Pneumatic Drill and Robot for MRI-Guided Pediatrics Long Bone Biopsy

摘要 这项提议的总体目标是完成儿科患者骨活检的I期临床试验。 使用了我们之前工作中开发的新型磁共振安全机器人。该机器人将有助于精确的核磁共振制导 骨活检和启用新的临床工作流程，以减少采样和评估获得的组织的时间 可疑的骨骼损伤。我们的团队一直在开发与MRI兼容的小型机器人，以实现 精确的针头放置，不会对患者或医生造成辐射。在以前的工作中，我们 设计、制造和评估一种新型的磁共振安全导针机器人，以提供准确的病变靶向 在腿部的长骨上。该机器人由独特的气动步进马达驱动，完全是金属的。 而且没有电，这使得它可以在磁共振环境中工作，完全没有伪影。目标是 在我们的1.5T西门子Aera磁共振成像中使用长骨模型成功到达，平均3D误差为 1.39 mm，最大误差为1.89 mm。然后我们完成了对胫骨和股骨的腿部身体研究。这个 身体研究表明，需要开发一种核磁共振安全的钻头，这将是具体目标的重点1。我们将 在这些技术发展之后，在特定目标2中进行额外的身体研究，然后是监管 针对特定目标的20名儿科患者的批准和临床安全性和可行性试验3.我们的特定目标 目标是： 1.为我们的MRI-Safe机器人开发必要的新组件，特别是一个新的气动MRI Safe 骨活检钻和支撑/固定机构，用于将腿部固定到MRI工作台上。 2.完成额外的身体研究，以测试机器人、钻机和安装机制，并确认 提出了临床工作流程和集成系统的准确性。 3.获得监管部门对I期临床试验的批准，包括FDA和IRB的批准，然后是 应用核磁共振安全机器人和钻机对20例儿科患者进行骨活检的安全性和可行性临床试验。

ABSTRACT The overall goal of this proposal is to complete a Phase I clinical trial of bone biopsy in pediatric patients using the novel MRI safe robot developed in our previous work. This robot will facilitate accurate MRI-guided bone biopsy and enable a new clinical workflow to reduce time to sampling and evaluation of tissue obtained from suspicious bone lesions. Our team has been developing small footprint MRI compatible robots to enable precision needle placement without radiation exposure to the patient or physician. In previous work, we designed, built, and evaluated a novel MRI safe needle guidance robot to provide accurate targeting of lesions in the long bones of the leg. The robot is actuated by unique pneumatic stepper motors and is entirely metal and electricity free, which allows it to work in the MRI environment completely free of artifacts. Targets were successfully reached using a long bone mockup in our 1.5T Siemens Aera MRI with an average 3D error of 1.39 mm and maximum error of 1.89 mm. We then completed a leg cadaver study in the tibia and femur. The cadaver study showed the need to develop an MRI-safe drill, which will be the focus of Specific Aim 1. We will follow these technical developments with additional cadaver studies in Specific Aim 2, followed by regulatory approvals and a clinical safety and feasibility trial in 20 pediatric patients in Specific Aim 3.Our specific aims are to: 1. Develop essential new components for our MRI-safe robot, specifically a new pneumatic power MRI safe bone biopsy drill and a support/fixation mechanism for securing the leg to the MRI table. 2. Complete additional cadaver studies to test the robot, drill, and mounting mechanism and confirm the proposed clinical workflow and the accuracy of the integrated system. 3. Obtain regulatory approvals for the Phase I clinical trial including FDA and IRB approval, followed by a safety and feasibility clinical trial of bone biopsy on 20 pediatric subjects using the MRI-safe robot and drill.