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造成的损失可能令人惊讶地巨大：每天大约有8次，外科医生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；总的来说，医疗事故是美国第六大死亡原因，每年给医疗系统造成数百亿美元的损失。随着手术室（OR）成为此类错误的主要来源，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、检查清单、术前暂停、手术室的扁平分层等来减少可预防的错误，但几乎没有证据表明趋势发生了逆转。拟议的研究将术中成像技术带到了前台，专门用于提高患者安全和手术室质量保证（QA）。这些进步利用了过去十年中在图像引导手术中出现的一些相同技术，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计划数据的3D- 2d和3D-3D配准），和图像重建（包括基于模型的3D图像重建方法，展示了诊断成像中图像质量和剂量减少方面令人兴奋的进展）。在激励这种技术直接面对患者安全和手术室质量保证的挑战时，我们意识到一种相对简单、低成本的形式，可以很好地适应广泛手术的主流应用（而不是局限于相当狭窄的手术范围，尽管复杂和成本高，但需要不断提高手术精度）。具体来说，我们提出了三种使能技术来提高手术室的安全性：(1)首次在临床研究中部署的新型临床原型移动c型臂（“S1”）；(2) 3-2D图像配准，在单次透视或移动x线片中直接自动定位手术目标和器械轨迹；(3)基于模型的三维图像重建，实现高质量的低剂量锥束CT，即使在手术设备存在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流程的4个特定目标来应对脊柱外科的主要挑战：(1)通过在术中透视下直接进行强大的3D-2D注册来定位目标椎骨；(2)通过3D-2D注册指导，无需常规跟踪器，并在整个过程中保持准确性；(3)在病例结束时使用高质量的移动c臂锥束CT对手术产品进行定性验证，验证手术产品，发现并发症和残留异物；(4)基于关节配准和重建的定量验证，定量测量螺钉置入和检测椎弓根断裂。该研究包括从实验室到安全性和首次临床研究可行性的每项技术的开发、评估和转化。

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.