A constant and interactive collaboration with medical experts and professionists in urinary incontinence is a important pillar of our approach. It allows continuous improvements of our products making it suitable for needs of the patients and professionists.
How does it work?
Benefits for physician
For the first time in this field, a unisex, minimally invasive endo-urethral magnetic device is proposed. It is implanted by urologist in outpatient setting under local anesthesia by using a traditional cystoscope (25 Fr). The procedure requires between 15-30 minutes. The same procedure, by means of the support of a biopsy forceps can be used for the removal.
The proposed sphincter, based on a solution protected by patent WO2013144770A2, consists of: (i) an external case, (ii) an anchoring system to constrain the sphincter to the bladder neck, (iii) a unidirectional polymeric valve that allows the flow of urine ensuring the tightness below a certain intra-vesical pressure and (iv) a magnetic safety system composed of a cursor, an elastic element and an internal magnetic system.
When the magnetic safety system is active, the valve is firmly closed thanks to the slider and to the elastic element that does not allow the deformation of the valve even if the intra-vesical pressure is higher than the opening pressure. The safety system is de-activated by moving the slider in the opposite direction of the valve, making it free to deform under the liquid pressure. The activation/deactivation of the safety system (and thus the sphincter opening/closing) is possible by simply approaching a small external magnet to the patient perianal area. This causes the translation of a moving internal magnet properly constrained to the slider. Thanks to the presence of an additional fixed internal magnet it is possible to have a bistable system that does not require the presence of the external magnet in the perianal area for the duration of the urination.
The device benefits from an extremely simple and innovative design, without electronic components on board, being based on a magnetic activation. This will facilitate the certification phases and will maximize the acceptability and usability of the device, even by patients with limited psychomotor skills.