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

摘要/摘要 在美国，每年有超过34万名新生儿进入新生儿重症监护病房(NICU) 各州。监测他们的动脉血压(BP)，特别是早产低出生体重儿，可以 很有挑战性。示波测量仪(OSC)臂袖在新生儿中的准确性远低于成人，因为它 使用基于人群的比率得出收缩压和舒张压。血压较低的新生儿作为一个群体 这些比率在统计上没有得到充分的反映，因此他们的BP测量往往是错误的。标准 新生儿血压监测方法是经脐动脉导管(UAC)。然而，UAC未能为 约10%的患者出生后两条脐动脉受损或退化。为了这些 对于患者来说，没有其他选择。UAC还存在重大风险，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得到满足的临床需求，JB HealthTech，Inc. (JBH)正在开发一种高精度的非侵入性血压监测仪，可在三种模式下运行。它的 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， 呼吸频率和一套血流动力学参数。它的间歇模式提供了方便的BP快照 和心率，类似于OSC。它的周期模式以预定义的运行/休息时间间隔运行，适用于任何临床 需要介于两者之间。新BP基于体积钳(VC)技术，该技术比其他技术更具优势 技术，如统计建模，其中新生儿代表不足，较不准确的设备 仅限安全气囊，以及无袖带设备，取决于UAC或OSC对每种用途的校准。用一本小说 封闭形式的理论框架没有经验元素，我们动态地构建针对患者的 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 在原型上实现了创新的算法，启动了初步的成人临床测试，并提交了四个 美国专利申请。JBH在医疗器械开发方面拥有强大的工程专业知识。我们还有 与新生儿专家和心脏病专家合作，从他们的临床经验和见解中受益。有了这个 多样化、互补性的团队，我们将把我们的设备从原型推进到实践。我们在这一阶段的任务 SBIR项目包括硬件重新设计和严格的临床测试。我们将建造我们的第二代 硬件和新生儿袖口，符合产品规格矩阵。我们还将验证以下各项的准确性 NeBP对照UAC的护理标准来证明其可行性。一项成功的比较研究 NICU将是该项目进入第二阶段的里程碑。 NICU中的有创血压监测，为所有新生儿提供了一种简单可靠的血压测量方法。使用 准确度堪比UAC，新BP将消除UAC相关并发症，成为不可或缺的 在每个新生儿医生的医疗机构里都有工具。在第二阶段，我们将在多中心临床研究中进一步测试它， 解决任何临床相关问题，为可制造性重新设计，并通过FDA 510(K)认证。

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.