A magnetic capsule endoscope for colonoscopy in patients with inflammatory bowel disease

我们建议开发，优化，并进行我们的磁性柔性的首次人体测量

We propose to develop, optimize, and conduct first in-human measurements of our Magnetic Flexible Endoscope (MFE) robotic platform that may provide a safer and more intelligent alternative to standard colonoscopy (CLS) for patients with Inflammatory Bowel Disease (IBD). Patients with IBD are at increased risk for colorectal cancer and therefore surveillance has been recommended to occur at intervals less than that recommended for the general population. Thus, over the course of their lifetime, they are subjected to more frequent CLS than their non-lBD counterparts, resulting in a more than 6-fold increase in adverse events. The main risks of CLS are related to procedural sedation, patient discomfort, or perforation of the colon from looping. Looping and mesenteric stretching occur due to the design of the colonoscope. Special maneuvers can be performed to minimize looping, making CLS a procedure that requires a great degree of technical skill and experience to perform safely. By using the proposed robotic platform, the endoscopist will be able to control the motion of the MFE to perform navigation, diagnosis, and therapy (i.e. biopsy, polyp removal/retrieval, injection) inside the human colon. MFE motion is achieved by magnetic coupling between an external permanent magnet (attached to a robotic arm outside the patient's body) and an internal permanent magnet (located inside the proximal head of the MFE). A small-diameter flexible tether between the head of the endoscope and the distal control module (outside the patient's body) allows for passage of commercially available therapeutic tools, insufflation, irrigation, suction/aspiration, and electrical wiring. Employing magnetic attraction at the head of the endoscope, for advancement and manipulation, permits the tether to follow passively-reducing the risk of mesenteric stretching or looping when compared to the traditional colonoscope. We will leverage our experience and extensive preliminary results to test the hypotheses that (1) intelligent robotic control and assistive autonomy in endoscopic tasks improves endoscopic performance, (2) quantifying the portion of colon lumen visualized provides valuable feedback to improve MFE operation and diagnostic yield, and (3) that the MFE is safe and successfully functions in the human colon in a manner similar to conventional CLS. The investigative team, combining engineering and clinical faculty, is uniquely positioned to achieve success of this study-collectively possessing expertise in endoscopic device design, clinical CLS, assessment and validation of innovative gastrointestinal technologies, robotics, magnetism, image processing, artificial intelligence, and translation of research-engineering developments into clinical applications. Additionally, the investigators have a long-standing history of close and fruitful collaboration including R01 EB018992. If successful, this approach will demonstrate first in-human use of the MFE that reduces potential adverse events in an at-risk population (IBD patients), is intuitive to control, and integrates intelligent guidance into colon exploration and inspection.