The biocompatibility of hydroxylapatite-polyethylene composite implants (HAPEX, Smith and Nephew) was investigated in this study. Eleven middle ear prostheses, removed during revision surgery, have been examined by light microscopy, transmission electron microscopy and scanning electron microscopy. The results show that the middle ear prostheses become overgrown by fibrous tissue inside a thin epithelial layer. In some cases the prosthesis is covered by fibrous tissue without an outer layer of epithelial cells. No arguments have been found for the accumulation of macrophages and foreign body giant cells associated with a foreign body reaction to the material. Therefore, hydroxylapatite-polyethylene composite implants (HAPEX, Smith and Nephew) would seem to be very suitable for reconstructive middle ear surgery.
Inner ear pressure was measured in scala tympani with a micropipette during square wave pressure manipulation of the intracranial compartment and, subsequently, of the external ear canal (EEC) in the same guinea pig. As expected, the combination of the cochlear aqueduct and the inner ear behaves as a low-pass filtering system for intracranial pressure manipulation and as a complementary high-pass system for ear canal pressure manipulation. Time constants for pressure equalization were in the order of seconds and depended on the direction of flow through the cochlear aqueduct. Pressure equalization curves could not be fitted to a single exponential function; more complicated functions were needed for good fits, showing that the pressure equalization process is nonlinear. This means that the flow resistance of the cochlear aqueduct and/or the compliance of the cochlear windows is not constant, which is in accordance with a flow-direction dependent resistance of the cochlear aqueduct. An explanation for this can be found in the special structure of the periotic duct inside the aqueduct.
In this experimental animal study, a cartilage disk was interposed between a synthetic middle ear prosthesis and the tympanic membrane in guinea pigs to investigate its effect on the extrusion process of the implant. Two groups of guinea pigs were studied. One group consisted of animals in which the prosthesis was directly in contact with the tympanic membrane, and the other group consisted of animals in which a cartilage disk had been inserted between the head of the prosthesis and the tympanic membrane. Before histologic processing, in situ inspection was performed with an operating microscope. After fixation and embedding, light microscopic and transmission electron microscopic examination were performed. We studied the histopathologic aspects of the tympanic membrane with regard to the protrusion and extrusion processes of the middle ear implant. In this experimental model, protrusion and extrusion of a hydroxylapatite middle ear prosthesis was greatly reduced by interposition of a cartilage disk. Further clinical evaluation of these experimental results is needed in the human middle ear.
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