"Real Space" navigation - 3D topographical imaging for spinal surgery guidance

人体脊柱为脊髓提供保护，运动的灵活性和运动的结构支撑。 它也是我们身体受创伤，退化，癌症和其他疾病过程影响的关键部分，所有这些疾病都可以折磨我们人口中从儿童到老年患者的个体。在需要脊柱的硬件植入的手术中，外科医生面临着将螺钉插入脊柱而不对患者的脊髓和相邻动脉或静脉造成损伤的非常困难的任务。困难在于外科医生必须将螺钉深深地植入椎骨中，但只能看到骨的顶部，导致脊柱螺钉或植入物错位的可能性高达55%。因此，我们的创新包括用于手术导航的系统和方法，其可以提供椎骨的连续亚表面可视化，以在脊柱手术期间准确地引导医疗植入物的插入，而不使用额外的电离辐射。我们的外科医生和工程师团队设计、制造并测试了Alpha原型手术导航系统，该系统可提供连续的手术引导反馈。该第一阶段提案将允许我们的团队获得行业和外科医生驱动的数据，以创建临床前包，以吸引战略合作伙伴关系，继续开发该技术，以实现商业化的手术导航系统。

The human spine provides protection for the spinal cord, flexibility for motion, and structural support for movement. It is also a key part of our body affected by trauma, degeneration, cancer and other disease processes, all of which can afflict individuals ranging from children to elderly patients in our population. In surgeries that require hardware implantation of the spine, surgeons are faced with the very difficult task of inserting screws into the spine without causing damage to the spinal cord and adjacent arteries or veins of the patient. The difficulty lies in the fact that the surgeon must place the screws deep into the vertebrae, but can only visualize the top of the bone resulting in up to a 55% chance of misplaced spinal screws or implants. Therefore, our innovation includes a system and method for surgical navigation, which can provide continuous sub-surface visualization of the vertebrae to accurately guide the insertion of medical implants without the use of additional ionizing radiation during spinal procedures. Our team of surgeons and engineers have designed, fabricated and tested an Alpha prototype surgical navigation system that provides continuous surgical guidance feedback. This Phase I proposal will allow our team to acquire industry and surgeon driven data to create a pre-clinical package to attract strategic partnerships for the continued development of this technology towards a commercially available surgical navigation system.