Development and Validation of a Wearable Ultrasonic Sensor for Noninvasive Beat-to-beat Blood Pressure Monitoring

用于无创逐次血压监测的可穿戴超声波传感器的开发和验证

• 批准号: 10699861
• 负责人: Sai Zhou
• 金额: $ 25.3万
• 依托单位: SOFTSONICS LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10699861
• 关键词: Acoustics; Anterior; Area; Arteries; Automation; Blood; Blood Pressure; Blood Pressure Monitors; Blood Vessels; Calibration; Cannulations; Catheterization; Catheters; Clinical; Complex; Consumption; Coupling; Data; Data Set; Development; Device Designs; Devices; Diagnosis; Diameter; Electronics; Elements; Environment; Equilibrium; Face; Future; Gel; Goals; Guidelines; Health Care Costs; Health Personnel; Healthcare Industry; Human; Industrialization; Indwelling Catheter; Infection; Infrastructure; Inpatients; Institutional Review Boards; Intensive Care Units; Interview; Knowledge; Location; Marketing; Measurement; Medical center; Methods; Mission; Monitor; Morphologic artifacts; Nursing Staff; Outcome; Output; Pathway interactions; Patient Care; Patient-Focused Outcomes; Patients; Performance; Phase; Physicians; Physiological; Positioning Attribute; Procedures; Process; Public Health; Publishing; Pulse Oximetry; Records; Research; Safety; Side; Signal Transduction; Skin; Small Business Innovation Research Grant; Statistical Data Interpretation; Stream; Structure; System; Techniques; Technology; Testing; Thrombosis; Time; Transducers; Translating; Translations; Ultrasonic wave; Ultrasonics; United States National Institutes of Health; Validation; Work; care outcomes; clinical practice; cost; data streams; design; experience; fabrication; flexibility; hemodynamics; human capital; human subject; imaging modality; improved; improved outcome; innovation; irritation; large scale production; limb ischemia; manufacturability; manufacture; practical application; pressure; pressure sensor; prevent; prototype; radial artery; radio frequency; research clinical testing; routine practice; scale up; sensor; simulation; success; ultrasound; wearable device; wearable monitor

PROJECT SUMMARY Hemodynamic monitoring is often carried out by invasive techniques. Noninvasive, continuous blood pressure monitoring is a major challenge in the multibillion-dollar healthcare industry. However, there is a clear lack of satisfactory noninvasive solution: blood pressure cuffs only provide intermittent data and can be irritating to patients, and other emerging non-invasive technologies require complex and frequent calibration procedures and oftentimes suffer from physiological or measurement artifacts. There is a critical need for new non-invasive technologies for blood pressure surveillance. The goal of this project is to develop an easy-to-use noninvasive blood pressure sensor prototype based on a proof-of-concept wearable device demonstrated by the team. The device records the human central blood pressure with a soft ultrasonic patch, which extracts blood vessel diameter based on A-mode ultrasound radiofrequency signals. The approach is enabled by stretchable electronic designs that allow conformal, seamless contact of a soft device with the human skin, eliminating the need for coupling gel at the device/skin interface. In this project, the current lab prototype will be redesigned to enable the device application in a clinical setting guided by physician interviews. The manufacturability will be enhanced to prepare for scale-up. The approach is innovative because it is the first-of-its-kind to acquire the blood pressure waveforms of major arteries non-invasively by a stretchable ultrasonic patch. In addition, because most existing devices on the market are either rigid or flexible but not stretchable, knowledge on stretchable device prototyping and packaging is critical to technological translation of similar wearable health monitoring sensors. The proposed research is significant because it aims to use a band-aid-like device to collect beat-to-beat pressure waveforms that are conventionally done invasively. Ultimately, the proposed approach has the potential to clear the roadblock to practical applications for cuffless blood pressure sensing and impact the clinical practice, which can eventually translate to improvements in patient outcomes and reductions in healthcare costs.

项目摘要 血流动力学监测通常通过侵入性技术进行。无创连续血压 监测是数十亿美元的医疗保健行业的主要挑战。然而，显然缺乏 令人满意的非侵入性解决方案：血压袖带只能提供间歇性数据， 患者和其他新兴的非侵入性技术需要复杂和频繁的校准程序 并且经常遭受生理或测量伪像。迫切需要新的非侵入性 血压监测技术。该项目的目标是开发一种易于使用的非侵入性 血压传感器原型基于团队演示的概念验证可穿戴设备。的 该设备记录了人体中心血压与软超声贴片，其中提取血管 基于A型超声射频信号的直径。该方法通过可拉伸电子 设计允许柔软装置与人体皮肤的适形、无缝接触， 在装置/皮肤界面处耦合凝胶。在本项目中，将重新设计当前的实验室原型， 在医生访谈指导下的临床环境中的器械应用。可制造性将得到增强， 准备扩大规模。这种方法是创新的，因为它是第一种获取血压的方法。 通过可拉伸的超声贴片非侵入性地测量主要动脉的波形。此外，由于大多数现有的 市场上的设备要么是刚性的，要么是柔性的，但不能拉伸，关于可拉伸设备原型的知识 并且封装对于类似的可穿戴健康监测传感器的技术转化至关重要。拟议 这项研究很重要，因为它的目标是使用类似创可贴的设备来收集逐拍压力波形 通常是侵入性的。最终，所提出的方法有可能清除 无袖带血压感测的实际应用的障碍并影响临床实践，这可以 最终转化为患者治疗效果的改善和医疗成本的降低。