Gross and histopathology of tissue - material interface in biocompatibility evaluation of biomaterials and medical devices- Part-I
No Thumbnail Available
Date
2024-03-16
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
SCTIMST
Abstract
Safety evaluation is a critical component in medical device development. Biological evaluation should be carried out to identify the biological risk of biomaterials intended for medical devices after physicochemical characterization. Biocompatibility evaluation is a comprehensive terminology that broadly comprises in-vitro and in-vivo biological evaluations such as cytotoxicity tests, blood-material interactions, toxicological evaluation, etc. Testing for local effects after implantation is a major indicator for any candidate biomaterial safety, which is carried out in an appropriate animal model. The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. At the histopathology laboratory, we have tested metal, polymer, ceramic and composite biomaterials over the years as short and long-term implantation studies in rat and rabbit animal models. Gross and Histology images of compatible and non-biocompatible tissue response from intramuscular, subcutaneous and bone implantation in rabbit model and their relevance will be presented. The temporal variations of tissues responses and stages of foreign body reaction will be discussed. Specimen preparations, both soft and hard tissues starting from grossing, tissue processing, embedding, microtomy will be discussed. Gross and Histopathology evaluation of Chitra-TTK mechanical heart valve evaluated in-house in ovine(Sheep) and swine(Pig) model will be presented.