| BackgroundUreteroscopic lithotripsy is an important method for the treatment of upper urinary tract stones.The surgical methods include ureteroscopic rigid lithotripsy,ureteroscopic semi-rigid lithotripsy,and flexible ureteroscopic lithotripsy.Traditional ureteroscopic lithotripsy cannot intelligently monitor and control the renal pelvic pressure,if high intrarenal pressure occurs,it can lead to adverse events such as fluid extravasation,urinary sepsis,and renal rupture,even death.Meanwhile,the basket or the foreign body clamps extraction of stone is not efficient.During the operation of ureteroscopic lithotripsy,it is necessary to strictly monitor the renal pelvic pressure.The development of an intelligent pressure measurement and control system that is real-time,sensitive and accurately reflects local pressure changes is a possible way to achieve this purpose.We could use such system to ensure the balance between perfusion and suctioning,and keep the renal pelvic pressureat a low level,which will help improve the efficiency and safety of the operation.To meet the needs above,we developed a device that could monitor renal pelvic pressure in real-time and could intelligently regulate perfusion and suctioning during ureteroscopic lithotripsy(namely the medical intelligent irrigation and suctioning platform),Our purpose was to adjust and control the renal pelvic pressure within a safe range through the medical irrigation and suctioning platform,and to avoid the complications caused by the high renal pelvic pressure,while increasing stone free rate and shorting the operation time,improving the quality of surgery.The results of this study are of great significance to the treatment and theoretical research of upper urinary calculi.Objective: To develope a device that could monitor the renal pelvic pressure in real-time and intelligently regulate perfusion and suctioning during ureteroscopic lithotripsy(the medical irrigation and suctioning platform).The device was applied to perform ureteroscopic lithotripsy under vacuum suctioning,and improve the safety and efficiency of ureteroscopic lithotripsy.Methods: the methods include 4 parts:Part Ⅰ: The development of the integrated device with intelligent irrigation,suctioning and monitoring of renal pelvic pressure(the medical irrigation and suctioning platform).The intelligent platform was developed in collaboration with Jiangxi University of Science and Technology.Part Ⅱ: Experimental study on the changes of renal pelvic pressure under vacuum suctioning with the medical irrigation and suctioning platform.The medical irrigation and suctioning platform was applied to animal experiments using domestic pigs.To understand the reliability and safety of the platform,determine the pressure within the renal pelvis of the experimental subjects,the characteristics of the renal pelvic pressure changes,explore the appropriate renal pelvic pressure control values.,nine healthy female pigs,a total of 18 kidneys,were randomly divided into 3 groups according to different irrigation flows rates(6 kidneys in each group): the medical irrigation and suctioning platform was applied to perform flexible ureteroscopy and retrograde placement of the suctioning ureter access sheath to the outlet of the renal pelvis.Pressure measurement method: Firstly,the ureteral catheter was retrogradely placed into the upper renal calyx and connected with an invasive blood pressure monitor to measure the suprarenal pressure values;Secondly,The suctioning ureter access sheath pressure measuring channel was connected with the medical irrigation and suctioning platform to measure the pressure values at the outlet of the renal pelvis.The irrigation and suctioning channels were connected to the platform,respectively.The parameters of the platform include perfusion flow,intracavity pressure control value(-2mmHg)and intracavity pressure warning value(30mmHg).The renal pelvic pressure was monitored and controled by the pressure feedback unit of the platform and the suctioning device.The flexible ureteroscope entered the upper,mid,lower calyx and the front end of the sheath,and the pressure values were recorded per second.Part Ⅲ: Intelligent monitoring of intracavitary pressure and vacuum suctioning ureteroscopy for the treatment of ureteral calculi below L4 level.A total of 122 patients with ureteral calculi below the 4th lumbar vertebrae were treated with ureteroscopic lithotripsy.The patients were randomly divided into two groups,including the experimental and control groups.Patients in the experimental group(60 cases)were treated with the medical irrigation and suctioning platform and suctioning ureteral access sheath.In the control group,60 patients underwent conventional transurethral ureteroscopic lithotripsy.The levels of procalcitonin(PCT),interleukin-6(IL-6)and endotoxin(BET)were measured before and after surgery,and the CT values of preoperative stones were measured.The postoperative stone-free rate,the number of fever cases,and the number of ureteral strictures were compared.Part Ⅳ: The clinical application research of Intelligent pressure-controlled flexible ureteroscopic suctioning lithotripsy for the treatment of 1.5 to 3 cm kidney stones with the Guy’s score of Ⅰ to Ⅱ.Patients with 1.5 to 3 cm kidney stones and the Guy’s score of Ⅰ to Ⅱ were recruited in the study.Among the patients,59 patients underwent intelligent pressure-controlled flexible