In vitro and in vivo corrosion properties of new iron-manganese alloys designed for cardiovascular applications.

The principle of biodegradation for the production of temporary implant materials (e.g. stents) plays an important role in the treatment of congenital heart defects. In the last decade several attempts have been made with different alloy materials-mainly based on iron and magnesium. None of the currently available materials in this field have demonstrated satisfying results and have therefore not found entry into broad clinical practice. While magnesium or magnesium alloy systems corrode too fast, the corrosion rate of pure iron-stents is too slow for cardiovascular applications. In the last years FeMn alloy systems were developed with the idea that galvanic effects, caused by different electrochemical properties of Fe and Mn, would increase the corrosion rate. In vitro tests with alloys containing up to 30% Mn showed promising results in terms of biocompatibility. This study deals with the development of new FeMn alloy systems with lower Mn concentrations (FeMn 0.5 wt %, FeMn 2.7 wt %, FeMn 6.9 wt %) to avoid Mn toxicity. Our results show, that these alloys exhibit good mechanical features as well as suitable in vitro biocompatibility and corrosion properties. In contrast, the evaluation of these alloys in a mouse model led to unexpected results-even after 9 months no significant corrosion was detectable. Preliminary SEM investigations showed that passivation layers (FeMn phosphates) might be the reason for corrosion resistance. If this can be proved in further experiments, strategies to prevent or dissolve those layers need to be developed to expedite the in vivo corrosion of FeMn alloys.

Machining human dentin by abrasive water jet drilling.

The aim of this experimental in-vitro study was to investigate the machining of human dentin using an abrasive water jet and to evaluate the influence of different abrasives and water pressures on the removal rate. Seventy-two human teeth had been collected after extraction and randomly divided into six homogeneous groups (n=12). The teeth were processed in the area of root dentin with an industrial water jet device. Different abrasives (saccharose, sorbitol, xylitol) and water pressures (15 or 25 MPa) were used in each group. Dimensions of dentin removal were analysed using a stripe projection microscope and both drilling depth as well as volume of abrasion were recorded. Morphological analyses of the dentin cavities were performed using scanning electron microscopy (SEM). Both drilling depth and volume of abrasion were significantly influenced by the abrasive and the water pressure. Depending on these parameters, the drilling depth averaged between 142 and 378 µm; the volume of abrasion averaged between 0.07 and 0.15 mm3. Microscopic images revealed that all cavities are spherical and with clearly defined margins. Slight differences between the abrasives were found with respect to the microroughness of the surface of the cavities. The results indicate that abrasive water jet machining is a promising technique for processing human dentin.

Intraprosthetic screw fixation increases primary fixation stability in periprosthetic fractures of the femur - a biomechanical study.

BACKGROUND: The purpose of this study was to develop a new fixation technique for the treatment of periprosthetic fractures using intraprosthetic screw fixation. The goal was to biomechanically evaluate the increase in primary fixation stability compared to unicortical locked-screw plating. METHODS: A Vancouver C periprosthetic fracture was simulated in femur prosthesis constructs. Fixation was then performed with either unicortical locked-screw plating using the LISS-plate or with intraprosthetic screw fixation. Fixation stability was compared in an axial load-to-failure model. RESULTS: The intraprosthetic fixation model was superior to the unicortical locked-screw fixation in all tested devices. The intraprosthetic fixation model required 11,807N±1596N for failure and the unicortical locked-screw plating required 7649N±653N (p=0.002). CONCLUSION: Intraprosthetic screw anchorage with a special prosthesis drill enhances the primary stability in treating periprosthetic fractures by internal fixation.

In vivo degradation of magnesium alloy LA63 scaffolds for temporary stabilization of biological myocardial grafts in a swine model.

