Low-cost handheld medical device for neuroaxial anesthesia guidance in the obese

用于肥胖患者椎管内麻醉指导的低成本手持医疗设备

• 批准号: 8928612
• 负责人: Frank William Mauldin
• 金额: $ 55.58万
• 依托单位: RIVANNA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-18 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8928612
• 关键词: Absence of pain sensation; Adverse effects; Anatomy; Anesthesia procedures; Back Pain; Body mass index; Client satisfaction; Clinical; Clinical Research; Custom; Detection; Development; Devices; Epidural Anesthesia; Exhibits; Failure; Familiarity; Family suidae; Fatty acid glycerol esters; Funding; Goals; Growth; Headache; Health; Hematoma; Hemorrhage; Image; Imaging Device; Imaging technology; Injection of therapeutic agent; Knowledge; Manuals; Manufacturer Name; Marketing; Medical; Medical Device; Medical Imaging; Methods; Modeling; Needles; Noise; Obesity; Outcome; Pain; Palpation; Paralysed; Patient risk; Patients; Performance; Phase; Plant Roots; Population; Procedures; Risk; Scanning; Signal Transduction; Site; Spinal; Spinal Anesthesia; Structure; System; Techniques; Technology; Testing; Thick; Time; Tissues; Transducers; Ultrasonic Transducer; Ultrasonography; Validation; Vertebral column; Virginia; base; blind; bone; bone imaging; bone quality; bone visualization; commercial application; commercialization; cost; design; image reconstruction; imaging modality; improved; in vivo; innovation; instrument; new technology; novel; phase 1 study; reconstruction; simulation; standard of care; success; technological innovation; three-dimensional modeling

DESCRIPTION (provided by applicant): The current standard of care for epidural blockades and related spinal anesthesia procedures is manual palpation of spinal bone landmarks followed by "blind" needle insertion. However, in the obese segment of the population, estimated at approximately 33% of the total US population, spinal bone landmarks are covered with thick layers of fat and are not detectable with palpation. As a result, first-pass failures occur at high rates (i.e. 40-80%), which results in increased rates of incomplete anesthesia, higher pain scores, and significantly lower patient satisfaction. Health complications also result, including: headache, bleeding, back pain, high spinal, and paralysis. While recent studies have shown that ultrasound guidance can improve success rates, failure rates remain high and the "blind" method remains standard of care. The lack of widespread acceptance for ultrasound guidance is largely due to technical challenges associated with ultrasound imaging of bone structures. Several studies have demonstrated that the utility of ultrasound guided epidurals correlates strongly with user familiarity and that most anesthesiologists are unable to reliably interpret the spinal anatomy using current medical ultrasound technology. During the Phase I project, the feasibility of a low-cost, handheld ultrasound system and new technologies was demonstrated in an ex vivo whole pig lumbar spine model. This Phase II proposal seeks funding to support the continued development of a low-cost, handheld medical device for neuroaxial anesthesia guidance in the obese. The key technological innovations of this project are focused on improvements to ultrasound- based bone visualization and include a new spinal bone imaging approach that enables the automatic detection of spinal bone landmarks and needle injection site. The long-term goal of this project is to demonstrate a portable, low-cost, ultrasound-based medical device that facilitates neuroaxial anesthesia in the obese, improves success rates, and lowers the risk of associated health complications. The Phase II hypothesis is that the handheld medical imaging device and associated technologies increases first-attempt epidural anesthesia success rates, defined as successful epidural administration on the first needle insertion attempt, in the obese. A new low-channel count ultrasound transducer design for improved bone imaging performance will be designed, fabricated, and tested. In addition, ultrasound imaging technologies central to this project will be optimized, integrated into the new device, and validated in a clinical study across a range of body mass index (BMI). Finally, the Phase II hypothesis will be directly tested in an 80 patient clinical study. With an estimated 22 million epidural and related procedures performed in the US per year, the estimated US market size for the proposed device is $234 M/yr.

描述（由申请人提供）：目前硬膜外阻滞和相关脊髓麻醉程序的护理标准是手动触诊脊柱骨标志，然后“盲”针插入。然而，在肥胖人群中（估计约占美国总人口的 33%），脊柱骨标志被厚厚的脂肪层覆盖，触诊无法检测到。结果，首次通过失败发生在高 率（即 40-80%），这会导致麻醉不完全率增加、疼痛评分更高以及患者满意度显着降低。还会导致健康并发症，包括：头痛、出血、背痛、脊柱高位和瘫痪。虽然最近的研究表明超声引导可以提高成功率，但失败率仍然很高，并且“盲目”方法仍然是标准护理方法。超声引导缺乏广泛接受主要是由于与骨结构超声成像相关的技术挑战。多项研究表明，超声引导硬膜外麻醉的实用性与用户的熟悉程度密切相关，并且大多数麻醉师无法可靠地解释超声引导硬膜外麻醉的效果。 使用当前医学超声技术进行脊柱解剖学。 在第一阶段项目中，低成本手持式超声系统和新技术的可行性在离体整猪腰椎模型中得到了证明。该第二阶段提案寻求资金支持持续开发低成本手持式医疗设备，用于肥胖患者的神经轴麻醉指导。该项目的关键技术创新集中在基于超声的骨骼可视化的改进，包括一种新的脊柱骨成像方法，该方法能够自动检测脊柱骨标志和针注射部位。该项目的长期目标是展示一种便携式、低成本、基于超声的医疗设备，该设备有助于肥胖患者的神经轴麻醉，提高成功率，并降低相关健康并发症的风险。 第二阶段的假设是，手持式医学成像设备和相关技术提高了首次尝试硬膜外麻醉的成功率，定义为肥胖患者首次尝试插入硬膜外麻醉时的成功率。将设计、制造和测试一种新的低通道数超声换能器设计，以提高骨成像性能。此外，该项目的核心超声成像技术将得到优化，集成到新设备中，并在一系列体重指数（BMI）的临床研究中得到验证。最后，II 期假设将在 80 名患者的临床研究中直接得到检验。据估计，美国每年进行 2200 万例硬膜外麻醉及相关手术，因此该设备的美国市场规模预计为 2.34 亿美元/年。

项目成果

Feasibility of Spinal Anesthesia Placement Using Automated Interpretation of Lumbar Ultrasound Images: A Prospective Randomized Controlled Trial.

使用腰椎超声图像自动判读进行脊髓麻醉的可行性：一项前瞻性随机对照试验。

• DOI: 10.4172/2155-6148.1000878
• 发表时间: 2019
• 期刊: Journal of anesthesia & clinical research
• 作者: Singla,Priyanka;Dixon,AdamJ;Sheeran,JessicaL;Scalzo,David;MauldinJr,FrankW;Tiouririne,Mohamed
• 通讯作者: Tiouririne,Mohamed