SMARTSHAPE - Development Of A Smart, Shape Memory Sensor For Biological Pressure Monitoring Applications

高血压是导致过早死亡的主要全球因素，每年在全世界造成超过900万人死亡。血压升高（BP）是一种慢性终生危险因素。如果不及时诊断或控制不良，高血压可导致严重的心血管和脑血管事件。尽管许多高风险患者需要长期BP监测，但目前还没有临床上可接受的可在医院外使用的连续BP监测方法。因此，对于用于长期连续BP监测的医疗级、用户友好且微创的解决方案，存在未满足的临床需求和巨大的市场机会。SMARTSHAPE联盟开发了一种技术上具有突破性的传感器，并对其进行了IP保护，用于连续压力测量。然而，要将传感器推向市场，还需要克服与生物相容性、寿命和递送至靶组织相关的几个挑战。该项目将通过创新生物材料的配方来解决这些挑战：一种新型的温度依赖性形状记忆聚合物（SMP）。SMP的使用将使微传感器的开发成为可能，该微传感器可以卷曲，通过微创手术引入体内，并且当放置在体温下时“打开”以采取预定义的形状。将生物材料集成到探头中后，将通过实验室试验和体内临床前研究生成性能证明、寿命、生物相容性、安全性和探头输送的确认数据。将解决质量和制造方面的问题，并提供监管策略和生命周期评估。BP监测将代表第一个应用，但传感器的潜力远远不止于此。将探索其他医疗保健应用的用例，如眼内压或颅内压，这将显着扩大项目成果的潜力和市场创造价值。

Hypertension is the leading global contributor to premature death, accounting for over 9M deaths worldwide each year. Elevated blood pressure (BP) is a chronic lifetime risk factor. If left undiagnosed or poorly controlled, high BP can lead to serious cardiovascular and cerebrovascular events. Whereas long-term BP monitoring is required in many high-risk patients, there is no clinically accepted method of continuous BP monitoring that can be used outside of hospital settings. Thus, there is an unmet clinical need and a huge market opportunity for a medical-grade, user-friendly, and minimally invasive solution for long-term, continuous BP monitoring. The SMARTSHAPE consortium has developed and IP-protected a technologically disruptive sensor for continuous pressure measurement. However, several challenges related to biocompatibility, longevity, and delivery to the target tissue need to be overcome to deliver the sensor to the market. This project will address these challenges by formulation of an innovative biomaterial: a novel temperature dependent shape memory polymer (SMP). The use of SMPs will enable the development of a microsensor that can be curled up, introduced into the body through a minimally invasive procedure, and ‘opened up’ when placed at body temperature to take a pre defined shape. After integration of the biomaterial in the sensor, validation data will be generated for proof-of-performance, longevity, biocompatibility, safety, and sensor delivery through bench testing and in vivo preclinical studies. Quality and manufacturing aspects will be addressed and a regulatory strategy and lifecycle assessment delivered. BP monitoring will represent the first application, but the potential of the sensor goes far beyond that. Use cases for other healthcare applications such as intraocular or intracranial pressure will be explored, which will significantly broaden the potential and market-creating value of the project results.