Fecobionics device for mapping colonic and anorectal neuromuscular function

用于绘制结肠和肛门直肠神经肌肉功能的 Fecobionics 装置

• 批准号: 9925983
• 负责人: Hans Gregersen
• 金额: $ 155.62万
• 依托单位: CALIFORNIA MEDICAL INNOVATIONS INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9925983
• 关键词: Address; Adverse effects; Aging; Agreement; Anal canal; Anatomy; Animals; Automation; Behavior; Benchmarking; Biological Markers; Bionics; Biosensor; Canis familiaris; Characteristics; Colon; Colorectal; Complex; Computer software; Conflict (Psychology); Data; Defecation; Defecography; Denervation; Development; Devices; Diagnostic; Diet; Disease; Documentation; Enteral; Enteric Nervous System; Feces; Functional Imaging; Functional disorder; Gastrointestinal Diseases; Goals; Health; Health Care Costs; Histologic; Intervention; Investigation; Knowledge; Lower Gastrointestinal Tract; Magnetic Resonance Imaging; Magnetism; Manometry; Maps; Measurement; Measures; Methods; Mission; Modeling; Mucous Membrane; Nerve; Nervous System control; Neuromuscular conditions; Organ; Pelvis; Performance; Peripheral Nerves; Peripheral Nervous System; Physiological; Physiology; Process; Pythons; Radiation; Rectum; Reflex action; Research; Research Personnel; Resolution; Risk; Sacral nerve; Safety; Shapes; Software Tools; Sterility; Technology; Test Result; Testing; Therapeutic; Time; TimeLine; Tissues; Treatment outcome; Ultrasonography; Vision; Wireless Technology; Work; associated symptom; biomaterial compatibility; body system; cost; cytotoxicity; design; gastrointestinal; gastrointestinal function; innovation; insight; interactive tool; mathematical model; models and simulation; neuromuscular; neuromuscular function; neuromuscular system; neuroregulation; new technology; novel; novel diagnostics; novel strategies; pressure; safety study; simulation; software development; support tools; symptom treatment; three dimensional structure; tool; transmission process; validation studies

NEW ABSTRACT The colon and anorectum have complex composition. Methods to study neuromuscular interactions and activity in health and gastrointestinal (GI) disease have been limited due to difficult access and lack of appropriate technologies. Many aspects of colonic mechanosensory physiology are still not well understood including the influence of enteric circuits and reflexes, and extrinsic nerve function in the various segments of the colon. The need for new technology and a better understanding of the neuromuscular function is substantial. A significant problem is a lack of physiologically-relevant and practical test for identifying the underlying mechanism(s). Hence, the overall objective is to validate a fully integrative dynamic tool that mimics feces transport in the lower GI tract. Accordingly, the following tasks are proposed: 1) Optimization of a wireless development of Fecobionics device and System for neuromuscular function studies of the colon. Milestone: Wireless device that can record during transport through colon and anorectum; 2) Conduct safety and performance studies in dogs (including IDE approval): Milestone: Studies that demonstrates safety and performance of the device under different neuromuscular conditions; and 3) Develop a validated mathematical model of the lower GI tract. Milestone: Geometric and functional mathematical model for colonic transport and defecation. The proposed technology (Fecobionics) is a simulated electronic feces that has the consistency and shape of normal stool. The measured variables in Fecobionics include multiple pressures, shape changes, velocity and orientation. Hence, it will be feasible to map and describe objectively (without disturbing the colonic transport and defecation processes) the transport characteristics and neuromuscular signatures during colonic transport and initial entry from the rectum into the relaxing anal canal. This unique device will provide new neuromuscular signatures of the lower GI tract under normal circumstances, and during intervention with enteric and peripheral nerve activity to enhance our understanding of physiological and pathophysiological mechanisms involved in the lower GI tract neuromuscular function. In line with SPARC mission, we intend to provide a new technology for lower GI testing, simulating normal stool transport and defecation with a bionics device. This technology will replace several current tests, because it provides an integrated frame work for assessing function and obviates the need for multiple tests of function. The central premise is that a novel and unique Fecobionics device that mimics natural lower GI transport will provide new mechanistic insights regarding colonic and anorectal physiology when compared to standard tests and facilitate development of new diagnostics for lower GI disorders. The significance is to address the major gaps in knowledge by developing a safe, low cost, less invasive, low risk, radiation-free device, and test its ability to provide new understanding of colonic neuromuscular and defecation function. This may later facilitate development of diagnostic and therapeutic tools that will reduce healthcare costs. An additional task of this project is to develop software, called Software for Organizing Data Automatically (SODA), that will help SPARC investigators navigate the data organization and sharing processes through interactive tools and automation. Milestones for this task include the development of 1) A Python module, 2) An Interactive User Interface, and 3) User support tools for the software.

新摘要 结肠和肛门直肠的组成复杂。由于难以获取和缺乏适当的技术，研究健康和胃肠道 (GI) 疾病中的神经肌肉相互作用和活动的方法受到限制。结肠机械感觉生理学的许多方面仍未得到很好的了解，包括肠回路和反射的影响，以及结肠各个部分的外在神经功能。对新技术和更好地了解神经肌肉功能的需求是巨大的。一个重要的问题是缺乏用于识别潜在机制的生理相关和实际测试。因此，总体目标是验证一种完全集成的动态工具，可以模拟下胃肠道中的粪便运输。因此，提出以下任务： 1）优化用于结肠神经肌肉功能研究的 Fecobionics 设备和系统的无线开发。里程碑：可在结肠和肛门直肠运输过程中进行记录的无线设备； 2）在狗身上进行安全性和性能研究（包括IDE批准）： 里程碑：证明设备在不同神经肌肉条件下的安全性和性能的研究； 3) 开发经过验证的下胃肠道数学模型。里程碑：结肠运输和排便的几何和功能数学模型。所提出的技术（Fecbionics）是一种模拟电子粪便，具有正常粪便的稠度和形状。 Fecobionics 中测量的变量包括多个压力、形状变化、速度和方向。因此，客观地绘制和描述（不干扰结肠运输和排便过程）结肠运输和从直肠初始进入松弛肛管期间的运输特征和神经肌肉特征将是可行的。这种独特的设备将在正常情况下以及在肠和周围神经活动干预期间提供下胃肠道的新神经肌肉特征，以增强我们对下胃肠道神经肌肉功能所涉及的生理和病理生理机制的理解。根据 SPARC 的使命，我们打算提供一种用于下胃肠道测试的新技术，用仿生设备模拟正常的粪便运输和排便。该技术将取代当前的多项测试，因为它提供了用于评估功能的集成框架，并且消除了对功能进行多次测试的需要。其核心前提是，与标准测试相比，一种模仿自然下消化道运输的新颖独特的 Fecobionics 装置将提供有关结肠和肛门直肠生理学的新机制见解，并促进下消化道疾病新诊断方法的开发。其意义在于通过开发一种安全、低成本、侵入性小、低风险、无辐射的装置来填补知识上的主要空白，并测试其提供对结肠神经肌肉和排便功能的新认识的能力。这可能会促进诊断和治疗工具的开发，从而降低医疗保健成本。该项目的另一项任务是开发称为自动组织数据软件 (SODA) 的软件，该软件将帮助 SPARC 研究人员通过交互式工具和自动化来导航数据组织和共享流程。此任务的里程碑包括开发 1) Python 模块、2) 交互式用户界面和 3) 软件的用户支持工具。