Isinnova have been contacted by a former head physician of the Gardone Valtrompia Hospital, Dr. Renato Favero, who’ve got in touch with the company through a doctor from the Chiari Hospital, the health facility for which they were manufacturing the emergency valves with 3D printing process.
Doctor Favero shared with Isinnova, an idea to fix the possible shortage of hospital C-PAP masks for sub-intensive therapy, which is emerging as a concrete problem linked to the spread of Covid-19: it’s the construction of an emergency ventilator mask, realized by adjusting a snorkeling mask already available on the market.
Isinnova analyzed the proposal together with the inventor. They contacted in little time Decathlon, as ideator, productor and supplier of the snorkeling Easybreath mask. The company was immediately willing to cooperate by providing the CAD drawing of the mask Isinnova had identified.
The product was dismantled, studied, and the changes to be made were evaluated. A new component was then designed to guarantee the connection to the ventilator. They called the link Charlotte valve, and quickly manufactured it using 3D printing.
The prototype as a whole has been tested on one of Isinnova colleagues directly inside the Chiari Hospital, connected to the ventilator body, and has proven to be correctly working. The hospital itself was enthusiastic about the idea and decided to test the device on a patient in need. The testing was successful. The company is 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 company specifies that usage by the patient is subjected to the acceptance of use of an uncertified biomedical device, by providing a signed declaration.
Whereas the effectiveness of the project, Isinnova decided to urgently patent the link valve (Charlotte Valve), to prevent any speculation on the price of the component. They clarify that the patent will remain free to use, because it is in our intention that all hospitals in need could use it if necessary.
The company decided to freely share the file for the realization of the link in 3D printing. Unlike the respirator valve, the link is easy to make, so it is possible for all makers to try to print it correctly.
Healthcare facilities in difficulty will be able to purchase the Decathlon mask and get in contact with 3D printers who could make the piece and provide it.
This initiative is totally non-profit, Isinnova will not obtain any royalties on the idea of the link, nor on the sales of Decathlon masks.
The company indicates that it can provide further support and further details to healthcare facilities and makers who want to make the connection, if necessary.
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 operators 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.
Depending on the needs, the company has identified different configurations detailed in the following diagram.
Following some requests, the company recommends some print settings (not mandatory) for the 3D production of the Charlotte and Dave components for the assisted breathing mask. For the production of these pieces, since high precision is not required, an FDM filament printer with “basic” settings is more than sufficient;
- PLA filament 1.75 mm
- Nozzle temperature: 205 – 210 ° C
- Builtplate temperature: 35-50 ° C
- Layer thickness: 0.2 mm
- Supports: only touching the builtplate.
- Orientation: Charlotte leaning on the terminal plane (as shown in the images), Dave leaning on the larger diameter vertically.
As for the printing material, they recommend the most common filament on the market, the PLA (polylactic); this for several reasons:
- Odorless (remember that patients must breathe air passing through these components)
- The least dangerous possible (PLA is not very dangerous and biocomposable)
- Relatively flexible (must be elastically deformed to be coupled with other components).
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.
Technologies: Other Processing Method