Pressure reduction and suction characteristics of the new digital single use Flexible Ureteroscope with Suction: An In-Vitro Experimental Study

Pressure reduction and suction characteristics of the new digital single use Flexible Ureteroscope with Suction: An In-Vitro Experimental Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Pressure reduction and suction characteristics of the new digital single use Flexible Ureteroscope with Suction: An In-Vitro Experimental Study Begoña Ballesta Martínez, Laurian Dragos, Vasileios Tatanis, Bhaskar Somani, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4701389/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 12 Nov, 2024 Read the published version in World Journal of Urology → Version 1 posted 12 You are reading this latest preprint version Abstract Purpose To assess the time taken by the single use 7.5Fr suction flexible ureteroscope to reduce pressure under 40 mm Hg and to characterize the behavior of stones, fragments and dust during suction activation Methods An in vitro setting was developed for this experiment. A saline-filled globe, with the 7.5Fr single use suction flexible ureteroscope, PU3033AH (ZhuHai Pusen Medical Technology Co, Ltd, Guangdon, China), an automatic irrigation pump and a pressure monitoring set were used at four modalities; i) continuous suction, no irrigation inflow; ii) continuous suction, irrigation inflow on; iii) one-second rate intermittent suction, irrigation inflow on, and iv) half-second rate intermittent suction, irrigation inflow on. The behavior of calcium oxalate stones from 0.5 to 5 mm when being aspirated via the ureteroscope into a plastic container filled with saline was recorded. Results Suction with the PU3033AH worked properly with the inflow irritation on. The fastest strategy to lower the pressure was by continuously pressing the suction button with the irrigation inflow on. Overall, the median time to reach 40 mg was roughly 3.5 seconds. The PU3033AH could aspirate 0.5 mm stones. The suction mode on a continuous pattern allowed relocation of stones ranging from 1 to 5 mm on an experimental setup with no obstacles. Conclusion The PU3033AH was efficient in lowering pressure in a closed cavity mimicking the renal pelvis. Likewise, stone fragments under one millimeter were aspirated by the device whereas stones from one to five mm could be displaced when activating suction in continuous mode on an experimental setup with no obstacles. RIRS FURS Suction Intrarenal Basic Research Figures Figure 1 Figure 2 Introduction Technological advances in flexible ureteroscopy (fURS) has gained momentum in recent years leading to a significant expansion of indications of such technique and miniaturization of instruments ( 1 – 3 ). Enhancing vision in this era requires increasing the irrigation inflow ( 3 – 5 ). Unfortunately, if balance between irrigation inflow and outflow is not achieved, intrarenal pressure (IRP) might reach unsafe levels leading to pyelovenous backflow, rupture of the collecting system and/or renal damage resulting in postoperative complications such as infections and sepsis ( 4 , 6 , 7 ). Other limitations of retrograde intrarenal surgery (RIRS) besides limited visualization, which requires increasing the IRP via increased irrigation flow, are the persistence of fragments that cannot be removed, and the need for accessories such as baskets or extraction devices ( 8 ). Additionally, the data suggests that IRP and intrarenal temperature (IRT) are closely related ( 9 ). High-power lithotripsy, especially in RIRS where outflow may be limited, may result in hazardous increases in IRT ( 9 – 11 ). A solution to the imbalance of fluid inflow and outflow during fURS is the use of suction devices. It can be achieved with vacuum-assisted ureteric access sheaths (UAS), with scopes modified with an accessory suction device or with direct in-scope suction option, or with a catheter type device ( 8 , 12 , 13 ). Suction devices during fURS seem to provide many advantages including lowering IRT and IRP, reducing the risk of urinary infections and sepsis, improving surgical outcomes with better stone-free rate (SFR) and visibility, and therefore an over decrease in operative time and complication rates ( 12 , 14 – 25 ). Direct in-scope suction (DISS) technique could potentially minimize the usage of such accessories for fragment removal by using suction aspiration, for dust and small fragments, to improve stone-free rates ( 8 ). The recently introduced Pusen 7.5 fr Digital Single-Use Flexible Ureteroscope PU3033AH (ZhuHai Pusen Medical Technology Co, Ltd, Guangdon, China) has an add-on suction accessory directly attached to the scope itself through the working channel. This allows clinicians to activate the suction for dust and small fragment removal during the procedure. The aim of the study was to characterize the suction effect of the new 7.5 Fr Single-Use Flexible Video Ureteroscope Digital Single Use Flexible Ureteroscope with the suction accessory, the PU3033AH, with an in vitro experimental setting. Materials and Methods An in vitro experimental study was performed to assess the time taken by the single use 7.5Fr PU3033AH scope (ZhuHai Pusen Medical Technology Co, Ltd, Guangdon, China) to reduce pressure under 40 mm Hg (considered as safe threshold level), and to characterize the behavior of stones, fragments and dust during suction activation. PU3033AH The PU3033AH is a 7.5 Fr single-use digital ureteroscope with a CMOS sensor and a LED light source on the tip. It is capable of 270 degrees of bidirectional deflection. The working channel is 3.6 Fr. It is advertised by the manufacturer as the thinnest single-use ureteroscope with integrated suction control abilities. The suction button is positioned on the ureteroscope handle, avoiding the need of extra expenses in accessories, and the user can easily press the button the procedure during the procedure either intermittently or continuously. As per the manufacturer, the irrigation inflow must be off when suctioning. Assessment of time taken to reduce pressure The experimental setting consisted of a non-powder nitrile medium sized glove index finger cut from the base and filled with 20 cc of normal saline with the pusen 7.5Fr PU3033AH connected to a lagoon 600 surgical vacuum regulator at -100 mBar (x100Pa) (Air Liquide, Paris, France) through a standard silicon tube on the suction connection button of the scope. This was then connected to an Endomat select UP 210 automatic irrigation pump (Karl Storz Se & Co. Tuttlingen, Germany) set at 80 mm Hg through an irrigation system (Cook Medical, Indiana, USA). An Arrow™ arterial catheterization set (Teleflex, Wayne, Pennsylvania, USA) TruWave™ 3cc/60 in (150 cm) was connected to a pressure monitoring set (Edwards Lifesciences (Irvine, California, USA) and to a pressure monitor (Philips, Amsterdam, Netherlands), and this was placed inside the nitrile glove finger in parallel with the 7.5Fr ureteroscope with suction as shown in Fig. 1 . The ureteroscope was tight with the