Reopening the Central Airway With Needle-Size Tentacle Manipulators

用针头大小的触手机械手重新打开中央气道

基本信息

批准号：
10020704
负责人：
Richard Joseph Hendrick
金额：
$ 7.42万
依托单位：
VIRTUOSO SURGICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-12-15 至 2021-07-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10020704
关键词：
Affect Animal Model Bronchoscopes Cadaver Cervical spine Cessation of life Clinical Clip Collection Complication Curved Tube Data Devices Diagnosis Effectiveness Endoscopes Excision Exhibits Fiber Funding Goals Guidelines Healthcare Systems Hemorrhage Human Imagery Laboratories Lasers Lateral Measures Mechanics Neck Neck Injuries Needles Operating Rooms Operative Surgical Procedures Oral cavity Outcome Patients Performance Pharyngeal structure Phase Physicians Positioning Attribute Procedures Process Research Risk Robot Robotics Safety Severities Side Small Business Innovation Research Grant Spinal Injuries Stream Surgeon Surgical Instruments System Testing Time Tissues Tooth Cervix Tooth structure Translating Tube United States National Institutes of Health Universities Validation Work airway obstruction arm biomaterial compatibility clinical translation clinically significant commercialization design design and construction dexterity experimental study improved individual patient innovation instrument new technology patient safety prototype public health relevance restoration robotic system standard of care tool

项目摘要

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.

项目摘要/摘要：该提案的目的是创造一种新的手术装置，可以在刚性的尖端提供灵活性。我们的新系统将通过支气管镜端口输送针头大小的触手状手臂，实现独立的组织操作、激光光纤瞄准和可视化，我们将率先实现这一点中央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 – 有仅在美国每年就有超过 80,000 例新诊断 [13, 15] – 以及个别患者的严重程度，因为缺乏足够的气道是致命的，因为仪器的存在，现有的手术方法具有挑战性。通过刚性支气管镜端口展开的装置缺乏横向灵活性，只能通过倾斜整个支气管来瞄准支气管镜会对患者的颈部和牙齿施加很大的力，32% 的患者接受过这种检查。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的弹性相互作用来创建可以弯曲的微型机械手这些操纵器足够小，可以穿过现有临床支气管镜中的端口。在其尖端提供触手般的灵活性，并且比目前的商业手术小一个数量级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。而且因为它的机械和电子元件比目前的要少得多。商用手术机器人，我们的最终产品有可能便宜一个数量级，同时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 的方法是设计一个可制造、可用于手术室的机器人系统，包括驱动组件和模块化一次性仪器，并完成 FDA 目标 2 的生物相容性测试。在目标 3 中，通过 FDA 人为因素测试流程进行用户界面控制映射和验证。我们通过实验验证整个系统，定量比较外科医生与我们的机器人的表现该项目的成果是（1）一个可用于手术室的机器人。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) 尸体定量实验数据的收集证明我们的系统使中央气道阻塞手术更安全、更有效、更高效。