Synthetic or biological patch materials used for surgical myocardial reconstruction are often fragile. Therefore, a transient support by degradable magnesium scaffolds can reduce the risk of dilation or rupture of the patch until physiological remodeling has led to a sufficient mechanical durability. However, there is evidence that magnesium implants can influence the growth and physiological behavior of the host's cells and tissue. Hence, we epicardially implanted scaffolds of the magnesium fluoride-coated magnesium alloy LA63 in a swine model to assess biocompatibility and degradation kinetics. Chemical analysis of the pigs' organs revealed no toxic accumulation of magnesium ions in the skeletal muscle, myocardium, liver, kidney, and bone of the pigs 1, 3, and 6 months postimplantation. The implants were surrounded by a fibrous granulation tissue, but no signs of necrosis were histologically evaluable. A sufficiently slow degradation rate of the magnesium alloy scaffold can be demonstrated via micro-computed tomography investigation. We conclude that stabilizing scaffolds of the magnesium fluoride-coated magnesium alloy LA63 can be used for epicardial application because no significant adverse effects to myocardial tissue were noted. Thus, degradable stabilizing scaffolds of this magnesium alloy with a slow degradation rate can extend the indication of innovative biological and synthetic patch materials.

Different thermal conductivity in drilling of cemented compared with cementless hip prostheses in the treatment of periprosthetic fractures of the proximal femur: an experimental biomechanical analysis.

PURPOSE: The purpose of this study was to evaluate the different temperature levels whilst drilling cemented and cementless hip prostheses implanted in bovine femora, and to evaluate the insulating function of the cement layer. METHODS: Standard hip prostheses were implanted in bovine donor diaphyses, with or without a cement layer. Drilling was then performed using high-performance-cutting drills with a reinforced core, a drilling diameter of 5.5 mm and cooling channels through the tip of the drill for constantly applied internal cooling solution. An open type cooling model was used in this setup. Temperature was continuously measured by seven thermocouples placed around the borehole. Thermographic scans were also performed during drilling. RESULTS: At the cemented implant surface, the temperature never surpassed 24.7 °C when constantly applied internal cooling was used. Without the insulating cement layer (i.e. during drilling of the cementless bone-prosthesis construct), the temperature increased to 47 °C. CONCLUSION: Constantly applied internal cooling can avoid structural bone and soft tissue damage during drilling procedures. With a cement layer, the temperatures only increased to non-damaging levels. The results could be useful in the treatment of periprosthetic fractures with intraprosthetic implant fixation.

The effects of handling and storage on magnesium based implants--first results.

The present work aimed to investigate the influence of acetone and formalin as well as the duration and type of storage on magnesium based implants by means of microscopic, µ-computed tomographic, scanning electron microscopic, EDX and metallographic investigations. In contrast to storing in acetone, storage in formalin led to an increase in surface to volume ratio, and a decrease of the volume and the density. The various types of storage exerted no differing effects on the implants but with increasing storage duration, a spreading of oxygen rich areas on the surface, increased precipitations and a decrease in grain size could be observed.

Strong and tough magnesium wire reinforced phosphate cement composites for load-bearing bone replacement.

Calcium phosphate cements are brittle biomaterials of low bending strength. One promising approach to improve their mechanical properties is reinforcement with fibers. State of the art degradable reinforced composites contain fibers made of polymers, resorbable glass or whiskers of calcium minerals. We introduce a new class of composite that is reinforced with degradable magnesium alloy wires. Bending strength and ductility of the composites increased with aspect ratio and volume content of the reinforcements up to a maximal bending strength of 139±41MPa. Hybrid reinforcement with metal and polymer fibers (PLA) further improved the qualitative fracture behavior and gave indication of enhanced strength and ductility. Immersion tests of composites in SBF for seven weeks showed high corrosion stability of ZEK100 wires and slow degradation of the magnesium calcium phosphate cement by struvite dissolution. Finally, in vitro tests with the osteoblast-like cell line MG63 demonstrate cytocompatibility of the composite materials.

Temperature control with internally applied cooling in solid material drilling: an experimental, biomechanical study.

