Na presente pesquisa, produziu-se amostras de ferro puro poroso como biomaterial degradável visando a aplicação em stents, pelo processo de moldagem por injeção de pós metálicos (MPI). Os efeitos da fração volumétrica de ferro puro na mistura de injeção e da temperatura de sinterização na porosidade, microestrutura, propriedades mecânicas, propriedades de superfície, de degradação in vitro e de biocompatibilidade, foram investigados. Os resultados obtidos foram comparados com o ferro puro fabricado por fusão e com o aço inoxidável AISI 316-L. Encontrou-se que o grau de porosidade remanescente nas amostras sinterizadas foi o principal fator influenciando as propriedades mecânicas e de superfície, influenciando indiretamente os demais resultados. O ferro puro produzido por MPI exibiu valores de limite de escoamento entre 59 e 114 MPa e limite de resistência máximo de 210 MPa, com alongamento entre 10 e 50 %. A alta ductilidade é uma propriedade especialmente requerida em materiais para potencial aplicação em stents. Suas taxas de degradação em solução de Hank foram superiores às do ferro puro fabricado por fusão. O material fabricado com mistura de injeção contendo fração de ferro de 66 % (acima da fração crítica) mostrou o maior alongamento e boa taxa de degradação, um resultado interessante, pois segundo a literatura, valores acima da fração volumétrica crítica não são amplamente explorados. Os testes de biocompatibilidade mostraram excelente hemocompatibilidade do ferro puro fabricado por MPI com as células do sangue. Todas as condições testadas mostraram um nível de citotoxicidade abaixo do recomendado pela norma vigente, mas este dependendo da concentração de íons de ferro empregada e do grau de porosidade. Entre todas as condições de ensaio investigadas, as amostras contendo fração volumétrica de ferro de 62 % inicialmente na mistura de injeção e sinterizadas a 1120 oC, apresentaram a melhor combinação de propriedades para aplicação em stents. Concluiu-se que a MPI é um método tecnicamente viável como rota de produção de tubos de parede fina precursores para fabricação de stents biodegradáveis. / In the present research, an attempt was made to produce porous pure iron, as a metallic degradable biomaterial potentially for stent application, via the MIM route. The effects of iron powder loading and sintering temperature on the porosity, microstructure, mechanical properties, surface properties and in vitro degradation behavior of MIM iron were investigated. The results obtained were compared to those of cast iron. It was found that the amount of porosity remained in the as-sintered specimens had a major effect on their surface and mechanical properties. The MIM pure iron showed yield strength values between 59 and 114 MPa and maximum tensile strength of 210 MPa, with elongation values between 10 and 50 %. A high ductility is a specially required property of stent materials. Its degradation rates in Hank’s solution were superior to the degradation rate of cast iron. The material made from the feedstock containing 66 % of iron powder, above the critical powder loading, showed the highest elongation and a good in vitro degradation rate. This result is interesting, once according to the literature, powder loadings above the critical value are not well explored. The biocompatibility tests showed excellent hemocompatibility of MIM pure iron with blood cells. All conditions tested showed toxicity level below the values determined by current standards, but depending of Fe ions concentration and porosity level. Between all the conditions tested in the present investigation, the 62 % powder loading sample, sintered at 1120 oC, showed the best combination of properties for stent application. In conclusion, MIM is a promising method to be developed as a new route to produce thin-wall tubes for biodegradable stents.

Na presente pesquisa, produziu-se amostras de ferro puro poroso como biomaterial degradável visando a aplicação em stents, pelo processo de moldagem por injeção de pós metálicos (MPI). Os efeitos da fração volumétrica de ferro puro na mistura de injeção e da temperatura de sinterização na porosidade, microestrutura, propriedades mecânicas, propriedades de superfície, de degradação in vitro e de biocompatibilidade, foram investigados. Os resultados obtidos foram comparados com o ferro puro fabricado por fusão e com o aço inoxidável AISI 316-L. Encontrou-se que o grau de porosidade remanescente nas amostras sinterizadas foi o principal fator influenciando as propriedades mecânicas e de superfície, influenciando indiretamente os demais resultados. O ferro puro produzido por MPI exibiu valores de limite de escoamento entre 59 e 114 MPa e limite de resistência máximo de 210 MPa, com alongamento entre 10 e 50 %. A alta ductilidade é uma propriedade especialmente requerida em materiais para potencial aplicação em stents. Suas taxas de degradação em solução de Hank foram superiores às do ferro puro fabricado por fusão. O material fabricado com mistura de injeção contendo fração de ferro de 66 % (acima da fração crítica) mostrou o maior alongamento e boa taxa de degradação, um resultado interessante, pois segundo a literatura, valores acima da fração volumétrica crítica não são amplamente explorados. Os testes de biocompatibilidade mostraram excelente hemocompatibilidade do ferro puro fabricado por MPI com as células do sangue. Todas as condições testadas mostraram um nível de citotoxicidade abaixo do recomendado pela norma vigente, mas este dependendo da concentração de íons de ferro empregada e do grau de porosidade. Entre todas as condições de ensaio investigadas, as amostras contendo fração volumétrica de ferro de 62 % inicialmente na mistura de injeção e sinterizadas a 1120 oC, apresentaram a melhor combinação de propriedades para aplicação em stents. Concluiu-se que a MPI é um método tecnicamente viável como rota de produção de tubos de parede fina precursores para fabricação de stents biodegradáveis. / In the present research, an attempt was made to produce porous pure iron, as a metallic degradable biomaterial potentially for stent application, via the MIM route. The effects of iron powder loading and sintering temperature on the porosity, microstructure, mechanical properties, surface properties and in vitro degradation behavior of MIM iron were investigated. The results obtained were compared to those of cast iron. It was found that the amount of porosity remained in the as-sintered specimens had a major effect on their surface and mechanical properties. The MIM pure iron showed yield strength values between 59 and 114 MPa and maximum tensile strength of 210 MPa, with elongation values between 10 and 50 %. A high ductility is a specially required property of stent materials. Its degradation rates in Hank’s solution were superior to the degradation rate of cast iron. The material made from the feedstock containing 66 % of iron powder, above the critical powder loading, showed the highest elongation and a good in vitro degradation rate. This result is interesting, once according to the literature, powder loadings above the critical value are not well explored. The biocompatibility tests showed excellent hemocompatibility of MIM pure iron with blood cells. All conditions tested showed toxicity level below the values determined by current standards, but depending of Fe ions concentration and porosity level. Between all the conditions tested in the present investigation, the 62 % powder loading sample, sintered at 1120 oC, showed the best combination of properties for stent application. In conclusion, MIM is a promising method to be developed as a new route to produce thin-wall tubes for biodegradable stents.

