OHSU 3D Printed CRISIS Ventilator

In response to national and international shortages in the availability of medical ventilators, our team has developed and tested a novel low-cost (~10 USD) 3D-printed fl ow-driven pressure-regulated mechanical ventilator capable of basic and complex ventilation needs. This device requires no electronics and can be sustained with either O2 tanks or standard hospital 50psi O2 wall supply. The design can be printed rapidly, massproduced and immediately deliverable to any crisis areas in need. The CRISIS Ventilator has the potential to be produced on site depending on 3D printing capabilities. Our team includes physicians, scientists, a respiratory therapist, and engineers in healthcare dedicated to developing a rapidly deliverable ventilator solution to the global COVID-19 pandemic.


Overview
In response to national and international shortages in the availability of medical ventilators, our team has developed and tested a novel low-cost (~10 USD) 3D-printed fl ow-driven pressure-regulated mechanical ventilator capable of basic and complex ventilation needs. This device requires no electronics and can be sustained with either O2 tanks or standard hospital 50psi O2 wall supply. The design can be printed rapidly, massproduced and immediately deliverable to any crisis areas in need. The CRISIS Ventilator has the potential to be produced on site depending on 3D printing capabilities. Our team includes physicians, scientists, a respiratory therapist, and engineers in healthcare dedicated to developing a rapidly deliverable ventilator solution to the global COVID-19 pandemic.

The Problem
The worldwide pandemic of COVID-19, a respiratory disease caused by the novel coronavirus (SARS-CoV-2019), is a monumental public health threat that has led to signifi cant impacts on healthcare systems worldwide. Based on current data, somewhere between 10% to 25% of patients sick with COVID-19 eventually require assistance breathing [1]. Roughly 5% of patients will develop acute respiratory distress syndrome (ARDS), at which point only mechanical ventilation can give them a chance of defeating COVID-19. The United States has approximately 173,000 ventilators scattered across the country, according to the Center for Health Security at Johns Hopkins University [2], but experts from Harvard University predict that there could be 1.4 to 31 times as many patients who need one [3]. The U.S. Food and Drug Administration (FDA) Emergency Use of Authorizations (EUAs) have expanded to mechanical ventilators to drive private and public industry to develop innovative solutions to this dire problem [4]. Globally the need for mechanical ventilation is even more dire in lowand middle-income countries, where resources are limited and hospitals are hindered by equipment and infrastructure challenges [5].

Our proposed solution
Here we propose the CRISIS VENT (CV) system as a solution, a multiple-use device that can be created with a standard 3D printer in a sterile environment and rapidly produced and deployed at minimal cost of approximately 10 US dollars in materials. This new device design has the capacity to treat patients requiring standard mechanical ventilatory support but can also effectively treat the sickest patients with progressive ARDS. We have included design features that allow lung protective ventilator strategies employed for ARDS treatment with low tidal volumes and high Positive End Expiratory Pressure (PEEP). Our device also has the advantage of using various oxygen sources and can be easily altered to meet patient demands regardless of the ventilator support required.

Key features of the CRISIS VENT System
1. Can be built entirely with off-the-shelf components and a basic 3D printer.
2. Diminishes supply chain issues, is rapidly scalable, and low cost.

Test Lung
The Michigan Instruments' Training and Test Lung (TTL) is a dynamic lung simulator used to evaluate and demonstrate mechanical ventilation and lung pathologies. The TTL is a unique, versatile instrument that provides simulation of the structures and mechanics of the human pulmonary system.

Ventilator
The Avea is a fourth generation, servo-controlled, softwaredriven ventilator from Vyaire Medical. It is a comprehensive ventilation system that has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. This is a FDA approved ventilator used in Intensive Care Units and currently available in the simulation lab. The Avea was connected to the TTL in a Volume Assist Control MODE with a set PEEP, Tidal Volume and Respiratory Rate (RR) for both POOR lung and NORMAL lung case scenarios. Pressure, fl ow and volume curves were observed and recorded with the FLUKE VT900A.

OHSU 3D crisis ventilator
The CRISIS Vent by design is dependent on 3 parameters of inlet fl ow, peak inspiratory pressure and expiratory resistance which can be set and or adjusted. PEEP values for the Crisis Vent is dependent and determined by the set PIP and fl ow which both can be manually adjusted. Changes in RR can be made by manual adjustments of the rate valve.
Once the performance curves were recorded, the AVEA was substituted with the CRISIS Vent and adjustments made to match the PEEP, PIP and RR for AVEA performance for both NORMAL and POOR test case scenarios Figures 7,8.

Methodology for CV vent changes
Step 1: Start Flow 30L/min (measures up to 60L/min) Step 2: Set Rate Valve to middle setting in order to insure cycling Step 2: Set PIP to desired TV (Max PIP 55 cc H2O) Step 3: Adjust Rate Valve to desired RR

The path forward
We have brought on partners for developing, manufacturing, and distributing our device. All partners have volunteered their manufacturing capabilities and gifted materials for rapid prototyping and manufacturing scalability of our device during the pandemic. The device could be rapidly produced and shipped to hospital systems in need worldwide at no cost. Locally we have the capability to produce up to 100 devices per week. Our partnerships with these large U.S.based companies have the potential of a worldwide footprint that will allow us to maintain and control the quality processes and regulatory requirements and to keep pace with production needs. Additionally, we plan to leverage their extensive global distribution channels to ensure that we can widely disperse our device to regions in greatest need. This device has the promise of broad global application beyond the COVID pandemic.

Summary
We are currently in the process of FDA Emergency Use Authorization Approval for emergency use during the COVID-19 pandemic with the goal of providing this technology for anyone in need for free.