Bioengineers Developed Open-Source NIV Helmet Design
In March 2020, as COVID-19 was declared a global pandemic, a group of volunteers banded together in Canada to create access to medical equipment around the world through open-source design solutions.
“When we saw pictures and news articles in Italy, we thought to ourselves, ‘Well, we haven’t seen these methods of helmet-based ventilation in North America. Why is that? And why has Italy been using it widely in managing its COVID-19 patients?’” explained Vionarica Gusti, a team leader on COSMIC Medical’s bubble helmet project.
As a result, a non-rigid ring helmet was designed for non-invasive ventilation (NIV). COSMIC Medical, based in Vancouver, BC, is a group of volunteer students and professionals who are committed to open-source design solutions for COVID. COSMIC Medical reached out to Aurika Savickaite, co-founder of HelmetBasedVentilation.com, in April. Savickaite connected with team members for an interview and updates on the helmet project.
Gusti and her team had been working on a bag-mask ventilator but switched to a helmet design when they saw them widely used in Italy and read the University of Chicago study which showed lots of benefits of helmet-based NIV for patients with acute respiratory distress syndrome (ARDS).
COSMIC Medical volunteers tried several designs but found them challenging because of rigid neck rings that required a large 3D printer or molding to create them. Gusti reached out to DIY Packraft, an inflatable raft maker in rural British Columbia for prototyping advice. The first functional prototypes of a soft neck collar that is heat-sealed to the bubble helmet were connected using a hairstyling flat iron to a plastic hood prototype from SEI Industries, Gusti said.
“Helping out with the testing of the non-rigid ring design, I also saw that it was far superior to the rigid ring,” said project co-leader Arpan Grover. “We noticed that because (we were) 3D printing our designs there was a lot of variation in terms of actually clipping the two pieces together, which caused a lot of leakage through the neck seal. We didn’t want that because it was geared toward COVID patients, and we didn’t want aerosols to be leaking from the helmet at all. We wanted to minimize leakage as much as we possibly could.” The soft ring design reduces leakage to close to 2 percent, he said.
The new design was simpler and better for the team, Gusti said. They could create prototypes in-house and test them right away.
The team settled on biocompatible thermoplastic polyurethane (TPU) to create both the helmet and the neck seal. It needed to be transparent and not have a plastic smell. It’s a little more expensive, Gusti said, but because of the elasticity of the material, it makes a good gasket with whatever port is used.
“We also noticed that using the TPU as a neck seal was very comfortable,” Grover said. “It was very easy to get on, as well, and surround the neck, even for four hours, it was very comfortable.”
“Because of its very thin TPU, it attaches (to) your neck without constricting it,” Gusti said. The positive pressure of the helmet makes the seal very good, she added.
The team plans clinical trials of the helmet and seeks fast-track options to produce it. Large-scale manufacturers with proper certifications are needed to partner with the team and bring the design to where patients need it. Helmets have been approved for use in NIV in Canada and the USA.
Additionally, the design is open source for anyone to use. The simple design means it can be produced in other countries, especially developing countries, Savickaite said.
Shipping to other countries is cost-prohibitive, Gusti added. Instead, other countries should manufacture their own. She said it costs about $100 (CAN) to produce one helmet. Large-scale manufacturing may bring the price down, she said.
Savickaite praised the team and its work. “You have a great helmet design that’s comfortable to use, and you’re sharing it with the world. Amazing.”
Link to helmet Design Files: https://github.com/COSMIC-medical/bubble-helmet