Saint-Gobain Seals Group Provides Sustainable Solution for Handheld Surgical Tool with FDA Compliant Rulon Polymer Material
Saint-Gobain Seals Group continues to provide sustainable solutions for handheld surgical power tools in the medical and dental fields as a key supplier of Rulon components in harmonic scalpel surgical tooling. Harmonic scalpels use ultrasonic technology to simultaneously cut and coagulate tissue and are utilised as an alternative to metal scalpels and electro-surgical devices. Benefits of the harmonic scalpel include greater precision, fewer instrument changes, the ability to cut through thicker tissue with more efficiency and an improved field of view due to the reduced amount of smoke created by the system.
The Seals Group’s Rulon product is a fluoropolymer based material with low frictional properties and superior resistance to high service temperatures, which are notable advantages during use of the harmonic scalpel. Rulon materials appropriate for this application can withstand temperatures up to 550°F (288°C), making them ideally suited for steam autoclaving. Depending on the application conditions, eight Rulon materials are available that are either FDA compliant (Title 21 CFR §177.1550), USP Class VI certified, and/or EU 1935/2004 and 10/2011 compliant.
Aside from contributing to the precision and efficiency of the harmonic scalpel, the Seals Group has also provided other sustainable polymer solutions in the Life Sciences industry through its Meldin 7000 and Meldin HT product lines that are suitable for gamma and e-beam sterilization. Another example of a surgical tool application is the use of their OmniSeal spring-energised seals and Meldin injection moulded PEEK bearings in a groundbreaking powered stapling system, the only full-powered, reusable, battery operated endoscopic stapler in the world. As a trusted manufacturing partner in the Life Sciences market for over 30 years, their sealing and polymer designs address critical sealing, friction control, chemical compatibility, material compliance and weight reduction.
In addition to the above product lines, the Seals Group’s product offering includes Fluoroloy material, consisting of a family of proprietary materials that are composed primarily of polytetrafluoroethylene (PTFE) based resins (similar to Rulon), and developed to perform in the most diverse and extreme applications for various markets such as Life Sciences, Aerospace, Oil & Gas and Automotive. There are more than 100 standard Fluoroloy and Rulon grades available, several of which are FDA compliant and USP Class VI certified, making them well suited for medical and analytical equipment applications.