Design of a fully intraureteral stent and proof-of-concept in vivo evaluation

Background: Ureteral stents are employed regularly to facilitate urine drainage and ureteral healing in a wide variety of endourological procedures, associated mainly with ureteral stone obstruction. However, stent use frequently impairs patient quality of life, which is generally attributed to the presence of anchoring stent curls in the bladder and/or kidney. The purpose of this study was to examine the potential effectiveness and safety of a newly designed, fully intraureteral stent, in an initial proof-of-concept in vivo evaluation. Methods: "Yoticurl" stents were synthesized from copolymeric, commercially-available ureteral stents. A first test to confirm the intended expansion of the spiral curls in a ureter was performed on a pig cadaver. Subsequently, a preliminary in vivo evaluation in a single pig model was completed to test gent viability, over a period of 25 days. Two stents were inserted to fully intraureteral positions into the two ureters, by standard human endourological procedure. Daily observational checks of the pig, and regular radiographic analyses were performed; the animal was then euthanized and examined by explorative laparotomy, followed by histological analysis of kidney, ureter and bladder tissue samples. Results: The pig displayed normal activity, appetite and sleep patterns, and radiography indicated free flow of urine, and no significant stent migration nor anatomical abnormalities. Subsequent histology found only mild inflammation in the ureter. Conclusions: The innovative stent design tested here, if ultimately proven safe and effective for human use, may offer an alternative to currently available gents for multiple indications.