PURPOSE: The purpose of this study was to evaluate the different temperature levels while drilling solid materials and to compare different cooling solutions for possible temperature control. An additional purpose was to develop an internal cooling device which can be connected to routinely used manual drilling devices in trauma surgery. METHODS: Drilling was performed on a straight hip stem implanted in bovine femora without cooling, with externally applied cooling and with a newly developed internal cooling device. Temperature changes were measured by seven thermocouples arranged near the borehole. Additionally, thermographic scans were performed during drilling. RESULTS: Drilling without cooling leads to an immediate increase in temperature to levels of thermal osteonecrosis (over 200 °C). With externally applied cooling temperatures were decreased, but were still up to a tissue damaging 85 °C. Internally applied cooling led to a temperature decrease to tissue-preserving levels during the drilling procedure (24.7 °C). CONCLUSION: Internal cooling with HPC-drillers lowered the measured temperatures to non-tissue damaging temperatures and should avoid structural tissue damage.

Biocompatibility of fluoride-coated magnesium-calcium alloys with optimized degradation kinetics in a subcutaneous mouse model.

The principle of biodegradation has been considered for many years in the development of cardiovascular stents, especially for patients with congenital heart defects. A variety of materials have been examined with regard to their suitability for cardiovascular devices. Iron- and magnesium-based stents were investigated intensively during the last years. It has been shown, that iron, or iron based alloys have slow degradation kinetics whereas magnesium-based systems exhibit rapid degradation rates. Recently we have developed fluoride coated binary magnesium-calcium alloys with reduced degradation kinetics. These alloys exhibit good biocompatibility and no major adverse effects toward smooth muscle and endothelial cells in in vitro experiments. In this study, these alloys were investigated in a subcutaneous mouse model. Fluoride coated (fc) magnesium, as well as MgCa0.4%, MgCa0.6%, MgCa0.8%, MgCa1.0%, and a commercially available WE43 alloy were implanted in form of (fc) cylindrical plates into the subcutaneous tissue of NMRI mice. After a 3 and 6 months follow-up, the (fc) alloy plates were examined by histomorphometric techniques to assess their degradation rate in vivo. Our data indicate that all (fc) alloys showed a significant corrosion. For both time points the (fc) MgCa alloys showed a higher corrosion rate in comparison to the (fc) WE43 reference alloy. Significant adverse effects were not observed. Fluoride coating of magnesium-based alloys can be a suitable way to reduce degradation rates. However, the (fc) MgCa alloys did not exhibit decreased degradation kinetics in comparison to the (fc) WE43 alloy in a subcutaneous mouse model.

Histological and molecular evaluation of iron as degradable medical implant material in a murine animal model.

A small animal model was established to evaluate the potential of iron as a degradable implant material. After insertion into the tail of mice, the implants gradually degraded over a clinically relevant time period of several months. Histological analysis and gene expression data from whole-genome microarray analyses indicated a limited inflammatory reaction. No evidence of cellular responses to excess iron ions was detected, suggesting that the iron degradation products were metabolically inactive. Iron-rich compounds could be detected in the vicinity of the implant and in individual cells distant from the implantation site. These results demonstrate that the mouse model could be useful for the primary in vivo evaluation of novel implant materials and that iron degradation products can accumulate in diverse organs of the body.

In vitro corrosion of ZEK100 plates in Hank's Balanced Salt Solution.

