Revolutionising lymphoedema treatment - A disruptive technology to improve quality of life

临床问题：治愈了一种致命的疾病(癌症)，但留下了终身慢性疾病(淋巴水肿[LE])。LE是一种慢性、进行性和不治之症。这是由于淋巴系统(身体的“管道”)无法从受影响的区域排出液体，导致过度肿胀(图1A-B)。风险可能包括年龄增加、肥胖，通常还包括癌症治疗(例如手术、放射治疗、化疗)。它影响高达70%的乳腺癌、前列腺癌、头颈癌患者；他们面临着发生淋巴水肿的终身风险，可在癌症治疗后数周至数年内表现出来；它是一个日益严重的老龄化挑战，也是一个未得到充分满足的医学问题。重要：日益严重的老龄化问题对生活质量(QOL)产生负面影响：据估计，全球约有1.2亿至2.5亿人受到LE的影响。随着老龄化人口的增加，淋巴水肿持续增加(国际淋巴水肿框架-ILF)。它是世界范围内导致残疾的主要原因，但在大多数医疗系统中，它仍然诊断不足、治疗不足、研究不足和资金不足，主要是由于公众和医疗保健专业人员(HCP)缺乏认识。淋巴水肿症患者面临着巨大的生理、心理和社会经济后果，这会显著降低他们的生活质量，并显著影响健康老龄化。身体后果包括：毁容、残疾、疲劳、疼痛、过度肿胀。心理后果包括：焦虑、抑郁、因身体形象扭曲而导致的自信心下降和丧失独立性。社会经济后果包括：由于治疗费用高，造成巨大的财政负担(每年治疗增加10K GB)。(例如，诊所就诊、按压治疗、物理治疗，每周几次)。由于不受身体影响的独立性降低而导致的生产力不足。需要一种新的方法：减少肢体体积的压迫策略，如手动淋巴引流(MLD-由认证按摩治疗师执行)，和/或使用先进的气动压缩设备(PCD-在专家诊所提供)是治疗的关键方面，这些被视为日常生活的障碍，并被描述为“可怕的日常盔甲”。缺乏有效的疾病管理方法和无法获得治疗意味着，这对收入较低的患者影响最大。建议：在这个项目中，将设计、开发、制造和测试一种完全便携的新型可穿戴套筒。这款可穿戴医疗设备的目的是：1)使用以需求为导向的方法，为LE患者提供更可持续、更负担得起和更容易获得的替代治疗；2)提高LE意识。我的目标是：1)提供世界上第一款便携式PCD设备-“LymphMotion”；允许患者频繁地自我管理自己的病情，使他们拥有更高的自主感，并提高他们的生活质量。2)与LE利益攸关方合作，提供外展讲习班，提高对淋巴水肿和有效管理战略的认识。

Clinical problem: Cured of a deadly disease (cancer), but left to survive with a lifelong chronic condition (lymphoedema [LE]). LE is a chronic, progressive, and incurable disease. It is caused by the inability of the lymphatic system (the "plumbing" of the body) to remove fluid from the affected area, resulting in excessive swelling (Fig.1A-B). Risks can include increased age, obesity, and commonly, cancer treatments (e.g., surgery, radiotherapy, chemotherapy). It affects up to 70% of breast, prostate, head and neck cancer patients; they face a lifelong risk of developing lymphoedema, which can manifest from weeks to years after cancer treatment; it is a growing aging challenge and an under-met medical problem.Importance: Growing aging problem with negative impact on quality of life (QoL): with an estimated ~120-250 million individuals globally being affected by LE. It continues to increase with the growing aging population (International Lymphoedema Framework-ILF). It is a leading cause of disability worldwide, yet it remains underdiagnosed, undertreated, under-researched, and underfunded in most healthcare systems, mainly due to lack of awareness from both the public and healthcare professionals (HCP). Lymphoedema patients face huge physical, psychological, and socioeconomic consequences which dramatically reduces their QoL, and significantly affect healthy aging. Physical consequences include: disfigurement, disability, fatigue, pain, excessive swelling. Psychological consequences include: anxiety, depression, decreased self-confidence from distorted body image and loss of independence. Socio-economic consequences include: Huge financial burden (£10K increase in annual treatment), due to the high cost of treatment. (e.g., clinic visits, compression therapy, physiotherapy, several times a week). Lack of productivity due to reduced independence from physical consequences. A new approach is needed: Compression strategies to reduce limb volume such as manual lymphatic drainage (MLD - performed by certified massage therapists), and/or the use of an advanced pneumatic compression device (PCD - delivered at specialist clinics) are critical aspects to treatment, which are viewed as barriers to daily life and described as "terrible daily armour". The lack of an effective way of managing the disease and the inaccessibility of treatment means that this has the most significant effect on patients who are lower income. Proposal: In this project, a new wearable sleeve that is fully portable will be designed, developed, manufactured and tested. The aims of this wearable medical device is to 1) Provide a more sustainable, affordable, and accessible alternative treatment for LE patients, using a needs-led approach 2) Increase LE awareness.My objectives is to : 1) Deliver the world's first portable PCD device - "LymphMotion"; allowing the patient to frequently self-manage their condition, empowering them to have a higher sense of self-autonomy and improve their quality of life. 2) Work with LE stakeholders to provide outreach workshops and increase awareness of lymphoedema and effective management strategies.