IVOS Medical: Intubation, optimized.

IVOS Medical：插管，优化。

• 批准号: 10483262
• 负责人: Gabriel Punsalan
• 金额: $ 24.73万
• 依托单位: IVOS MEDICAL LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483262
• 关键词: 3D Print; Accident and Emergency department; Affect; Anatomy; Aspirate substance; Aspiration Pneumonia; Blood; Brain Injuries; Breathing; COVID-19 outbreak; COVID-19 pandemic; Cadaver; Cessation of life; Critical Illness; Data; Development; Devices; Distal; Effectiveness; Event; Excision; Feedback; Finite Element Analysis; Foundations; Frequencies; Gases; Goals; Health Personnel; Heart Arrest; Human; Individual; Injections; Intensive Care Units; Intratracheal Intubation; Intubation; Laryngoscopes; Laryngoscopy; Lead; Life; Liquid substance; Manikins; Manufacturer Name; Materials Testing; Medical; Medical Device; Medical center; Methods; Modeling; Molds; Monitor; Mutation; Operating Rooms; Operative Surgical Procedures; Oral cavity; Oropharyngeal; Oxygen; Patients; Phase; Procedures; Research; Risk; Safety; Sampling; Savings; Specialist; Speed; Stomach; Suction; Testing; Time; Tube; Urethane; Viral; Vision; Visual Acuity; Visualization; Work; base; design; first responder; hemodynamics; high risk; lens; mortality risk; novel; particle; prevent; prototype; respiratory; safety net; symposium; tool; virtual; vocal cord

Abstract Endotracheal intubation (ETI) is a frequently used life-saving procedure performed daily. In the US alone, 15 million operating room intubations and 650,000 out-of-operating room intubations are performed annually. At the initial outbreak of the SARS-Cov-2 pandemic of 2020, more than 70% of critically ill patients were intubated and with new mutations, the increase in emergent intubation is only going to continue. Despite its frequency, ETI is a high-risk procedure, with significant rates of respiratory complications, hemodynamic instability, and cardiac arrest. Developed in the early 2000s, the video laryngoscope (VL) was created to assist with difficult intubations vs the traditional practice by direct laryngoscopy (DL). This new method of intubation works by means of a video camera on the distal end of the laryngoscope blade which is inserted into the mouth and provides an indirect view of the vocal cords on a separate monitor. This widely-used tool for visualizing the airway has garnered more acceptance as a first line tool for intubation in an emergent setting.The current problem with intubation by means of video laryngoscopy is that they become virtually useless when the camera view is obscured by bodily fluids, e.g., gastric contents and blood. IVOS Medical, LLC is a new medical device startup developing an economical, disposable and novel video laryngoscope sleeve for maintaining clear vision during breathing tube placement. The goal for our video laryngoscope apparatus is to elevate the current safety profile of intubation by decreasing aspiration risk and the time an individual goes without oxygen, while increasing intubation accuracy in patients who present with high risk of mortality. We believe our device will benefit first responders and healthcare providers throughout our nations’ medical centers in particular emergency departments, surgical suites and intensive care units. Preliminary testing in our Laerdal airway manikin with our prototype IVOS Medical BOSS G4, has shown significant improvement of visual acuity after clearing away simulated bodily fluids from the camera lens. Aims of this proposal are 1: Further development of 3D printed IVOS Medical BOSS Glide 4 (G4) video laryngoscope sleeve and compare speed and efficiency of successful intubation under aspiration conditions against the popular Verathon Glidescope AVL Blade 4, among 60 medical operators. 2: Perform Finite Element Analysis (FEA) of the BOSS G4 sleeve. 3: Develop and create 25 urethane injection molded samples of IVOS Medical Boss G4 laryngoscope sleeves. Phase II will focus on design based on end user feedback, additional testing including on human cadavers. Analysis of the suction capabilities to capture and remove potential airborne viral particles from the oropharyngeal space can be investigated at this time. Furthermore, additional physical and materials testing will be performed to reach the commercial-ready point at the end of Phase II. We believe that we can help save many lives affected everyday as well as increase the safety net for other medical professionals performing this life saving procedure.

抽象的 气管插管（ETI）是每天执行的一种常用生命的程序。仅在美国，15 每年进行数百万个手术室插管和650,000个操纵室插管。 SARS-COV-2大流行的最初爆发是2020年，超过70％的重症患者被插管 随着新的突变，新兴插管的增加只会继续。尽管有频率 ETI是一种高风险手术，呼吸并发症，血液动力学不稳定和 心脏停搏。在2000年代初期开发的视频喉镜（VL）的创建是为了帮助遇到困难 通过直接喉镜检查（DL）与传统实践。这种新的插管方法可通过 在喉镜刀片远端的摄像机的手段，该摄像机被插入嘴巴和 在单独的显示器上提供声带的间接视图。这个广泛使用的工具，用于可视化 Airway在紧急情况下已获得更多的接受作为插管的第一行工具。 通过视频Larryngoscope进行插管的问题是，当相机时它们几乎变得有用 视图被体液，例如胃含量和血液所掩盖。 IVOS Medical，LLC是一种新的医疗设备 启动开发经济，一次性和新颖的视频喉镜套筒，以保持清晰的视力 在呼吸管放置期间。我们的视频Larryngoscope设备的目标是提升电流 插管的安全性通过降低抽吸风险和个人没有氧气的时间，而 具有高死亡率风险的患者的插管精度提高。我们相信我们的设备会 在整个国家的医疗中心，福利的急救人员和医疗保健提供者 急诊科，外科套房和重症监护病房。在我们的Laerdal气道中进行初步测试 Manikin与我们的原型IVOS Medical Boss G4，显示出视力的显着提高 清除相机镜头的模拟体液。该提议的目的是1：进一步发展 3D印刷IVOS Medical Boss Glide 4（G4）视频喉镜套筒并比较速度和效率 在攻击条件下成功插管对流行的Verathon GlideScope AVL Blade 4的成功插管， 在60个医疗运营商中。 2：执行Boss G4套筒的有限元分析（FEA）。 3：发展 并创建25个IVOS Medical Boss G4 Laryngoscope套筒的尿电烷注射模制样品。第二阶段 将重点关注基于最终用户反馈的设计，包括人尸体在内的其他测试。分析 从口咽空间捕获和去除潜在空气传播病毒颗粒的假设能力 目前可以调查。此外，将进行其他物理和材料测试 在第二阶段结束时到达商业就绪的点。我们相信我们可以帮助挽救许多受影响的生命 每天以及增加其他医疗专业人员的安全网 程序。