Biodegradable Fe-based alloys for use in osteosynthesis: outcome of an in vivo study after 52 weeks.

This study investigates the degradation performance of three Fe-based materials in a growing rat skeleton over a period of 1 year. Pins of pure Fe and two Fe-based alloys (Fe-10 Mn-1Pd and Fe-21 Mn-0.7C-1Pd, in wt.%) were implanted transcortically into the femur of 38 Sprague-Dawley rats and inspected after 4, 12, 24 and 52 weeks. The assessment was performed by ex vivo microfocus computed tomography, weight-loss determination, surface analysis of the explanted pins and histological examination. The materials investigated showed signs of degradation; however, the degradation proceeded rather slowly and no significant differences between the materials were detected. We discuss these unexpected findings on the basis of fundamental considerations regarding iron corrosion. Dense layers of degradation products were formed on the implants' surfaces, and act as barriers against oxygen transport. For the degradation of iron, however, the presence of oxygen is an indispensable prerequisite. Its availability is generally a critical factor in bony tissue and rather limited there, i.e. in the vicinity of our implants. Because of the relatively slow degradation of both pure Fe and the Fe-based alloys, their suitability for bulk temporary implants such as those in osteosynthesis applications appears questionable.

Degradation performance of biodegradable Fe-Mn-C(-Pd) alloys.

Biodegradable metals offer great potential in circumventing the long-term risks and side effects of medical implants. Austenitic Fe-Mn-C-Pd alloys feature a well-balanced combination of high strength and considerable ductility which make them attractive for use as degradable implant material. The focus of this study is the evaluation of the degradation performance of these alloys by means of immersion testing and electrochemical impedance spectroscopy in simulated body fluid. The Fe-Mn-C-Pd alloys are characterized by an increased degradation rate compared to pure Fe, as revealed by both techniques. Electrochemical measurements turned out to be a sensitive tool for investigating the degradation behavior. They not only show that the polarization resistance is a measure of corrosion tendency, but also provide information on the evolution of the degradation product layers. The mass loss data from immersion tests indicate a decreasing degradation rate for longer times due to the formation of degradation products on the sample surfaces. The results are discussed in detail in terms of the degradation mechanism of Fe-based alloys in physiological media.

On the cytocompatibility of biodegradable Fe-based alloys.

Biodegradable iron-based alloys are potential candidates for application as temporary implant material. This study summarizes the design strategy applied in the development of biodegradable Fe-Mn-C-Pd alloys and describes the key factors which make them suitable for medical applications. The study's in vitro cytotoxicity tests using human umbilical vein endothelial cells revealed acceptable cytocompatibility based on the alloys' eluates. An analysis of the eluates revealed that Fe is predominantly bound in insoluble degradation products, whereas a considerable amount of Mn is in solution. The investigation's results are discussed using dose-response curves for the main alloying elements Fe and Mn. They show that it is mainly Mn which limits the cytocompatibility of the alloys. The study also supplies a summary of the alloying elements' influence on metabolic processes. The results and discussion presented are considered important and instructive for future alloy development. The Fe-based alloys developed show an advantageous combination of microstructural, mechanical and biological properties, which makes them interesting as degradable implant material.

Towards biodegradable wireless implants.

A new generation of partially or even fully biodegradable implants is emerging. The idea of using temporary devices is to avoid a second surgery to remove the implant after its period of use, thereby improving considerably the patient's comfort and safety. This paper provides a state-of-the-art overview and an experimental section that describes the key technological challenges for making biodegradable devices. The general considerations for the design and synthesis of biodegradable components are illustrated with radiofrequency-driven resistor-inductor-capacitor (RLC) resonators made of biodegradable metals (Mg, Mg alloy, Fe, Fe alloys) and biodegradable conductive polymer composites (polycaprolactone-polypyrrole, polylactide-polypyrrole). Two concepts for partially/fully biodegradable wireless implants are discussed, the ultimate goal being to obtain a fully biodegradable sensor for in vivo sensing.

