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

描述（由申请人提供）：硬膜外阻滞和相关脊髓麻醉手术的当前护理标准是手动触诊脊柱骨标志，然后进行“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。因此，首次通过故障发生在高 发生率（即40-80%），这导致麻醉不完全率增加，疼痛评分升高，患者满意度显著降低。健康并发症也会导致，包括：头痛，出血，背痛，高脊柱和瘫痪。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，“盲”方法仍然是护理标准。超声引导缺乏广泛接受主要是由于与骨结构的超声成像相关的技术挑战。几项研究表明，超声引导麻醉的实用性与用户熟悉程度密切相关，大多数麻醉师无法可靠地解释麻醉的效果。 脊柱解剖学使用当前的医学超声技术。 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猪腰椎模型中得到了证明。该第二阶段提案寻求资金，以支持继续开发用于肥胖患者神经轴向麻醉指导的低成本手持式医疗设备。该项目的关键技术创新集中在基于超声的骨可视化的改进上，并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，有助于肥胖患者的神经轴向麻醉，提高成功率，并降低相关健康并发症的风险。 第二阶段假设是，手持医疗成像设备和相关技术增加了首次尝试硬膜外麻醉的成功率，定义为在第一次针插入尝试时成功的硬膜外给药。将设计、制造和测试一种新的低通道数超声换能器设计，以改善骨成像性能。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，将在80例患者的临床研究中直接检验II期假设。据估计，美国每年进行2200万例硬膜外及相关手术，申报器械的美国市场规模估计为2.34亿美元/年。

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.