Balloon catheters are manufactured in our certified class 10,000 controlled environments. Most drawings and processes are already established for Nylon and PU balloons. Some designs are made using adhesive bonded components and some of them are designed to use heat bonds based on the products performance requirements.
Balloons have very unique requirements based on the specific products performance requirements.
Volume tested balloons are used using volume sources such as syringes and usually have a larger expansion ratios so the user can start with a small crossing profile and inflate the balloons to large sizes to fill the areas required such a a balloon to measure the size of a heart defect or to implant an expandable valve.
These balloons have unique expansions ratios (generally over 20% from its starting size up to 4000%) and can be adjusted based on the processing method for blowing or casting to minimize or maximize the tensile modulus of the balloons as needed in the procedure.
Pressure tested balloons are generally used during angioplasty procedures or procedures that require high pressures and low elongation.
Some customers generalize these balloons into two categories ( compliant and non-compliant). All balloons are compliant to some extent when using a variety of pressures which increases at body temperature.
Distension (balloon expansion) is generally measured using the OD of final size (generally the OD @ maximum rated pressure or burst) minus the OD of blown size divided by the OD of the blown size.
Burst pressures can be determined using stress analysis and material tensile stress calculations to determine the required wall thicknesses to withstand the inflation pressures based on families of stress levels.