A magnetic capsule endoscope for colonoscopy in patients with IBD

描述（由申请人提供）：我们建议开发、优化和临床前评估一种机器人平台，该平台可为炎症性肠病（IBD）患者提供标准结肠镜检查的更安全替代方案。IBD患者患结直肠癌的风险增加，因此建议监测间隔比一般人群更短。因此，在IBD患者的一生中，他们经历的结肠镜检查次数显著多于他们的结肠镜检查次数。 非IBD对应物，导致术后不良事件增加6倍以上。结肠镜检查的主要风险是与操作镇静、患者不适或结肠成环穿孔相关的风险。由于结肠镜的设计，会发生肠袢和肠系膜牵拉。可以进行特殊的操作以最大限度地减少循环，使结肠镜检查成为一种需要大量技术技能和经验才能安全进行的程序。胶囊式内窥镜对IBD患者非常有帮助，特别是在儿童和年轻人克罗恩病的诊断中。如本项目所建议的，将胶囊式内窥镜用于结肠镜检查将降低不良事件的风险，从而为IBD患者提供极大的获益。通过使用我们提出的机器人平台，内窥镜医生将能够远程控制软栓胶囊的运动，以在人体结肠内的任何位置进行诊断和治疗。胶囊的操纵是通过磁耦合实现的，这要归功于两个永磁体的相互作用-一个集成在胶囊内，另一个放置在机器人手臂的末端执行器。利用广泛的初步结果，通过这项研究，我们将开发一个完整的 经过审查的系统已准备好进行人体临床试验，我们将测试我们的方法具有与标准结肠镜检查相当的诊断和治疗能力的假设，同时缩短学习曲线并降低成环和肠系膜拉伸的程度。我们将通过以下方式实现这些目标：（1）优化我们的机器人平台供人类使用，（2）实现安全、稳健和直观的控制，以及（3）将所提出的技术与涉及三个不同层次的标准结肠镜检查进行基准测试。该研究小组，结合工程和临床教师从范德比尔特大学，是独特的定位，以实现这项研究的成功。具体而言，研究者共同拥有内窥镜器械设计、临床结肠镜检查、创新胃肠道技术的评估和验证以及将研究工程开发转化为临床应用的专业知识。如果成功，这种方法将扩大IBD监测计划的实施到农村地区，这要归功于平台的低成本（即，低于20，000美元），运输方便，不需要麻醉师或镇静监测器，也不需要进行检查的专门设施。

DESCRIPTION (provided by applicant): We propose to develop, optimize, and pre-clinically assess a robotic platform that may provide a safer alternative to standard colonoscopy 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 a shorter interval than that recommended for the general population. Therefore, over the course of an IBD patient's lifetime, they are subjected to a significantly larger number of colonoscopies than their non-IBD counterparts, resulting in a more than 6-fold increase in post-procedure adverse events. The main risks of colonoscopy are those 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 colonoscopy a procedure that requires a great degree of technical skill and experience to safely perform. Capsule endoscopy has already been extremely helpful for IBD patients, especially in the diagnosis of Crohn's disease in children and young adults. Adapting capsule endoscopy to colonoscopy as proposed by this project would allow for reduced risk of adverse events, thus providing great benefit to patients with IBD. By using the robotic platform we propose, the endoscopist will be able to remotely control the motion of a soft-tethered capsule to perform diagnosis and treatment at any location inside the human colon. Manipulation of the capsule is achieved by magnetic coupling, thanks to the interaction of two permanent magnets - one integrated inside the capsule and the other placed at the end effector of a robotic arm. Leveraging extensive preliminary results, with this study we will develop a fully vetted system ready for human clinical trials, and we will test the hypothesis that our approach has diagnostic and therapeutic capabilities comparable to standard colonoscopy, while at the same time, shortening the learning curve and decreasing both the degree of looping and mesenteric stretching. We will pursue these goals by (1) optimizing our robotic platform for human use, (2) implementing a safe, robust, and intuitive control, and (3) benchmarking the proposed technology with standard colonoscopy involving three different tiers. The Investigative Team, combining engineering and clinical faculty from Vanderbilt University, is uniquely positioned to achieve the success of this study. Specifically, the Investigators collectively possess expertise in endoscopic device design, clinical colonoscopy, assessment and validation of innovative gastrointestinal technologies, and translation of research-engineering developments into clinical applications. If successful, this approach will widen the implementation of IBD surveillance programs to rural areas thanks to the low cost of the platform (i.e., less than $20,000), ease of transport, no need for anesthesiologists or sedation monitors, and no need for specialized facilities within which examinations are performed.