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

VeinSensor™：治疗腿部静脉溃疡的创新医疗技术

• 批准号: 53280
• 金额: $ 35.66万
• 依托单位: VEINSENSE LTD
• 依托单位国家: 英国
• 项目类别: Study
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=53280
• 关键词: VeinSensor; innovative; medical; technology; treatment

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).

下肢静脉溃疡（VLU）是影响下肢的伤口，与深静脉血栓形成（DVT）和静脉曲张有关，进而产生“静脉高血压”（与受影响部位的血液、液体和蛋白质积聚有关）。皮肤破裂，伤口经常感染，渗出，并发出难闻的气味。患者长期遭受相当大的疼痛和痛苦，通常长达数月或数年，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。使用张紧的弹性绷带进行渐进式加压治疗是VLU公认的“黄金标准”治疗。成功在很大程度上依赖于护士达到精确的规定压缩配置文件;然而，研究表明，护士在70%的情况下明显不正确（并且在10%的情况下严重错误，造成更多伤害）。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压迫意味着溃疡不会愈合，可能会变得更糟，患者继续受苦。医疗服务的成本螺旋上升，因为病人必须接受更长时间的治疗，往往是几年。VLU治疗的改进将提高患者的健康和结果，减轻护理服务的负担，并减少医疗保健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“第一次，每次”实现准确和可重复的渐进压缩轮廓，而不管使用的绷带类型，肢体的周长或形状，或护士经验。“VeinSensor”是一种基于光学的多点压力传感器条（放置在患者腿部，进行包扎），连接到一个小型电子处理单元，该单元在移动的/平板电脑/笔记本电脑上实时显示所施加的分级压缩水平。这一概念已被证明使用基本的，台式的，多件式原型，从不同的VLU护理组显示出显着的兴趣。该项目将在这一早期成果的基础上，设计和开发原型，使其成为低成本、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。项目产出将为研发的下一阶段提供信息（1）改善VLU治愈率、生活质量和治疗依从性的患者结果，对全球2000万以上的所有VLU患者产生积极影响;（2）显著的NHS/医疗保健系统的成本节约（VLU目前在英国的总成本为22亿英镑/年（在美国为200亿美元/年））。