EPSRC - NIHR HTC Partnership Award: Medical devices and vulnerable skin: Optimising safety in design

EPSRC - NIHR HTC 合作伙伴奖：医疗设备和脆弱皮肤：优化设计安全性

• 批准号: EP/M000303/1
• 负责人: Daniel Bader
• 金额: $ 18.19万
• 依托单位: University of Southampton
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=EP%2FM000303%2F1
• 关键词: EPSRC; NIHR; HTC; Partnership; Award

Chronic wounds, as typified in the development of pressure ulcers (PUs) and diabetic foot ulcers, represent a huge problem for many patients, their families and the carers. Indeed, the management of such wounds can prove problematic and in some cases can be life threatening. Non-healing wounds continue to be a major issue in all health care systems, resulting in considerable distress to patients and carers and providing an estimated financial burden to the NHS of £4 billion pa. They are caused when parts of the body involving soft tissues, namely skin, muscle and fat, are exposed to prolonged mechanical loading. Although commonly involving immobile subjects who are bedridden or confined to chairs, these ulcers can arise in many other situations in which interventional medical devices introduce potentially damaging loads at the skin surface, afflicting patients of all ages. Indeed device-related ulcers represent a major healthcare problem, accounting for over 30% of hospital-acquired PUs. Current devices are based on designs employing traditional materials which are relatively stiff/rigid and do not match the compliance of fragile skin tissues. Accordingly the Network will provide a technological platform for novel designs of medical devices, incorporating suitable materials to make contact with fragile skin tissues, and manufacturing capability, which will protect them from device related injury.The network is designed to integrate expertise from the NHS, healthcare industry, engineering consultancy and academia. It will provide cutting edge technologies and scientific understanding in order to ensure safety of vulnerable skin in situations arising from medical devices. As an example the Network will utilise imaging techniques and simple robust biomarkers to evaluate the health of loaded skin. The Network will also develop computer generated models to test device performance prior to evaluation on vulnerable patients. Materials developed in other engineering applications will be evaluated for their suitability in new and existing device designs. Three proposed studies provide exemplars of devices attached to skin tissues; to provide breathing assistance for pre-term infants, protection for infants and adults with inherited disease and incontinence management for males. The network will engage with other partners and in particular our two supporting HTCs in Wound Prevention & Treatment and Devices for Dignity, who will prioritise subsequent activities based on identified clinical needs. These will inevitably involve engagement with other academic, clinical and industrial partners, which the Network will fully encourage.Activity within the Network will provide benefits to patient-centric Quality of Life. Improving device design will reduce discomfort and lower the occurrence of lifelong scarring and disfigurement injuries. This will also offer the opportunity for the NHS to reduce costs associated with treatment of medical-device related skin damage and their potential recurrence. This, in turn, will attract interest from the healthcare industry to reinvest in a range of safe devices with novel materials and designs which can prevent damage to vulnerable tissues. The Network aims to extend the success of UK plc in the advanced wound dressing market, which currently embraces over 20% of the global market, into the wound prevention or avoidance market. The wide dissemination strategy will attract other academics in the UK and Internationally to offer additional expertise to the innovation platform in the form of methodological or theoretical techniques and engage with the Network. In addition, activities from the Network will attract interest from additional Health Technology Cooperatives, thereby enhancing its scope and increasing its associations with the wider academic and clinical communities. The Network will also establish key links with organisations, such as the MHRA who regulate the medical device industry.

慢性伤口，如典型的压力溃疡（PU）和糖尿病足溃疡的发展，代表了许多患者，他们的家人和护理人员的一个巨大的问题。事实上，这种伤口的管理可能是有问题的，在某些情况下可能危及生命。不愈合的伤口仍然是所有医疗保健系统中的一个主要问题，给患者和护理人员带来了相当大的痛苦，并为NHS提供了估计40亿英镑的财政负担。当涉及软组织的身体部分，即皮肤，肌肉和脂肪，暴露于长时间的机械负荷时，会引起它们。虽然这些溃疡通常涉及卧床不起或局限于椅子的不动受试者，但这些溃疡可能出现在许多其他情况下，其中介入性医疗器械在皮肤表面引入潜在的破坏性载荷，使所有年龄段的患者都受到影响。事实上，器械相关溃疡是一个主要的医疗保健问题，占医院获得性PU的30%以上。目前的装置是基于采用传统材料的设计，传统材料相对坚硬/刚性并且不匹配脆弱皮肤组织的顺应性。因此，该网络将为医疗设备的新设计提供一个技术平台，包括与脆弱的皮肤组织接触的合适材料，以及保护它们免受设备相关伤害的制造能力。该网络旨在整合NHS，医疗保健行业，工程咨询和学术界的专业知识。它将提供尖端技术和科学知识，以确保脆弱皮肤在医疗设备引起的情况下的安全。例如，该网络将利用成像技术和简单可靠的生物标志物来评估负载皮肤的健康状况。该网络还将开发计算机生成的模型，以在对脆弱患者进行评估之前测试设备性能。将评价在其他工程应用中开发的材料在新器械和现有器械设计中的适用性。三项拟议的研究提供了附着在皮肤组织上的器械范例;为早产儿提供呼吸辅助，为患有遗传性疾病的婴儿和成人提供保护，为男性提供失禁管理。该网络将与其他合作伙伴合作，特别是我们在伤口预防和治疗以及尊严设备方面的两个支持HTC，他们将根据确定的临床需求优先考虑后续活动。这将不可避免地涉及与其他学术，临床和工业合作伙伴的参与，网络将充分鼓励。网络内的活动将为以患者为中心的生活质量带来好处。改进器械设计将减少不适，降低终身疤痕和毁容损伤的发生率。这也将为NHS提供机会，以降低与医疗器械相关的皮肤损伤及其潜在复发的治疗相关的成本。反过来，这将吸引医疗保健行业的兴趣，重新投资于一系列具有新材料和设计的安全设备，这些设备可以防止对脆弱组织的损伤。该网络旨在将英国公司在先进伤口敷料市场的成功（目前占全球市场的20%以上）扩展到伤口预防或避免市场。广泛的传播战略将吸引英国和国际上的其他学者以方法或理论技术的形式为创新平台提供额外的专业知识，并与该网络合作。此外，该网络的活动将吸引更多的卫生技术合作社的兴趣，从而扩大其范围，并增加其与更广泛的学术界和临床界的联系。该网络还将与监管医疗器械行业的MHRA等组织建立关键联系。

项目成果

A reflection-mode fibre-optic sensor for breath carbon dioxide measurement in healthcare

用于医疗保健中呼吸二氧化碳测量的反射模式光纤传感器

• DOI: 10.1016/j.sbsr.2018.100254
• 发表时间: 2019-02-01
• 期刊: SENSING AND BIO-SENSING RESEARCH
• 影响因子: 5.3
• 作者: Liu, LiangLiang;Hao, FengHuan;Korposh, Serhiy
• 通讯作者: Korposh, Serhiy

Technologies to monitor the health of loaded skin tissues.

• DOI: 10.1186/s12938-018-0470-z
• 发表时间: 2018-04-12
• 期刊: Biomedical engineering online
• 影响因子: 3.9
• 作者: Bader DL;Worsley PR
• 通讯作者: Worsley PR

A trial of devices for urinary incontinence after treatment for prostate cancer.

前列腺癌治疗后尿失禁装置的试验。

• DOI: 10.1111/bju.13016
• 发表时间: 2015
• 期刊: BJU international
• 影响因子: 4.5
• 作者: Macaulay M