L'h. Yahia

Plasma Sterilization: A Review of Parameters, Mechanisms, and Limitations

Low-temperature plasma is a promising method for destroying microorganisms, an alternative to “conventional” methods which have numerous drawbacks. Several plasma-based sterilization technologies are presently under development, but their mechanisms of action are still incompletely understood. Since more than five years, we have investigated the effects of plasma on microorganisms (killing efficacy, and related mechanisms), as well as on the materials being sterilized. This article reports some important observations made during this work, using the commercialized so-called “plasma sterilizers” and “real” low-pressure plasma systems. The mechanism of etching (volatilization) of microorganisms by plasma that we have observed, leads us to believe that plasma may constitute a powerful solution to the clinical problems of deactivating also prions and endotoxins. However, plasma effectiveness is influenced by numerous experimental parameters, which we review here. This inherent complexity, and the weak penetrating power of plasma species, that severely limits plasma effectiveness in the presence of organic residues, packaging material, or complex geometries, are the main limitations of plasma sterilization.

Effect of surface treatment and sterilization processes on the corrosion behavior of NiTi shape memory alloy

Nickel-titanium (NiTi) alloy derives its biocompatibility and good corrosion resistance from a homogeneous oxide layer mainly composed of TiO(2), with a very low concentration of nickel. In this article, we described the corrosion behavior of NiTi alloys after mechanical polishing, electropolishing, and sterilization processes using cyclic polarization and atomic absorption. As a preparative surface treatment, electropolishing decreased the amount of nickel on the surface and remarkably improved the corrosion behavior of the alloy by increasing the mean breakdown potential value and the reproducibility of the results (0.99 +/- 0.05 V/SCE vs. 0.53 +/- 0. 42). Ethylene oxide and Sterrad(R) sterilization techniques did not modify the corrosion resistance of electropolished NiTi, whereas a steam autoclave and, to a lesser extent, peracetic acid sterilization produced scattered breakdown potential. In comparing the corrosion resistance of common biomaterials, NiTi ranked between 316L stainless steel and Ti6A14V even after sterilization. Electropolished NiTi and 316L stainless-steel alloys released similar amounts of nickel after a few days of immersion in Hanks solution. Measurements by atomic absorption have shown that the amount of released nickel from passive dissolution was below the expected toxic level in the human body. Auger electron spectroscopy analyses indicated surface contamination by Ca and P on NiTi during immersion, but no significant modification in oxide thickness was observed.

Effects of sterilization processes on NiTi alloy: Surface characterization

Sterilization is required for using any device in contact with the human body. Numerous authors have studied device properties after sterilization and reported on bulk and surface modifications of many materials after processing. These surface modifications may in turn influence device biocompatibility. Still, data are missing on the effect of sterilization procedures on new biomaterials such as nickel-titanium (NiTi). Herein we report on the effect of dry heat, steam autoclaving, ethylene oxide, peracetic acid, and plasma-based sterilization techniques on the surface properties of NiTi. After processing electropolished NiTi disks with these techniques, surface analyses were performed by Auger electron spectroscopy (AES), atomic force microscopy (AFM), and contact angle measurements. AES analyses revealed a higher Ni concentration (6-7 vs. 1%) and a slightly thicker oxide layer on the surface for heat and ethylene oxide processed materials. Studies of surface topography by AFM showed up to a threefold increase of the surface roughness when disks were dry heat sterilized. An increase of the surface energy of up to 100% was calculated for plasma treated surfaces. Our results point out that some surface modifications are induced by sterilization procedures. Further work is required to assess the effect of these modifications on biocompatibility, and to determine the most appropriate methods to sterilize NiTi.

Characterization of in vivo wear debris from ceramic—ceramic total hip arthroplasties

In contrast to the much-studied mechanism of aseptic loosening of the metal-polyethylene joint couple, the mechanism responsible for failure of ceramic-ceramic (CC) total hip arthroplasties (THAs) has not been evaluated. The aim of this study was to conduct a systematic characterization of the in vivo wear debris from 15 cases of CC THAs revised for aseptic loosening. Two methods were used to evaluate the wear debris; a semiquantitative histological analysis of H&E-stained periprosthetic pseudomembranes; and an evaluation of isolated debris particles using SEM, energy-dispersive X-ray analysis, and image analysis. The three main types of particulate debris identified were titanium alloy (TiAlV) and alumina ceramic (Al2O3) of prosthetic origin, and zirconium dioxide (ZrO2) from the contrast agent used in the cement for prosthetic fixation. Alumina debris was present in the smallest proportion (12%) and was consistent with the low wear rate of the CC joint couple. Zirconium dioxide debris was present in the greatest proportion (76%) and was an unexpected finding. The ZrO2 debris represented microstructural grains of the original ZrO2 particles added as contrast agent to the cement. The presence of a histiocytic foreign body reaction to ZrO2 debris on histologic sections leads us to believe that these particles play an important role in aseptic loosening of the CC THAs evaluated in this study.

