The Magnetic Flexible Endoscope, MFE, a novel platform for diagnostic and therapeutic colonoscopy. Authors are as follows. Funding and disclosures are as follows. Colonoscopy is widely performed for direct visualization and therapeutic intervention in the colon. While colonoscopy is a relatively safe procedure, there are several limitations due to the unintuitive drive mechanism and mechanical design of current conventional colonoscopes. These include sedation-related events, patient discomfort due to looping, perforation and colon trauma, long learning curve and training time, variable quality, and endoscopist injury due to poor ergonomics. To overcome these limitations, endoscopy as currently practiced would require a dramatic transformation in both the design of the endoscope and the technique used for colon exploration and endoscopic actuation. Thus, our team developed in our academic lab the MFE, a Magnetic Flexible Endoscope. The MFE is a highly flexible, single-use, robot-assisted, magnetically manipulated endoscope designed to investigate and provide therapeutic interventions within the colonic lumen. The MFE system is composed of the Magnetic Flexible Endoscope, a handheld controller, and a robot cart supporting a robot manipulator that is used to position a magnetic end effector. The MFE maintains the same functionality as a conventional colonoscope with a camera, illumination, insufflation and camera cleaning, therapeutic working channel, and irrigation, with the addition of a magnet in the tip of the MFE. Unlike a traditional semi-rigid colonoscope visible on the left, the MFE on the right is highly compliant with flexibility to navigate a torturous colon without stretching it. A conventional colonoscope actuates by manipulation of large wheels attached to cables that traverse a long semi-rigid insertion tube that is pushed for advancement. Conversely, the MFE is driven by a magnetic coupling of the endoscope head, which contains an internal permanent magnet, to the robotic arm that holds an external permanent magnet. This enables a front-pull actuation mechanism to eliminate the need for pushing a semi-rigid insertion tube for advancement. The forward drive mechanism prevents buckling of the insertion tube, looping, and colon wall stress. This reduces the risk of perforation and pain during the procedure to allow for less, if any, procedural sedation. As demonstrated, the integration of robotic assistance can make the normally challenging task of endoscope navigation effortless with use of autonomous functions. Throughout extensive benchtop evaluation, the MFE has demonstrated robust reliability of system hardware and software, allowing for intuitive drive mechanism and easy navigation, including achievement of autonomous retroflexion visualized here in a colon phantom. Additionally, the MFE has successfully performed autonomous navigation using artificial intelligence in a colon phantom, as visualized here by lumen tracking on the left, the image segmentation algorithm in the center, and colonic feature detection on the right. Our most recent work focused on in vivo validation of colon navigation for diagnostic and therapeutic colonoscopy. In addition, the MFE platform is actively controlling the endoscope tip through 3D magnetic field sensing and manipulation with the pathway traveled graphed on the left. This allows creation of a colon visualization index. To evaluate system safety and core functionality, we tested the MFE in vivo using two 37-kilogram female Danish durock large white landrace crosswines. The MFE was successfully and safely navigated through the swine colon and withdrawn five times. Throughout all trials, the MFE allowed for good visibility of the lumen with no trauma to the colonic mucosa. Additionally, autonomous navigation of the MFE was performed with software demonstrating the capability to autonomously detect and orient the endoscope tip towards the lumen center. Retroflexion of the MFE was successfully performed both manually and autonomously in the swine colonic lumen, as visualized here from the perspective of a standard colonoscope on the left and the view of the MFE camera on the right. To demonstrate biopsy using the MFE, a suction mark was created on the lumen wall and the MFE was able to successfully take three manual biopsies. Additionally, this maneuver was conducted semi-autonomously and with an AI overlay shown as a green box that follows the target biopsy. The detection algorithm tracks the target location while the motion control software steers the endoscope tip to align with the predicted biopsy forceps location. Once the operator is satisfied that the endoscope tip is aligned, they insert the forceps and take a biopsy. During in vivo swine trials, the MFE successfully performed six endoscopic mucosal resections, EMRs. After marking the site, the lesion was lifted with a submucosal lifting agent injectable composition and snare cautery was used to remove the lesion. Throughout all EMR trials, the MFE system maintained hardware integrity and intact camera visualization with no significant submucosal damage, thus demonstrating the MFE's ability to perform an involved therapeutic intervention. In conclusion, the MFE is a novel platform capable of diagnostic and therapeutic colonoscopy. The MFE demonstrated safety throughout in vivo swine trials while remaining easy to use both mentally and physically. Preparations for first in human in vivo trials are underway. Thank you for your time and attention.

Magnetic Flexible Endoscope

diagnostic colonoscopy

therapeutic colonoscopy

magnetic coupling system

autonomous navigation