It’s been only a few days since the world learned about the life-saving effort by a young team of engineers to design and 3D print venturi valves in order to save COVID-19 patients’ lives at an Italian Hospital. As further recognition that 3D printing has the potential to deliver fast solutions in emergency situations, the Isinnova team now developed and successfully tested a 3D printed adapter to turn a snorkelling mask into a non-invasive ventilator for COVID-19 patients.

“In recent days we have been contacted by a former head physician of the Gardone Valtrompia Hospital, Dr. Renato Favero, who got in touch with Isinnova through a doctor from the Chiari Hospital, the health facility for which we were manufacturing the emergency venturi valves,” the Isinnova team writes. “Doctor Favero shared with us an idea to address the possible shortage of hospital C-PAP masks for sub-intensive oxygen therapy, which is emerging as a concrete problem linked to the spread of COVID-19: an emergency ventilator mask, produced by adjusting a commercially available snorkelling mask.”

Isinnova collaborated with Decathlon, the French firm that produces the snorkelling masks. The product was dismantled and studied so that a new component could be used to connect the mask to the ventilator. This new part was named Charlotte valve, and quickly prototyped using stereolithographic 3D printing.

While some designers had already created 3D printable adapters to transform Decathlon-like snorkelling masks into protective PPE masks, the key innovation by Isinnova is that the adapter was modified for the mask to be connected to a ventilator. This way the evolutionary process of the mask has come full circle since the Decathlon mask can be seen as consumer evolution of devices such as the Philips Fit Life mask, which are used for oxygen therapy.

The prototype was tested at the Chiari Hospital, connected to the ventilator body, proved to be working. The hospital was enthusiastic about the idea and decided to test the device on a patient. That test was also successful. However, the inventors emphasize that neither the mask nor the link is certified and their use is recommended only in an emergency situation (which are now increasingly becoming the standard at hospitals around the world). Use by the patient is subject to acceptance of the use of an uncertified biomedical device, by providing a signed declaration.

Isinnova went ahead and urgently patented the link valve (Charlotte Valve) in order to prevent any speculation on the price of the component. “The patent will remain free to use because it is in our intention that all hospitals in need could use it if necessary,” Isinnova stated. They decided to freely share the file for the realization of the link using 3D printing. Unlike the respirator valve, the link is easy to make, so it is possible for everyone that has a 3D printer to try to print it correctly. Healthcare facilities will be able to purchase the Decathlon mask and then local 3D printing facilities can produce the part. “Our initiative is totally non-profit, we will not obtain any royalties on the idea of ​​the link, nor on the sales of Decathlon masks,” the Isinnova founders clarified.

You can download the file from this link in the dedicated section of the Forum, where you will also find a selection of other useful 3D printable files for both healthcare institutions and the general public. Please be advised that some of these files have not been validated for therapeutical use.

This device is not certified. It is recommended, for those who want to use the documentation to replicate it, to avail themselves of the collaboration of specialized technical personnel for the realization and supervision of a doctor for the use. It is absolutely inadvisable to replicate it if you do not have such skills.

Isinnova declares that it releases the drawings, logics and any other intellectual property rights relating to Charlotte valve device is released free of charge provided that it is NOT used for commercial purposes.

The Charlotte Valve 3D printable file available for download.

Document to be signed by the patient for the use of the device in an emergency situation (in Italian, please consult your local authorities)

Isinnova can provide further support and further details to healthcare facilities and makers who want to make the connection, if necessary.