Challenges to the Development of the Next Generation of Self-Reporting Cardiovascular Implantable Medical Devices.
Challenges to the Development of the Next Generation of Self-Reporting Cardiovascular Implantable Medical Devices.
复制标题
下一代自我报告心血管植入式医疗器械开发面临的挑战。
DOI：
10.1109/rbme.2021.3110084
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发表时间：
2022
影响因子：
17.6
通讯作者：
Molloy A
中科院分区：
文献类型：
--
作者：
Molloy A
心血管疾病（CVD）是一组心脏和血管系统疾病，是全球死亡的主要形式。血管会变窄，限制血液流动，并导致大多数心脏病发作和中风。经常需要反应性手术干预;包括经皮冠状动脉介入治疗（PCI）和冠状动脉旁路移植术（CABG）。尽管成功打开血管并恢复血流，但通常仍可能发生支架内再狭窄（ISR）和移植物失效，导致后续患者发病和死亡。具有传感器和实时监测能力的新一代心血管植入物正在开发中，以对抗ISR和移植失败。自我报告支架/移植物技术可以通过检测疾病的最早特征，甚至在症状出现之前，实现基于精确医学和预测性医疗保健。将具有无线电子感测能力的可植入医疗设备推向市场是复杂的并且通常是阻碍性的任务。这篇批判性评论分析了开发自我报告支架/移植物需要克服的障碍，并为心血管患者提供基于精确医学的医疗保健。在这里，我们评估了该领域的最新研究和技术进步，当前的设备;包括智能心血管植入式生物传感器和相关的无线数据和功率传输解决方案。我们包括对已达到临床试验的设备及其最终用户实施的市场潜力的评估。
Cardiovascular disease (CVD) is a group of heart and vasculature conditions which are the leading form of mortality worldwide. Blood vessels can become narrowed, restricting blood flow, and drive the majority of hearts attacks and strokes. Reactive surgical interventions are frequently required; including percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Despite successful opening of vessels and restoration of blood flow, often in-stent restenosis (ISR) and graft failure can still occur, resulting in subsequent patient morbidity and mortality. A new generation of cardiovascular implants that have sensors and real-time monitoring capabilities are being developed to combat ISR and graft failure. Self-reporting stent/graft technology could enable precision medicine-based and predictive healthcare by detecting the earliest features of disease, even before symptoms occur. Bringing an implantable medical device with wireless electronic sensing capabilities to market is complex and often obstructive undertaking. This critical review analyses the obstacles that need to be overcome for self-reporting stents/grafts to be developed and provide a precision-medicine based healthcare for cardiovascular patients. Here we assess the latest research and technological advancement in the field, the current devices; including smart cardiovascular implantable biosensors and associated wireless data and power transfer solutions. We include an evaluation of devices that have reached clinical trials and the market potential for their end-user implementation.