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.

抽象的 每年约有 175,000 例腿部和髋部骨折，最好的治疗方法是由骨科医生进行植入 将坚硬的金属棒或髓内 (IM) 钉穿过骨头中心，并用螺钉将钉子固定在骨头上 （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。 该手术使用 C 形臂透视进行引导，并使外科医生暴露在高辐射下。 病例数量（1 级和 2 级创伤中心），这导致近期研究的辐射暴露率更高。 已经证明，普遍持有的“暴露可以忽略不计”的观念是具有误导性的，并且大多数矫形外科 其次，手术需要很高的精确度，以避免低于标准。 理想的患者结果，例如肢体旋转不良，骨科多面手会遇到更多的对齐挑战。 该手术过程中的困难也会影响手术时间较长的患者， 额外的失血和增加的辐射暴露需要一种更快、更安全的方法来减少辐射。 Eclipse Orthopedics (EO) 是一家专注于改善内部疾病的初创公司。 基于专利技术，Eclipse Orthopedics 正在开发一种徒手瞄准的方法。 设备，即射线照相靶向附件™ (RTA)，它具有字面上的靶向和钻孔功能 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，与它配对时。 成像仪和钻头成为一种荧光镜引导钻头，可在一次操作中定位和钻孔。 目前正在开发这项技术，同时寻求与一家主要创伤供应商签订许可协议，该供应商将 在广泛的初步基础上，将 RTA 作为其内固定产品组合的一个组成部分进行营销。 通过 I-Corps 和 NIH 期间 100 多次客户访谈获得的数据和客户知识 利基评估，直接进入第二阶段的目标是完成广泛范围内的多地点研究 Direct to Phase II 项目是为了响应 FDA 的医疗器械而设计的。 设计控制指导文件的具体目标如下：（目标1）设计、构建和验证原型， 这会将辐射剂量减少到标准方法的一半以下（目标 2）验证有效性和 多地点尸体研究中的可用性（目标 3）开始设计控制、定义监管途径并改进 RTA 系统在 Direct 第二阶段结束时，Eclipse Orthopedics 将拥有关键系统。 绩效数据、目标用户评估中的人为因素见解以及明确的监管路径。 Eclipse 将在位于印第安纳州华沙的 EO 阶段制定全面的产品开发计划。 作为骨科创新和行业的中心，EO 将继续利用其行业关系。 探索领先的骨科器械制造商对许可的浓厚兴趣。