Miniaturisation and design-for-manufacture of a fibre-optic pressure and flow sensor for guiding minimally invasive cardiovascular therapies

Echopoint Medical是一家新兴的医疗技术初创企业，专注于开发新技术，以显著改善心血管疾病（CHD）的诊断和治疗。在全球范围内，心血管疾病是女性和男性的主要死亡原因（英国有180万患者）。这些患者中的许多人在他们的心脏中有血管阻塞或阻塞，限制血液流动，这可能导致慢性疼痛（心绞痛）和心脏病发作。最常见的治疗方法之一是使用金属丝网管，称为“支架”，以保持病变血管开放并恢复足够的血液流向心肌。在这些支架的植入过程中，临床医生的治疗决策通常由放置在心脏动脉内的医疗设备的数据指导。然而，今天的设备仅提供有关心脏疾病的不完整信息，因此许多患者未得到完全或不正确的治疗。患有心血管疾病的女性患者服务不足：与男性相比，她们的症状负担更高，结局相似或更差，但不太可能出现可以通过支架治疗的阻塞。Echopoint将解决一个关键需求：提供来自冠状动脉内部的同步压力和流量测量，以显著改善心血管疾病患者的诊断和治疗--特别是患有阻塞性冠状动脉疾病和冠状动脉微血管功能障碍的患者。申请人开发了一种新技术，使用微型光纤传感器来测量血压和动脉内的流量。这些传感器将提供关键的临床数据，以改善是否在血管中放置支架的临床决策，并指导未接受支架的患者的治疗。该项目的资金将是变革性的，使Echopoint Medical能够为NHS提供具有成本效益的产品。我们的电流传感器已被证明是高度准确的;然而，我们面临两个关键挑战：1）尺寸减小，以允许集成到当前临床实践中使用的称为导丝的器械中; 2）显著降低制造成本。首先，我们将执行将传感器从两根光纤减少到单根光纤的关键步骤：这是一个具有挑战性但可以实现的与伦敦大学学院的密切联系。第二，我们将与英国的制造分包商密切合作，确保扩大规模，大幅降低成本，以便在全球市场上有效竞争。

Echopoint Medical are a new med-tech start-up who are focused on developing new technology to significantly improve diagnosis and treatment of cardiovascular disease (CHD).Globally, cardiovascular disease is the leading cause of death among women and men (1.8M patients in the UK). Many of these patients have narrowings or blockages of blood vessels in their heart that limit blood flow, which can lead to chronic pain (angina) and heart attacks. One of the most common treatments is to use a wire mesh tube, known as a "stent", to hold the diseased vessel open and restore adequate blood flow to the heart muscle. During the implantation of these stents, clinicians' treatment decisions are often guided by data from medical devices placed inside the arteries of the heart. However, today's devices provide only incomplete information about disease in the heart and consequently many patients are incompletely or incorrectly treated. Women with cardiovascular disease are underserved: compared with men, they present with a higher burden of symptoms and experience similar or worse outcomes, but are less likely to have obstructions that can be treated by stents.Echopoint will address a key need: to provide concurrent pressure and flow measurements from inside coronary arteries to significantly improve diagnosis and treatment for patients with cardiovascular disease -- particularly those with obstructive coronary artery disease and coronary microvascular dysfunction. The applicants have developed new technology that uses miniature fibre optic sensors to measure both blood pressure and flow from inside arteries. These sensors will provide key clinical data to improve clinical decision making about whether to place a stent in the vessel and also to guide treatments for patients who do not receive stents.Funding from this project will be transformative and enable Echopoint Medical to offer a cost-effective product for the NHS. Our current sensor has been shown to be highly accurate; however, we face two key challenges: 1) a size reduction to permit integration into devices called guidewires that are used in current clinical practice and 2) a significant reduction in manufacturing costs. For the first, we will perform the key step of reducing the sensor from two optical fibres to a single optical fibre: a challenging but attainable with close links to the University College London. For the second, we will work closely with manufacturing subcontractors in the UK to ensure scale-up with significant cost reductions for competing effectively in global markets.