SBIR Phase I: Tactile sensing for spinal-needle placements

SBIR第一阶段项目将开发一种创新的成像设备，将触觉传感应用于椎骨的表面检测，以帮助临床医生为美国每年进行的近1300万次诊断和治疗脊柱穿刺放置针头。护理标准包括背部的手动触诊，以估计用于针插入的椎骨间隙。这种技术非常不准确，通常需要多次尝试，这会导致疼痛和并发症，不可预测的手术时间，吞吐量差，以及转诊到放射科进行荧光透视引导的高比率。通过提供一种精确定位骨骼标志的方法，该项目将能够在更少的尝试中成功插入，从而改善临床结果并降低320万美元市场的成本，包括急诊医学，神经病学，麻醉学和疼痛医学。该设备还可以用于培训，减少鞘内药物临床测试中的错误;并可以通过为具有挑战性的病例提供替代的床边解决方案来增加程序访问。迄今为止，触觉成像仅在临床上应用于软组织评估。该项目将为这种低成本、无辐射的方式的推广使用铺平道路;可能取代触诊用于其他程序，如关节注射和胸腔穿刺术。该创新是第一个独立的临床触觉成像仪。它的成像子系统包括一个灵敏的高分辨率压力传感阵列，当脊椎标志被压在背部时，该阵列检测脊椎标志，并将它们作为2D压力图传送到集成显示器。该装置还包括一个新颖的针导，允许灵活和可靠的插入。在早期开发中已经验证了正间隙定位。该项目将首先通过表征导引器和可视化标志位置之间的关系，并通过开发一种机制来稳定器械以应对不可预测的腰椎弯曲，来确认相对于成像输出的准确插入。接下来，2D压力信息将演变成最佳鲁棒性和直观的图像。将开发高级算法来检测、跟踪和突出显示感兴趣的特征;并了解和预测病例中的器械使用。在每个阶段，该器械将在体模上进行测试，并通过麻醉患者的IRB测试。将在解剖结构变异中评价性能，并与标准治疗进行比较。由此产生的设备将被证明是一个全面的脊椎穿刺定位和插入解决方案的可行性，使其适合于进一步的开发和测试，以监管提交，并提供令人信服的证据，在第二阶段的持续优化。该奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。

This SBIR Phase I project will develop an innovative imaging device that applies tactile sensing to the surface detection of vertebrae to help clinicians place needles for the nearly 13 million diagnostic and therapeutic spinal punctures performed in the United States each year. The standard of care involves manual palpation of the back to estimate a vertebral gap for needle insertion. This technique is highly inaccurate, often requiring multiple attempts, which lead to pain and complications, unpredictable procedure times, poor throughput, and high rates of referrals to radiology for fluoroscopic guidance. By offering an accurate means of localizing bony landmarks, this project will enable successful insertion in fewer attempts, thereby improving clinical outcomes and reducing costs across the $3.2 million market, including emergency medicine, neurology, anesthesiology, and pain medicine. The device can also be introduced for training and to reduce errors in clinical testing of intrathecal drugs; and can increase procedure access by offering an alternative, bedside solution for challenging cases. To date, tactile imaging has only been applied clinically to soft-tissue evaluations. This project will pave the way for expanded use of this low-cost, non-radiative modality; to possibly replace palpation for other procedures, such as joint injections and thoracenteses.The innovation is the first standalone, clinical tactile imager. Its imaging subsystem comprises a sensitive, high-resolution pressure-sensing array, which detects vertebral landmarks when pressed against the back, and communicates them as a 2D pressure map to an integrated display. The device also includes a novel needle guide, which allows for flexible and reliable insertion. Positive gap localization has been verified in early development. This project will first confirm accurate insertion relative to imaging output by characterizing the relationship between guide and visualized-landmark locations, and by developing a mechanism to stabilize the device over unpredictable lumbar curvatures. Next, 2D pressure information will be evolved into an optimally robust and intuitive image. Advanced algorithms will be developed to detect, track, and highlight features of interest; and to understand and predict device use across cases. At each stage, the device will be tested on phantoms and through IRB testing on anesthesiology patients. Performance will be evaluated across anatomical variations, and compared with the standard of care. The resulting device will have demonstrated feasibility as a comprehensive spinal-puncture localization and insertion solution, rendering it suitable for further development and testing toward a regulatory submission, and providing compelling evidence for continued optimization in Phase II.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.