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Endoscopic versatile robotic guidance, diagnosis and therapy of magnetic-driven soft-tethered endoluminal robots

Periodic Reporting for period 2 - Endoo (Endoscopic versatile robotic guidance, diagnosis and therapy of magnetic-driven soft-tethered endoluminal robots)

Berichtszeitraum: 2017-06-01 bis 2019-05-31

The Endoo project (Endoscopic versatile robotic guidance, diagnosis and therapy of magnetic-driven soft-tethered endoluminal robots) aimed at developing an integrated robotic platform for the navigation of a soft-tethered colonoscope capable of performing painless diagnosis and treatment.
Colorectal cancer is one of the major causes of mortality (fourth of the cancers for incidence), but survival rate dramatically increases in case of early diagnosis.
Current screening colonoscopy is limited due to a variety of factors including invasiveness, patient discomfort, fear of pain, and the need for sedation; these factors consistently limit the pervasiveness of mass screening campaigns.
The Endoo project concluded all the planned activities. The project work packages, i.e. WP2, WP3, WP4, WP5 and WP6 made very good progresses and generated relevant results in the field of robotic capsule endoscopy. All the partners constantly contributed to the progress of the project. As regards WP1 (“Project Management and Coordination”) the Endoo web-based management system was implemented and constantly updated. Conferences among the Endoo project partners were held approximately two times a month, by using a professional conference system to easily and promptly address technical issues/problems, to discuss the most adequate solutions and to keep up to date the entire Consortium about progresses. The progress status of the project was constantly supervised by the Project Coordinator (Prof. Paolo Dario), the Project Manager (Dr. Gastone Ciuti) and by the Scientific Investigators in SSSA. The deliverable and presentation templates were prepared and used for any formal communication and all the deliverables were submitted after approval by all the partners. Regarding WP2 (“Magnetic Navigation Platform and Robotic Capsule”), a detailed analysis of the medical and technological requirements and specifications were accomplished and a final complete version of the Endoo platform was produced in order to experimentally test the developed endoscopic device. Concerning WP3 (“Optical 3D Mapping of the Lumen and Diagnostic Imaging), the teams working on the 3D lumen mapping and reconstruction developed an advanced software and performed the integration of the algorithms on board the Endoo control unit. In WP4 (“Experimental Protocols and Test), a sensorized set-up for experimental simulations was developed and extensive sessions of pre-clinical tests were performed with the valuable collaboration of the medical partners. WP5 (“Industrial-oriented Process”) is carrying out the tasks regarding the CE-mark labelling process in order to design and produce a platform clinically effective and industrial-oriented from the very beginning of the project. The dissemination activities carried out from the beginning of the project continued with several national and international communications and presentations: the Endoo project has been presented in conferences, workshops, special sessions, and events and a significant number of patents were submitted, as papers published in international conferences proceedings or international journals.
All the Consortium obtained valuable results within the Endoo Project during the project lifetime. The collaboration has been fruitful and the active work packages produced very good results. During the project lifetime some external industrial entities have been contacted and involved to provide, in collaboration with the Endoo partners, specific technical contributions. Medical, technical and market/industrial (also regarding Intellectual Properties Rights) background have been analysed in depth, and an advanced final version (hardware and software) of the Endoo platform was developed and presented during the final review meeting. Tests performed during several meetings generated fruitful discussion within the Consortium, which served to highlight/re-tune continuously several aspects of the platform for improvement until the final version released and presented during the final review meeting.

Further details are reported in the Endoo website: http://www.endoo-project.eu/
Distal control of tip deflection by wires running through the length of the device imposes a lower bound on the outer diameter of the instrument. Having a “front-wheel” steering and propulsion method would enable a drastic reduction of shaft diameter down to the size of the operative channel plus the space needed for electrical connection to the vision module and the space for medically driven functionalities. Magnetic steering and control of endoscopic capsules have been reported by several groups worldwide, with authors always identifying the need for insufflation, and lack of instrumentation for tissue interaction, as the main limitations. In the Endoo project, robotic magnetic control and steering, reported elsewhere for wireless capsule endoscopy, were defined and tuned to an endoscopic device containing a frontal magnetic stereoscopic camera connected to an external control box by a soft tether. The tether connection is used for providing insufflation, lens cleaning, water flushing, passing operative tools, and operating the stereoscopic vision module. The “front-wheel” magnetic propulsion was adopted with the Endoo project to eliminate the need of pushing the shaft to advance the scope, thus preventing looping and the colonic “stretching” phenomena currently associated with colonoscopy. These advantageous characteristics were enhanced by a drastic reduction in both the bending stiffness of the shaft and the mass of the proposed device, while the therapeutic capabilities provided by a standard colonoscope are retained. In this framework, a deep engineering study on tether material and properties was performed within the Endoo project together with sensors integration; moreover, a 3D optical system, composed by two cameras and specific illumination sources, was integrated for enhanced 3D vision and diagnosis. Additionally, robotic control drastically speeded up the learning curve associated with training physicians thanks to motion scaling, enhanced repeatability, and precision of movement (all in a transparent closed-loop control). These features made advancement along the tortuous path towards the cecum easier while reducing patient discomfort and enhancing the possibility of sedation–free screening.

The expected impact of Endoo project can be summarised as follows:
• to open a new market of robotics technologies for colonoscopic applications at European SMEs, actually represented, with standard flexible colonoscopes by STORZ, Olympus etc., and with capsule endoscopes by Given Imaging Ltd. (Covidien - Medtronic);
• to establish a scientific and market-oriented collaboration between research institutions and industrial SMEs: this will create real benefits for both, with the possibility to exchange personnel in both directions, but also in order to maximise the outcome of allocated resources;
• to reduce / overcome the distrust of robotic technologies of both the medical community and patients;
• to improve the TRL of robotic soft-tethered capsule colonoscopes towards certification of new robotic system and clinical use for mass screening campaign;
• to explore and develop other applications of the Endoo platform towards increasing market potential and improving patient treatment beyond colonoscopic procedures (such as systems for pipe inspection).
Endoo capsule
Reconstruction of the Endoo platform
Endoo Human-Machine-Interface
Endoo capsule
Reconstruction of the Endoo capsule - internal view
Endoo capsules
Reconstruction of the Endoo platform
Endoo platform
Reconstruction of the Endoo procedure
Endoo experimantal testing activities
Endoo capsule