Plasma-based sterilization: effect on surface and bulk properties, and hydrolytic stability of reprocessed polyurethane electrophysiology catheters

Plasma-based sterilization is a promising alternative to ethylene oxide (EO) for reprocessing of electrophysiology catheters. To assess its safety in terms of material damage, modifications of surface and bulk properties as well as hydrolytic stability of sterilized catheters were evaluated. Polyurethane (PU) single-use electrophysiology catheters were subjected to one, five, and ten sterilization cycles by Sterrad-100S and Plazlyte, as well as by pure EO for comparison. Surface analysis techniques (ATR-FTIR, XPS, DCA) showed oxidation limited to the near-surface layer induced by both plasma-based sterilizers, whereas EO induced slight but deeper alkylation. Using bulk analysis techniques (RP-HPLC, SEC), oligomer alteration was observed after all three sterilization techniques, without modification of molecular weights. Hydrolytic stability of catheters was slightly changed by plasma-based sterilization, with a small increase in released oligomers. Finally, although Plazlyte and Sterrad are both plasma-based techniques, they induced different impacts on catheters, such as the degradation of an additive with Sterrad, and a clear difference in coloration with Plazlyte.

Improvement of the Corrosion Resistance of NiTi Stents by Surface Treatments

Because of its optimal radiopacity, superelasticity and shape memory properties Nickel-Titanium (NiTi) is an ideal material for the fabrication of stents. Indeed, these properties can facilitate the implantation and precise positioning of those devices. However, in vitro studies on NiTi report the dependency of the alloy biocompatibility and corrosion behavior to surface treatments. Oxidation of the surface seems to be very promising to improve both the corrosion resistance and the biocompatibility of NiTi. The present study investigate the effect of electropolishing, heat treatment (in air and in a salt bath) and nitric acid passivation to modify the oxide layer on NiTi stents. Techniques such as potentiodynamic polarization tests, Scanning Electron Microscopy (SEM) and Auger Electron Spectroscopy (AES) have been used to develop relationships between corrosion behavior, surface characteristics and surface treatment. Results show that all surface treatments improve the corrosion behavior of the alloy. SEM results indicate that treated stents which exhibit a smooth and uniform surface show a higher corrosion resistance than non treated stents which possess a very porous oxide layer. AES results, indicate that the best corrosion behavior was observed for the stents which exhibit the thinnest oxide layer (electropolished and passivated samples).

Computer-based method for the 3-D kinematic analysis of posterior cruciate ligament and postero-lateral corner lesions

Posterior cruciate ligament (PCL) rupture, whether or not combined with postero-lateral corner (PLC) tears, are more often diagnosed today thanks to improved imaging techniques. However, due to the lack of reliable instrumentation to quantitatively evaluate the knee, much is still unknown about the function of these ligamentous structures. The aim of this paper is to present results on the effect of progressive resection of the PCL and PLC on knee laxity and 3-D knee kinematics. The results show that 3-D movement analysis is important and complements laxity measurements by helping to interpret the complex alteration of knee function.

A Computer-Controlled Apparatus for In Vitro Mechanical Stimulation and Characterization of Ligaments

A system has been developed to study in vitro the effects of mechanical stimulation on the biomechanical properties of ligaments. The apparatus is based on a ball screw driven by a microcomputer-controlled stepper motor capable of generating 100 Newtons of traction, the resulting force in the tissue is monitored in real-time acquisition by a load cell. It is programmed to perform virtually any kind of mechanical stimulation or biomechanical characterization tests. Preliminary tests on canine anterior cruciate ligaments indicate that this system is adequate for a variety of mechanical stimulations and characterization assays.

Light and Scanning Electron Microscopy of Human Spinal Ligaments

Spinal ligaments were obtained from normal and scoliotic individuals. Detailed morphological studies were carried out on the yellow, interspinous and supraspinous ligaments by light and scanning electron microscopy. Normal yellow ligaments are mostly constituted of dense elastin fibers with only a few collagen fibers and sparse blood vessels, while in normal interspinous and supraspinous ligaments, the presence of collagen is highly dominant. In the latter structures, the collagen fascicles are characterized by a regular waviness morphology. The fibrils constituting the fascicles appear either parallel or helical with respect to the fascicle axis. Structural changes are observed in the spinal ligaments of patients with congenital as well as idiopathic scoliosis. For yellow ligaments, only slight differences are found between normal and scoliotic specimens. However, alterations in collagen waviness and architecture are observed mainly in the supraspinous ligaments and to a lesser extent in the interspinous ligaments. In addition, increases in the cellularity, loose connective tissue and vessels are found in both forgoing ligaments. These results indicate that the more pronounced scoliosis-related changes occur in ligaments having the farthest distance from the axis of flexion-rotation.

Processing Biodegradable Natural Polyesters for Porous Soft-Materials

Absorbable polymeric scaffolds have been recently experimented for cell culture and transplantation, tissular reconstruction and In-Vivo drug or protein release. In the present work, the building of artificial porous soft-material is proposed by salt-leaching/solvent-casting a microbial poly(3-hydroxybutyrate-co-3-hydroxyvalerate) polyester. The electron microscopy and mercury porosimetry show a highly-porous well-interconnected micro-structures with a porosity level of 0.85 and a mean pore diameter of 122nm. The weight loss of the porous structures is about 50% for a 140 days period of hydrolytic degradation in Phosphate Buffered Solutions, pH 7.4 at 70°C. Incubations from 1 to 35 days of canine Anterior Cruciate Ligaments (ACLs) fibroblasts in P(HB-HV) scaffolds have shown a limited proliferation rate (150xl06 cells/g maximal density), but high protein synthesis (2.4+/-0.1 x1O-2 ng/cell.day at day 28th). Future studies on biodegradable P(HB-HV) foams will evaluate more deeply the potential applications for orthopaedic reconstructions.