Clinical application of flexible ureteroscopic sheath with controllable intraluminal pressure in treating ureteral stones.

Objective: The purpose of the study was to assess the clinical efficacy and safety of a combined perfusion suction platform with pressure feedback control function and an ureteroscopic suction sheath that can measure the ureteropelvic pressure in implementing lithotripsies. Methods: Fifty-two patients who underwent lithotripsy under intelligent monitoring of ureteral intraluminal pressure from June 2016 to January 2018 were retrospectively recruited. The inclusion standard was stone diameter >1.5 cm but <2.5 cm. After the 12/14 Fr suction sheath was placed, manometer interface and suction interface of the sheath were connected to the platform via the pressure sensor and suction tube, respectively. The ureteroscope was connected to the platform perfusion pump, and the crushed stones were aspirated out under negative pressure. Results: According to the location of the stone, 21 (40.4%) cases were classified as upper ureteral stones, 19 (36.5%) were midureteral stones, and 12 (23.1%) were lower ureteral stones. Forty-seven patients underwent successful primary sheath placement and lithotripsy with a mean operative time of 34.5 (standard deviation 18.3) min. Retrograde stone migration did not occur. There were eight patients with hematuria postoperatively. Serious complication was 1.9% with one case of ureteral perforation. Stone clearance was 95.7% at Day 1-2 postoperatively, and 100% at Day 30 postoperatively. Conclusion: Ureteroscopic lithotripsy with intelligent pressure control using our device improved the efficiency of the lithotripsy and rate of stone clearance. The safety of the operation can be ensured. It is worth popularization and application in clinical practice.

A study on the clinical application of a patented perfusion and suctioning platform and ureteral access sheath in the treatment of large ureteral stones below L4 level.

PURPOSE: The purpose of the study was to evaluate the efficacy and safety of a patented perfusion and suctioning platform and ureteral access sheath in the treatment of large ureteral stones (≥ 1.5 cm) below L4 level. METHODS: We recruited 122 patients with large ureteral stones below L4 level at our hospital from December 2014 to June 2017. The patients were randomly divided into the study and control groups. Multiple operative and perioperative parameters were compared between the two groups. RESULTS: The study group had shorter operation time, less cases of postoperative fever, lower serum levels of PCT, IL-6 and BET within 24 h after surgery, as well as less number of cases receiving secondary surgery than the control group. Moreover, the former had a significantly higher stone clearance rate than the latter (P < 0.05; t-test or χ2 test). CONCLUSIONS: The patented perfusion and suctioning platform and ureteral access sheath are safe and effective in treating large ureteral stones (≥ 1.5 cm) below L4 level.

Suctioning Minimally Invasive Percutaneous Nephrolithotomy with a Patented System Is Effective to Treat Renal Staghorn Calculi: A Prospective Multicenter Study.

OBJECTIVES: To investigate the safety, efficacy, and practicability of minimally invasive percutaneous nephrolithotomy (MPCNL) with the aid of a patented irrigation clearance system in treating renal staghorn calculi. METHODS: From August 2009 to July 2014, 4 hospitals had executed a prospective multicenter study with a total of 912 cases. The patients were randomly divided into 3 groups: suctioning MPCNL, standard percutaneous nephrolithotomy (PCNL), and traditional MPCNL groups. Multiple operative and perioperative parameters were compared. RESULTS: Blood loss and intrapelvic pressure in the suctioning MPCNL group were significantly less than those in the standard PCNL group. The average operation time, intrapelvic pressure, and amount of bleeding in the suctioning MPCNL group were better than those in the traditional MPCNL group. The suctioning MPCNL used one tract more frequently and 2 or 3 tracts less frequently than the standard MPCNL and traditional MPCNL groups. The stone-free rate by one surgery in the suctioning MPCNL group was significantly higher than that in standard PCNL and traditional MPNCL groups. CONCLUSIONS: Suctioning MPCNL using our patented system shows several advantages in treating renal staghorn calculi, including minimal invasion, shorter operation time, lower intrapelvic pressure, less bleeding and the need for a smaller number of -percutaneous tracts, and higher stone clearance rate by one -surgery.

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 20 mmHg 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.

Predicting Outcomes after Minimally Percutaneous Nephrolithotomy with the Aid of a Patented System by Using the Guy's Stone Score.

