Новые технологии и интеллектуальные системы повышают безопасность удаления камней в почках

Innovative collaborations are improving the safety and efficacy of stone procedures. Several new and emerging technologies are making the “Quadfecta” more attainable (clear vision, controlled temperature, safe pressure, and ideal suction) and are being discussed at major urology conferences, such as the recent American Urological Association (AUA26) annual meeting and the European Association of Urology (EAU26) congress. At AUA26, a panel debated treatment of a 2 cm renal pelvis stone. They discussed the pros and cons of contemporary options: flexible and navigable suction ureteral access sheath (FANS) ureteroscopy, direct-in-scope suction (DISS) ureteroscopy, robotic flexible ureteroscopy, mini percutaneous nephrolithotomy (mPCNL), and standard flexible ureteroscopy. Each had its potential risks, such as pre-stenting and ureteral damage for FANS; bleeding, pain, and perforation during mPCNL; the larger sheath size and need for staging when treating larger stones using DISS, and pressure, temperature, and sepsis risks with standard flexible ureteroscopy. “The future of endourology, procedure optimization, safety, and outcomes reside in the ‘Quadfecta’ advancements. The landscape is fast changing for the better. Integrated systems optimizing vision, temperature, pressure, suction, and lasers with built-in communication between each will forever change our field,” Kyle Wood, MD, MBA, who is an associate professor at the University of Alabama at Birmingham, said in an interview. Dr Wood and his colleagues have developed an assist device designed to improve ureteroscopy ergonomics as well as patient care. Dr Wood said while the technology inside the scope has advanced significantly, the external surgical environment has not kept pace. He noted that surgeons often are forced to manage delicate equipment in crowded spaces, sometimes resting scopes on the patient or relying on assistants to hold them. The recently developed device is called ScopeAssist. It allows surgeons to stabilize and control the scope hands-free when needed. ScopeAssist has a mobile base and features a modular, articulating arm with a zero gravity scope holder that allows movement in all directions with a locking mechanism. Since the system attaches to existing equipment and moves with the surgeon, it offers flexibility while reducing fatigue. By securely holding the scope in place, the device helps prevent drops, maintains camera positioning, and streamlines workflow during procedures. “ScopeAssist was designed to optimize the surgical field during ureteroscopy. Functionally, it provides the surgeon with a third arm, limiting dependence on an assistant and optimizing and integrating the use of all the novel and advancing technology in endourology. It takes the Quadfecta and adds another dimension,” Dr Wood said. The technology improves organization in the operating field by managing cables and allowing surgical tools to remain within reach. Beyond convenience, the device has the potential to improve patient outcomes by reducing procedure time, minimizing contamination risks, and decreasing reliance on additional staff. “As a field, we need to believe that the interval improvement from each of the Quadfecta advancements, when brought together, will be additive and result in the real-world benefits that can be measured. In my opinion, it is time for the field to adopt all aspects of the Quadfecta and design a study that demonstrates the benefits in safety and outcomes,” said Dr Wood. Improved Stone Management Tools A prospective, single-center clinical study using the prototype integrated laser urology platform (iLUP) system (IPG Medical, Marlborough, MA) is suggesting that it may provide excellent safety and efficacy by achieving complete stone clearance and efficient aspiration of sub-millimeter fragments. Its ability to integrate Thulium fiber laser (TFL) lithotripsy with automated suction and pressure control represents a significant technological advancement toward safer, more efficient, and dust-free endoscopic stone surgery, according to data presented at EAU26. The iLUP combines TFL lithotripsy, DISS, and integrated irrigation/aspiration pumps under automated pressure control. The developers report that this all-in-one system aims to improve stone-clearance efficiency and reduce operative risks. In a study with 12 patients, the team used primary efficacy outcome measures (PEOMs). These included total procedure time, laser operation time, and total laser “on” time. Ablation rates and stone-free rates (SFR) were assessed endoscopically at the end of the procedure and by postoperative CT at 1-day follow-up. No significant