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).

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.

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).

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.

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).

Table 17.4

Comparison of ergonomics of conventional versus robot-assisted flexible ureteroscopy using a validated questionnaire

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