access is achieved, but device complexity increases and procedural time extends
Solution Approach 1:
The patent merges multiple functions into a single integrated access device system. The piercer assembly combines the puncture function (replacing needle and guidewire) with the stylet that maintains channel patency (replacing balloon dilator), allowing all components to be introduced through a single delivery system rather than requiring multiple separate insertion steps.
Solution Approach 2:
The piercer with stylet serves multiple functions: it pierces the digestive tract wall and hollow organ wall to create access, maintains the puncture channel open during tool introduction, and guides the treatment tool into position. This multi-functional design replaces the need for separate needle, guidewire, and balloon dilator components.
3Ease of operation
If conventional piercing methods are used without controlled energy application, then access is obtained, but tissue damage and procedural risks increase
Solution Approach 1:
The patent applies parameter changes by incorporating an energy device that delivers controlled energy (such as radiofrequency or microwave energy) to the tissue at the puncture site. This controlled energy application facilitates cleaner tissue separation, reduces mechanical trauma, and minimizes bleeding compared to conventional mechanical piercing methods.
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
Minimizes bile leakage and ensures safe, controlled access to hollow organs for treatment, reducing complications and enhancing procedural safety.
Implementation Method 1
The piercer includes an energy device configured to apply energy
Data Source
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.