Optical microcatheters for coronary physiology assessments

该项目的重点是开发一种新的医疗器械，以改善冠心病（CHD）的诊断和治疗。CHD仍然是全球主要的死亡原因。当斑块的积聚限制了冠状动脉血流时，患者就会出现症状。临床医生关于治疗的决定通常由放置在心脏动脉内的医疗设备的数据指导。目前，这些设备提供有关斑块积聚两侧血压差异的信息，以确定是否放置支架。我们正在开发一种新的医疗设备，可以提供有关血流和血压的直接信息。直接测量血流已被证明是有价值的，以改善临床决策是否放置冠状动脉支架。我们的解决方案将与临床工作流程兼容，通过提供直接的血流测量，它将导致更准确的评估是否需要支架放置，这将改善患者的治疗效果并降低医疗保健系统的成本。我们的设备的创新之一是一种新型的光纤传感平台，包括高度集成的光纤流量和压力传感器，该技术已在台式实验室和早期临床前模型中得到验证。该项目的目的是开发先进的原型设备，并在临床现实环境中对其进行测试。该项目将完成一个关键的开发步骤：进展到临床验证的临床前原型，以实现未来临床试验的商业制造。

This project is focused on the development of a new medical device to improve diagnosis and treatment of Coronary Heart Disease (CHD). CHD remains the leading cause of death worldwide. Patient symptoms occur when a build-up of plaque restricts coronary blood flow. Clinicians' decisions about treatment are often guided by data from medical devices placed inside the arteries of the heart. Currently, these devices provide information about differences in blood pressure on either side of plaque build-up, to determine whether to place a stent.We are developing a new medical device that provides direct information about both blood flow and blood pressure. Direct measures of blood flow have been shown to be valuable to improve clinical decision-making about whether to place a coronary stent. Our solution will be compatible with clinical workflow, and by providing direct measures of blood flow, it will lead to more accurate assessments about whether stent placement is required, which will improve patient outcomes and reduce costs to the healthcare system.One of the innovative aspects of our device is a novel fibre-optic sensing platform that comprises a highly miniaturised, fibre-optic flow and pressure sensor, and a single-use miniature microcatheter device into which the sensor is integrated.The technology has been validated in the benchtop laboratory and in early-stage pre-clinical models. The aim of this project is to develop advanced prototype devices and to test them in clinically-realistic settings. The project will fulfil a key development step: the progression to clinically-validated pre-clinical prototypes to enable commercial manufacturing for future clinical trials.