Na presente pesquisa, produziu-se amostras de ferro puro poroso como biomaterial degradável visando a aplicação em stents, pelo processo de moldagem por injeção de pós metálicos (MPI). Os efeitos da fração volumétrica de ferro puro na mistura de injeção e da temperatura de sinterização na porosidade, microestrutura, propriedades mecânicas, propriedades de superfície, de degradação in vitro e de biocompatibilidade, foram investigados. Os resultados obtidos foram comparados com o ferro puro fabricado por fusão e com o aço inoxidável AISI 316-L. Encontrou-se que o grau de porosidade remanescente nas amostras sinterizadas foi o principal fator influenciando as propriedades mecânicas e de superfície, influenciando indiretamente os demais resultados. O ferro puro produzido por MPI exibiu valores de limite de escoamento entre 59 e 114 MPa e limite de resistência máximo de 210 MPa, com alongamento entre 10 e 50 %. A alta ductilidade é uma propriedade especialmente requerida em materiais para potencial aplicação em stents. Suas taxas de degradação em solução de Hank foram superiores às do ferro puro fabricado por fusão. O material fabricado com mistura de injeção contendo fração de ferro de 66 % (acima da fração crítica) mostrou o maior alongamento e boa taxa de degradação, um resultado interessante, pois segundo a literatura, valores acima da fração volumétrica crítica não são amplamente explorados. Os testes de biocompatibilidade mostraram excelente hemocompatibilidade do ferro puro fabricado por MPI com as células do sangue. Todas as condições testadas mostraram um nível de citotoxicidade abaixo do recomendado pela norma vigente, mas este dependendo da concentração de íons de ferro empregada e do grau de porosidade. Entre todas as condições de ensaio investigadas, as amostras contendo fração volumétrica de ferro de 62 % inicialmente na mistura de injeção e sinterizadas a 1120 oC, apresentaram a melhor combinação de propriedades para aplicação em stents. Concluiu-se que a MPI é um método tecnicamente viável como rota de produção de tubos de parede fina precursores para fabricação de stents biodegradáveis. / In the present research, an attempt was made to produce porous pure iron, as a metallic degradable biomaterial potentially for stent application, via the MIM route. The effects of iron powder loading and sintering temperature on the porosity, microstructure, mechanical properties, surface properties and in vitro degradation behavior of MIM iron were investigated. The results obtained were compared to those of cast iron. It was found that the amount of porosity remained in the as-sintered specimens had a major effect on their surface and mechanical properties. The MIM pure iron showed yield strength values between 59 and 114 MPa and maximum tensile strength of 210 MPa, with elongation values between 10 and 50 %. A high ductility is a specially required property of stent materials. Its degradation rates in Hank’s solution were superior to the degradation rate of cast iron. The material made from the feedstock containing 66 % of iron powder, above the critical powder loading, showed the highest elongation and a good in vitro degradation rate. This result is interesting, once according to the literature, powder loadings above the critical value are not well explored. The biocompatibility tests showed excellent hemocompatibility of MIM pure iron with blood cells. All conditions tested showed toxicity level below the values determined by current standards, but depending of Fe ions concentration and porosity level. Between all the conditions tested in the present investigation, the 62 % powder loading sample, sintered at 1120 oC, showed the best combination of properties for stent application. In conclusion, MIM is a promising method to be developed as a new route to produce thin-wall tubes for biodegradable stents.

No description available.

