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