differences were observed among PEOMs. The SFR was 100% immediately after treatment and at 1-day follow-up on CT. No intraoperative or postoperative complications were reported. Federico Zorzio, MD, who is a urology resident at University of Trieste and a fellow at Tenon Hôpital-Sorbonne Université, Paris, France, said this new platform combining laser ablation, irrigation, aspiration, and pressure monitoring showed no safety concerns. “It may improve immediate stone-free rates, ablation efficiency, procedure time, fragment clearance, and recurrence risk,” said Dr Zorzi, who presented the study findings at EAU26. “Further clinical studies are needed to confirm our findings.” Automated Target Recognition During Laser Lithotripsy A pre-clinical evaluation is demonstrating that the StoneSense™ module (SSM) automated target recognition system may effectively discriminate between stone and soft tissue, markedly reducing the risk of mucosal injury without compromising procedural efficiency. Automated target recognition during laser lithotripsy represents a promising strategy to enhance safety by preventing inadvertent laser activation on soft tissue, according to research presented at EAU26. The SSM achieves real-time classification of the object in front of the laser fiber tip by analyzing reflected optical signals. This ensures laser emission only when a stone is detected. The SSM was integrated into a prototype TFL platform from IPG Medical. The current evaluation was conducted in 2 phases (ex-vivo and in-vivo testing). In the ex-vivo phase, human urinary stones were embedded in porcine kidney tissue. The distal tip of a single-use flexible ureteroscope with a 200-µm laser fiber was mounted on a 2D motorized stage. It moved across both stone and soft tissue at 2 and 5 mm/s, while the laser foot pedal was continuously activated. Ablation patterns were compared between SSM “on” and “off” modes. In the ex-vivo phase, soft-tissue ablation was completely avoided when SSM was active, achieving 100% sensitivity compared with the SSM “off” pattern. Specificity exceeded 95% across all stone compositions. In the GLP-animal study, all stones were successfully ablated with no or minimal mucosal injury. “We confirm the efficacy of this system. It seems that this kind of automatic system will improve safety in laser use,” said study investigator Olivier Taxer, MD, who is chair of urology at Sorbonne University Tenon Hospital, Paris, France. Another new study is suggesting that adopting MOSES Raydar™ may increase ablation rates and could lead to shorter treatment and laser times. MOSES Raydar is a prototype holmium laser system designed to provide surgeons with real-time proximity indication between a fiber distal tip and a stone target during urinary lithotripsy procedures. In September 2025, 7 physicians with no prior MOSES Raydar experience performed lithotripsy in a silicone model. During timed procedures, stones that were lased to completion with Raydar mode “on” had significantly reduced session time (8.6 ± 2.1 vs 9.7 ± 2.6 min; P =.02) and laser use time (8.1 ± 2.2 vs 9.4 ± 2.5 min; P =.001) compared with lasing without Raydar mode. Distance distribution metrics suggest physicians can achieve closer and more precise working distance when combining the laser with Raydar mode even after a short learning curve. “We are using the laser more efficiently,” said Benjamin Turney, MA, MSc, of Oxford University Hospitals in the UK, who presented the findings at EAU 2026. New Approaches to Monitor Intrarenal Pressure and Temperature A separate intelligent temperature- and pressure-controlled flexible ureteroscope was developed and tested with the Henan Provincial Center for Diagnosis and Treatment of Urinary Calculi as the main completing unit. A temperature and pressure sensor was installed at its tip, which can monitor and regulate the pressure and temperature in the renal pelvis during lithotripsy in real time. The researchers retrospectively examined the medical records of 152 patients with upper urinary tract calculi who underwent holmium laser lithotripsy using an intelligent temperature- and pressure-controlled flexible ureteroscope combined with negative pressure suction sheath at a single center. Data such as intraoperative intrarenal pressure, intrarenal temperature, complication rate, stone-free rate at 2 days after surgery and other perioperative-related data were analyzed. In holmium laser lithotripsy using this intelligent temperature- and pressure-controlled flexible ureteroscope combined with negative pressure suction sheath, the intrarenal pressure and temperature can be regulated within a preset safe threshold. The researchers concluded that this method appears to cause few postoperative