Abstract:

The biomimetic properties of implants are the most important aspects of their long-term clinical performance and safety. The gynecological as well as general surgery procedures of soft tissue defect reconstructions require the use of implantable medical devices of more sophisticated complex mechanical features. The aim of the study was to evaluate an optimal (taking into account implantation localisations) structure for knitted implantable medical devices for potential use in gynecological reconstructions, such as vaginal wall reconstructions and urinary incontinence treatment, as well as in general surgery for hernia treatment, in both standard and less-invasive procedures. The study shows a selection of the most optimal knitted structures based on mechanical criteria and further anatomical localisation of the implants designed. The choice of the selection criteria was carried out based on risk analysis according to Standard EN ISO 14971:2009. The idea of the research was to elaborate knitted three dimensional structures of an enhanced one-side surface for better connective tissue incorporation as well as a reduction in the surface mass while retaining the mechanical strength, taking into account anatomical requirements.