Last week, while the COVID-19 pandemic was entering a decisive phase in Italy, a group of engineers from Isinnova faced deadly circumstances and saved the lives of people who could be brought to respirators by their valves made by 3D printing technology. This achievement have been covered by media around the world, and their actions inspired thousands of people who decided to use their 3D printers to create the most diverse health protection measures – masks, face shields or functional tools hindering the spread of coronavirus. Now the Issinova team is back with another project that once again has the chance to help medical staff save patients’ lives.
It started with former head physician of the Gardone Valtrompia Hospital – Dr. Renato Favero, who contacted Isinnova with an idea to fix the possible shortage of hospital C-PAP masks for sub-intensive therapy. Together they analyzed the possible sloutions and came to the conclusion, that the easiest and fastest way to solve the problem is usage of existing products and adapting them to more advanced needs. They picked Decathlon’s “Easybreath” snorkeling masks as source design.
When the previous time Isinnova engineers took up 3D printing of the missing valves to respirators, they were exposed to legal threats from their manufacturer, who wanted to accuse them of patent infrigement. This time there was no such problem – Decathlon shared CAD files and supported the team. The mask was dismantled and studied. Then the new component was designed to guarantee the connection to the ventilator. Final step was 3D printing the prototype and testing it. The test was run at Chiari Hospital and it proved the mask is working correctly.
This is an idea brilliant in its simplicity. Relatively cheap, it does not require any permanent alterations to the mask, so after the epidemic is over, you’ll be able to go diving with it as part of your relaxation. Such DIY mask can be used in two ways: as a above, as a mask for non-invasive ventilation of the patient, it allows the administration of oxygen and maintaining positive end-expiratory pressure (CPAP) and the administration of an oxygen-enriched breathing mix. The set also needs to add a venturi vent (available in DIY version), an oxygen source and a positive pressure valve (PEEP), the latter element can be replaced with a regular water bottle.
Another way to use it consists the fact that the direction of the valves does not change, but an antibacterial filter is mounted on the pipe for taking air from above the water surface. Then such a mask is used to protect personnel.
The company is aware of all the functional flaws and imperfections of the resulting product – it currently has no certification and is not approved for use as a biomedical device.
We’are reiterating that the idea is designed for healthcare facilities and wants to help in realization of an emergency mask in the case of a full-blown difficult situation, where is not possible to in find official healthcare supplies. Neither the mask nor the link are certified and their use is subject to a situation of mandatory need.
The consent for the patient and the procedure illustrated below refer to the laws of the Italian state, we do not know if they are also valid abroad. It is reccomended to evaluate the eventually compliance of the device to the local laws.
Authorisation for the compassionate use of medical devices without CE marking for the intended purpose requested.
In exceptional cases of necessity and urgency, in the interest of protecting the health of an individual patient and in the absence of viable therapeutic alternatives, a medical device without CE marking for the proposed indication may be used for compassionate use.
The Isinnova team recommends 3D printing Charlotte valve with PLA with standard settings, and 0,2 mm layer. It consists of two elements. 3D printing time is about 6-7 hours depending on the 3D printer and advanced settings.