Ultrasound navigated spinal fusion surgery

2012年，仅在美国就进行了约130万例脊柱手术，其中53%是需要插入螺钉植入物的脊柱融合手术。由于脊柱的可见性有限、暴露区域持续出血以及形态变异性，这些螺钉的放置非常复杂。不幸的是，文献报告了令人担忧的高螺钉错位率（20-40%）。最令人担忧的是，螺钉放置不当可能会危及周围的重要结构。这可能导致潜在的患者瘫痪，医院诉讼以及医疗保健翻修手术的经济负担。确定最佳螺钉轨迹的一种潜在引导方法是使用实时超声成像：一种小型化超声器械，可插入椎弓根骨中心，以便从内部对解剖结构进行成像，从而识别骨边界。我们目前的技术开发目标是减少实践成像设备的非常新颖的设计，以帮助确保外科医生接受并与其工作流程顺利集成。我们的技术将是便携式的，负担得起的，从安全和成本的角度来看，将比X射线技术以及其他不提供真实的时间反馈的技术更有优势。据估计，通过降低翻修手术率，我们的成像设备每年可为美国医疗保健节省高达6亿美元的成本，相当于安大略省节省6000万美元。此外，它可以用于减少外科住院医生的培训时间，并可用于战场诊所，那里没有便携式成像。

In 2012, approximately 1.3 million cases of spine surgeries were performed in the United States alone, 53% of which consisted of spinal fusion surgeries necessitating insertion of screw implants. The placement of these screws is complex due to limited visibility of the spine, continuous bleeding in the exposed regions, and variability in morphology. Unfortunately, literature reports an alarmingly high rate of screw misplacements (20-40%). Of major concern is the fact that improperly placed screws could place the surrounding vital structures at risk. This could lead to potential patient paralysis, lawsuits for hospitals and the financial burden of revision surgeries for healthcare. A potential guidance method for determining the best screw trajectory is by using real-time ultrasound imaging: a miniaturized ultrasound device that can be inserted into the center of the pedicle bone in order to image the anatomy from within, for identification of bone boundaries. Our current technology development goals are to reduce to practice a very novel design for an imaging device to help ensure surgeon acceptance and smooth integration with their workflow. Our technology will be portable, affordable and will have advantage over X-ray technologies from a safety and cost standpoint, as well as with other technologies that do not provide real time feedback. It is estimated that through a reduction in the rate of revision surgeries, our imaging device could result in up to $600M of annual cost savings to the U.S. healthcare, an equivalent of $60M to Ontario. In addition, it could be used for reducing training time for surgical residents and could be used in battlefield clinics, where no portable imaging available.