Polyamide 6.12 Balloon Envelope for High-Pressure Catheter Deliverability
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing balloon catheters with multi-layer structures are complex to produce and have difficulties with deliverability due to increased wall thickness, which affects their ability to reach target locations effectively.
Innovation Solution
A high-pressure balloon with a single-layer balloon envelope made of polyamide 6.12, which allows for a thinner wall thickness and improved fatigue resistance, enabling better trackability and integration with catheter components without the need for coextrusion or telescoping, and can be produced using conventional balloon forming systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If multi-layer balloon structures are used to increase burst pressure, then burst pressure resistance is improved, but wall thickness increases and deliverability worsens
Solution Approach 1:
The patent employs polyamide 6.12 as a composite material that combines high strength properties with thin wall capability. This single-layer composite material achieves the required burst pressure resistance (RBP > 20 bar) while maintaining a thin wall structure that enables good deliverability, eliminating the need for multi-layer constructions.
Solution Approach 2:
The patent changes the material parameter from conventional polyamide 12 to polyamide 6.12, which has superior mechanical properties. This parameter change allows the balloon to achieve higher burst pressure resistance with thinner walls, directly resolving the contradiction between strength and wall thickness.
2Strength
If multi-layer balloon structures are used to increase burst pressure, then burst pressure resistance is improved, but production complexity increases
Solution Approach 1:
The patent extracts the need for multi-layer construction by using a single-layer polyamide 6.12 material that inherently provides the required strength. This eliminates the complex processes of coextrusion or telescoping multiple tubes, simplifying production while maintaining burst pressure resistance.
Solution Approach 2:
By using polyamide 6.12 as a high-performance composite material, the patent achieves the required mechanical strength in a single layer, eliminating the need for multi-layer composite structures and their associated complex manufacturing processes.
3Strength
If wall thickness is increased to improve burst pressure resistance, then burst pressure resistance is improved, but trackability and deliverability worsen
Solution Approach 1:
The patent changes the material parameter from polyamide 12 to polyamide 6.12, which has superior strength-to-thickness ratio. This allows the balloon to maintain thin walls (good trackability and deliverability) while achieving high burst pressure resistance through the enhanced material properties.
Solution Approach 2:
The use of polyamide 6.12 composite material provides exceptional mechanical properties that allow thin wall construction without compromising strength, thereby maintaining both good deliverability and high burst pressure resistance simultaneously.
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 polyamide 6.12 material achieves a Rated Burst Pressure above 20 bar with 20 cycles of fatigue resistance, allowing for a smaller diameter balloon suitable for small French sizes and improved deliverability, while maintaining high-pressure properties and ease of sterilization and welding to catheter components.
Implementation Method 1
The blank is subjected to stretching in the axial direction, e.g. B. by applying an axial stretching force to the extruded blank and by heating the extruded blank so that it can stretch in the axial direction
Implementation Method 2
the extruded blank is brought to a temperature in the range from 120 ° C to 160 ° C, in particular 140 ° C, and is expanded radially to the shape of the balloon envelope
Implementation Method 3
the balloon can be dilated by filling the interior with a fluid
Implementation Method 4
The balloon material polyamide 6.12 according to the invention advantageously enables the production of a high-pressure balloon with an RBP (Rated Burst Pressure), which is above 20 bar and has fatigue resistance (20 cycles) at RBP
Data Source
Figure 1~2
Figure 3
Figure 4
AI summary
The invention relates to a balloon (1) for a balloon catheter (2), wherein the balloon (1) has an inflatable, single-layer balloon shell (10) that surrounds an interior space (11) and is dilatable by filling the interior space (11) with a fluid (F). According to the invention, the balloon shell (10) is made of or comprises polyamide 6.12. The invention further relates to a balloon catheter and a method for manufacturing a balloon according to the invention.