arterial catherization set and inserted in the glove finger.The system was hand sealed until a closed system was reached. The automatic pump was preferred to keep the inflow uniform during all tests and avoid biases. All devices used were set and secured at the same height on an operating theater table at “level” height mode. Irrigation inflow through the automatic pump was activated until reaching stable pressures between 60–80 mm Hg. Once a stable pressure was obtained the suction button was pressed in 4 different modalities; It was pressed continuously and with the irrigation inflow off; pressed continuously and with the irrigation inflow on i.e. without stopping the irritation inflow; pressed on an intermittent pattern on a rate of pressing/releasing of one second with the irrigation inflow on, and pressed on an intermittent pattern on a rate of pressing/releasing of half a second and with the irrigation inflow on. The intermittent pattern was tested because it is common to use it on the clinical practice in order to avoid system collapse. Time to reach a pressure of 40 mm Hg was recorded by two different researchers with two different chronometers. 24 tests were done to assess the time to lower the pressure to the theoretical safety threshold of below 40 mm Hg. Characterization of Stones Suction Experimental Setting The behavior of stones of different sizes were recorded. A real calcium oxalate kidney stone was smashed with a FL038R stainless hammer (Aesculap Inc, Pennsylvania, USA) until obtaining smaller stones of 0.5, 1, 2, 3, 4 and 5 millimeters as per measurements with a ruler. The fragments were placed in small plastic containers filled with saline, according to their size. Ten stones of the same size were placed per container. The PU3033AH was inserted in the container while connected to an irrigation system and to the automatic pressure pump at 80 mm Hg on the irrigation channel, and to an empty standard suction tube on the suction button which was connected to a standard surgical suction device at -100 mBar (x100Pa), likewise as described in the methods section. The suction buttom was pressed continuously pointing to the target stone (Fig. 2 ). The behavior of the stones when being sucked was recorded. Statistical analysis SPSS v25 software (IBM Statistics, NY, USA) was used for statistical analysis. Descriptive statistical calculation of median values per cohort of suction modality and activation/deactivation of inflow was done. ANalysis Of VAriance (ANOVA) was conducted to explore the differences in the time to reach 40 mmHg between continuous and intermittent pressing, as well as between the four suction techniques. Initial pressure was used as the covariate to control the effect over time. The Tuckey post-hoc test was used for equal variances. Results Suction with the PU3033AH worked properly with the inflow irrigation on and resulted in a more rapid pressure reduction compared to while using it with the inflow irrigation off. Results from the assessment of time to register a pressure reduction to 40 mm Hg using the PU3033AH on different suction button finger-pressing techniques with inflow irrigation on and off and with different initial pressures are displayed at Table 1. Overall, the median time to reach 40 mg was roughly 3.5 seconds. The ANOVA revealed that continuous button-pressing suction technique reached 40 mm Hg significantly faster, averaging 3.0 seconds, compared to intermittent pressing at an average of 4.8 seconds (F = 11.7; p = 0.002). The initial pressure did not show a significant effect (p = 0.725). When comparing four techniques, statistically significant variations were found (F = 5.9; p = 0.005), with the initial pressure once again showing no significant effect (p = 0.528). The continuous pressing technique with the irrigation inflow off and the continuous pressing technique with the irrigation inflow on showed similar times for achieving 40 mm Hg (3.5 and 2.6 seconds, respectively), and both were significantly faster than the intermittent technique at a 1 second rate which took longer at 5.3 seconds (p = 0.046 and p = 0.003, respectively). In contrast, the intermittent pressing technique at 0.5 seconds rate (resulting in 4.2 seconds) did not show any significant differences when compared to other techniques . Regarding the characterization of suctioning fragments and dust, the PU3033AH was capable to aspirate 0.5 mm stones. Stones ranging from 1–5 mm were attracted to the tip of the scope and did not pass through the working channel when activating suction in continuous mode, However, they remained attached to the tip while suction was activated, irrespective of the ureteroscope movement. This showed that, in our experimental setup and in the absence of obstacles, small stone fragments could potentially be relocated using the continuous suction mode. Discussion Suction during retrograde intrarenal surgery has proved to improve outcomes by decreasing the operative time, increasing SFR and preventing complications, especially infectious complications ( 15 – 18 , 23 – 25 ). Several papers provided clinical and preclinical data on the benefits of suction through UAS of different configurations and flexibility properties ( 14 – 20 , 22 – 25 ). Nevertheless, data on direct in-scope suction are scarce. We designed a custom and reproducible experimental setting to assess time for pressure reduction to 40 mmHg as low pressure target because previous studies proposed the safety threshold between 30 and 45 mmHg ( 26 ). We also assessed the behavior of fragments while suction activation. The PU3033AH worked well with the inflow irrigation on and resulted in faster pressure reduction than with the inflow irrigation off. Initial pressures were set at values between 60–80 mm Hg as per previously reported IRP during simple fURS ( 4 , 27 ). The manufacturer’s recommendation is, understandably, not to use suction with irrigation inflow on. However, in our study, interestingly, the fastest strategy to lower the pressure was by actually pressing the suction button continuously, with the irrigation on. This can be explained because the irrigation inflow channel of the scope and the section channel are both connected to a single working channel as per the manufacturer. In our tests, the initial pressure did not correlate in time to reach 40 mm Hg, with time taken to reach this being a non-significant factor. The overall median time to reach 40 mg was 3.86 seconds. That correlated with Ostergar and colleagues’ findings on an ex vivo study with a porcine model to assess the effect of vacuum assisted UAS, where they recently proposed to use lower suction settings and short, 200 mm Hg) ( 20 ). DISS has been investigated in semirigid ureteroscopy and fURS with promising results in clinical studies ( 8 , 28 – 30 ). Gauhar and colleagues presented an aspiration technique directly from the ureteroscope by using the scope channel to remove debris, fragments or dust through a simple system that can mount into the operating channel of any ureteroscope, attached