OsteoMark - A Navigation Aid for Orthognathic Surgical Procedures

OsteoMark - 正颌外科手术的导航辅助工具

• 批准号: 8092643
• 负责人: JOHN C MAGILL
• 金额: $ 58.08万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8092643
• 关键词: Algorithms; Anatomy; Anesthesia procedures; Animal Testing; Animals; Back; Biological Products; Biology; Bone Regeneration; Cadaver; Cicatrix; Clinical; Complex; Computer Graphics; Computer Simulation; Computer software; Computers; Conflict (Psychology); Data; Development; Devices; Endoscopy; Ensure; Equilibrium; Esthetics; Evaluation; FDA approved; Face; Family suidae; General Hospitals; Goals; Guidelines; Hand; Head; Healed; Hospitals; Human; Image; Image Analysis; Image-Guided Surgery; Ionizing radiation; Laboratories; Life; Location; Mandible; Marketing; Massachusetts; Medical; Medical Device; Medical Imaging; Miniature Swine; Modification; Motion; Natural regeneration; Notification; Operative Surgical Procedures; Oral Surgical Procedures; Osteotomy; Outcome; Pain; Patients; Phase; Procedures; Recovery; Research; Safety; Science; Series; Slice; Small Business Innovation Research Grant; Sterilization; Suction; Surgeon; Surgical Instruments; Surgical incisions; System; Techniques; Technology; Testing; Three-Dimensional Image; Time; Tissues; Woman; Work; X-Ray Computed Tomography; base; bone; commercialization; design; ergonomics; feeding; healing; image registration; improved; information display; instrument; minimally invasive; navigation aid; open source; operation; oral surgery specialty; orthognathic; patient safety; physical science; product development; programs; prototype; public health relevance; reconstruction; repaired; research and development; sample fixation; sensor; software development; tool; treatment planning; usability

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.

描述（由申请人提供）：成功完成了I期计划后，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牙性手术计划的工具。物理科学公司在马萨诸塞州综合医院的临床伴侣的口腔和上颌面外科部门的临床伴侣的支持下，领导着产品的开发，以及布里格姆和女子医院外科手术计划实验室的图像引导的手术专家。该设备可在内窥镜和开放程序中使用，以将基于计算机的3D手术计划工具的治疗计划转移到骨骼上。该系统将向患者提供图像的术中注册，不需要在术前图像中的基准标记，也没有附着在头部上的固定框架。外科医生将使用该痕迹指导骨骼的修饰，将骨骼，螺钉孔和对齐的骨骼标记为骨骼，螺钉孔和对齐，然后使用没有任何跟踪的仪器来完成过程。与在执行过程时跟踪多个手术仪器运动的系统相比，该设备将更便宜且不复杂。尽管计划在II阶段后期计划与FDA批准的商业计划进行集成，但仍开发了OsteomArk与开源医学成像软件片/骨器相互作用。在第一阶段，我们证明了在猪尸体上将治疗计划转移到下颌骨手术中的能力。在第二阶段，我们将完善系统组件和算法，在尸体上进行多个操作，然后对实时迷你游戏进行测试。 公共卫生相关性：微创手术在重建骨骼中越来越广泛地使用，因为它导致恢复时间更快，疼痛和不适感减少，而疤痕少于开放程序。最近的另一个进步是使用计算机图形工具来计划复杂的重建操作。我们建议开发一种设备，该设备将使外科医生甚至通过很小的切口将计算机治疗计划复制到骨骼，从而使外科医生能够执行更复杂的手术，而对患者的难度和改善的结果也更少。