OBJECTIVES: At present, there is no report on the application of Guy's stone (GS) score in minimally invasive percutaneous nephrolithotomy (MPCNL). We therefore investigate the clinical effect of MPCNL by using a patented irrigation and clearance system according to the GS. METHODS: A total of 222 consecutive patients were divided into 2 groups that were treated with MPCNL using the patented system or standard PCNL using Electro Medical System (EMS) ultrasound/ballistic trajectory lithotripsy and clearance system, respectively (124 patients in patented system group, 98 patients in EMS system group). The stone complexity and severity of complications were stratified by GS and Modified Clavien grading system in this study, respectively. The success and complication rates between MPCNL and PCNL were compared. RESULTS: The patented system group had a significantly higher success rate (GS3: 95 vs. 43% and GS4: 67 vs. 31%) and a significantly less complications rate (GS3: 12 vs. 27% and GS4: 21 vs. 46%) in GS3 and GS4 compared with the EMS system group. Also, the patented system had significant lower complication rates in Clavien grades II-IV than that of the EMS system. CONCLUSION: The MPCNL using the patented irrigation and clearance system was more efficient in dealing with renal stones of high complexity (GS3-4).

Animal Experimental Study to Test Application of Intelligent Pressure Control Device in Monitoring and Control of Renal Pelvic Pressure During Flexible Ureteroscopy.

OBJECTIVE: To investigate the application of intelligent pressure control devices (medical irrigation and suctioning platform with pressure feedback function, and suctioning ureteral access sheath with pressure-measuring function) in flexible ureteroscopy for monitoring and control of renal pelvic pressure. MATERIALS AND METHODS: Nine pigs with a total of 18 kidneys were randomly divided into 3 groups according to varied renal perfusion flow rates: group A, 50 mL/min; group B, 100 mL/min; and group C, 150 mL/min. A ureteral catheter connected to an invasive blood pressure monitor was retrogradely placed to the upper renal calyx to measure upper calyceal pressure; the suctioning sheath was connected to a 3-channel tubing and was connected to an invasive blood pressure monitor; and the platform and renal pelvic outlet pressure was measured. Perfusion flow, intraluminal pressure control, and warning values were preset on the platform. A flexible ureteroscope was inserted into the upper, mid, and lower renal calyces, and to the front end of the sheath, respectively, each location was irrigated for 5 minutes, and pressure was measured every second. RESULTS: No statistical significance was found between monitor renal pelvic outlet pressure and platform renal pelvic outlet pressure for each group, or between platform renal pelvic outlet pressure and upper renal caliceal pressure for each group at different locations when varied irrigation flow rates were used, or among groups for platform renal pelvic outlet pressure at various irrigation flow rates. CONCLUSION: The intelligent devices used in the flexible ureteroscopy can reliably and stably monitor and control the renal pelvic pressure within a safety range.

The New Generation Mini-PCNL System - Monitoring and Controlling of Renal Pelvic Pressure by Suctioning Device for Efficient and Safe PCNL in Managing Renal Staghorn Calculi.

INTRODUCTION: In order to better control renal pelvic pressure (RPP), reduce surgical complications and increase operative efficacy of minimally invasive percutaneous nephrolithotomy (MPCNL), we designed an MPCNL with intelligent monitoring and control of RPP and sought to explore its clinical efficacy and characteristics. SUBJECT AND METHODS: This study included 60 patients with renal staghorn calculi. A 5F ureteral catheter was connected to an invasive blood pressure monitor for monitoring and control of RPP. A 12F renoscope was inserted through a percutaneous tract for lithotripsy using a laser, with the help of an intelligent system to monitor RPP continuously, which includes an irrigation and suctioning platform and an integrated intraluminal pressure sensory PCNL suctioning sheath. Before the lithotripsy, intraluminal pressure control value and perfusion flow were set on the platform. RESULTS: RPP was maintained at a range of -12 to 2 mm Hg. The mean operative time was 120 min. The mean intraoperative bleeding amount was 100 ml. Fifty-two of the 60 patients the stones were cleared by one surgery. CONCLUSIONS: In our suctioning MPCNL with the intelligent control of RPP, the intraoperative RPP could be accurately controlled within the preset safety range. The stone clearance rate was high.

The Application of Pediatric Ureteroscope for Seminal Vesiculoscopy.

To describe a novel technique of transurethral seminal vesiculoscopy using a pediatric ureteroscope in the diagnosis and management of persistent hematospermia, a retrospective study was carried out for 20 patients with recurrent hematospermia whom we evaluated and treated using a 6-7.5F (6F front end and 7.5F rear end) pediatric ureteroscope from August 2009 to September 2013. For the 20 patients, the age ranges from 25 to 48 years with a mean age of 36 years. The duration of the hematospermia ranges from 6 to 48 months with a mean duration of 18 months. Transurethral seminal vesiculoscopy was successfully performed in the 20 cases and the mean operative time was 35 min (ranges from 25 to 90 min). Among the 20 patients, 11 patients were found to have seminal vesiculitis, five were with seminal vesicle stone, one was with prostatic utricle stone, one was with prostate cyst, and one was with ejaculatory duct obstruction. The mean follow-up period was 7 months (ranged from 6 to 12 months). Hematospermia in 19 cases disappeared after the surgery and only in one patient the hematospermia recurred 6 months after the surgery. The cure rate was 95%. This study indicated that transurethral seminal vesiculoscopy could be performed easily using a semirigid pediatric ureteroscope with few complications and is an effective therapeutic approach for persistent hematospermia.

