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International Journal of Bioprinting                                       3DP PILF cage for osteoporotic



            A                                                  geometric size. Conversely, our CS-type cage is likely to
                                                               be standardized and defined as the worst cage (usually the
                                                               smallest cage) to perform the mechanical tests required by
                                                               the FDA.
                                                                 In general, STO can only calculate the structural
                                                               optimization under a single load. However, WTO needed
                                                               to be applied in this study to solve multi-directional spine
                                                               load conditions in daily life. The WTO is represented by
                                                               values between 0 and 1 for each condition, corresponding
                                                               with  proportions  of  different  load  conditions.  In  the
                                                               present study, 21.5% for flexion and extension, 33% for
                                                               bending, and 24% for axial rotation correspond to values
                                                               of 0.215, 0.33, and 0.24 of weight coefficient for each
                                                               element, respectively [20,21] . Therefore, our designed cage
            B                                                  structure (gray mesh found in Figure 2) was calculated by
                                                               multiplying the respective weight coefficients of different
                                                               loads to the corresponding STO result (Figure  2). This
                                                               kind of protocol using WTO considering different load
                                                               percentages can also be a new mode for designing other
                                                               cages, such as anterior lumbar interbody fusion (ALIF)
                                                               and transforaminal lumbar interbody fusion (TLIF).
                                                                 The combination of internal cavity lattice design
                                                               in the cage structure has been proven to increase
                                                               the ingrowth capability of bone cells with strong
                                                               stabilization. However, there are many lattice design
                                                               parameters, such as porosity, pore size, and unit size,
                                                               that still cannot be confirmed to integrate with implant
                                                               design [9-13] . At present, we only considered the spiral
            Figure 8. The CS-type cage fracture pattern after in vitro test: (A) ISO   lattice provided by the CAD software. Other lattice
            view and (B) back view.
                                                               design parameters can be further considered in the
                                                               future. However, the complex contour surface combined
            the posterior side under extension, and at the lateral side   with the internal cage cavity lattice design cannot be
            under bending and torsion.                         manufactured by traditional mechanical cutting. Three-

              This study screened elderly osteoporosis patients to   dimensional printing techniques are well established for
            obtain the endplate curved surface characteristics, which   building complex 3D constructions from CAD models.
            are more in line with the fit of the general population   3D printing techniques have great potential to solve the
            of osteoporosis patients for the cage and the endplate.   problems of creating a porous (lattice) surface coating
            Although the curved surface design of our CS-type cage   on dense titanium and porous titanium body [9-13] .
            may not be able to achieve 100% endplate-conformation for   Therefore, this study utilized metal 3D printing to
            each patient, that is, patient-specific endplate morphology   fabricate our designed CS-type cage to perform the
            can match compatibility. However, a CS-type cage with   following functional tests. Our 3D printer laboratory
            enhanced load-bearing surfaces can be applied in clinical   was approved by ISO13485 quality management system
            practice for design and manufacture purposes. The cage   (Certificate Number: 1760.190828) to ensure that
            complex  surface can  be manufactured  using  traditional   implants manufactured by 3D printing can provide a
            machining or 3D printing fabrication if the internal lattice   practical foundation to meet the regulations as well as
            design is not considered. According to the Food and Drug   demonstrate a commitment to safety and quality.
            Administration (FDA) regulations, a spine cage must pass   Although the current in vitro mechanical experiment
            5 million fatigue functional tests, such as compression,   in this study only considers the static state, the results
            compression-shear, and torsion, before it can be marketed.   found that the yielding load and stiffness under all load
            A patient-specific design is unlikely to perform relevant   conditions were much higher than the recommended ISO
            mechanical tests alone due to excessive variation in the   23089 values . This document specifies requirements
                                                                          [24]

            Volume 9 Issue 3 (2023)                        418                         https://doi.org/10.18063/ijb.697
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