via two 3-way plug system ( 8 ). They reported that RIRS with the DISS technique was feasible with an acceptable retreatment rate, compared to vacuum assisted UAS, with the added values of low cost, efficiency and versatility ( 8 ). In an ex vivo study in a porcine kidney model Jiang P et al ( 21 ) reported a combined system with the use of a UAS and active aspiration using a dual-channel fiberoptic ureteroscope specific with a 5.2 Fr tip, a 9.9 Fr shaft and a 3.3 Fr specific irrigation port with an aspiration port of 3.3 Fr. The system allowed aspiration while maintaining constant irrigation and suction during laser lithotripsy ( 21 ). We also proved that 0.5 mm stones are completely aspirated by the device when directed at them, and stones between 1 and 5 mm inclusive are attracted by the tip of the scope while pressing the suction button in continuous mode. Although further clinical studies are needed to characterize this effect, it could be very useful in a real clinical scenario for stone manipulation and avoiding the use of baskets or other disposables to relocate stones. One limitation of the study is that the model resulted in variability in initial pressures with the same irrigation inflow pressure. However, similar variations are reported in the clinical setting( 4 ). Additionally, we did not assess reported maximum peak values at higher levels. However, those peaks are usually achieved with manual pumping which is not beneficial to use at the same time than suction because the purpose of manual pumping is to increase the irrigation inflow to improve vision, and increasing the outflow by suction would annul the effect. Also, the experiments were performed without any instruments i.e. the laser fiber inside the working channel which would be the regular practice. This might modify the effect. Likewise, we only tested one stone composition and 5 different fixed sizes of stones for the suction behavior. However, for fragment repositioning, we think that it would not be clinically relevant to test stones larger than 5 mm as they would perhaps be large in volume and weight to have any movement from suction. Future work could look at stones of different compositions and sizes, and with different pressure parameters. Conclusions On the presented study, the PU3033AH was efficient in lowering pressure with a median time of roughly 3.5 seconds. The fastest strategy to lower the pressure was by continuously pressing the suction button with the irrigation inflow on. It was capable of aspirating 0.5 mm stones and moving stones of 1–5 mm when activating suction in a continuous mode on a set up with no obstacles. Further clinical studies are however needed to confirm our results. Declarations Acknowledgements The authors thank the collaboration of Dr. Javier Calahorra, Dr. Rafael Carrasco and Dr. Pedro Gonzalez Cabezas por their logistical contribution. Funding No funding was received Contributions BBM: Concept, Design, Performance of the experiment, data collection and analysis, paper writing and review LD: Concept, Design, data analysis, paper writing and review VT: Design, data analysis, paper writing and review BS: Design, data analysis, paper writing and review PC: Design, Performance of the experiment, data collection. OA: Design, data analysis, paper writing and review AP: Design, paper writing and review AT: Design, paper writing and review AK: Design, paper writing and review MGV: Design, Performance of the experiment, data collection. MCGS: Design, Performance of the experiment, data collection. JLV: Design, Performance of the experiment, data collection. SFA: Design, paper writing and review EL: Concept, Design, paper writing and review PK: Concept, Design, data analysis, paper writing and review Disclosure Dr. Laurian Dragos is lecturer for EMS and Boston Scientific and consultant for Ambu. Dr. Bhaskar Somani is consultant for Pusen, Boston Scientific, Cook Medical, Coloplast and Olympus. Dr. Oriol Angerri is lecturer for Boston Scientific and Cook Medical. Dr. Evangelos Liatsikos is consultant for Cook Medical and Karl Storz and lecturer for Karl Storz, Boston Scientific, EMS and Redpine. Dr. Panagiotis Kallidonis is lecturer for EMS and Cook Medical. None of the rest of authors have any conflict of interest to disclose References Noureldin YA, Kallidonis P, Liatsikos EN (2020) Lasers for stone treatment: How safe are they? Curr Opin Urol 30(2):130–134 Kronenberg P, Somani B (2018) Advances in Lasers for the Treatment of Stones—a Systematic Review. Curr Urol Rep. ;19(6 https://mail.google.com/mail/u/0?ui = 2 & ik = 993d0642cd & attid = 0.1 & permmsgid = msg-f:1706781290314263576 & th = 17afb48a6676ec18 & view = att & disp = inline & realattid = 88510fa7802aa63_0.1). 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J Endourol 32(12):1154–1159 Lechevallier E, Luciani M, Nahon O, Lay F, Coulange C (2003) Transurethral Ureterorenolithotripsy Using New Automated Irrigation/Suction System Controlling Pressure and Flow Compared with Standard Irrigation: A Randomized Pilot Study. J Endourol 17(2):97–101 Tables Table 1 is available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table.pptx Time for pressure reduction to 40 mm Hg with the PU3033AH Legend: Results from the assessment of time to register a pressure reduction to 40 mm Hg using the suction accessory of the PU3033AH on different suction button finger-pressing techniques with inflow irrigation on and off and with different initial pressures. Time is presented in seconds as it was recorded. Cite Share Download PDF Status: Published Journal Publication published 12 Nov, 2024 Read the published version in World Journal of Urology → Version 1 posted Editorial decision: Revision requested 07 Sep, 2024 Reviews received at journal 06 Sep, 2024 Reviews received at journal 01 Sep, 2024 Reviews received at journal 30 Aug, 2024 Reviewers agreed at journal 29 Aug, 2024 Reviewers agreed at journal 28 Aug, 2024 Reviewers agreed at journal 27 Aug, 2024 Reviewers agreed at journal 26 Aug, 2024 Reviewers invited by journal 26 Aug, 2024 Editor assigned by journal 12 Jul, 2024 Submission checks completed at journal 12 Jul, 2024 First submitted to journal 07 Jul, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4701389","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":329575117,"identity":"ed5b971d-073e-44b2-b3e5-c25c8da97715","order_by":0,"name":"Begoña Ballesta 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Garcia","lastName":"Serrano","suffix":""},{"id":329575134,"identity":"a45b7cfe-5d8a-4a8e-88b7-34da6a23cefd","order_by":11,"name":"Francisco Javiert Lopez Vivo","email":"","orcid":"","institution":"University Hospital Vinalopó","correspondingAuthor":false,"prefix":"","firstName":"Francisco","middleName":"Javiert Lopez","lastName":"Vivo","suffix":""},{"id":329575135,"identity":"68fb7cd1-a8a1-4fad-859d-73f5a3b718ff","order_by":12,"name":"Sergio Fumero","email":"","orcid":"","institution":"Hospital Universitario Ntra Sra de