Addressing the Challenges of Film-Cast PTFE Liners

Overview

The document discusses the manufacturing processes and properties of PTFE (polytetrafluoroethylene) liners used in medical devices, particularly focusing on film-cast liners. It outlines three primary manufacturing methods: free-extrusion, extrusion over-the-wire (OTW), and film-cast.

Free-extrusion results in strong and rigid liners due to the molecular orientation of PTFE chains, while extrusion OTW leads to partial molecular orientation, yielding more flexible but slightly weaker liners. Film-cast liners, produced through a process that involves applying a PTFE dispersion onto a metal core wire followed by sintering, exhibit incredible flexibility due to the lack of molecular orientation. This flexibility makes them suitable for applications in small, complex, and highly tortuous vasculatures, such as those found below-the-knee and above-the-neck.

However, traditional film-cast liners face significant challenges, including susceptibility to surface imperfections and pinholes. These defects can compromise the mechanical performance and reliability of medical devices, leading to unpredictable burst strength and increased manufacturing costs. If imperfections are not detected early, they can result in scrapped devices after substantial resources have been invested.

In response to these challenges, Zeus, a company with nearly 60 years of experience in high-performance PTFE components, has developed a new proprietary film-cast process. This innovative approach aims to reduce surface imperfections and pinholes, resulting in the StreamLiner™ NG catheter liner. This new product promises enhanced flexibility, mechanical performance, and reliability, providing greater design freedom for engineers working on next-generation medical devices.

The document emphasizes Zeus's commitment to quality and innovation, highlighting their goal to improve the performance of film-cast liners while addressing the historical challenges associated with legacy products. By introducing the StreamLiner™ NG, Zeus aims to set a new standard in the industry, enabling engineers to create more effective and reliable medical devices.

Overall, the document provides a comprehensive overview of the evolution of PTFE liners, the challenges faced in their production, and the advancements made by Zeus to enhance the quality and performance of film-cast liners in medical applications.