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.

新的抽象 结肠和肛门直肠的组成复杂。由于难以获得和缺乏适当的技术，研究健康和胃肠道（GI）疾病中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然没有很好地理解，包括肠回路和反射的影响，以及结肠各段中的外源性神经功能。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生理相关的和实际的测试来识别潜在的机制。因此，总体目标是验证一种完全集成的动态工具，模拟下胃肠道中的粪便转运。因此，提出了以下任务：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：可在通过结肠和肛门直肠运输期间进行记录的无线器械; 2）在犬中进行安全性和性能研究（包括IDE批准）：里程碑：证明器械在不同神经肌肉条件下的安全性和性能的研究;以及3）开发经确认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（Fecobionics）是一种模拟电子粪便，具有正常粪便的稠度和形状。Fecobionics中的测量变量包括多个压力、形状变化、速度和方向。因此，这将是可行的映射和客观地描述（不干扰结肠运输和排便过程）的运输特性和神经肌肉签名在结肠运输和初始进入从直肠到放松肛管。这种独特的器械将在正常情况下以及在肠神经和外周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消化道测试的新技术，使用仿生设备模拟正常的粪便运输和排便。这项技术将取代目前的几项测试，因为它提供了一个评估功能的综合框架，并消除了对多种功能测试的需要。中心前提是，与标准测试相比，一种模拟天然下消化道转运的新型独特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的开发。其意义在于通过开发一种安全、低成本、侵入性小、风险低、无辐射的设备来解决知识上的主要差距，并测试其提供对结肠神经肌肉和排便功能的新理解的能力。这以后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，该软件将帮助调查员通过交互式工具和自动化操作来导航数据组织和共享过程。该任务的主要任务包括：1）开发Python模块，2）开发交互式用户界面，3）开发软件的用户支持工具。