IOPSxV: Novel Visualization for Non-Fluoroscopic 3D Image Guidance for Peripheral Vascular Interventions.

项目总结/摘要 该SBIR直接进入第二阶段项目将推进我们术中定位的商业化 系统（IOPS），用于改善外周动脉粥样硬化患者动脉粥样硬化血管的可视化和导航 血管疾病（PVD），从而克服了2D X射线荧光透视（“荧光”）在外周血管疾病中的局限性。 干预措施。我们的新产品采用配准方法，将提高导航的精度， 通过狭窄或严重钙化的脉管系统，并提供可视化 从透视无法实现的角度和增强。这种方法不仅使运营商能够 在干预期间看得更清楚，而且还大大减少了暴露于有害电离辐射的需要。 辐射对临床医生和患者都构成健康风险。重要的是，使这种新的水平， 可视化将导致PVD治疗方式的潜在范式转变。在这项研究中，我们奋进 展示新的IOPS功能，以1）消除IOPS对锥形束CT成像的依赖，同时 保持高跟踪精度，2）提供钙化血管的即时直观3D彩色可视化 增强手术经验和结果，以及3）减少手术所需的时间和辐射剂量。 导航最终，不受2D显示限制的非辐射可视化将影响 通过减少对患者和手术室工作人员的辐射，减少手术时间和成本， 减少手术和术后并发症。 Centerline Biomedical投入了大量的公司资源来开发IOPS技术， 目前正在接受FDA的510（k）批准审查。下一代产品IOPSxV基于此构建 平台，并已被证明具有为临床医生提供无与伦比的导航能力的可行性 通过可能具有复杂的钙化斑块并且膨胀或变形的血管。在第二阶段， 我们将优化配备传感器的微型导管和患者位置跟踪垫，并验证 人体尸体肢体模型中的钙化和变形配准数学模型。二期 结果将证明，使用IOPSxV作为辅助并经X线透视确认是安全有效的 并且可以降低辐射剂量，同时获得PVD患者中患病脉管系统的上级成像， 为实现血管内介入的全部临床和经济效益铺平了道路。转换 这种产品创新将扩大适合微创PVD治疗的患者群体。 此外，通过降低组件成本和对通常仅在大型医疗器械中发现的复杂成像的依赖， 混合手术套件，我们将使IOPS更负担得起，农村人口更容易获得。 我们技术的商业化将产生超越PVD的影响，包括许多新兴的血管， 心脏和神经系统手术，使更广泛的患者、护理人员受益， 在全球范围内提供更优质的医疗服务！

Project Summary/ Abstract This SBIR Direct to Phase II project will advance the commercialization of our Intra-Operative Positioning System (IOPS) to improve visualization and navigation of atherosclerotic vessels in patients with peripheral vascular disease (PVD), thereby overcoming limitations of 2D x-ray fluoroscopy (“fluoro”) in peripheral interventions. Our novel product employs registration methods that will increase precision of navigation of catheters and guidewires devices through narrow or heavily calcified vasculature and provide visualization from angles and with enhancement not achievable with fluoro. This approach not only enables operators to see better during an intervention, but also dramatically reduces the need for exposure to harmful ionizing radiation that poses health risks for both clinicians and patients. Importantly, enabling this novel level of visualization will lead to a potential paradigm shift in the way PVD is treated. In this study we endeavor to demonstrate new IOPS capabilities to 1) remove the IOPS dependency on cone beam CT imaging while maintaining high tracking accuracy, 2) provide immediately intuitive 3D color visualization of calcified vessels for enhanced surgical experience and outcomes, and 3) reduce the time and radiation dose required for navigation. Ultimately, non-radiation-based visualization that is not limited by a 2D display will impact healthcare by decreasing radiation to patients and OR staff, reducing procedure time and cost, and decreasing operative and postoperative complications. Centerline Biomedical has invested significant company resources to develop the IOPS technology, which is currently under FDA review for 510(k) clearance. The next generation product, IOPSxV, builds on this platform and, has been demonstrated to have feasibility to provide clinicians unparalleled ability to navigate through a blood vessel which may have complex calcified plaque and be distending or deforming. In Phase II, we will optimize miniaturized sensor-equipped catheters and patient position tracking pads, and validate the calcification and deformation registration mathematical models in the human cadaveric limb model. Phase II outcomes will demonstrate that use of IOPSxV as an adjunct to and confirmed by fluoro is safe and effective and can lower radiation dose, while obtaining superior imaging of diseased vasculature in PVD patients, paving the way to realizing the full clinical and economic benefits of endovascular interventions. Converting this innovation to a product will expand the patient population eligible for minimally-invasive PVD treatment. Additionally, by reducing component costs and dependence on complex imaging typically found only in large hybrid surgical suites, we will be making IOPS more affordable and accessible to rural populations. Commercialization of our technology will have implications beyond PVD, to include many emerging vascular, cardiac, and neurologic procedures to benefit a broader population of patients, caregivers, and enable delivery of better quality healthcare globally.!