Development of a novel cuff-less wrist wearable continuous blood pressure monitor

项目总结 临床上对准确的、独立的、连续的无创血压(CNIBP)的需求尚未得到满足 监视器。目前基于手臂袖带的非侵入性、闭塞型BP技术不准确，仅提供单一的 点BP测量值。在美国医院，每年有近4400万例住院和手术 需要BP监测的一年，但定期的基于袖带的措施导致监测差距和较差的结果， 包括每年30万例可预防的心脏骤停。在医院，可以实现连续的血压监测 有创性动脉内压(IAP)监测，但风险很大。除了重症监护和其他 医院设置，cNIBP技术在1.03亿美国高血压患者中有更广泛的应用 中风和心脏病发作的主要原因。心动过速的最初市场重点是开发独立的cNIBP 用于重症监护病房和手术室的基于IAP和ARM袖带的设备的替代方案。心动过速 ViTrack®是第一款用于cNIBP监测的独立、无袖带手腕可穿戴设备。与其他cNIBP相比 技术方面，ViTrack的优势包括：(1)无创连续测量血压的新方法 袖口：ViTrack使用皮肤力/位移信息提供直接、连续的收缩压测量 和舒张压。这种方法类似于黄金标准听诊法，在这种方法中，医生 在单个时间点使用臂套和听诊器(声音)直接测量收缩压和舒张压，但 ViTrack连续测量；(2)精度：至少与黄金标准一样准确(3)新技术： 首创无袖口可穿戴技术；(4)多功能性：还可测量呼吸、心率等 血流动力学参数；和(5)易用性：采用基于相机的光学机械传感器，可以锁定 自动脉动，无需精确放置。在SBIR类1期临床前研究中，使用 全自动化实验室原型，在大小动物研究中，ViTrack一对一(R2=0.96)与 侵袭性IAP。在对80名门诊患者进行的广泛BP的临床研究中，ViTrack达到了FDA的等效性 测量血压的标准和在进一步的门诊研究中，可靠地连续测量逐次血压， 论证了其作为独立cNIBP监测仪的可行性。这项直接到第二阶段的提案的目标是 根据ISO13485设计控制改进当前原型以构建临床研究设备，然后评估 在人类受试者中的临床表现，以生产优化的商业上可行的ViTrack设备用于 重症监护设置。这项研究的结果将使ViTrack成为第一款独立的、可穿戴的cNIBP 替代IAP并支持下一阶段资金，以制造相当于生产的ViTrack手腕设备，作为 最终临床验证和FDA 510(K)批准的前奏。

PROJECT SUMMARY There is an unmet clinical need for an accurate, standalone, continuous non-invasive blood pressure (cNIBP) monitor. Current non-invasive, occlusive arm cuff-based BP technologies are inaccurate and provide only single- point BP measurements. In US hospitals, there are close to 44 million in-patient admissions and surgeries per year that require BP monitoring, but periodic cuff-based measures lead to monitoring gaps and poorer outcomes, including 300,000 preventable cardiac arrests per year. In hospitals, continuous BP monitoring can be achieved with invasive intra-arterial pressure (IAP) monitoring, but with significant risks. Apart from critical care and other hospital settings, cNIBP technology has broader application in 103 million Americans with hypertension, a leading cause of stroke and heart attacks. Initial market focus for Dynocardia is to develop standalone cNIBP alternative to IAP and arm cuff-based devices for use in intensive care units and operating rooms. Dynocardia’s ViTrack® is the first standalone, cuff-less, wrist wearable device for cNIBP monitoring. Compared to other cNIBP technologies, the advantages of ViTrack include: (1) New method for continuous measurement of BP without a cuff: ViTrack uses skin force/displacement information to provide a direct, continuous measurement of systolic and diastolic BP. This method is analogous to the gold standard auscultatory method in which the physician measures systolic and diastolic BP directly with an arm cuff and stethoscope (sound) at a single time point, but ViTrack measures continuously; (2) Accuracy: At least as accurate as the gold standard (3) Novel Technology: First-of-its-kind cuff-less, wearable technology; (4) Versatility: Also measures respiratory, heart rate other hemodynamic parameters; and (5) Ease of Use: Utilizes a camera-based optomechanical sensor that can lock pulsation automatically without need for precise placement. In SBIR Phase 1-like preclinical studies, using the fully automated lab prototype, in large and small animal studies, ViTrack correlated one-to one (R2= 0.96) with invasive IAP. In clinical studies of 80 outpatients over a wide range of BPs, ViTrack met FDA equivalency standards for measuring BP and in further outpatient studies, continuously measured beat-to-beat BP reliably, demonstrating its feasibility as a standalone cNIBP monitor. The goal of this Direct to Phase II proposal is to refine the current prototype to build clinical study devices as per ISO13485 design controls and then assess clinical performance in human subjects to produce an optimized commercially viable ViTrack device for use in critical care settings. The outcome of this study will establish ViTrack as the first standalone, wearable cNIBP alternate to IAP and enable next phase funding to build the production equivalent ViTrack wrist devices, as a prelude to final clinical validation and FDA 510(k) clearance.