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个机器人平台，该平台可能为炎症性肠病(IBD)患者提供比标准结肠镜检查更安全的替代方案。IBD患者患结直肠癌的风险增加，因此建议监测间隔短于普通人群的建议。因此，在IBD患者的一生中，他们接受的结肠镜检查数量明显多于他们的 非IBD患者，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手术镇静、患者不适或环状结肠穿孔有关的风险。由于结肠镜的设计，会出现肠环和肠系膜伸展。可以进行特殊的操作以减少环状，使结肠镜检查成为一种需要很高程度的技术技能和经验才能安全执行的程序。胶囊内窥镜检查已经对IBD患者非常有帮助，特别是在儿童和年轻人的克罗恩病的诊断中。根据本项目的建议，将胶囊内窥镜应用于结肠镜检查将减少不良事件的风险，从而为IBD患者提供极大的好处。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系绳胶囊的运动，以便在人体结肠内的任何位置进行诊断和治疗。由于两个永久磁铁的相互作用，对太空舱的操纵是通过磁耦合实现的-一个集成在太空舱内，另一个放置在机械臂的末端执行器上。利用广泛的初步结果，通过这项研究，我们将制定一个全面的 经过审查的系统已经为人类临床试验做好了准备，我们将测试这一假设，即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，同时缩短学习曲线，减少环状和肠系膜拉伸的程度。我们将通过(1)优化我们的机器人平台供人类使用，(2)实施安全、稳健和直观的控制，以及(3)使用涉及三个不同级别的标准结肠镜检查来对拟议的技术进行基准测试，以实现这些目标。研究团队结合了范德比尔特大学的工程学和临床教师，在实现这项研究的成功方面处于独特的地位。具体地说，研究人员共同拥有内窥镜设备设计、临床结肠镜检查、创新胃肠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，这种方法将把IBD监测方案的实施范围扩大到农村地区，这要归功于该平台的低成本(即不到20,000美元)、运输方便、不需要麻醉师或镇静监测仪，也不需要专门的设施进行检查。

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.