CPAP Mask Design Rant to Designers
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CPAP Mask Design Rant to Designers

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Posted by Ducky on May 10, 2004 at 12:31:50:

Greetings Folks, the following is an essay I am posting **everywhere** about my CPAP experience, being recently diagnosed with severe OSA. May it assist us all! Respectfully, Ducky

This essay is addressed to everyone involved in the design and marketing of CPAP masks, headgear and accessories. All of you with hyper vigilant attitudes over patent infringement, bottom line focus, and an obsession with ensuring a proprietary product at all costs, listen up! I am your CUSTOMER. I was recently diagnosed with severe obstructive sleep apnea. I have been through the sleep study. I now own a CPAP machine (a Resmed Elite S7) and am sleeping each night in an Innomed Nasal Aire unit. Reaching this point in my treatment has been more than uncomfortable. It has been infuriating, and most enlightening in a very negative way. I am here today to share this enlightenment with you. Take it as constructive criticism and please, oh please, take it back to R& D because you people really need to examine your design processes.

I have a background in technology. I worked for years as a programmer and IT Director. So it is only natural that when I got my CPAP machine and began trying to use it, I spent time analyzing what it is exactly that we are doing here. I can reduce it to a simple statement. We are creating a pressurized interface between a compressor and a human being. Simple enough, right? One would think so.

However, in all my years of building and installing peripheral interfaces in CPUs, not once did I ever attempt to use suction to attach the interface. Why? A CPU is going to move around in unpredictable ways. People kick Ďem, bump Ďem, knock Ďem over, spill water on them Ė you get the idea. So people, why on Earth would you attempt to use suction to interface a compressor with a squirming, writhing, fidgety human being? Itís like trying to attach a printer to a water balloon with a suction cup and expecting to still get a data signal from the balloon. Talk about an exercise in futility.

The more I looked at it, the more I realized that the product you are attempting to deliver in this interface (compressed air) has a lot of similarities to data. Itís invisible. It is devastatingly easy to corrupt (pressure loss, leaks, etc.). The critical part of the problem is obvious Ė you must have a solid, incorruptible point of interface. In the world of computers, thatís why we have 25-pin, 9-pin, parallel and USB connectors. They are internal to the port. And that internal quality is what makes them work. Seems to me, the CPAP problem has the same requirement.

One of you has figured this out Ė Innomed Technologies. My Nasal Aire unit comes down to the medical equivalent of a two-pin connector plugged into my nasal port. It works effectively, all night, every night. And that is because Innomed understands the basic problem better than any other CPAP mask manufacturer out there.

But what I donít get is why this problem is so difficult for the rest of you to understand. Due to the fact that Innomed is so busy suing the pants off the maker of the Spiritus (also a two-pin nasal interface mask) that they could not ship my Nasal Aire unit in a timely manner, I had the unenviable opportunity to try out a couple of other masks before I got my Nasal Aire. Both used the suction methodology of interface.

I suppose I have them to thank for being able to analyze the CPAP algorithm so thoroughly. When it is impossible to sleep you have a lot of time to think. The mask I used most that first week was a Resmed Mirage Vista model. The nosepiece on this thing is pretty good. I have to give you that. It has a dual layer of plastic in it that creates a truly bodacious seal around the nose. It is also soft enough that it doesnít dig holes in your facial tissue (like the first mask I tried did). However, the headgear is abominable!

The Mirage Vista has a kind of ďcranial cageĒ style headgear with adjustable straps across the top of the head and the back of the head. These are made of a stretchy, spandex/neoprene kind of material that is very soft. But it also has a rigid framework in the front that holds the mounting brackets for the nosepiece. I suspect this framework is the only reason that nosepiece works as well as it does. The rigid material runs underneath the ears. While it is backed with the soft spandex stuff, the rigid material is not covered and has rough edges. I think you folks thought that by putting the backing on it, that the end user would never have an issue with the rigid material.

Obviously, your engineers never slept in it. The whole unit rides up when you lay on a pillow and do what humans naturally do when we sleep Ė squirm around. When the unit slips upward on the head, the rigid framework comes in contact with the ear lobes in rapid fashion. As the night wears on, the squishy spandex stuff gets compressed and the rigid, sharp, rough edge of the superstructure starts digging into the tender posterior portion of the ear lobes. You tend to wake up at 3:00 a.m. feeling like your ears are being ripped off your head!

It did not seem to matter how many different ways I adjusted the straps on the thing. It still rode up and crushed my ear lobes. I had sore ears that entire week. The last night I wore this mask, I ended up putting a thick athletic sock over each ear to try to stop the problem. Well, the socks rode up as the mask did. I stopped using my CPAP machine entirely after that night and waited for my Innomed rig to arrive.

You need to cover that hard superstructure completely with a softer-than-soft padded material. Because no matter how good the seal on the nosepiece, when the headgear hurts that bad, the end user is going to be yanking and pulling at it all night and the obvious will happen Ė you will lose the interface.

Of course, to my line of thinking, even with a good seal, you are still approaching the problem from the wrong direction and are bound to create something uncomfortable as long as you persist in using suction methodology.

Now, before you start complaining that end users donít want the invasive feeling up something up their nostrils, I would urge you to take at look at Innomedís product. (I would also urge end users reading this who feel squeamish about the concept to at least try it for a night Ė if youíve ever used an oxygen cannula, this isnít much different.) Pay close attention to the material used in the nasal plugs. That has to be the softest, most pliable plastic Iíve ever encountered. If you want a real research and development project, jump on trying to figure out how to reduce the size of those plugs while still maintaining proper pressures and keeping the material soft and pliable. Plastics technology is a booming industry with all sorts of potential. Put it to use. No telling what kind of improvements you could come up with.

Now, Innomed, this is specifically for you. Iíve read all about your lawsuit with the makers of the Spiritus mask. What I want to know is how come the original designer of the oxygen cannula isnít suing the pants off of YOU? Did the patent expire? Because all the Nasal Aire unit is is an oxygen cannula on steroids. Thatís all youíve got there. Thatís also why it works so well. The cannula idea is NOT your original idea and I think you are being greedy and pompous in demanding that it be treated as proprietary. Instead of stepping up to the plate and going full bore with enhancements to make YOUR nasal interface the BEST available, you are playing schoolyard bully and refusing to share the playground.

In the end, that kind of litigious and greedy attitude hurts ME, the consumer. And Iím already sick of paying more for everything because of corporate greed. Get over it, Innomed. Take a more global and compassionate view. Let the other kids play with the ball. Learn from what they do and let them learn from what you do. In the end, you are all going to make money because those of us with sleep apnea are a captive market. We HAVE to have this interface and we have to make it work. Our lives depend on it. You need to keep that idea as your central focus.

So there is some enlightenment for you straight from the horseís mouth (nose?) and end userís direct experience. Innomed has the right idea and the wrong attitude. The rest of you need to think about my analogy of computer peripherals as you try to improve your product. The rest of you also need to have all your research and development staff SLEEP in the headgear you are sending to market. Believe me, they will improve the design in a hurry once they spend the night with it.

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