頭蓋骨欠損修復用3Dプリント生体吸収性インプラントの生体模倣条件下での物理化学的変化の評価

Once implanted, biodegradable devices gradually deteriorate, potentially compromising clinical performance. Consequently, evaluating the alterations in physicochemical characteristics after implantation is crucial. Nonetheless, there is currently no established methodology for precisely assessing these alterations. This study sought to develop accurately simulated cranial defect physiological conditions (SCDPC) and examine the physicochemical modifications in biodegradable cranioplasty plates (BCP) to anticipate their performance changes following implantation in humans. We analyzed the physicochemical property alterations of BCP following 24 weeks of exposure to SCDPC. Following 24 weeks under SCDPC, the BCP showed a notable reduction in mass (- 0.79%) and tensile strength (- 69.30%). A decrease in molecular weight was noted after 12 weeks of implantation in rabbits (- 9.67%) and following 12 weeks of exposure to SCDPC (- 4.73%). The physicochemical alterations identified under simulated in vitro cranial defect conditions closely mirrored those found in the in vivo setting. In summary, assessing BCP under SCDPC offers an innovative and dependable approach for precisely forecasting performance shifts after implantation. This strategy could provide meaningful guidance for the advancement of BCP and various other biodegradable medical devices.