Candelaria","correspondingAuthor":false,"prefix":"","firstName":"Sergio","middleName":"","lastName":"Fumero","suffix":""},{"id":329575136,"identity":"3d65b78f-6209-4719-9335-8ad7e4d6c14c","order_by":13,"name":"Evangelos Liatsikos","email":"","orcid":"","institution":"University of Patras","correspondingAuthor":false,"prefix":"","firstName":"Evangelos","middleName":"","lastName":"Liatsikos","suffix":""},{"id":329575137,"identity":"1536f16d-562b-4d55-ab9a-33eef57db393","order_by":14,"name":"Panagiotis Kallidonis","email":"","orcid":"","institution":"University of Patras","correspondingAuthor":false,"prefix":"","firstName":"Panagiotis","middleName":"","lastName":"Kallidonis","suffix":""}],"badges":[],"createdAt":"2024-07-07 18:42:40","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4701389/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4701389/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00345-024-05334-1","type":"published","date":"2024-11-12T15:57:18+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":61876638,"identity":"08132316-2090-4f88-bc3f-a6d351f76284","added_by":"auto","created_at":"2024-08-06 14:24:46","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":154187,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eExperimental set up a) for the assessment of time to pressure reduction up to 40 mm Hg\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4701389/v1/2bf776ce039f00cd9f474a5b.jpg"},{"id":61876668,"identity":"2e547efa-b72e-4db5-91b4-d680f59a8524","added_by":"auto","created_at":"2024-08-06 14:24:55","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":112703,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCharacterization of Stones Suction Experimental Set Up\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLegend: A: \u003c/strong\u003eStones divided by size obtained after smashing the collected real calcium oxalate stone with a FL038R stainless hammer (Aesculap Inc, Pennsylvania, USA). \u003cstrong\u003eB:\u003c/strong\u003eExperimental Set Up \u003cstrong\u003eC:\u003c/strong\u003e Test example with the 2 mm stones cohort.\u003c/p\u003e","description":"","filename":"figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4701389/v1/55d7900a6c4c7e30841091c0.jpg"},{"id":69274971,"identity":"c1a8f02f-7162-49db-a070-fd4f38a56861","added_by":"auto","created_at":"2024-11-18 16:42:04","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":714122,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4701389/v1/d21250c9-e153-457b-b34c-e93afdaf7767.pdf"},{"id":61876642,"identity":"af1c22af-d51a-4fb8-974b-4266002156d1","added_by":"auto","created_at":"2024-08-06 14:24:49","extension":"pptx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":41004,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTime for pressure reduction to 40 mm Hg with the PU3033AH\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLegend:\u003c/strong\u003e Results from the assessment of time to register a pressure reduction to 40 mm Hg using the suction accessory of the PU3033AH on different suction button finger-pressing techniques with inflow irrigation on and off and with different initial pressures. Time is presented in seconds as it was recorded.\u003c/p\u003e","description":"","filename":"Table.pptx","url":"https://assets-eu.researchsquare.com/files/rs-4701389/v1/66c735f3cb4c34be65510841.pptx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Pressure reduction and suction characteristics of the new digital single use Flexible Ureteroscope with Suction: An In-Vitro Experimental Study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eTechnological advances in flexible ureteroscopy (fURS) has gained momentum in recent years leading to a significant expansion of indications of such technique and miniaturization of instruments (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). Enhancing vision in this era requires increasing the irrigation inflow (\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Unfortunately, if balance between irrigation inflow and outflow is not achieved, intrarenal pressure (IRP) might reach unsafe levels leading to pyelovenous backflow, rupture of the collecting system and/or renal damage resulting in postoperative complications such as infections and sepsis (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Other limitations of retrograde intrarenal surgery (RIRS) besides limited visualization, which requires increasing the IRP via increased irrigation flow, are the persistence of fragments that cannot be removed, and the need for accessories such as baskets or extraction devices (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). Additionally, the data suggests that IRP and intrarenal temperature (IRT) are closely related (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e). High-power lithotripsy, especially in RIRS where outflow may be limited, may result in hazardous increases in IRT (\u003cspan additionalcitationids=\"CR10\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eA solution to the imbalance of fluid inflow and outflow during fURS is the use of suction devices. It can be achieved with vacuum-assisted ureteric access sheaths (UAS), with scopes modified with an accessory suction device or with direct in-scope suction option, or with a catheter type device (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSuction devices during fURS seem to provide many advantages including lowering IRT and IRP, reducing the risk of urinary infections and sepsis, improving surgical outcomes with better stone-free rate (SFR) and visibility, and therefore an over decrease in operative time and complication rates (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan additionalcitationids=\"CR15 CR16 CR17 CR18 CR19 CR20 CR21 CR22 CR23 CR24\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Direct in-scope suction (DISS) technique could potentially minimize the usage of such accessories for fragment removal by using suction aspiration, for dust and small fragments, to improve stone-free rates (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe recently introduced Pusen 7.5 fr Digital Single-Use Flexible Ureteroscope PU3033AH (ZhuHai Pusen Medical Technology Co, Ltd, Guangdon, China) has an add-on suction accessory directly attached to the scope itself through the working channel. This allows clinicians to activate the suction for dust and small fragment removal during the procedure.\u003c/p\u003e \u003cp\u003eThe aim of the study was to characterize the suction effect of the new 7.5 Fr Single-Use Flexible Video Ureteroscope Digital Single Use Flexible Ureteroscope with the suction accessory, the PU3033AH, with an in vitro experimental setting.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003eAn in vitro experimental study was performed to assess the time taken by the single use 7.5Fr PU3033AH scope (ZhuHai Pusen Medical Technology Co, Ltd, Guangdon, China) to reduce pressure under 40 mm Hg (considered as safe threshold level), and to characterize the behavior of stones, fragments and dust during suction activation.