Oct. 1st, 2021
⚕ Dr. Naoyuki Ishikita ⚕
Meet the 2021 OSMS-BC inventor of the year!
Dr. Naoyuki Ishikita with “E-mail Ventilator“
Q&A With Dr. Naoyuki Ishikita
OSMS: What did you want to do when you were a kid?
Dr. Ishikita: "Dentist (under the influence of my father)."
OSMS: When did you know you wanted to go into the medical field?
Dr. Ishikita: "Lower grades of elementary school student."
OSMS: What inspired you to create the 3D printable ventilator?
Dr. Ishikita: "In 2011, I invented a ultracompact inhalation anesthesia attachment, called “VapoJect" to apply inhalation anesthesia bedside. Japanese precision plastic manufacturing company "NewTon" and Takayuki Fujita (now Coshell Lab) helped my imagination to become reality. Without their help, I was just a daydream believer.
"VapoJect" has 3 key functions of an inhalation anesthesia machine: Gas generation, Automatic ventilation, Gas filtration. It was considered to be an epoch-making product because it can be mass-produced with plastic and has the potential to be used not only in hospitals but also in ambulances, airplanes, emergency disasters, and spaceships. When I was testing the “VapoJect” prototype Ver.3, I was convinced that the automatic ventilation function itself had great potential, and “MicroVent” was born as a spin-off product of "VapoJect".
Both "VapoJect" and "MicroVent" were so small and lightweight that they could be loaded onto spaceships. However, when I heard the news that NASA would launch a 3D printer into space in 2014, I realized that the original design needed to be 3D printable."
System setting of simple inhalation anesthesia system “VapoJect”
“VapoJect” prototype Ver.3
VapoJect’s spin-off product "MicroVent"
OSMS: How did you create the 3D printable ventilator design?
"At first I thought about printing the “MicroVent” as it was, but it didn't work.
"MicroVent" consists of four parts: pressure adjustment handle, body, spiral spring and valve.
Original designs could not be printed by Fused Deposition Modelling (FDM) 3D printers without support materials. Support materials are harmful to astronauts (peeled off support materials float in the cabin), and also the modelling quality is so poor that it requires polish."
State when printing the original design by FDM method
Exploded view of "MicroVent"
OSMS: What were your biggest challenges in creating the 3D printable ventilator?
Dr. Ishikita: "Biggest challenge was to invent a method for manufacturing spiral springs, second was to improve the design that could be printed without support material."
OSMS: How did you overcome unsuccessful results and remake to create the 3D printable ventilator?
Dr. Ishikita: "For spring making, we tried many prototypes with various shapes and thicknesses, but none of them was satisfactory. I changed my mind and changed to a method of winding and fixing the filament itself, which is the material of 3D printing, along the groove of the 3D printed frame, and applying heat to shape it. And finally succeeded in manufacturing a perfect spring.
FDM method cannot hold the melted filament in the air, so we arranged the original design to gradually enlarge or reduce the printed surface in order from the bottom. And finally succeeded manufacturing without support material."
Examples of support-less design
A new spring manufacturing method using 3D printing filaments
OSMS: How long did it take to design and create the 3D printable ventilator?
Dr. Ishikita: "More than 2 years for designing "E-mail Ventilator" and "VapoJET". The "?VENT " took another six months from there.
World's first 3D printable ventilator “E-mail Ventilator” space transmission experiment
3D printable VapoJect “VapoJET” setting example
OSMS: How much does it cost to produce a single "?VENT"?
"Total Filament weight of the filament is 114 g, which costs about $3.00 USD.
Total print time is 14 hours."
State of print setting
“?VENT”, a 3D printable ventilator
OSMS: How does the "?VENT" compare to the top of the line electric ventilators used today?
Dr. Ishikita: "Although it is inferior to general electric ventilators used today, it does not use electronic components, operates only by air pressure, and can be manufactured at ultra-low cost.
It can be disposable and is useful for temporary emergency use and use during MRI examination (Magnetic free)."
OSMS: Where do you see the biggest potential for "?VENT"?
Dr. Ishikita: "With a 3D printer and internet access, we can manufacture "?VENT" anywhere on the earth. Yes, even in space."
OSMS: What made you decide to make your design open source?
Dr. Ishikita: "Helping people is natural. After many years of research, I finally have the opportunity to help others."
OSMS: What partners have you had in the open source community and how have they helped further your mission?
Dr. Ishikita: "OSMS-BC is the only partner I have at the moment outside of Japan, and I need more.
Social implementation of conventional medical devices requires a wide range of processes such as development design, non-clinical / clinical testing, IP management, acquisition of manufacturing and sales business, establishment of production and sales system, manufacturing and sales approval application, insurance approval application, etc. And More, a large amount of funding is needed.
Since “?VENT” is also a medical device, it requires the same or higher process and cost as conventional medical devices."
OSMS: How has the "?VENT" changed the field of medicine since COVID-19?
Dr. Ishikita: "Unfortunately, nothing has changed yet in the medical field.
Technically, it can be manufactured all over the world, but it can only be manufactured by a licensed manufacturer by the current laws and regulations. Therefore, it is stipulated to export from Japan. This wastes the greatest benefits of 3D printing.
There is no precedent for regulatory approval of 3D printed medical devices, so it must be deployed in five steps.
#1. Obtain regulatory approval for a product “MicroVent V3” with the same principle as a 3D printable ventilator, (We are here! Thanks to the donations of volunteers and the support of the Japanese government, we obtained domestic approval in June, 2021.)
#2. Obtain regulatory approval for a 3D printable ventilator “?VENT” from a licensed manufacturer,
#3. Obtain permission to use the same model of the 3D printer used by the licensed manufacturer elsewhere,
#4. Obtain permission to use 3D printers made by other companies,
#5. Overseas expansion (in the same process)."
"Microvent V3" (mass production model)
“?VENT”, a 3D printable ventilator
OSMS: What colour of your product do you like the most?
Dr. Ishikita: "Blue. It is a symbol colour that encourages us to fight against COVID-19 all over the world."
OSMS: What other designs have you worked on that you are most proud of?
Dr. Ishikita: “SPUTA VACUUMER”, a novel aspiration device for Sputum. It was first developed with a 3D printer, and then upgraded to a plastic mold injection model. We believe that the widespread use of this invention will dramatically reduce patient distress and prevent it from becoming more severe.
OSMS: What advice do you have to new 3D printing designers?
Dr. Ishikita: "Solve inconveniences with a simple design or idea as much as possible. Many 3D printing projects do not work on their own and require electronic components."
OSMS: I acknowledge that the "?VENT" can be recycled. However, when do you know it is time to change to a new device?
Dr. Ishikita: "The durability test is currently underway, and it has exceeded 10,000 hours. However, I am worried about the deterioration of the spring due to the warm and moist exhalation of patient. I recommend replacing spring with a new one every 24 hours."
OSMS: How do you think 3D printing has changed our society?
Dr. Ishikita: "There is no doubt that 3D printing technology will be indispensable for future long-term manned space missions.
Even on the earth, we can highly appreciate the shortened prototyping time, enables small quantity on-demand production, and the reduction of distribution and manufacturing costs."
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