From the coral reef to the COVID ward: the snorkelling equipment at the forefront of Italy’s coronavirus fight
As the coronavirus outbreak hit northern Italy, Brescia lacked respiratory masks supplies. A small team of engineers created a valve that attached to a snorkeling mask provides a ventilator device.
Oxygen enters the lungs and Andrea breathes. In a hospital bed in Northern Italy, he is still puzzled about how he ended up in a COVID-19 ward with an oxygen mask on his face. He is one of the 132,000 people who tested positive for the Coronavirus infection in Italy. He recalls that a week before, after grocery shopping, he came back home and used some hand sanitiser. He couldn’t smell anything. At night, his dinner “tasted like paper”. He later learned that lack of sense of smell or taste are thought to be symptoms of the infection. While in isolation, he felt debilitated for a week but didn't show any signs of a fever. However, his breath started running short. The same night, he entered A&E.
The Coronavirus outbreak hit Italy dramatically, with more than 16,000 fatalities at the time of writing. Lombardy, a wealthy region in the north, faces the highest numbers of infections and deaths. Bergamo and nearby Brescia mourn a truly tragic number of fatalities.
In March, Brescian A&E departments started filling up with patients who had tested positive for the infection and with respiratory issues. When lungs are attacked by COVID-19, alveoli fill with the infection and lungs become more rigid. Alveoli, the most peripheral area of the lungs, can no longer provide the exchange between oxygen and carbon dioxide. “COVID-19 causes serious respiratory insufficiency. Sometimes, the simple oxygen supplementation is not enough,” said Dr Luca Ronchi, head of the respiratory department of Mellini hospital in Chiari, near Brescia. A possible solution to avoid respiratory failures is providing oxygen and a little pressure, to allow lungs to open, preventing the proliferation of inflamed cells. In order to do that, in sub-intensive wards, doctors use devices such as the CPAP (Continuous Positive Airway Pressure) system: a non-invasive ventilation system composed of an air pump, a face mask and a tube that links the two devices. The CPAP system delivers oxygen and a constant positive pressure that opens the lungs, preventing the proliferation of inflamed cells.
After almost a day in A&E, Andrea was admitted into the Covid-19 ward. His breathing was difficult. “Walking from my bed to the toilet felt as if I did fifty lengths in the pool,” he said. While being brought to the x-ray room, he passed the intensive care unit. Luckily his pneumonia didn't get that severe.
“There are a variety of treatments that patients can undergo before being brought to the intensive care unit,” said Dr Ronchi. “Apart from age or preexisting health conditions, the time factor is fundamental for a good response of the organism to the treatments”. Entering an intensive care unit is a quite dramatic step: the patient is asleep, under medication, and has endotracheal intubation. In sub-intensive care, doctors stabilise patients fighting against time. Here, patients are conscious, awake in their beds and can communicate with the doctors.
As more people tested positive to the virus and wards were filling up with patients, some hospitals in the Brescia area started facing medical device shortages. They had medically-certified oxygen, tubes and wall-mounted oxygen distributors, but didn’t have enough face masks for the oxygen and pressure-combined treatment. “Our supplies were suitable for a normal situation, but not enough for an emergency, even if the production worked 24/7,” said Dr Ronchi. He recalls discussing with his colleagues at Gardone Valtrompia, another hospital in the area, about solutions to face the shortages of valves and masks.
Brescia, a historical Roman-founded centre in Lombardy in a valley between the Alps and Lake Garda, is at the centre of a large, industrialised area. Isinnova is one of the companies on the territory. Featuring a small team of engineers and founded in 2014 by its CEO Cristian Fracassi, Isinnova provides research and development services for companies. Now, it is at the forefront of the fight against the Coronavirus outbreak. Dr Renato Favero, former head physician of Gardone Valtrompia hospital, contacted Isinnova to propose his idea. “The doctor contacted us. He thought that it would have been clever to use masks already available in stocks for sub-intensive care,” said Marco Ruocco, Project Manager at Isinnova. “We thought that the Decathlon snorkeling mask would have been appropriate, and we designed a junction valve that could be adapted to the certified systems already available in the hospitals.”
The engineers of Isinnova drew a valve to connect the air pump and face mask, printed it in 3D, and tested it for a few days. “For a week we worked day and night,” said Alessandro Romaioli, Technical Officer at Isinnova. The entire team worked so much that they barely got home. Cristian, Isinnova’s CEO, didn’t see his wife Carlotta for a week. “We called the valve Charlotte as a homage to Cristian’s wife”, said Alessandro. After some testing the system was ready: they put the 3D-printed Charlotte valve onto the mouthpiece of the snorkeling mask. The valve has two channels, an oxygen connection and a positive end-expiratory pressure connection that creates a pressure, allowing patients to ventilate. “This allowed us to avoid critical situations such as intubation in ICU or even deaths,” said Dr Ronchi. “Nobody experimented on patients. They solved the problem of the missing piece: this valve allowed us to connect the Decathlon mask to tubes and oxygen distribution systems already available and medically certified by hospitals.”
