Effect of the Advanced Cranial and Craniofacial Implant Fabrication on Their Degradation Affinity.

Biodegradable craniofacial and cranial implants are a new aspect in terms of reducing potential complications, especially in the long term after surgery. They are also an important contribution in the field of surgical reconstructions for children, for whom it is important to restore natural bone in a relatively short time, due to the continuous growth of bones. The aim of this study was to verify the impact of the technology on biodegradability and to estimate the risk of inappropriate implant resorption time, which is an important aspect necessary to select prototypes of implants for in vivo testing. Prototypes of implants were made using two technologies: 3D printing using a PLDLA: poly(L-co-D,L lactide) (PLDLA) filament containing hydroxyapatite nanoparticles, and injection using PLDLA. After the radiation sterilization process, they were subjected to in vitro degradation under accelerated conditions. As part of this study, the in vitro degradation of newly developed biodegradable implant technologies was assessed in accordance with the guidelines of European standards. It was found that the implant manufacturing process had a significant impact on the degradation time under simulated conditions in various media. Implants made using the injection technique were characterized by lower susceptibility to degradation media compared to the 3D-printed implant under accelerated conditions.

Effect of Sterilization on Bone Implants Based on Biodegradable Polylactide and Hydroxyapatite.

Medical devices intended for implantation must be, in accordance with the legal provisions in force in the European Union, sterile. The effect of sterilization on the structural and thermal properties of implants, made by 3D printing from biodegradable polylactide and hydroxyapatite in a proportion of 9/1 by weight, was evaluated. The implants were sterilized using three different methods, i.e., steam sterilization, ethylene oxide sterilization, and electron beam radiation sterilization. As a result of the assessment of the structural properties of the implants after sterilization, a change in the molecular weight of the raw material of the designed implants was found after each of the performed sterilization methods, while maintaining similar characteristics of the thermal properties and functional groups present.

Effect of Accelerated Ageing on the Mechanical and Structural Properties of the Material System Used in Protectors.

Currently, there is a wide range of materials for motorcyclists available on the market that have a significant ability to absorb impact energy. Understanding the aging processes of materials is crucial for guaranteeing the long-term durability and safety of a new product. For this reason, the effect of accelerated aging on the mechanical and structural properties of the multifunctional materials used in commercial protectors was analyzed. The accelerated aging considered in this study simulated 3 years of use under real conditions. Then, DMTA and FT-IR research, as well as impact tests, were carried out on the commercially available protectors for motorcyclists, before and after the accelerated aging processes. Structural analysis using FT-IR showed no significant changes in the structure of the polymers used for producing the protectors. The DMA test results are consistent with those obtained from the impact study. Both methods showed that the samples maintain their protective properties, after accelerated aging. All of the examined protectors show that an increase in force is transferred through the sample, after the accelerated aging processes, but they still provide protection, according to the ISO standard.

Design of New-Generation Usable Forms of Topical Haemostatic Agents Containing Chitosan.

Designing usable forms of topical haemostatic agents is the most important activity during the design process, resulting in strengthened functional properties of the final medical devices. This study aimed to propose indications for a research programme based on risk management supporting the development of two usable forms of a topical haemostatic agent: chitosan/alginate lyophilized foam and chitosan/alginate impregnated gauze. Both of the usable forms of the topical haemostatic agent, being the main part of the modified combat gauze, were fabricated using the chitosan/alginate complex. Risk analysis is helpful in developing an appropriate research programme, significantly reducing the risk to an acceptable level.