Protecting Healthcare Workers Using a Patient-Worn Negative Pressure System to Prevent the Spread of Highly Transmissible Infectious Diseases

PROJECT SUMMARY The goal of this project is to develop a solution that allows for rapid, safe, and scalable initial treatment and transport of patients with highly transmissible infectious diseases. This is a necessary innovation because resource management and infectious transmission control were two of the greatest challenges healthcare

providers faced when fighting the COVID-19 pandemic. When a patient is suffering from highly transmissible respiratory diseases and requires breathing assistance, they are placed in negative pressure rooms. However, given the limited supply of negative pressure rooms available to prevent virus transmission, and

the misperception regarding the safety and effectiveness of negative pressure rooms, a new solution is needed. To help prevent the spread of highly transmissible infectious diseases, start-up company Inspire Rx has developed a personal negative pressure device called the AerosolVE™ BioHelmet. The BioHelmet is

capable of preventing the spread of aerosolized pathogens while also enabling the use of non-invasive oxygen therapies on patients with respiratory diseases such as COVID-19, influenza, tuberculosis, measles, and chicken pox. The negative pressure AerosolVE™ BioHelmet immediately isolates patients with any

highly transmissible respiratory infectious disease and serves as an instant personal negative pressure environment that is more effective than a traditional negative pressure room. The BioHelmet is intended to provide safe transportation via ambulance, airplane, or helicopter, allowing critical EMS and transportation

staff to remain safe, and it can also be used in any area of a hospital (including waiting rooms, hallways, imaging facilities, and any patient room). In this project the team will refine and further evaluate the AerosolVE BioHelmet, building on their preliminary data collected during the COVID-19 pandemic. They will

first refine the BioHelmet design and fabricate 5 AerosolVE BioHelmets and pump units for follow-on bench testing and obtaining end-user feedback (Aim 1). They will conduct performance and bench testing for the different device components of the BioHelmet to demonstrate that the device performs as expected for its

intended use, including particulate testing (Aim 2). Finally, they will obtain end-user feedback from clinicians, hospital administrators, and others to inform final design requirements (Aim 3). In a future Phase II grant, they will conduct performance and bench testing in FDA approved labs to ensure safety and efficacy, as well as

clinical testing to ensure the BioHelmet can be comfortably worn for an extended period (several days). They will then submit an FDA 510(k) application to enable commercialization. The BioHelmet will provide a novel, compact, portable, and inexpensive solution that offers a safe negative pressure environment both inside and

outside the hospital, which will ultimately save lives by protecting healthcare workers while treating patients.