J. A. Puértolas

Fractography evolution in accelerated aging of UHMWPE after gamma irradiation in air.

We studied the fracture surface evolution of ultra high molecular weight polyethylene (UHMWPE) specimens, manufactured from GUR 1050 compression moulded sheets, after gamma sterilisation in air followed by different aging times after thermal treatment at 120 degrees C. Degradation profiles were obtained by FTIR and DSC measurements after 0, 7, 14, 24 and 36h aging. We observed by SEM the morphology patterns at these aging times, in surface fractographies after uniaxial tensile test of standardised samples. The results pointed out clear differences between short and long aging times. At shorter times, 7h, the behaviour was similar to non-degraded UHMWPE, exhibiting ductile behaviour. At longer times, 24-36h, this thermal protocol provided a highly degraded zone in the subsurface, similar to the white band found after gamma irradiation in air followed by natural aging, although closer to the surface, at 150-200mum. The microstructure of this oxidation zone, similarly found in gamma irradiated samples shelf-aged for 6-7 years, although with different distribution of microvoids, was formed by fibrils, associated with embrittlement of the oxidised UHMWPE. In addition, the evolution of the oxidation index, the enthalpy content, the mechanical parameters, and the depth of the oxidation front deduced from the fractographies versus aging time showed that a changing behaviour in the degradation rate appeared at intermediate aging times.

Hollow porous implants filled with mesoporous silica particles as a two-stage antibiotic-eluting device

A new type of implantable drug eluting device is presented, consisting of a bed of mesoporous microparticles packed inside a reservoir with a porous wall. This provides two sets of variables for drug release control that can be tailored independently. The first is related to the microparticles (packing density, size and pore structure) and the second to the reservoir (pore diameter and thickness of the wall, permeation area). In this work the concept is developed into a working model, used to fight bacterial (Staphylococcus aureus) growth by releasing linezolid that had previously been adsorbed on silica microparticles. These particles were placed inside the hollow interior of a porous medical grade stainless steel pin mimicking those used in traumatology and in orthopedic surgery. The mechanical behavior of the porous drug-eluting pin was tested and found satisfactory.

Microstructure, thermooxidation and mechanical behavior of a novel highly linear, vitamin E stabilized, UHMWPE.

A novel, vitamin E-stabilized, medical grade ultra-high molecular polyethylene, MG003 (DSM Biomedical; The Netherlands), has been very recently introduced for use in total joint replacements. This homopolymer resin features average molecular weight similar to that of conventional GUR 1050 resin (5.5-6*10(6)g/mol), but a higher degree of linearity. The aim of this study was to characterize the microstructure, thermal and thermooxidation properties as well as the mechanical behavior of this novel MG003 resin before and after gamma irradiation in air to 90 kGy. For this purpose, a combination of experimental techniques were performed including differential scanning calorimetry (DSC), thermogravimetry (TG), transmission electron microscopy (TEM), X-Ray Diffraction, electron paramagnetic resonance (EPR), and uniaxial tensile tests. As-consolidated MG003 materials exhibited higher crystalline contents (~62%), transition temperatures (~140 °C), crystal thickness (~36 nm), yield stress (~25 MPa) and elastic modulus (~400 MPa) than GUR 1050 controls (55%, 136 °C, 27 nm, 19 MPa, and 353 MPa, respectively). Irradiation produced similar changes in both MG003 and GUR 1050 materials, specifically increased crystallinity (63% and 60%, respectively), crystal thickness (39 nm and 30 nm), yield stress (27 MPa and 21 MPa), but, above of all, loss of elongation to breakage (down to 442 and 469%, respectively). Thermogravimetric and EPR results suggest comparable susceptibilities to oxidation for both MG003 and GUR 1050 polyethylenes. Based on the present findings, MG003 appears as a promising alternative medical grade polyethylene and it may satisfactorily contribute to the performance of total joint replacements.

Effect of Nitinol surface treatments on its physico-chemical properties

The main purpose of this work is the study of different physicochemical treatments on Nitinol slabs and wires, with the aim of inducing the formation of a TiO(2) surface film capable of increasing the corrosion resistance of the material and of reducing the release of Ni when the Nitinol samples were immersed in simulated body fluid (SBF). To this end, a battery of measurements (surface roughness, contact angle, electrochemical corrosion, chemical analysis as a function of depth, and Ni release to SBF) has been used to characterize Nitinol commercial samples, as received, and also after the different treatments performed. The results clearly indicate the effectiveness of the passivation TiO(2) layer as a barrier against Ni leaching, and the detrimental effects of any processes (such as polishing or cutting) that result in exposure of areas not coated by the TiO(2) film. Chemical methods such as oxidation in nitric acid or hydrothermal treatment of the samples (by prolonged immersion in boiling water) seem to provide simple and efficient ways of forming TiO(2) films of adequate thickness on the Nitinol surface.

Polyethylene Oxidation in Total Hip Arthroplasty: Evolution and New Advances

Ultra-high molecular weight polyethylene (UHMWPE) remains the gold standard acetabular bearing material for hip arthroplasty. Its successful performance has shown consistent results and survivorship in total hip replacement (THR) above 85% after 15 years, with different patients, surgeons, or designs. As THR results have been challenged by wear, oxidation, and liner fracture, relevant research on the material properties in the past decade has led to the development and clinical introduction of highly crosslinked polyethylenes (HXLPE). More stress on the bearing (more active, overweighted, younger patients), and more variability in the implantation technique in different small and large Hospitals may further compromise the clinical performance for many patients. The long-term in vivo performance of these materials remains to be proven. Clinical and retrieval studies after more than 5 years of in vivo use with HXLPE in THR are reviewed and consistently show a substantial decrease in wear rate. Moreover, a second generation of improved polyethylenes is backed by in vitro data and awaits more clinical experience to confirm the experimental improvements. Also, new antioxidant, free radical scavengers, candidates and the reinforcement of polyethylene through composites are currently under basic research. Oxidation of polyethylene is today significantly reduced by present formulations, and this forgiving, affordable, and wellknown material is still reliable to meet today’s higher requirements in total hip replacement.

