Recent Advances in Manufacturing Innovative Stents.

Cardiovascular diseases are the most distributed cause of death worldwide. Stenting of arteries as a percutaneous transluminal angioplasty procedure became a promising minimally invasive therapy based on re-opening narrowed arteries by stent insertion. In order to improve and optimize this method, many research groups are focusing on designing new or improving existent stents. Since the beginning of the stent development in 1986, starting with bare-metal stents (BMS), these devices have been continuously enhanced by applying new materials, developing stent coatings based on inorganic and organic compounds including drugs, nanoparticles or biological components such as genes and cells, as well as adapting stent designs with different fabrication technologies. Drug eluting stents (DES) have been developed to overcome the main shortcomings of BMS or coated stents. Coatings are mainly applied to control biocompatibility, degradation rate, protein adsorption, and allow adequate endothelialization in order to ensure better clinical outcome of BMS, reducing restenosis and thrombosis. As coating materials (i) organic polymers: polyurethanes, poly(ε-caprolactone), styrene-b-isobutylene-b-styrene, polyhydroxybutyrates, poly(lactide-co-glycolide), and phosphoryl choline; (ii) biological components: vascular endothelial growth factor (VEGF) and anti-CD34 antibody and (iii) inorganic coatings: noble metals, wide class of oxides, nitrides, silicide and carbide, hydroxyapatite, diamond-like carbon, and others are used. DES were developed to reduce the tissue hyperplasia and in-stent restenosis utilizing antiproliferative substances like paclitaxel, limus (siro-, zotaro-, evero-, bio-, amphi-, tacro-limus), ABT-578, tyrphostin AGL-2043, genes, etc. The innovative solutions aim at overcoming the main limitations of the stent technology, such as in-stent restenosis and stent thrombosis, while maintaining the prime requirements on biocompatibility, biodegradability, and mechanical behavior. This paper provides an overview of the existing stent types, their functionality, materials, and manufacturing conditions demonstrating the still huge potential for the development of promising stent solutions.

Surface Modification of Poly(Vinylchloride) for Manufacturing Advanced Catheters.

Polymeric materials, due to their excellent physicochemical properties and versatility found applicability in multiples areas, including biomaterials used in tissue regeneration, prosthetics (hip, artificial valves), medical devices, controlled drug delivery systems, etc. Medical devices and their applications are very important in modern medicine and the need to develop new materials with improved properties or to improve the existent materials is increasing every day. Numerous reasearches are activated in this domain in order to obtain materials/surfaces that does not have drawbacks such as structural failure, calcifications, infections or thrombosis. One of the most used material is poly(vinylchloride) (PVC) due to its unique properties, availability and low cost. The most common method used for obtaining tubular devices that meet the requirements of medical use is the surface modification of polymers without changing their physical and mechanical properties, in bulk. PVC is a hydrophobic polymer and therefore many research studies were conducted in order to increase the hydrophilicity of the surface by chemical modification in order to improve biocompatibility, to enhance wettability, reduce friction or to make lubricious or antimicrobial coatings. Surface modification of PVC can be achieved by several strategies, in only one step or, in some cases, in two or more steps by applying several techniques consecutively to obtain the desired modification / performances. The most common processes used for modifying the surface of PVC devices are: plasma treatment, corona discharge, chemical grafting, electric discharge, vapour deposition of metals, flame treatment, direct chemical modification (oxidation, hydrolysis, etc.) or even some physical modification of the roughness of the surface.

Advanced Drug-Eluting Poly (Vinyl Chloride) Surfaces Deposited by Spin Coating.

Background and objectives: Medical devices such as catheters are used on a large scale to treat heart and cardiovascular diseases. Unfortunately, they present some important drawbacks (structure failure, calcifications, infections, thrombosis, etc.), with the main side effects occurring due to adhesion and proliferation of bacteria and living cells on the surface of the implanted devices. The aim of this work is to modify the surface of polyvinyl chloride (PVC), an affordable biocompatible material, in order to reduce these aforementioned side effects. Materials and Methods: The surface of PVC was modified by depositing a thin layer also of PVC that incorporates an active substance, dicoumarol (a well-known anticoagulant), by spin coating process. The modified surfaces were analyzed by Fourier-transform infrared (FT-IR) microscopy, Fourier-transform infrared (FT-IR) spectroscopy, Ultraviolet-visible spectroscopy (UV-VIS), and Scanning electron microscopy (SEM) in order to determine the surface morphology and behavior. The samples were tested for Gram-positive (S. aureus ATCC 25923) and Gram-negative (P. aeruginosa ATCC 27853) standard strains from American Type Culture Collection (ATCC). Results: The material obtained had a smooth surface with a uniform distribution of dicoumarol, which is released depending on the deposition parameters. The concentration of dicoumarol at the surface of the material and also the release rate is important for the applications for which the surface modification was designed. PVC modified using the proposed method showed a good ability to prevent salt deposition and decreased the protein adhesion, and the resistance to bacterial adherence was improved compared with standard PVC.

Surface evaluation of titanium oxynitride coatings used for developing layered cardiovascular stents.

Stents are important medical devices used to increase the quality and life expectancy of patients with heart diseases and stroke, leading causes of death, worldwide. In order to minimize the risk of restenosis, different coating on bare metal stents (BMS) such as polymer coatings; titanium dioxide, titanium nitride or titanium oxynitride coatings; carbon coatings and others are used. The aim of this work was to develop novel stents coated with titanium oxynitride (TiOxNy) with optimal chemical, mechanical and biological properties having possibly good coverage rate of inner and outer stent surfaces. The improvement should be achieved by optimization and development of a magnetron sputtering deposition technology. The goal of the study is understanding of the existing potential for improvement of the deposition technology and the coating quality itself. For this study, different O2/N2 ratios, meaning 1/2, 1/5 and 1/10 (the ratios of reagent gasses are given for the values of mass flows into the chamber) has been selected. Stability in simulated body fluids, surface morphology and protein adsorption as well as preliminary cytotoxic behaviour of the samples on HUVEC cells has been analysed. SEM experiments have shown the potential in the improvement of coating-stent adhesion by all samples. TiOxNy 1:5 samples were found to have the lowest adsorption, the smoothest surface morphology and the smallest rate of salt deposition from simulated body fluids (SBFs). This kind of surface has been recommended for further optimization and application.