Silicone medical balloon, as the core component of silicone medical balloon, plays an important role in vascular pre-dilation, shaping, and stent placement in angioplasty. Silicone medical balloons have high requirements for use and safety, and are required to maintain a certain shape under rated pressure without breaking, have sufficient elasticity to pass through curved blood vessels, and have sufficient rigidity to support the stent. At present, the success rate of balloon production is not high. The actual success rate of balloon production is only about 50%, decreasing as the length of the silicone medical balloon increases.
In addition to the tube blank itself, the reason for the low balloon forming rate is also closely related to the process technology. Generally speaking, before forming a new balloon, it takes many processes debugging, that is, trial and error, to find the right process. This traditional trial-and-error approach, especially for the production of balloons of various sizes, would be time-consuming and cost-intensive. These undoubtedly greatly increase the production cost of silicone medical balloons, which are ultimately reflected in clinical treatment costs. Therefore, the relationship between silicone medical balloon molding and the wall thickness of silicone medical balloons has important research value.
The study of the balloon forming process has always been a “black box” art. The balloon forming process is complex, and numerical simulation is difficult with the changes in process parameters such as temperature, stretching speed, and inflation pressure. At present, there are few reports on the numerical simulation of balloons forming at home and abroad. Only memory and Armstrong used ABAQUS finite element software to simulate the first stretch stage of balloon forming and then verified the correctness of the simulation by comparing the balloon forming process with the simulation process captured by high-speed cameras.
The numerical simulation method provides a new idea for studying the forming mechanism of silicone balloons, which can quickly determine the size of the tube blank and optimize the forming process parameters, instead of trial and error. Therefore, in order to overcome the disadvantages of the traditional trial and error method, promote the development of new balloons, and determine the appropriate process conditions for the balloon production process, the relationship between the forming process of silicone medical balloons and the wall thickness was studied by finite element numerical analysis.