Implantable sensors have been extensively investigated to facilitate diagnosis or to provide a means to generated closed loop control of therapy by yielding in vivo measurements of physical and chemical signals. Biodegradable sensors which degrade gradually after they are no longer functionally needed exhibit great potential in acute or shorter-term medical diagnostic and sensing applications due to the advantages of (a) exclusion of the need to a secondary surgery for sensor removal, and (b) reduction of the risk of long-term infection. The objective of this research is to design and characterize microfabricated RF wireless pressure sensors that are made of completely biodegradable materials and degrade at time-controlled manner (in the order of years and months). This was achieved by means of investigation of appropriate biodegradable materials and development of appropriate fabrication processes for these non-standard (Microelectromechanical systems) MEMS materials. Four subareas of research are performed: (1) Design of sensors that operate wirelessly and are made of biodegradable materials. The structure of the wireless sensor consists a very compact and relatively simple design of passive LC resonant circuits embedded in a polymer dielectric package. To design the sensor with a particular resonant frequency range, an electromagnetic model of the sensor and a mechanical model for circular plate are developed. The geometry of the sensor is established based on the analytical and finite element simulations results. (2) Investigation of the biodegradable materials in the application of implantable biodegradable wireless sensors to achieve controllable degradation lifetimes. Commercially available and FDA approved biodegradable polymers poly(L-lactic acid) (PLLA) and a "shell-core" structure of poly(lactic-co-glycolic acid) (PLGA) and polyvinyl alcohol (PVA) are utilized as the dielectric package for slow and rapid degradation sensors, respectively. Biodegradable metallic zinc and zinc/iron couples are chosen as conductor materials. The degradation behavior of Zn and Zn/Fe-couple are investigated in vitro. (3) Development of novel fabrication processes. The process exploit the advantages of MEMS technology in fabricating miniaturized devices, while protecting vulnerable biodegradable materials from the strong and/or hazardous chemicals that are commonly used in conventional MEMS fabrication process. These new processes enable the fabrication of biocompatible and biodegradable 3-D devices with embedded, near-hermetic cavities. (4) Testing the pressure response functionality and studying the degradation behavior of the wireless biodegradable pressure sensors. Both PLLA-based and PLGA/PVA-based sensors are characterized in vitro by being immersed in 0.9% saline for prolonged time. All the sensors exhibit three stages of behavior in vitro: equilibration, functional lifetime, and performance degradation. During the functional lifetime, most sensors exhibit fully stable functionality. The PLLA-based sensors show no significant weight loss within 8 month and are expected to fully degrade after 2 years, while the PLGA/PVA-based sensors can degrade completely within 26 days.

The performance of artificial nerve guidance conduits (NGC) in peripheral nerve regeneration can be improved by providing structures with multiple small channels instead of a single wide lumen. 3D-printing is a strategy to access such multi-channeled structures in a defined and reproducible way. This study explores extrusion-based 3D-printing of two-component hydrogels from a single cartridge printhead into multi-channeled structures under aseptic conditions. The gels are based on a platform of synthetic, anhydride-containing oligomers for cross-linking of gelatinous peptides. Stable constructs with continuous small channels and a variety of footprints and sizes were successfully generated from formulations containing either an organic or inorganic gelation base. The adjustability of the system was investigated by varying the cross-linking oligomer and substituting the gelation bases controlling the cross-linking kinetics. Formulations with organic N-methyl-piperidin-3-ol and inorganic K2HPO4 yielded hydrogels with comparable properties after manual processing and extrusion-based 3D-printing. The slower reaction kinetics of formulations with K2HPO4 can be beneficial for extending the time frame for printing. The two-component hydrogels displayed both slow hydrolytic and activity-dependent enzymatic degradability. Together with satisfying in vitro cell proliferation data, these results indicate the suitability of our cross-linked hydrogels as multi-channeled NGC for enhanced peripheral nerve regeneration.

Despite the recent development in PLA and PLGA based medical devices, there are still needs to further improve the mechanical performance of bioresorbable medical implants and their bioactivity. This is normally done by optimizing the filler compositions in selected groups ofbiodegradable polymer matrices. In this study, the effects of various filler levels on mechanical strength and thermal properties of PLA and PLGA composites were investigated. Composites containing different dosage of osteoconductive HAp with various particles size (0-5μm, 0-50 μm, nano size), β-TCP, bioactive glass and biodegradable Poly-L-lactide and Polylactide-glycolic acid was manufactured with melt blending, using a twin-screw extruder.The samples were investigated by Differential Scanning Calorimetry (DSC), thermo gravimetric analysis (TGA), Scanning Electron Microscopy (SEM), viscometer, three points bending machine, and Optical Microscopy (OM). The Extruder produced a porous profile. The result from TGA and SEM indicated that there was homogenous filler dispersion in the matrix after compounding.The result from DSC and Viscometer shows that there was some degradation duringcompounding. Mechanical properties of composites were modified by adding filler to matrix. The addition of Bioactive glass, as a filler, increases the degradation of the polymer matrix. The best filler that was applied is 0-5μm and nano HAp. Also in in-vitro degradation part of this thesis work, the effects of calcium phosphate materialsare investigated on degradation process.