Effect of electrolyte composition and deposition current for Fe/Fe-P electroformed bilayers for biodegradable metallic medical applications.

With its proven biocompatibility and excellent mechanical properties, iron is an excellent source material for clinical cardiac and vascular applications. However, its relatively low degradation rate limits its use for the healing and remodeling of diseased blood vessels. To address these issues, a multi-purpose fabrication process to develop a bilayer alloy composed of electroformed iron (E-Fe) and iron-phosphorus (Fe-P) was employed. Bilayers of Fe/Fe-P were produced in an electrolytic bath. The effects of electrolyte chemical composition and deposition current density (idep) on layer structure and chemical composition were assessed by scanning electron microscopy, electron probe microanalysis, X-ray diffraction and X-ray photoelectron spectroscopy. The corrosion rate was determined by potentiodynamic polarization tests. The bilayers showed an increasing amount of P with increasing NaH2PO4·H2O in the electrolyte. Fe-P structure became finer for higher P amounts. Potentiodynamic polarization tests revealed that the corrosion rate was strongly influenced by deposition conditions. For a P amount of ~2 wt.%, the corrosion rate was 1.46mm/year, which confirms the potential of this material to demonstrate high mechanical properties and a suitable corrosion rate for biomedical applications.

In vitro degradation behavior of Fe-20 Mn-1.2C alloy in three different pseudo-physiological solutions.

High manganese austenitic steels such as Fe-20Mn-1.2C alloys are among the most promising candidates for biodegradable stents applications due to their high strength, high ductility and their chemical composition. In the current work, 14 day static in-vitro tests were performed in controlled atmosphere to assess the degradation behavior in three common pseudo-physiological solutions, i.e. commercial Hanks' (CH), modified Hanks' (MH) and albumin-enriched Dulbecco's modified phosphate buffered saline (DPBS) solutions. The degraded samples surfaces as well as the degradation products were characterized by X-ray diffraction (XRD), scanning electron microscopy (SEM) and Fourier transform infrared spectroscopy (FTIR). Degradation of material and degradation products are shown to be strongly dependent on the test medium due to the presence of different ionic species such as HCO3(-), CO3(2-), Cl(-), Ca(2+) or phosphate groups. In both MH and CH solutions, the increased content of HCO3(-) ions seems to promote MnCO3 crystal growth on sample surfaces whereas the presence of albumin and high content of phosphate ions promotes the formation of an amorphous layer rich in phosphates, iron and manganese.

Degradable metallic biomaterials: design and development of Fe-Mn alloys for stents.

Designing materials having suitable mechanical properties and targeted degradation behavior is the key for the development of biodegradable materials for medical applications, including stents. A series of Fe-Mn alloys was developed with the objective to obtain mechanical properties similar to those of stainless steel 316L and degradation behavior more suited than pure iron. Four alloys with Mn content ranging between 20 and 35 wt % were compared in this study. Their microstructure, mechanical properties, magnetic properties as well as degradation behavior were carefully investigated. Results show that their microstructure is mainly composed of gamma phase with the appearance of epsilon phase in alloys having a lower Mn content. The yield strength and elongation of alloys was comprised between 234 MPa and 32% for Fe-35%Mn alloy to 421 MPa and 7.5% for the Fe-20%Mn alloy. All alloys show similar magnetic susceptibility ( approximately 1.8 x 10(-7) m(3)/kg) in the quenched condition. This magnetic susceptibility remains constant after plastic deformation for all the tested alloys except for the Fe-20%Mn alloy. The corrosion rate was higher than pure iron. Among the alloys studied in this work, the Fe-35%Mn alloy shows mechanical properties and degradation behavior closely approaching those required for biodegradable stents application.

Fe-Mn alloys for metallic biodegradable stents: degradation and cell viability studies.

Biodegradable stents have shown their potential to be a valid alternative for the treatment of coronary artery occlusion. This new class of stents requires materials having excellent mechanical properties and controllable degradation behaviour without inducing toxicological problems. The properties of the currently considered gold standard material for stents, stainless steel 316L, were approached by new Fe-Mn alloys. The degradation characteristics of these Fe-Mn alloys were investigated including in vitro cell viability. A specific test bench was used to investigate the degradation in flow conditions simulating those of coronary artery. A water-soluble tetrazolium test method was used to study the effect of the alloy's degradation product to the viability of fibroblast cells. These tests have revealed the corrosion mechanism of the alloys. The degradation products consist of metal hydroxides and calcium/phosphorus layers. The alloys have shown low inhibition to fibroblast cells' metabolic activities. It is concluded that they demonstrate their potential to be developed as degradable metallic biomaterials.

Design of a pseudo-physiological test bench specific to the development of biodegradable metallic biomaterials.

Endovascular stents have proven effective in treating coronary and peripheral arterial occlusions. Since the first attempts, metals used to make these devices have been generally selected, and designed to be highly resistant to corrosion. Therefore, as almost the totality of metallic biomaterials, they are implanted on a long-term basis. However, complications associated with permanent stents, such as in-stent restenosis and thrombosis, have often been reported. In order to reduce those complications, it would be clinically useful to develop a new family of degradable stents. An interesting material for fabrication of degradable stents is based on magnesium, an essential element involved in human metabolism. Success in using magnesium alloys for the fabrication of endovascular devices is closely related to the properties of the selected alloy. In this context, a test bench was specifically designed to reproduce the physiological conditions to which stents are submitted when implanted in the coronary arteries. Then the test bench was validated using a magnesium-based alloy. Results showed that the corrosion rate and the corrosion mechanisms vary with the applied shear stress and that corrosion products strongly depend on the composition of the corrosive solution. This test bench will thus be useful in further investigations for the development of metallic alloys as degradable biomaterials.