06/23/2021 Chicago
Panicked by the global pandemic in early 2020, some Brazilian researchers found a way to help patients living in their state when they developed and brought to market a helmet design for non-invasive ventilation.
Herbert Lima Santos da Rocha, an industrial designer since 2000, professor at University of Fortaleza (Unifor), and co-coordinator of lab research and innovation related to cities, teamed with others on a video call to talk about what they could do. News reports from Italy about COVID patients were grim.
“We were expecting something bad,” Santos da Rocha said. “By what we were seeing in Italy, we were expecting something very bad.”
During that initial meeting, they decided: “Let’s do something that would ease (the) impact on society.”
First, they considered mechanical ventilators, but they faced an obstacle: Many of the companies and suppliers, such as those in China that they needed to rely on, were closed. By their second meeting, the team had landed on the idea of a helmet, like the ones used on old diving suits. They thought it was interesting that a patient could breathe oxygenated air, Santos da Rocha said.
A team member, the pulmonologist Dr. Marcelo Alcantara, had worked with transparent helmets years before – an Italian model – to treat other lung diseases and suggested it could be used for COVID. The team agreed to pursue buying helmets, but that was impossible. The demand was so high, they never even got a call back from the manufacturers.
At their next meeting, the team decided: Let’s make one. And so began the creation of Elmo, an assisted breathing helmet for patients with mild to moderate breathing issues.
The team, based in the Brazilian state of Ceará, still faced the issue of not being able to get parts from other countries or even other states in their country. Instead, they decided to make the device using locally sourced supplies.
“That was one of our first directives of our product. We need to find a solution to make it in our house,” Santos da Rocha said. The project was a joint effort between the University of Fortaleza (Unifor), the Federal University of Ceará (UFC), the Federation of Industries of the State of Ceará (Fiec), National Service for Industrial Training (Senai), and the Government of the State of Ceará, through the Secretariat of Health of Ceará (Sesa), the Public Health School of Ceará (ESP) and the Cearense Foundation for Scientific and Technological Development Support (Funcap).
Injected, moldable plastic can be complicated and expensive. Even to make a mold would take months, Santos da Rocha said. They needed an efficient solution and came up with a simple two-ring design with a silicone neck seal. The design was easy to make into a mold and easy to produce 1,000 units, he said.
Everybody was working at home at that time, Santos da Rocha said. He’d built a small home lab but didn’t have access to materials. He called a local store to buy a sheet of transparent PVC, picked it up, brought it home, and made the first version of the helmet using scissors and hot iron to weld the borders.
As prototypes were tested, Esmaltec, a company in Ceará that makes refrigerators and stoves, was getting set up to produce the medical devices. The company has the machines and knowledge of the industrial process as well as “very good minds working there,” Santos da Rocha said.
By 23 of June 2020, the helmets were being used on sick patients. One of the first was a woman aged 77 with oxygen saturation of about 90 percent, during the treatment with a face mask. After a few minutes of using a helmet, her saturation increased to 96 percent.
During their months of production, they’d heard of other universities doing similar COVID work, even developing helmets, but they never were produced, Santos da Rocha said.
“Many universities are used to research and publication,” he said, producing one unit to show the results. “But to make the product possible to be mass-produced, and finally be able to have a thousand units on the market, you don’t see that in university classes.”
The other universities never reached the point of production, he said. “We had a team of people to make products for (the) market.
“During research, tests, we were already contacting the government agencies with documentation to get the license to allow (us) to make the product,” he said. Esmaltec was doing its part to get ready for the production of a medical device.
The prototype was simple, but “to deliver thousands of seals and thousands of hoods, all of that takes time.”
Today, the company is able to produce around 500 units a day, and 9,000 helmets have already been delivered to hospitals, he said.
![NAZAreno Júnior [@nazarenojr_]. (2021, April 29). EMPATIA sendo exercitada na prática! O capacete Elmo é uma criação cearense! Ele ajuda muito no tratamento da Covid19, contribuindo. Instagram. https://www.instagram.com/p/COQYTmphmyC/](https://static.wixstatic.com/media/fa2db5_139106ae33c8473a8e31f17f4fa38d04~mv2.jpg/v1/fill/w_147,h_94,al_c,q_80,usm_0.66_1.00_0.01,blur_2,enc_auto/fa2db5_139106ae33c8473a8e31f17f4fa38d04~mv2.jpg)
The clinical trial results are excellent but not yet published, Santos da Rocha said. “Fifty to 60 percent of (COVID) patients that normally would be intubated, they got the helmet, and they recovered without needing to be intubated,” he said.
