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Improvement of cold plasma process to produce carbon and silver coating on surgical materials aiming biocompatibility and bio-integration

Grant number: 14/21690-8
Support type:Research Grants - Innovative Research in Small Business - PIPE
Duration: November 01, 2015 - April 30, 2019
Field of knowledge:Engineering - Biomedical Engineering
Principal Investigator:Maria Antonia dos Santos
Grantee:Maria Antonia dos Santos
Company:BioTecnoVale Pesquisa e Desenvolvimento Ltda. - EPP
City: São José dos Campos
Assoc. researchers:Ana Maria Alvim Liberatore ; Argemiro Soares da Silva Sobrinho ; Gilberto Petraconi ; Ivan Hong Jun Koh ; Jose Elias Matieli ; Marcos Massi
Associated grant(s):17/07307-5 - 11th International Conference on Advanced Computational Engineering and Experimenting, ACE-X 2017, AR.EXT

Abstract

Multinational companies have invested continuously, a significant sum in search of new technologies to provide the properties of biocompatibility and anti-infective action in polymeric prosthetic medical devices. Although new technologies coupled to polymeric implants have driven a dizzying market (order of $ 200 billion / year in the USA), the current rate of complications after implantation showed that the prostheses still have limited biocompatibility, indicating the need for new materials . As an example of these materials can be cited the use of surgical meshes for the treatment of major abdominal hernia defects, which have been increasingly greater after the first use reported by Usher et col. in 1958. Despite the broad spread of their use, current surgical meshes cannot yet be considered ideal due to the infective postoperative complications up to 8% of cases and with serious physical consequences. Even polymeric materials of non-permanent application such as probes, drains and catheters are important factors in the induction of inflammatory response from the host due to the antigenicity of its substrate. Aiming to circumvent postoperative complications, it was proposed in a previous project (FAPESP Research: 2011-14038-4), the coating of polypropylene mesh (in small dimensions - 2cmx2cm) with nanostructured carbon films or silver, and also with the combination thereof, by cold plasma-assisted technique, such technique allows to modify the surface characteristics without compromising the physical and mechanical properties of the fabric. The joint use of materials with known characteristics; biocompatibility (film amorphous carbon), and bacteriostatic and / or bactericidal action (silver film), aimed to attribute to the surgical mesh both properties, reducing the incidence and / or magnitude of infectious complications, thus providing the ease of the healing process and adequate tissue repair peri-prothesis. These characteristics aggregated to biomaterials are not found in similar medical supplies available in the market. In view of the satisfactory results observed, both from the point of view of the tissue repair and of the antimicrobial activity, in addition to the fact that the technology in development presents a great social and commercial contribution, this project aims to optimize the coating process with the nanocarbon film in polypropylene surgical mesh, as regard to the thickness, quantity and adhesion, in order to maximize its biocompatibility characteristics. Besides, coating with silver nanofilm aims the optimization of the antimicrobial action coupled with the biocompatibility in the development of the non-permanent medical devices in order to minimize the ANVISA restrictions directed to the silver nanoparticles coating in permanent devices. In both cases, we intend to conduct depositions in substrates dimensions of true greatness, i.e., the real surgical mesh size. The biological results in vitro and in vivo will be correlated with the physical and mechanical characteristics of the nanofilms. Furthermore, the non-permanent materials will be tested in relation to the detachment of the nanosilver particles after a long-term implantation (> 1 year) into animals. To accomplish both objectives, the plasma reactor will be designed and built in order to allow the nanofilm deposition in varying substrates and shapes of the medical devices in a real dimension. Additionally, the infrastructure needed to perform biological assays will be created to allow faster and more efficient analysis of the results. Embodied in the previous results, the improvement of the coating methodology aims the obtaining of a significant evolution, from the physical-biological view, and enables the BioTecnoVale company offers to the market an efficient and competitive national solution enough to solve problems related to biocompatibility and infection of the medical prosthesis. (AU)