Wearable Cardiotocography System

可穿戴式心宫监护系统

• 批准号: 9170094
• 负责人: Rahul Singh
• 金额: $ 58.73万
• 依托单位: FARUS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-18 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9170094
• 关键词: Abdomen; Adhesions; Adhesives; Award; Birth trauma; Cardiotocography; Cardiovascular system; Caring; Chronic; Clinical; Clinical Research; Clinical Trials; Companions; Data; Development; Devices; Discipline of obstetrics; Effectiveness; Environment; Fatigue; Fetal Heart Rate; Fetal Monitoring; Freedom; Goals; Health; Incidence; Laboratories; Lead; Length; Malpractice; Measurement; Modeling; Monitor; Mothers; Movement; National Institute of Child Health and Human Development; Nurse Midwives; Nurse Practitioners; Output; Patient Care; Patients; Performance; Personal Satisfaction; Phase; Physicians; Pilot Projects; Positioning Attribute; Production; Provider; Recommendation; Reporting; Signal Transduction; Skin; Small Business Innovation Research Grant; Stress Tests; Surveys; System; Systems Integration; Technology; Telemetry; Testing; Time; Ultrasonic Transducer; Ultrasonography; United States National Institutes of Health; Uterine Contraction; Validation; Wireless Technology; base; commercialization; design; fetal; improved; innovation; intrapartum; operation; programs; prototype; research clinical testing; satisfaction

 DESCRIPTION (provided by applicant): Cardiotocography (CTG) provides safe and effective monitoring of fetal cardiovascular status before and during labor, and allows for more efficient utilization of dedicated patient care time provided by nurses, midwives, and physicians. However, current external fetal ultrasound transducers (US) and tocodynamometers (TOCO) are cumbersome in design and often produce false data due to loss of the fetal heart rate (FHR) signal, loss of the uterine contraction signal, and improper fit. The current model lacks freedom of maternal movement as it is rigid, requires minimally adjustable belts, and is tethered to a cart based CTG monitor. Simple movement of the laboring mother often causes signal interference, leading to gaps in data pertaining to fetal well-being, chronic repositioning of the external US and TOCO devices, and consequent alarm fatigue of the clinical staff. The high incidence of malpractice claims in obstetric care and the importance of CTG strips in birth injury liability claims further underscore the need for more reliable US and TOCO devices. Farus proposes to assess the feasibility of a vastly improved CTG system that features wearable US and TOCO devices. The wearable US and TOCO devices will be soft, conformal, adhere to the skin, and have wireless and belt-free operation. The improved devices will provide more reliable output of FHR and uterine contractions, independent of maternal movement or repositioning. The ultimate goals are to reduce the need for chronic repositioning of the US and TOCO, reduce the rate at which alarms are activated by false data or interference, and encourage freedom of maternal movement. The improved devices offer clinical staff the assurance of safe and effective CTG monitoring, while improving patient comfort and satisfaction. Further, a complete wireless telemetry system solution will be developed, improving maternal mobility that is currently limited by the length of wires connected to the CTG monitor. Together, these innovations will provide significant improvement over existing rigid and hard-wired devices, bettering patient care and the practice of nurses and practitioners involved in obstetric care. The hypothesis of the Fast-Track SBIR is that wearable US and TOCO devices can more consistently maintain the FHR and uterine contraction signals than standard devices, with improved signal quality and superior patient and clinician satisfaction. The goal of the Phase I SBIR effort is to build an alpha prototype of a wearable TOCO, integrate it with an accompanying wearable US and wireless base-station, and verify performance of the components and integrated system through benchtop laboratory tests and a pilot clinical study. The goal of the Phase II SBIR effort is to develop a refined beta prototype of the complete wearable CTG system, including a wearable US and TOCO, to validate its performance through antenatal and intrapartum clinical trials, and to perform regulatory testing. It is anticipated that the complete SBIR effort will lead to an FDA 510(k) application and commercialization of the technology.

 描述（由申请人提供）：分娩描记术（CTG）可在分娩前和分娩期间安全有效地监测胎儿心血管状态，并可更有效地利用护士、助产士和医生提供的专用患者护理时间。然而，目前的外部胎儿超声换能器（US）和分娩力计（TOCO）在设计上是麻烦的，并且由于胎儿心率（FHR）信号的丢失、子宫收缩信号的丢失以及不适当的配合而经常产生错误的数据。目前的模型缺乏产妇的运动自由，因为它是刚性的，需要最低限度的可调带，并拴在一个推车 基于CTG的监视器分娩母亲的简单移动通常会引起信号干扰，导致与胎儿健康相关的数据出现缺口，外部US和TOCO设备的长期重新定位，以及随之而来的临床工作人员的警报疲劳。产科护理中医疗事故索赔的高发生率以及CTG条在出生伤害责任索赔中的重要性进一步强调了对更可靠的US和TOCO器械的需求。Farus建议评估大幅改进CTG系统的可行性，该系统具有可穿戴US和TOCO设备。可穿戴US和TOCO设备将是柔软的，适形的，粘附在皮肤上，并且具有无线和无带操作。改进后的装置将提供更可靠的胎心率和子宫收缩输出，而不依赖于产妇的移动或重新定位。最终目标是减少US和TOCO长期重新定位的需要，降低错误数据或干扰激活警报的频率，并鼓励产妇自由移动。改进后的设备为临床工作人员提供了安全有效的CTG监测保证，同时提高了患者的舒适度和满意度。此外，还将开发一个完整的无线遥测系统解决方案，改善目前受连接到CTG监护仪的电线长度限制的产妇移动性。总之，这些创新将提供显着改善现有的刚性和硬连线设备，改善病人护理和护士和从业人员参与产科护理的做法。Fast-Track SBIR的假设是，与标准器械相比，可穿戴US和TOCO器械可以更一致地维持FHR和子宫收缩信号，改善信号质量，并获得上级患者和临床医生满意度。第一阶段SBIR工作的目标是构建可穿戴TOCO的alpha原型，将其与附带的可穿戴US和无线基站集成，并通过台式实验室测试和试点临床研究验证组件和集成系统的性能。第二阶段SBIR工作的目标是开发一个完整的可穿戴CTG系统的改进测试原型，包括可穿戴US和TOCO，通过产前和分娩期临床试验验证其性能，并进行监管测试。预计完整的SBIR工作将导致FDA 510（k）申请和该技术的商业化。