Anyone here working on a ventilator design?

Keith Tanner said:

alfadriver said:

Seems to me that another option instead of actual ventilator is to make remote breathing devices- much like what some use for painting a car.  Which can be very helpful for the people working in the screening area.

Use a stander HEPA filter that can be changed every once in a while.

That can be 3d printed.

That's what the Ford sketches are right now, yes? Basically a positive pressure hood driven by an off-the-shelf fan and running off a work tool battery. It's a good idea to help protect those who are caring for the sick.

I was hoping to hear details of that this morning, but that was not part of the meeting..  Oh, well.

The idea of running it off a tool battery is excellent. Chargers and batteries are in good supply.

Doing a few things with GM on this application.  Seems interesting but not clear how this gets managed from a regulatory standpoint.

I think at this point they are coming out of the woodwork. The Dyson vacuum guy designed and approved one in a couple weeks and is churning out 15000 of them.

bearmtnmartin said:

I thought my factory was going to get on board but they decided not to. So I am working with a couple friends to come up with a simple emergency ventilator for Covid patients. I have a relative who is an intensivist specializing in lungs and she is giving us some solid medical advice so we do not go barking up pointless trees. It may get no farther than a clunky old thing made of cast off plumbing supplies, but after a few days of studying and thinking I have a basic idea mapped out. It is a really interesting project, and it looks like there will be a need for quite a few of them in the coming weeks or months. If you are interested, I know there are lots of very smart and mechanically inclined people on here. 

https://cdn.fs.agorize.com/eeVFkxUWQgSQRR9b6Q5K

If you Google Bird Mark 7, or look at some of the ones sprouting up on the webs and tubes, you will get an idea what is required. At a minimum people are starting to reproduce some of the necessary valves and other components. 

I work for a big Med Device company but I work for a different business unit and don't have any connection to the group that builds ventilators. Send me a PM, I'm happy to spend some time on the phone to help identify any roadblocks you may incur.  

I don't work in R&D, manufacturing or regulatory, but I do have a good understanding of what's required to develop and sell (or distribute or donate) ventilators.   I have had lots of interaction w/startups so I'm aware of the typical problems they encounter.   

If you haven't already been in touch w/the FDA, I recommend doing so ASAP.  "New" ventilators or manufacturers can get approved through an emergency process that should be much quicker than the typical 510k.  Be sure to ask what kind of data/testing they'll want to see to grant an approval quickly. After reading their emergency enforcement guidance, they're allowing similar devices to be marketing under new claims or CE mark products to be approved quickly.  Some people seem to think that the exemption is more broad than it really is.  The exemption is more around claims and indications than exempting new devices.  I haven' tread the full guidance, but I expect they'll still required the devices to be assembled in a facility registered w/the FDA.  Also, hospitals are directed to only use these exempted products as a last resort.  Shouldn't be an issue, since many hospitals are already piggybacking their existing equipment w/multiple patients.  

I can't stress how complicated it is to manufacture and safely sell medical devices. FDA regulations and requirements can be overburdensome and sometimes contrary to common sense...but they also help ensure that patient safety is maximized.  If a device is pumping air into someones lungs, they'll likely expect to prove the filters are effective.

Per the disposable products that actually touch a patient:  Anything that should be sterilized should have the sterilization method and packaging design validated.  This means you run a batch of the product through the process and test at different increments to make sure there aren't any bugs growing.  You'll also want to check for offgassing, biocompatibility, etc.  Obviously, in an emergency you do the best with what you have.  If all you have ar e3D printed parts run through an autoclave or an alcohol bath...you use it.  

There are a lot of big players getting into it. I doubt any home designed 3d printed product is going to make it into production or large scale use. 

Ford joins Tesla and GM in helping with ventilator and mask supply

I also think there is a big demand for a real low tech ventilator solution for all the 3rd world countries , 

Something out of the 1960s  that is old design but still works , the Volks Ventilator (TM)   !

californiamilleghia said:

I also think there is a big demand for a real low tech ventilator solution for all the 3rd world countries , 

Something out of the 1960s  that is old design but still works , the Volks Ventilator (TM)   !

More of them around then you'd think; problem is, most of the old vents are powered by pressurized air and not electricity (aka from a D-sized oxygen bottle tank) to keep them simple, and giving someone 100% oxygen even for short periods can really mess them up.

