Development of a 4Mhz suprasternal Doppler probe for cardiac output measurement

开发用于心输出量测量的 4Mhz 胸骨上多普勒探头

• 批准号: 720663
• 金额: $ 21.47万
• 依托单位: DELTEX MEDICAL LIMITED
• 依托单位国家: 英国
• 项目类别: GRD Development of Prototype
• 财政年份: 2015
• 资助国家: 英国
• 起止时间: 2015 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=720663
• 关键词: Development; 4Mhz; suprasternal; Doppler; probe

The accurate measurement of Cardiac Output (CO), the volume of blood pumped/min, iscritical for clinicians to assess cardiovascular function & fluid status. Several invasive & noninvasive techniques are currently available to determine CO; however these possesslimitations with accuracy & suitability for use in all patient types. Deltex Medical (Deltex)currently manufactures a leading technology to assess CO using a 4MHz ultrasoundOesophageal Doppler Monitor (ODM). The technology is highly precise & has been widelydemonstrated to improve patient outcome. However the probe is placed into the oesophaguswhich can initiate a ‘gag reflex’. The oesophageal probe is therefore not well tolerated inawake patients. To address this issue, Deltex aims to develop a non invasive CO measurementsystem based on Doppler ultrasound that can be applied non-invasively at the suprasternalnotch. Such an approach has been adopted previously by both Deltex & a competitor(USCOM) using a reusable probe, resulting in issues with product sterility & high capitalcosts (see innovation question). Therefore, Deltex intends to develop the suprasternalultrasound technique using a disposable 4 MHz probe. This has the major added advantage ofbeing compatible with the company’s existing installed monitor base. The technology willinitially be targeted towards the Enhanced Recovery Programme used in surgery, & inintensive care, where success will reduce the length of hospital stay & associated healthcarecosts, & then extend CO measurement for use in new departments (e.g. cardiology, A&E,sports medicine, etc.). To date, Deltex has undertaken a pilot study to identify the optimalDoppler frequency, anatomical targets & begin verification of technical parameters such ashead size & signal resolution. With the intended development of the pre-production prototype& a clinical trial, Deltex expects accumulated sales of at least £10M over 5yrs.

准确测量心输出量（CO），即泵血量/分钟，对于临床医生评估心血管功能和体液状态至关重要。目前有几种侵入性和非侵入性技术可用于测定CO；然而，这些在所有患者类型中使用的准确性和适用性方面存在局限性。Deltex Medical （Deltex）目前生产一种领先的技术，使用4MHz超声食管多普勒监测器（ODM）来评估CO。该技术高度精确，并已被广泛证明可以改善患者的预后。然而，探针被放置在食道中会引发“呕吐反射”。因此，在清醒的患者中，食道探头的耐受性不佳。为了解决这一问题，Deltex旨在开发一种基于多普勒超声的非侵入性CO测量系统，该系统可用于胸骨上切迹的非侵入性测量。Deltex及其竞争对手（USCOM）之前采用了这种方法，使用可重复使用的探针，导致产品无菌和高资本成本的问题（参见创新问题）。因此，Deltex打算开发使用一次性4mhz探头的胸骨上超声技术。这具有与公司现有安装的监视器库兼容的主要附加优势。该技术最初将针对外科和重症监护中使用的增强恢复计划，在这些计划中，成功将减少住院时间和相关的医疗保健成本，然后将CO测量扩展到新的部门（例如心脏病学，急症室，运动医学等）。迄今为止，Deltex已经进行了一项试点研究，以确定最佳的多普勒频率、解剖目标，并开始验证诸如头部尺寸和信号分辨率等技术参数。随着预生产原型和临床试验的预期发展，Deltex预计在5年内累计销售额至少为1000万英镑。