Shilo Yaniv, Willenz Udi, Berkowitz Brian
Department of Urology, Kaplan Medical Center, Affiliated with the Hebrew University, Rehovot, Israel.
GLPigs, Pre-Clinical R&D Department, Shamir Medical Center, Zerifin, Israel.
Transl Androl Urol. 2022 Jun;11(6):773-779. doi: 10.21037/tau-22-41.
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 evaluation.
"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 evaluation in a single pig model was completed to test stent 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.
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.
The innovative stent design tested here, if ultimately proven safe and effective for human use, may offer an alternative to currently available stents for multiple indications.
输尿管支架常用于多种腔内泌尿外科手术中，以促进尿液引流和输尿管愈合，主要与输尿管结石梗阻相关。然而，使用支架常常会损害患者的生活质量，这通常归因于膀胱和/或肾脏中存在支架固定卷曲。本研究的目的是在初步概念验证评估中检验一种新设计的完全输尿管内支架的潜在有效性和安全性。
“Yoticurl”支架由市售的共聚输尿管支架合成。首先在猪尸体上进行测试，以确认输尿管中螺旋卷曲的预期扩张情况。随后，在单个猪模型中完成了为期25天的初步评估，以测试支架的可行性。通过标准的人类腔内泌尿外科手术，将两个支架插入两个输尿管的完全输尿管内位置。对猪进行每日观察检查，并定期进行影像学分析；然后对动物实施安乐死，并通过剖腹探查进行检查，随后对肾脏、输尿管和膀胱组织样本进行组织学分析。
猪表现出正常的活动、食欲和睡眠模式，影像学检查表明尿液流动通畅，没有明显的支架移位或解剖异常。随后的组织学检查仅发现输尿管有轻度炎症。
此处测试的创新支架设计，如果最终被证明对人类使用安全有效，可能为目前多种适应症的现有支架提供一种替代方案。
