FlexSys Develops Two Novel Devices to Treat Covid Patients and Protect Healthcare Workers

Resource management and control of transmission are two of the greatest challenges faced by providers fighting the Covid-19 pandemic. Depending on the progression and severity of the disease, many patients must be placed in negative pressure rooms and/or on mechanical ventilators, which are in limited supply and pose an elevated risk to healthcare workers due to potential aerosolization of the virus.

Rising to the challenge posed by the Emergency Care physicians at the University of Michigan, Sridhar Kota and David Hornick co-developed two novel devices, dubbed Aerosolve,  that doctors are calling “game changers” in the fight against Covid-19. FlexSys developed two  negative pressure devices, a helmet and a tent, to treat Covid patients, protect healthcare workers and spare ventilators.

Critical care physicians at the University of Michigan Hospital have already used these devices and the patient trails were very successful. These simple devices have proven to be very effective in protecting healthcare workers.

Intubation using ventilators is high risk for patients, let alone the shortage of ventilators even in high-resource countries. A preferred alternative to intubation is to non-invasively by providing oxygen through a nasal cannula at high flow rates. But the doctors are not permitted to use this preferred method because of the fear of aerosolizing Covid-19. A negative pressure room is not a scalable option because they are expensive and very few are available even in high-resource hospitals. 

In contrast to a negative pressure room where the virus from the patient is allowed to spread in the room before the contaminated air is exchanged, the Aerosolve helmet captures the virus at its source and  draws patient’s exhaled air through a vacuum and a HEPA filter – and thus it serves as a compact, personal negative pressure room.

Aerosolve Helmet

Fog test video (shown here) vividly illustrates that there is sufficient negative pressure in the helmet to draw patient’s exhaled air through a HEPA filter to protect healthcare workers in hospital settings or any other people around even in public settings. The Aerosolve Helmet enables what is called “clinical distancing” in hospitals as well as social distancing in public spaces.

With Aersolve helmet, Covid patients have been taken off the ventilators and are treated non-invasively  with oxygen flowing  through a nasal cannula at high flow rates of up to 60 L/min. The vacuum draws 320 L/min to prevent virus from escaping the helmet even when the face shield in opened to access the patient. The result was many smiles on patients, nurses and doctors.

“The negative pressure helmet is an incredibly innovative device which will immediately fill a significant and urgent need. This novel device will greatly benefit patients with COVID-19 and other aerosol-transmitted diseases, and will also aid in protection of health care workers by preventing disease transmission.”— LENA NAPOLITANO, M.D., DIRECTOR OF THE U-M SURGICAL INTENSIVE CARE UNIT AND AN ASSOCIATE DIRECTOR AT MCIRCC

The Aerosolve helmet is portable and easy to use during transport and movement throughout the hospital for imaging studies, as well as use in ambulances, helicopters and other confined environments. It could also be used in homes, airplanes, cruise ships and other environments to limit viral transmission. The AerosolVE helmet systems is over 100 times less expensive and over 20 times more effective than a negative pressure room.

Aerosolve Tent

A important variation of the negative pressure helmet concept is a negative pressure tent. It allows physicians to perform various procedures on Covid patients that they would otherwise not be able to perform due to the risk of virus transmission.  Patients are often kept on ventilators much longer than they may need to be (sometimes an additional 7-10 days or longer) because of the perceived aerosol risk of needed procedures such as tracheostomy.

Using Aerosolve Tent, doctors at the University Hospital were able to perform various procedures including tracheostomy, bronchoscopy, extubation, airway management, and chest compressions associated with CPR. Clinical, nursing, and respiratory therapy staff found the tent did not interfere with complex patient care, while providing a greater level of comfort and safety while performing the procedure.

The Isolation tent is made of clear plastic that is easy to unfold and set up. The device has multiple ports for access to the patient.

A vacuum motor with a HEPA filter is attached to the tent to draw exhaled air as well as the room air at high rates of 300 cubic feet per minute. It provides 50 times more air exchanges than a traditional negative pressure room.  

“As we move past the surge and into the tail of COVID-19 at Michigan Medicine, it is vital that we discover innovative ways to provide high quality care and the safest way possible. I strongly believe that the AerosolVE Tent will be a tremendous asset to both the patients as well as the health system.”— PHILIP J CHOI, MD ASSISTANT PROFESSOR OF INTERNAL MEDICINE, DIVISION OF PULMONARY AND CRITICAL CARE MEDICAL DIRECTOR, ASSISTED VENTILATION CLINIC UNIVERSITY OF MICHIGAN

Thanks to heroic efforts of the FlexSys team, numerous isolation tents were delivered to the University of Michigan Hospital at the height of the pandemic to keep staff and other patients safe from Covid.

FlexSys and the University of Michigan received Emergency Use Authorization from FDA and contract manufacturers to expedite commercialization efforts. 

Wearable Negative Pressure System Engineered for COVID-19 and Similar Pandemics

For details visit AerosolVEDevices.com - a subsidiary of FlexSys Inc.