Addressing Lumbar Puncture Challenges Using Patch Ultrasound and Augmented Reality

使用贴片超声和增强现实解决腰椎穿刺挑战

基本信息

批准号：
10258250
负责人：
Purnima Rajan
金额：
$ 31.19万
依托单位：
CLEAR GUIDE MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-05-01 至 2022-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10258250
关键词：
3-Dimensional 3D Print Address Adipose tissue Adoption Anatomy Animal Experiments Animals Attention Augmented Reality Automobile Driving Cerebrospinal Fluid Clinical Collaborations Dangerousness Data Collection Development Diagnosis Diagnostic Economics Environment Face Failure Feedback Freedom Future Goals Hand Image Industry Inpatients Institution Ionizing radiation Lead Length Liquid substance Measurement Medical Modeling Motion Navigation System Needles Neurologist Obesity Participant Pathway interactions Patients Performance Phase Physicians Positioning Attribute Procedures Puncture procedure Resolution Rotation Sampling Small Business Innovation Research Grant Spinal Puncture Structure System Tablets Technology Therapeutic Time Tissues Transducers Translations Ultrasonography Universities Update Validation Vertebral column Visualization base blind clinical application commercialization contrast imaging cost effective design emergency service responder experimental study head mounted display in vivo instrument nervous system disorder prototype real-time images spine bone structure standard care standard of care tool usability

项目摘要

PROJECT SUMMARY Every year, neurologists and emergency personnel perform over 400,000 diagnostic and therapeutic lumbar punctures (LP) to collect cerebrospinal fluid (CSF), a vital fluid in the diagnosis and treatment of a myriad of neurological diseases and disorders. Under standard care, LPs are performed in an inpatient environment at the bedside. The procedure involves navigating a needle that can be up to 14 cm in length into a 3-6 mm target window in the lumbar spine region. Physicians face the challenge of precise, accurate navigation and placement of the needle to the target. Failure to collect a viable sample and procedure-related complications can lead to misdiagnoses, treatment delays, and unnecessary and even dangerous procedures. Currently, the average physician takes 3 attempts to correctly place the needle. The associated failure rate of the procedure is ~23.3%. The failure rate rises to 50% in obese and scoliotic patients, for which the physician must navigate through excess adipose tissue and difficult anatomy. Failure to collect CSF leads the use of fluoroscopic guidance, which takes longer and subjects the patient and physician to ionizing radiation. Except for fluoroscopic guidance, the current standard of care does not involve any visualization of tissue using technology such as topical ultrasound. In this phase I application, we propose a navigation system featuring a patient-anchored ultrasound patch which transforms LPs from a blind procedure with high failure rate to a fast and simple one. Our solution addresses the typical shortcomings of regular ultrasound guidance which has limited its wide adoption for LPs. The patch ultrasound relieves the clinician from handling the ultrasound and needle simultaneously, yields high-contrast images of the vertebrae pathway, and provides a reliable 3D volume. The navigation system with augmented reality helps the clinician to successfully reach the target on the first try. Most importantly, the combination of these technologies offers what we call active needle visualization, where the imaging plane of the ultrasound is controlled to provide an optimal view of the needle in a closed-loop system. Our hypothesis in this proposal is that the simplicity of the patch design and the availability of off-the-shelf navigation components combined with Clear Guide’s matured navigation platform promises a cost-effective solution suitable for the clinical application at hand. We will achieve our goal through the following aims: (1) Develop and Integrate Patient-anchored Ultrasound Imaging Patch with Clear Guide Medical Tracking System, (2) Interface Design and Incorporation into a Tablet and head-mounted display (HMD), and (3) Accuracy Measurement and User Data Collection. The ultimate goal of this academic (Johns Hopkins University) and industry (Clear Guide Medical) collaboration is the safe, economic, and effective development of patient-anchored ultrasound patch to actively guide LP procedures.

项目概要每年，神经科医生和急救人员都会进行超过 400,000 次腰椎诊断和治疗穿刺（LP）收集脑脊液（CSF），脑脊液是诊断和治疗多种疾病的重要液体神经系统疾病和紊乱在标准护理下，LP 在医院的住院环境中进行。该手术涉及将长达 14 厘米的针刺入 3-6 毫米的目标。医生面临着腰椎区域的精确导航和定位的挑战。未能收集可行的样本和与手术相关的并发症可能会导致。目前，平均而言，误诊、治疗延误以及不必要甚至危险的手术。医生尝试 3 次才能正确放置针头，手术的相关失败率约为 23.3%。肥胖和脊柱侧弯患者的失败率高达 50%，医生必须解决这一问题过多的脂肪组织和困难的解剖结构导致无法收集脑脊液导致使用荧光镜引导。需要更长的时间并使患者和医生受到电离辐射除了荧光镜引导外，目前的护理标准不涉及使用局部超声等技术对组织进行任何可视化。在此一期应用中，我们提出了一种导航系统，其特点是患者锚定超声贴片将 LP 从高失败率的盲目程序转变为快速而简单的程序，我们的解决方案解决了这一问题。常规超声引导的典型缺点限制了其在腰椎间盘突出症中的广泛采用。超声波使临床医生无需同时操作超声波针，产生高对比度椎骨通路的图像，并提供可靠的 3D 体积增强导航系统。现实可以帮助临床医生在第一次尝试时成功达到目标。最重要的是，两者的结合。这些技术提供了我们所说的主动针可视化，其中超声波的成像平面是控制以提供闭环系统中针的最佳视图。我们在该提案中的假设是贴片设计的简单性和现成导航组件的可用性与 Clear Guide成熟的导航平台为临床应用提供了经济高效的解决方案我们将通过以下目标实现我们的目标： (1) 开发和整合以患者为中心的服务。具有清晰引导医疗跟踪系统的超声成像贴片，(2) 界面设计和整合集成到平板电脑和头戴式显示器 (HMD) 中，以及 (3) 精度测量和用户数据收集。这种学术（约翰霍普金斯大学）和工业（Clear Guide Medical）合作的最终目标是安全、经济、有效地开发患者锚定超声贴片以主动引导腰椎穿刺程序。