New chamber stapes prosthesis: Effect of ionizing radiation on material and functional properties

Abstract New chamber stapes prosthesis (ChSP) is a middle-ear prosthesis intended for use in ear surgery for restoring the patient's middle ear function. As the prosthesis is an implantable medical device, it must be sterilized before use. However, possible alterations in the material and the functional properties following the sterilization process can influence the safety aspects while using the prosthesis. The purpose of this paper was to determine the effects of ionizing radiation (IR) on the physicochemical and biological properties of the new chamber prosthesis by utilizing EPR spectroscopy, mechanical testing, and cytotoxicity studies. Our research shows that the radiation treatment increases the hardness and the elastic modulus of the polymer, decreases the stiffness of the prosthesis membrane, and does not cause chemical changes in the polymers that may result in cytotoxicity. Furthermore, new ChSPs were successfully tested in preclinical in vitro tests. The test results justify the undertaking of further work, including in vivo biocompatibility tests and clinical trials, which would eventually lead to the increased use of the prosthesis in clinical practice.