Medical Balloon Heat-Setting to Prevent Fiber Braid Delamination
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Solution Overview
Problem
Medical balloons used in procedures like angioplasty often experience delamination of the fiber braid from the base balloon during heat sterilization, leading to reduced performance and increased risk of fluid leakage due to pocket formation, which affects the balloon's ability to maintain pressure and stability.
Innovation Solution
A composite expandable medical balloon is formed by heat-setting a base balloon made of elastomeric polymer with a fiber braid, where a thermoplastic layer is applied between the base balloon and the fiber braid to enhance adhesion, and the entire assembly is sterilized at elevated temperatures to minimize delamination and maintain dimensional stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If heat sterilization is performed on the composite balloon, then sterilization is achieved, but delamination of the fiber braid from the base balloon occurs
Solution Approach 1:
A thermoplastic adhesive layer is introduced as an intermediary between the base balloon and the fiber braid. This adhesive layer bonds to both surfaces and remains stable during heat sterilization, preventing delamination while allowing sterilization to proceed. The adhesive acts as a mediator that withstands the thermal stress without failing the bond.
Solution Approach 2:
The base balloon undergoes heat setting at specific temperatures (145-160°C) to stabilize its dimensional parameters before sterilization. This pre-conditioning of the base balloon's physical parameters reduces thermal shrinkage and stabilizes the structure during subsequent sterilization, preventing delamination.
2Reliability
If heat sterilization is performed on the composite balloon, then sterilization is achieved, but shrinkage of the balloon occurs
Solution Approach 1:
The base balloon is heat-set in advance at elevated temperatures (145-160°C) to pre-stabilize its dimensions before sterilization. This preliminary thermal treatment eliminates or minimizes subsequent shrinkage during sterilization by already relaxing the polymer chains and setting the dimensional parameters.
Solution Approach 2:
The heat setting process permanently changes the dimensional parameters of the base balloon by stabilizing the elastomeric polymer structure at the desired dimensions. This parameter stabilization prevents shrinkage during the subsequent sterilization process.
3Strength
If a fiber braid is added to the base balloon, then structural reinforcement is achieved, but adhesion between layers deteriorates
Solution Approach 1:
A thermoplastic adhesive layer is placed between the base balloon and the fiber braid to provide bonding. This adhesive layer chemically or physically bonds to both the elastomeric base balloon and the polymeric fiber braid, creating strong interlayer adhesion while allowing the fiber braid to provide structural reinforcement.
Solution Approach 2:
The balloon is constructed as a composite structure with an elastomeric base balloon, a thermoplastic adhesive layer, and a polymeric fiber braid. Each material is selected for its specific properties, and their combination creates a structure that combines flexibility, adhesion, and structural strength.
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 solution significantly reduces delamination and shrinkage of the balloon, maintaining structural integrity and burst pressure, thereby enhancing the performance and reliability of the medical balloon during procedures.
Implementation Method 1
the polymer material of the at least one first layer promotes adhesion between the base balloon and the fiber braid
Implementation Method 2
sterilizing the composite expandable medical balloon at a temperature of at least about 40° C or greater
Implementation Method 3
the base balloon has a first length prior to sterilizing the composite expandable medical balloon, the first length being defined between a distal end of the distal waist portion and a proximal end of the proximal waist portion; wherein the base balloon has a second length after sterilizing the composite expandable medical balloon
Data Source
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AI summary
Composite expandable medical balloons and methods for forming composite expandable medical balloons are disclosed. An example composite expandable medical balloon may include a base balloon. A fiber braid may be disposed along the base balloon. The base balloon may have a first length prior to heat sterilization of the composite expandable medical balloon, and a second length after heat sterilization of the composite expandable medical balloon. The second length may be at least 95% of the first length.