Precision Freehand Sculptor

描述（由申请人提供）：成人重建骨科手术是一种重要的、不断增长的手术类型。微创手术（MIS）虽然具有挑战性，但对患者和医疗保健提供者有多种好处。Precision Freehand Sculptor（PFS）是一种用于实现MIS的手持式工具，可帮助外科医生在骨中准确切割预定形状。它提供了一层安全性和准确性，可以应用于一系列程序。 项目假设：PFS可以为患者和医疗保健行业提供MIS的优势，而不会影响准确性。 第二阶段的目标是： 1：确定PFS的理想跟踪模式-评估PFS使用电磁跟踪的可行性和相对优势。 第二章：证明PFS可用于使用MIS比传统手术更准确地进行UKR，而不会显著增加手术时间。 3：基于Aim 2试验反馈优化控制算法和用户界面 4：设计和构建OR兼容PFS -改进先前设计，以优化用于尸体和最终人体试验的新工具。 5：在尸体试验期间证明PFS在OR环境中的可行性-显示MIS PFS单髁膝关节置换术（UKR）的可行性。与标准技术相比，评价准确性、手术时间和手术室人体工程学。 一旦证明PFS在UKR中的可行性，它就可以应用于更广泛的骨科手术，增加器械的市场，同时通过为这种更广泛的应用提供通用解决方案，为医疗保健提供者提供进一步的节省。

DESCRIPTION (provided by applicant): Adult reconstructive orthopaedic procedures represent a significant, growing class of surgeries. Minimally invasive surgery (MIS), though challenging, has multiple benefits to the patient and healthcare providers. The Precision Freehand Sculptor (PFS), a handheld tool for enabling MIS, assists the surgeon in accurately cutting predetermined shapes in bone. It provides a layer of safety and accuracy and can be applied required over a range of procedures. Project Hypothesis: The PFS can provide the advantages of MIS to both patients and the healthcare industry without compromising accuracy. The Phase II Aims are: 1: Determine ideal tracking modality for PFS - Assess the viability and relative advantages of using electromagnetic tracking with the PFS. 2: Show that the PFS can be used to perform UKR more accurately using MIS than the conventional procedure, without adding significant time to the procedure. 3: Refine control algorithm and user interface based on Aim 2 trial feedback 4: Design and construct an OR-compatible PFS - Improve the prior design to optimize a new tool for used in cadaveric and eventual human trials. 5: Prove feasibility of PFS in the OR setting during cadaver trials - Show feasibility of an MIS PFS unicondylar knee replacement procedure (UKR). Evaluate accuracy, procedure time, and OR ergonomics compared to standard techniques. Once feasibility of the PFS is shown for UKR, it can be applied to a wider range of orthopaedic procedures, increasing the market for the device while providing further savings to the healthcare providers by providing a general solution to this broader range of applications.