The aim of this work was to investigate of biocompatibility of polymeric implants modified with silver nanoparticles (AgNPs). Middle ear prostheses (otoimplants) made of the (poly)acrylonitrile butadiene styrene (ABS) and ABS modified with silver nanoparticles were prepared through extrusion and injection moulding process. The obtained prostheses were characterized by SEM-EDX, micro-CT and mechanical tests, confirming their proper shape, good AgNPs homogenization and mechanical parameters stability. The biocompatibility of the implants was evaluated in vivo on rats, after 4, 12, 24 and 48 weeks of implantation. The tissue-healing process and cytotoxicity of the implants were evaluated on the basis of microscopic observations of the materials morphology after histochemical staining with cytochrome c oxidase (OCC) and acid phosphatase (AP), as well as via micro-tomography (ex vivo). The in vivo studies confirmed biocompatibility of the implants in the surrounding tissue environment. Both the pure ABS and nanosilver-modified ABS implants exhibited a distinct decrease in the area of granulation tissue which was replaced with the regenerating muscle tissue. Moreover, a slightly smaller area of granulation tissue was observed in the surroundings of the silver-doped prosthesis than in the case of pure ABS prosthesis. The kinetics of silver ions releasing from implants was investigated by ICP-MS spectrometry. The measurement confirmed that concentration of the silver ions increased within the implant's immersion period. Our results showed that middle ear implant with the nanoscale modification is biocompatible and might be used in ossicular reconstruction.
Keywords: biocompatibility; medical devices; middle ear prosthesis; nanocomposites; silver nanoparticles; thermoplastic polymer.