Knee model of hydrodynamic lubrication during the gait cycle and the influence of prosthetic joint conformity

BackgroundThe influence of the total joint components’ elastic deformation on lubrication is generally accepted, but little is known about the influence of joint conformity under hydrodynamic lubrication based on fluid film interposition. The aim of this study was to evaluate induced pressure and stresses in the knee under fluid film lubrication during the stance phase of walking under various joint conformity conditions.MethodsA theoretical two-dimensional (2D) geometric model of knee prosthesis contact, with Dirichlet boundary conditions at both edges, and with a conformity index (CI) of 0, 0.3, 0.5, 0.6, 0.7, 0.8, 0.9, 0.92, 0.94, 0.96, 0.98, 0.99, 0.995, and 1.0, was used to calculate the spatiotemporal lubricant flow on a synovial fluid rheological model. With the instantaneous load as a source term, the Reynolds lubrication equation was subsequently solved following a finite volume approach in two dimensions and three dimensions.ResultsConformity strongly influenced the peak pressure, from 47 MPa with CI = 0 to 1.4 MPa with CI = 1, with a definite behavior change from CI = 0.96. The role of hydrodynamic lubrication was restricted to early steps of the stance phase. With CI < 0.96, there was a smooth maximum pressure decrease with increasing CI. In contrast, the maximum pressure fell abruptly with conformity > 0.96.ConclusionThe present model suggested the limited modifying effect of hydrodynamic lubrication in total knee replacement systems. However, its role during the early stance phase, coupled with high conformity, helps significantly to decrease compressive stresses on the polyethylene, fostering the beneficial effect of high conformity in a mixed lubrication regime. This beneficial effect may also be of great interest in total knee replacement systems based on materials with less deformation.

Mechanical comparative analysis of stents for colorectal obstruction

The goal of this work is the mechanical comparison of different types of stents for colorectal obstructions. We consider self‐expanding and balloon‐expanding stents made of two different materials such as stainless steel and shape memory NiTi alloy. The mechanical parameters are expansion rate, shortening, radial compression resistance, longitudinal and perimetral adaptability, and buckling resistance. This analysis results in a better understanding of global mechanical behavior and also allows better design and device selection for colonic lesions.

Study of the Behavior of a Bell-Shaped Colonic Self-Expandable NiTi Stent under Peristaltic Movements

Managing bowel obstruction produced by colon cancer requires an emergency intervention to patients usually in poor conditions, and it requires creating an intestinal stoma in most cases. Regardless of that the tumor may be resectable, a two-stage surgery is mandatory. To avoid these disadvantages, endoscopic placement of self-expanding stents has been introduced more than 10 years ago, as an alternative to relieve colonic obstruction. It can be used as a bridge to elective single-stage surgery avoiding a stoma or as a definitive palliative solution in patients with irresectable tumor or poor estimated survival. Stents must be capable of exerting an adequate radial pressure on the stenosed wall, keeping in mind that stent must not move or be crushed, guaranteeing an adequate lumen when affected by peristaltic waves. A finite element simulation of bell-shaped nitinol stent functionality has been done. Catheter introduction, releasing at position, and the effect of peristaltic wave were simulated. To check the reliability of the simulation, a clinical experimentation with porcine specimens was carried out. The stent presented a good deployment and flexibility. Stent behavior was excellent, expanding from the very narrow lumen corresponding to the maximum peristaltic pressure to the complete recovery of operative lumen when the pressure disappears.

UHMWPE Matrix Composites

Ultra-high molecular weight polyethylene (UHMWPE) composites reinforced with different filler materials are being developed for aerospace, industrial, and biomedical applications, with the aim of enhancing the mechanical performances of virgin UHMWPE. In orthopedics, these UHMWPE-based composites are being researched as a potential alternative to the highly cross-linked UHMWPE (HXLPE) obtained by high-energy radiation and thermal or antioxidant stabilization. Therefore, there is increased interest in UHMWPE composites to improve the strength of the current UHMWPE components in total joint arthoplasty, without sacrificing their other excellent attributes such as biocompatibility, chemical stability, and wear resistance.

Probabilistic assessment of fatigue initiation data on highly crosslinked ultrahigh molecular weight polyethylenes

Ultrahigh molecular weight polyethylenes (UHMWPE) showing wear resistance, oxidative stability and good mechanical performance go on being a relevant research area in biomaterials for total joint replacements, where fatigue happens to be a recurrent damage mode that needs to be investigated. While crack propagation lifetime has been extensively studied, fatigue initiation data are scarcely offered in the literature, often due to the higher costs implied in the experimental programs. Moreover, their analysis is not always suitable to obtain reliable guidance. Different deterministic and probabilistic methods, generally resting on empirical bases have been previously used to analyze the fatigue initiation data. In this work, the probabilistic Weibull regression model of Castillo et al., based on both physical and statistical conditions, such as weakest link principle and the necessary compatibility between life-time and stress range distributions, is applied for the first time in the assessment of fatigue results of polymers, particularly to highly crosslinked UHMWPEs (HXLPEs). Accordingly, different published experimental data corresponding to HXLPE stabilized by thermal treatments and with α-tocopherol (vitamin E) are re-analyzed. Additional data are incorporated to assess the influence of notched HXLPE on fatigue performance. New conclusions are drawn from this revision.