Development of distributed wireless implantable sensors for the management of heart failure (HF)

心力衰竭影响着60多万加拿大人和全球2600万人。在加拿大，心力衰竭的直接经济影响估计为每年28亿美元，其中很大一部分费用与住院和急诊室就诊有关。除了频繁的住院治疗外，HF患者还必须接受不舒服的诊断程序和体格检查。在20世纪90年代引入了远程监测（或远程监测），以在需要紧急住院之前在家庭环境中检测患者状况的恶化。当时，远程监控依赖于患者记录他们的生理参数，如体重和血压，并通过电话将其传达给他们的临床团队。对更有效的远程监测方法的需求促使医疗公司将传感器纳入传统的植入式起搏器和心脏复律器设备中。这些传感器能够实时监测多个参数，包括电活动、血压和肺部液体水平，这些参数与潜在的心力衰竭直接相关。虽然这些器械不再需要患者的积极参与和依从性，但它们确实涉及额外的外科手术，导致潜在风险和并发症。为了消除植入长延长电缆的需要，最近开发了可插入无线监视器。这些监护仪的尺寸像回形针一样，可以通过小切口或简单的导管手术插入。在心力衰竭的背景下，最成功的临床设备是植入肺动脉中的压力传感器。虽然该设备目前被广泛采用作为心力衰竭恶化的早期指标，但该系统需要患者每天操作外部电子单元。此外，当前的无线监视器被设计成测量来自一个特定解剖区域的一个参数。心脏研究的真正目标是使用无创或微创工具同时测量不同解剖区域的多个相关参数。为了实现这一目标，该计划提出了一个小型化的无线生物传感模块的智能网络的发展，用于远程监测心力衰竭。通过将这些传感器分布在相关的解剖区域，可以准确测量物理、电气和化学参数，而无需昂贵和不舒适的程序。利用半导体技术，生物传感设备将被小型化到米粒大小，而不会牺牲性能。中央植入单元将负责收集数据和控制传感器活动。组合的多参数数据将实时提供关于患者状态的丰富信息，并将确保及时监测和管理心力衰竭。

Heart failure affects more than 600,000 Canadians and 26 million people worldwide. The direct economic impact of heart failure is estimated to be $2.8 billion per year in Canada, with a significant portion of this cost associated to hospitalizations and emergency room visits. Beside frequent hospitalizations, HF patients must undergo uncomfortable diagnostic procedures and physical examinations. Remote monitoring (or telemonitoring) was introduced in the 1990's to detect the worsening of a patient's condition at a home setting before the need for emergency hospitalization. At the time, remote monitoring relied on patients to record their physiological parameters, such as weight and blood pressure, and communicate them to their clinical team over the phone. The need for more effective methods of remote monitoring led medical companies to incorporate sensors in traditional implantable pacemaker and cardioverter devices. These sensors are capable of real-time monitoring of several parameters, including electrical activity, blood pressure and fluid levels in the lungs, which are directly related to potential heart failure. While these devices no longer required patients' active participation and compliance, they did involve additional surgical procedure leading to potential risks and complications. To eliminate the need to implant long extension cables, insertable wireless monitors have recently been developed. Sized like paperclips, these monitors can be inserted through small incisions or simple catheter procedures. In the context of heart failure, the most successful clinical device is a pressure sensor implanted in the pulmonary artery. While this device is currently widely adopted as an early indicator of worsening of heart failure, the system requires patients to operate an external electronic unit daily. Moreover, current wireless monitors are designed to measure one parameter from one specific anatomical area. The true ambition of cardiac research is to measure several relevant parameters concurrently from different anatomical regions using non-invasive or minimally invasive tools. To fulfill this goal, this program proposes the development of a smart network of miniaturized wireless biosensing modules for remote monitoring of heart failure. By distributing these sensors across relevant anatomical regions, accurate measurement of physical, electrical and chemical parameters will be possible without the need for expensive and uncomfortable procedures. Leveraging semiconductor technology, the biosensing devices will be miniaturized to the scale of a grain of rice without sacrificing performance. A central implant unit will be responsible of collecting data and controlling sensor activity. Combined multi-parameter data will provide rich information about the patients' status in real-time and will ensure timely monitoring and management of heart failure.