Novel, Ambulatory Cuff-less Non-invasive Arterial Blood Pressure Monitor

新型动态无袖带无创动脉血压监测仪

• 批准号: 8839117
• 负责人: David James Jorgenson
• 金额: $ 19.8万
• 依托单位: KRISARA ENGINEERING
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-01-01 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8839117
• 关键词: Activities of Daily Living; Address; Adult; Am 80; American; Arteries; Blood Pressure; Blood Pressure Monitors; Calibration; Cardiovascular system; Cellular Phone; Clinic; Clinic Visits; Clinical; Coats' disease; Computerized Medical Record; Congestive Heart Failure; Data; Development; Device or Instrument Development; Devices; Diagnostic; Diastolic blood pressure; Disease; Economic Inflation; Elbow; Electronics; Engineering; Exhibits; FarGo; Goals; Health; Health Care Costs; Hospitals; Hour; Human; Hypertension; Investments; Left; Legal patent; Life; Location; Measurement; Measures; Medical Device; Methods; Modality; Movement; Myocardial Infarction; Organ; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Physiologic pulse; Population; Positioning Attribute; Productivity; Reporting; Resources; Sioux Falls; Sleep; Software Design; Stroke; System; Techniques; Technology; Testing; Time; Variant; Wireless Technology; abstracting; arm; brachial artery; clinically actionable; compliance behavior; constriction; cost; design; human subject; hypertension treatment; improved; novel; patient monitoring device; prototype; public health relevance; sensor; standard of care; tonometry

 DESCRIPTION (provided by applicant): The objective of this proposal is to complete the engineering development and testing of the Non-Invasive Self- calibrating Ambulatory Multi-Modality (NISAM) blood pressure device to recognize hypertensive patients not currently identified using today's technology. As well as providing better management of hypertensive patients by presenting a truer round-the-clock picture of their blood pressure (BP) variation. Hypertension is increasing worldwide and represents an annual burden of $47.5 billion in healthcare costs and resources in addition to $3.5 billion yearly in lost productivity. In the U.S. 80 million people have hypertension, though only 80% are aware of their condition, and only 48% have it adequately controlled. As with every disease state, proper measurement of the problem is required. Patient BP varies throughout the day, week and year. Existing in- clinic BP measurements are infrequent and prone to errors. The NISAM device combines four different sensor technologies into a wearable wireless non-invasive BP measurement device that does not require an inflation cuff. The device is worn over the patient's brachial artery near the elbow At only 3 cm x 3 cm it is small, unobtrusive and easy to use. The device monitors patient movement and uses this information to assess when to collect data. It can store months and up to years of data and wirelessly transmit this to a smart phone or to a hospital's electronic medical records system. The NISAM device's clinical benefits include: an unobtrusive BP measurement system to identify hypertensive patients not currently recognized using today's methods, as well as better managing existing hypertensive patients by understanding their true BP variation. Also, the NISAM device will display the BP data to support clinically actionable decisions through patient-specific, efficient and easy to understand diagnostic reports. In addition, patient compliance is greatly improved because this device does not require an inflation cuff, which is disruptive to patient's sleep. In this Phase I proposal we will demonstrat feasibility and complete engineering development and testing of the NISAM BP sensors and actuator system, and compare measurements with a standard clinical BP cuff in bench/mock and human testing. To achieve this objective a mock artery setup will be used to demonstrate performance and accuracy using the force actuator and four different sensor techniques. Also, prototypes will be built to measure the accuracy of the four sensors on human subjects and compare results to inflation cuff systems. The long-term goal is to clinically utilize the NISAM device to better identify and manage hypertensive patients, using a small, wearable, wireless easy to use BP device.

 描述(由申请人提供)：本提案的目标是完成非侵入性自校准动态多模式(NISAM)血压设备的工程开发和测试，以识别目前使用当今技术无法识别的高血压患者。以及通过呈现血压(BP)变化的更真实的全天候图像，为高血压患者提供更好的管理。高血压在全球范围内不断增加，每年造成475亿美元的医疗成本和资源负担，另外每年还会造成35亿美元的生产力损失。在美国 8000万人患有高血压，尽管只有80%的人知道自己的病情，只有48%的人得到了充分的控制。对于每一种疾病状态，都需要对问题进行适当的衡量。患者的血压在一天、一周和一年中都有所不同。现有的门诊血压测量很少，而且容易出错。NISAM设备将四种不同的传感器技术结合到一种不需要充气袖口的可穿戴无线非侵入性血压测量设备中。该装置戴在患者肘部附近的臂动脉上，距离只有3厘米x 3厘米。它体积小，不显眼，使用方便。该设备监控患者的行动，并使用这些信息来评估何时收集数据。它可以存储数月甚至数年的数据，并将这些数据无线传输到智能手机或医院的电子病历系统。NISAM设备的临床好处包括：一个不显眼的血压测量系统，可以识别目前使用当今方法无法识别的高血压患者，以及通过了解现有高血压患者的真实血压变化来更好地管理他们。此外，NISAM设备将显示BP数据，通过针对患者的、有效和易于理解的诊断报告支持临床上可操作的决定。此外，患者的依从性大大提高，因为这种设备不需要充气袖口，这会扰乱患者的睡眠。在这个第一阶段的提案中，我们将展示NISAM BP传感器和执行器系统的可行性和完整的工程开发和测试，并在工作台/模拟和人体测试中将测量结果与标准临床BP袖带进行比较。为了实现这一目标，将使用模拟动脉设置来演示使用力致动器和四种不同的传感器技术的性能和准确性。此外，还将建立原型来测量四个传感器在人体受试者身上的准确性，并将结果与充气袖口系统进行比较。长期目标是在临床上使用NISAM设备，使用一种小型、可穿戴、无线、易于使用的BP设备，更好地识别和管理高血压患者。