Bumpe ECO: A bio-derived wearable smart garment to prevent stillbirth

在英国，每244个新生儿中就有1个是死胎。胎儿可能表现出妥协的迹象，作为死产前应激反应的一部分，一个关键指标是胎动减少。妥协的迹象往往只在胎儿死亡前几小时或最多几天出现，因此目前的监测做法很可能会错过，这些做法是间歇性进行的，通常要求孕妇警惕活动减少，并积极寻求专业建议。有充分的证据表明，准确和早期识别胎动减少（RFM）和进行早期临床干预的能力可以预防死产。胎儿运动在产前监测中发挥着重要作用，但目前，在临床环境中，明显缺乏有效的技术来客观地利用这一重要的健康标志。目前，识别RFM的负担落在了准妈妈身上，她必须去急诊室，在那里进行初步检查，如果没有发现异常，患者就会出院，并建议继续监测活动。显然，有必要通过一种非侵入性可穿戴解决方案，提供一种客观的RFM测量方法，并让准妈妈们放心。Radical fibers （RF）和KYMIRA开发了一种可穿戴的胎儿运动监测设备BUMPE，它嵌入了一个多传感器系统，可以24小时连续监测胎儿。然而，该产品在开发过程中遇到了一个关键的停顿：所使用的活性纳米纤维传感器材料聚偏氟乙烯（PVDF）正受到威胁，因为它是由一种永久化学物质（PFAS；多氟烷基物质）制造的。这些人造化学物质在我们的身体和环境中积累，它们不会分解。因此，它们正在被逐步淘汰和禁止。这项Innovate UK可行性资助将支持RF和KYMIRA将BUMPE从这些化学品转向生物衍生替代品。我们的技术的持续成功依赖于使用合适的生物衍生材料和可持续的生命周期来重新开发它。这是一个重大的技术挑战，因为替代材料需要具有类似的性能。在医院外使用可穿戴式监测设备监测胎儿运动是一种创新做法，将彻底改变为经历RFM的孕妇提供护理的方式。这是在临床环境中前所未有地使用可穿戴技术，这将消除主观评估的风险并挽救生命。

Stillbirth affects approximately 1 in 244 births in the United Kingdom. Foetuses may exhibit signs of compromise as part of a stress response before stillbirth and a key indicator is a reduction in foetal movements.Signs of compromise often occur only hours or at best days before foetal death, so it is highly likely to be missed by current monitoring practices, which are performed intermittently and usually require a pregnant mother to alert of experiencing a reduction in movement and actively seek professional advice.It has been well documented that accurate and early identification of reduced foetal movements (RFM) and the ability to perform early clinical intervention may prevent stillbirth. Foetal movements have an important role in antenatal surveillance, but currently, there is a distinct lack of effective technology to objectively utilise this important marker of well-being in the clinical setting.Currently, the burden of identifying RFM is on the expecting mother who has to attend A&E, where an initial check is carried out and if no abnormalities are found, the patient is discharged and advised to continue to monitor movements. There is clearly a need to provide an objective measurement of RFM and reassurance to expecting mothers through a non-invasive wearable solution.Radical Fibres (RF) and KYMIRA have developed a wearable foetal movement monitoring device, BUMPE, embedded with a multi-sensor system that monitors 24-hour continuous foetal monitoring.However, the product has hit a critical standstill in its development: the active nanofibre sensor material used, polyvinylidene fluoride (PVDF), is under threat because it is manufactured from a forever-chemical (PFAS; polyfluorinated alkyl substances). These man-made chemicals build up in our bodies and environment, they do not break down. As a result, they are being phased out and banned.This Innovate UK feasibility grant will support RF and KYMIRA to move BUMPE away from these chemicals to bio-derived alternatives. The continued success of our technology relies on redeveloping it using a suitable bio-derived material and with a sustainable lifecycle. This is a significant technological challenge, as the replacement material is required to have comparable properties.Using a wearable monitoring device for foetal movement outside of a hospital is an innovative practice that will revolutionise the way care is delivered to pregnant women who experience RFM. This is an unprecedented use of wearable technology in a clinical setting, that will remove the risk of subjective assessment and save lives.