artificial urethral sphincter cuff
Today urinary incontinence is one of the major socio-health problems globally, which associated costs are enormous. The artificial urethral sphincter is the main treatment, with particular reference to male subjects. The devices currently available they have also shown that they have various limitations: after the application phase of the device, complications occur in 50% of cases that require re-intervention. This artificial urethral sphincter allows a safer occlusion of the urethral duct and reliable, thanks to the design carried out through bio-mechanical computational methods.
The operating principle of current devices involves the swelling of a polymer cuff which causes occlusion / disocclusion of the urethra, thus controlling urination. In current devices, the annular cuff that causes occlusion of the urethra generates an uneven mechanical stress on the biological tissues, resulting in over-stress phenomena. Excessive tissue tension can lead to vasoconstriction processes with consequent inflammation of the tissues and the formation of constrictions, and sometimes even urethral erosion. The novelty of the patented system lies in the particular geometry and materials that make up the annular cuff, capable of exerting an almost completely homogeneous mechanical action on the urethra. This conformation during mechanical occlusion allows to minimize the mechanical stimulation of biological tissues and the consequent damage, making the implantation of the sphincter device more reliable and durable. Conception, design and validation took place through “in silico” medicine procedures. The current TRL is 3.
- Artificial urinary sphincters;
- Artificial anal sphincters.
- Uniform mechanical stimulation of urethral tissues during occlusion to minimize tissue vasoconstriction phenomena and urethra erosion;
- Greater safety and durability of the device;
- Reduction of healthcare system costs;
- Greater psychological wellness of patients;
- Design of the surgical device by means of bio-engineering methods;
- “In silico” methods for the definition, design and validation of the device (3R approach).