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.

项目摘要每年，神经科医生和紧急人员的诊断和治疗性腰部超过40万穿刺（LP）收集脑脊液（CSF），这是一种诊断和治疗的重要液体神经疾病和疾病。在标准护理下，LPS在住院环境中进行床头。该过程涉及导航一根长度可达14厘米的针头腰椎区域的窗户。医师面临精确，准确的导航和放置的挑战针对目标的针头。未能收集可行的样本和与程序有关的并发症可能导致误诊，治疗延迟，不必要甚至危险的程序。目前，平均水平 Buthyanian需要3次尝试正确放置针。该程序的相关故障率为约23.3％。在肥胖和肩co乱的患者中，故障率上升到50％超过脂肪组织和困难的解剖结构。未能收集CSF的领导透视指导的使用，这需要更长的时间，并受到病人的影响，并进行电离辐射。除荧光指导外，当前的护理标准不涉及使用局部超声等技术对组织的任何可视化。在此I阶段应用程序中，我们提出了一个带有患者锚定的超声补丁的导航系统将LPS从具有较高故障率的盲目程序转换为快速而简单的唱片。我们的解决方案解决了常规超声指导的典型缺点限制了其对LP的广泛采用。补丁超声挽救临床免于同时处理超声和针头，产生高对比度椎式途径的图像，并提供可靠的3D体积。带有增强的导航系统现实有助于临床在第一次尝试中成功实现目标。最重要的是，结合这些技术提供了我们称为主动针的可视化，超声的成像平面是受控以提供闭环系统中针的最佳视图。我们在此提议中的假设是补丁设计的简单性以及现成的导航组件的可用性与 Clear Guide的成熟导航平台承诺将适合临床应用的具有成本效益的解决方案手头。我们将通过以下目标实现我们的目标：（1）开发和整合患者锚定的超声成像补丁，具有清晰的指南医疗跟踪系统，（2）接口设计和融合进入平板电脑和头部安装显示（HMD），以及（3）准确性测量和用户数据收集。这这所学者（约翰·霍普金斯大学）和行业（明确的指南医学）合作的最终目标是安全，经济和有效开发的患者锚定超声贴片积极指导LP 程序。