BE-7598 Injection moulded, functionally graded ceramics for biomedical applications.
Co-ordinator:
Dr Naseem Theilgaard (Naseem.Theilgaard@teknologisk.dk)
Danish Technological Institute
Centre for Materials Technology - Medical Devices Technology Section
Gregersensvej Taastrup
Denmark 2630
Other partners:
- Biocomposites Ltd., GB
- Morgan Matroc Ltd, Rugby Division, GB
- IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY & MEDICINE, GB
- IRTEC-CNR, I
- FIN-CERAMICA FAENZA srl, I
Period: 01/07/1994-30/06/1998
Project summary: The main objective of this study is to design and
produce an innovative spinal spacer that will achieve sound mechanical and biological
fusion between adjacent vertebrae. The spacers have been designed to be inserted in pairs,
one on either side of the space created by disc excision. They will be located between the
vertebral bodies and designed to interlock with the vertebrae without catching on the
dura. They would be introduced posteriorally by retracting the nerve roots of the cauda
equina, carefully preserving the dura. This demands production of a complex shape
comprising a composite of bioactive and bioinert materials and will be achieved by the
adaptation of injection moulding technology of technical ceramic materials to produce
components with functionally graded properties. The technology developed can be thereafter
applied to other areas, both in the biomedical field as well as in the production of
technical ceramics.
Project achievements April 1999: A new and novel prototype
composite spinal spacer has been produced. Extensive in vitro evaluations of the
materials of the composite spacer have been carried out. In vivo tests of the
materials have been carried out in rabbits. Finite element work was carried out on various
designs of spinal spacers. The operative techniques and instrumentation for inserting the
spinal spacer have been defined. Materials and manufacturing technologies to produce the
proposed device have been identified. In vivo assessment of the prototype has been
carried out in a sheep model with very promising results. A patent application has been
filed on the device design.
   
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