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Solvay reports that its Ixef polyarylamide (PARA) resin delivered the high stiffness and biocompatibility that Reign Medical needed to develop its new Clench compression staple system, a single-use bone staple kit for orthopaedic procedures targeting the hand and foot.
The Clench Staple System kit comprises a disposable sterile surgical tool set for fixating hand and foot bone fragments, osteotomy fixation and joint arthrodesis. Its design utilises a patented threaded hub that allows surgeons to incrementally expand the implant for proper insertion, while retaining the mechanical properties of the Nitinol staples for continuous compression across the fusion site after implantation. Reign Medical specified Solvay’s Ixef GS-1022 PARA, a 50% glass fibre reinforced grade, for several components: the implant sizer, the drill guide and each part of the implant delivery instrument, including its handle, the saddle on which the staple sits, and the threaded compressor that forces the staples fully open.
The mechanical strain on these components requires them to be moulded from a very high-stiffness material, and the Ixef GS-1022 PARA compound proved to be the optimal solution. This biocompatible polymer is said to offering metal-like strength, rigidity and dimensional stability, as well as an exceptional surface finish. Available in a range of gamma-stabilised colours, Ixef PARA is optimised for sterilization using high-energy gamma radiation, showing no significant change in appearance or performance after sterilisation. The material has been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File.
“Our impetus for this kit was to develop a more robust, single-use bone fixation system than currently available,” states Daniel Lanois, Development Engineer for Reign Medical’s Clench Staple System. “Many competitive solutions use lower performing plastics that do not reliably withstand the force required to hold Nitinol staples open, causing the staples to disengage prematurely. After briefly considering polycarbonate and ABS blends, we chose Ixef PARA primarily for its outstanding stiffness, which enabled even the smaller components of the delivery tool to reliably withstand the compression of the staples as well as the torsional, tamping and axial loads applied during fixation procedures.”
“Solvay’s practice of open innovation promotes the success of customers like Reign Medical by enabling them to focus on their medical device design while we help navigate issues related to materials science and moulding challenges,” says Jeff Hrivnak, Business Manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “Solvay also conducted a crystallinity study of moulded prototypes of Clench system components to validate the tool and ensure that parts were moulded properly.”
The single-use Clench Staple System received FDA clearance in April this year. The company is now undergoing the beta test for its first production launch.
Image provided by Solvay
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