Fluorination of PVC medical devices to prevent plasticizers migration.

Medical devices (MD) are often made of plasticized polyvinylchloride (PVC). However, plasticizers may leach out into infused solutions and expose the patients to a toxic risk. The aim of the present work is to fluorinate plasticized PVC tubular MDs to create a barrier layer on their internal surface, and to study the impact of such a chemical treatment on the migration of the plasticizers. Following fluorination by pure molecular fluorine, the physico-chemical characterization of these modified MDs was carried out using various spectroscopic and microscopic techniques or tensile tests, evidencing the formation of covalent C-F bonds on the surface of the treated samples without modification of their mechanical and optical properties. The migration of plasticizers from fluorinated MDs was assessed using gas chromatography coupled with mass spectrometry and was found considerably decreased in comparison with the pristine MDs. After 24 h, the amount of tri-octyltrimellitate plasticizer (TOTM) detected in migrates from fluorinated MDs was even lower than the limit of quantification. Complementary cytotoxicity assays were performed according to the ISO EN 10993-5 standard, showing that the new fluorinated material does not cause a cytotoxic effect on L929 cells.

Do bevacizumab solutions interact with silicone or polyurethane catheters during an infusion through implantable venous access ports?

This work aims to evaluate the possible impact of interactions between bevacizumab solutions and an implantable port equipped with a silicone or a polyurethane catheter after infusion through a complete infusion set-up in simulated use conditions. Physico-chemical and structural stability of bevacizumab solution was assessed by visual examination, subvisible particles counting, dynamic light scattering, size exclusion chromatography and ion exchange chromatography. Mechanical properties of the catheters were evaluated by measuring Shore A hardness, strain at break, strain at stress and Young's modulus. The physico-chemical surface state of the catheters was assessed by FTIR-ATR spectroscopy, scanning electron microscopy (SEM) and by water contact angle measurement. The analysis of the bevacizumab solution did not highlight any signs of instability or loss of active substance. Mechanical properties of both materials remained unchanged after the infusion. During material analysis, a decrease in water contact angle observed after infusion and was more pronounced for polyurethane catheters than for silicone, possibly due to bevacizumab adsorption or possible leachable extraction from the materials. Surface modifications were also noted at SEM. This study did not highlight any modifications that could alter the quality of the bevacizumab infusion, nor of the infusion catheter in polyurethane or silicone, despite a modification of surface hydrophilicity. Even if after a single infusion, implantable ports remained safe to use, they aim to be used for several infusion of various drugs during their lifetime, and further studies are needed to assess the impact of repeated infusions.

Irradiation at 11 kGy conserves the biomechanical properties of fascia lata better than irradiation at 25 kGy.

The objective of this study was to determine the biomechanical properties of the fascia lata and the effects of three preservation methods: freezing, cryopreservation with dimethylsulfoxide solution and lyophilization; and to compare the effects of low-dose (11 kGy) and normal-dose (25 kGy) gamma-ray sterilization versus no irradiation. 248 samples from 14 fasciae latae were collected. Freezing samples were frozen at -80 °C. Cryopreservation with dimethylsulfoxide solution samples were frozen with 10 cl dimethylsulfoxide solution at -80 °C. Lyophilization samples were frozen at -22 °C and lyophilized. Each preservation group were then randomly divided into 3 irradiation groups. The cryopreservation with dimethylsulfoxide solution samples had significantly worse results in all 3 irradiation conditions. Young's modulus was lower for the freezing samples (p < 0.001) and lyophilization samples groups (p < 0.001). Tear deformation was lower for the freezing samples (p = 0.001) and lyophilization samples groups (p = 0.003), as was stress at break (p < 0.001 and p < 0.001). Taking all preservation methods together, samples irradiated at 25 kGy had worse results than the 0 kGy and 11 kGy groups in terms of Young's modulus (p = 0.007 and p = 0.13) and of stress at break (p = 0.006 and p = 0.06). The biomechanical properties of fascia lata allografts were significantly worse under dimethylsulfoxide cryopreservation. The deleterious effects of irradiation were dose-dependent.

