Single-use disposable laparoscopic and endoscopic instruments have become mainstream surgical tools for use when performing minimally invasive surgical procedures.
These devices can be handheld and robotic, including staplers, clip appliers, suturing devices, cutters and shears, scissors, tissue dissectors, tissue sealers, forceps, graspers, retractors, retrieval bags, catch bags, and collection bags.
The design of these devices can pose challenges in leak testing, often containing complex articulations and networks of seals designed to prevent loss of insufflated gasses. Leak testing is conducted to ensure no gross leaks, and correct placement of each seal within the cannula of the instrument during the assembly process.
Process Overview: Leak Testing Laparoscopy and Endoscopy Instruments
Given the important role these devices play in surgical procedures, it is often required to test 100% of manufactured devices. Most of these assemblies require testing pressures ranging from 10 - 20 mmHg or 0.2 – 0.4 psig—the approximate typical laparoscopic insufflation pressure. This type of testing typically requires dry compressed air mass flow methods in order to maintain the test pressures required throughout the tests, delivering a constant resupply of test air required for repeatable testing.
- 1. Sealing
First, the distal or patient end of the medical instrument’s cannula is mated to the test port(s) of the leak test instrument. You must ensure you have a reliable connector for this process to ensure a tight, reliable connection. The cannula is sealed to atmosphere. - 2. Pressurization
The mass flow leak test cycle begins, pressurizing the cannula of the assembly with regulated compressed air for a user-defined Fill time. The pressure is measured by the leak test instrument’s pressure transducer and compared to min/max limits in order to detect improper pressure supply or massive leaks on the instrument assembly. - 3. Measurement
After the Fill timer expires, the source air is routed through the instrument’s mass flow transducer where actual flow (leak) through the part to atmosphere is recorded at the end of the user-defined Test time and compared to min/max flow limits to determine whether fine leaks are present, typically in leak rate units of standard cubic centimeters per minute (sccm). - 4. Exhaust
After the Test time, source pressure is disconnected from the mass flow measurement circuit. Any pressure trapped inside the assembly is vented to atmosphere for a user-defined Exhaust time. After Exhaust, the final test result data is displayed on the leak test instrument identifying whether the part under test has passed or failed. This part can then be moved down the production line or into a reject area.
For full details on this test process, read the application note ➡️
Medical Leak Test Equipment for Laparoscopy & Endoscopy Instruments
With over 40 years’ experience, CTS has worked with top medical manufacturers across the globe. CTS leak test solutions provide both the effective sealing and pressure sensitivity required to produce accurate, reliable leak test results in medical device testing applications. We understand there is no one-size-fits-all solution for medical device testing. Our team will work with you to identify your needs and design a leak test solution that best meets your needs.
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Sentinel Blackbelt: As the industry’s most versatile single-channel, multi-port sequential benchtop pressure decay, mass flow leak, and blockage tester, the Sentinel Blackbelt is a top choice for medical manufacturers testing disposable medical devices in industrial and medical lab settings. Learn more >>
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Sentinel Blackbelt Pro: The Sentinel Blackbelt Pro is an advanced multi-channel concurrent test instrument for leak, flow pressure, and vacuum testing, and offers the flexibility of a custom instrument in a standard instrument platform. It also supports 21 CFR Part 11 and EU Annex 11, making it an ideal choice for medical device leak testing. Learn more >>
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CTS Connects: CTS provides high-quality seals and connectors designed specifically for these medical applications, including the CTS Connect models CO31 or CO32. Find the CTS Connect for your specific needs >>
Looking for help with your medical device leak testing?
Contact the leak test experts at CTS!
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