Magnetically Controlled Endourethral Artificial Urinary Sphincter

Abstract

Urinary incontinence is a largely spread disfunction that affects more than 300 million people worldwide. At present, no technological solutions are able to restore continence in a minimally invasive and effective way. In this article the authors report the design, fabrication, and testing of a novel artificial endourethral urinary sphincter able to fully restore continence. The device can be inserted/retracted in a minimally invasive fashion without hospital admission, does not alter the body scheme and can be applied to both women and men. The device core is a unidirectional polymeric valve and a magnetically activated system able to modulate its opening pressure. Bench tests and ex vivo tests on a human cadaver demonstrated that the device is able to fully restore continence and to allow urination when desired. Overall, the proposed system shows a high potential as a technological solution able to restore a normal daily life in patients affected by urinary incontinence.

Artificial Sphincters to Manage Urinary Incontinence: A Review

“…(d) Vysera Biomedical Limited's patent . (e) Mazzocchi et al's research prototype . [Color figure can be viewed at http://wileyonlinelibrary.com]…”

“…In 2017, Mazzocchi et al designed a novel unisex endo‐urethral AUS, which could be inserted into the urethra with endo‐luminal access and with a quick procedure (Fig. e) . It was tested ex vivo on a human cadaver with successful results.…”

“…Anchoring systems can limit these problems. Solutions based on custom balloons to be inflated on demand or distal and proximal stents with shape memory features can be devised, as proposed in . Friction enhancement between the device external case and the urethral lumen might also represent a strategy to guarantee the long‐term stability of the device.…”

PDMS and DLC‐coated unidirectional valves for artificial urinary sphincters: Opening performance after 126 days of immersion in urine

“…Encrustations and infections, indeed, still represent an open issue for medical devices to be employed in the urinary system: Urine alters the device properties and functionality, raising the need for frequent replacements 11 . Regarding the AUS reported in Reference 10, the main component subjected to a risk of functional failure due to encrustations is the polymeric valve, made of polydimethylsiloxane (PDMS) 12 . Anyhow, there are many other endo‐urethral devices based on silicone 9 .…”

“…9 Recently, the authors proposed an innovative endo-urethral AUS based on a unidirectional polymeric valve and a magnetic activation/deactivation system. 10 Such a device can be inserted/ removed in a minimally invasive fashion such that it does not alter the body scheme and can be applied to both women and men.…”