Rehydration improves the ductility of dry bone allografts.

Processing of bone allografts improves infectious safety and allows storing bone substitutes at room temperature. The aim of this study was to compare mechanical properties of the processed Osteopure™ bone with fresh frozen bone. All the samples were pieces from femoral heads retrieved during hip arthroplasty operations. The processing includes chemical decellularization, drying and irradiation with 25 kGy. Three types of samples were tested: 1. fresh frozen thawed wet, 2. dry non-rehydrated graft 3. dry rehydrated graft. In the 3-point bending test Young's modulus and stress at break yielded no significant difference among the 3 different sample groups. Rehydrating of the dry graft showed increased ductility in strain at break test compared with the other 2 groups (p = 0.003). In compression tests dry grafts had significantly higher maximum effective stress and apparent maximum deformation compared with the grafts of other groups (p < 0.05). Processed bone has almost similar mechanical properties compared with fresh frozen bone. However, rehydration of processed dry graft increases its ductility. These grafts may tolerate bending forces better before breakage.

Fabrication of Acrylonitrile-Butadiene-Styrene Nanostructures with Anodic Alumina Oxide Templates, Characterization and Biofilm Development Test for Staphylococcus epidermidis.

Medical devices can be contaminated by microbial biofilm which causes nosocomial infections. One of the strategies for the prevention of such microbial adhesion is to modify the biomaterials by creating micro or nanofeatures on their surface. This study aimed (1) to nanostructure acrylonitrile-butadiene-styrene (ABS), a polymer composing connectors in perfusion devices, using Anodic Alumina Oxide templates, and to control the reproducibility of this process; (2) to characterize the physico-chemical properties of the nanostructured surfaces such as wettability using captive-bubble contact angle measurement technique; (3) to test the impact of nanostructures on Staphylococcus epidermidis biofilm development. Fabrication of Anodic Alumina Oxide molds was realized by double anodization in oxalic acid. This process was reproducible. The obtained molds present hexagonally arranged 50 nm diameter pores, with a 100 nm interpore distance and a length of 100 nm. Acrylonitrile-butadiene-styrene nanostructures were successfully prepared using a polymer solution and two melt wetting methods. For all methods, the nanopicots were obtained but inside each sample their length was different. One method was selected essentially for industrial purposes and for better reproducibility results. The flat ABS surface presents a slightly hydrophilic character, which remains roughly unchanged after nanostructuration, the increasing apparent wettability observed in that case being explained by roughness effects. Also, the nanostructuration of the polymer surface does not induce any significant effect on Staphylococcus epidermidis adhesion.

Analysis of plasticizers in poly(vinyl chloride) medical devices for infusion and artificial nutrition: comparison and optimization of the extraction procedures, a pre-migration test step.

Medical devices (MDs) for infusion and enteral and parenteral nutrition are essentially made of plasticized polyvinyl chloride (PVC). The first step in assessing patient exposure to these plasticizers, as well as ensuring that the MDs are free from di(2-ethylhexyl) phthalate (DEHP), consists of identifying and quantifying the plasticizers present and, consequently, determining which ones are likely to migrate into the patient's body. We compared three different extraction methods using 0.1 g of plasticized PVC: Soxhlet extraction in diethyl ether and ethyl acetate, polymer dissolution, and room temperature extraction in different solvents. It was found that simple room temperature chloroform extraction under optimized conditions (30 min, 50 mL) gave the best separation of plasticizers from the PVC matrix, with extraction yields ranging from 92 to 100% for all plasticizers. This result was confirmed by supplemented Fourier transform infrared spectroscopy-attenuated total reflection (FTIR-ATR) and gravimetric analyses. The technique was used on eight marketed medical devices and showed that they contained different amounts of plasticizers, ranging from 25 to 36% of the PVC weight. These yields, associated with the individual physicochemical properties of each plasticizer, highlight the need for further migration studies.