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。鉴于全球肾供体短缺，绝大多数患者依赖血液透析（HD）。目前全世界有超过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人数的10%。解决方案：目前高达70%的动静脉移植物（AVG）在植入后的第一年失败。这主要是由于血栓形成、腔内瘢痕形成和感染。在我们突破性的新型AVG中，仿生两性离子可以防止血栓形成，药物递送可以防止疤痕形成和感染，ECM涂层可以确保快速组织整合，从而实现早期HD。智能：TeleGraft包括两个诊断工具，以监测和防止设备并发症。压力变送器用于监测血液流动，光学传感器用于检测炎症和感染。这些数据由人工智能机器学习模型处理，并显示在一个易于理解的仪表板上，供医疗保健专业人员使用。这些数据允许远程医疗保健专业人员进行在线远程监控和咨询。这使得家庭透析对患者来说是安全的，即使在基础设施差的地区，患者居住的地方远离HD诊所。手术植入：TeleGraft系统将通过一项两阶段随机临床试验，在欧洲5家医院招募60名患者，并通过家庭HD实地研究，在操作环境中进行演示。资源受限的环境：(1)在中低收入国家，TeleGraft将取代复杂昂贵的肾移植，允许更简单廉价的AVG移植HD。(2) TeleGraft是唯一的诊断工具，可以实时在线检测和远程监测并发症和设备故障。这样就可以从医院的家庭保健过渡到资源有限的家庭环境。

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.