VeinSensor™: An innovative medical technology for the treatment of venous leg ulcers

静脉性小腿溃疡(VLU)是影响腿部下部的伤口，与深静脉血栓形成(DVT)和静脉曲张有关，继而产生“静脉高压”(与受影响部位的血液、液体和蛋白质的积聚有关)。皮肤破裂，伤口经常受到感染，渗出，并散发出难闻的气味。患者长时间遭受相当大的痛苦和痛苦，通常是几个月或几年，并变得越来越孤立。此外，在全球范围内，VLU吸收了大量的财政和护理资源。使用张力弹力绷带的渐变压迫疗法是VLU公认的“黄金标准”治疗。成功在很大程度上取决于护士达到准确的规定压缩曲线；然而，研究表明，在70%的病例中，护士的错误非常严重(而且严重错误，以至于在10%的病例中造成更大的伤害)。过度收紧仍然是最常见的问题，导致更多的疼痛，额外的皮肤损伤，以及不遵守治疗。无法用绷带实现准确和可重复的渐进式按压意味着溃疡无法愈合，可能会变得更加严重，患者将继续遭受痛苦。随着患者不得不接受更长时间的治疗，通常是数年，医疗服务的成本急剧上升。VLU治疗的改进将增加患者的福祉和结果，减轻护理服务的负担，并减少医疗系统在这种昂贵的慢性疾病上的支出。为了应对这一挑战，VeinSense Limited正在开发一种新型医疗设备，以帮助护士实现准确和可重复性的分级按压轮廓，无论使用的绷带类型、肢体周长或形状或护士经验如何。VeinSensor是一种基于光学的多点压力传感器条(在包扎患者的腿部时放置)，连接到一个小型电子处理单元，实时显示在移动/平板电脑/笔记本电脑上，施加分级的压缩水平。这一概念已被证实使用基本的，工作台，多件原型，表现出极大的兴趣从各种VLU护理小组。该项目将在这一早期成果的基础上，将原型设计和开发成低成本、单件、可批量生产的设计，并进行“健康志愿者”测试，以实现初步的技术验证。项目成果将在商业启动之前为下一阶段的研发(商业原型、随机临床试验)提供信息。好处包括：(1)改善了VLU治愈率、生活质量和治疗依从性的患者结果，对所有VLU患者产生了积极影响，全球有2000万VLU患者，以及(2)显著的NHS/医疗系统成本节约(VLU目前在英国的总成本为22亿GB/年(在美国为200亿美元/年)。

Venous leg ulcers (VLUs) are wounds affecting the lower part of the legs linked to deep vein thrombosis (DVT) and varicose veins, in turn creating 'venous hypertension' (associated with a build-up of blood, fluids and proteins in the affected parts). The skin breaks down and frequently, the wounds become infected, oozing, and offensive smelling. Patients suffer considerable pain and distress for prolonged periods, often for many months or years, and become increasingly socially isolated. Furthermore, globally, VLUs absorb significant financial and nursing resources.Graduated compression therapy using tensioned, elasticated bandages is the accepted 'gold standard' treatment for VLUs. Success relies heavily on nurses achieving the exact prescribed compression profile; however, research shows that nurses are significantly incorrect in \>70% of cases (and so seriously wrong as to cause more harm in \>10% of cases). Over-tightening remains the most common problem causing more pain, additional skin damage, and non-compliance with treatment. The inability to achieve accurate and reproducible graduated compression with bandages means ulcers do not heal, potentially become far worse, and patients continue to suffer. Health Services' costs spiral as patients have to be treated for much longer, often years. Improvements in the treatment of VLUs will increase patient wellbeing and outcomes, un-burden nursing services and reduce healthcare systems' expenditure on this costly, chronic condition.To address this challenge, VeinSense Limited are developing a novel medical device to help nurses achieve accurate and reproducible graduated compression profiles 'first time, every time', irrespective of bandage-type used, circumference or shape of limb, or nurse experience. 'VeinSensor' is an optical-based, multi-point pressure sensor strip (placed on the patients' leg under bandaging being applied), connected to a small electronics-processing-unit that displays in real-time onto a mobile/tablet/laptop, the graduated compression levels being applied. The concept has been proven using basic, bench-top, multi-piece prototypes, with significant interest shown from various VLU nursing groups. This project will build upon this early achievement to design and develop prototypes into a low-cost, single piece, mass-producible design, and undertake 'healthy volunteer' testing to achieve initial technology validation. Project outputs will inform next stages of R&D (commercial prototyping, randomised clinical trials) prior to commercial launch.Benefits include: (1) improved patient outcomes for VLU healing rates, quality of life, and treatment compliance, positively affecting all VLU sufferers of which there are \>20m globally, and; (2) significant NHS/healthcare systems' cost-savings (VLUs currently cost £2.2bn/year overall in the UK (and \>$20bn/year in the USA).