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003ePU3033AH\u003c/h2\u003e \u003cp\u003eThe PU3033AH is a 7.5 Fr single-use digital ureteroscope with a CMOS sensor and a LED light source on the tip. It is capable of 270 degrees of bidirectional deflection. The working channel is 3.6 Fr. It is advertised by the manufacturer as the thinnest single-use ureteroscope with integrated suction control abilities. The suction button is positioned on the ureteroscope handle, avoiding the need of extra expenses in accessories, and the user can easily press the button the procedure during the procedure either intermittently or continuously. As per the manufacturer, the irrigation inflow must be off when suctioning.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eAssessment of time taken to reduce pressure\u003c/h2\u003e \u003cp\u003eThe experimental setting consisted of a non-powder nitrile medium sized glove index finger cut from the base and filled with 20 cc of normal saline with the pusen 7.5Fr PU3033AH connected to a lagoon 600 surgical vacuum regulator at -100 mBar (x100Pa) (Air Liquide, Paris, France) through a standard silicon tube on the suction connection button of the scope. This was then connected to an Endomat select UP 210 automatic irrigation pump (Karl Storz Se \u0026amp; Co. Tuttlingen, Germany) set at 80 mm Hg through an irrigation system (Cook Medical, Indiana, USA). An Arrow\u0026trade; arterial catheterization set (Teleflex, Wayne, Pennsylvania, USA) TruWave\u0026trade; 3cc/60 in (150 cm) was connected to a pressure monitoring set (Edwards Lifesciences (Irvine, California, USA) and to a pressure monitor (Philips, Amsterdam, Netherlands), and this was placed inside the nitrile glove finger in parallel with the 7.5Fr ureteroscope with suction as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe ureteroscope was tight with the arterial catherization set and inserted in the glove finger.The system was hand sealed until a closed system was reached. The automatic pump was preferred to keep the inflow uniform during all tests and avoid biases. All devices used were set and secured at the same height on an operating theater table at \u0026ldquo;level\u0026rdquo; height mode.\u003c/p\u003e \u003cp\u003eIrrigation inflow through the automatic pump was activated until reaching stable pressures between 60\u0026ndash;80 mm Hg. Once a stable pressure was obtained the suction button was pressed in 4 different modalities; It was pressed continuously and with the irrigation inflow off; pressed continuously and with the irrigation inflow on i.e. without stopping the irritation inflow; pressed on an intermittent pattern on a rate of pressing/releasing of one second with the irrigation inflow on, and pressed on an intermittent pattern on a rate of pressing/releasing of half a second and with the irrigation inflow on. The intermittent pattern was tested because it is common to use it on the clinical practice in order to avoid system collapse. Time to reach a pressure of 40 mm Hg was recorded by two different researchers with two different chronometers.\u003c/p\u003e \u003cp\u003e24 tests were done to assess the time to lower the pressure to the theoretical safety threshold of below 40 mm Hg.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eCharacterization of Stones Suction Experimental Setting\u003c/h2\u003e \u003cp\u003eThe behavior of stones of different sizes were recorded. A real calcium oxalate kidney stone was smashed with a FL038R stainless hammer (Aesculap Inc, Pennsylvania, USA) until obtaining smaller stones of 0.5, 1, 2, 3, 4 and 5 millimeters as per measurements with a ruler. The fragments were placed in small plastic containers filled with saline, according to their size. Ten stones of the same size were placed per container. The PU3033AH was inserted in the container while connected to an irrigation system and to the automatic pressure pump at 80 mm Hg on the irrigation channel, and to an empty standard suction tube on the suction button which was connected to a standard surgical suction device at -100 mBar (x100Pa), likewise as described in the methods section. The suction buttom was pressed continuously pointing to the target stone (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The behavior of the stones when being sucked was recorded.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eSPSS v25 software (IBM Statistics, NY, USA) was used for statistical analysis. Descriptive statistical calculation of median values per cohort of suction modality and activation/deactivation of inflow was done. ANalysis Of VAriance (ANOVA) was conducted to explore the differences in the time to reach 40 mmHg between continuous and intermittent pressing, as well as between the four suction techniques. Initial pressure was used as the covariate to control the effect over time. The Tuckey post-hoc test was used for equal variances.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eSuction with the PU3033AH worked properly with the inflow irrigation on and resulted in a more rapid pressure reduction compared to while using it with the inflow irrigation off.\u003c/p\u003e \u003cp\u003eResults from the assessment of time to register a pressure reduction to 40 mm Hg using the PU3033AH on different suction button finger-pressing techniques with inflow irrigation on and off and with different initial pressures are displayed at Table\u0026nbsp;1. Overall, the median time to reach 40 mg was roughly 3.5 seconds.\u003c/p\u003e \u003cp\u003eThe ANOVA revealed that continuous button-pressing suction technique reached 40 mm Hg significantly faster, averaging 3.0 seconds, compared to intermittent pressing at an average of 4.8 seconds (F\u0026thinsp;=\u0026thinsp;11.7; p\u0026thinsp;=\u0026thinsp;0.002). The initial pressure did not show a significant effect (p\u0026thinsp;=\u0026thinsp;0.725).\u003c/p\u003e \u003cp\u003eWhen comparing four techniques, statistically significant variations were found (F\u0026thinsp;=\u0026thinsp;5.9; p\u0026thinsp;=\u0026thinsp;0.005), with the initial pressure once again showing no significant effect (p\u0026thinsp;=\u0026thinsp;0.528). The continuous pressing technique with the irrigation inflow off and the continuous pressing technique with the irrigation inflow on showed similar times for achieving 40 mm Hg (3.5 and 2.6 seconds, respectively), and both were significantly faster than the intermittent technique at a 1 second rate which took longer at 5.3 seconds (p\u0026thinsp;=\u0026thinsp;0.046 and p\u0026thinsp;=\u0026thinsp;0.003, respectively). In contrast, the intermittent pressing technique at 0.5 seconds rate (resulting in 4.2 seconds) did not show any significant differences when compared to other techniques .\u003c/p\u003e \u003cp\u003eRegarding the characterization of suctioning fragments and dust, the PU3033AH was capable to aspirate 0.5 mm stones. Stones ranging from 1\u0026ndash;5 mm were attracted to the tip of the scope and did not pass through the working channel when activating suction in continuous mode, However, they remained attached to the tip while suction was activated, irrespective of the ureteroscope movement. This showed that, in our experimental setup and in the absence of obstacles, small stone fragments could potentially be relocated using the continuous suction mode.