Telemonitoring of home dialysis utilizing a smart biomimetic arteriovenous graft (TELEGRAFT)

临床需求：全球10%的人口受到慢性肾脏疾病(CKD)的影响，每年有数百万人因无法获得治疗而死亡。由于全球肾脏捐赠者短缺，绝大多数患者依赖血液透析(HD)。全球目前有超过260万人接受HD治疗以维持生命，但这一数字可能只占需要治疗的人的10%。解决方案：目前高达70%的动静脉移植物(AVG)在植入后第一年失败。这主要是由于血栓形成、管腔疤痕形成和感染。在我们开创性的新型AVG中，仿生两性离子可防止血栓形成，药物输送可防止疤痕形成和感染，ECM涂层可确保快速的组织整合，从而实现早期HD。SMART：TeleGraft包括两种诊断工具，用于监测和预防设备并发症。压力变送器用于监测血流，光学传感器用于检测炎症和感染。数据由人工智能机器学习模型处理，并显示在医疗保健专业人员易于理解的仪表板中。这些数据允许远程医疗专业人员进行在线远程监护和咨询。这使得家庭透析对患者来说是安全的，即使在基础设施较差的地区，患者住在远离HD诊所的地方。外科植入：TeleGraft系统将通过在欧洲5家医院招募60名患者的两阶段随机临床试验和家庭HD现场研究在操作环境中进行演示。资源受限环境：(1)在中低收入国家，TeleGraft将取代复杂而昂贵的肾脏移植，并允许更简单、更廉价的AVG移植来取代HD。(2)TeleGraft是唯一具有诊断工具的解决方案，允许对并发症和设备故障进行实时在线检测和远程监控。这允许从医院的高清设备过渡到资源受限的家庭环境。

Clinical need: 10% of the population worldwide is affected by chronic kidney disease (CKD) and millions die each year because they do not have access to treatment. Giving global shortage of kidney donors, the vast majority of patients rely on hemodialysis (HD). Over 2.6M people worldwide currently receive HD to stay alive, yet this number may only represent 10% of people needing treatment. Solution: Up to 70% of current arteriovenous grafts (AVG) fail in the first year after implantation. This is primarily due to thrombosis, luminal scar formation, and infection. In our ground-breaking new AVG, biomimicking zwitterions prevent thrombosis, drug delivery prevents scar formation and infection, and an ECM coating ensures fast tissue integration allowing early HD. Smart: TeleGraft comprises two diagnostic tools to monitor and prevent device complication. Pressure transmitters are used to monitor blood flow and optical sensors to detect inflammation and infections. The data is processed by AI machine learning models and displayed in an easy to understand dashboard for healthcare professionals. The data allows online telemonitoring and consultations by remote healthcare professionals. This makes home dialysis safe for patients, even in areas with poor infrastructure, where patients live far from HD clinics. Surgical implantation: The TeleGraft system will be demonstrated in an operational environment through a 2-stage randomized clinical trial enrolling 60 patients at 5 hospitals across Europe and through a home HD field study. Resource constrained setting: (1) In low and middle income countries, TeleGraft will substitute complicated and expensive kidney transplantation and allow simpler and cheap implantation of AVG for HD. (2) TeleGraft is the only solution with diagnostic tools allowing real-time online detection and remote monitoring of complications and device failure. This allows transition from HD at the hospital to the resource constrained home setting.