MgNd2 alloy in contact with nasal mucosa: an in vivo and in vitro approach.

Biodegradable and biocompatible magnesium alloys appear to be very promising not only for temporary clinical application but also for developing deformable and degradable medical implants. This study analyzes the in vivo degradation behavior and the impact on the paranasal sinuses of the highly ductile Mg-2 wt%Nd alloy (MgNd2) in order to provide a basis for a satisfying stent system for the therapy of a chronic sinusitis. Moreover, in vitro tests were carried out on primary porcine nasal epithelial cells (PNEC). For the in vivo tests, cylindrical MgNd2 specimens were implanted into the sinus' mucosa of minipigs. During and after a total period of 180 days the long-term biodegradation and biocompatibility properties after direct contact with the physiological tissue were analyzed. Biodegradation was investigated by measuring the mass and volume losses of the MgNd2 specimens as well as by performing element analyses to obtain information about the degradation layer. The influence on the surrounding tissue of paranasal sinuses was evaluated by endoscopic and histopathological examinations of the mucosa. Here, only a locally unspecific chronic infection was found. The degradation rate showed a maximum after 45 days postsurgery and was determined to decrease subsequently. In vitro experiments using PNEC showed adequate biocompatibility of MgNd2. This study demonstrates a good in vivo biocompatibility for MgNd2 in the system of paranasal sinuses and underlines the promising properties of alloy MgNd2 for biodegradable nasal stent applications.

In vivo degradation effects of alloy MgNd2 in contact with mucous tissue.

Magnesium alloys are currently being investigated for use as resorbable biomaterials. Various applications for magnesium based implant materials have already been presented. Currently, stents and structures that sustain diseased or narrowed vessels seem to be the most promising areas. This study focuses on the use of a magnesium fluoride (MgF2 ) coated magnesium neodymium based alloy (MgNd2 ) and its use as a postsurgery stent material to avoid proliferation in the sinus region. Simple cylindrical shaped specimens were sown to the sinus' mucosa of pigs and left in place for different periods of time to investigate the long-term corrosion resistance of the alloy and its coating during direct contact with physiological tissue. Investigations made within this study explicitly focused on the corrosive behavior of the alloy in the region of a physiological sinus. Thus, losses in mass and volume, and element analyses were considered to obtain information about the specimens' corrosion performance over time. Furthermore, micrographs support the alloy specific corrosion type analyses which focus on grain boundary effects. This study demonstrates the general in vivo applicability of fluoride coated MgNd2 . The progress of corrosion was determined to be adequate and homogeneous over a total period of 180 days.

Magnetic resonance imaging compatibility testing of the Clarion 1.2 cochlear implant.

OBJECTIVE: This study aimed to investigate the compatibility of the Clarion 1.2 magnet-containing cochlear implant with a 1.5-tesla (T) and 0.3-T magnetic resonance imager. BACKGROUND: Cochlear implants restore functional hearing to patients with sensorineural deafness. With the rapidly increasing number of patients with cochlear implants, there is a need to investigate the implant's magnetic resonance imaging (MRI) compatibility. METHODS: The authors tested the potential torque and force on the metallic components of the implant, heating of the implant and surrounding tissue, unintentional output, implant damage, and image distortion. Tests were performed in both a 1.5-T and 0.3-T MRI. RESULTS: The torque experienced by the implant in the 1.5-T MRI (0.19 nm) was large enough that it could potentially cause implant movement in some patients. An acceptable amount of torque (0.04 nm) was found in the 0.3-T MRI. Image distortion occurred in the area directly around the implant with a radius of up to 60 mm in the 1.5-T MRI and 100 mm in the 0.3-T MRI. In both MRI units, there was no detectable temperature increase or unintentional output. There was no implant damage except that with worst-case conditions, the internal magnet was demagnetized by 78.5% with the 1.5-T unit and 3.36% with the 0.3-T unit. CONCLUSIONS: The authors recommend patients with cochlear implants avoid imaging in a 1.5-T MRI. The results suggest that the 0.3-T MRI poses little or no risks to patients with cochlear implants.