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eSuction during retrograde intrarenal surgery has proved to improve outcomes by decreasing the operative time, increasing SFR and preventing complications, especially infectious complications (\u003cspan additionalcitationids=\"CR16 CR17\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan additionalcitationids=\"CR24\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Several papers provided clinical and preclinical data on the benefits of suction through UAS of different configurations and flexibility properties (\u003cspan additionalcitationids=\"CR15 CR16 CR17 CR18 CR19\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan additionalcitationids=\"CR23 CR24\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Nevertheless, data on direct in-scope suction are scarce.\u003c/p\u003e \u003cp\u003eWe designed a custom and reproducible experimental setting to assess time for pressure reduction to 40 mmHg as low pressure target because previous studies proposed the safety threshold between 30 and 45 mmHg (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). We also assessed the behavior of fragments while suction activation. The PU3033AH worked well with the inflow irrigation on and resulted in faster pressure reduction than with the inflow irrigation off. Initial pressures were set at values between 60\u0026ndash;80 mm Hg as per previously reported IRP during simple fURS (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). The manufacturer\u0026rsquo;s recommendation is, understandably, not to use suction with irrigation inflow on. However, in our study, interestingly, the fastest strategy to lower the pressure was by actually pressing the suction button continuously, with the irrigation on. This can be explained because the irrigation inflow channel of the scope and the section channel are both connected to a single working channel as per the manufacturer.\u003c/p\u003e \u003cp\u003eIn our tests, the initial pressure did not correlate in time to reach 40 mm Hg, with time taken to reach this being a non-significant factor. The overall median time to reach 40 mg was 3.86 seconds. That correlated with Ostergar and colleagues\u0026rsquo; findings on an ex vivo study with a porcine model to assess the effect of vacuum assisted UAS, where they recently proposed to use lower suction settings and short, \u0026lt;\u0026thinsp;5-second bursts to maximize therapeutic benefit, and avoid outflow tract collapse, that is likely to happen on high-vacuum pressures (\u0026gt;\u0026thinsp;200 mm Hg) (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eDISS has been investigated in semirigid ureteroscopy and fURS with promising results in clinical studies (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan additionalcitationids=\"CR29\" citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e). Gauhar and colleagues presented an aspiration technique directly from the ureteroscope by using the scope channel to remove debris, fragments or dust through a simple system that can mount into the operating channel of any ureteroscope, attached via two 3-way plug system (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). They reported that RIRS with the DISS technique was feasible with an acceptable retreatment rate, compared to vacuum assisted UAS, with the added values of low cost, efficiency and versatility (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn an ex vivo study in a porcine kidney model Jiang P et al (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) reported a combined system with the use of a UAS and active aspiration using a dual-channel fiberoptic ureteroscope specific with a 5.2 Fr tip, a 9.9 Fr shaft and a 3.3 Fr specific irrigation port with an aspiration port of 3.3 Fr. The system allowed aspiration while maintaining constant irrigation and suction during laser lithotripsy (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eWe also proved that 0.5 mm stones are completely aspirated by the device when directed at them, and stones between 1 and 5 mm inclusive are attracted by the tip of the scope while pressing the suction button in continuous mode. Although further clinical studies are needed to characterize this effect, it could be very useful in a real clinical scenario for stone manipulation and avoiding the use of baskets or other disposables to relocate stones.\u003c/p\u003e \u003cp\u003eOne limitation of the study is that the model resulted in variability in initial pressures with the same irrigation inflow pressure. However, similar variations are reported in the clinical setting(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). Additionally, we did not assess reported maximum peak values at higher levels. However, those peaks are usually achieved with manual pumping which is not beneficial to use at the same time than suction because the purpose of manual pumping is to increase the irrigation inflow to improve vision, and increasing the outflow by suction would annul the effect. Also, the experiments were performed without any instruments i.e. the laser fiber inside the working channel which would be the regular practice. This might modify the effect. Likewise, we only tested one stone composition and 5 different fixed sizes of stones for the suction behavior. However, for fragment repositioning, we think that it would not be clinically relevant to test stones larger than 5 mm as they would perhaps be large in volume and weight to have any movement from suction. Future work could look at stones of different compositions and sizes, and with different pressure parameters.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eOn the presented study, the PU3033AH was efficient in lowering pressure with a median time of roughly 3.5 seconds. The fastest strategy to lower the pressure was by continuously pressing the suction button with the irrigation inflow on. It was capable of aspirating 0.5 mm stones and moving stones of 1\u0026ndash;5 mm when activating suction in a continuous mode on a set up with no obstacles. Further clinical studies are however needed to confirm our results.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the collaboration of Dr. Javier Calahorra, Dr. Rafael Carrasco and Dr. Pedro Gonzalez Cabezas por their logistical contribution.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo funding was received\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eContributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBBM: Concept, Design, Performance of the experiment, data collection and analysis, paper writing and review\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLD: Concept, Design, data analysis, paper writing and review\u003c/p\u003e\n\u003cp\u003eVT: Design, data analysis, paper writing and review\u003c/p\u003e\n\u003cp\u003eBS: Design, data analysis, paper writing and review\u003c/p\u003e\n\u003cp\u003ePC: Design, Performance of the experiment, data collection.