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:
  • 金额:
    $ 5.5万
  • 依托单位:
  • 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

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.
总结/摘要 在美国,每年有超过340,000名新生儿入住新生儿重症监护室(NICU)。 States.监测他们的动脉血压(BP),特别是早产低出生体重新生儿, 挑战性新生儿肱动脉袖带的准确性远低于成人,因为它 使用基于人口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, 在这些比率中统计上代表性不足,因此他们的BP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未能为 大约10%的患者在出生后双侧脐动脉受损或退化。为这些 患者没有其他选择。UAC也有很大的风险,包括血栓形成,血肿, 感染,甚至死亡。为了解决新生儿BP监测的未满足的临床需求,JB HealthTech,Inc. (JBH)正在开发一种高度准确的非侵入性BP监测仪neoBPTM,可在3种模式下运行。其 连续模式提供类似于UAC的高保真动脉BP波形,以导出动脉压, 呼吸率和一系列血液动力学参数。它的间歇模式提供了一个方便的BP快照 和心率,类似于OSC其周期性模式以预定义的运行/休息时间间隔运行, 之间的需要。neoBP基于体积箝位(VC)技术,这比其他技术更有优势。 技术,例如新生儿代表性不足的统计建模, 仅限安全气囊和无袖带设备,具体取决于每次使用时UAC或OSC的校准。使用一种新 封闭形式的理论框架,没有经验的元素,我们动态地建立患者特异性 压力-容积函数,解决了BP行业长期存在的误差问题。我们有 在原型上实施了创新算法,启动了初步的成人临床测试,并提交了四份 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。我们也有 与心脏病学家和心脏病学家合作,从他们的临床经验和见解中受益。与此 多元化、互补的团队,我们将推进我们的设备从原型到实践。我们在第一阶段的任务 SBIR项目包括硬件重新设计和严格的临床测试。我们将打造第二代 硬件和新生儿袖带,符合产品规范矩阵。我们还将验证 neoBP与标准治疗UAC进行比较,以证明其可行性。一项成功的比较研究, 新生儿重症监护室将是该项目进入第二阶段的里程碑。neoBP将是第一个高度准确的非 本研究为新生儿重症监护室(NICU)中有创血压监测提供了一种简单可靠的方法。与 准确性与UAC相当,neoBP将消除UAC相关并发症,并成为不可或缺的 是每个解剖学家的工具在第二阶段,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。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

Sharon X. Wang其他文献

Complete genome sequence of two chromosomes of Vibrio metoecus strain ZF102 isolated from the abdominal cavity of moribund laboratory zebrafish (Danio rerio)
从垂死实验室斑马鱼(斑马鱼)腹腔分离的气象弧菌菌株 ZF102 两条染色体的完整基因组序列
A new non-LTR retrotransposon provides evidence for multiple distinct site-specific elements in Crithidia fasciculata miniexon arrays.
一种新的非 LTR 逆转录转座子为 Crithidia fasciculata 微型外显子阵列中多个不同的位点特异性元件提供了证据。
  • DOI:
  • 发表时间:
    1995
  • 期刊:
  • 影响因子:
    14.9
  • 作者:
    Shu;Sharon X. Wang;Abram Gabriel
  • 通讯作者:
    Abram Gabriel
A Phenotypic Screen Identifies Calcium Overload as a Key Mechanism of β-Cell Glucolipotoxicity
表型筛选确定钙超载是 β 细胞糖脂毒性的关键机制
  • DOI:
  • 发表时间:
    2020
  • 期刊:
  • 影响因子:
    7.7
  • 作者:
    Jennifer Vogel;Jianning Yin;L. Su;Sharon X. Wang;Richard Zessis;S. Fowler;C. Chiu;Aaron C Wilson;Amy Y. Chen;F. Zécri;Gordon M Turner;Thomas M. Smith;Brian DeChristopher;Heming Xing;Deborah M. Rothman;Xinming Cai;Alina Berdichevsky
  • 通讯作者:
    Alina Berdichevsky
Inhibition of mTORC1 signaling in aged rats counteracts the decline in muscle mass and reverses multiple parameters of muscle signaling associated with sarcopenia
抑制老年大鼠的 mTORC1 信号传导可以抵消肌肉质量的下降,并逆转与肌肉减少症相关的肌肉信号传导的多个参数
  • DOI:
  • 发表时间:
    2019
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Giselle A. Joseph;Sharon X. Wang;Weihua Zhou;Garrett C. Kimble;H. Tse;J. Eash;T. Shavlakadze;D. Glass
  • 通讯作者:
    D. Glass
Complete genome sequences of Campylobacter jejuni subsp. jejuni strain P4549 isolated from an asymptomatic rhesus monkey (Macaca mulatta).
空肠弯曲杆菌亚种的完整基因组序列。

Sharon X. Wang的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了