In the medical device field, data generation along with scientific documentation can be crucial to the development of your device when it comes to validation and optimizing your device. For angioplasty balloons, data is generated by conducting two types of testing that are used to measure a balloon’s physical attributes and performance; dimensional and burst testing. Dimensional testing is used to look at the physical attributes of a balloon such as the internal and outer wall diameter of a balloon tail, as well as the double wall thickness. While burst testing measures the rate of pressure a balloon can withstand. 

When performing dimensional testing, various tools are used to measure a balloon’s internal diameter, and micrometers are used to measure the double wall thickness. Measuring the internal diameter of a balloon helps identify the proper shaft to use for the specific catheter, while the double wall thickness tells us what profile to expect. A thicker balloon will generally have a larger profile. Additionally, sometimes customers have custom specifications that the balloon needs to meet, which require additional measurements such as the tail thickness or full balloon length. 

The other type of testing that is performed to better understand a balloon’s specifications is burst testing which measures the balloon's volume or amount  of pressure a balloon can hold. Burst testing can be done using various testing methods such as pressure testing and volume testing. This testing is done to ensure that the balloon meets specific performance requirements for specific applications. For example, doctors may need to know the amount of pressure it takes to inflate to a certain diameter size for a specific procedure. The type of balloon determines the type of burst testing that is performed. Nylon and PEBAX balloons usually require pressure tests because they can hold higher pressures, vs Pellethane balloons that burst at really low levels, which is why volume testing is done. 

Understanding the physical and performance attributes of a balloon are crucial to balloon catheter applications and procedures, as each one may require different specifications. It is during the recipe development phase, in which testing of the balloons is conducted. This is especially important for manufacturing engineers to know what they need to change in order to get the desired balloon outputs. Testing also provides essential data Poba needs in order to keep improving it’s balloon formulas and calculations.  

Here at Poba we provide full testing documentation for each balloon project that includes the dimensional and functional performance of the balloon. By using top of the line equipment such as Crescent Designs Hydraulic Burst and Leak tester we are able to provide accurate data to ensure top quality and that each balloon meets customer requirements.