Page 237 - IJB-9-2
P. 237

International Journal of Bioprinting                      Coronary and peripheral artery disease. State of the art.



               The optimization of BRS VS manufacturing and    a cylindrical mold called carrier. The wires are braided
            features could be the answer to thrombotic and in-stent   along the carrier axis of rotation. At the end of the braiding
            restenosis issues. The “disappearance” of the medical   step, the carrier is removed from the braids. Consequently,
            device, leaving behind a completely restructured, opened   the dimensions of the resultant VS will mainly depend
            and healthy vessel would completely eliminate the long-  on the diameter and length of the carrier, although the
            term complications. It is, therefore, logical to observe   materials and braiding pattern are also determinants [12,38] .
            that the majority of the current scientific literature on   Inert metals and some polymers are prone to be braided
            VS is focused on the formulation, manufacturing and   due to their higher  mechanical resistance [39,40] . This
            optimization of BRS medical devices.               manufacturing method is currently underused due to the
               The biocompatibility is related to the immunological   lack of radial strength presented by braided VS.
            response that the VS could cause in the host after    Micro-injection molding is a manufacturing process
            implantation. A biocompatible medical device, by   involving high temperatures and pre-formed molds.
            definition, does not produce toxic or immunological   Generally, the VS material must be liquefied (melted) to
            response when implanted or put in intimate contact with   be injected into a mold with the desired final shape. After
            body fluids. In other words, after the implantation of   cooling (solidification), the VS is unmolded and released.
            biocompatible  VS, the  surrounding tissues  “accept” the   In this manufacturing technique, biocompatible polymers
            medical device without triggering allergic or inflammatory   are the most commonly used materials. According to the
            responses (nor acute neither chronic) as well as in the total   recent review of Gao  et  al., micro-injection molding is
            absence of toxicity (including carcinogenicity) . As wisely   widely used for the production of VS, only outpaced by
                                                [34]
            highlighted by Cvrček and Horáková, the biocompatibility   laser-cutting .
                                                                         [12]
            is a concept that not only depends on the chemical and   Laser-cutting can be envisaged as the contrary of
            superficial composition of the device, but also on its   additive manufacturing, since it involves the elimination of
            interaction with the surroundings, the period of the   excessive material from an original piece until the desired
            implant application, the mechanical properties (adaptable   shape remains. To do that, a high-power laser beam
            to the mechanical properties of the host tissue) and the   focuses on the original material piece (frequently a hollow,
            dimensions and shape of the VS . Biocompatibility   tubular piece) to cut it by melting, ablating or vaporizing
                                         [35]
            tests can be performed either in vitro or in vivo and are   the irradiated area. Then, the cut piece is eliminated by
            crucial to determine the safety of both the materials   high-speed  airflow .  In this  process,  the  laser  beam  is
                                                                              [12]
            and the final device. To maximize the comparability   immobile, while the moving piece being the tubular, hollow
            between biocompatibility results among laboratories   piece of material, which is attached to a rotating axis, are
            and industries, the International Standard established   mobile in x, y, and z axes. After laser-cutting, deburring
            normalized biocompatibility studies for medical devices    and polishing post-processes are usually required.
            (ISO 10993-5).
                                                                  Despite the continuous evolution of medical devices,
            3. Production techniques for the                   none of the currently available VS guarantee all the
            manufacturing of vascular stents                   desirable  features  and  they are  unable  to  achieve  full
                                                               patency. Suboptimal stent sizes and possible malposition
            The most frequently used manufacturing techniques   is probable due to inaccurate and limited and pre-
            for the production of VS are braiding, knitting, micro-  established VS dimensions and shapes. In this regard, the
            injection molding and laser cutting. The use of each of   production of artificial, individualized stents according to
            them depends on the materials and type of medical device   the dimensions, shape, and requirements of each patient
            under production. Additionally, other less commonly used   would reduce vessel injuries, inflammation, restenosis
            methods, such as micro-electrical discharge machining,   risks and other complications. It is at this point that 3DP
            micro-photochemical etching, water jet, chemical vapor   comes into play.
            deposition (CVD), magnetron sputtering, and micro-    3DP is a manufacturing technique that creates a physical,
            precision milling, have also been employed [12,28] . Depending   3D piece from a digital design (also known as computer-
            on the manufacturing method used, the materials and the   aided design) and adds the material layer-by-layer. The major
            final VS features, an additional post-processing step might   advantage of 3DP is the versatility of material production and
            be required, including drug-coating, surface modification,   the possibility of easily modify the dimensions or the shape
            and surface microstructure [12,36,37] .
                                                               of the resultant piece just by changing the digital design to be
               The  braiding  technique  produces  mesh-like  VS  by   printed. Furthermore, the different types of lesions together
            winding wires (with one or more than one material) around   with  the  different  requirements  of VS for  treating CAD


            Volume 9 Issue 2 (2023)                        229                     https://doi.org/10.18063/ijb.v9i2.664
   232   233   234   235   236   237   238   239   240   241   242