The German federal government held a hackathon called #WirvsVirus (“We against the virus”) where 42,000 people met to find solutions to challenges from the coronavirus. Infineon engineers, led by Mahmoud Ismail who has a doctorate in lung mechanics, submitted a 3D print design and a design for the electronics and algorithms to develop and open-source lung ventilator.
The OpenVent team used the concept of a bag valve mask to make a ventilator with stepper motors, 3D printed components, motor drivers, sensors and Arduino compatible software. The team also used electronics and sensor technologies from Infineon.
“We’re working for the most simple concept possible so that others can work further on it. The objective is for hospitals to be able to order lung ventilators,” Nico Kelling, one of the engineers on the OpenVent team, said. “Naturally, this is also a showcase for our products. But that’s really a secondary factor for us. We hope our idea will make it possible to provide a large number of devices within a short period of time. We can save lives.”
The 3D printed ventilator actuates the action of the bag valve mask. A belt and motor are placed in a housing and the bag valve is placed within the belt. The motor then applies pressure to the belt to deflate the bag and releases it to inflate.
Sensors on the device can give clinicians feedback on pressure and volumetric flow to adjust respiration rates.
Since the device was developed as part of a hackathon, other aspects of the ventilator are still in development. Other engineers can access the open-source ventilator information, including all design files, software and documentation on a GitHub repository.
“The OpenVent project would like to emphasize that the material and documentation for OpenVent is provided with no warranties explicit or implied. No material of the OpenVent project is intended to provide medical advice and all designs are for investigational use only. Any usage of the OpenVent project has to comply with the respective local and global laws and regulations accordingly,” Manuel Hollfelder, an OpenVent project member, told Medical Design & Outsourcing.
As the pandemic continues, many COVID-19 tests have gone through emergency use approval and the FDA has started to relax some of its regulations on ventilators.
“There is no generic and universal answer to this question as the legal situation changes currently due to COVID-19 depending on the country and region,” Hollfelder said. “However, at any time the use of the device has to comply with the respective local and global laws and regulations applicable to it.”
“Generally, the CE mark is required if a device is supposed to be used not only for evaluation purposes by experts and if it is commercially distributed in the European Union,” Hollfeder said. “The CE mark states that the product complies with the respective regulations of the European Union. Without having the full legal background check, we assume that similar regulations like for MIT e-vent and other open-source ventilator projects also hold true for the OpenVent project.”
A team of researchers at the University of Minnesota also recently developed a makeshift $150 ventilator to treat coronavirus. The mechanical ventilator was designed as a compact device the size of a cereal box that doesn’t require pressurized oxygen or air supply.