What is Considered a Variation of Biomechanical Parameters in Tensile Tests of Collagen-Rich Human Soft Tissues? - Critical Considerations Using the Human Cranial Dura Mater as a Representative Morpho-Mechanic Model.

Background and Objectives: Profound knowledge on the load-dependent behavior of human soft tissues is required for the development of suitable replacements as well as for realistic computer simulations. Regarding the former, e.g., the anisotropy of a particular biological tissue has to be represented with site- and direction-dependent particular mechanical values. Contrary to this concept of consistent mechanical properties of a defined soft tissue, mechanical parameters of soft tissues scatter considerably when being determined in tensile tests. In spite of numerous measures taken to standardize the mechanical testing of soft tissues, several setup- and tissue-related factors remain to influence the mechanical parameters of human soft tissues to a yet unknown extent. It is to date unclear if measurement extremes should be considered a variation or whether these data have to be deemed incorrect measurement outliers. This given study aimed to determine mechanical parameters of the human cranial dura mater as a model for human soft tissues using a highly standardized protocol and based on this, critically evaluate the definition for the term mechanical "variation" of human soft tissue. Materials and Methods: A total of 124 human dura mater samples with an age range of 3 weeks to 94 years were uniformly retrieved, osmotically adapted and mechanically tested using customized 3D-printed equipment in a quasi-static tensile testing setup. Scanning electron microscopy of 14 samples was conducted to relate the mechanical parameters to morphological features of the dura mater. Results: The here obtained mechanical parameters were scattered (elastic modulus = 46.06 MPa, interquartile range = 33.78 MPa; ultimate tensile strength = 5.56 MPa, interquartile range = 4.09 MPa; strain at maximum force = 16.58%, interquartile range = 4.81%). Scanning electron microscopy revealed a multi-layered nature of the dura mater with varying fiber directions between its outer and inner surface. Conclusions: It is concluded that mechanical parameters of soft tissues such as human dura mater are highly variable even if a highly standardized testing setup is involved. The tissue structure and composition appeared to be the main contributor to the scatter of the mechanical parameters. In consequence, mechanical variation of soft tissues can be defined as the extremes of a biomechanical parameter due to an uncontrollable change in tissue structure and/or the respective testing setup.