Uniaxial and biaxial properties of terminally sterilized porcine urinary bladder matrix scaffolds

Abstract

Scaffolds composed of extracellular matrix have been successfully used to support the reconstruction of a variety of tissues in preclinical studies and in clinical applications. As an off-the-shelf product, extracellular matrix (ECM) scaffolds must be subjected to terminal sterilization before use. The choice of sterilization method may alter the integrity of the ECM's composition and structure such that the mechanical and material properties are adversely affected. The present study evaluated selected structural properties of an ECM scaffold derived from the urinary bladder termed urinary bladder matrix after being sterilized by three different methods: ethylene oxide (ETO) (750 mg/h for 16 h), gamma irradiation (2.0 Mrads), or electron beam irradiation (e-beam) (2.2 Mrads). The structural properties that were evaluated include maximum force, maximum elongation, maximum tangential stiffness, energy dissipation, and ball-burst strength. All sterilization methods affected at least two of the measured properties. ETO was shown to have the least detrimental effect upon the measured properties. Gamma and e-beam irradiation were shown to decrease the uniaxial and biaxial strength, maximum tangential stiffness, and the energy dissipation of the ECM scaffolds. The present study showed that the choice of terminal sterilization method affects the structural properties of scaffolds composed of extracellular matrix.