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

高血压是全球导致过早死亡的主要因素，全球每年有超过900万人死于高血压。高血压(BP)是一种慢性终生危险因素。如果不及时诊断或控制不良，高血压会导致严重的心脑血管事件。虽然许多高危患者需要长期的血压监测，但临床上还没有一种可以在医院外使用的持续血压监测方法。因此，对于用于长期、持续的血压监测的医疗级、用户友好、微创的解决方案，存在着未得到满足的临床需求和巨大的市场机会。SMARTSHAPE财团开发了一种用于连续压力测量的技术颠覆性传感器，并对其进行了IP保护。然而，要将传感器推向市场，需要克服与生物兼容性、寿命和向目标组织传递相关的几个挑战。该项目将通过配制一种创新的生物材料来应对这些挑战：一种新型的温度相关形状记忆聚合物(SMP)。SMPS的使用将使微型传感器的开发成为可能，这种传感器可以卷曲，通过微创程序引入体内，并在体温下打开，形成预定的形状。将生物材料集成到传感器中后，将通过台架测试和体内临床前研究生成用于性能、寿命、生物兼容性、安全性和传感器交付的验证数据。将解决质量和制造方面的问题，并提供监管战略和生命周期评估。BP监测将是第一个应用，但传感器的潜力远远不止于此。还将探讨其他医疗保健应用的用例，如眼内或颅内压，这将大大拓宽项目成果的潜力和创造市场的价值。

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.