Zusammenfassung
Ziel
Ziel dieser Arbeit ist es, zu klären, ob in Reintitan oder in Titanlegierungen allergieauslösende Bestandteile nachweisbar sind.
Material und Methode
Es wurden von 5 internationalen Titanherstellern Rundscheiben zwischen 6 und 60 mm Durchmesser und 6 mm Dicke aus Reintitan, TiAl6Nb7 und TiAl6V4 einer Spektralanalyse unterzogen.
Ergebnisse
In allen Proben der Implantatwerkstoffe waren mit 0,012–0,034 Gew.-% geringe Nickelgehalte nachweisbar. Jodidtitan stellt mit 0,002 Gew.-% die Nachweisgrenze dar und ist somit als nickelfrei zu bezeichnen.
Schlussfolgerung
In allen Proben der Implantatwerkstoffe war Nickel nachweisbar. Diese niedrigen Gehalte an Nickel sind herstellungsprozessbedingt und vollständig im Gitter des Titans gelöst; sie könnten aber bei Patienten mit Nickelallergie ausreichen, um eine allergische Reaktion auszulösen. Diese wäre dann aber nicht direkt dem Titan oder seinen Legierungen, sondern der Nickelverunreinigung zuzuordnen. Weitere Untersuchungen über die Freisetzung der Legierungskomponenten und Reaktionsschwellen von Patienten sind erforderlich sowie—von Metallherstellerseite—zu alternativen Prozessen, um Reintitan und Titanlegierungen noch reiner bzw. nickelfrei herzustellen.
Abstract
Aim
The aim of this investigation is to evaluate the allergic potential of titanium and titanium alloys for surgical implant applications.
Materials and methods
Discs cut from rods supplied by five different titanium suppliers in several diameters were investigated. The samples were cp-Titanium as well as Ti6Al4 V and Ti6Al7Nb, 6 mm thick with a diameter of between 6 and 60 mm. The material was checked by optical spectral analysis.
Results
In all samples except iodidtitanium, a Nickel content of 0.012—0,034 wt% could be detected.
Conclusion
The low nickel content in the implant material results from the production process. The nickel atoms are in solid solution in the titanium lattice. Nickel allergic patients may develop hypersensitivity reactions even due to this low nickel content. Hence, this reaction may be falsely attributed to the titanium material itself. Measurements of ion concentration in the body are helpful for quantifying the maximum content of nickel in titanium materials for surgical implant applications. In addition, technical questions related to the production of nickel free titanium materials for allergic patients have to be solved.
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ASTM F 1813: Specification for wrought titanium-12molybdenum-6zirconium-2iron alloy for surgical implant applications
ASTM F 2066: Specification for wrought titanium-15molybdenum alloy for surgical implant applications
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Schuh, A., Thomas, P., Kachler, W. et al. Das Allergiepotenzial von Implantatwerkstoffen auf Titanbasis. Orthopäde 34, 327–333 (2005). https://doi.org/10.1007/s00132-005-0764-2
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DOI: https://doi.org/10.1007/s00132-005-0764-2