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

在英国，死产影响到大约每244名新生儿中就有一名。作为死产前应激反应的一部分，胎儿可能会表现出妥协的迹象，一个关键的指标是胎儿运动减少。妥协的迹象通常发生在胎儿死亡前几个小时，甚至是最好的几天，所以很有可能被当前的监测方法遗漏，这些监测方法是间歇性的，通常需要孕妇对体验到的运动减少保持警觉并积极寻求专业建议。有充分的证据表明，准确和早期识别胎儿运动减少(RFM)以及早期进行临床干预的能力可能会防止死产。胎儿运动在产前监测中扮演着重要的角色，但目前明显缺乏有效的技术来客观地在临床环境中使用这一重要的健康标志。目前，识别RFM的重担落在了孕妇身上，她必须去急症室接受初步检查，如果没有发现异常，病人就会出院，并建议她继续监测胎儿的运动。显然，有必要通过非侵入性可穿戴解决方案提供RFM的客观测量并让准妈妈放心。径向纤维(RF)和KYMIRA开发了一种可穿戴的胎儿运动监测设备BUMPE，该设备嵌入了一个多传感器系统，可以监测24小时连续的胎儿监测。然而，该产品在开发过程中遇到了严重停滞：所使用的活性纳米纤维传感器材料聚偏氟乙烯(PVDF)受到威胁，因为它是由永久化学物质(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聚，它们不会分解。因此，它们正被逐步淘汰和禁止。这项创新英国可行性拨款将支持RF和KYMIRA将BUMPE从这些化学品转移到生物衍生替代品。我们技术的持续成功有赖于使用合适的生物衍生材料和可持续的生命周期对其进行再开发。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胎儿运动监测设备是一项创新实践，将彻底改变对经历RFM的孕妇的护理方式。这是可穿戴技术在临床环境中史无前例的使用，将消除主观评估的风险，拯救生命。

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.