3D Printing ProcessesAM in the time of COVID-19

Isinnova shares 3D printed adapter to turn snorkeling mask into a non-invasive ventilator

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.

 

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Davide Sher

Since 2002, I have built up extensive experience as a technology journalist, market analyst and consultant for the additive manufacturing industry. Born in Milan, Italy, I spent 12 years in the United States, where I received my Bachelor of Arts undergraduate degree. As a journalist covering the tech industry - especially the videogame industry - for over 10 years, I began covering the AM industry specifically in 2013, as blogger. In 2016 I co-founded London-based 3D Printing Business Media Ltd. (now 3dpbm) which operates in marketing, editorial, and market analysis & consultancy services for the additive manufacturing industry. 3dpbm publishes 3D Printing Business Directory, the largest global directory of companies related to 3DP, and leading news and insights websites 3D Printing Media Network and Replicatore. I am also a Senior Analyst for leading US-based firm SmarTech Analysis focusing on the additive manufacturing industry and relative vertical markets.

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16 Comments

    1. Thank you, however, please note that the info in the link you shared is for a PPE respirator (for protection of doctors), while this is an adapter for an oxygen mask which needs to connect to the oxygen flow (for oxygen therapy for patients).

      1. Have they tested this with patients yet?
        Are they looking to get it certified and notify MHRA before you provide it to patients?

        I am currently working on a mask at the moment to use to ventilate patients and looked at 3D printing as a route to produce the components. I have been looking at ISO 18562 Biocompatibility evaluation of breathing gas pathways in healthcare applications. I suggest reviewing part 2 and 3 to make sure the parts are safe to use in this application using 3D printing.

        I am not trying to be dismissive of the idea, I applaud everyones effort in these troubling times I just want to make sure this is safe to use.

  1. Tried printing this. Didn’t fit my mask, there must be a few different designs out there. For FDM the walls need to be thicker to get better air tightness I think. Can I change it to fit my mask please ?

  2. What about using a resin printed version? Tighter tolerances and stronger. Less porous than FDM.

  3. Spiritplumber & Matthew Bellis, keep up the good work. I am just your average tech support agent over the phone for medical hardware. I am loving the ingenuity people are showing.

  4. Could something similar be done to turn this same mask into a protective one for doctors/nurses? In other words, could a makeshift filter be installed at the opening on the top?

  5. As I suspect that many are considering preparing for the worst, I am interested in obtaining the Charlotte valve and the PEEP to try with the mask and my Resmed Airsense 10 CPAP. I, as probably many others, don’t have access to a 3D printer, nor if I did, would I know how to build it from the shared specs. I am super impressed with the collaborative efforts here and believe you all will certainly help save lives. For people like me with no access to a PRN, how can we obtain the Charlotte valve and the PEEP? Can we order and buy it somewhere?

    Second question.. what exactly is the PEEP and how do I know if I should use that or the Reservoir and the Dave valve instead? In looking over the drawings, is the PEEP valve like a Studor valve used in plumbing?

    I know these are a bunch of questions, and I am most interested in how do I obtain the Charlotte valve and a PEEP?

    God bless you all.

    –Eric L from Seattle WA

  6. Eric L
    Did you get a Charlotte valve and PEEP?
    I’m in Portland Oregon and gave the Charlotte valve zip file to RapidMade. They do medical grade nylon parts in 7 days. I made 4 at a cost of Appx $65 each. I found several PEEP’s online and they range in price from $12-75 each. I went to 911EmergencySupply for the PEEP. Also bought 4.
    If you’re not have luck reach out. I have no idea the parts will fit yet. Just not enough info. I’m hoping this will work with a resmed 10 cpap in a situation I would need it.

    Nate H
    Portland OR

  7. I don’t understand what he inverted the valve at the chin. This will allow room air to enter during inhalation. Should it be covered to make it air tight so the oy air is coming from the ventilator.

    Also anyone used it with a real ventilator?

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