Omnidirectional (Flexible) Ureteral Access Sheath: Safety, Efficacy, and Initial Experience Report

Area of Science:

• Urology
• Medical Devices
• Endourology

Background:

• Flexible ureteroscopic lithotripsy (FURL) is a common procedure for kidney stones.
• Conventional ureteral access sheaths (UAS) have limitations in maneuverability.
• A novel omnidirectional (OD) UAS has been developed to potentially improve FURL outcomes.

Purpose of the Study:

• To evaluate the safety and efficacy of the novel OD UAS compared to conventional UAS in FURL.
• To assess the impact of OD UAS on stone-free rates and operative parameters.
• To explore the usability and relevant issues associated with OD UAS.

Main Methods:

• Retrospective review of 199 FURL cases (61 conventional UAS, 138 OD UAS).
• Comparison of patient demographics, stone characteristics, and surgical outcomes.
• Measurement of OD UAS deflection angles with different ureteroscopes and instruments.

Main Results:

• OD UAS demonstrated deflection angles of 110°-130° (free load) and 90°-130° (loaded).
• The OD UAS group showed a significantly higher single-session stone-free rate (94.2% vs 63.9%, p<0.0001).
• Similar pre-stent ratios and operation times were observed between groups.

Conclusions:

• The OD UAS is a safe and effective device for FURL.
• Its flexible design facilitates access to renal calices and improves stone clearance.
• OD UAS contributes to better outcomes in treating large-burden kidney stones.