Development of the initial prototype of a pill sensor to detect colonic polyps and early bowel cancer

肠癌每年导致近100万人死亡，其中一半以上的病例是致命的。虽然早期癌症检测可以显着改善患者的预后，但英国超过一半的肠癌病例是在晚期诊断的。肠癌和癌前息肉的检测目前主要通过在内窥镜检查（结肠镜检查）期间对结肠粘膜的视觉检查（其是侵入性程序）或通过横截面成像（其对于不容易可视化的小尺寸病变不太可靠）来进行。如果这种息肉没有在早期发现和切除，它们就有可能癌变。最近，结肠胶囊内窥镜的结肠直接可视化已经被引入，但由于担心这种模式会遗漏病变，临床医生的使用受到限制，可能会给患者带来灾难性的后果。利用我们在可控胶囊技术领域的开创性工作，我们的团队开发了一种新型的，无束缚的，振动的，AI辅助的，可摄入的药丸传感器，目的是通过一种新的方式检测小的结肠病变（DOI：10.1109/LRA.2023.3251853）。在吞咽这种基于药丸的装置后，它将通过肠道蠕动和蠕动穿过患者的胃肠道（GI）。可以获取来自与原位肠病变接触的药丸的动态信号，并分析指示组织中的生物力学变化的特征，以推断良性或恶性病变。设计创新包括鼓励药丸-病变相互作用的振动机制，用于相互作用信号采集的便携式平台，以及一次性组件：每次手术后，药丸的外壳被丢弃，而主要组件无需再处理即可回收，大大降低了成本。该平台体积小，重量轻，与标准结肠镜检查相比，资本成本显著降低。我们实验室的早期实验表明，成功检测模拟结肠病变的平均准确率为96.5%（DOI：10.1109/LRA.2023.3251853）。因此，这种新型药丸传感器计划成为结肠镜检查和当前结肠胶囊式内窥镜检查的替代方案。该项目旨在开发这种药丸传感器的初始原型，与人工智能融合，以帮助检测难以可视化的肠道病变。这项新的诊断工具将在为期18个月的研究计划中进行开发、优化和测试。在这个项目结束时，我们将在TRL 3提供一个概念验证原型，为体内测试做好准备。为此，我们将通过以下方式实现这一目标：（1）集成所有所需的组件，包括板载振动器和传感器（例如，加速计）、数据存储和电源，（2）优化药丸的可控性和完整性，（3）使用由机载传感器获取的动态信号来执行病变的自主检测，（4）在实验室环境中的多个验证场景中用标准结肠胶囊内窥镜检查对所提出的技术进行基准测试，（5）根据临床反馈优化初始原型用于临床。从长远来看，这项工作将为患者和临床医生开创一种舒适、安全、可靠的新型微创研究模式，在癌前病变和早期癌病变的检测中准确且具有成本效益。

Bowel cancer causes nearly a million deaths per annum, and more than half of cases are fatal. Although early cancer detection can significantly improve patients' outcomes, more than half of bowel cancer cases in the UK are diagnosed at a late stage. Detection of bowel cancer and pre-cancerous polyps is currently predominantly performed by either visual inspection of the colonic mucosa during endoscopy (colonoscopy), which is an invasive procedure, or by cross-sectional imaging, which is less reliable for small-sized lesions that are not easily visualised. If such polyps are not detected and removed at an early stage, there is a chance that they may become cancerous. Recently, direct visualisation of the colon using colonic capsule endoscopy has been introduced, but uptake by clinicians has been limited due to concerns about missed lesions with this modality, with potentially catastrophic outcomes for patients.Leveraging our pioneering work in the field of controllable capsule technologies, our team has developed a novel, untethered, vibrational, AI-assisted, ingestible pill sensor, with the aim of detecting small colonic lesions by a new modality (DOI:10.1109/LRA.2023.3251853). After swallowing this pill-based device, it will pass through the patient's gastrointestinal (GI) tract through gut motility and peristalsis. Dynamic signals from the pill in contact with in-situ bowel lesions can be acquired and analysed for features that are indicative of biomechanical changes in the tissues, to infer benign or malignant lesions. Design innovations include the vibrational mechanism for encouraging pill-lesion interactions, a portable platform for interaction signal acquisition, and disposable components: after each procedure, the pill's outer shell is discarded, whilst the main components are reclaimed without reprocessing, dramatically reducing the cost. The platform is small and lightweight, with significantly reduced capital costs compared to standard colonoscopy. Early experiments in our laboratory demonstrate an average accuracy of 96.5% in successful detection of simulated colonic lesions (DOI:10.1109/LRA.2023.3251853). This novel pill sensor is therefore planned to facilitate an alternative to both colonoscopy and current colonic capsule endoscopy.This project aims to develop an initial prototype of this pill sensor in fusion with artificial intelligence to aid the detection of hard-to-visualise bowel lesions. This novel diagnostic tool will be developed, optimised, and tested in this 18-month research programme. By the end of this project, we will deliver a proof-of-concept prototype at TRL 3 that is ready for in-vivo testing. To this end, we will pursue this aim by (1) integrating all the required components, including on-board vibrator and sensor (e.g., accelerometer), data storage, and power supply, (2) optimising the controllability and integrity of the pill, (3) using the dynamic signals acquired by the on-board sensor to perform autonomous detection of lesions, (4) benchmarking the proposed technology with standard colonic capsule endoscopy in multiple validation scenarios in a laboratory setting, (5) optimising the initial prototype for clinical use based on clinical feedback.In the long term, this work will initiate a new, minimally invasive, investigative modality for patients and clinicians that is comfortable, safe, reliable, accurate and cost-effective in the detection of pre-cancerous and early cancerous lesions.