and Ureteroscopy


Device


Description


Comment


Robodoc


Automated drilling of the shaft for hip prosthesis based on CT


Clinical problems (pain)


Caspar


Automated drilling for hip prosthesis based on CT


No more in clinical use


Probot


Automated resection of the prostate based on TRUS


No more in clinical use (only prototype)


Neuro-arm


Master-slave system with open console for neurosurgery


Developing company does not exist anymore


AESOP


Voice-controlled camera-arm for laparoscopy


Developing company does not exist anymore


ARTEMIS


Master-slave system with open console for laparoscopy


Only experimental


ZEUS


Master-slave system with open console for laparoscopy


Developing company does not exist anymore


da Vinci


Master-slave system with closed console for laparoscopy


Still used in the fourth generation of device


Sensei-Magellan


Master-slave system for angiography and cardiology


Not suitable for endourology (i.e. FURS)


Avicenna Roboflex


Master-slave system with open console for flexible ureteroscopy


Still used in the third improved version


Focal one


Automated system to perform transrectal HIFU


Still used in the third improved version


Aquabeam


Automated system to perform TURP (Aquablation) based on TRUS


First clinical trials


Monarch


Master-slave system with game-pad for bronchoscopy


First clinical cases




In this chapter, we want to focus on actual developments of robot-assisted flexible ureteroscopy including technical evolutions in video endoscopy, endoscopic armamentarium, and intraoperative navigation [1115].


Historical Update of Development of Robotic Surgical Devices


Such new developments require a short historical review of robotic devices for laparoscopic surgery, which revolutionized video-endoscopic surgery particularly in urology (Table 17.1). Already in 1996, Buess and Schurr et al. [16] developed the ARTEMIS-System and presented the first experimental results, when successfully performing a telesurgical laparoscopic cholecystectomy in an experimental model (Fig. 17.1a). However, despite various promising experimental trials in abdominal and cardiac surgery, the device never made it beyond the experimental state.

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Fig. 17.1

History of robotic devices for laparoscopic surgery. (a) ARTEMIS: first master-slave system used experimentally (G. Buess, German Nuclear Research Centre, Karlsuhe, Germany). Open console, 3D video technology with polarizing glasses. (b) ZEUS: first clinically used robotic system for laparoscopic coronary artery revascularization. Open console, instruments with only 5° of freedom (DOF). 3D video technology with helmet or 2D video. (c) dA Vinci XI: console of last generation of robotic system for interdisciplinary use. In-line view with 3D HD video technology, 7 DOF for all instruments. (d) dA Vinci XI: four-arm system, telescope can be inserted via every port access. OR table (Trumpf Medical) can be moved without undocking of the robot. Integration of the robot in new OR-1 system (Karl Storz). (Figure 1a, b from Rassweiler et al. [30], with permission of Springer Nature)


Based on the voice-controlled camera-arm AESOP, the ZEUS System (Computer motion Inc., Goleta, CA, USA) has been developed and used for cardiac surgery and gynaecological procedures [17]. The ZEUS System (Fig. 17.1b) was based on the combination of a control unit and three tele-manipulators. Three separate robot arms were transported on small carts. The arms were mounted by hand on the rails of the operating table. The surgeon was seated on an open console with a high-backed chair with armrests, handling the instrument controllers. The most impressive demonstration with ZEUS represented the transatlantic laparoscopic cholecystectomy (Lindbergh-procedure) pioneered by Marescaux [18].


Parallel to ZEUS, the da Vinci Surgical system (Intuitive Surgical, Sunnyvale, United States) was introduced initially also designed for robot-assisted coronary artery surgery [19]. In 2000, Binder pioneered the first robot-assisted radical prostatectomy in Frankfurt followed by other European groups [2022]. In 2001, Menon et al. achieved the breakthrough in urologic surgery establishing a full-working clinical programme [23]. Subsequently, FDA approved the use of the system for prostatic surgery. The da Vinci 2000 addressed most ergonomic problems of classical laparoscopy sufficiently, such as limited depth perception, eye-hand coordination and range of motion by introducing the Endo-wrist™ technology. da Vinci provided a closed console offering a 3D-CCD-video-system with in-line view. The cable-driven instruments with up to seven DOF and loop-like handles enabled an ergonomic working position due to the clutch mechanism [24] and instruments with 7° of freedom. In the last decade, the company introduced further elaborated systems, such as da Vinci SI, X and XI (Fig. 17.1c, d), which nowadays represent a very high standard [2427].


