Performance of functionally graded implants of polylactides and calcium phosphate/calcium carbonate in an ovine model for computer assisted craniectomy and cranioplasty.

Biodegradable functionally graded skull implants on the basis of polylactides and calcium phosphate/calcium carbonate were prepared in an individual mould using a combination of different processing techniques. A geometrically corresponding resection template was designed to enable a craniectomy and cranioplasty with the prepared implant in the same operation. After various preliminary experiments concerning degradation kinetics, pH evolution during degradation, micromorphology, biocompatibility tests in human osteoblast cell cultures and surgery of cadaver heads, a new large-animal model was developed for long-term in vivo studies. In eight 12-months-old sheep, the surgical templates were used to create 4.5 x 5 cm(2) calvarial defects which were then filled with the corresponding degradable implants in the same operation. The animals were sacrificed after 2, 9, 12 and 18 months, and the implants and the surrounding tissues were analysed by computer tomography (CT), macroscopic examination and microscopy. The new animal model proved to be reliable and very suitable for large individual craniectomies and cranioplasties. The formation of new bone from the dural layer of the meninges corresponded well to the degradation of the porous inner layer of the implants whereas the skull contour was stabilised by the compact outer layer over the follow-up period.

Datamining methodology for LC-MALDI-MS based peptide profiling.

This report will provide a brief overview of the application of data mining in proteomic peptide profiling used for medical biomarker research. Mass spectrometry based profiling of peptides and proteins is frequently used to distinguish disease from non-disease groups and to monitor and predict drug effects. It has the promising potential to enter clinical laboratories as a general purpose diagnostic tool. Data mining methodologies support biomedical science to manage the vast data sets obtained from these instrumentations. Here we will review the typical workflow of peptide profiling, together with typical data mining methodology. Mass spectrometric experiments in peptidomics raise numerous questions in the fields of signal processing, statistics, experimental design and discriminant analysis.

Carbonated calcium phosphates are suitable pH-stabilising fillers for biodegradable polyesters.

Carbonated amorphous calcium phosphates were prepared with different carbonate content. Their ability to neutralise acidity was probed by time-resolved titration experiments with lactic acid, the monomer that results from degradation of polylactide. The results show that although calcium phosphate as such can reduce acidity, their buffering range lies at a pH of about 4, i.e. outside the physiological range. This is not related to the rate of dissolution. Carbonated calcium phosphates as well as calcium carbonate (calcite) alone are able to keep the pH around 7.4. Consequently, carbonated calcium phosphates are suitable basic filler materials as they are able to compensate acidity, and to buffer within the physiological pH-range.

Geometrically structured implants for cranial reconstruction made of biodegradable polyesters and calcium phosphate/calcium carbonate.

The aim of this study was the development of a processing pathway for manufacturing of biodegradable skull implants with individual geometry. The implants on the basis of polylactide and calcium phosphate/calcium carbonate were prepared by a combination of hot pressing and gas foaming. On the inside, the implant consists of a macroporous and faster degradable material (poly(D,L-lactide)+CaCO3) to allow the ingrowth of bone cells. The pore size is in the range of 200-400 microm. On the outside, the implant consists of a compact and slower biodegradable material (poly(L-lactide) and calcium phosphate) to ensure mechanical stability and protection. To overcome problems like inflammatory reactions caused by acidic degradation products of polylactide, the polyester was combined with basic filling materials (calcium salts). The filler neutralises the lactic acid produced during polymer degradation and increases the bioactivity of the material. The stabilised pH was demonstrated by long-term in vitro pH studies. Over a time period of 250 d in demineralised water, the pH was in the physiological range. The in vitro biocompatibility was shown by cell cultures with human osteoblasts. A good proliferation of the cells was observed over the whole test period of 4 weeks.