Engineering and Manufacturing of a Dynamizable Fracture Fixation Device System
The present work illustrates the dynamization of an orthopaedic plate for internal fracture fixation which is thought to shorten healing times and enhance the quality of the new formed bone. The dynamization is performed wirelessly thanks to a magnetic coupling. The paper shows the peculiarities of...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2020-09-01
|
| Series: | Applied Sciences |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-3417/10/19/6844 |
| _version_ | 1797552300112216064 |
|---|---|
| author | Giancarlo Dichio Michele Calì Mara Terzini Giovanni Putame Elisabetta Maria Zanetti Piero Costa Alberto Luigi Audenino |
| author_facet | Giancarlo Dichio Michele Calì Mara Terzini Giovanni Putame Elisabetta Maria Zanetti Piero Costa Alberto Luigi Audenino |
| author_sort | Giancarlo Dichio |
| collection | DOAJ |
| description | The present work illustrates the dynamization of an orthopaedic plate for internal fracture fixation which is thought to shorten healing times and enhance the quality of the new formed bone. The dynamization is performed wirelessly thanks to a magnetic coupling. The paper shows the peculiarities of the design and manufacturing of this system: it involves two components, sliding with respect to each other with an uncertain coefficient of friction, and with a specific compounded geometry; there are stringent limits on component size, and on the required activation energy. Finally, the device belongs to medical devices and, as such, it must comply with the respective regulation (EU 2017/745, ASTM F382). The design of the dynamizable fracture fixation plate has required verifying the dynamic of the unlocking mechanism through the development of a parametric multibody model which has allowed us to fix the main design variables. As a second step, the fatigue strength of the device and the static strength of the whole bone-plate system was evaluated by finite element analysis. Both analyses have contributed to defining the final optimized geometry and the constitutive materials of the plate; finally, the respective working process was set up and its performance was tested experimentally on a reference fractured femur. As a result of these tests, the flexural stiffness of the bone-plate system resulted equal to 370 N/mm, while a maximum bending moment equal to 75.3 kN·mm can be withstood without plate failure. On the whole, the performance of this dynamic plate was proved to be equal or superior to those measured for static plates already on the market, with excellent clinical results. At the same time, pre-clinical tests will be an interesting step of the future research, for which more prototypes are now being produced. |
| first_indexed | 2024-03-10T15:58:04Z |
| format | Article |
| id | doaj.art-a7c6672e2af5430aae65147ffdec287b |
| institution | Directory Open Access Journal |
| issn | 2076-3417 |
| language | English |
| last_indexed | 2024-03-10T15:58:04Z |
| publishDate | 2020-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Applied Sciences |
| spelling | doaj.art-a7c6672e2af5430aae65147ffdec287b2023-11-20T15:31:25ZengMDPI AGApplied Sciences2076-34172020-09-011019684410.3390/app10196844Engineering and Manufacturing of a Dynamizable Fracture Fixation Device SystemGiancarlo Dichio0Michele Calì1Mara Terzini2Giovanni Putame3Elisabetta Maria Zanetti4Piero Costa5Alberto Luigi Audenino6Department of Mechanical and Aerospace Engineering (DIMEAS), Politecnico di Torino, 10129 Turin, ItalyDepartment of Electrical, Electronics and Computer Engineering (DIEEI), University of Catania, 95124 Catania, ItalyDepartment of Mechanical and Aerospace Engineering (DIMEAS), Politecnico di Torino, 10129 Turin, ItalyDepartment of Mechanical and Aerospace Engineering (DIMEAS), Politecnico di Torino, 10129 Turin, ItalyDepartment of Engineering, University of Perugia, 06125 Perugia, ItalyIntrauma S.p.A., 10098 Rivoli, ItalyDepartment of Mechanical and Aerospace Engineering (DIMEAS), Politecnico di Torino, 10129 Turin, ItalyThe present work illustrates the dynamization of an orthopaedic plate for internal fracture fixation which is thought to shorten healing times and enhance the quality of the new formed bone. The dynamization is performed wirelessly thanks to a magnetic coupling. The paper shows the peculiarities of the design and manufacturing of this system: it involves two components, sliding with respect to each other with an uncertain coefficient of friction, and with a specific compounded geometry; there are stringent limits on component size, and on the required activation energy. Finally, the device belongs to medical devices and, as such, it must comply with the respective regulation (EU 2017/745, ASTM F382). The design of the dynamizable fracture fixation plate has required verifying the dynamic of the unlocking mechanism through the development of a parametric multibody model which has allowed us to fix the main design variables. As a second step, the fatigue strength of the device and the static strength of the whole bone-plate system was evaluated by finite element analysis. Both analyses have contributed to defining the final optimized geometry and the constitutive materials of the plate; finally, the respective working process was set up and its performance was tested experimentally on a reference fractured femur. As a result of these tests, the flexural stiffness of the bone-plate system resulted equal to 370 N/mm, while a maximum bending moment equal to 75.3 kN·mm can be withstood without plate failure. On the whole, the performance of this dynamic plate was proved to be equal or superior to those measured for static plates already on the market, with excellent clinical results. At the same time, pre-clinical tests will be an interesting step of the future research, for which more prototypes are now being produced.https://www.mdpi.com/2076-3417/10/19/6844fracture synthesisinternal fixationstress analysisdynamizable platemechanical testsmedical device manufacturing |
| spellingShingle | Giancarlo Dichio Michele Calì Mara Terzini Giovanni Putame Elisabetta Maria Zanetti Piero Costa Alberto Luigi Audenino Engineering and Manufacturing of a Dynamizable Fracture Fixation Device System Applied Sciences fracture synthesis internal fixation stress analysis dynamizable plate mechanical tests medical device manufacturing |
| title | Engineering and Manufacturing of a Dynamizable Fracture Fixation Device System |
| title_full | Engineering and Manufacturing of a Dynamizable Fracture Fixation Device System |
| title_fullStr | Engineering and Manufacturing of a Dynamizable Fracture Fixation Device System |
| title_full_unstemmed | Engineering and Manufacturing of a Dynamizable Fracture Fixation Device System |
| title_short | Engineering and Manufacturing of a Dynamizable Fracture Fixation Device System |
| title_sort | engineering and manufacturing of a dynamizable fracture fixation device system |
| topic | fracture synthesis internal fixation stress analysis dynamizable plate mechanical tests medical device manufacturing |
| url | https://www.mdpi.com/2076-3417/10/19/6844 |
| work_keys_str_mv | AT giancarlodichio engineeringandmanufacturingofadynamizablefracturefixationdevicesystem AT michelecali engineeringandmanufacturingofadynamizablefracturefixationdevicesystem AT maraterzini engineeringandmanufacturingofadynamizablefracturefixationdevicesystem AT giovanniputame engineeringandmanufacturingofadynamizablefracturefixationdevicesystem AT elisabettamariazanetti engineeringandmanufacturingofadynamizablefracturefixationdevicesystem AT pierocosta engineeringandmanufacturingofadynamizablefracturefixationdevicesystem AT albertoluigiaudenino engineeringandmanufacturingofadynamizablefracturefixationdevicesystem |