Portable 3D ultrasound for bone fracture diagnosis in emergency medicine

描述（由申请人提供）：尽管与不良健康结果相关，但在美国90%的急诊科（ED）中，每周都会发生几次过度拥挤。急诊科人满为患的主要原因是对放射学服务（即x光）的高需求，每年有720万非时间敏感的疑似骨折患者依赖于x光诊断骨折。在美国，这项耗时耗力的任务造成的总财务影响估计每年超过19亿美元。超声已被广泛研究作为x射线的替代品，用于ED的骨折诊断和治疗评估（即骨折复位）；然而，传统的骨解剖超声图像质量差，视野有限，并且具有挑战性。第一阶段SBIR提案寻求资金来测试一种便携式超声3D骨成像设备的可行性，该设备被称为fracrefinder，用于诊断ED中的骨折。该项目的关键技术创新包括一种新型符合要求的、基于活塞阵列的3D成像换能器，该换能器在技术上比传统超声更先进，因为：减少骨成像伪影，增加视野，符合患者皮肤表面形状。此外，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骨成像系统，该系统对骨折的灵敏度和特异性与数字x射线相当。第一阶段的假设是，在猪胫骨-腓骨离体骨折模型中，可以制造一种基于超声的三维骨成像设备，以达到与x射线相当的骨折检测性能。将制造一个包含尺寸< 25 cm x 20 cm x 6 cm的合格换能器的功能手持式超声原型。骨成像重建技术将在模拟中开发，以实现分辨率<= 200¿m，灵敏度bbb99 %，骨角度跨越100¿。成像技术和重建算法将在原型上实现，并在离体全猪胫骨-腓骨模型上进行测试。第二阶段的研究计划包括一个具有工业设计和图形用户界面开发的精致原型，目的是在弗吉尼亚大学医院进行体内试点研究。提出的3D骨成像设备有望加快急诊科骨折的诊断，在不占用宝贵的放射学资源的情况下加快治疗和患者出院。据估计，该设备每年可以为医疗系统节省至少630万个急诊小时和11.6亿美元。美国急诊医疗市场对fracrefinder完全饱和，估计每年的收入为1.2亿美元。该产品的其他应用包括农村医疗保健，运动医学，战场和骨科，后者在美国市场估计达到2.09亿美元/年的完全饱和。

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.