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

磁性胶囊内窥镜用于炎症性肠病患者的结肠镜检查

• 批准号: 10374776
• 负责人: Keith L Obstein
• 金额: $ 31.61万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-18 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10374776
• 关键词: 3-Dimensional; Address; Adverse event; Algorithms; American; Anatomy; Animal Model; Articulation; Artificial Intelligence; Automation; Benchmarking; Benign; Biopsy; Cadaver; Caliber; Cecum; Clinical; Collaborations; Collection; Colon; Colonoscopes; Colonoscopy; Complication; Coupling; Crohn' s disease; Detection; Development; Device Designs; Devices; Diagnosis; Diagnostic; Disease; Distal; Dysplasia; Electric Wiring; Endoscopes; Endoscopy; Engineering; Excision; Failure; Feedback; Frequencies; Funding; Future; General Population; Goals; Gold; Guidelines; Head; Human; Image; Inflammatory Bowel Diseases; Injections; Insufflation; Intelligence; Intervention; Intubation; Intuition; Irrigation; Learning; Lesion; Magnetism; Malignant Neoplasms; Maps; Measurement; Measures; Mechanics; Medical; Medical Device; Mesentery; Methods; Modeling; Motion; Mucositis; Mucous Membrane; Nature; Nursing Faculty; Pain; Painless; Pathology; Patients; Perforation; Performance; Polyps; Populations at Risk; Positioning Attribute; Procedures; Prognosis; Provider; Recording of previous events; Research Personnel; Retrieval; Risk; Robotics; Safety; Sedation procedure; Software Validation; Stream; Stretching; Suction; Surface; Technical Degree; Technical Expertise; Technology; Testing; Therapeutic; Time; Training; Translational Research; Ulcerative Colitis; Validation; Vision; Visualization; Work; arm; base; biomaterial compatibility; capsule; clinical application; colorectal cancer risk; comorbidity; design; detection method; experience; first-in-human; flexibility; gastrointestinal; human study; image processing; improved; in vivo; indexing; innovation; instrument; lifetime risk; magnetic field; novel; operation; phantom model; porcine model; prevent; procedure safety; reconstruction; response; robot assistance; robot control; skills; success; tool; trial comparing

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.

我们建议首先对我们的磁性柔性开发，优化和进行人类的测量 内窥镜（MFE）机器人平台，可以为标准提供更安全，更聪明的替代品 炎症性肠病（IBD）患者的结肠镜检查（CLS）。 IBD患者正在增加 建议进行结直肠癌的风险，因此建议以小时的时间间隔发生监视 建议为普通人群。因此，在他们的一生中，他们受到了 比非LBD对应物更频繁的CL，导致不良增长超过6倍 事件。 CL的主要风险与程序镇静，患者不适或穿孔有关 循环的结肠。循环和肠系膜拉伸是由于结肠镜的设计而发生的。特别的 可以执行操作以最大程度地减少循环，使CLS成为需要很大程度的程序 安全性能的技术技能和经验。通过使用拟议的机器人平台，内镜医生将 能够控制MFE进行导航，诊断和治疗的运动（即活检，息肉 移除/检索，注射）在人类结肠内。 MFE运动是通过磁耦合来实现的 外部永久磁铁（连接到患者身体外的机器人手臂）和一个内部 永久磁铁（位于MFE的近端头部）。小直径的柔性系绳 内窥镜和远端控制模块的头部（患者身体外）允许通过 市售的治疗工具，不足，灌溉，吸力/吸气和电线。 在内窥镜的头部采用磁吸引力，以进行进步和操纵，允许 束缚遵循被动减少肠系膜拉伸或循环的风险 传统结肠镜。我们将利用我们的经验和广泛的初步结果来测试 假设（1）内窥镜任务中智能机器人控制和辅助自主权改善 内窥镜表现，（2）量化结肠管腔的一部分可视化提供了有价值的反馈 提高MFE的运行和诊断产量，（3）MFE是安全且成功地在 人类结肠的方式类似于传统的CL。调查团队，结合了工程和 临床教职员工的独特位置，可以实现这项研究的成功，从而拥有专业知识 内窥镜设备设计，临床CL，评估和验证创新的胃肠道 技术，机器人技术，磁性，图像处理，人工智能以及研究工程的翻译 发展到临床应用。此外，调查人员有一个长期的 包括R01 EB018992在内的亲密和富有成果的历史。如果成功，这种方法将 展示首次在人口内使用MFE，以减少处于危险人群中的潜在不利事件 （IBD患者），对控制直觉，并将智能指导纳入结肠勘探和检查。