ureteroscopic suctioning lithotripsy,and 58 patients underwent conventional flexible Ureteroscopic lithotripsy.The average operation time,stone-free rate,fever,blood WBC count,blood C-reactive protein value,average postoperative hospital stay and the number of re-operational stones were compared between the two groups.ResultPart Ⅰ: The development of the medical irrigation and suctioning platformWe developed the medical irrigation and suctioning platform,and tested its performance on isolated pig kidneys in vitro,and pressure feedback function.We found that the platfrom could accurately set the pressure alarm value and automatically adjust perfusion and suctioning according to renal pelvic pressure.In addition,the platform parameters were dynamically displayed on the screen and convenient to operate.Part II: Experimental study on the changes of renal pelvic pressure in flexible ureteroscopy under vacuum suction with irrigation and suction platform for medical.Part Ⅱ: Experimental study on the changes of renal pelvic pressure under vacuum suctioning with the medical irrigation and suctioning platformComparing of the pressure at the outlet of the renal pelvis of the monitor and the pressure at the outlet of the renal pelvis at the platform,no significant difference was found between the pressure at the outlet of the renal pelvis of the monitor and the pressure at the outlet of the renal pelvis at different perfusion flows.To compare the pressure of the outlet of renal pelvis and the pressure of upper renal calyx at different sites and different irrigation flow rates,flexible ureteroscope was inserted into the upper,mid and lower renal calyx and perfusion was conducted accordingly.There was no significant difference in the pressure between the upper renal calyx and the outlet of renal pelvis,indicating that the pressure at the outlet of the pelvis can reflect the pressure in the renal pelvis at different irrigation sites and flow rates.To compare the pressure of platform at the outlet of renal pelvis in different groups under different perfusion flow rates,there was no significant difference in the pressure values at the outlet of the renal pelvis among groups,indicating the pressure at the outlet of the renal pelvis was relatively stable under different perfusion flow rates.Part Ⅲ: Intelligent monitoring of intracavitary pressure and vacuum suctioning ureteroscopy for the treatment of ureteral calculi below L4 level.The surgeries have been completed for the patients in the two groups on time.The operation time of the experimental group was 25.3±5.6 min,the stone-free rate was 100%,1 case had postoperative fever(38.2℃).There was no postoperative ureteral stricture.The operation time of the control group was 47.2±9.8min,the stone-free rate was 81.7%,7 cases had postoperative fever and 3 cases had ureteral stricture.The differences were statistically significant(P<0.05).The operation time,the number of ureteral perforation,PCT,IL-6,BET and postoperative retreatment were lower in the experimental group than those in the control group.The experimental group had a higher stone free rate than the control group.The difference was statistically significant(P<0.05).Part Ⅳ: The clinical application research of Intelligent pressure-controlled flexible ureteroscopic suctioning lithotripsy for the treatment of 1.5 to 3 cm kidney stones with the Guy’s score of Ⅰ to Ⅱ.The average operation time of the traditional flexible ureteroscopic lithotripsy(FURL)group was significantly longer than that of the intelligent pressure-controlled flexible ureteroscopic suctioning lithotripsy(IPFUSL)group(69.31 ± 27.711 min vs.35.21 ± 21.27 min,P<0.05).Postoperative WBC,postoperative CRP,postoperative fever was lower in the IPFUSL group than those in the traditional FURL group.The stone free rates of the traditional FURL group were 56.9% and 72.1%.4 weeks and 12 weeks after surgeries,respectively,which were significantly lower than 74.6% and 91.5 % of the IPFUSL group(P<0.05).In the IPFUSL group,only one patient experienced secondary surgery due to residual stones,which was less than 5 patients in the traditional FURL group(P<0.05).There was no significant difference in postoperative hospital stay between the IPFUSL group and the traditional FURL group(3.15±1.320 d vs 3.78±2.476 d,P>0.05).ConclusionThe medical irrigation and suctioning platform developed by our institution has the advantages of reliability,stability and multiple functions.It is an integrated system with main control unit,suction unit,irrigation unit and pressure feedback unit.The platform can timely,sensitively and accurately reflect pressure changes and intelligently control pressure to ensure a balance between irrigation and suctioning,so that the intrarenal pressure remains stable within a safe range,ensuring safe operation.The application of irrigation and suctioning platform to Intelligent pressure-controlled ureteroscopic suctioning lithotripsy could avoid the snowstorm effect during the gravel process,reduce the stone displacement,quickly remove stones,effectively control the renal pelvic pressure,reduce the absorption of bacteria and endotoxin and the incidence of postoperative infection.The surgical method has the advantages of high efficiency,less residual stones,less complications,short hospitalization time and less bleeding,and has strong clinical practicability. |
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