\u003c/p\u003e\n\u003cp\u003eOA: Design, data analysis, paper writing and review\u003c/p\u003e\n\u003cp\u003eAP: Design, paper writing and review\u003c/p\u003e\n\u003cp\u003eAT: Design, paper writing and review\u003c/p\u003e\n\u003cp\u003eAK: Design, paper writing and review\u003c/p\u003e\n\u003cp\u003eMGV: Design, Performance of the experiment, data collection.\u003c/p\u003e\n\u003cp\u003eMCGS: Design, Performance of the experiment, data collection.\u003c/p\u003e\n\u003cp\u003eJLV: Design, Performance of the experiment, data collection.\u003c/p\u003e\n\u003cp\u003eSFA: Design, paper writing and review\u003c/p\u003e\n\u003cp\u003eEL: Concept, Design, paper writing and review\u003c/p\u003e\n\u003cp\u003ePK: Concept, Design, data analysis, paper writing and review\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDisclosure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDr. Laurian Dragos is lecturer for EMS and Boston Scientific and consultant for Ambu.\u003c/p\u003e\n\u003cp\u003eDr. Bhaskar Somani is consultant for Pusen, Boston Scientific, Cook Medical, Coloplast and Olympus.\u003c/p\u003e\n\u003cp\u003eDr. Oriol Angerri is lecturer for Boston Scientific and Cook Medical.\u003c/p\u003e\n\u003cp\u003eDr. Evangelos Liatsikos is consultant for Cook Medical and Karl Storz and lecturer for Karl Storz, Boston Scientific, EMS and Redpine.\u003c/p\u003e\n\u003cp\u003eDr. Panagiotis Kallidonis is lecturer for EMS and Cook Medical.\u003c/p\u003e\n\u003cp\u003eNone of the rest of authors have any conflict of interest to disclose\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eNoureldin YA, Kallidonis P, Liatsikos EN (2020) Lasers for stone treatment: How safe are they? Curr Opin Urol 30(2):130\u0026ndash;134\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKronenberg P, Somani B (2018) Advances in Lasers for the Treatment of Stones\u0026mdash;a Systematic Review. Curr Urol Rep. ;19(6\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://mail.google.com/mail/u/0?ui = 2\u003c/span\u003e\u003cspan address=\"https://mail.google.com/mail/u/0?ui = 2\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e \u0026amp; ik = 993d0642cd \u0026amp; attid = 0.1 \u0026amp; permmsgid = msg-f:1706781290314263576 \u0026amp; th = 17afb48a6676ec18 \u0026amp; view = att \u0026amp; disp = inline \u0026amp; realattid = 88510fa7802aa63_0.1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eProietti S, Dragos L, Somani B, Buttic\u0026egrave; S, Talso M, Emiliani E et al (2017) In Vitro Comparison of Maximum Pressure Developed by Irrigation Systems in a Kidney Model. J Endourol 31(5):522\u0026ndash;527\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDoizi S, Letendre J, Cloutier J, Ploumidis A, Traxer O (2021) Continuous monitoring of intrapelvic pressure during flexible ureteroscopy using a sensor wire: a pilot study. World J Urol 39(2):555\u0026ndash;561\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBratt CG, Aurell M, Erlandson BE, Nilson AE, Nilsson S (1982) Intrapelvic Pressure and Urinary Flow Rate in Obstructed and Nonobstructed Human Kidneys. J Urol 127(6):1136\u0026ndash;1142\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTokas T, Herrmann TRW, Skolarikos A, Nagele U (2019) Pressure matters: intrarenal pressures during normal and pathological conditions, and impact of increased values to renal physiology. World J Urol 37(1):125\u0026ndash;131\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCroghan SM, Skolarikos A, Jack GS, Manecksha RP, Walsh MT, O\u0026rsquo;Brien FJ et al (2023) Upper urinary tract pressures in endourology: a systematic review of range, variables and implications. BJU Int 131(3):267\u0026ndash;279\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGauhar V, Somani BK, Heng CT, Gauhar V, Chew BH, Sarica K et al (2022) Technique, Feasibility, Utility, Limitations, and Future Perspectives of a New Technique of Applying Direct In-Scope Suction to Improve Outcomes of Retrograde Intrarenal Surgery for Stones. J Clin Med 11(19):5710\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePanthier F, Pauchard F, Traxer O (2023) Retrograde intra renal surgery and safety: pressure and temperature. A systematic review. Curr Opin Urol 33(4):308\u0026ndash;317\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWinship B, Wollin D, Carlos E, Peters C, Li J, Terry R et al (2019) The Rise and Fall of High Temperatures during Ureteroscopic Holmium Laser Lithotripsy. J Endourol 33(10):794\u0026ndash;799\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePeteinaris A, Tsaturyan A, Pantazis L, Farsari E, Ballesta Martinez B, Pagonis K et al (2022) Factors Affecting the Irrigation Fluid Temperature During Laser Lithotripsy: In Vitro Experimental Study. Urology 170:53\u0026ndash;59\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSolano C, Chicaud M, Kutchukian S, Candela L, Corrales M, Panthier F et al (2023) Optimizing Outcomes in Flexible Ureteroscopy: A Narrative Review of Suction Techniques. J Clin Med 12(8):2815\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGiulioni C, Castellani D, Traxer O, Gadzhiev N, Pirola GM, Tanidir Y et al (2024) Experimental and clinical applications and outcomes of using different forms of suction in retrograde intrarenal surgery. Results from a systematic review. Actas Urol\u0026oacute;gicas Espa\u0026ntilde;olas (English Edition) 48(1):57\u0026ndash;70\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLai D, He Y, Li X, Chen M, Zeng X (2020) RIRS with Vacuum-Assisted Ureteral Access Sheath versus MPCNL for the Treatment of 2\u0026ndash;4 cm Renal Stone. Biomed Res Int 2020:1\u0026ndash;8\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGauhar V, Traxer O, Castellani D, Ragoori D, Heng CT, Chew BH et al (2023) A Feasibility Study on Clinical Utility, Efficacy and Limitations of 2 Types of Flexible and Navigable Suction Ureteral Access Sheaths in Retrograde Intrarenal Surgery for Renal Stones. Urology 178:173\u0026ndash;179\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQuhal F, Zeng G, Seitz C (2023) Current evidence for suction in endourological procedures: comprehensive review of literature. Curr Opin Urol 33(2):77\u0026ndash;83\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYue G, Dou S, Cai C, Liu B, Liu Y (2023) A Novel Distal Active Flexible Vacuum-assisted Ureteric Access Sheath in Retrograde Intrarenal Surgery. Urology 179:204\u0026ndash;205\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang Z, Leng S, Xie T, Yuan Y, Wang X (2023) Flexible ureteroscopic lithotripsy with a suctioning ureteral access sheath for removing upper urinary calculi under local anesthesia. Front Surg. ;10\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDu C, Song L, Wu X, Deng X, Yang Z, Zhu X et al (2019) 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. Int Urol Nephrol 51(2):207\u0026ndash;213\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOstergar A, Wong D, Shiang A, Ngo S, Venkatesh R, Desai A et al (2023) Intrarenal Pressure with Vacuum-Assisted Ureteral Access Sheaths Using an In Situ Cadaveric Porcine Model. J Endourol 37(3):353\u0026ndash;357\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJiang P, Peta A, Brevik A, Arada RB, Ayad M, Afyouni AS et al (2022) Ex Vivo Renal Stone Dusting: Impact of Laser Modality, Ureteral Access Sheath, and Suction on Total Stone Clearance. 