The Ergonomic Deficiencies of Flexible Ureteroscopy


The surgeon usually stands and has to control fluoroscopy and the laser device by a foot-pedal, while fixing the position of the endoscope with one hand and deflecting/rotating it with the other hand (Table 17.2). Additionally, the assistant needs to insert the laser fibre or any accessory instrument (basket, N-gage) and then activate it according to the surgeon’s demand. During this process the surgeon and assistant have a very limited working space. Thus the aim of a robotic device should mainly act also as a master-slave system trying to help the surgeon by offering an ergonomic working position and alleviating the manipulation of the endoscope without increasing the risk of damaging the urogenital system.


Table 17.2

Ergonomic requirements for classical flexible ureterorenoscopy (FURS) during intrarenal stone management

















































































Operative manoeuvre


Extremity used


Action by


Insertion of ureteroscope


Fingers of both hands (at glans and instrument)


Surgeon


Deflection of ureterscope


Hand holding hand-piece


Surgeon


Thumb at handle


Fingers at meatus


Rotation of ureterscope


Hand holding hand-piece


Surgeon


Fingers of the other hand at meatus


Fluoroscopy


Right foot (foot switch)


Surgeon (radiotechnician)


Movement of table/C-arm


Right foot (foot switch)Hand (manually)


Radiotechnician (surgeon, assistant)


Irrigation


 By syringe


Hand


Nurse/assistant


 By mechanic device


Foot


Nurse/assistant (surgeon)


 By pump


Finger activation (button)


Nurse/technician


Laser lithotripsy


 Insertion of fibre


Fingers at ureteroscope


Nurse/assistant


 Laser settings


Finger (button)


Nurse/technician


 Activation


Right foot (foot switch)


Surgeon


Use of basket/grasper


 Insertion


Fingers at ureteroscope


Nurse/assistant


 Manipulation


Hand and thumb


Surgeon


 Closure


Fingers at handle


Nurse/assistant



From Rassweiler et al. [30], with permission of Springer Nature


Historical Development of Master-Slave Systems for Flexible Ureteroscopy


The development of robotic master-slave systems was not only limited to laparoscopy (Table 17.1). Also for neurosurgery, NOTES, interventional radiology, cardiology and endourology, several robotic devices have been developed [2831].


Sensei-Magellan System


In 2008, Desai et al. [12] first reported a robotic flexible ureteroscopy using the Sensei-Magellan system (Hansen Medical, Mountain View, USA) designed for cardiology and angiography. This device has different components: an open console providing a chair with armrest and a joystick to control the movement of the inserted catheter. The console offers two screens for fluoroscopic and endoscopic images. The robotic arm is driven by electronic motors to manipulate the flexible catheter. The electronic rack contains computer hardware, power supplies and video distribution units (Fig. 17.2a).

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Fig. 17.2

Sensei-Magellan system (Hansen Medical, Mountain View, United States). (a) Master-slave system designed for angiography and transvascular cardiologic interventions. (b) Open console with the joystick analog endoscopic and fluoroscopic image during robotic flexible ureteroscopy. (c) Joystick at the console controls the deflection and rotation of the inner sheath. (d) Robotic arm covered with sterile drape mounted to the operating table (here during angiography). (Figure 2a, b from Rassweiler et al. [30], with permission of Springer Nature)


The robotic flexible catheter system consists of an outer catheter sheath (14/12F) and inner catheter guide (12/10F). For robotic FURS, a 7.5F fibre-optic flexible ureteroscope was inserted and fixed in the inner catheter guide. Thus, remote manipulation of the catheter system manoeuvres the ureteroscope tip (Fig. 17.2b). The tip of the outer sheath was positioned at ureteropelvic junction to stabilize navigation of inner guide inside the collecting system (Fig. 17.2c). In this system, the ureteroscope is manipulated only passively, which proved to be a problem, because the robotic arm was mainly designed for interventional radiology (Table 17.3; Fig. 17.2d). Consecutively, this project has been discontinued after the first 18 treated [1113].


Table 17.3

Comparison of ergonomic features of Sensei™ and Roboflex™
























































Functions


Sensei


Roboflex


Seat


Adjustable saddle-type seat


Adjustable seat


No arm rest


With integrated arm rest and foot-pedal


Imaging


Console with integrated


Console with integrated


Fluoroscopy and endoscopic image screens


Endoscopic image screen


Animation of position of catheter-tip (3D navigation)


Animation of position of ureteroscope in collecting system


Insertion of ureteroscope


Indirect insertion of inner sheath (scope glued to the sheath)


Fine-tunable by left joystick with numeric display of horizontal movement


Deflection of ureteroscope


Indirect deflection by the inner sheath based on single joystick (omega-force dimension)


Fine-tunable deflection via wheel for right hand with display of grade and direction of deflection


Rotation of ureterscope


Indirect rotation by the inner sheath (scope glued to the sheath)


