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Mandibular magnetic distractor: preclinical validation

  • N. Kadlub
    Correspondence
    Corresponding author at: Service de Chirurgie Maxillo-faciale et chirurgie Plastique, 149 rue de Sèvres, 75015 Paris, France
    Affiliations
    Unit of maxillofacial and plastic surgery, Reference Center for Cleft and Facial Malformation, Necker Children Hospital, 149 rue de Sèvres, Paris, France

    University of Paris, Paris, France
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  • J. Dallard
    Affiliations
    IMSIA, ENSTA-Paris, Institute Polytechnique of Paris, 828 Boulevard des Maréchaux, Palaiseau, France
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  • N. Kogane
    Affiliations
    IMSIA, ENSTA-Paris, Institute Polytechnique of Paris, 828 Boulevard des Maréchaux, Palaiseau, France
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  • Eva Galliani
    Affiliations
    Unit of maxillofacial and plastic surgery, Reference Center for Cleft and Facial Malformation, Necker Children Hospital, 149 rue de Sèvres, Paris, France
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  • J. Boisson
    Affiliations
    IMSIA, ENSTA-Paris, Institute Polytechnique of Paris, 828 Boulevard des Maréchaux, Palaiseau, France
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Published:November 16, 2021DOI:https://doi.org/10.1016/j.bjoms.2021.11.008

      Abstract

      The feasibility of magnetic activation for mandibular distraction has been demonstrated previously. In this study, we developed a biocompatible device to evaluate the feasibility of distraction in cadaveric subjects and the functionality of the device in bench tests. To confirm, considering the dimension of the distractor, that the torque applied on the internal magnet would be sufficient to activate distraction osteogenesis we measured, for different distances, the transmitted torque between a magnet (internal and external). We evaluated the friction force of the device, and the resilience of the magnet to the sterilisation process. To confirm the feasibility of distraction with this device, we proceeded to cadaveric tests, and evaluated the satisfaction of four surgeons. The force applied to the moving plate was greater than 50 Newtons (N) with a friction coefficient of η = 0.2 . We determined a friction torque of 65.10-3 N.mm in the distractor mechanism and demonstrated that sterilisation did not alter the magnet. Mandibular distraction had been successfully achieved in cadaveric trials, and surgeons were satisfied. This new device could be implanted in human subjects, for clinical assay, after approval by the regulatory agencies. The use of this fully internalised device should improve patients’ comfort.

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      References

        • Goldstein R.Y.
        • Jordan C.J.
        • Mclaurin T.M.
        • et al.
        The evolution of the Ilizarov technique: part 2: the principles of distraction osteosynthesis.
        Bull Hospital Joint Dis. 2013; 71: 96-103
        • Gubin A.V.
        • Borzunov D.Y.
        • Marchenkova L.O.
        • et al.
        Contribution of G.A. Ilizarov to bone reconstruction: historical achievements and state of the art.
        Strategies Trauma Limb Reconstr. 2016; 11: 145-152
        • Winters R.
        • Tatum S.A.
        Craniofacial distraction osteogenesis.
        Facial Plastic Surg Clin North Am. 2014; 22: 653-664
        • Diner P.A.
        • Kollar E.M.
        • Martinez H.
        • et al.
        Intraoral distraction for mandibular lengthening: a technical innovation.
        J Craniomaxillofacial Surg. 1996; 24: 92-95
        • Diner P.A.
        • Tomat C.
        • Hamou C.
        • et al.
        Maxillary and mandibular distraction osteogenesis in growing patients: lessons learned after 14 years and update on indications.
        Ann R Autralas Coll Dent Surg. 2008; 19: 116-122
        • Verlinden C.R.
        • van de Vijfeijken S.E.
        • Jansma E.P.
        • et al.
        Complications of mandibular distraction osteogenesis for congenital deformities: a systematic review of the literature and proposal of a new classification for complications.
        Int J Oral Maxillofac Surg. 2015; 44: 37-43
        • Mofid M.M.
        • Inoue N.
        • Tufaro A.P.
        • et al.
        Spring-mediated mandibular distraction osteogenesis.
        J Craniofac Surg. 2003; 14: 756-762
        • Goldwasser B.R.
        • Papadaki M.E.
        • Kaban L.B.
        • et al.
        Automated continuous mandibular distraction osteogenesis: review of the literature.
        J Oral Maxillofac Surg. 2012; 70: 407-416
        • Goldwaser B.R.
        • Magill J.
        • Papadaki M.E.
        • et al.
        Continuous mandibular distraction osteogenesis: novel device and preliminary results in minipigs.
        J Oral Maxillofac Surg. 2013; 71: e168-e177
        • Aykan A.
        • Ugurlutan R.
        • Zor F.
        • et al.
        Mandibular distraction osteogenesis with newly designed electromechanical distractor.
        J Craniofac Surg. 2014; 25: 1519-1523
        • Paley D.
        PRECICE intramedullary limb lengthening system.
        Expert Rev Med Devices. 2015; 12: 231-249
        • Boisson J.
        • Strozyk H.
        • Diner P.
        • et al.
        Feasibility of magnetic activation of a maxillofacial distraction osteogenesis, design of a new device.
        J Craniomaxillofac Surg. 2016; 44: 684-688
      1. International Organization for Standardization. Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes, 3rd Ed. ISO 13485:2016 Geneva: ISO.

        • Jackson D.D.
        Maxwell equations, macroscopic electromagnetism, conservation laws.
        in: Classical Electrodynamics. 3rd ed. John Willey and Sons Inc, 1998: 237-240
      2. International Organization for Standardization. Medical Devices. Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. ISO 17665-1:2006 Geneva: ISO.

        • Ratner B.D.
        A perspective on titanium biocompatibility. In, Titanium in medicine.
        Springer. 2001; : 1-12
        • Jackson D.D.
        Magneto-Statics, Faraday’s law, quasi-static fields.
        in: Classical Electrodynamics. 3rd ed. John Willey and Sons Inc, 1998: 174-236
        • Debelmas A.
        • Picard A.
        • Kadlub N.
        • et al.
        Contribution of the periosteum to mandibular distraction.
        PLoS One. 2018; 28e0199116
        • Robinson R.C.
        • O’Neal P.J.
        • Robinson G.H.
        Mandibular distraction force: laboratory data and clinical correlation.
        J Oral Maxillofac Surg. 2001; 59: 539-544
      3. Harris RI, Speight J, Fuad RM, et al. Distraction device. WO 2008/003952 A1, World Intellectual Property Organization; 2008. Available at URL: https://patentimages.storage.googleapis.com/9f/9f/74/5bc73e34151aa4/WO2008003952A1.pdf (last accessed 14 April 2022).