IVOS Medical: Intubation, optimized.

摘要

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.