BACKGROUND: In recent years magnesium alloys have been intensively investigated as potential resorbable materials with appropriate mechanical and corrosion properties. Particularly in orthopedic research magnesium is interesting because of its mechanical properties close to those of natural bone, the prevention of both stress shielding and removal of the implant after surgery. METHODS: ZEK100 plates were examined in this in vitro study with Hank's Balanced Salt Solution under physiological conditions with a constant laminar flow rate. After 14, 28 and 42 days of immersion the ZEK100 plates were mechanically tested via four point bending test. The surfaces of the immersed specimens were characterized by SEM, EDX and XRD. RESULTS: The four point bending test displayed an increased bending strength after 6 weeks immersion compared to the 2 week group and 4 week group. The characterization of the surface revealed the presence of high amounts of O, P and Ca on the surface and small Mg content. This indicates the precipitation of calcium phosphates with low solubility on the surface of the ZEK100 plates. CONCLUSIONS: The results of the present in vitro study indicate that ZEK100 is a potential candidate for degradable orthopedic implants. Further investigations are needed to examine the degradation behavior.

Influence of cobalt on the properties of load-sensitive magnesium alloys.

In this study, magnesium is alloyed with varying amounts of the ferromagnetic alloying element cobalt in order to obtain lightweight load-sensitive materials with sensory properties which allow an online-monitoring of mechanical forces applied to components made from Mg-Co alloys. An optimized casting process with the use of extruded Mg-Co powder rods is utilized which enables the production of magnetic magnesium alloys with a reproducible Co concentration. The efficiency of the casting process is confirmed by SEM analyses. Microstructures and Co-rich precipitations of various Mg-Co alloys are investigated by means of EDS and XRD analyses. The Mg-Co alloys' mechanical strengths are determined by tensile tests. Magnetic properties of the Mg-Co sensor alloys depending on the cobalt content and the acting mechanical load are measured utilizing the harmonic analysis of eddy-current signals. Within the scope of this work, the influence of the element cobalt on magnesium is investigated in detail and an optimal cobalt concentration is defined based on the performed examinations.

Intraprosthetic fixation techniques in the treatment of periprosthetic fractures-A biomechanical study.

AIM: To develop new fixation techniques for the treatment of periprosthetic fractures using intraprosthetic screw fixation with inserted threaded liners. METHODS: A Vancouver B1 periprosthetic fracture was simulated in femur prosthesis constructs using sawbones and cemented regular straight hip stems. Fixation was then performed with either unicortical locked-screw plating using the less invasive stabilization system-plate or with intraprosthetic screw fixation using inserted liners. Two experimental groups were formed using either prostheses made of titanium alloy or prostheses made of cobalt chrome alloy. Fixation stability was compared in an axial load-to-failure model. Drilling was performed using a specially invented prosthesis drill with constantly applied internal cooling. RESULTS: The intraprosthetic fixation model with titanium prostheses was superior to the unicortical locked-screw fixation in all tested devices. The intraprosthetic fixation model required 10 456 N ± 1892 N for failure and the unicortical locked-screw plating required 7649 N ± 653 N (P < 0.05). There was no significant difference between the second experimental group and the control group. CONCLUSION: Intraprosthetic screw anchorage with special threaded liners enhances the primary stability in treating periprosthetic fractures by internal fixation.

Effect of thermal expansion mismatch on the Y-TZP/veneer interfacial adhesion determined by strain energy release rate.

PURPOSES: The aim of this study was to assess the effect of differences in the thermal expansion behaviour of veneering ceramics on the adhesion to Y-TZP, using a fracture mechanics approach. METHODS: Seven veneering ceramics (VM7, VM9, VM13, Lava Ceram, Zirox, Triceram, Allux) and one Y-TZP ceramic were investigated. Thermal expansion coefficients and glass transition temperatures were determined to calculate residual stresses (σ(R), MPa) between core and veneer. Subsequently, the veneering ceramics were fired onto rectangular shaped zirconia specimens, ground flat and notched on the veneering porcelain side. Then specimens were loaded in a four-point bending test and load-displacement curves were recorded. The critical load to induce stable crack extension at the adhesion interface was evaluated to calculate the strain energy release rate (G, J/m(2)) for each system. RESULTS: Residual stresses ranged from -48.3±1.5MPa (VM7) to 36.1±4.8MPa (VM13) with significant differences between all groups (p<0.05). The strain energy release rate of the Y-TZP/veneer specimens ranged from 8.2±1.7J/m(2) (Lava Ceram) to 17.1±2.8J/m(2) (VM9). Values for G could not be obtained with the VM7, Allux and VM13 specimens, due to spontaneous debonding or unstable crack growth. Except for Triceram and Zirox specimens, strain energy release rate was significantly different between all groups (p<0.05). CONCLUSION: Thermal residual stresses and strain energy release rates were correlated. Slight compressive stresses in the region of -20MPa were beneficial for the Y-TZP/veneer interfacial adhesion. Stresses higher or lower than this value exhibited decreased adhesion.

