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

心输出量（CO）是指每分钟泵出的血液量，其准确测量对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确定CO;然而，这些技术在准确性和适用性方面存在局限性。Deltex Medical（Deltex）目前制造了一种使用4 MHz超声食管多普勒监测仪（ODM）评估CO的领先技术。该技术是高度精确的，并已被广泛证明可以改善患者的预后。然而，探针被放置到食管中，这可能引发“呕吐反射”。因此，清醒患者对食管探针的耐受性不佳。为了解决这个问题，Deltex旨在开发一种基于多普勒超声的无创CO测量系统，可以无创地应用于胸骨上切迹。Deltex和竞争对手（USCOM）之前都采用了这种方法，使用可重复使用的探针，导致产品无菌性和高资本成本问题（见创新问题）。因此，Deltex计划使用一次性4 MHz探头开发胸骨上超声技术。这的主要附加优势是与公司现有的已安装显示器库兼容。该技术将主要针对手术和重症监护中使用的增强恢复计划，成功将减少住院时间和相关的健康成本，然后将CO测量扩展到新部门（例如心脏病学，A&E，运动医学等）。到目前为止，Deltex已经进行了一项试点研究，以确定最佳多普勒频率，解剖目标和开始验证技术参数，如头部尺寸和信号分辨率。随着预生产原型和临床试验的预期发展，Deltex预计5年内的累计销售额至少为1000万英镑。

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.