complications and has a satisfactory stone-free rate, supporting its clinical value. “There were no serious problems and no fevers,” said Shi Xinyu, MD, of First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China, who presented the data at EAU26. Real-time intrarenal pressure monitoring using intelligent automated control appears feasible and safe. A first-in-human pilot study tested the iMimer™ FANS system (ZSR Biomedical Technology, China). Intrarenal pressure during fURS is a known risk factor for infectious complications and renal damage. The technology effectively minimizes hazardous elevated intrarenal pressure elevations during flexible ureterorenoscopy (fURS). This automated approach represents a significant step towards standardizing a critical safety parameter in endourology, according to the researchers. This approach may facilitate more complex procedures with a superior safety profile, relieving surgeon mental burden on intraoperative devices control. A prospective pilot study was conducted in patients undergoing fURS for renal stones during October 2024 to March 2025. Prior to insertion, the FANS intrarenal pressure sensing channel was primed with 2 mL normal saline and connected to the sensor and iMimer, calibrated to zero. This was followed by deployment of 10/12Fr intrarenal pressure monitoring FANS under fluoroscopic guidance beyond the ureteropelvic junction. iMimer employs an intelligent algorithm to autoregulate irrigation flow and suction to maintain a user-set intrarenal pressure threshold (set at 30 mmHg for this study). The intrarenal pressure-monitoring FANS and iMimer system were successfully deployed in all 24 cases without device-related adverse events. The intelligent autoregulation system maintained intrarenal pressure below the 30 mmHg threshold for 96.5% of total operative time. Transient spikes in pressure readings correlated with real-time endoscopic view, most commonly signaling obstruction of the pressure-sensing port at the FANS tip. A notable reduction in subjective manual adjustments of irrigation and suction settings by the surgeon was observed. A satisfactory optimally distended pelvicalyceal system was reported more than 90% of the time. “This first-in-human pilot study shows that the iMimer™ FANS system is safe and feasible,” said Steffi Yuen, MD, with the S.H. Ho urology centre at The Chinese University of Hong Kong, Hong Kong, China. Dr Yuen, who presented the data at EAU26, said the results suggest this automated approach may represent a significant step towards standardizing a critical safety parameter in endourology. Further, it may facilitate more complex procedures with a superior safety profile, relieving surgeon mental burden on intraoperative devices control. Ureteral Stent Monitoring Advances The ureteral stent sleeve, UroSleeve, is another new tool for surgeons. It is a modular wireless pressure monitoring system that integrates seamlessly with standard ureteral stents without altering their existing designs or manufacturing processes. The UroSleeve incorporates a flexible, printed,circuitboard-based spiral antenna and a surface-micromachined capacitive pressure sensor, forming an inductor-capacitor tank circuit capable of wireless telemetry through near-field inductive coupling. In a 2026 study published in Microsystems & Nanoengineering, a University of British Columbia-led team reported a wireless ureteral stent sleeve for early detection of hydronephrosis. The researchers developed UroSleeve to fit over standard double-J ureteral stents without altering their established design or manufacturing process. Hydronephrosis can lead to deterioration of renal function due to prolonged increased intrarenal pressure. Currently, the only way to diagnose hydronephrosis is radiographic imaging. A continuous, non-invasive method is not available. UroSleeve offers an advanced and effective approach to addressing the limitations of current ureteral stent monitoring methodologies. Ex vivo results are now providing evidence of the potential of this technology, showcasing its sensitivity and adaptability to biological conditions. The device was evaluated in an ex vivo porcine kidney model whose internal pressure was externally controlled to mimic a hydronephrosis condition. Kidney pressure changes were successfully monitored by detecting shifts in the resonant frequency of the device. The study demonstrated a high sensitivity with -5.3 ± 0.74 kHz/mmHg with a baseline resonant frequency of 15.234 MHz at 8.5 mmHg. The frequency response showed a strong correlation with kidney pressure. Additionally, the device maintained consistent performance in a relevant biological environment. The results indicate that UroSleeve offers a practical