The first case is confirmedin Italy appeared on February 20, in the administrative district of Lombardy, which includes the city of Milan. The next day, in the neighboring district of Veneto, in the city of Vo ‘, near Padua, the first death from an illness in Italy was recorded.
Italy is locked March 9th. Sudden and drastic action wakes the world at a deeper risk than COVID-19.
For Italians, there is another surprise, an feeling of isolation.
“For several weeks in Italy, we were at the center of the epidemic, and it felt very bad because it seemed like a limited problem in Italy,” recalls Cristiano Galbiati, a physicist in Milan.
“We sometimes feel that other countries in the European Union really don’t appreciate what is happening here.”
Then he did something that showed Galbiati that Italy was not alone. He came up with an idea for a new type of mechanical ventilator. Will be cheap and easy to build. Ventilator supplies are limited, so this has a real opportunity to help save lives. He called on scientific colleagues around the world to ask for their help. They heeded his calls by dozens. Before long, there were more than a hundred scientists on the Zoom call, several times a day, coordinating science, prototyping, testing, and construction.
This month, an effort called The Mechanical Ventilator Milano, reached a major milestone. U.S. Food & Drug Administration give “emergency use authorization” to the device.
In a telephone call from Italy, Galbiati remembered how everything came together, clearly touched by support.
“It’s a relief, personally, to see so many friends in the US and Canada, and in Spain, and in France, in the US and Poland, coming to help us,” Galbiati said.
“This is a great international teamwork exercise,” said Art McDonald, a recipient of the 2015 Nobel Prize in Physics, and longtime collaborator from Galbiati, who acted as project co-leader. “It is truly heartwarming to see how happy these people can do something to contribute to facing the COVID-19 crisis.”
ZDNet describe the MVM project in April, based on an initial paper posted by the group on March 27 on the medRxiv pre-printed server. (Paper has been updated. That project website has additional information.)
Galbiati speaking ZDNet by phone from Milan on May 8 to offer updates on group progress.
Everything is brighter in Italy because the number of daily cases has decreased, although Galbiati has not been able to return to his laboratory.
“There is little hope,” he said. “People can finally get their noses out of their homes and the atmosphere is lighter.”
Getting to this point means working at “warp speed,” as McDonald said. For Galbiati, it is first necessary to move beyond the feeling of being frozen.
“The first week was a week of absolutely no confidence and surprise,” he said.
“For several days, I felt unable to function.”
Normally, Galbiati and colleagues will focus on their current project, one mile below the mountains of Gran Sasso in central Italy. Galbiati is a professor in the physics department at Princeton University, but also holds teaching appointments at the Gran Sasso Science Institute.
That project, called Global Argon Dark Matter Collaboration, is formed in 2017, and has been over the last few years in the process of building a dark matter detector called “DarkSide-20k” in a tunnel under the Gran Sasso. Shielded from radioactive particles that bombard the earth’s surface, the detector is finely tuned with a compressed argon gas network to take on traces of very faint dark matter. (More information about DarkSide website.)
Under locking, Galbiati and his Italian collaborator could not enter the facility. “My mind at that time really changed,” he said, “in the sense that I felt it was far more important to do something about this situation than to continue our routine research.”
On March 19, Galbiati spoke in Milan with a collaborator from his dark matter work. “I told him that we must be able to do something” about this pandemic, Galbiati recalled.
His mind turned to a very complicated instrument which he had spent years building. The most challenging work in Galbiati’s career was a large instrument called Borexino, also made at Gran Sasso. Galbiati described the detector as “two very sensitive lungs,” a large container formed from a very thin sheet of nylon, measuring only 125 million meters. “You have to treat it very, very gently,” he recalls the process of moving argon gas through a giant container.
The human lung is “a very complicated, very complicated organ,” Galbiati mused. Nevertheless, “if you look at it, in the end, it boils down to basic physics.” The lungs can be defined by a small number of physical parameters, he said: “Airway barriers and elasticity, also called compliance.”
“The performance of each ventilator is basically determined by its ability to work within a range of parameters that are permitted complete while guaranteeing very fine transients for pressure and volume waveforms,” Galbiati explained.
That day in March, Galbiati did not sketch the concept on a cocktail napkin. “My napkin will be something that no one else can understand,” he said. Instead, he reaches out to colleagues who will quickly understand his vision.
“I am very fortunate that I have a set of collaborators with whom I have worked very well in my dark matter experiments,” Galbiati said. “The way we do it is, I summon three, four people that I know are closest to the way I think.”
Among them were Cary Kendziora, an engineer with the Fermilab Department of Energy in Batavia, Illinois, and Hanguo Wang, a physics professor at UCLA, two “mechanics teachers,” as he called them. Galbiati called Kendziora and Wang on March 21, two days after her original inspiration, “and at the end of the night, we have a beautiful illustration that everyone can understand.”
For the ventilator control unit, electronic brain, including processor chips and software, Galbiati reaches out to another longtime colleague, Alessandro Razeto at Gran Sasso. “I just explained to him in a few words what we needed as a control unit, and six hours later, he had a concept that was fully refined,” Galbiati said.
Galbiati called McDonald, the Nobel Prize winner, to ask for his support. “I immediately saw that was a good idea,” McDonald said. “But I also admit that it would be very valuable if we could expand its business.”