Design strategy for biodegradable Fe-based alloys for medical applications.

The aim of this article is to describe a design strategy for the development of new biodegradable Fe-based alloys offering a performance considered appropriate for temporary implant applications, in terms of both an enhanced degradation rate compared to pure iron, and suitable strength and ductility. The design strategy is based on electrochemical, microstructural and toxicological considerations. The influence of alloying elements on the electrochemical modification of the Fe matrix and the controlled formation of noble intermetallic phases is deployed. Such intermetallic phases are responsible for both an increased degradation rate and enhanced strength. Manganese and palladium have been shown to be suitable alloying additions for this design strategy: Mn lowers the standard electrode potential, while Pd forms noble (Fe,Mn)Pd intermetallics that act as cathodic sites. We discuss the efficiency and the potential of the design approach, and evaluate the resulting characteristics of the new alloys using metal-physical experiments including electrochemical measurements, phase identification analysis and electron microscopy studies. The newly developed Fe-Mn-Pd alloys reveal a degradation resistance that is one order of magnitude lower than observed for pure iron. Additionally, the mechanical performance is shown to be adjustable not only by the choice of alloying elements but also by heat treatment procedures; high strength values >1400MPa at ductility levels >10% can be achieved. Thus, the new alloys offer an attractive combination of electrochemical and mechanical characteristics considered suitable for biodegradable medical applications.

On the in vitro and in vivo degradation performance and biological response of new biodegradable Mg-Y-Zn alloys.

A design strategy deployed in developing new biodegradable Mg-Y-Zn alloys is summarized and the key factors influencing their suitability for medical applications are described. The Mg-Y-Zn alloys reveal microstructural features and mechanical characteristics expected to be appropriate for vascular intervention applications. The focus of this article lies in the evaluation of the degradation performance and biological response of the alloys with respect to their potential as implant materials (stents). The degradation characteristics analyzed by immersion testing and electrochemical impedance spectroscopy in simulated physiological media reveal slow and homogeneous degradation. In vitro cell tests using human umbilical vein endothelial cells indicate good cytocompatibility on the basis of the alloys' eluates (extracts). Animal studies carried out with pigs on Mg-2Y-1Zn (in wt.%) reveal an auspicious in vivo performance. Evaluation of preparations derived from implants in various types of tissues indicates homogeneous degradation and only limited gas formation during in vivo testing. The characteristics of the tissue reactions indicate good biocompatibility. The new Mg-Y-Zn alloys show an interesting combination of preferred microstructural, mechanical, electrochemical and biological properties, which make them very promising for degradable implant applications.

On the biodegradation performance of an Mg-Y-RE alloy with various surface conditions in simulated body fluid.

This study documents the influence of different surface conditions produced by various heat treatments on the in vitro degradation performance of an Mg-Y-RE alloy (WE43) investigated by immersion in simulated body fluid. WE43 samples were, respectively (i) annealed at 525 degrees C (plus artificial aging at 250 degrees C in one case) and afterwards polished; and (ii) polished, annealed at 500 degrees C in air and subsequently investigated in the oxidized state. Thermogravimetric analysis (TGA) indicates a mass gain during oxidation in air, following a square-root law over time. X-ray diffraction spectra imply a growing Y(2)O(3) layer upon oxidation, and Auger electron spectroscopy depth profiles show an increased oxide layer thickness which develops according to the behavior observed by TGA. Macroscopically, the degradation performance of the differently heat-treated samples can be divided into two groups. Annealed and polished samples show a fast and homogeneous degradation which slows with time. Their degradation behavior is approximated by a parabolic law. Oxidized samples exhibit a slow initial degradation rate which increases when the protection of the oxide layer is reduced. Overall, they reveal a sigmoidal degradation behavior. Here the differing degradation performances of the annealed-polished and the oxidized samples are related to the different surface conditions and explained on the basis of a depletion hypothesis.