and versatile solution for wireless intrarenal pressure monitoring, amenable to future clinical translation, according to the Canadian researchers. Treating Stones Noninvasively With a Mini Robot? Researchers from the University of Waterloo in Canada have created a soft, rice-sized, biocompatible magnetic robot that can theoretically travel up the urinary tract to dissolve renal and ureteral stones. In a preclinical study using a 3D-printed urinary tract model, published in Advanced Healthcare Materials, the investigators demonstrated robot navigation and stone dissolution. They steered the tetherless robot using external magnetic guidance to reach the stone. To fragment the stone, the robot delivered urease, a stone-dissolving enzyme. This novel technology still needs to undergo several stages of testing before it can enter human clinical trials. FDA-Approved Break Wave™ Lithotripsy Is Ready for Prime Time At AUA26, Ben H. Chew, MD, MSc, of the University of British Columbia, Vancouver, Canada, presented findings from the SOUND pivotal trial of Break Wave lithotripsy™ (Sonomotion) for non-invasive and anesthesia-free lithotripsy. In Break Wave, a generator attached to a probe delivers ultrasonic waves that amplify pressure and create stress points within the stone leading to fragmentation. Compared with extracorporeal shock wave lithotripsy (ESWL), Break Wave delivers lower focal pressure. The prospective SOUND trial (ClinicalTrials.gov identifier, NCT05701098) compared Break Wave vs ESWL for noninferiority in 64 patients at 10 centers in the US and Canada. Patients without a viable acoustic window – adequate distance from the pelvic iliac crest to the twelfth rib to fit the probe — could not participate. Stone size was required to be larger than 4 mm and up to 10 mm and eligible for ESWL. One-third of stones were approximately 1200 Hounsfield units in density. Lower pole stones and ureterovesical junction stones each accounted for approximately one-third of cases. The trial allowed retreatment, and 27% of patients needed it. The primary effectiveness endpoint was stone-free status or fragments 4 mm or less. Break Wave had a 70% effectiveness rate, meeting noninferiority criterion compared with ESWL (57.6%). Ureteral stones had a higher success rate compared with renal stones (87% vs 52%). Ureterovesical junction stones had a 90% success rate compared with 47% for lower pole stones. The primary safety endpoint was the rate of hematoma, urinary tract sepsis, or serious cardiac arrhythmia. It was 0% for Break Wave demonstrating noninferiority to ESWL. Moderate and severe adverse events occurred in 18.8% and 4.7% of the overall population, respectively. References: - Traxer O, Zorzi F, Martov A, et al. ILUP (integrated laser urology platform) all-in-one laser, irrigation/aspiration, and suction. Fragment size distribution in a clinical study of a novel integrated system combining flexible DISS and thulium fiber laser lithotripsy. Presented at EAU Congress; March 13-16, 2026; London, UK. Abstract A0162. - Traxer O, Zorzi F, Yaroslavsky I, et al. Ex-vivo and in-vivo evaluation of an automated target recognition system for thulium fiber laser lithotripsy . Presented at EAU Congress; March 13-16, 2026; London, UK. Abstract A0094. - Pietropaolo A, Kamphuis G, Angerri O, et al. Initial physician experience with MOSES Raydar™: A bench test to discover the potential of fiber-stone proximity approximation. Presented at EAU Congress; March 13-16, 2026; London, UK. Abstract A0096. - Xinyu S, Wenhao C,Mohan G, et al. Preliminary application of intelligent temperature-and pressure-controlled flexible ureteroscope combined with negative-pressure suction sheath in holmium laser lithotripsy for upper urinary tract calculi. Presented at EAU Congress; March 13-16, 2026; London, UK. Abstract A0103. - Yuen S, Gauhar V, Kwok JL, et al. Real-time intrarenal pressure (IRP) monitoring and intelligent autoregulation during flexible ureterorenoscopy using an IRP-monitoring flexible and navigable suction ureteral access sheath (FANS) with iMimer™: A pilot study. Presented at EAU Congress; March 13-16, 2026; London, UK. Abstract A0108. - Shalabi N, Searles K, Herout R, Almutairi K, Chew BH, Lange D, Takahata K. Ureteral stent sleeve for early detection of hydronephrosis. Microsyst Nanoeng. 2026 Mar 18;12(1):97. doi:10.1038/s41378-026-01224-1 - Khabbazian A, Kwong L, Lewis A, et al. Kidney stone dissolution by tetherless, enzyme-loaded, soft magnetic miniature robots. Adv Healthc Mater. 2025 Sep;14(23):e2403423. doi:10.1002/adhm.202403423 - Chew B, et al. Break Wave lithotripsy: FDA-cleared, anesthesia-free point-of-care technology redefining stone management (S.O.U.N.D. pivotal trial). Presented at AUA26. LBA.