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

描述(申请人提供)：目前对硬膜外阻滞和相关的脊椎麻醉程序的护理标准是手动触诊脊柱骨标，然后“盲针”插入。然而，在肥胖人群中，据估计约占美国总人口的33%，脊柱地标被厚厚的脂肪层覆盖，用触诊无法检测到。因此，首次通过故障在高电平时发生 这会导致不完全麻醉的发生率增加，疼痛评分更高，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、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，而且“盲目”方法仍然是标准的护理方法。超声引导缺乏被广泛接受的主要原因是与骨骼结构的超声成像相关的技术挑战。一些研究表明，超声引导硬膜外麻醉的有效性与使用者的熟悉度密切相关，而且大多数麻醉师无法可靠地解释 使用现代医学超声技术进行脊柱解剖。在第一阶段项目中，低成本手持超声系统和新技术的可行性在体外全猪腰椎模型中得到了验证。这项第二阶段的提案寻求资金，以支持继续开发一种低成本的手持医疗设备，用于肥胖者的神经轴麻指导。该项目的关键技术创新集中在基于超声波的骨骼可视化的改进上，并包括一种新的脊柱成像方法，该方法能够自动检测脊柱标志物和针头注射部位。该项目的长期目标是展示一种便携式、低成本、基于超声波的医疗设备，该设备可以促进肥胖者的神经轴麻，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，手持医学成像设备和相关技术提高了肥胖者首次尝试硬膜外麻醉的成功率，即首次插入针头时成功的硬膜外给药。为提高骨成像性能，将设计、制造和测试一种新的低通道计数超声换能器。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，并在一项针对一系列身体质量指数(BMI)的临床研究中得到验证。最后，第二阶段假说将直接在80名患者的临床研究中得到验证。据估计，美国每年进行2200万例硬膜外及相关手术，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.