Dual-Layer Balloon Catheter Protrusions for Stable Stenosis Incision
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional balloon catheters face issues with deformation of protrusions during inflation, leading to reduced embedding ability into stenotic sites and potential damage to vascular lumens, especially in calcified or ISR lesions.
Innovation Solution
A balloon catheter design featuring a two-layer structure with an outer layer and an inner layer of differing Shore D hardness, where the inner layer has a lower hardness, allowing the protrusions to stretch more easily and maintain shape during inflation, reducing deformation and minimizing damage to the lumen.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional balloon catheters with protrusions are used to dilate stenotic areas, then the protrusions can embed into the stenosis, but the protrusions deform when the balloon is pressurized and expanded, reducing their ability to embed into the stenotic site
Solution Approach 1:
The balloon is constructed with a composite structure comprising an inner layer and an outer layer with different material properties. The inner layer has lower Shore D hardness and higher elasticity to allow deformation and embedding into stenotic areas, while the outer layer has higher Shore D hardness and greater rigidity to maintain the overall shape and structural integrity of the protrusions during balloon expansion, thus resolving the contradiction between embedding ability and shape stability
Solution Approach 2:
Different regions of the balloon are assigned different material properties: the inner layer material is specifically selected to be softer and more compliant at the protrusion regions to facilitate embedding, while the outer layer material is selected to be harder and more rigid to maintain protrusion geometry. This local differentiation of material qualities allows simultaneous achievement of embedding capability and shape maintenance
2Productivity
If protrusions are provided at the leading end of the balloon for cutting stenosis, then incision efficiency is improved, but the protrusions may damage the inner wall of the vessel or other lumen during insertion or withdrawal
Solution Approach 1:
The Shore D hardness parameter of the balloon material is optimized to balance between incision capability and safety. By selecting a specific hardness range that is sufficiently hard to cut stenotic tissue but not excessively hard to cause vessel wall damage during insertion/withdrawal, the contradiction between incision efficiency and harm reduction is resolved
Solution Approach 2:
The dual-layer composite structure allows the protrusions to have enhanced cutting performance through the rigid outer layer while the softer inner layer provides compliance that reduces trauma to the vessel wall during navigation, thus achieving both high incision efficiency and minimized harmful effects
3Ease of operation
If the balloon is inserted into the lumen with protrusions at the leading end, then deliverability is improved, but the protrusions may unintentionally pierce areas of the vascular lumen wall
Solution Approach 1:
The elasticity and hardness parameters of the protrusion material are carefully selected to provide sufficient rigidity for navigation through the vascular system while maintaining enough compliance to conform to the lumen wall and avoid unintentional piercing during insertion and withdrawal maneuvers
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 design enhances deliverability and incision efficiency by preventing deformation of protrusions and reducing damage to the inner wall of blood vessels during treatment, ensuring safe and effective stenosis incision.
Implementation Method 1
an inner layer composed of a material having a Shore D hardness lower than that of the outer layer... allowing the protrusions to stretch more easily and maintain shape during inflation
Data Source
AI summary
A balloon for a balloon catheter having an outer layer, an inner layer composed of a material having a Shore D hardness lower than that of the outer layer and a protrusion part, is provided. A region where the protrusion part is present includes an outer layer protrusion part formed by the outer layer and protruding outward in the radial direction and an inner layer protrusion part formed by the inner layer and protruding outward in the radial direction. An angle (θ1) between a straight line that connects the two inner layer ends and a straight line that connects the inner layer apex and one of the two inner layer ends is smaller than an angle (θ2) between a straight line that connects the two outer layer ends and a straight line that connects the outer layer apex and one of the two outer layer ends.