Response from clinicians was excellent, as well, he said. The team prepared materials to train medical teams and show them the possibilities for using Elmo.
Santos da Rocha listened in at a meeting a couple of months ago when physicians in Ceará related patient success stories about the helmets that nearly made him cry.
“They (patients) were able to take a bath. Before that they were bedbound. They couldn’t do anything. Now they were able to take a bath,” he said. Patients who finished treatment posted videos on Instagram. “No one asked them to do this,” he added.
“We heard a story a few weeks ago that was very interesting, touching,” Santos da Rocha said. A morbidly obese patient with COVID needed to be transported via ambulance from his home in the south of the state. He was very ill, Santos da Rocha said. Ceará is a large state, and the trip would take four or five hours.
“They placed the helmet on him, and he made the whole trip from his small city to the capital by ambulance wearing the helmet,” he said. “We designed something thinking to use (it) inside hospitals,” but it also works in other conditions. “That’s great!” he said.
Elmo is intentionally designed to have a smaller volume of 20L inflated to help with flow and reduce rebreathing CO2, Santos da Rocha said. Two tubes connect to wall air and oxygen provide 30L per minute per each tube. An antibacterial filter adds about 2 to 3 cm of water. At setup, clinicians use a manometer to test pressure inside the helmet. Manual flows, including a mixture of air and oxygen, are 40, 45, 50, 55, and 60, depending on the patient, he said.
In some prototypes, they noticed that CO2 was higher. “If we placed the outflow of the helmet higher, the CO2 is heavier, the patient would breathe CO2 (more),” Santos da Rocha said, noting he’s seen many helmet designs around the world where he’s sure the patient is breathing CO2 because of this design flaw.
NAZAreno Júnior [@nazarenojr_]. (2021, April 29). EMPATIA sendo exercitada na prática! O capacete Elmo é uma criação cearense! Ele ajuda muito no tratamento da Covid19, contribuindo. Instagram. https://www.instagram.com/p/COQYTmphmyC/
Some patients need a higher flow and higher oxygen supplementation. In cases where oxygen is in short supply, the nasal cannula can be used inside a helmet to provide oxygen while creating flow with just medical air.
“We tried to find some solutions that would lower the oxygen consumption,” Santos da Rocha said, but they wanted to make the helmet available as soon as possible. “The project could have taken more months if we went to find solutions to small problems that we knew were there, but we needed to make this product available.” In December 2020, Brazil was at the beginning of the second wave, with the recording of 750 COVID deaths a day. During the apex of the second wave a month ago, it was surpassing 3,200 COVID deaths per day.
“We’re working now at this exact moment, we have another team, working on a better version of the helmet, different materials for the membrane,” he said. The goal is to make it at a lower cost and to last longer. Helmets can be cleaned and used for four to five patients before they start to degrade.
Additionally, they are considering accessories for the helmet, such as a manometer to track breathing frequency and pressures. A new accessory will replace the PEEP valve to regulate outside flux and control internal pressure in the helmet, Santos da Rocha said. It will be cheaper than a PEEP valve, costing cents of a dollar.
The plan is for the design to be done in October, he said.
The new design team involves students, as well. During the initial design process, Santos da Rocha shared weekly updates with his students. Coincidentally, they were learning about creating equipment for people with disabilities. He could tell them in real-time about the equipment they actually planned to produce.
“Usually, you don’t have this kind of richness of information. Usually, a professor creates a problem for them to solve. In this case, it was a real problem appearing,” he said. “Some contacted me months after when it appeared in (the) media.” “That one?” they’d ask. “Yes, that one,” he’d reply.
Pictures:
NAZAreno Júnior [@nazarenojr_]. (2021, April 29). EMPATIA sendo exercitada na prática! O capacete Elmo é uma criação cearense! Ele ajuda muito no tratamento da Covid19, contribuindo. Instagram. https://www.instagram.com/p/COQYTmphmyC/
Herbert Lima Santos da Rocha (2020). Home photography