Balloon Catheter Testing - Balloon Inflation Deflation Time
Balloon Inflation Deflation Time

 

 

 

 

 

 

 

Balloon Catheter Testing: Measured parameters

  • Balloon fatigue assessment
  • Inflation and deflation time
  • Rate burst pressure
  • Balloon compliance
  • Pressurized Water Leak Test
  • Pressurized Air Leak Test
  • Catheter Bond Strength
  • Catheter Torsion Bond Strength
  • Balloon corrosion
  • Balloon Dimensional characterization

Balloon Catheter Testing: Scope


  • Angioplasty balloon catheters
  • PTA, PTCA balloon catheters
  • Any interventional systems with balloon technology
  • Any delivery system with balloon technology

Balloon Catheter Testing: Associated tests

  • Acute particulate evaluation
  • Radiopacity
  • Optical Inspection
  • Any balloon expandable stent performance tests

Test Method Description

Balloon Catheter Testing: Fatigue assessment

Balloons must withstand multiple inflations during clinical use to avoid inducing device failure or vessel damage. Tested balloons with mounted stents that are not constrained by any test fixture are inflated in incremental steps to defined target pressure. Pressure is held for a specific interval of time. Balloons are repeatedly deflated and inflated to the target pressure for a total of multiple cycles. Any loss of pressure, due to failure of the balloon, shaft, or proximal or distal seals is reported as a test failure. The test is performed with an automatic inflation/deflation system.

Balloon Catheter Testing: Inflation and deflation time

The time to inflate each balloon catheter to a predefined target pressure is measured. The pressure signal is recorded at a sampling frequency of 1000 Hz and is used to estimate the inflation time. Using the same test method, the time to deflate each balloon catheter from a predefined target pressure to 0+/- 0.1 bar is measured. Between the inflation and deflation phase, the target pressure is held constant for a specific interval of time. The test is performed with an automatic inflation/deflation system.

Balloon Catheter Testing: Rate burst pressure

The rated burst pressure (RBP) is the pressure at which 99.9% of balloons can survive with 95% confidence. Failure of a balloon to maintain integrity at the RBP could result in device failure or vessel damage. The test is performed with an automatic inflation/deflation system.

Balloon Catheter Testing: Balloon compliance

A compliance chart that correlate balloon diameter to balloon pressure is generated for the full range of recommended inflation diameters and product sizes. The compliance chart may include pressures up to (but not exceeding) 25% above the RBP. The test is performed with an automatic inflation/deflation system and a 5 micron precision optical microscope.

Balloon Catheter Testing: Pressurized Water Leak Test

Balloons are connected to a syringe and entire system subjected to hydraulic pressure with a small water volume up to 3 bar for 30 sec. The catheter is inspected for any presence of leaks. The test is performed with an automatic inflation/deflation system.

Balloon Catheter Testing: Pressurized Air Leak Test

Balloons are connected to a syringe and entire system subjected to small hydraulic depression. The syringe is visually inspected for any presence of air in it.

Balloon Catheter Testing: Bond Strength

Tensile test (uniaxial) to determine the bond strength at locations where adhesives, thermal fusion, or other joining methods are used for bonding components of the delivery system. All bonds must withstand tensile forces greater than those that may be experienced during clinical use.

Balloon Catheter Testing: Torsion Bond Strength

Tensile test (torque) to determine the bond strength at locations where adhesives, thermal fusion, or other joining methods are used for bonding components of the delivery system. All bonds must withstand tensile forces greater than those that may be experienced during clinical use.

Balloon Catheter Testing: Corrosion

The balloon catheter is immersed in a physiological saline solution for 5 hours then in boiling distilled or dionized water for 30 min. Samples are kept at 37°C for 48 hours before cooling down to room temperature. Test samples are visually inspected for traces of corrosion with an optical microscope in comparison to reference samples.

Balloon Catheter Testing: Dimensional characterization

The dimensions of the balloon catheter are measured as required in ISO 10555. A 5 micron precision optical microscope is used to perform the inspections