Artificial sphincters: An overview from existing devices to novel technologies

Artificial sphincters (ASs) are used to replace the function of the biological sphincters in case of severe urinary and fecal incontinence (UI and FI), and gastroesophageal reflux disease (GERD). The design of ASs is established on different mechanisms, e.g., magnetic forces or hydraulic pressure, with the final goal to achieve a implantable and durable AS. In clinical practice, the implantation of in-commerce AS is considered a reasonable solution, despite the sub-optimal clinical outcomes. The failure of these surgeries is due to the malfunction of the devices (between 46 and 51%) or the side effects on the biological tissues (more than 38%), such as infection and atrophy. Concentrating on this latter characteristic, particular attention has been given to the interaction between the biological tissues and AS, pointing out the closing mechanism around the duct and the effect on the tissues. To analyze this aspect, an overview of existing commercial/ready-on-market ASs for GERD, UI, and FI, together with the clinical outcomes available from the in-commerce AS, is given. Moreover, this invited review discusses ongoing developments and future research pathways for creating novel ASs. The application of engineering principles and design concepts to medicine enhances the quality of healthcare and improves patient outcomes. In this context, computational methods represent an innovative solution in the design of ASs, proving data on the occlusive force and pressure necessary to guarantee occlusion and avoid tissue damage, considering the coupling between different device sizes and individual variability

Mechanical Characterization of the Male Lower Urinary Tract: Comparison among Soft Tissues from the Same Human Case Study

Background: Nowadays, a challenging task concerns the biomechanical study of the human lower urinary tract (LUT) due to the variety of its tissues and the low availability of samples. Methods: This work attempted to further extend the knowledge through a comprehensive mechanical characterization of the male LUT by considering numerous tissues harvested from the same cadaver, including some never studied before. Samples of the bladder, urethra, prostate, Buck’s fascia and tunica albuginea related to corpora cavernosa were considered and distinguished according to testing direction, specimen conformation and anatomical region. Uniaxial tensile and indentation tests were performed and ad hoc protocols were developed. Results: The tissues showed a non-linear and viscoelastic response but different mechanical properties due to their specific functionality and microstructural configuration. Tunica albuginea longitudinally displayed the highest stiffness (12.77 MPa), while the prostate transversally had the lowest one (0.66 MPa). The minimum stress relaxation degree (65.74%) was reached by the tunica albuginea and the maximum (88.55%) by the bladder. The prostate elastic modulus was shown to vary according to the presence of pathological changes at the microstructure. Conclusions: This is the first experimental work that considers the mechanical evaluation of the LUT tissues in relation to the same subject, setting the basis for future developments by expanding the sample population and for the development of effective in silico models to improve the solutions for most LUT pathologies