A. Undisz, Friedrich-Schiller-University, Jena, Germany; M. Rettenmayr, Friedrich-Schiller-University Jena, Jena, Germany; R. Moszner, Occlutech GmbH, Jena, Germany
The application of nearly equi-atomic Ni-Ti alloys for medical devices and implants has allowed for new implant designs and more reliable and risk-reduced surgery methods. In recent years a growing number of such devices is entering the medical implant market.Before new designs or materials of implants can be applied, the properties and the quality have to be investigated carefully. The fatigue behavior of implants that are subjected to dynamic deformation has to be critically assessed. As a consequence of the variety of new implant designs and categories, in many cases defined standard testing methods have not been worked out. The standard testing methods for existing devices and medical implants can only be applied partially.
In the present work, a new testing device for occlusion implants that are applied for surgical treatment of atrium septum defects (ASD) is presented. The testing device generates a dynamic loading characteristics that is aimed to approach the conditions in the human heart. Considering the long testing periods, the device is designed for parallel testing of up to 16 implants. Within the device the occlusion implants are kept in a saline solution at 37±1°C. The materials for constructing the testing device, the suitable mounting of the implants, the details of loading and deformation of the implants, the necessary testing environment and the integrated observation and documentation system of the testing device are described and discussed.
Summary: In the present work, a new testing device for occlusion implants that are applied for surgical treatment of atrium septum defects (ASD) is presented. The materials for constructing the testing device, the suitable mounting of the implants, the details of loading and deformation of the implants, the necessary testing environment and the integrated observation and documentation system of the testing device are described and discussed.