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

这个SBIR第一阶段项目将推进技术进步，显著提高脊柱畸形矫正手术中的护理标准。在美国，每年约有55000名脊柱畸形患者通过手术寻求改善他们降低的生活质量。这些手术的目标是通过机械调整并将脊柱固定到生物力学平衡的位置。外科医生在手术前计划这些密集手术是很常见的。然而，手术室环境带来了许多挑战，使得外科医生很难测量患者脊柱在手术过程中发生变化时的轮廓。目前的商业产品依赖于基于辐射的成像，这涉及到显著的操作延迟、电离辐射暴露和狭窄的二维视场。这些不太理想的解决方案导致了术后持续畸形的高比率以及重复手术的需要。该项目专注于成像技术的开发，该技术将能够对患者的脊柱对齐进行实时、3D、全脊柱评估，与当前标准相比，每次对齐评估的时间和辐射暴露都大大减少。通过在这些情况下向外科医生提供实时、定量的反馈，该技术将极大地改善手术结果，减少重复手术的需要。该项目通过将现成的光学跟踪系统与新的硬件和软件配准算法相结合来改变其功能的用途。当与这些增强相结合时，摄像系统将能够在手术室中对患者的脊柱进行快速生成的定量测量。通过利用大多数外科中心已经存在的技术，这项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，同时还无缝地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还将使人们能够为各种手术做出更多由数据驱动的、针对患者的决定该项目由一个由科学家、工程师和世界级神经外科医生组成的多学科团队领导，他们在将医疗设备转化为有效的商业产品方面具有经验。该项目的目标包括开发新的跟踪系统增强硬件、图像分析算法、通过台式测试优化精度，以及通过身体样本测试进行验证。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.