Wearable Cardiotocography System

 描述(由申请人提供)：胎心监护(CTG)可安全有效地监测分娩前和分娩期间胎儿的心血管状况，并允许更有效地利用护士、助产士和医生提供的专职患者护理时间。然而，目前的体外胎儿超声换能器(US)和产力计(TOCO)在设计上很麻烦，而且由于胎儿心率(FHR)信号的丢失、子宫收缩信号的丢失以及不合适的匹配，经常会产生错误的数据。目前的车型缺乏产妇行动的自由，因为它僵硬，需要最小限度地调整皮带，并被拴在手推车上 基于CTG的显示器。分娩母亲的简单移动往往会导致信号干扰，导致与胎儿健康相关的数据空白，外部US和TOCO设备的长期重新定位，以及由此导致的临床工作人员的警报疲劳。产科医疗事故索赔的高发生率以及CTG试条在出生伤害赔偿索赔中的重要性进一步突显了美国和TOCO设备更可靠的必要性。法鲁斯建议评估大幅改进的CTG系统的可行性，该系统采用可穿戴的US和Toco设备。可穿戴的US和Toco设备将是柔软的、适形的、附着在皮肤上的，并具有无线和无腰带操作。改进后的装置将提供更可靠的胎心率和子宫收缩输出，而不受产妇移动或重新定位的影响。最终目标是减少美国和Toco长期重新定位的需要，降低因虚假数据或干扰而触发警报的比率，并鼓励母亲自由流动。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，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监视器的电线长度限制的产妇流动性。总而言之，这些创新将对现有僵化和硬连接的设备提供重大改进，改善患者护理以及参与产科护理的护士和从业者的实践。Fast-Track SBIR的假设是，与标准设备相比，可穿戴US和Toco设备可以更一致地保持FHR和子宫收缩信号，信号质量更高，患者和临床医生的满意度更高。第一阶段SBIR工作的目标是构建可穿戴TOCO的阿尔法原型，将其与随附的可穿戴美国和无线基站集成，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工作的目标是开发完整的可穿戴CTG系统的改进Beta原型，包括可穿戴US和Toco，通过产前和产中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)的应用和该技术的商业化。

 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.