OsteoMark - A Navigation Aid for Orthognathic Surgical Procedures

描述（由申请人提供）：在成功完成I期项目后，我们建议继续开发和演示OsteoMark，这是一种用于实施基于计算机的正颌手术计划的工具。在麻省总医院口腔颌面外科的临床合作伙伴和布里格姆妇女医院手术计划实验室的图像引导手术专家的支持下，物理科学公司领导了该产品的开发。该设备可用于内窥镜和开放式手术，将基于计算机的3D手术计划工具的治疗计划转移到骨骼上。该系统将为患者提供术中图像注册，不需要术前图像中的基准标记，也不需要头部固定框架。外科医生会在骨上做上标记，以便进行造口术、螺钉孔和对齐，然后在没有任何跟踪的情况下使用器械完成手术，用这些标记来指导骨的修改。与在手术过程中跟踪多个手术器械运动的系统相比，该设备将更便宜、更简单。OsteoMark是为了与开源医学成像软件Slicer/Osteoplan进行交互而开发的，尽管与fda批准的商业程序的集成计划在II期后期进行。在第一阶段，我们展示了在猪尸体的内窥镜手术中将治疗方案转移到下颌骨的能力。在第二阶段，我们将完善系统组件和算法，在尸体上进行几项操作，然后在活的迷你猪上进行测试。

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.