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

我们建议开发、优化和进行第一次人体内测量我们的磁弹性 内窥镜(MFE)机器人平台，可提供更安全、更智能的标准替代方案 炎症性肠病患者的结肠镜检查(CLS)。炎症性肠病患者的发病率增加 结直肠癌的风险，因此建议监测的间隔时间少于 这是为普通民众推荐的。因此，在他们的一生中，他们受到 比非LBD患者更频繁地发生CLS，导致不良反应增加6倍以上 事件。CLS的主要风险与手术镇静、患者不适或穿孔有关。 循环中的冒号。由于结肠镜的设计，会出现肠环和肠系膜伸展。特价 可以执行操作以最大限度地减少循环，使CLS成为一个需要很大程度的 安全执行的技术技能和经验。通过使用提议的机器人平台，内窥镜医生将 能够控制MFE的运动以执行导航、诊断和治疗(如活检、息肉 移除/取回、注射)在人体结肠内。磁铁的运动是通过磁力耦合来实现的 外部永久磁铁(连接到患者身体外部的机械臂)和内部 永磁体(位于MFE近端磁头内部)。一种小直径的柔韧系绳 内窥镜的头部和远端控制模块(在患者身体外部)允许通过 商业上可用的治疗工具、注气、冲洗、抽吸/抽吸和电线。 在内窥镜的头部使用磁吸力以推进和操纵，允许 被动地系绳跟随-与以下情况相比，降低肠系膜拉伸或环行的风险 传统结肠镜检查。我们将利用我们的经验和广泛的初步结果来测试 内窥镜任务中智能机器人控制和辅助自主性改善的假设 内窥镜表现，(2)量化显示的结肠腔部分提供有价值的反馈 改进MFE操作和诊断良率，以及(3)MFE在 人结肠，其方式类似于传统的CLS。调查小组，结合工程学和 临床教员是这项研究成功的得天独厚的条件-集体拥有 创新胃肠道的内窥镜设备设计、临床CLS、评估和验证 技术、机器人、磁学、图像处理、人工智能和研究工程翻译 临床应用方面的进展。此外，调查人员还有一个长期存在的 密切而富有成效的合作历史，包括R01 EB018992。如果成功，这种方法将 展示首次在人类中使用MFE，减少高危人群中潜在的不良事件 (IBD患者)，控制直观，并将智能引导集成到结肠探查和检查中。

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.