Fine-tunable by sophisticated left joystick


Irrigation


No irrigation system included


Integrated irrigation pump activated by touchscreen


Laser lithotripsy


No function for laser fibre integrated


Integrated control of laser fibre by touchscreen


Activation by foot-pedal


Use of basket/grasper


No function for basket or grasper integrated


No function for basket or grasper integrated



From Rassweiler et al. [30], with permission of Springer Nature


Roboflex Avicenna Prototype


Since 2010, ELMED (Ankara, Turkey) is working on a robot specifically designed for FURS [14]. Roboflex Avicenna was continuously developed to perform flexible ureteroscopy providing all necessary functions for FURS [15]. The prototype consisted of a small console with an integrated flat screen and two joysticks to move the endoscope, which is held by the hand-piece of the robotic arm (manipulator). This basic designed has not changed; however, several significant improvements have been accomplished during further development including size and design of the function screen, design of the joysticks to control rotation and deflection of endoscope, fine adjustment of deflection of endoscope and range of rotation of the manipulator (Table 17.3). Actually, Roboflex Avicenna represents the only robot , especially developed for flexible ureteroscopy [21, 32]. The device has CE mark since 2013, and FDA approval is pending.


Monarch


In March 2018 Monarch Platform was used in a clinical case of robotic bronchoscopy for the first time [31]. The system utilizes the common endoscopy procedure to insert a flexible robot into hard-to-reach places inside the human body (Table 17.1). A doctor trained on the system uses a video game-style controller to navigate inside, with help from 3D models. Like in the Sensei-Magellan system, the technology is based on the robotic control of an external tube using two robotic arms (one for the outer and one for the endoscope) also to advance and retract the endoscope. However, the Monarch Platform also enables the additional movement of the flexible scope to reach small distal branches of the bronchial system. An irrigation system is integrated. Another main feature of the device represents the integration of CT imaging to guide the biopsy. Of course, the same technology might be used for flexible ureteroscopy in the near future.


Clinical Experience with Avicenna Roboflex


Since we have significant experience with Avicenna Roboflex based on a close collaboration with developing company and clinical partner in Ankara, Turkey, we want to focus more in detail on this robotic system [32].


Design of the Device


The robot consists of an open console and the manipulator of the flexible ureterorenoscope. The manipulator drives the flexible ureteroscope using its own mechanics (Fig. 17.3a). For this purpose the hand-piece of scope has to be attached directly to an especially designed master plate of the manipulator (Fig. 17.3b). Micromotors move the steering lever of the hand-piece for deflection with several ranges of motion. The robotic arm enables bilateral rotation, advancement and retraction of the ureteroscope. Additionally the height of the robotic arm can be adjusted according to the patient’s size. Actually, there are three exchangeable master plates available for three flexible digital ureteroscopes (Karl Storz Flex X2; Olympus URF-V2; Wolf Cobra/Viper digital).

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Fig. 17.3

Avicenna Roboflex System (ELMED, Ankara, Turkey). (a) Robotic arm with the hand-piece of a digital flexible ureteroscope (Flex XC, Karl Storz, Tuttlingen, Germany) fixed in the master plate and the flexible part supported by one or two stabilizers before entering the access sheath. (b) Exchange of the master plate (i.e. when using a disposable device). (c) Open console with sophisticated left-hand joystick for rotation and insertion/retraction and fine-tuned right-hand wheel for deflection. Touchscreen functions for laser activation, irrigation, and fine-tuning of movements. (d) Integrated screen with display of digital endoscopic image and graphic information about axis and deflection of endoscope. (Fig. 3a–c from Rassweiler et al. [30], with permission of Springer Nature)


All functions of the robotic arm are controlled at the console providing an integrated adjustable seat with two armrests and two integrated foot-pedals for activation of fluoroscopy and the laser lithotripter via a pneumatic pedal controller (Fig. 17.3c). The control panel at the console is used by touchscreen functions. The integrated HD monitor displays the endoscopic image and all information about the position of ureteroscope in the collecting system (Fig. 17.3d). All main manoeuvres to navigate the flexible endoscope can be fine-tuned at the control panel, such as horizontal movement (= insertion/retraction of the endoscope) with a range of 150 mm, bilateral rotation (220° to each side) and deflection of the scope (262° to each side). For this purpose the left hand controls a specifically developed horizontal joystick, whereas the right hand uses a wheel for deflection. All numeric parameters of endoscope navigation are displayed on the control panel and the HD-screen. The deflection can be adjusted to European as well as US settings. Additionally, the infusion speed of the irrigation fluid can be adjusted together with a motorized insertion and retraction of laser fibre.


