Reopening the Central Airway With Needle-Size Tentacle Manipulators

项目概要/摘要： 本提案的目的是创造一种新的外科手术装置，其在刚性外科手术装置的尖端提供灵活性。 支气管镜我们的新系统将通过支气管镜端口提供针头大小的触手状臂， 实现独立的组织操作，激光纤维瞄准和可视化，我们假设这将使 中心气道阻塞手术更安全、更有效、更高效。 临床意义来自于大量受中央气道阻塞影响的患者- 仅在美国每年就有超过80，000例新诊断[13，15] -以及个体患者的严重程度， 因为缺乏足够气道是致命的。现有的手术方法具有挑战性，因为器械 通过刚性支气管镜端口展开缺乏侧向灵活性， 支气管镜，它对病人的颈部和牙齿施加很大的力。32%的患者 并发症包括牙齿折断，颈椎损伤，出血，甚至死亡。 创新来自于利用弯曲管道的弹性相互作用来创造可以弯曲的微型操纵器 并且伸长。这些操纵器足够小，可以通过现有临床支气管镜中的端口 以在其尖端提供类似触手的灵活性，并且比当前商业外科手术器械小一个数量级， 机械手我们提出的系统也将是第一个为中央气道设计的机器人系统 梗阻手术因为它的机械和电子元件比现在的要少得多， 商业手术机器人，我们的最终产品有可能是一个数量级便宜，而 仍然为我们公司提供健康的收入来源和利润率。 我们的目标1是设计一个可制造的，手术室准备的机器人系统，包括驱动 组件和模块化一次性器械，并完成FDA生物相容性测试。目标2重点 通过FDA人为因素测试过程对用户界面控件映射和确认进行了验证。在目标3中， 我们通过实验验证了整个系统，定量比较了外科医生的表现与我们的机器人 目前的护理标准。该项目的成果是（1）手术室准备机器人 系统，（2）完成510（k）批准所需的FDA生物相容性和人为因素测试，以及 (3)在尸体中收集的定量实验数据表明，我们的系统使中央 气道阻塞手术更安全、更有效、更高效。

Project Summary/Abstract: The objective of this proposal is to create a new surgical device that provides dexterity at the tip of a rigid bronchoscope. Our new system will deliver needle-sized, tentacle-like arms through the bronchoscope port, enabling independent tissue manipulation, laser fiber aiming, and visualization, which we hypothesize will make central airway obstruction surgery safer, more effective, and more efficient. Clinical significance comes from the large number of patients affected by central airway obstruction – There are over 80,000 new diagnoses per year in the USA alone [13, 15] – as well as the severity for individual patients, since lack of an adequate airway is fatal. Existing surgical approaches are challenging because instruments deployed through rigid bronchoscope ports lack lateral dexterity, and can only be aimed by tilting the entire bronchoscope, which applies large forces on the patient's neck and teeth. Consequently, 32% of patients have complications including broken teeth, cervical spine injury, hemorrhage, and even death. Innovation comes from using elastic interactions of curved tubes to create miniature manipulators that can bend and elongate. These manipulators are small enough to pass through the port in an existing clinical bronchoscope to provide tentacle-like dexterity at its tip, and are an order of magnitude smaller than current commercial surgical robot manipulators. The system we propose will also be the first robotic system designed for central airway obstruction surgery. And because it has dramatically fewer mechanical and electronic components than current commercial surgical robots, our end product has the potential to be an order of magnitude less expensive, while still providing a healthy revenue stream and profit margin for our company. Our approach in Aim 1 is to design a manufacturable, operating-room-ready robotic system including actuation components and modular, disposable instruments, and to complete FDA biocompatibility testing. Aim 2 focuses on the user interface control mappings and validation through the FDA human factors testing process. In Aim 3, we validate the entire system experimentally, quantitatively comparing surgeon performance with our robotic system to the current standard of care. The outcomes of this project are (1) an operating-room-ready robotic system, (2) completion of the FDA biocompatibility and human factors testing needed for 510(k) approval, and (3) the collection of quantitative experimental data in cadavers demonstrating that our system makes central airway obstruction surgery safer, more effective, and more efficient.