I don't think printed PLA(?) plastics can withstand a trachoma or the constant force of the throat muscles on it, and I'm not sure how you'll 3D-print a plastic material to be sterile.

In Italy several maker labs and 3D printing services self-developed 3D parts to produce or turn existing products into life-saving items. For example, a company designed a 3D printed adapter capable of turning Decathlon's snorkeling mask into a ventilator.

FWIW - In This thread I saw a link for making masks. A nose wire will make it seal much better.

I found 1/16 aluminum tube in the model section that seems to work pretty good.

I have aluminum wire strands from some mains power cable but it is too stiff.

FYI:  

Medtronic Shares Ventilation Design Specifications to Accelerate Efforts to Increase Global Ventilator Production

DUBLIN, March 30, 2020 (GLOBE NEWSWIRE) --  Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it is publicly sharing the design specifications for the Puritan Bennett™ 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help doctors and patients dealing with COVID-19. This decision is consistent with the recent FDA Guidance and in accordance with the public health and medical response of governmental agencies globally.

Introduced in 2010, the PB 560 is sold in 35 countries around the world. This ventilator’s ability to be used in a range of care settings, as well as its technology and design, make it a solid ventilation solution for manufacturers, inventors, start-ups, and academic institutions seeking to quickly ramp up ventilator design and production. PB 560 product and service manuals, design requirement documents, manufacturing documents, and schematics are now available at Medtronic.com/openventilator. The PB 560 design specifications are available today, software code and other information will follow shortly.

The PB 560 ventilator is a compact, lightweight, and portable ventilator that provides airway support for both adults and children. It can be used in clinical settings and at home and provides mobile respiratory support.

“Medtronic recognizes the acute need for ventilators as life-saving devices in the management of COVID-19 infections. We know this global crisis needs a global response. Over the past few weeks, we have ramped up production of our Puritan Bennett™ 980 ventilators. But we also know we can do more, and we are,” said Bob White, executive vice president and president of the Minimally Invasive Therapies Group at Medtronic. “By openly sharing the PB 560 design information, we hope to increase global production of ventilator solutions for the fight against COVID-19.”

Ventilators play a critical role in the management of patients with severe respiratory illness, such as COVID-19, who require assistance because they cannot breathe effectively. By placing a patient on a ventilator, the patient’s lungs are permitted to rest and recover while the ventilator performs the functions of supplying oxygen and simulating the actions of breathing. Without ventilation support, some patients with severe respiratory disease might not survive.

I work in med device R&D but not ventilator type stuff......lots of rules to keep people safe.  Anyway my bother asked me the other day if all the CPAP machines out there could be used and to bring to back to motorsports the answer is yes and Mercedes F1 has build one and gotten it approved in the UK and is ready to produce them from what I read.

Mercedes CPAP ventilator

In the US something like this at this time with such need would fall under what is called "compassionate use"...which means they give you permission to sell/use it even though it hasn't completed all the safety testing because the people who need it will die without it so safe or not is basically irrelevant...if there is a good chance it will help you get a chance to prove it does.

In reply to mke :

That's interesting.  Roughly 1/2 the people who try CPAP stop using them...so I imagine there's a few hundred thousand machines that could be modified (not counting the available inventory of the big CPAP mfgs). 

Not quite related, but Jim glickenhouse  has been sharing DIY instructions for making an N95 mask using a full face snorkel mask.  It seems like it would fog up and/or be too restrictive for regular use...but I suppose they've done some feasibility to show it works.   The device hasn't been approved by the FDA, so they can only show how to DIY it.

In reply to Hoondavan :

That is more like a gasmask, an N95 is just nose/mouth and doesn't include eye/face protection.  Cool idea. 

My last job was at a company that made gas masks and fire rescue type breathing systems but I was only there for 6 moths (what a f'ked up place) so I have some experience but not a lot......I do however have 4 gasmasks (to of the US military M50 design and 2 older stles ones) I bought home for holloween (the oler ones look scarier) but felt wearing one out in public with a hazmat suit was overkill and would scare the bejesus out of people around me :)

As an aside, I mean Jim years ago...nice guy with some VERY cool cars.