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: 9513947
• 负责人: Hans Gregersen
• 金额: $ 24.95万
• 依托单位: CALIFORNIA MEDICAL INNOVATIONS INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-22 至 2020-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9513947
• 关键词: Address; Adverse effects; Aging; Agreement; Anal canal; Anatomy; Animals; Behavior; Benchmarking; Biological Markers; Bionics; Biosensor; Canis familiaris; Characteristics; Colon; Colorectal; Complex; Conflict (Psychology); 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; Nerve; Neuromuscular conditions; Organ; Pelvis; Performance; Peripheral Nerves; Peripheral Nervous System; Physiological; Physiology; Process; Radiation; Rectum; Reflex action; Research; Resolution; Risk; Sacral nerve; Safety; Shapes; 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; mathematical model; models and simulation; neuromuscular; neuromuscular function; neuromuscular system; neuroregulation; new technology; novel; novel diagnostics; novel strategies; pressure; safety study; simulation; symptom treatment; three dimensional structure; tool; transmission process; validation studies

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.

摘要 结肠和肛门直肠有复杂的成分。研究神经肌肉相互作用和活性的方法 在健康和胃肠(GI)疾病方面，由于难以获得和缺乏适当的 技术。结肠机械感觉生理学的许多方面仍未被很好地理解，包括 结肠不同节段的肠路和反射以及外源性神经功能的影响。这个 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 问题是缺乏与生理相关的实用测试来确定潜在的机制(S)。 因此，总体目标是验证一种完全集成的动态工具，该工具模拟较低的粪便传输 胃肠道。在此基础上，提出了以下工作：1)无线开发的优化 用于结肠神经肌肉功能研究的生物仿生学装置和系统。里程碑：无线设备 可以在通过结肠和肛门直肠运输的过程中进行记录；2)进行安全和性能研究 在狗身上(包括IDE批准)：里程碑：证明该设备的安全性和性能的研究 在不同的神经肌肉条件下；以及3)建立一个有效的下GI数学模型 一条小路。里程碑：结肠运输和排便的几何和功能数学模型。这个 提出的技术(Fecobionics)是一种模拟电子粪便，具有正常的稠度和形状 凳子。生物仿生学中的测量变量包括多个压力、形状变化、速度和 定位。因此，客观地绘制和描述(而不干扰结肠运输)将是可行的 和排便过程)结肠运输过程中的运输特征和神经肌肉信号 以及最初从直肠进入放松的肛管。这一独特的装置将提供新的神经肌肉 在正常情况下以及在肠道和外周介入治疗期间，下消化道的特征 神经活动，以加强我们对生理和病理生理学机制的了解 下消化道神经肌肉功能。根据SPARC的使命，我们打算为 较低的胃肠道指数测试，用仿生设备模拟正常的大便运输和排便。这项技术将 取代几个当前的测试，因为它提供了一个评估功能的集成框架，并避免了 需要对功能进行多次测试。中心前提是一种新颖而独特的生物仿生设备 模拟自然较低的GI运输将为结肠和肛门直肠提供新的机械学见解 生理学与标准测试相比，并促进针对较低GI的新诊断方法的开发 精神错乱。其意义在于通过开发一种安全、低成本、更少的 有创、低风险、无辐射的设备，并测试其能力，以提供对结肠的新理解 神经肌肉和排便功能。这可能会促进以后诊断和治疗工具的开发 这将降低医疗成本。