Mechanical properties, in vitro and in vivo biocompatibility analysis of pure iron porous implant produced by metal injection molding: A new eco-friendly feedstock from natural rubber (Hevea brasiliensis).

Metal injection molding (MIM) has become an important manufacturing technology for biodegradable medical devices. As a biodegradable metal, pure iron is a promising biomaterial due to its mechanical properties and biocompatibility. In light of this, we performed the first study that manufactured and evaluated the in vitro and in vivo biocompatibility of samples of iron porous implants produced by MIM with a new eco-friendly feedstock from natural rubber (Hevea brasiliensis), a promisor binder that provides elastic property in the green parts. The iron samples were submitted to tests to determine density, microhardness, hardness, yield strength, and stretching. The biocompatibility of the samples was studied in vitro with adipose-derived mesenchymal stromal cells (ADSCs) and erythrocytes, and in vivo on a preclinical model with Wistar rats, testing the iron samples after subcutaneous implant. Results showed that the manufactured samples have adequate physical, and mechanical characteristics to biomedical devices and they are cytocompatible with ADSCs, hemocompatible and biocompatible with Wistars rats. Therefore, pure iron produced by MIM can be considered a promising material for biomedical applications.

Evaluation of in vitro and in vivo biocompatibility of iron produced by powder metallurgy.

Biodegradable metallic materials (BMMs) are expected to corrode gradually in vivo after providing the structural support to the tissue during its regeneration and healing processes. These characteristics make them promising candidates for use in stents. These endoprostheses are produced from metal alloys by casting and thermomechanical treatment. Since porous alloys and metals have less corrosion resistance than dense ones, the use of powder metallurgy becomes an option to produce them. Among the metals, iron has been proposed as a material in the manufacturing of stents because of its mechanical properties. However, even then it is unclear what toxicity threshold is safe to the body. Thus, the objective of this research was to verify the biocompatibility of sintered 99.95% and 99.5% pure iron by powder metallurgy in vitro with Adipose-derived mesenchymal stromal cells (ADSCs) and in vivo with a Wistar rat model. Herein, characterizations of iron powder samples produced by the powder metallurgy and the process parameters as compression pressure, atmosphere, sintering time and temperature were determined to evaluate the potential of production of biodegradable implants. The samples obtained from pure iron were submitted to tests of green and sintered density, porosity, microhardness, hardness and metallography. The biocompatibility study was performed by indirect and direct cell culture with iron. The effects of corrosion products of iron on morphology, viability, and proliferation of ADSCs were evaluated in vitro. Hemolysis assay was performed to verify the hemocompatibility of the samples. In vivo biocompatibility was evaluated after pure iron discs were implanted subcutaneously into the dorsal area of Wistar rats that were followed up to 6 months. The results presented in this paper validated the potential to produce biodegradable medical implants by powder metallurgy. Both iron samples were hemocompatible and biocompatible in vitro and in vivo, although the 99.95% iron had better performance in vitro than 99.5%.

Manufacture of custom-made cranial implants from DICOM® images using 3D printing, CAD/CAM technology and incremental sheet forming

INTRODUCTION: This work aims to pre-operatively manufacture custom-made low-cost implants and physical models (‘biomodels’) of fractured skulls. The pre-DOI: operative manufacturing of biomodels and implants allows physicians to study and plan surgery with a greater possibility of achieving the expected result. Customization contributes to both the esthetic and functional outcome of the implant because it considers the anatomy of each patient, while the low cost allows a greater number of people to potentially benefit. METHODS: From CT images of a fractured skull, a CAD model of the skull (biomodel) and a restorative implant were constructed digitally. The biomodel was then physically constructed with 3D Printing, and Incremental Sheet Forming (ISF) was used to manufacture the implant from a sheet of pure grade 2 titanium. Before cutting the implant’s final shape from a pre-formed sheet, heat treatment was performed to avoid deformations caused by residual stresses generated during the ISF process. RESULTS: A comparison of the dimensions of the implant and its respective CAD biomodel revealed geometric discrepancies that can affect both functional and aesthetic efficiency. Nevertheless, the final shape preserved symmetry between the right and left sides of the skull. Electron microscopy analysis did not indicate the presence of elements other than pure titanium. CONCLUSION: Dimensional variability can be decreased with changes in the manufacturing process (i.e., forming and cutting) and the heating ramp. Despite biomedical characteristics, there was no contamination of the implant by harmful chemical elements. 3D Printing was effective in making the biomodel, enabling pre-operative planning and improving physician-patient communication. Current results indicate that ISF is a process that can be used to obtain custom-made implants.

