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

项目摘要 准确、独立、连续无创血压（cNIBP）的临床需求尚未得到满足 监视器.目前的非侵入性、基于臂袖带的闭合BP技术是不准确的，并且仅提供单一的- 点BP测量。在美国医院，每年有近4400万住院病人和手术。 需要BP监测的年份，但基于袖带的定期测量会导致监测缺口和较差的结果， 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 有创动脉内压（IAP）监测，但风险很大。除了重症监护和其他 在医院环境中，cNIBP技术在1.03亿美国高血压患者中有更广泛的应用， 中风和心脏病的主要原因心动过速的最初市场焦点是开发独立的cNIBP 替代IAP和臂袖带器械，用于重症监护室和手术室。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，ViTrack的优点包括：（1）连续测量BP的新方法， 袖带：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金标准听诊方法，其中医生 在单个时间点用臂袖带和听诊器（声音）直接测量收缩压和舒张压，但 ViTrack连续测量;（2）准确性：至少与黄金标准一样准确（3）新颖技术： 首创无袖带可穿戴技术;（4）多功能性：还可测量呼吸、心率等 血流动力学参数;以及（5）易于使用：用途：利用基于相机的光学机械传感器，其可以锁定 自动脉动，无需精确放置。在SBIR 1期临床前研究中，使用 全自动实验室原型，在大型和小型动物研究中，ViTrack将一对一（R2= 0.96）与 侵入性IAP。在80名门诊患者的广泛BP临床研究中，ViTrack符合FDA等同性 测量血压的标准，并在进一步的门诊研究中，连续可靠地测量逐搏血压， 证明了其作为独立cNIBP监测器的可行性。本“直接进入第二阶段”提案的目标是 根据ISO 13485设计控制完善当前原型以构建临床研究器械，然后进行评估 在人类受试者中的临床性能，以生产优化的商业可行ViTrack器械，用于 重症监护室这项研究的结果将使ViTrack成为第一个独立的可穿戴cNIBP 作为IAP的替代品，并启动下一阶段的资金，以构建生产等效的ViTrack手腕设备， 最终临床验证和FDA 510（k）许可的前奏。

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.