At the peak of the critical situation, Dr Ronchi treated ten patients with the Issinova system composed of the Charlotte valve and the Decathlon mask. “Patients were desperate for air - they had no breath. After we used the masks, we could see a swift improvement,” Dr Ronchi said.
Isinnova released an open patent for the Charlotte valve on their website. The guidelines to create it are free and available in a multitude of languages. Those creating 3D supplies can give their availability to the nearby hospitals, and print the valve if needed. In Brescia, Isinnova partnered with the civil authority, which gave the valves to the hospitals requesting them.
The 3D valve project sparked interest around the world. “We have been contacted by doctors in Milan, Sicily, Sardinia. They are using our valve in Spain, South America and South-East Asia,” Marco Ruocco said. It was extremely important to issue the patent as a non-profit-making system. “No-one should make money out of this emergency,” Marco said.
From the North of Italy, the small Charlotte valve has travelled the world. Edwin Tadeo Gomez is a clinical cardiologist at Hospital Universitario Infanta Elena in Madrid. He started researching and learning about 3D printing, and got to know the engineers of Isinnova. He volunteered to help in the hospital‘s emergency department. “There I began to encounter quite dramatic patient situations,” he said. One day, a 63-year-old male patient arrived at the hospital with severe respiratory difficulties. “At that time in the hospital we did not have the possibility of a bed with non-invasive mechanical ventilation in the UCI, so we decided to try the device, as a desperate measure,” Dr Tadeo Gomez said, talking about the Isinnova system. “The improvement was amazing, and the patient improved clinically. This device could become a great alternative for places where they don't have enough capacity.”
Not far away from Brescia, in Pavia, Dr Francesco Falaschi can finally wear his protective gear again to enter the COVID-19 ward after weeks of isolation. He is an intern doctor of general medicine at Policlinico San Matteo, one of the biggest hospitals of Pavia, a university city located in south Lombardy. At the beginning of April, after days treating patients, he tested positive for the infection. For a week, he had mild symptoms. As soon as he recovered, he couldn’t wait to go back to the ward with his patients. But, after testing positive, he was forced into quarantine again.
“I couldn’t come back to work, so I asked myself how I could help my colleagues,” Dr Falaschi said. Confined in his small room, away from his wife, patients and colleagues, he had a lot of spare time. Talking with his colleagues, Dr Falaschi realised they were concerned about a possible lack of CPAP helmets, and they were discussing which measures to take to have them ready in case of a spike in patient admissions. “We cannot sterilise used helmets: imagine, they stay on the patients’ head for a week, they get deformed,” Dr Falaschi said. “I spent a lot of time on the Internet and found the engineers of Isinnova”. He tried the mask on himself for one hour, and so far, he has never used it on patients, but valves and masks are ready to be used in case of necessity. “I was inundated by private citizens offering me Decathlon masks,” he recalled. He spent his isolation busily answering emails from people willing to help, offering masks, and engineers calling offering their 3D-printing services for free as gifts. “Everyone wants to help. There is some sort of enthusiasm… I was in my room isolated from everyone, and I wanted to cry. I felt that the entire community was united”.
“We realised that this device could have greatly helped patients and doctors. It wasn’t just a device, but something from which people could benefit. It spread throughout Italy and everywhere else in the world. That’s why we left the patent open, so as it could have the widest diffusion possible,” Marco Ruocco said.
Andrea is now back in his house. After a few days in sub-intensive care, he has been discharged from the hospital. He clearly remembers the atmosphere. From his bed, he saw so many ambulances, arriving every time with more and more patients. “Doctors and nurses were so busy. They did an awesome job.“
Dr Ronchi lived through days of constant emergency. “We keep going thanks to everyone’s determination: the doctors, the nurses, the health workers, the engineers”. Sharing the professional skills of doctors and engineers achieved an important result. “Everyone comes from a different path. We opened a communication chain between doctors and engineers. No-one experimented with anything more than a mask and valve junction. A moment of crisis allowed patients to avoid critical situations such as intensive care or, worse, death.”
Lucrezia Lozza is a freelance journalist and documentary maker, passionate about social and environmental issues. She is the co-founder of production company DogmaFilms, and writes for the geopolitical newsletter Good Morning Italia. @lucrezialz