McDonald gathered its colleagues in various Canadian institutions, including The McDonald Institute at Queen’s University in Kingston, Ontario, from which McDonald had retired but where he still maintained affiliation; TRIUMF, Canada’s national laboratory for particle and nuclear physics, in Vancouver; Canadian Nuclear Laboratory, Kapur River; and SNOLAB, another dark matter laboratory, buried underground near Sudbury, Ontario.
Galbiati also appointed Fernando Ferroni, president of the Grann Sasso Institute, to become the team leader along with McDonald.
Years of collaboration have made the project organizational structure almost fall on its own. “The organizational structure is very similar to the structure you have for large projects,” McDonald said. “Cristiano and I have been working together for quite a long time and it is not difficult for us to agree on what is our main task, and then we are fast enough into projects that are able to identify people who are skilled in this area. people in the area that shows leadership. “
Remarkably, what ended in the research paper posted by Galbiati and colleagues on March 27 was more or less as Galbiati imagined, despite improvements.
There was a design refinement that occurred with the help of the Italian doctor Galbiati visited.
“Cristiano himself is an extraordinary individual,” McDonald said. “He has faced a very difficult situation in Italy.”
“He must get a special dispensation from the government just to travel within Milan.”
The first doctor to consider was Antonio Besenti, who runs a crisis unit in Lombardy, which was flooded with cases in the first weeks of the outbreak.
“He was very inspiring to me,” Galbiati from Besenti said. “He gave me instructions on how the lungs should be treated properly and very gentle actions.” Besenti directed Galbiati to work with his students, Drs. Giuseppe Foti and Giacomo Bellani from San Gerardo Hospital in Monza, near Milan; the two doctors shared their authorship on the MVM paper. Foti and Bellani helped Galbiati improve their understanding of lung physics.
“For COVID-19 patients, it is very important that the peak flow given at the beginning of the breathing cycle becomes very high, to immediately fill the alveoli, all while maintaining a very fine pressure waveform,” Galbiati explained.
To make sure the treatment is running properly, the doctor must examine the patient with a ventilator four to five times a day. Each such examination involves pressing five or six different buttons on the ventilator control panel. On the advice of Foti and Bellani, the MVM team drastically simplified this problem. Doctors and nurses will be able to do the same procedure by pressing a button on the MVM control panel, Galbiati said.
“I don’t think it’s less scary than what we tried to do in our experiments,” McDonald said, comparing work with looking for dark matter. “We are always very careful from a security standpoint, but in this case, we are dealing with human life.”
“That’s a scary prospect when it comes to what you design and how careful you have to be.”
Ventilators are not without controversy. Some doctors recommend that more needs to be done to avoid using ventilators in generalbecause they can have long-term adverse effects on patients.
How serious is the concern? “I’m not a doctor, so I think the decision will be left to them,” Galbiati said ZDNet. “What the doctor told me was that it was the last step, and unfortunately that was the last step that had to be adopted for a very small number of patients.”
Asked by ZDNet whether the MVM ventilator might be safer than some commercial ventilators because of the way it was designed, Galbiati returned to the doctor.
“I believe these questions need to be addressed by medical doctors in clinical studies,” he said.
In addition to the FDA’s emergency use agreement, Galbiati and his team have applied for an emergency use grant in Italy from the Italian Ministry of Health. The MVM is the first device to apply for authorization in Italy in 23 years after the law on emergency use has come into force, Galbiati said.
Galbiati and his team have also started applications for permanent FDA approval, and also for permanent approval under the so-called “CE mark,” comprehensive authorization in the European Union.
Mass production of MVM is underway at Elemaster S.p.A., an Italian-based manufacturing service company that Galbiati and colleagues have relied on for years for their work; and in the US and Canada at manufacturing company facilities Vexos, with additional production in Canada by JMP Solution from London, Ontario.
The initial target for production by Elemaster and Vexos and JMP is hundreds of units per week. As the production process becomes more and more streamlined, Galbiati expects that number to “significantly increase in the coming months.”
“If you look at the simplicity of the engine, that’s surprising,” Galbiati said. “That is something that is very, very easy to assemble and requires very low power.” Among the most important design points is the use of what is known as a manifold, a piece of metal that functions to join several parts, such as valves.
“All engineering to integrate machines comes naturally from past experience in building other things,” Galbiati said.
The design of MVM is open, meaning that scientists do not patent any intellectual property, McDonald noted. That means that other manufacturers can easily reach designs and enter the market.
“That’s our humanitarian contribution, if you like,” McDonald said. “We are very open, like most scientists are; this is a good example of how international cooperation and science can help.”
Collaboration for Galbiati is the justification of the basic value of basic research. “People are very curious in this field, and they are able to recognize something important,” Galbiati said. “When the time comes, you can steal a lot of talents from something that is immediately recognized as being very beneficial to society.”
The fact that so many are jumping, “tells you how agile this basic research work is.”
Other basic research, underground work in Gran Sasso, poaching of dark matter, must wait. Galbiati is not sure when he will be able to return to the lab. He adapted to changing habits, he said, and he had embraced the requirements for patience. “Everything in life has a great time,” he said.
Galbiati is more focused on changes that have not yet come, in particular, the possibility of a second wave of COVID-19.
“I’m most afraid of what will happen in the fall,” Galbiati said.
“The much warmer weather we have here, starting in May, may play a role in reducing it, but who knows what happens when it gets cold again.”
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