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Non rejection bioreabsorbable scaffold for jaw implant, developed by Custom-Fit.

When dealing with a surgical implant, the first issue we are worried about is rejection, i.e. the mechanism with which our body refuses substances, or organs, that it recognizes as foreign. Even jaw implants have this problem. It becomes necessary to repair jaw bone defects due to trauma or illness, such as cancer therapy (Image #1).

The risk of rejection is normally lowered by using Autolog Bone Transplant or using a metal, normally titanium, which is usually well accepted by the human immunity system. But both Autolog Transplants and titanium scaffolds have drawbacks. The first being that they are very invasive and the second is that although the implant is part of the body for a long time there is still the possibility of rejection even after 20 years. The EU funded project Custom-Fit has been working on a solution to the rejection issue: a scaffold made using a brand new material which is bioreabsorbable, that is, once implanted, it is substituted by re-grown natural bone in 6-12 months. The Custom-Fit project is a technological research program involving 30 partners from 12 European countries. Its goal is the development a new manufacturing paradigm for producing personalised products, customised to the individual shape of the human body. This has been done by integrating Scanning Technologies, newly developed CAD systems (Computer Aided Design) and Rapid Manufacturing technologies, the so called ‘additive techniques, which build a object layer by layer, starting from a 3D design, adding material where needed instead of removing it where not. The mandible implant has been chosen as one of the test benches to try out this new manufacturing technology, together with knee implants, trans-femoral prosthesis, and two consumer goods, motorbike seats and motorbike helmets, products that are well suited to be customised to meet individual body shapes. The Custom-Fit way to manufacture a mandible implant takes advantage of the best available technologies in design, in material science and in manufacturing, thanks to the member partners of the Custom-Fit consortium. The process is the following (Image #2). The jaw bone geometry is studied through Computerised Tomography, CT images are then worked using specialised software (Mimics by Materialise) capable of extracting the jaw bone surface in a standard file format for later surface design which uses STL (Standard Triangulation Language). This is capable of distinguishing the damaged part of the bone from the healthy one. Then, a surface model of the implant, which has to replace the damaged bone part, is easily designed with a CAD system (3-matic, by Materialise in Germany) that allows the direct playing with facet models (STL-files) avoiding the conversion to CAD-surfaces, which normally requires a long computer processing time; this dramatically shortens the implant design phase. Here, engineers and surgeons work in collaboration to decide were to cut the jaw and consequently the size of the scaffold. The 3D model of the implant is then completed by adding the internal structure, i.e. adding porosity using more design software called Innerspace that was developed by the Custom-Fit partner, TNO, in the Netherlands. Finally the model is sliced ready to be manufactured on a special Rapid Manufacturing tool, capable of printing multi-material and porous objects, using high viscosity resins, the Inkjet Printing tool also developed by TNO. And one of the resins printable by IP is the bioreabsorbable resin developed by DSM, a German company and Custom-Fit partner, that is responsible for new material development. First samples have been successfully printed (Image #3). It will take years for the new scaffolds to be approved for implantation in human beings, but the approval procedure has now been started, with In-Vitro Cytoxicity tests. Several advantages will be brought about by bioreabsorbable scaffolds: no rejection of the foreign material, new bone will be able to grow over time (for children), further treatment like dental implants will remain possible and definitively the implant will not be a foreign object any more, but will be completely replaced by new natural bone. It is a revolution in implant surgery, Custom-Fit made the first step. ------------------------------------------------------------------------------------------------------------- Visit Custom-Fit at http://www.custom-fit.org/ About Custom-Fit: Custom-Fit is an industry led project to investigate the possibility of moving towards knowledge based manufacturing and customised production through integration of knowledge in Rapid Manufacturing, Information Technology and Material Science. Funded under the Sixth Framework Programme, the project involves 30 partners from around Europe. The aim is to create a fully integrated system for the design, production and supply of individualised products. It has targeted products for implementing the new technology, including motorcycle seats, helmets, implants and prosthesis. For all media enquiries, please contact: Suny Martínez AIJU Product Engineering Department - Laboratory Avda. de la Industria, 23 03440 IBI (Alicante) Spain Telephone number: +34 965554475 Fax number: +34 965554490 e-mail: customfit@aiju.info Website: www.customfit.org www.aiju.info

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