Liga com memória de forma: estudo preliminar do grampo de judet de nitinol e sua possível aplicação em tórax instável / Shape memory alloy: a preliminary study of nitinol judet staples for future application in flail chest

Este artigo sucintamente descreve a evolução da liga metálica “inteligente”, com memória de forma na área de Saúde. A confecção de grampos de Judet em nitinol ocorreu no Laboratório de Transformação Mecânica da UFRGS (LdTM) e a simples verificação das qualidades superelásticas e de memória de forma foram contempladas no LdTM e no HCPA pela equipe envolvida no projeto. A título de ilustração, demonstramos com um caso clínico a aplicabilidade do grampo de Judet no cenário de instabilidade da parede torácica, a qual, além de prejudicar a mecânica respiratória, apresenta uma alta taxa de mortalidade. Os resultados preliminares evidenciaram a transformação provocada pelo calor, ocasionando o fechamento das garras dos grampos de Judet, que se manteve firme e sem alteração da consistência com o tempo, permitindo antever sua aplicabilidade num modelo experimental. Grampos de Judet em Nitinol são apresentados teoricamente como vantajosos em relação aos já existentes em aço inoxidável 316L, especialmente pela facilidade de manuseio e possível simplificação do procedimento cirúrgico. Detalhes no acabamento permitem a biocompatibilidade e o engenheiro projetista de materiais deve compatibilizar as ligas de níquel e titânio (NiTi) utilizadas nos grampos. O nitinol possui amplo emprego no cenário médico-odontológico e há normas técnicas bem definidas. A epidemiologia do trauma e a gravidade das lesões associadas à instabilidade da parede torácica evidenciam a oportunidade de estudos nessa direção. Concluímos sobre a necessidade de prosseguir para uma avaliação experimental, agregando a mensuração de parâmetros viscosos e viscoelásticos da mecânica respiratória, especialmente em seu componente de parede torácica (cw).

The aim of this article is to briefly describe the incorporation of nitinol (NiTi) – an intelligent nickel-titanium alloy presenting shape memory – for use in medical applications. Nitinol Judet staples were developed at the Mechanical Processing Laboratory (LdTM) at Universidade Federal do Rio Grande do Sul. Simple confirmation assays of superelasticity and shape memory were performed at the LdTM and Hospital de Clínicas de Porto Alegre by the project team. A clinical case was used to demonstrate the applicability of nitinol Judet staples in the treatment of flail chest, a condition characterized by respiratory mechanics associated with fairly high mortality. The initial observation revealed a transformation resulting from heat exposure causing the closure of staple prongs. With time, the consistency of the Judet staples remained unchanged, indicating the feasibility of an experimental model employing these staples. The advantages of NiTi-made Judet staples in relation to 316L stainless steel staples are outlined, with emphasis on the ease of use and possible simplification of the surgical procedure. Finishing details ensure biocompatibility, with a focus on specific adaptations in the NiTi alloy employed to manufacture the staples; nevertheless, nitinol is widely employed in medicine and dentistry, with well-defined standards. The epidemiology of trauma and the severity of lesions associated with flail chest provide an opportunity for the proposed studies. The experimental assessment of nitinol Judet staples must now address viscosity and viscoelastic parameters of respiratory mechanics, especially concerning the chest wall.

Development and in vivo testing of a Nitinol tracheal stent.

This article describes the development of a Nitinol tracheal stent (HCPA NiTi-stent) and its application in a feline animal model. Straight-annealed, bright-polished Nitinol wire (55.8%Ni-44.2%Ti) was weaved around a 40-mm-long metal fixture with 8-mm diameter. The prototypes were submitted to different times of shape-setting heat treatment (530 degrees C), which resulted in stents of different colors and caused some variation in length and diameter. The prototypes were then submitted to compression testing, and the most resistant pieces, requiring the greatest force to achieve a 25% reduction in diameter and presenting the least variation in length and diameter (dark blue, 9 min of heat treatment), were submitted to fatigue testing. After that, only dark blue stents were manufactured and implanted in felines. No migration, tracheal stenosis, or any other type of damage were observed after 40 weeks. The integrity of the tracheal wall in contact with the stent was confirmed by macro and microscopic analyses. The development and in vivo testing of the HCPA NiTi-stent were successful.