Leak testing compliant materials, such as balloon catheters, presents a unique challenge: the part volume expands under pressure. This shifting volume alters the pressure decay characteristics, often leading to inconsistent results.
Zaxis saw an opportunity to do it differently.
Zaxis has been awarded a patent for a new volumetric leak testing system designed to bring greater precision and consistency to testing compliant and inflatable products, without relying on external compressed air.
A Controlled, Known-Volume Approach
At the core of this technology is a simple but powerful concept: instead of relying on facility air, the system generates pressure internally by displacing a known volume within a sealed chamber.
We utilize a volumetric test method to solve the inherent challenges of testing compliant materials. Unlike house air, which can cause indefinite expansion and risk destroying the part, this method delivers a precise, known volume to reach the target pressure. This controlled approach ensures the material reaches a physical equilibrium, facilitating a stable and repeatable pressure decay test.
This controlled approach enables a wide range of test methods, including:
- Pressure decay, vacuum decay
- Volume change analysis
- Check valve opening pressure (with peak hold)
- Specification verification and validation
Why It Matters for Compliant Materials
Compliant products like balloon catheters don’t always behave well under traditional pressure-based testing. Small variations in input pressure can lead to inconsistent or misleading results.
By working from a known volume instead of an external air source, this system provides:
- Greater repeatability
- Improved sensitivity to small leaks
- More consistent test conditions
- Reduced dependency on facility infrastructure
The result is a more stable and reliable testing process, especially critical in medical device manufacturing.
Designed for Balloon Catheters and Beyond
While this technology is particularly well-suited for balloon catheter testing, its flexibility extends to a wide range of applications.
It can be used to test:
1. Inflatable & Highly Compliant Products
Ideal for materials that stretch, creep, or expand under load.
- Medical: Angioplasty balloons, stent delivery systems, and endotracheal tube (ETT) cuffs.
- Consumer/Industrial: Inflatable life vests (PFDs), blood pressure cuffs, and athletic balls/bladders.
- Flexible Packaging: IV bags, saline pouches, and sterile blister packs that may “pillow” during testing.
2. Flow Control & Pressure-Sensitive Devices
Ideal for components that open, close, or regulate flow at specific thresholds.
- Medical: One-way check valves, IV drip sets, and needle-free access sites (luer-activated valves).
- Industrial: Pressure relief valves (PRVs), pneumatic actuators, and fuel system breathers.
- Automotive: Fuel injectors, spray nozzles, and venting caps.
3. Ingress & Egress Testing (Sealed Units)
Ideal for parts that must keep fluids out or internal pressure in.
- Consumer Electronics: Smartwatches, smartphones, and action cameras (IP67/IP68 validation).
- Sensors: Automotive pressure sensors, LiDAR housings, and industrial flow meters.
- Wearables: Hearing aids, glucose monitors, and fitness trackers.
4. Sealed & Non-Flexible Components
Ideal for small-volume parts where even a tiny air surge could cause damage.
- Electronics: Fully encapsulated PCB housings, micro-relays, and hermetically sealed battery packs.
- Aerospace: Small-scale hydraulic manifolds, avionics enclosures, and fuel line connectors.
- Diagnostics: Microfluidic cartridges and lab-on-a-chip devices.
Self-Contained, More Capable Testing
Because the system operates without house air, it offers a more self-contained solution that simplifies setup and reduces external variables. That means more consistent performance across different environments and easier integration into production lines.
Looking Ahead
This patented volumetric approach reflects our ongoing focus on solving real-world challenges in leak testing, particularly for applications where precision and reliability are critical.
If you’re currently testing compliant materials or balloon catheters and struggling with consistency, we’d be happy to show how this method can improve your process. Reach out to sales@zaxisinc.com.
If you are interested in diving deeper into the technology, you can view the full patent here.