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

项目摘要/摘要 这个SBIR直达第二阶段的项目将推进我们术中定位的商业化 改善外周动脉硬化患者动脉粥样硬化血管可视化和导航的系统(IOPS) 血管疾病(PVD)，从而克服了二维X射线透视(“透视”)在外周的局限性 干预措施。我们的新产品采用了配准方法，将提高导航的精度 导管和导丝装置穿过狭窄或严重钙化的血管系统，并提供可视化 从角度和增强效果是荧光透视所不能实现的。这种方法不仅使运营商能够 在干预期间看得更好，但也极大地减少了接触有害电离的需要 对临床医生和患者都构成健康风险的辐射。重要的是，使这种新奇的水平 可视化将导致PVD治疗方式的潜在范式转变。在这项研究中，我们努力 演示新的IOPS功能以1)消除IOPS对锥束CT成像的依赖，同时 保持高跟踪精度，2)提供钙化血管的直观3D彩色可视化 改善手术体验和结果，以及3)减少所需的时间和辐射剂量 导航。最终，不受2D显示限制的非基于辐射的可视化将影响 通过减少对患者和/或工作人员的辐射，减少程序时间和成本，以及 减少手术和术后并发症。 Centerline Biomedical已投入大量公司资源来开发IOPS技术，这是 目前正在接受FDA对510(K)计划的审查。下一代产品IOPSxV建立在此基础上 平台和，已被证明具有可行性，为临床医生提供无与伦比的导航能力 通过血管，可能有复杂的钙化斑块，并正在扩张或变形。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 人体身体肢体模型中钙化和变形配准的数学模型。第二阶段 结果将证明，使用IOPSxV作为辅助并经荧光检查证实是安全和有效的 并且可以降低辐射剂量，同时对PVD患者的病变血管获得更好的成像， 为充分实现血管内介入治疗的临床和经济效益铺平道路。转换 这一产品的创新将扩大有资格接受微创PVD治疗的患者群体。 此外，通过降低组件成本和对复杂成像的依赖，通常只能在大型 混合手术套间，我们将使IOPS更实惠，更容易为农村人口所接受。 我们技术的商业化将影响到PVD以外的领域，包括许多新兴的血管， 心脏和神经程序，使更多的患者、护理人员受益，并使 在全球范围内提供更高质量的医疗保健。

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.!