Design, realization and preliminary validation of an active physical simulator for the study of pelvic floor damages during childbirth

Pelvic floor (PF) is a muscle-fascial system that inferiorly closes the pelvis. It is really important in woman's life because it guarantees the correct positioning of the pelvic organs, the urines and feces continence and evacuation, and it allows sexual activity and childbirth [1]. Dysfunctions of PF involve important physical and psychological consequences in the daily life of a woman and significant expenses for their treatment. Vaginal delivery represents one of the main risk factor for the onset of PF disorders. Pelvic muscles in pregnant women show very different elastic characteristics if compared with non-pregnant women’s muscles. Moreover, they undergo considerable stretching during the passage of the foetus, that often results in a medium and/or long-term tissues injury. Thus, dedicated studies could both pave the way to a better comprehension of this phenomena, and improve the use of prevention clinical techniques, i.e., c-section. High-fidelity and active physical simulators deepen the study of the factors characterizing a clinical event and allow the doctor to have a physical support and real time feedback, which are essential for technique refinement and knowledge transfer in the clinical practice. Currently, there are only birth simulators available on the market, in which the PF is merely an additional element recreated at a low-fidelity level in terms of anatomical and physiological features. In addition, commercial simulators equipped with PF are limited in number and entirely passive, hence they don’t provide any feedback to the clinician. In this framework, the aim of this paper is to realize a sensorized physical simulator of maternal PF that can be used both as a teaching and/or a training system for gynaecologists and obstetrics. The innovative features of the proposed simulator are the following: i) high- fidelity reconstruction of the maternal PF anatomy; ii) use of soft materials able to replicate the biomechanical properties of human tissues; iii) active evaluation of the muscle deformation induced by the foetal head (FH) passage through the PF structure.