Single-use disposable laparoscopic/endoscopic access ports and trocars are essential tools for many minimally invasive abdominal surgeries to permit access of various vision and surgical instruments – such as grippers, cutters, electrosurgical tissue sealers, dissection bags, etc.
Common trocars include bladed/bladeless trocars, dilating trocars, cutting trocars, optical trocars, pediatric trocars, disposable trocars, universal/disposable cannulas, optical access ports, working access ports, etc.
These devices, especially the aperture seal, must be leak tested, and often also blockage tested, to ensure effective function during the execution of surgical procedures.
Process Overview: Leak and Blockage Testing of Laparoscopy & Endoscopy Access Ports & Trocars
Testing of these types of assemblies often requires a multi-step process to detect both leaks and potential blockages. These tests are designed to catch any leaks that may be caused during the assembly process where various engineered slitted aperture seals exist, and have the potential to be damaged, mispositioned, or malformed during assembly.
For these types of parts, it is most often required to test 100% of parts in production. We typically suggest using dry compressed air mass flow methods, with testing pressures ranging from 10 - 20 mmHg or 0.2 – 0.4 psig (approximate typical laparoscopic insufflation pressure).
1. Sealing
First, the instrument must be mated to the cannula or sleeve by a strong and repeatable sealed connection with the instrument test port to ensure an accurate, reliable test result. At CTS, instruments are most often (optional) supplied with one of CTS’ specialized connectors designed for medical applications, including the CO31 or CO32 (dependent on trocar diameter) OD Connects controlled by the test instrument to ensure the tightest, most reliable seal.
2. Pressurization
The assembly is then pressurized with regulated compressed air for a user-defined Fill time. The pressure is measured by the test instrument’s pressure transducer and compared to min/max limits, enabling detection of improper pressure supply or gross leaks on the trocar 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 Exhaust time, the final variable test result data is displayed on the instrument. If it finds a Reject result, the test is halted and the operator receives the reject indication both on the display and front panel, as well as an audible alarm if desired. If it finds an Accept result, the instrument halts awaiting the operators next initiation of the start button.
The operator then opens the insufflation path to ATM, presses the start button again. The above process is then followed again to test for blockages, with the measurement stage used to determine whether partial blockages are present, typically in flow rate units of standard cubic centimeters per minute (sccm) or standard liters per minute (slm).
The operator then opens the insufflation path to ATM, presses the start button again. The above process is then followed again to test for blockages, with the measurement stage used to determine whether partial blockages are present, typically in flow rate units of standard cubic centimeters per minute (sccm) or standard liters per minute (slm).
For full details on this test process, read the application note ➡️
Using the Right Test Instruments for Leak and Blockage Testing of Laparoscopy & Endoscopy Access Ports & Trocars
CTS works with major medical manufacturers to accurately and reliably test medical devices such as catheters, tubing sets, and fluid bags for leaks and blockages. Our team prides itself on having extensive knowledge of regulations and industry-accepted equipment testing guidelines for medical device testing, including applications, process validation, data collection and storage, calibration, and test specifications. To meet the unique needs of our customers, we provide reliable medical device leak testers that can be configured based on your exact specifications and requirements, including benchtop setup, automated assembly operations, etc.
- Sentinel Blackbelt: The Sentinel Blackbelt is the industry’s most versatile single-channel, multi-port benchtop pressure decay & mass flow leak/blockage tester. A top choice for testing disposable medical devices in production cleanrooms or R&D labs. Learn more >
- Sentinel Blackbelt Pro: The Sentinel Blackbelt Pro is an advanced multi-channel test instrument for pressure decay & mass flow leak/blockage testing. This instrument offers the flexibility of a custom instrument in a standard instrument platform, including features that support 21 CFR Part 11 and EU Annex 11, making it an ideal choice for 100% production testing of higher throughput single-use disposable medical devices. Learn more >
- CTS Connect: CTS has designed its own high-quality seals and connectors specially for the needs of medical applications, including CTS Connect models CO31 or CO32. Browse CTS Connect built for your needs >
Looking for help with your medical leak and blockage testing? Contact the experts
at CTS!
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