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International Journal of Bioprinting                         Efficacy of 3D-printed customized titanium implants




            Table 1. Chemical composition of Ti-6Al-4V alloy powder
             Element              H         C         O         N         Fe         Al        V        Ti
             Content (wt.%)     0.003      0.005     0.14      0.009      0.22      6.49      4.00      Bal

            for orthopedic internal fixation. Three-dimensional (3D)
            printing is a new rapid prototyping technology in the
            additive manufacturing (AM) industry. As an excellent
            biomaterial, Ti-6Al-4V alloys is frequently applied in
            metal 3D printing process in medical area. 3,4

               The application of 3D printing technology in
            orthopedics is rapidly progressing and mainly focuses
            on five aspects: 5-11  (i) preparation of lesion model and
            3D display of complex lesion structure, which would
            help  surgeons  improve  the  surgical  plan  and  enable
            better  preoperative  communication  with  the  patients;
            (ii) preparation of customized guide plates to assist the
            positioning during surgery, thereby reducing surgical
            trauma and saving the operation time; (iii) preparation   Figure 1. Morphology of Ti-6Al-4V alloy powders (scanning electron
            of customized protective gears and rehabilitation   microscope, 200× magnification).
            supplies, which would improve the outcome compared
            with traditional treatment such as cast immobilization;   2. Material and methods
            (iv) preparation of grafts implanted intraoperatively   2.1. Materials preparation
            in  patients  to  overcome  the  deficiencies  of  using   The Ti-6Al-4V spherical metal powder was produced
            volume-produced products; and (v) direct printing   with plasma rotating electrode process by Northwest
            of cell–material complexes, which would simplify   Institute for Nonferrous Metal Research, and the
            the construction process of engineered tissues and   chemical composition of Ti-6Al-4V alloy powder is listed
            organs. Among them, the application of 3D-printed   in Table 1. The Ti-6Al-4V powder was spherical and the
            orthopedic implants has been applied in the clinic,   particle size was in the range of 40–180 µm (Figure 1 and
            such as spinal fusion cages, acetabular cups, knee   Table 1).
            joints, etc. These 3D-printed implants have received
            certifications of Conformité Européenne (CE), Food   2.2. Establishing the technical path of 3D-printed
            and Drug Administration (FDA), and China Food and   customized titanium implants
            Drug  Administration  (CFDA).  As  of  2017,  more  than   We used Ti-6Al-4V spherical metal powder as raw
            one hundred thousand 3D-printed acetabular cups have   material and used selective  electron beam  melting
            been implanted in the clinical setting globally. However,   (SEBM), a  type of metal  3D  printing technology, to
            rare applications have been reported in ankle surgeries.  prepare titanium alloy implants. 17-19  The designed

               Foot and ankle disease is very common in orthopedics.   implant model  was  processed  into  a  layer  with a
            In surgery, it is often necessary to choose internal fixation   thickness of 70 μm, and then imported into the SEBM
            or bone grafting to maintain the anatomical position of the   machine (model Arcam A2, Arcam, Sweden). The main
            bone or joint. 12-16  Unfortunately, there are very few types   technical parameters are shown in Table 2. The baseplate
            of internal fixation available for surgeons to choose from.   used was a  stainless steel plate  with  the size of 210 ×
            They are limited to a small number of screws and plates,   210 × 10 mm.  Figure 2 shows the schematic diagram
            which are extremely unfavorable for accurate treatment.   of the molded sample models, which include six plates
            As a new rapid prototyping technology, 3D printing has   for tibiotalocalcaneal (TTC) arthrodesis and two sets of
            created conditions for solving this problem.       fusion cages in different sizes for subtalar arthrodesis.
                                                               In order to further improve the quality of the implants,
               This  study  focused  on  the  feasibility  of using  3D   hot isostatic pressing (HIP) was conducted under a
            printing technology to prepare customized titanium   temperature of 930°C and a pressure of 100 MPa, which
            implants and apply them to more complex foot and ankle   were maintained for 2 h. The finished implants are
            surgeries. Follow-ups were conducted to observe the short-  shown in Figure 3. Implants were sealed after ethylene
            term efficacy.                                     oxide sterilization for intraoperative use.


            Volume 10 Issue 1 (2024)                       447                        https://doi.org/10.36922/ijb.0125
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