SBIR Phase I: Low-cost needle guidance system for bedside lumbar puncture

SBIR 第一阶段：用于床边腰椎穿刺的低成本针引导系统

• 批准号: 1938039
• 负责人: Cassidy Wang
• 金额: $ 22.5万
• 依托单位: ETHOS MEDICAL, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-01-15 至 2020-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1938039&HistoricalAwards=false
• 关键词: SBIR; Phase; Low; cost; needle

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to improve the quality and efficiency of spinal access procedures by developing a needle guidance system that attaches to ultrasound machines. Lumbar punctures (LPs) are procedures used to diagnose and treat neurological conditions such as meningitis, multiple sclerosis and others. Without prompt intervention, meningitis infections can be fatal within days. During an LP, fluid must be collected from the center of the spine for diagnosis. The procedure can be challenging, costly, and time-consuming and is subject to practitioner experience and patient body type. Practitioners must manually feel for spinal landmarks at the skin surface to position the needle, then blindly insert into the spine. Up to 42% of procedures fail to access the target. In these cases, patients are referred to the Radiology department for an x-ray guided LP, which increases the cost of care, lengthens patient stay, and exposes the patient to radiation. The proposed research aims to develop a needle guidance system that enables spinal access procedures to be performed under real-time ultrasound imaging. By allowing providers to continuously monitor the needle’s trajectory, the proposed system can significantly improve first-attempt success rates.The proposed project aims to demonstrate the feasibility of a low-cost needle guidance system that interfaces with ultrasound equipment in bedside environments. Problems associated with LPs can be attributed to two primary causes: (1) the practitioner often cannot be certain of the target’s location and the needle’s trajectory; and (2) effective use of ultrasound imaging equipment as an alternative to the traditional blind technique relies on practitioner expertise in interpreting spinal ultrasound, which is rare in bedside settings. To remedy the first deficiency, the proposed system will consist of a needle-guiding attachment for an ultrasound probe and a software overlay that displays the needle’s trajectory on top of the ultrasound image. To address the barrier of ultrasound expertise, the software will also incorporate an anatomy recognition algorithm, displaying interpretable spine renderings corresponding to the imaged region. The proposed research will evaluate the needle trajectory prediction accuracy of the system in bench, cadaver, and live tissue models, ensuring minimal prediction error so the needle can consistently be guided to the target. Anatomy recognition software will be developed using images captured from the tissue models with the aim of correctly identifying important anatomical landmarks in at least 93% of cases.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响是通过开发连接到超声机的针引导系统来提高脊柱入路手术的质量和效率。腰椎穿刺（LP）是用于诊断和治疗神经系统疾病的程序，如脑膜炎，多发性硬化症等。如果不及时干预，脑膜炎感染可能在几天内致命。在LP期间，必须从脊柱中心收集液体以进行诊断。该手术可能具有挑战性，成本高，耗时长，并且受从业者经验和患者体型的影响。医生必须在皮肤表面手动感觉脊柱标志以定位针，然后盲目地插入脊柱。高达42%的过程无法访问目标。在这些情况下，患者被转诊到放射科进行X射线引导的LP，这增加了护理成本，延长了患者住院时间，并使患者暴露于辐射。拟议的研究旨在开发一种针引导系统，使脊柱进入程序下进行实时超声成像。通过允许供应商持续监测针的轨迹，拟议的系统可以显着提高首次尝试的成功率。拟议的项目旨在证明一个低成本的针引导系统，在床边环境中与超声设备接口的可行性。与LP相关的问题可归因于两个主要原因：（1）从业者通常不能确定目标的位置和针的轨迹;以及（2）有效使用超声成像设备作为传统盲法技术的替代方案依赖于从业者在解释脊柱超声方面的专业知识，这在床边设置中是罕见的。为了弥补第一个缺陷，所提出的系统将包括一个超声探头的针引导附件和一个在超声图像顶部显示针轨迹的软件覆盖。为了解决超声专业知识的障碍，该软件还将集成解剖识别算法，显示与成像区域对应的可解释的脊柱渲染图。拟议的研究将评估系统在工作台、尸体和活组织模型中的针轨迹预测准确性，确保预测误差最小，从而使针能够始终引导到目标。解剖识别软件将使用从组织模型中捕获的图像开发，目的是在至少93%的情况下正确识别重要的解剖标志。该奖项反映了NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。