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An In-Situ Biliary Manometer for Sphincter of Oddi Dysfunction Diagnosis

用于 Oddi 括约肌功能障碍诊断的原位胆管压力计

基本信息

批准号：
7457431
负责人：
Keat Ghee Ong
金额：
$ 23.4万
依托单位：
MICHIGAN TECHNOLOGICAL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-04-01 至 2012-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7457431
关键词：
Abdominal Cramps Algorithms Animals Arteries Bile fluid Biliary Biosensor Caliber Calibration Catheters Clinic Clinical Trials Condition Data Detection Development Devices Diagnosis Diagnostic Dimensions Disease Duodenum Eating Elasticity Electronics Elements Endoscopic Retrograde Cholangiopancreatography Endoscopy Ensure Evaluation Fasting Figs - dietary Future Goals In Situ Iron Left Length Liver Location Magnetism Manometry Measurement Measures Medical Modification Monitor Muscle Muscle Contraction Nature Noise Pain Pancreas Pancreatic duct Pancreatitis Patients Performance Perfusion Physiology Positioning Attribute Power Sources Procedures Process Property Public Health Signal Transduction Skeletal Muscle Smooth Muscle Spasm Sphincter Sphincter of Oddi Dysfunction Sphincter of Oddi structure Standards of Weights and Measures Stenosis Stents Stomach Stress Stretching Surgical Flaps Symptoms System Technology Thick Time Toxic effect Tube United States Food and Drug Administration Variant Water Week Width Wireless Technology Work awake base biomaterial compatibility cooking design improved novel pressure prevent response seal sensor size tool upper GI series

项目摘要

DESCRIPTION (provided by applicant): The focus of this project is to develop an in-situ manometer for continuous monitoring of Sphincter of Oddi (SO) pressure over a prolonged period of time as a means to accurately diagnose Sphincter of Oddi Dysfunction (SOD), as well as to advance the understanding of Sphincter of Oddi spasm to enable future treatment of this condition. The proposed manometer consists of a biliary stent with an open channel to permit uninterrupted flow of bile from the liver to the duodenum. An array of wireless, passive magnetoelastic pressure sensors are embedded along the length of the stent for real-time assessment of the pressure within the SO without the use of wires or specific sensor alignment. In the application described here, the responses of the sensors are conveyed to a device with data logger system to permit patients to electronically log symptoms such as abdominal cramps or pain. This feature permits establishment of a correlation, or lack of correlation, between pain attacks and sphincter spasm, which provides critical information for the diagnosis and treatment of SOD. Moreover, because pain attacks may occur infrequently, the monitoring stent can be left in situ until a typical pain attack occurs, after which the manometer can be removed. This project focuses on the development of the manometer. Although this project does not include a clinical trial to investigate the underlying causes of SOD, the development of the manometer alone would present an advance in medical diagnostic devices by providing a useful tool for further studies of SOD. Specific focuses of this project include {1} the fabrication and characterization of the magnetoelastic pressure sensors, {2} integration of the sensors into the stent, {3} fabrication of the measurement device, {4} calibration of sensor data, and {5} evaluation and optimization of the sensor system.Narrative Public Health Relevance: To date, there is no reliable way for long-term (from a few weeks to a few months) monitoring of the pressure within the Sphincter of Oddi (SO). The diagnosis of Sphincter of Oddi Dysfunction (SOD) is made on the basis of several minutes of SO manometry performed during Endoscopic Retrograde Cholangio- pancreatography (ERCP), during which the patient is fasting and sedated. Little is known about SO function in awake, ambulatory, non-fasting patients. This project, upon successful completion, will provide a tool for improved study of SO physiology and diagnosis of SOD since it can provide ambulatory, continuous monitoring of the pressure within the SO, and will allow correlation between SO pressures, activities such as eating, and episodes of pain. The ultimate goal of this project is to develop a passive, wireless implantable biosensor technology to improve diagnosis capabilities on various diseases. As an example, with proper modifications the same sensor technology can be applied for measuring the pressure within an artery stent for in-stent stenosis detection.

描述（由申请人提供）：该项目的重点是开发一种原位压力计，用于长时间连续监测奥迪括约肌（SO）压力，作为准确诊断奥迪括约肌功能障碍（SOD）的手段，并增进对奥迪括约肌痉挛的了解，以便将来能够治疗这种疾病。所提出的压力计由带有开放通道的胆管支架组成，以允许胆汁从肝脏不间断地流向十二指肠。沿着支架的长度嵌入了一系列无线、无源磁弹性压力传感器，用于实时评估 SO 内的压力，而无需使用电线或特定的传感器对准。在这里描述的应用中，传感器的响应被传送到带有数据记录系统的设备，以允许患者以电子方式记录腹部绞痛或疼痛等症状。这一特征允许在疼痛发作和括约肌痉挛之间建立相关性或缺乏相关性，这为 SOD 的诊断和治疗提供了关键信息。此外，由于疼痛发作可能很少发生，因此可以将监测支架留在原位，直到发生典型的疼痛发作，然后可以移除压力计。该项目的重点是压力计的开发。尽管该项目不包括调查 SOD 根本原因的临床试验，但压力计的开发本身就可以为 SOD 的进一步研究提供有用的工具，从而推动医疗诊断设备的进步。该项目的具体重点包括{1}磁弹性压力传感器的制造和表征、{2}将传感器集成到支架中、{3}测量设备的制造、{4}传感器数据的校准以及{5}传感器系统的评估和优化。叙述公共卫生相关性：迄今为止，还没有可靠的方法来长期（从几周到几个月）监测奥迪括约肌 (SO) 内的压力。奥迪括约肌功能障碍 (SOD) 的诊断是基于在内窥镜逆行胰胆管造影 (ERCP) 期间进行的几分钟 SO 测压，在此期间患者禁食并服用镇静剂。对于清醒、非卧床、非禁食患者的 SO 功能知之甚少。该项目成功完成后，将为改进 SO 生理学研究和 SOD 诊断提供工具，因为它可以动态、连续监测 SO 内的压力，并将允许 SO 压力、进食等活动和疼痛发作之间的关联。该项目的最终目标是开发一种无源、无线植入式生物传感器技术，以提高对各种疾病的诊断能力。例如，通过适当的修改，可以应用相同的传感器技术来测量动脉支架内的压力，以检测支架内狭窄。