Fluoroscopic drill attachment for orthopedic trauma surgery

摘要 对于每年约175，000例腿部和髋部骨折，最好的治疗方法是由整形外科医生植入 硬金属棒或髓内（IM）钉，穿过骨中心，并用螺钉将钉固定在骨上 （远端锁定）。远端锁定可能是困难且耗时的步骤，并且存在两个主要挑战。第一、 该手术使用C形臂荧光透视进行引导，并使外科医生暴露于辐射。对于高血压的外科医生 病例量（1级和2级创伤中心），这导致更高的辐射暴露率。最近的研究 已经证明，通常认为暴露可以忽略不计的观点是误导性的， 外科医生没有得到充分的保护。其次，程序要求精度高，避免小于 理想的患者结局，如肢体旋转不良。骨科通才面临的对齐挑战更多 这通常是由于较小的病例量。手术过程中的困难也会影响手术时间较长的患者， 失血过多和辐射暴露增加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 Orthopaedics（EO）是一家专注于改善内部 固定程序。基于专利技术，Eclipse Orthopaedics正在开发一种徒手瞄准 器械，即放射性定位附件™（RTA），它将定位和钻孔功能从字面上 在外科医生的手中。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在一次操作中定位和钻孔的荧光镜引导的钻头。eo是 目前正在开发这项技术，同时与一家主要的创伤供应商达成许可协议， 将RTA作为其内固定产品组合的组成部分进行营销。建立在广泛的初步 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 生态位评估，这直接到第二阶段的目标是完成一个多中心的研究中，广泛的 整形外科医生直接进入第二阶段项目的设计是为了响应FDA的医疗器械 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， 这将使辐射剂量减少到标准方法的一半以下。(Aim 2）验证有效性， 多中心尸体研究中的可用性。(Aim 3）开始设计控制，明确调控路径，完善 RTA系统。在直接进入第二阶段结束时，Eclipse骨科将拥有关键系统 性能数据、来自目标用户评估的人为因素洞察以及明确定义的监管路径。 Eclipse将在第IIB阶段规划全面的产品开发时间表。EO位于印第安纳州的华沙， 整形外科创新和产业的中心利用其行业关系，EO将继续 探索领先的骨科器械制造商对许可的高度兴趣。

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.