A comparison of supracostal and infracostal access approaches in treating renal and upper ureteral stones using MPCNL with the aid of a patented system.

BACKGROUND: There are still disagreements on which is a better approach to choose to establish percutaneous tract for percutaneous nephrolitotomy (PCNL), between supracostal and infracostal approaches. The aim of this study is to investigate the safety, efficacy and practicability of minimally invasive PCNL (MPCNL) with the aid of a patented system either through supracostal or through infracostal access. METHODS: A retrospective study was carried out for 83 patients with renal or upper ureteral stones. Under the guidance of B ultrasound or C-arm, these patients were treated by MPCNL through either 12th rib infracostal (Group 1, 43 cases) or supracostal (Group 2, 40 cases) access approach. These 2 groups were compared for total number of percutaneous tracts, average time in establishing a given percutaneous tract, the number of percutaneous tract used for each case, the average stone clearance time, the clearance rate of all stones by one surgery, and the amount of bleeding using a single percutaneous tract. RESULTS: There was a significantly smaller total number of percutaneous tracts needed, a smaller number of cases that needed two percutaneous tracts to clear stones completely, a shorter average time in establishing a percutaneous tract, and a smaller average amount of bleeding in infracostal access group. At the same time, there were a significantly larger number of cases in which stones were cleared completely using a single percutaneous tract and a higher renal stone clearance rate by one surgery. CONCLUSION: There were several advantages of infracostal access. These included accuracy in establishing a percutaneous tract, safety, quickness, convenience and flexibility in moving the patented sheath, and higher renal and upper ureteral stone clearance rate by one surgery.

Comparative study of outcome in treating upper ureteral impacted stones using minimally invasive percutaneous nephrolithotomy with aid of patented system or transurethral ureteroscopy.

OBJECTIVE: To determine an efficient method for treating upper ureteral impacted stones, we compared the outcome of minimally invasive percutaneous nephrolithotomy with the aid of our patented system and transurethral ureteroscopy. MATERIALS AND METHODS: A total of 182 patients with complicated impacted upper ureteral stones above the level of L4 were randomly divided into 2 groups. Group 1 included 91 patients who were treated with minimally invasive percutaneous nephrolithotomy with the aid of a patented system. Group 2 included 91 patients who were treated with ureteroscopy. The patients underwent postoperative shock wave lithotripsy, when necessary. The operative time, stone clearance rate, operative complication markers (amount of intraoperative bleeding and postoperative fever rate), and cost of treatment were compared. RESULTS: A significantly shorter operative time, greater rate of stone clearance, lower need for postoperative shock wave lithotripsy, and lower rate of postoperative fever was found in group 1 than in group 2 (P <.05). However, the cost of treatment and amount of intraoperative bleeding were significantly greater. CONCLUSION: We believe minimally invasive percutaneous nephrolithotomy with the aid of the patented system could be the first choice in treating complicated impacted upper ureteral stones above the level of L4.

The application of a patented system to minimally invasive percutaneous nephrolithotomy.

PURPOSE: To investigate the clinical effect of minimally invasive percutaneous nephrolithotomy (MPCNL) using a patented irrigation and clearance system. PATIENTS AND METHODS: From August 2008 to August 2009, 60 patients with renal stones ≥2.0 cm were randomly assigned to two groups. Group 1 included 30 patients who were treated by MPCNL through a patented 16F sheath with the aid of a patented irrigation and clearance system combined with a high power holmium laser. Group 2 included 30 patients who were treated by a third generation EMS ultrasound/ballistic trajectory lithotripsy and clearance system through a standard 24F sheath. The differences in (1) average time needed for stone clearance; (2) percentage of cases in which one surgery resulted in freedom from stones; (3) mean renal pelvic pressure; and (4) mean amount of intraoperative bleeding were compared. RESULTS: Compared with the EMS ballistic trajectory/ultrasound lithotripsy and clearance system, the MPCNL irrigation and clearance system had a significantly higher percentage of stone-free outcomes after one surgery and a lower amount of introperative bleeding (P<0.05). There was no difference in mean stone-clearance time and mean renal pelvic pressure (P>0.05). When comparing the cases with one percutaneous tract in the patented system group with the cases with one percutaneous tract in the EMS system group, the findings were similar. CONCLUSION: The patented MPCNL irrigation and clearance system is safe and highly efficient in managing renal stones.