42 Technology designs novel surgical toolset for TiGenix
The central device – a disposable applicator – will be used to deliver resorbable biomaterial implants into circular cavities that have been prepared to remove damaged cartilage or an underlying bone defect. The biomaterial has been specifically developed by TiGenix to stimulate rapid regenerative repair of damaged joint surfaces.
One of the key challenges for 42 Technology’s engineering team was to develop a simple, easy-to-manufacture applicator that compresses and delivers a cylindrical implant of the porous, elastic material. The applicator – manufactured from six moulded components to allow the maximum number of common components to be shared between different size applicators – has been designed with a flexible, selfaligning plunger incorporating a series of ‘fingers’ and guide rings to gently compress the hydrated plug. Once the trigger is activated, the spring plunger retains the hydrated material in the site as the device is withdrawn where it expands to fill the cavity.
The consultancy helped design, prototype and prepare documentation to support a CE mark approval for the new applicator, as well as developing a site preparation kit for use during the initial surgical procedure. The site preparation kit includes a circular cutting tube and a fluted drill bit to penetrate to pre-determined depths, while at the same time removing all bone fragments from the cavity.
“We have worked with other Cambridge-based consultancies and found 42 Technology to be our ideal partner. The team combined good engineering analysis, problem solving and project management to deliver a great solution, on time and to budget. In addition, they helped with manufacturing scale-up and preparation of documents for regulatory approval enabling us to move quickly towards more extensive trials and market launch of our unique biocompatible implant material,”
Tim Mead, head of product and process development at Cambridge-based OrthoMimetics, which was acquired by TiGenix in December 2009.