Operative Technique


During the procedure the robotic arm is covered by a sterile plastic drape which is accomplished parallel to the anaesthesia of the patient. We have standardized our technique using routinely a 12/14F access sheath with hydrophilic coating (35 to 45–55 cm; Flexor parallel, Cook-Medical, Daniels Way, USA) enabling placement a safety guide wire (Expert Nitinol wire 0.35i × 150 cm, IMP, Karlsruhe, Germany) parallel to the sheath. Position of the access sheath should be 1 cm below the UPJ (Fig. 17.4a), to allow enough flexibility of the ureteroscope. After arranging the position of seat and armrest by activating the memorized setting of each surgeon, the ureteroscope is inserted manually into the access sheath and fixed by one or two stabilizers (Fig. 17.3a). The definitive placement of the manipulator depends on the side of the stone and the size of the patient. Then the brakes of the manipulator are locked.

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Fig. 17.4

Stone treatment during robot-assisted flexible ureteroscopy. (a) Fluoroscopy before the procedure (Siemens Lithoskop, Erlangen, Germany). The access sheath has to be positioned 1 cm below the ureteropelvic junction to minimize the risk of injury to the endoscope during deflection. (b) Fluoroscopy during laser lithotripsy to verify the position of the endoscope. (c) Digital endoscopic image (3× magnification) during lithotripsy using dusting mode (Holmium-YAG laser; 0.5 J, 15 Hz). (d) Endoscopic image during fragment extraction using N-Gage basket (Cook-Medical, Daniels Way, USA). The robot separates the assistant from the surgeon. (Figure 4a–c from Rassweiler et al. [30], with permission of Springer Nature)


The endoscope is placed at the distal end of the access sheath with a horizontal value of 50 mm. Short-term digital fluoroscopy is used to determine the actual localization of stone and instrument (Fig. 17.4b). Once the endoscope has reached the renal pelvis, the scope needs to be rotated according to the axis of the kidney. Then, a systematic inspection of the entire collecting system is carried out. When the stone is visualized, the endoscope needs to be retracted and straightened slightly (<70°) to guarantee safe insertion of the laser fibre. Optionally Roboflex™ provides a memory function to guide the scope to its previous place once the laser fibre is inserted and the tip visualized endoscopically. However, with increasing experience there was no need to use this function.


Basically, any Holmium-YAG laser can be used, but we strongly recommend a laser, which allows application of higher frequencies on low energy level such as Lumenis Pulse 120 (Lumenis, Yokneam, Israel) or Sphinx Jr. (LISA laser products, Katlenburg, Germany) with adequate small-calibre laser fibres (200–270 μ-fibre; Slimline™, Rigifib™). Laser-induced lithotripsy is initiated preferably aiming at pulverization or “dusting” of the stone (0.5 J, 15 Hz) by meander-like movement of the tip of the laser fibre in the range of millimetres (Fig. 17.4c). The smaller fibre size allows sufficient bending of scope without deteriorating the efficacy of stone dusting or fragmentation (1.2 J, 10 Hz). Once fragmentation is progressing, increase of energy might be helpful to apply the “pop-corn effect” or better “Jacuzzi effect” for fine disintegration of the fragments similar to intracorporeal shock wave lithotripsy with a stable position of the laser fibre at the neck of the calyx (Fig. 17.4d).


If necessary, introduction of tip-less baskets or other forceps-like devices (i.e. N-gage™, Cook) for retrieval of fragments is performed. Here, the separation of the surgeon at the console from the assistant at the bed-side is very helpful (Fig. 17.4d). Once the fragment is entrapped, the endoscope is driven back. Herein, the numeric demonstration of position of the tip of the endoscope along the horizontal axis is very helpful to anticipate, when the fragment will reach the distal end of the access sheath. When the fragment is pulled into the sheath, the assistant disconnects the ureteroscope from the distal stabilizer and extracts the stone. The endpoint of the treatment represents a stone-free status based on endoscopic inspection respectively remaining stone dust or fragments less than 2 mm. Then, the access sheath is retrieved under endoscopic inspection and a double J-stent placed. We usually introduce the stent with a string taped to the Foley catheter to be extracted the following morning.


Clinical Studies


The clinical introduction of the device was accomplished according to the IDEAL-system (idea, development, evaluation, assessment, long-term study) for the stages in surgical innovation [33]. First studies with the prototypes in Ankara were able to prove safety of the device [14]. Next step represented a proctored multicentric study, where seven experienced surgeons treated 81 patients (mean age 42, range 6–68) with renal calculi (mean volume 1296 +/− 544, range 432–3100 mm3) in an observational study (IDEAL stage 2) proctored by the urologist (R.S.) being involved in development and clinical introduction of the device [15]. In this study the positive impact of Roboflex™ on ergonomics could be verified by use of a validated questionnaire (Table 17.4).
Oct 20, 2020 | Posted by in UROLOGY | Comments Off on and Ureteroscopy
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