A new collagen-based biomaterial is set to launch in Europe this year. It has been specifically developed by TiGenix to stimulate rapid regenerative repair of damaged joint surfaces.
One of the challenges for this biomaterial was creating a surgical applicator to deliver the resorbable scaffold into circular cavities that have been prepared to remove damaged cartilage or an underlying bone defect.
To solve this problem, 42Technology engineering team deveoped an easy-to-manufacture applicator that compresses and delivers a cylindrical implant of the porous material. It is created from six molded components that can be shared between different-sized applicators.
To operate, a flexible, self-aligning plunger incorporating a series of fingers and guide rings 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plug.Once the trigger is activated, the spring plunger retains the hydrated material in the site as the device is withdrawn where it expands to fill the cavity.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 predetermined depths, while at the same time removing all bone fragments from the cavity.