Optoelectronic Sensor for Venous Leg Ulcer Management

牛津健康科技有限公司（OHL）正在开发一种独特的光电传感器，用于静脉下肢溃疡的管理。1类医疗器械将解决未满足的临床需求。下肢静脉溃疡（VLU）是一种使人衰弱的疾病，影响全世界数百万人（患病率约占50岁以上人口的1.8%）。在英国，任何时候都有30万人患有腿部溃疡。VLU是由瓣膜功能不全引起的静脉高压引起的。造成这种情况的因素包括不活动、肥胖、动脉疾病、糖尿病和深静脉血栓形成。主要的相关问题包括明显的疼痛、恶臭、水肿和社会隔离。压迫疗法（使用弹性绷带）被广泛认为是治疗VLU的“金标准”，提供从脚踝到小腿的逐步减少的压力，减少肢体水肿并逆转静脉高压的症状。需要有经验的护士来应用这种疗法。即使这样，实现最佳压力梯度也是极其困难的。不正确的压力梯度导致愈合延迟、不必要的痛苦和额外的治疗费用。OHL正在开发一种独特的“绷带下压力传感器”，供从业人员在VLU治疗中使用绷带时使用。它包括具有多个独立感测点的感测器和具有视觉读出的检测器。该装置将允许最佳水平的渐进式压缩，提高愈合率，改善恢复和生活质量。医疗保健提供者将受益于；更快的愈合速度，节省护理人员的时间，减少员工培训要求。该项目将提供先进的原型技术，包括传感器硬件和软件。将对产品进行CE标识，随后将对健康志愿者进行非临床“使用中”测试。该项目将利用顾问血管外科医生和供应链分包商的指导。

Oxford Healthtech Ltd. (OHL) is developing a unique optoelectronic sensor for venous leg ulcer management. The Class 1 medical device will address an unmet clinical need.Venous leg ulcer (VLU) is a debilitating condition affecting millions of people worldwide (prevalence ~1.8% of the population aged over 50years. In the UK \>300,000 people suffer from leg ulcers at any one time. VLU is caused by venous hypertension resulting from valvular incompetence. Contributing factors include immobility, obesity, arterial disease, diabetes and deep vein thrombosis. Major associated problems include significant pain, malodour, oedema and social isolation.Compression therapy (using elasticated bandages) is widely held as the 'gold standard' for management of VLU providing a graduated decreasing pressure from ankle to calf, which reduces limb oedema and reverses the symptoms of venous hypertension.Experienced nurses are required to apply the therapy. Even then, achievement of optimal pressure gradient is extremely difficult to attain. Incorrect pressure gradient results in delayed healing, unnecessary suffering and additional treatment costs.OHL is developing a unique 'under-bandage pressure sensor' to be used by practitioners during the application of bandages in VLU treatment. It comprises a sensor with multiple independent sensing points, and a detector with visual readout. The device will allow optimum levels of graduated compression, increasing rates of healing, improved recuperation and quality of life. Healthcare provider will benefit from; faster healing rate, carer time saving and reduced staff training requirement.This project will deliver an advanced prototype technology including sensor hardware and software. Product CE marking will be undertaken, following which non-clinical 'in-use' tests on healthy volunteers will be carried out.The project will leverage the guidance of a consultant vascular surgeon and supply chain subcontractors.