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) 是一种经常使用的救生手术，仅在美国就每天进行 15。 每年进行 100,000 次手术室插管和 650,000 次手术室外插管。 2020年SARS-Cov-2大流行初期，超过70%的重症患者接受了插管 随着新的突变的出现，紧急插管的数量只会继续增加，尽管这种情况很频繁。 ETI 是一种高风险手术，呼吸系统并发症、血流动力学不稳定和 视频喉镜 (VL) 于 2000 年代初开发，旨在帮助解决心脏骤停的问题。 插管与直接喉镜 (DL) 的传统做法相比，这种新的插管方法的工作原理是： 位于插入口腔的喉镜刀片远端的摄像机装置，以及 这种广泛使用的可视化工具可以在单独的监视器上提供声带的间接视图。 气道作为紧急情况下插管的一线工具已获得更多认可。目前 通过视频喉镜进行插管的问题是，当摄像头拍摄时，它们实际上变得毫无用处 视野被体液（例如胃内容物和血液）遮挡。 IVOS Medical, LLC 是一种新型医疗设备。 初创公司开发一种经济、一次性、新颖的视频喉镜套，以保持清晰的视野 在放置呼吸管期间，我们的视频喉镜装置的目标是提高电流。 通过降低误吸风险和个人无氧时间来保证插管的安全性，同时 我们相信我们的设备能够提高死亡风险较高的患者的插管准确性。 特别有利于我们国家医疗中心的急救人员和医疗保健提供者 在我们的挪度气道中进行急诊室、手术室和重症监护室的初步测试。 使用我们的原型 IVOS Medical BOSS G4 的人体模型，在使用后显示出视力的显着改善 清除相机镜头中的模拟体液 该提案的目的是 1：进一步发展。 3D 打印 IVOS Medical BOSS Glide 4 (G4) 视频喉镜套并比较速度和效率 与流行的 Verathon Glidescope AVL Blade 4 相比，在抽吸条件下成功插管， 60 名医疗操作员 2：对 BOSS G4 套筒进行有限元分析 (FEA) 3：开发。 并制作 25 个 IVOS Medical Boss G4 喉镜套管 II 期聚氨酯注塑样品。 将重点关注基于最终用户反馈的设计以及包括人体尸体分析在内的额外测试。 具有捕获和清除口咽腔中潜在的空气传播病毒颗粒的抽吸能力 此外，还将进行额外的物理和材料测试。 我们相信，我们可以帮助拯救许多受影响的生命。 每天，并为其他从事这种救生工作的医疗专业人员增加安全网 程序。