Portable 3D ultrasound for bone fracture diagnosis in emergency medicine

描述(申请人提供)：尽管与不良的健康状况相关，美国90%的急诊科(ED)每周都会发生几次急诊科过度拥挤的情况。急症室过度挤迫的一个主要原因是对放射科服务(即X光)的需求很高，每年有720万名没有时间敏感性的疑似骨折患者依赖这种服务来诊断骨折。在美国，这项耗费时间和资源的任务每年造成的总财务影响估计超过19亿美元。在急诊科，超声已被广泛用于骨折诊断和治疗评估(即骨折复位)，但传统的骨解剖超声图像质量较差，视野有限，难以解释。这项第一阶段的SBIR建议寻求拨款，以测试便携式超声波3D骨骼成像设备(称为FractureFinder)的可行性，以诊断ED的骨骼骨折。该项目的主要技术创新包括一种新的基于活塞阵列的可整合3D成像换能器，该换能器在技术上比传统超声波先进，因为：减少了骨骼成像伪影，扩大了视野，并可适应患者皮肤表面的形状。此外，还介绍了一种先进的骨成像序列和重建方法，增强了骨表面的描绘。该项目的长期目标是创建一种紧凑、便携的基于超声波的3D骨骼成像系统，对骨折的灵敏度和特异性与数字X光相当。第一阶段的假设是，基于超声的3D骨成像设备可以在猪的体外胫腓骨骨折模型中实现与X射线同等的骨折检测性能。将制造一个功能性手持式超声原型，其中包含一个尺寸为&lt；25 cm x 20 cm x 6 cm的可整合换能器。骨成像重建技术将在模拟中开发，以在100°的骨骼角度上达到&lt；=200？m的分辨率和&gt；99%的灵敏度。成像技术和重建算法将在原型上实现，并在体外完整的猪胫腓骨模型上进行测试。第二阶段的研究计划包括一个经过改进的原型，带有工业设计和图形用户界面开发，目的是在弗吉尼亚大学医院进行体内试验研究。拟议的3D骨成像设备预计将加快急诊室骨折的诊断速度，从而在不使用宝贵的放射资源的情况下更快地治疗和患者出院。据估计，该设备每年可为医疗系统节省至少630万个ED小时和11.6亿美元。FractureFinder在美国完全饱和的急救医疗市场，每年的收入估计为1.2亿美元。该产品的其他应用包括农村保健、运动医学、战场和整形外科，后者在美国的市场估计已完全饱和，年销售额为2.09亿美元。

DESCRIPTION (provided by applicant): Despite being correlated to poor health outcomes, emergency department (ED) overcrowding occurs several times per week in 90% of all EDs in the US. A primary contributor to ED overcrowding is high demand for radiology services (i.e. X-rays), which are relied upon for diagnosis of bone fractures in 7.2 million non-time- sensitive suspected bone fracture patients per year. The total financial impact of this time and resource- consuming task is estimated at more than $1.9 B per year in the US. Ultrasound has been widely investigated as an alternative to X-ray for fracture diagnosis and assessment of treatment (i.e. fracture reduction) in the ED; however, conventional ultrasound image quality of bone anatomy is poor, has a limited field of view, and is challenging to interpret. This Phase I SBIR proposal seeks funding to test the feasibility of a portable ultrasound-based 3D bone imaging device, referred to as the FractureFinder, for diagnosis of bone fractures in the ED. Key technological innovations of this project include a new conformable, piston-array-based 3D imaging transducer that is technologically advanced over conventional ultrasound due to: reduced bone imaging artifact, increased field of view, and conformability to the shape of the patient's skin surface. Additionally, an advanced bone imaging sequence and reconstruction method is introduced that enhances delineation of bone surfaces. The long-term goal of this project is to create a compact, portable ultrasound-based 3D bone imaging system with sensitivity and specificity for bone fractures equivalent to that of digital X-ray. The Phase I hypothesis is that an ultrasound-based 3D bone imaging device can be fabricated to achieve equivalent fracture detection performance to X-ray in an ex vivo porcine tibia-fibula fracture model. A functional handheld ultrasound prototype incorporating a conformable transducer with dimensions < 25 cm x 20 cm x 6 cm will be fabricated. Bone imaging reconstruction techniques will be developed in simulation to achieve resolution <= 200 ¿m with sensitivity > 99% over bone angles spanning 100¿. The imaging techniques and reconstruction algorithms will be implemented on the prototype and tested in an ex vivo whole porcine tibia- fibula model. Research plans for Phase II include a refined prototype with industrial design and graphic user interface development for the purposes of conducting an in vivo pilot study at the University of Virginia Hospital. The proposed 3D bone imaging device is expected to speed diagnosis of bone fractures in the ED, allowing faster treatment and patient discharge without using valuable radiology resources. It is estimated that the device could save at least 6.3 million ED hours and $1.16 B to the healthcare system, annually. The fully saturated US emergency medicine market for the FractureFinder is estimated at $120 M in revenues per year. Additional applications for the product include rural healthcare, sports medicine, battlefield, and orthopedic, the latter of which has an estimated fully saturated US market of $209 M/yr.