Intraoperative Imaging for Guidance, Patient Safety, and OR Quality Assurance

描述(由申请人提供)：医疗差错对美国人健康的影响是巨大的--或许令人惊讶--巨大的：外科医生每天大约8次在错误的身体部位进行手术；超过40%的手术患者会遇到某种形式的不良事件；综合起来，医疗差错是美国第六大主要死亡原因，每年给医疗保健系统造成数百亿美元的损失。由于手术室(OR)是此类差错的主要来源，在过去的十年中，人们越来越意识到并有动力使用新的手术工作流程、核对表、术前超时、OR中的扁平层次结构等来减少可预防的差错，但几乎没有证据表明趋势发生逆转。拟议中的研究将术中成像技术推向前台，特别是为了改善患者的安全性和OR质量保证(QA)。这些进展利用了过去十年图像引导手术中出现的一些相同的技术-例如，术中成像(用于高质量、低剂量3D成像的移动C臂)、图像配准(包括术中图像与术前图像和规划数据的3D-2D和3D-3D配准)以及图像重建(包括基于模型的3D图像重建方法，展示了诊断成像在图像质量和剂量减少方面的令人兴奋的进步)。在推动这种技术直接向患者安全和或质量保证挑战的过程中，我们意识到一种相对简单、低成本的形式可以很好地适合在广泛的手术中的主流使用(而不是限制在相当狭窄的范围内，尽管复杂和成本高，但要求越来越高的手术精度)。具体地说，我们提出了三项使能技术来提高手术的安全性：(1)首次在临床研究中部署的新的临床原型移动式C臂(“S1”)；(2)3-2D图像配准，以在单次拍摄透视或移动X光照片中直接自动定位手术靶点和设备轨迹；(3)基于模型的三维图像重建，能够实现高质量的低剂量锥束CT，并即使在有手术设备的情况下也能产生高质量的图像。这些技术通过遵循自然手术工作流程的4个具体目标应用于脊柱外科的主要挑战：(1)通过术中透视直接进行稳健的3D-2D注册来定位目标椎体；(2)在没有传统跟踪器的情况下通过3D-2D注册引导，并在整个手术过程中保持准确性；(3)在病例结束时使用高质量的移动式C臂锥束CT对手术产品进行定性验证，以验证手术产品并检测并发症和残留异物；以及(4)基于关节注册和重建的定量验证，以定量测量螺钉位置和检测椎弓根断裂。这项研究包括每项技术的开发、评估和转化，从实验室到第一次临床研究的安全性和可行性。

DESCRIPTION (provided by applicant): The toll of medical errors on the health of Americans is - perhaps surprisingly - enormous: approximately 8 times per day, surgeons operate on the wrong body part; over 40% of surgery patients meet with some form of adverse event; and taken together, medical errors constitute the sixth leading cause of death in the US and cost tens of billions of dollars per year to the healthcare system. With the operating room (OR) presenting a major source of such errors, the last decade saw a growing awareness and motivation to reduce preventable errors using new surgical workflow, checklists, preoperative time-outs, flat hierarchy in the OR, etc., but with little evidence to suggest a reversal of trends The proposed research brings intraoperative imaging technology to the fore motivated specifically to improve patient safety and OR quality assurance (QA). These advances leverage some of the same technologies emerging over the last decade for image-guided surgery - for example, intraoperative imaging (mobile C-arms for high-quality, low-dose 3D imaging), image registration (including 3D-2D and 3D-3D registration of intraoperative images with preoperative images and planning data), and image reconstruction (including model-based 3D image reconstruction methods demonstrating exciting advances in image quality and dose reduction in diagnostic imaging). In motivating such technology directly toward challenges of patient safety and OR QA, we realize a comparatively simple, low-cost form that could be well suited to mainstream utilization in a broad spectrum of surgeries (rather than limited to a fairly narrow scope of procedures requiring ever increasing levels of surgical precision despite complexity and cost). Specifically, we advance three enabling technologies to improve safety in the OR: (1) a new clinical prototype mobile C-arm ("S1") deployed for the first time in clinical studies; (2) 3-2D image registration to automatically localize the surgical target and device trajectories directl in single-shot fluoroscopy or mobile radiographs; and (3) model-based 3D image reconstruction enabling high-quality low-dose cone-beam CT and yield high-quality images even in the presence of surgical devices. These technologies are brought to bear on major challenges in spine surgery via 4 Specific Aims following natural surgical workflow: (1) Localization of target vertebrae by robust 3D-2D registration directly on intraoperative fluoroscopy; (2) Guidance by 3D-2D registration without conventional trackers and maintaining accuracy throughout the procedure; (3) Qualitative Verification of the surgical product using high-quality mobile C-arm cone-beam CT at the conclusion of the case to verify the surgical product and detect complications and retained foreign bodies; and (4) Quantitative Verification based on joint registration and reconstruction to quantitatively measure screw placement and detect pedicle breach. The research encompasses the development, evaluation, and translation of each technology from the laboratory to safety and feasibility in first clinical studies.