The HP PTA balloon dilation catheter is a type of medical device used in the treatment of vascular diseases, particularly upper digestive tract strictures. It is composed of a balloon, dilation tube, catheter seat, and guide wire, and is designed to dilate or expand narrowed or blocked blood vessels in the body.

In terms of physical properties testing, peak tension is an important parameter that measures the maximum force or load capacity that the catheter can withstand before it breaks or fails. This test is typically performed by gradually applying force to the catheter until it reaches its maximum load capacity. The results of this test are used to determine the catheter's strength and durability.

Another important test is liquid leakage, which measures the catheter's ability to prevent fluids from leaking out. This test is typically performed by filling the catheter with a liquid, such as water or saline solution, and then monitoring it for leaks over a specified period of time. The results of this test are used to determine the catheter's reliability and effectiveness in medical procedures.

Overall, proper testing of the HP PTA balloon dilation catheter is essential to ensure its safety and effectiveness in clinical use.

Here is the content:

• Leak detection under pressure

• Peak tension

Leak detection under pressure

In this test, the catheter is connected to the syringe through leak-proof connection, and a certain amount of water pressure is applied to the assembly of the catheter and catheter seat (if any) and the catheter pipeline to check whether there is leakage. LEAK-L1 leakage and sealing strength tester is selected for this test, and the principle of positive pressure method is adopted, and the pressure of at least 300kPa is applied. Maintain this pressure for 30s. Check the liquid leakage at the catheter/seat assembly (if any) and the catheter pipeline, for example, forming one or more droplets, and recording whether there is any leakage. The instrument adopts a large LCD touch screen display, and the high-precision pressure sensor ensures the accuracy of the test results. It can measure various pressures at one time, and quickly evaluate the overall sealing effect of the product and whether it leaks.

Peak tension

The peak tensile force includes the peak tensile force of each section of the catheter and the joint between the catheter and the seat and the tensile strength of the tip. Although YY0285.1 standard does not require products below 0.55mm, it does not mean that the risk is not evaluated in the performance study. In this test, we use MTL-01 intelligent electronic tensile testing machine to conduct the test, which meets the test method requirements of YY0285 General Requirements for Sterile Endovascular Catheters for One-time Use. Prepare the sample and stretch it at the unit strain rate of 20mm/min, until the test section is separated into two or more sections. Make multiple verifications and get the results.

KOSSEL is a leading enterprise in the aortic field, and the company is also actively deploying in the field of peripheral vascular intervention. The industry believes that it has great potential in the future. The company's HP PTA balloon dilation catheter are mainly used to treat restenosis after peripheral vascular diseases, reduce the incidence of restrictive dissection and improve the patency rate of lumen. The performance of the product is directly the benchmark product in the market, and it is expected to become another support in the peripheral arterial products of the company after listing. In the future, the company also has a new generation of drug balloon dilatation catheter in research, and the service layout is gradually improved.

In the future, it is believed that apart from the progress in materials science, the structural design of coronary balloon, including the ability to fold and hold back, the ability to pass through lesions and the ability to withstand high pressure, can be improved through more research investment. It is also believed that the performance of domestic coronary balloon will be better and better, and it will meet the clinical needs more comprehensively.