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

• 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
• 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

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： 这项提议的目标是创造一种新的手术装置，它能在僵硬的 支气管镜检查。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fi对准和可视化，这是我们假设将实现的 中心气道阻塞手术更安全，更有效，更有效的fi。 临床意义fiCance来自于大量受中央呼吸道阻塞影响的患者--有 仅在美国，每年就有超过8万例新诊断病例[13，15]--以及个别患者的严重程度， 因为缺乏足够的呼吸道是致命的。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部署，缺乏横向灵活性，只能通过倾斜整个支气管镜端口进行瞄准 支气管镜，对患者的颈部和牙齿施加很大的力。因此，32%的患者有 并发症包括牙齿折断、颈椎损伤、出血，甚至死亡。 创新来自于利用弯管的弹性相互作用来创造可以弯曲的微型机械手 并拉长。这些操纵器足够小，可以在现有的临床支气管镜中通过端口。 在其顶端提供触须般的灵活性，比目前的商业外科手术小一个数量级 机器人操纵器。我们提出的系统也将是专为中央呼吸道设计的fiRst机器人系统 梗阻手术。因为它的机械和电子部件比目前的要少得多 商用外科机器人，我们的最终产品可能会便宜一个数量级，而 仍然为我们的公司提供健康的收入来源和良好的fi利润率。 我们在目标1中的方法是设计一个可制造的、可供手术室使用的机器人系统，包括执行机构。 组件和模块化一次性器械，并完成FDA的生物兼容性测试。目标2重点 通过FDA人为因素测试流程对用户界面控件进行映射和验证。在《目标3》中， 我们通过实验验证整个系统，将外科医生的表现与我们的机器人进行定量比较 系统达到目前的护理标准。该项目的成果是(1)一个可供手术室使用的机器人 系统，(2)完成510(K)批准所需的FDA生物兼容性和人为因素测试，以及 (3)身体定量实验数据的收集表明，我们的系统使中枢 气道阻塞手术更安全，更有效，更有效的fi。