Strategy on biological evaluation for biodegradable/absorbable materials and medical devices

Abstract

During the last two decades, biodegradable/absorbable materials which have many benefits over conventional implants are being sought in clinical practices. However, to date, it still remains obscure for us to perform full physic-chemical characterization and biological risk assessment for these materials and related devices due to their complex design and coherent processing. In this review, based on the art of knowledge for biodegradable/absorbable materials and biological risk assessment, we demonstrated some promising strategies to establish and improve the current biological evaluation systems for these biodegradable/absorbable materials and related medical devices.

Fish scale derived hydroxyapatite incorporated 3D printed PLA scaffold for bone tissue engineering

“…This observation piqued interest in a deeper quantitative dive to discern the extent of differential tissue reactions between the two scaffold variations. Guided by the standards laid down in ISO 10993 Part-6, 24 a ‘reactivity score’ was calculated. This score encapsulates the severity and nature of tissue reactions post-implantation.…”

“…The design and execution of animal experiments adhered to the recommendations of ISO 10993- Part 6, 24 having secured the approval from the Institutional Animal Ethics Committee of the host institution. The study utilized adult male Sprague Dawley rats with weights ranging between 250–350 grams.…”

“…The response of local tissue to PLA-FSHA was assessed following the guidelines of ISO standard 10993- Part 6, 24 using PLA as the benchmark material. The evaluation involved computing an average semi-quantitative score, determined by the formula: [(subtotal-I × 2) + subtotal-II].…”

“…Semiquantitative parameters studied for evaluating histopathology (Parameters as per ISO 10993, Part 624 ) …”

Development of 3D Printed Biodegradable, Entirely X‐ray Visible Stents for Rabbit Carotid Artery Implantation

“…[16][17][18][19] In terms of chemical modification, in spite of the increased radiopacity of the polymer via chemical methods, the complex preparation process and potential toxicity in chemical synthesis hinder its clinical application in interventional medical devices. [20] In comparison, the combination of contrast agent and polymer matrix has been considered as a robust method for polymeric stent visualization. X-ray contrast agents, such as barium sulfate, [21] zirconia, [22] and iron oxide, [23] can be blended with polymer materials to prepare a radiopaque polymer composite.…”