Materials Transform Surgical Catheters, Enable Repeatable Tests in IVD Cartridges

Medical devices are becoming smaller and smaller, and the need for advanced material solutions keeps growing. There’s also a critical call for manufacturers to adhere to stringent regulations while improving device functionality. Through our deep understanding and application of fundamental chemistry, Chemours materials have emerged as effective alternatives — helping innovators in the medical industry achieve continued success across medical device design.

Meeting the Needs of the Medical Industry

The core characteristics of these materials enable greater performance in minimally invasive medical device applications. Some benefits include:

• Extremely high lubricity to enable easy transport of other devices through tight tolerances and tortuous anatomy.

• Processing flexibility that allows manufacturers to make a wide range of tubing dimensions without changing equipment.

• A dependable product that facilitates a consistent process for manufacturers.

• Materials that can withstand exposure to most solvents and other chemicals used in the manufacturing and sterilization process.

• Inert chemistry that minimizes interactions with the body and other materials.

Surgical Catheters: Putting Material Science to the Test

A European manufacturer shifted their catheter manufacturing production to Asia, and they needed to qualify a material for the new facility. The material had to have similar or better characteristics and quality as the fluoropolymer used at their existing site.

As they set out to identify the product and supplier for their new facility, the manufacturer partnered with the technology team at Chemours. We immersed ourselves in the manufacturer’s application and curing process and used this knowledge — along with our foundational chemistry expertise — to offer a polytetrafluoroethylene (PTFE) resin that both met regulation and performed extremely well in the customer’s process.

Teflon™ PTFE was selected as the single solution for their catheter liner offering. With a new resin, the manufacturer achieved better outcomes, including:

• Higher quality through a more consistent product.

• High lubricity and low coefficient of friction to maintain performance.

• Chemical and heat resistance that met material quality requirements.

• Globally reliable supply to meet customer orders with confidence.

IVD Cartridges: Consistent, Repeatable Tests

A market leader in diagnostics developed an in vitro diagnostic (IVD) system using a self-contained test cartridge. During development, they experienced two issues that led to testing process failures: 1) the syringe pump in their cartridge would fail by sticking at the bottom of the cylinder, and 2) the valve used to control the pumping of fluids would occasionally fail to actuate. In both cases, the friction levels in these mechanisms were too high. Our customer needed to lubricate both the pump and the valve to improve their cartridge and make their testing process consistent and repeatable.

The Challenge. To address the issue, the company was looking for a lubricant to reduce the force required to actuate both the pump and the valve. Given the location of the lubricant and the potential for contact with the sample, the lubricant also needed to be chemically inert to the sample, all cartridge materials, and testing reagents. The lubricant also needed high shelf stability to endure the many shipping and storage conditions associated with decentralized testing in both developed and developing economies.

The Solution. Working closely with the diagnostic company, Chemours’ technologists and technical team helped the customer evaluate different Krytox™ lubricants in their application. Based on the customer’s requirements, they offered a few lubricants that were most likely to succeed, and then worked with the customer to determine which lubricant performed best in their application. Subsequently, the customer qualified two Krytox™ lubricants in their product, helping to ensure security of supply through their growth phase.

Advantages in Diagnostic Applications. Krytox™ lubricants do not support microbial growth and are chemically inert to nearly all test reagents and analytes. These lubricants are compatible with a wide range of plastics and other cartridge materials and are thermally and oxidatively stable over long periods of time.

The Outcome. With Krytox™ lubricants in place, the customer’s equipment was able to run consistent, repeatable analysis. In addition to understanding the customer’s challenge, Chemours technologists and technical team used their experience and expertise to support the customer in improving their lubricant application process and building the needed in-house expertise. The team continues support by ensuring their in-house experience is sustainable and partnering with them as they uncover other challenges in their device development.

Solving Diagnostic Equipment Challenges. Reducing and eliminating process failures is critical to reducing regulatory risk in the product development cycle and maintaining user acceptance after commercialization. Although lubricants may not be the driving factor in diagnostic device design, proper lubrication is crucial to ensure a consistent, repeatable process. Chemours’ technical service team can help reduce the burden on our customers’ engineers through assistance in selecting and applying the right lubricant for the customers’ application. They are also available to help with training and troubleshooting as needed.

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