OsteoMark - A Navigation Aid for Orthognathic Surgical Procedures

描述(由申请人提供)：在成功完成第一阶段计划后，我们建议继续开发和演示OsteoMark，这是一种用于实施正颌外科计算机计划的工具。在马萨诸塞州总医院口腔和颌面外科的临床合作伙伴以及布里格姆妇女医院外科规划实验室的图像引导外科专家的支持下，物理科学公司正在领导该产品的开发。该设备可用于内窥镜和开放手术，将治疗计划从基于计算机的3D外科计划工具转移到骨骼上。该系统将为患者提供术中图像配准，不需要在术前图像中使用基准标记，也不需要固定框架连接到头部。外科医生将对骨骼进行截骨、螺丝孔和对齐标记，然后在没有任何跟踪的情况下使用器械完成手术，使用这些标记来指导骨骼的修改。与在手术过程中跟踪多台手术器械运动的系统相比，拟议的设备将更便宜、更复杂。OsteoMark正在开发中，以与开源医学成像软件Slicer/Osteoplan进行交互，尽管与FDA批准的商业程序的集成计划计划在第二阶段后期进行。在第一阶段，我们在猪身体的内窥镜手术中展示了将治疗计划转移到下颌的能力。在第二阶段，我们将完善系统组件和算法，在身体上进行几次手术，然后在活体小型猪上进行测试。 公共卫生相关性：微创手术正越来越广泛地应用于面部骨骼重建，因为它比开放手术恢复时间更快，疼痛和不适更少，疤痕也更少。最近的另一项进步是使用计算机图形工具来规划复杂的重建操作。我们建议开发一种设备，使外科医生能够将计算机治疗计划复制到骨骼上，即使是通过一个非常小的切口，使外科医生能够执行更复杂的程序，而患者的难度更小，结果更好。

DESCRIPTION (provided by applicant): Having successfully completed a Phase I program, we propose to continue the development and demonstration of OsteoMark, a tool for implementing computer-based plans for orthognathic surgery. Physical Sciences Inc., is leading the development of the product with support from our clinical partners in the Dept of Oral and Maxillofacial Surgery at the Massachusetts General Hospital and image-guided surgery experts in the Surgical Planning Laboratory at Brigham and Women's Hospital. The device can be used in both endoscopic and open procedures to transfer treatment plans from computer-based 3D surgical planning tools onto the bone. The system will provide for intraoperative registration of the image to the patient, with no requirement for fiducial markers in the pre-operative images and no fixation frame attached to the head. The surgeon will mark the bone for ostotomies, screw holes, and alignment, and then complete the procedure using instruments without any tracking, using the marks to guide the modification of bone. The proposed device will be less expensive and less complex than a system that tracks the motion of multiple surgical instruments as procedures are performed. OsteoMark is being developed to interact with the open-source medical imaging software Slicer/Osteoplan, though integration with an FDA-approved commercial program is planned for late in Phase II. In Phase I, we demonstrated the ability to transfer treatment plans to the mandible in endoscopic surgery on a pig cadaver. In Phase II, we will refine the system components and algorithms, carry out several operations on cadavers, and then perform tests on live minipigs. PUBLIC HEALTH RELEVANCE: Minimally-invasive surgery is becoming more widely used in reconstruction of bones in the face because it results in faster recovery times, less pain and discomfort, and less scarring than open procedures. Another recent advancement has been the use of computer graphics tools to plan complex reconstruction operations. We are proposing to develop a device that will enable surgeons to copy computer treatment plans to the bone even through a very small incision, allowing surgeons to perform more sophisticated procedures with less difficulty for the patient and improved outcomes.