Ranier Technology Ltd – titanium is ideal solution
Ranier Technology is a Cambridge based medical device development company that makes world leading spinal disc implants. The Ranier™ Distractor is the instrument used at all stages of Total Disc Replacement (TDR) procedures involving their revolutionary Cadisc™-L implant. This highly innovative instrument provides a working channel to safely and accurately implant the replacement discs, whilst also protecting and retracting the surrounding anatomy of the patient.
A complete Distractor instrument is assembled from a number of complex parts. Conforming to precise dimensional parameters and made of biocompatible materials, the Distractor has to meet the needs of the medical profession and regulatory controls. Ranier approached 3T to work on the manufacture of this sophisticated instrument which presented a number of manufacturing challenges.
Timely and cost effective manufacture of the Distractor via metal additive manufacturing (AM) requiring no significant machine set-up or expensive tooling.
Ranier investigated a number of production methods and materials. Additive manufacturing (also known as DMLS) was determined to be the ideal production method as it did not constrain the design allowing complex features and geometries – unlike traditional manufacturing techniques. The development of this complex instrument, which has been designed to exploit the benefits of AM, has resulted in the combining of several components into one production part.
The product development cycle itself required a number of iterations to ensure the optimum design outcome, so that batches of Distractor components can be built in a minimum number of manufacturing operations. AM offered the best manufacturing option to reduce both time and the overall cost.
The titanium alloy Ti6Al4V, referred to as Ti64, was suggested by 3T as the ideal alternative for the carbon fibre / stainless steel parts used in the early iterations of the Distractor because Ti64 is a material which is already commonly used for medical applications. It meets the needs of the clinical environment (biocompatibility, repeated sterilisation without degradation, and a high strength to weight ratio), and 3T is the only UK based company to have commissioned a system specifically for production of Ti64 parts conforming to the requirements of ISO 13485. Furthermore, the additive manufacturing process reduces material waste during manufacture which means that titanium remained an economically viable option for Ranier.
3T has enabled Ranier to produce instrumentation with geometries resulting in a superior product that has been delivered to the market place faster than the conventional route would have allowed. The manufacture of the single piece parts via the AM process has not only reduced the number of subsequent assembly operations to produce the Ranier™ Distractor, but has also significantly improved the ease of cleaning the instrument in use. Ultimately, the new Distractor from Ranier Technology gives surgeons the paramount levels of accuracy and control needed when undertaking complex and delicate spinal surgery.
Jonathan Lawson, Development Engineer at Ranier said, “3T were the only company in the UK that could provide DMLS titanium parts and the associated paperwork necessary to fulfil the requirements of the heavily regulated medical industry.” He added: “The use of DMLS has given Ranier Technology a strategic advantage.”
The parts were polished using the Micro Machining Process (MMP) at First Surface. The parts needed to have a highly polished surface without being highly reflective, and the ability of MMP to achieve this on the additive manufactured parts, and without any subsequent surface treatments, was key to Ranier’s delivery requirements.
CADISC™ and RANIER™ are registered trademarks of Ranier Limited in the E.U., U.S. and other countries. The Cadisc™ technology is covered by EP Patent No. 1305155 and additional patents pending in Europe, U.S. and other countries. The Ranier™ Distractor is covered by patents pending in Europe, U.S. and other countries. Images of the Ranier™ Distractor are copyright Ranier Technology Limited and are used with permission.