SBIR Phase I: Novel Method To Quantitatively Assess Spinal Alignment Intraoperatively With Reduced Reliance On Radiation-Based Imaging

SBIR 第一阶段：术中定量评估脊柱排列的新方法，减少对放射成像的依赖

• 批准号: 1843816
• 负责人: Amir Soltanianzadeh
• 金额: $ 22.5万
• 依托单位: Spine Align LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1843816&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Method; Quantitatively

This SBIR Phase 1 project will advance technology to significantly improve the standard of care within corrective surgery for spinal deformity. Approximately 55,000 patients with spinal deformity seek improvement in their reduced quality of life through surgery each year in the US. The goal of these surgeries is to mechanically adjust and fix the spine into a biomechanically balanced position. It is common for surgeons to plan these intensive surgeries before the operation. However, the operating room environment introduces many challenges that make it difficult for the surgeon to measure the contour of the patient's spine as it changes during surgery. Current commercial offerings rely on radiation-based imaging which involves significant operative delays, ionizing radiation exposure, and narrow 2-dimensional fields of view. These suboptimal solutions contribute to the high rates of continued postoperative deformity along with the need for repeated surgeries. This project focuses on the development of imaging technology that will enable real-time, 3D, whole-spine assessments of a patient's spinal alignment with significant reduction in both time per alignment assessment and radiation exposure compared to current standards. By providing real-time, quantitative feedback to surgeons during these cases, the technology stands to greatly improve surgical outcomes and reduce the need for repeat operations. This project repurposes the functionality of an off-the-shelf optical tracking system by coupling it with novel hardware and software registration algorithms. When coupled with these enhancements, the camera system will enable rapidly-generated, quantitative measurements of a patient's spine while in the operating room. By leveraging technology that is already present in the majority of surgical centers, the path to commercialization for this innovation is greatly accelerated. This removes the need for most centers to purchase additional capital equipment, while also integrating seamlessly into a system that is familiar to many surgeons. The expansion of this high-precision technology will also enable more data-driven and patient-specific decisions to be made for a variety of surgeries The project is led by a multidisciplinary team of scientists, engineers, and world-class neurosurgeons with experience in translating medical devices into impactful commercial products. The aims within this project include the development of novel tracking-system augmentation hardware, image-analysis algorithms, optimization of accuracy via benchtop testing, and validation via testing with cadaveric specimens.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.

该SBIR第1阶段项目将推进技术，以显著提高脊柱畸形矫正手术的护理标准。在美国，每年约有55，000名脊柱畸形患者通过手术寻求改善其生活质量。这些手术的目的是机械调整和固定脊柱到生物力学平衡的位置。 外科医生在手术前计划这些密集的手术是很常见的。 然而，手术室环境引入了许多挑战，使得外科医生难以测量患者脊柱在手术期间变化的轮廓。 目前的商业产品依赖于基于辐射的成像，其涉及显著的手术延迟、电离辐射暴露和狭窄的二维视野。 这些次优解决方案导致术后畸形持续发生率高，沿着需要重复手术。该项目的重点是成像技术的开发，该技术将能够对患者的脊柱对线进行实时、3D、全脊柱评估，与当前标准相比，每次对线评估的时间和辐射暴露均显著减少。通过在这些病例中为外科医生提供实时、定量的反馈，该技术将大大改善手术效果，减少重复手术的需要。该项目通过将其与新颖的硬件和软件配准算法相结合来重新利用现成的光学跟踪系统的功能。 当与这些增强功能相结合时，相机系统将能够在手术室中快速生成患者脊柱的定量测量。 通过利用大多数外科中心已经存在的技术，这一创新的商业化道路大大加快。这消除了大多数中心购买额外资本设备的需要，同时还无缝集成到许多外科医生熟悉的系统中。这种高精度技术的扩展也将使更多的数据驱动和患者特定的决定，以作出各种手术该项目是由多学科团队的科学家，工程师和世界一流的神经外科医生在翻译医疗设备到有影响力的商业产品的经验。该项目的目标包括开发新型跟踪系统增强硬件、图像分析算法、通过台式测试优化精度以及通过尸体标本测试进行验证。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。