Biodegradable stents are not established in neurovascular interventions. In this study, mechanical, radiological, and histological characteristics of a stent prototype developed for neurovascular use are presented. The elasticity and brittleness of PLA 96/4, PLDL 70/30, PCL, and PLGA 85/15 and 10/90 polymers in in vitro experiments are first analyzed. After excluding the inapt polymers, degradability and mechanical characteristics of 78 PLGA 85/15 and PLGA 10/90 stent prototypes are analyzed. After excluding PLGA 10/90 stents because of rapid loss of mass PLGA 85/15 stents in porcine in vivo experiments are analyzed. Angiographic occlusion rates 7 d, 1 month, 3 months, and 6 months after stent implantation are assessed. Histological outcome measures are the presence of signs of inflammation, endothelialization, and the homogeneity of degradation after six months. One case of stent occlusion occurs within the first 7 d. There is a prominent foreign-body reaction with considerable mononuclear and minor granulocytic inflammation combined with incomplete fragmental degradation of the struts. It is possible to produce a stent prototype with dimensions that fit the typical size of carotid arteries. Major improvements concerning thrombogenicity, degradation, and inflammatory response are required to produce biodegradable stents that are suitable for neurovascular interventions.
Resorbable polymers have been established for several decades in biomedical applications. The most frequently used resorbable polymers are still the aliphatic polyesters polylactides (PLA), polyglycolid (PGA) and polycaprolactone (PCL) homo-and copolymers. However, inherent pH dropping during degradation of some biomaterials may provoke inflammation and, thus, hamper the healing process. In this study we investigate the manufacturing method of microgel functionalised PLA Fibres in a dry-spinning process and the buffering effect of the poly(N-vinylcaprolactam-co-acetoacetoxyethyl methacrylate) vinylimidazole (VCL/AAEM/Vlm) microgels during the degradation of the fibres. Furthermore we examine the biocompatibility of the produced fibres and established a mathematical model to describe and analyse the pH level in the vicinity of the PLA fibre.
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