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。物理科学公司，在马萨诸塞州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，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手术计划工具转移到骨骼上。该系统将提供图像与患者的术中配准，无需术前图像中的基准标记，也无需将固定架连接到头部。外科医生将标记骨以进行截骨、螺孔和对线，然后使用无任何跟踪的工具完成手术，使用标记引导骨修改。所提出的设备将比在执行手术时跟踪多个手术器械的运动的系统更便宜且更简单。OsteoMark正在开发中，以与开源医学成像软件Slicer/Osteoplan进行交互，尽管计划在第二阶段后期与FDA批准的商业程序集成。在第一阶段，我们证明了在猪尸体的内窥镜手术中将治疗计划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，然后在活体小型猪上进行测试。 公共卫生相关性：微创手术越来越广泛地用于面部骨骼重建，因为它比开放手术恢复时间更快，疼痛和不适更少，疤痕更少。另一个最近的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，使外科医生能够通过非常小的切口将计算机治疗计划复制到骨骼上，从而使外科医生能够执行更复杂的手术，减少患者的困难并改善结果。

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.