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World J Urol 37(5):921\u0026ndash;929\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTonyali S (2019) Suctioning ureteral access sheath use in flexible ureteroscopy might decrease operation time and prevent infectious complications. World J Urol 37(2):393\u0026ndash;394\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eThomsen HS (1984) Pyelorenal backflow. Clinical and experimental investigations. Radiologic, nuclear, medical and pathoanatomic studies. Dan Med Bull 31(6):438\u0026ndash;457\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCroghan SM, Cunnane EM, O\u0026rsquo;Meara S, Muheilan M, Cunnane CV, Patterson K et al (2023) In vivo ureteroscopic intrarenal pressures and clinical outcomes: a multi-institutional analysis of 120 consecutive patients. BJU Int 132(5):531\u0026ndash;540\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHuang J, Xie D, Xiong R, Deng X, Huang C, Fan D et al (2018) The Application of Suctioning Flexible Ureteroscopy With Intelligent Pressure Control in Treating Upper Urinary Tract Calculi on Patients With a Solitary Kidney. Urology 111:44\u0026ndash;47\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi K, Liao Z, Lin T, Li Z, He W, Liu C et al (2018) A Novel Semirigid Ureterorenoscope with Vacuum Suctioning System for Management of Single Proximal Ureteral and Renal Pelvic Stones: An Initial Experience. J Endourol 32(12):1154\u0026ndash;1159\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLechevallier E, Luciani M, Nahon O, Lay F, Coulange C (2003) Transurethral Ureterorenolithotripsy Using New Automated Irrigation/Suction System Controlling Pressure and Flow Compared with Standard Irrigation: A Randomized Pilot Study. J Endourol 17(2):97\u0026ndash;101\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjur","sideBox":"Learn more about [World Journal of Urology](https://link.springer.com/journal/345)","snPcode":"345","submissionUrl":"https://submission.nature.com/new-submission/345/3","title":"World Journal of Urology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"RIRS, FURS, Suction, Intrarenal Basic Research","lastPublishedDoi":"10.21203/rs.3.rs-4701389/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4701389/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eTo assess the time taken by the single use 7.5Fr suction flexible ureteroscope to reduce pressure under 40 mm Hg and to characterize the behavior of stones, fragments and dust during suction activation\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eAn in vitro setting was developed for this experiment. A saline-filled globe, with the 7.5Fr single use suction flexible ureteroscope, PU3033AH (ZhuHai Pusen Medical Technology Co, Ltd, Guangdon, China), an automatic irrigation pump and a pressure monitoring set were used at four modalities; i) continuous suction, no irrigation inflow; ii) continuous suction, irrigation inflow on; iii) one-second rate intermittent suction, irrigation inflow on, and iv) half-second rate intermittent suction, irrigation inflow on. The behavior of calcium oxalate stones from 0.5 to 5 mm when being aspirated via the ureteroscope into a plastic container filled with saline was recorded.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eSuction with the PU3033AH worked properly with the inflow irritation on. The fastest strategy to lower the pressure was by continuously pressing the suction button with the irrigation inflow on. Overall, the median time to reach 40 mg was roughly 3.5 seconds. The PU3033AH could aspirate 0.5 mm stones. The suction mode on a continuous pattern allowed relocation of stones ranging from 1 to 5 mm on an experimental setup with no obstacles.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe PU3033AH was efficient in lowering pressure in a closed cavity mimicking the renal pelvis. Likewise, stone fragments under one millimeter were aspirated by the device whereas stones from one to five mm could be displaced when activating suction in continuous mode on an experimental setup with no obstacles.\u003c/p\u003e","manuscriptTitle":"Pressure reduction and suction characteristics of the new digital single use Flexible Ureteroscope with Suction: An In-Vitro Experimental Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-06 14:24:37","doi":"10.21203/rs.3.rs-4701389/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-09-07T17:22:05+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-09-06T16:13:52+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-09-01T17:05:58+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-08-30T14:04:25+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"243547222957768232469882147400626028569","date":"2024-08-29T14:00:48+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"89654232910363149782361464392624029755","date":"2024-08-28T16:03:58+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"207006085591374319207769563618900275726","date":"2024-08-27T18:55:31+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"98789192729685844796759613537884270439","date":"2024-08-26T16:07:24+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-08-26T16:01:05+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-07-12T18:13:20+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-07-12T13:25:03+00:00","index":"","fulltext":""},{"type":"submitted","content":"World Journal of Urology","date":"2024-07-07T18:41:18+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjur","sideBox":"Learn more about [World Journal of Urology](https://link.springer.com/journal/345)","snPcode":"345","submissionUrl":"https://submission.nature.com/new-submission/345/3","title":"World Journal of Urology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"b47e2d7a-4c4a-4984-9099-15e0abea2c87","owner":[],"postedDate":"August 6th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-11-18T16:01:09+00:00","versionOfRecord":{"articleIdentity":"rs-4701389","link":"https://doi.org/10.1007/s00345-024-05334-1","journal":{"identity":"world-journal-of-urology","isVorOnly":false,"title":"World Journal of Urology"},"publishedOn":"2024-11-12 15:57:18","publishedOnDateReadable":"November 12th, 2024"},"versionCreatedAt":"2024-08-06 14:24:37","video":"","vorDoi":"10.1007/s00345-024-05334-1","vorDoiUrl":"https://doi.org/10.1007/s00345-024-05334-1","workflowStages":[]},"version":"v1","identity":"rs-4701389","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4701389","identity":"rs-4701389","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}