Fluoroscopic drill attachment for orthopedic trauma surgery

用于骨科创伤手术的透视钻附件

• 批准号: 10819235
• 负责人: David Boyd Rich
• 金额: $ 91.88万
• 依托单位: ECLIPSE ORTHOPAEDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10819235
• 关键词: Affect; Agreement; Bite; Cadaver; Capital; Certification; Clinical Trials; Collaborations; Communities; Computers; Consumption; Data; Development; Device Designs; Devices; Distal; Effectiveness; Engineering; Evaluation; Feasibility Studies; Feedback; Femur; Fluoroscopy; Fracture; General Practitioners; Goals; Hand; Health; Hemorrhage; Hip Fractures; Human; Image; Implant; Indiana; Industry; Innovation Corps; Interview; Intramedullary Nailing; Knowledge; Learning; Leg; Legal patent; Licensing; Limb structure; Manufacturer; Marketing; Measurable; Measures; Medical; Medical Device; Medical Device Designs; Metals; Methods; Modeling; Nail plate; Operating Rooms; Operative Surgical Procedures; Orthopedic Procedures; Orthopedics; Patient-Focused Outcomes; Patients; Performance; Phase; Preparation; Procedures; Protocols documentation; Qualifying; Radiation; Radiation Dose Unit; Radiation exposure; Regulatory Pathway; Risk; Rod; Roentgen Rays; Safety; Schedule; Secure; Site; Small Business Innovation Research Grant; Source; Surgeon; System; Technology; Testing; Time; Trauma; United States National Institutes of Health; Veterans; Work; arm; bone; commercialization; design; design verification; experience; imager; implantation; improved; innovation; insight; interest; long bone; operation; product development; programs; prototype; radiological imaging; response; sample fixation; tibia; tool; trauma centers; trauma surgery; usability; wireless

Abstract For about 175,000 leg and hip fractures each year, the best treatment is for an orthopaedic surgeon to implant a stiff metal rod, or intramedullary (IM) nail, through the center of the bone and fix the nail to the bone with screws (distal locking). Distal locking can be difficult and time-consuming step and presents two major challenges. First, the procedure uses C-arm fluoroscopy for guidance and exposes surgeons to radiation. For surgeons with high case volumes (Level 1 and 2 trauma centers), this results in higher rates of radiation exposure. Recent studies have demonstrated that the commonly held notion that exposure is negligible is misleading and most orthopaedic surgeons are inadequately protected. Second, the procedure requires a high rate of precision to avoid less than ideal patient outcomes, such as limb malrotation. Orthopaedic generalists experience alignment challenges more often due to smaller case volumes. Difficulty during this procedure also affects patients with longer surgery times, additional blood loss and increased radiation exposure. A faster and safer method is needed to reduce radiation exposure and improve patient outcomes. Eclipse Orthopaedics (EO) is a startup focused on improving internal fixation procedures. Based on patented technology, Eclipse Orthopaedics is developing a freehand targeting device, the Radiographic Targeting Attachment™ (RTA) that puts both targeting and drilling capabilities literally in the surgeons’ hands. The RTA combines a small X-ray source and a drill attachment that, when paired with the imager and drill, becomes a fluoroscopically-guided drill that locates and drills holes in one operation. EO is currently developing this technology while pursuing a licensing agreement with a major trauma supplier, who will market the RTA as an integral part of their internal fixation product portfolio. Building off of extensive preliminary data as well as customer knowledge gained through over 100 customer interviews during I-Corps and an NIH Niche Assessment, the goal of this Direct to Phase II is to complete a multi-site study among a wide range of orthopaedic surgeons. The Direct to Phase II project has been designed in response to the FDA’s medical device design control guidance document. Specific Aims are as follows: (Aim 1) Design, build and verify prototype, which will reduce the radiation dose to less than half the standard method. (Aim 2) Verify effectiveness and usability in a multi-site cadaver study. (Aim 3) Begin design control, define regulatory pathway, and improve the RTA system. At the conclusion of the Direct to Phase II, Eclipse Orthopaedics will have the key system performance data, human factors insights from evaluations of target users, and a well-defined regulatory path. Eclipse will plan a comprehensive product development schedule in Phase IIB. EO is located in Warsaw, Indiana, an epicenter of orthopaedic innovation and industry. Leveraging its industry relationships, EO will continue to explore the already high interest in licensing from leading orthopedic device manufacturers.

摘要 每年约有17.5万人的腿部和髋部骨折，最好的治疗方法是由骨科医生植入 一根硬金属棒或髓内钉(IM钉)穿过骨头中心，用螺丝将钉子固定在骨头上 (远端锁定)。远端锁定可能是一个困难和耗时的步骤，并带来两个主要挑战。第一, 该手术使用C型臂透视进行指导，并将外科医生暴露在辐射下。对于兴奋的外科医生 病例数量(1级和2级创伤中心)，这会导致更高的辐射暴露率。最新研究 已经证明，通常认为暴露是可以忽略的概念是误导的，而且最具矫形外科的是 外科医生没有得到充分的保护。其次，该程序需要很高的精确率，以避免低于 理想的患者结果，如肢体旋转不良。矫形外科全科医生面临更多的对准挑战 通常是由于案件数量较小。手术过程中的困难也会影响到手术时间较长的患者， 额外的失血和更多的辐射暴露。需要一种更快更安全的方法来减少辐射。 暴露和改善患者的预后。Eclipse Orthopedics(EO)是一家初创公司，专注于改善内部 固定程序。基于专利技术，Eclipse Orthopedics正在开发一种徒手定位 设备，射线定位附件™(RTA)，将定位和钻探功能真正地实现 在外科医生手中。RTA结合了一个小型X射线源和一个钻头附件，当与 成像器和钻头变成了一种透视引导钻头，只需一次操作就可以定位和钻孔。EO是 目前正在开发这项技术，同时寻求与一家主要的创伤供应商达成许可协议，该供应商将 将RTA作为其内固定产品组合不可或缺的一部分进行营销。在广泛的初步工作的基础上 在I-Corps和NIH期间通过100多次客户访谈获得的数据和客户知识 利基评估，这一直达第二阶段的目标是在广泛的 整形外科医生。Direct to II项目是为了响应FDA的医疗设备而设计的 设计控制指导文件。具体目标如下：(目标1)设计、建造和验证原型， 这将把辐射剂量降低到标准方法的一半以下。(目标2)核实有效性和 在多地点身体研究中的可用性。(目标3)开始设计控制，定义调控途径，并改进 RTA系统。在直接到第二阶段的结束时，日食整形外科将拥有关键系统 绩效数据，对目标用户评估的人为因素洞察，以及定义明确的监管路径。 ECLIPSE将在第二阶段规划一个全面的产品开发时间表。EO位于印第安纳州华沙， 整形外科创新和产业的中心。利用其行业关系，EO将继续 探索领先的整形外科设备制造商对许可已经很感兴趣。