Balloon Catheter Projection Portions Welding
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Solution Overview
Problem
The complexity and cost of manufacturing balloon catheters with blades, along with the risk of balloon damage, arise from the need to install a rigid blade on a balloon, which can impair flexibility and lead to detachment or surface damage.
Innovation Solution
A balloon catheter with a flexible elongated shaft and a balloon that includes an effective expansion portion and projection portions formed integrally, where the projection portions are part of the balloon itself, preventing the need for a separate blade and reducing manufacturing complexity and cost.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid blade is installed on the balloon to cut into the stenosed site, then the treatment effect on calcified lesions is improved, but the flexibility of the balloon is impaired and the blade may detach
Solution Approach 1:
The blade and balloon are merged into a single integrated structure where the blade is formed as an extension of the balloon body from the same elastomeric material. This eliminates the interface between separate components, preventing detachment while maintaining flexibility throughout the entire structure.
Solution Approach 2:
The invention uses a single elastomeric material for both the balloon and blade portions, creating a homogeneous composite structure. This ensures uniform mechanical properties and flexibility across the entire device, avoiding the rigidity issues that would arise from combining dissimilar materials.
2Strength
If a rigid blade is installed on the balloon to cut into the stenosed site, then the treatment effect on calcified lesions is improved, but the manufacturing complexity and cost increase
Solution Approach 1:
The blade and balloon are manufactured as a single integrated piece using one continuous molding process. This eliminates separate manufacturing steps for the blade, assembly operations, and quality checks for interfaces, significantly reducing manufacturing complexity and cost.
Solution Approach 2:
The blade structure is pre-formed as an integral part of the balloon during the initial molding process. This preliminary formation of the blade geometry within the mold eliminates subsequent manufacturing steps that would be required if the blade were made separately and attached later.
3Strength
If a rigid blade is installed on the balloon, then the blade can bite into the stenosed site, but the outer surface of the balloon may be damaged during folding or operation
Solution Approach 1:
The blade and balloon form a continuous homogeneous structure made from the same elastomeric material. This integration ensures that the blade and balloon expand and contract together as a unified system, preventing relative motion that could cause the blade to cut or damage the balloon surface during folding or deployment.
Solution Approach 2:
The entire device including both the balloon and blade portions is made from the same elastomeric material with uniform properties. This homogeneity ensures consistent mechanical behavior throughout the structure, preventing the blade from acting as a separate rigid element that could damage the softer balloon material during movement or folding.
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
This design enhances the balloon's expansion performance, prevents flexibility loss and detachment, and reduces manufacturing costs by forming the projection portions from the same material as the balloon, thus minimizing damage during use.
Implementation Method 1
The inner surface of the first part of the balloon is at least partially welded to the inner surface of the second part of the balloon
Data Source
AI summary
A balloon catheter includes a flexible elongated shaft and a balloon fixed to the distal portion of the shaft. The balloon expands and contracts. The balloon includes an effective expansion portion and at least one projection portion on the effective expansion portion. The effective expansion portion possesses a cylindrical shape when the balloon is expanded, and the projection portion extends for a predetermined length along the axial direction of the balloon. The projection portion has first and second parts so that the inner surface of the first part of the balloon faces the inner surface of the second part of the balloon. The first and second parts project radially outwardly away from immediately adjacent parts of the balloon. The inner surface of the first part of the balloon is at least partially welded to the inner surface of the second part of the balloon.