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

描述(申请人提供)：本项目的重点是开发一种原位压力计，用于在较长时间内连续监测Oddi括约肌(SO)压力，作为一种准确诊断Oddi括约肌功能障碍(SOD)的手段，以及促进对Oddi括约肌痉挛的了解，以便将来能够治疗这种情况。建议的压力计包括一个带有开放通道的胆道支架，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支架的长度嵌入，无需使用电线或特定的传感器对齐，即可实时评估SO内的压力。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诸如腹部痉挛或疼痛等症状。这一特征允许建立疼痛发作和括约肌痉挛之间的相关性或缺乏相关性，这为超氧化物歧化酶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，直到典型的疼痛发作发生，之后可以移除压力计。本项目致力于压力计的研制。尽管该项目不包括调查超氧化物歧化酶的潜在原因的临床试验，但压力计的开发本身将为进一步研究超氧化物歧化酶提供有用的工具，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}传感器与支架的集成，{3}测量装置的制造，{4}传感器数据的校准，以及{5}传感器系统的评估和优化。 公共卫生相关性：到目前为止，还没有可靠的方法来长期(从几周到几个月)监测Oddi括约肌(SO)内的压力。Oddi括约肌功能障碍(SOD)的诊断是在患者禁食和镇静的内窥镜逆行胆胰管造影术(ERCP)过程中进行的几分钟SO测压的基础上做出的。对清醒的、非空腹的非卧床患者的SO功能知之甚少。该项目成功完成后，将为改进SO生理学研究和超氧化物歧化酶的诊断提供工具，因为它可以对SO内的压力进行动态、持续的监测，并允许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，相同的传感器技术可以应用于测量动脉支架内的压力，用于支架内狭窄的检测。

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.