Low-temperature degradation of different zirconia ceramics for dental applications.

The aim of this investigation was to determine the influence of simulated ageing on the tetragonal-to-monoclinic phase transformation and on the flexural strength of a 3Y-TZP ceramic, compared to alumina toughened zirconia (ATZ) and ceria-stabilized zirconia (12Ce-TZP). Standardized disc specimens of each material were hydrothermally aged in steam at 134°C and 3bar for 0, 16, 32, 64 or 128h. The phase transformation was determined by X-ray diffraction (XRD) and atomic force microscopy. Scanning electron microscopy was performed to estimate the depth of the transformation zone. The flexural strength was investigated in a biaxial flexural test. XRD revealed a significant increase in the monoclinic phase content for 3Y-TZP and ATZ due to ageing, although this increase was less pronounced for ATZ. In contrast, the monoclinic phase content of 12Ce-TZP was not influenced. For 3Y-TZP and ATZ, a transformation zone was found of which the depth linearly correlated with ageing time, while for 12Ce-TZP no transformation zone could be observed. Changes in flexural strength after ageing were heterogeneous: while 3Y-TZP showed a significant decrease in strength - from 1740 to 1169 MPa - with ATZ there was a considerable increase - from 1093 to 1378 MPa. The flexural strength of 12Ce-TZP remained unaffected at the low level of about 500 MPa. These results indicate that both alumina and ceria, as stabilizing oxides, reduce the susceptibility of zirconia to hydrothermal degradation; the alternative use of these oxides may enhance the clinical long-term stability of dental zirconia restorations.

Ex vivo examination of the biocompatibility of biodegradable magnesium via microdialysis in the isolated perfused bovine udder model.

PURPOSE: Being biodegradable, magnesium is considered a promising future implant material but very little is known about the biocompatibility for the tissues in direct contact with it. In this study, the degradation of pure magnesium implants in the skin of an isolated bovine udder was examined over a period of five hours. METHODS: Microdialysis technique was used in order to investigate the reactions at the interface of implant and tissue. Pure titanium implants served as control. Degradation behavior and biocompatibility were evaluated via extracellular magnesium ion concentration and PGE2 and TNF alpha served as indicators of inflammation. RESULTS: Concentrations of 5.5 mmol/l Mg2+ were detected at the beginning, which decreased to a plateau of about 3.5 mmol/l after approximately two and a half hours. PGE2 and TNF alpha concentrations indicated no major inflammatory tissue response to the degradation. CONCLUSIONS: These results give an idea of the ion burden at the implantation site of degrading magnesium and suggest good biocompatibility even at the tissue-implant interface.

Novel Repair Concept for Composite Materials by Repetitive Geometrical Interlock Elements.

Material adapted repair technologies for fiber-reinforced polymers with thermosetting matrix systems are currently characterized by requiring major efforts for repair preparation and accomplishment in all industrial areas of application. In order to allow for a uniform distribution of material and geometrical parameters over the repair zone, a novel composite interlock repair concept is introduced, which is based on a repair zone with undercuts prepared by water-jet technology. The presented numerical and experimental sensitivity analyses make a contribution to the systematic development of the interlock repair technology with respect to material and geometrical factors of influence. The results show the ability of the novel concept for a reproducible and automatable composite repair.