The manufacture of balloons used for angioplasty catheters requires tubing that has more stringent requirements than those used for other applications, such as catheter bodies or strain relief.
To ensure the correct tube is selected, it is important to understand the balloon requirements and the balloon forming process. Continue reading to know more about medical balloon testing.
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Balloon catheter for angioplasty
Balloon catheters are used for plain old balloon angioplasty (POBA) and stent delivery and placement. The catheter is usually inserted into the femoral artery through a small introduction (eg, 5 or 6 Fr) and the balloon is placed in the narrow passageway in the stenosis. As a result, the balloon must have very thin walls, typically 0.001 in (25 m) in size.
However, because calcified stenosis can be difficult to open, the balloon must be rupturable and have a high burst pressure, with a pressure rating typically between 6 and 8 atm and a burst pressure rating in the 12 to 8 atm 20 atm range.
Some applications may be required, so balloon fatigue is also a factor. Finally, to avoid damage to the vessel walls caused by over-inflation, the balloon must have a diameter that is reliable throughout the balloon at nominal pressure.
They should also only be semi-compatible (e.g. a limited increase above the pressure rating in the 5-10% range from the pressure rating to the burst pressure rating). To make a balloon with these properties, a high-quality tube with the same properties is a prerequisite.