Balloon dilation catheter is a medical interventional device. It is commonly used balloon dilation catheter, mainly composed of a balloon, a dilation tube, a catheter base and a guidewire. Using a fast exchange balloon dilation catheter When treating vascular disease, a small hole is usually reserved around 25 cm of the catheter and balloon for use as replacement catheter and guidewire. The main function is the treatment of upper gastrointestinal stenosis and dilation. Balloon dilation catheter is crucial in medical use and is also a very important link in the detection of its physical performance. The main testing items include peak tension, liquid leakage, etc. Today we will learn more about it.
balloon dilation catheter
1. Peak tension
Peak tension includes two aspects: peak tension at each section of the catheter and the connection between the catheter and the seat and the tip tensile resistance. Although the YY0285.1 standard does not require products below 0.55mm, it does not mean that this risk is not evaluated in performance studies. In this test, we used the MTL-01 intelligent electronic tensile test machine to test, which complies with the test method requirements for breaking force and firmness in the general requirements of YY0285 single-use sterile intravascular catheter. Prepare the sample and stretch it at a unit strain rate of 20 mm/min until the test section is separated into two or more sections. Perform multiple verifications to obtain the results.
balloon dilation catheter peak tension
2. Liquid leakage
1. Leak detection under pressure
1. This test connects the catheter to the syringe through an anti-leak connection, and applies a certain amount of water pressure to the catheter and catheter seat assembly (if any) and in the catheter pipeline to check whether it is leak-proof. This test uses the LEAK-L1 leakage and sealing strength tester, and uses the positive pressure method to test the principle, and applies a pressure of at least 300kPa. Keep this pressure for 30s. Check for liquid leakage at the catheter/seat assembly (if any) and catheter line, for example, forming one or more droplets, and record whether any leakage occurs. The instrument uses a large LCD touch screen to display, and a high-precision pressure sensor ensures the accuracy of the test results. It can measure multiple pressures at a time, and quickly evaluate the overall sealing effect of the product and whether it is leaked.
LEAK-L1 Leak and Sealing Strength Tester
2. Leak at the assembly of the seat during suction
The detection method for this leakage is to connect the catheter seat to a partially filled syringe. Pull the core rod of the syringe to form a negative pressure at the connection between the seat and the standard cone head. Eye-check whether there are bubbles entering the syringe. The MFY-M3 sealing tester evacuated to the vacuum chamber , so that the sample immersed in water can generate an internal and external pressure difference, and observe the gases in the test sample or water seeping inward, thereby determining the sealing performance of the sample. The instrument's vacuum degree is automatically maintained, backblowing and unloading and automatic ending of tests. The test process is fully automatic and has a multi-stage vacuum gradient test mode to meet the GMP permission requirements.
MFY-M3 Sealing Tester
In the detection project of balloon dilation catheter, Jinan Milai Instrument has high measurement accuracy and high detection efficiency, and is an ideal solution for medical device detection.
