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

项目描述（由申请人提供）：本项目的重点是开发一种原位压力计，用于长时间连续监测Oddi括约肌（SO）压力，作为准确诊断Oddi括约肌功能障碍（SOD）的手段，并提高对Oddi括约肌痉挛的认识，以便将来治疗这种疾病。建议的压力计包括一个胆道支架和一个开放的通道，以允许胆汁不间断地从肝脏流向十二指肠。一组无线无源磁弹性压力传感器沿着支架的长度嵌入，用于实时评估SO内的压力，而无需使用导线或特定的传感器校准。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器系统的设备，以允许患者以电子方式记录腹部痉挛或疼痛等症状。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，由于疼痛发作可能不经常发生，监测支架可以留在原位，直到发生典型的疼痛发作，之后可以取出压力计。本项目重点研制压力计。尽管该项目不包括临床试验，以调查SOD的潜在原因，但单是压力计的开发就为进一步研究SOD提供了有用的工具，从而在医疗诊断设备方面取得了进步。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}传感器集成到支架中，{3}测量装置的制造，{4}传感器数据的校准，{5}传感器系统的评估和优化。叙述

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.