Deformable Catheter Tip for ERCP Pressure Distribution
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Solution Overview
Problem
Conventional ERCP procedures face challenges in inserting catheters into bile ducts due to narrow entrances and curved ducts, leading to mucous membrane edema and increased risk of pancreatitis, as existing catheters often cause concentrated pressure on tissues and may thrust into the submucosa.
Innovation Solution
A treatment device with a catheter and deformable distal piece that distributes pressure concentration, featuring a broad curved surface shape to minimize tissue damage, allowing for smooth insertion and retraction, and formed from elastic materials like rubber or elastomeric plastics for easy deformation into the catheter lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a catheter is inserted through the papilla to access the bile duct, then diagnostic imaging can be achieved, but the catheter may cause concentrated pressure on tissues leading to mucous membrane edema and increased risk of pancreatitis
Solution Approach 1:
The catheter is divided into multiple functional segments: a soft distal end portion for gentle tissue contact, a mid-portion with contrast agent injection capability, and a proximal control section. This segmentation allows the distal end to be optimized for tissue safety while other sections provide diagnostic functionality.
Solution Approach 2:
The catheter employs gradual parameter changes along its length, with the outer diameter transitioning from a smaller distal end (0.5-1.0mm) to a larger proximal end, and the bending radius increasing from the distal to proximal sections. This gradual transition prevents sudden pressure concentration on tissues while maintaining flexibility for navigation.
2Ease of operation
If the catheter distal end is made narrow to facilitate insertion, then insertion difficulty is reduced, but pressure concentration on tissues increases causing edema and submucosa puncture
Solution Approach 1:
The distal end portion of the catheter is designed with a spherical or rounded tip shape instead of a sharp or flat end. This curved geometry distributes contact pressure over a larger surface area of the tissue, reducing peak pressure while maintaining the narrow overall diameter needed for easy insertion through the papilla.
3Adaptability or versatility
If a guidewire with flexible distal end is used to access the bile duct, then access to curved ducts is improved, but force concentration on a single point increases causing edema or submucosa puncture
Solution Approach 1:
The harmful sharp tip is extracted from the guidewire structure and replaced with a dedicated soft distal end portion that has a rounded, tissue-friendly geometry. The guidewire retains its flexibility for navigating curved ducts while the modified distal end eliminates the force concentration problem.
4Measurement precision
If contrast agent is injected when catheter is thrust into submucosa, then imaging can be performed, but mucous membrane inflation occurs further obstructing the papilla entrance
Solution Approach 1:
The catheter design ensures proper positioning and stabilization of the distal end in the bile duct before contrast agent injection is initiated. The gradual bending radius and soft distal end facilitate controlled advancement and positioning, preventing premature injection that would cause mucous membrane inflation and obstruction.
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 reduces the risk of mucous membrane edema and pancreatitis by distributing pressure evenly, enabling smooth insertion and imaging while allowing for easy deformation and retraction, thus improving the usability and safety of ERCP procedures.
Implementation Method 1
a piece disposed at a distal end of the wire and having a maximum width when the piece is protruded out from the distal end of the catheter is set larger than the diameter of the lumen, wherein the piece is formed of a deformable material having a broad curved surface shape that distributes concentration of pressure acting on tissues
Implementation Method 2
the piece is formed of a deformable material having a broad curved surface shape that distributes concentration of pressure acting on tissues, and when the wire is pulled in toward the catheter, the piece being extended in the axial direction by the lumen and reduced in its outer diameter so as to be pulled into the lumen
Data Source
AI summary
A treatment device is provided including a catheter having a lumen that is opened to a distal end of the catheter; a wire passing through the lumen so that the wire is inserted into or retracted from the lumen; and a piece disposed at a distal end of the wire and having the maximum width when the piece is protruded from the distal end of the catheter is set larger than the diameter of the lumen, wherein the piece body is formed of a deformable material having a broad curved surface shape that distributes concentration of pressure acting on tissues, and when the wire is pulled in toward the catheter, the piece being extended in the axial direction by the lumen and reduced in its outer diameter so as to be pulled into the lumen.