A Novel Flexible Ureteroscopy with Intelligent Control of Renal Pelvic Pressure: An Initial Experience of 93 Cases.

Background: Flexible ureteroscopic lithotripsy (URS) is rapidly becoming a first-line therapy for patients with renal and ureteral calculi. Most current medical infusion devices can only monitor infusion flow and pressure, but not renal pelvic pressure (RPP). Patients and Methods: We designed a patented intelligent system to facilitate flexible URS that included an irrigation and suctioning platform and a ureteral access sheath (UAS) with a pressure-sensitive tip, enabling regulation of the infusion flow precisely and control of the vacuum suctioning by computerized real-time recording and monitoring of RPP. A stable RPP was ensured by pressure feedback technology. Ninety-three patients with renal or ureteral calculi participated in the study and received flexible URS. Gravel particles were sucked out automatically during the flexible URS. Patients were evaluated on postoperative days 1 and 30 by X-ray of kidneys, ureters, and bladder to assess stone-free status. Results: In 81 of the 93 patients, only one surgery was needed to remove the stone. There were nine cases who failed the first surgery due to difficulty in placing the UAS, but flexible URS was performed in these patients after indwelling a Double-J stent to the ureter with the calculus for 2 weeks. Three cases were converted to percutaneous nephrolithotomy due to significant ureteral stenosis. For the 90 patients who underwent flexible URS, the actual RPP was controlled under 20mmHg with clear operative visualization. The stone-free rates at postoperative days 1 and 30 were 90.0% (81/90) and 95.6% (86/90), respectively. Clavien I complications were noted in 13 cases, while Clavien II complications were noted in two cases. No major complications (Clavien III-V) were noted. Conclusions: Our patented system is technically feasible, safe, and efficient for treating upper urinary calculi. The advantages include breaking stones effectively and low complication rates because of its automatic control of RPP.