Abstract
Abstract New technologies are great opportunities for personalized medicine. Custom made implants can be very helpful for patients with severe bone defects or in case of bone tumor. Through the European Union it is regulated how many possibilities and restrictions all medical devices have. Because of critical vulnerabilities a new European Medical Device Regulation (MDR) was published in May 2017 and it will enter into force in May 2020. For the manufacturers of customized products it will change the documentation of the manufacturing and tracking of serious incidents. Patients with a pelvis defect of Paprosky IIb and higher can benefit from a custom made pelvis implant, because all planning steps according to biomechanic and bone contact to the implant can be designed and proofed during a reconstruction process. With regular modular implant systems, it probably can be a trial and error procedure during the surgery according to biomechanic and a stable position of the implant. Based on the 3D-Reconstruction of CT-Scans of a patient with a Paprosky 2b pelvis defect, a personalized acetabulum implant was designed. To maintain as much bone as possible, the implant was shaped to the remaining pelvic bone stock. Additive manufacturing gives the opportunity to produce custom made single items even in a quality that ful-fills the requirements of the MDR. Modern Selective Laser Melting (SLM) and Electron Beam melting (EBM) Systems are able to produce Titanium or CoCr parts in the ISO standards for Implants (ISO 5832 ff). In this study the process chain, starting from the reconstruction, to the design and the production of a custom made acetabulum cup was run through on an exemplary CTData of one patient. With this example, it was shown that it is possible, to establish a process, that is able to address surgical needs for patients that benefit from those techniques.
Highlights
New technologies are great opportunities for personalized medicine
Patients with a pelvis defect of Paprosky IIb and higher can benefit from a custom made pelvis implant, because all planning steps according to biomechanic and bone contact to the implant can be designed and proofed during a reconstruction process
To maintain as much bone as possible, the implant was shaped to the remaining pelvic bone stock
Summary
Aufgrund des Erreichens des hohen Lebensalters und den Wunsch auf erhaltene Mobilität, steigt diese Zahl von Jahr zu Jahr. Bei Revisionsendoprothesen kommt es wegen der individuell vorhandenen Knochensubstanz in manchen Fällen zu Schwierigkeiten bei dem Einsetzen von einer standardisierten Endoprothese. Bei einem Paprosky Defekt 2B oder höher kommt für den Patienten ein individuell hergestelltes Implantat in Frage [2]. Aufgrund der seit 2017 veröffentlichten neuen Medizinprodukteverordnung (MDR) verändert sich die Gesetzeslage in der europäischen Union für alle Medizinprodukte [3]. Mithilfe der MDR soll ein Überblick über die grundlegenden Veränderungen für die Hersteller von Medizinprodukte geschaffen und ein Prozess erarbeitet werden, der zeigt, wie eine individualisierte Hüftpfanne hergestellt werden kann. Die neuen Technologien, die unter den Begriff des Rapid Prototyping fallen, sind besonders für die personalisierte Medizintechnik geeignet. Development and manufacturing of a custom made implant regarding the new European Medical Device Regulation — 254
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