Development of a Highly Accurate Wrist/Ankle-Mount Non-invasive Blood Pressure Monitor for Neonatal Patients

为新生儿患者开发高精度腕/踝无创血压监测仪

基本信息

批准号：
10773214
负责人：
Sharon X. Wang
金额：
$ 5.5万
依托单位：
JB HEALTHTECH, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-06-01 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10773214
关键词：
Address Admission activity Adult Air Bags Algorithms Ankle Base Ratios Birth Blood Pressure Blood Pressure Monitors Calibration Catheters Cessation of life Clinical Clinical Management Closure by clamp Comparative Study Critical Illness Development Device or Instrument Development Devices Diastolic blood pressure Elements Engineering Generations Heart Rate Hematoma Industrialization Industry Infection Legal patent Life Low Birth Weight Infant Measurement Measures Medical Device Methods Monitor Multi-site clinical study Neonatal Neonatal Intensive Care Units Newborn Infant Organ Patients Perfusion Periodicals Phase Respiration Rest Risk Running Small Business Innovation Research Grant Specific qualifier value Statistical Models Structure of umbilical artery Systolic Pressure Technology Testing Thrombosis Umbilicus United States Work Wrist blood pressure reduction blood pressure variability design experience hemodynamics innovation insight manufacturability neonatal patient neonate novel population based pressure prototype public health relevance research clinical testing standard of care time interval tool

项目摘要

SUMMARY/ABSTRACT More than 340,000 neonates are admitted to the neonatal intensive care unit (NICU) each year in the United States. Monitoring arterial blood pressure (BP) for them, particularly preterm low-birthweight newborns, can be challenging. The oscillometric (OSC) brachial cuff is much less accurate in neonates than in adults because it derives systolic and diastolic pressures using population-based ratios. With lower BP, neonates as a group are statistically underrepresented in these ratios, thus their BP measurements tend to be erroneous. The standard method for neonatal BP monitoring is via the umbilical arterial catheter (UAC). However, UAC fails to work for approximately 10% of patients when both umbilical arteries are damaged or regressed after birth. For these patients, there is no alternative available. UAC also carries significant risks, including thrombosis, hematomas, infections, and even death. To address this unmet clinical need for neonatal BP monitoring, JB HealthTech, Inc. (JBH) is developing a highly accurate non-invasive BP monitor neoBPTM that operates in 3 modes. Its continuous mode provides high-fidelity arterial BP waveforms similar to UAC, to derive arterial pressures, respiration rate, and a suite of hemodynamic parameters. Its intermittent mode gives a convenient BP snapshot and heart rate, similar to OSC. Its periodic mode runs at predefined running/resting time intervals for any clinical needs in between. neoBP is based on a volume clamp (VC) technology, which is advantageous over other technologies, such as statistical modeling where neonates are underrepresented, less accurate devices with airbags only, and cuffless devices depending on calibration with UAC or OSC for every use. Using a novel closed-form theoretical framework without empirical elements, we dynamically build the patient-specific pressure-volume function and solved a long-standing inaccuracy problem of the BP industry. We have implemented the innovative algorithms on the prototype, initiated preliminary adult clinical testing, and filed four US patent applications. JBH has strong engineering expertise in medical device development. We also have partnered with neonatologists and cardiologists to benefit from their clinical experiences and insights. With this diverse, complementary team, we will advance our device from prototype to practice. Our tasks for this Phase I SBIR project include hardware redesigns and rigorous clinical tests. We will build our second-generation hardware and neonatal cuffs, which meet product specification matrixes. We will also validate the accuracy of neoBP against the standard of care UAC to demonstrate its feasibility. A successful comparative study in the NICU will be the milestone for the project to advance to Phase II. neoBP would be the first highly accurate non- invasive BP monitor in the NICU and provide a simple and reliable way to measure BP for all neonates. With accuracy comparable to UAC, neoBP will eliminate UAC-related complications and become an indispensable tool in every neonatologist's armamentarium. In Phase II, we will further test it in multi-center clinical studies, resolve any clinical related issues, redesign it for manufacturability, and receive FDA 510(k) clearance.

摘要/摘要美国每年有超过 340,000 名新生儿入住新生儿重症监护病房 (NICU) 国家。监测他们的动脉血压（BP），特别是早产低出生体重新生儿，可以具有挑战性的。示波 (OSC) 臂套在新生儿中的准确度远低于成人，因为它使用基于人群的比率得出收缩压和舒张压。由于血压较低，新生儿作为一个群体这些比率在统计上代表性不足，因此他们的血压测量往往是错误的。标准新生儿血压监测的方法是通过脐动脉导管（UAC）。然而，UAC 无法工作大约 10% 的患者出生后双侧脐动脉均受损或退化。对于这些患者，没有其他选择。 UAC还具有重大风险，包括血栓形成、血肿、感染，甚至死亡。为了解决新生儿血压监测这一未满足的临床需求，JB HealthTech, Inc. (JBH) 正在开发一种高精度无创血压监测仪 neoBPTM，可在 3 种模式下运行。它是连续模式提供类似于 UAC 的高保真动脉血压波形，以得出动脉压，呼吸速率和一套血流动力学参数。其间歇模式提供方便的血压快照和心率，与 OSC 类似。其周期性模式以预定义的运行/休息时间间隔运行，适用于任何临床之间的需要。 neoBP 基于容量钳 (VC) 技术，与其他技术相比具有优势技术，例如新生儿代表性不足的统计建模、不太准确的设备仅安全气囊，以及无袖套设备，每次使用时均需通过 UAC 或 OSC 进行校准。使用小说没有经验元素的封闭式理论框架，我们动态地构建患者特定的压力-体积函数，解决了BP行业长期存在的不准确问题。我们有在原型机上实施了创新算法，启动了初步成人临床测试，并提交了四份申请美国专利申请。 JBH 在医疗设备开发方面拥有强大的工程专业知识。我们还有与新生儿科医生和心脏病专家合作，从他们的临床经验和见解中受益。有了这个多元化、互补的团队，我们将把我们的设备从原型推进到实践。我们第一阶段的任务 SBIR 项目包括硬件重新设计和严格的临床测试。我们将打造我们的第二代符合产品规格矩阵的硬件和新生儿袖带。我们还将验证其准确性 neoBP对照护理标准UAC来证明其可行性。一项成功的比较研究 NICU将是该项目推进到二期的里程碑。 neoBP 将是第一个高度准确的非 NICU 中的有创血压监测仪为所有新生儿提供简单可靠的血压测量方法。和准确性与UAC相当，neoBP将消除UAC相关并发症，成为不可或缺的每个新生儿科医生的设备中都有一个工具。在II期，我们将进一步在多中心临床研究中进行测试，解决任何临床相关问题，重新设计其可制造性，并获得 FDA 510(k) 许可。