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#110001 - 10/21/13 05:20 PM Beyond the Selectif Pro – viability of ultrasound
korkskrew Offline
Contributor

Registered: 12/30/10
Posts: 39
I’ve been pondering this for a couple years, and I want to act on it now.

What I’ve been pondering is the failure of the Applisonix Selectif Pro device. When I first saw it, I thought it was a brilliant idea (in part because it was something that had kind of been brewing in the back of my brain for a while). In fact, researching it is was what brought me to hairtell in the first place.

Obviously it wasn’t that brilliant but it left me wondering “why?” - it should have worked. Dee Fahey posted a link to an article from a critic, who was trying to explain why it shouldn’t work but actually further convinced me that it should have worked.
... Hair is made of keratin, a fibrous protein. This composite material is very strong and elastic, but it neither conducts electricity nor radiofrequency and even less ultrasound. ...

Since hair is an electrical insulator, the comment is true of electricity (which includes radio frequency), but the properties of “very strong and elastic” are exactly the properties that make something a very good conductor of sound (or ultrasound) energy. The critics phrase “and even less ultrasound” simply reveals a lack of understanding, of the difference between electrical energy and ultrasound energy.

Conceptually, ultrasound is basically just another thermolysis method. Using ultrasound to heat things is a tried and true technology, especially in the area of ultrasonic welding. You know how your palms heat up when you rub your hands together? Imagine being able to rub them thousands of times faster. That would get pretty hot, right? This is sort of how ultrasonic welding works. The ultrasound vibrations cause friction heating between the two pieces that you want to weld, and melts them together. The limitation of ultrasonic welders is the amount of energy they can transmit to the parts being welded. This is why ultrasonic welding is usually reserved for plastic parts or very tiny metal parts. Still, ultrasonic welders routinely produce temperatures of hundreds of degrees so it should be no problem for them to cause a thermolysis reaction, which happens at 66 to 98 degrees Celsius (150 to 200 degrees Fahrenheit).

The contradiction between what I expected and what really happened made me go back and look critically at the Applisonix device and why it failed. An ultrasonic welder uses a transducer to vibrate a horn. The horn is used to focus the vibrations where the heating is desired. What Applisonix tried to do was use the hair as a horn to produce heating in the follicle. This is what the verbiage in their marketing material about “waveguides” is. That is what the horn is in an ultrasonic welder; a waveguide. It guides the sound waves where you want them.

I think this is the main error Applisonix made. Designing waveguides is straightforward, but precise work. The length, width, and sonic velocity all combine to produce a waveguide that works for a very specific frequency. All three of those properties can vary a lot from one hair to another on one person, not to mention how much hair varies from one person to the next. Based on what I read in their patent, Applisonix tried to accommodate these variations by making the frequency variable, but I don’t think they were able to accommodate enough, which is what led to the spotty results and different reports of success or failure.

On top of all this, Applisonix had some major failures in business strategy and execution, and I fear it may have made it impossible for another ultrasonic device to succeed in the market place. This is why I’m posting; I want to find out if I should pursue my ideas for correcting the deficiencies in the Applisonix design.

I’m sure it can be done, and I’ve been thinking about the how of it for two years now. I have an idea for a device that will produce more consistent heating in the follicle, as well as eliminate the need for extensive training and practice to operate it, thus making it a good device for DIY. It will extract hairs automatically so it functions more like an epilator rather than tweezers. This way, a lot of hair can be treated quickly. It will also eliminate the risk of burns to the person using it (which was a flaw associated with the Applisonix design). Skin and hair color are irrelevant when it comes to ultrasound, so it’s more broadly applicable than laser.

On the down side, it can’t be as effective as electrolysis because it is strictly thermolysis (though it should be as effective as laser). It wouldn’t be as fast as laser, but it should be a good deal less painful because the heating is limited to the follicle rather than the entire epidermis. The ultrasonic transducers usually have a short life time so there is a certain level of maintenance involved to keep the device working. It will be about the size and weight of a smallish personal trimmer, but will require an electric cord. The hair would have to be allowed to grow to 3 or 4 millimeters (about 3/16 of an inch) for the mechanism to be able to grab the hair and effectively get the ultrasound into it.

The device I envision would slide slowly along the skin so the hairs slip into a very thin slot at the tip of the device. The device would tug slowly and gently on the hair while it heats the follicle. When the follicle has been heated enough, the hair will release and be extracted. The slot will be 1.5 to 2 cm wide (about 3/4 of an inch) so many hairs can be treated simultaneously. It will be safe to use on any part of the body. The same effectiveness should be expected as that of a well done laser treatment or conventional thermolysis treatment.

Here's the stinker. I have worked this idea out as far as I can without consulting expert ultrasonic engineers. I have selected an engineering company that specializes in the type of ultrasonic design that I need. It will require a fair chunk of money (about $50,000 I think) to pursue this to a level where I have something I can test in real life to see if it works the way I expect. Since the outcome is hoped for, but still unknown, I hope to fund this next step by crowd funding. Kickstarter will not accept any projects that are medical devices or anything to do with cosmetics, so I think this project will be a tough sell to them. I don’t really know where else I would go, but without the power of Kickstarter behind it, I will need help getting the word out to get the needed funding for a test prototype. As with any crowd funding effort, I plan to be very open and transparent about the non-proprietary information, and progress of the testing afterwards.

I invite any suggestions, questions, comments, or criticism of this idea, but constructive suggestions, questions, comments, and criticism are most welcome. wink Any ideas concerning funding are especially welcome. I have a hell of a time asking for money, especially when I don't plan to offer anything in return. I really have no idea how I'm going to put the money together to get a prototype to test.

Thanks for reading this really long effing post.

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#110119 - 10/25/13 07:50 PM Re: Beyond the Selectif Pro – viability of ultrasound [Re: korkskrew]
korkskrew Offline
Contributor

Registered: 12/30/10
Posts: 39
Wow. Nothin huh?

I didn't quite expect nothing. I guess I'll have to reconsider pursuing this. It's weird, because the friends I've told about this seem to think it's a pretty good idea.

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#110125 - 10/25/13 08:57 PM Re: Beyond the Selectif Pro – viability of ultrasound [Re: korkskrew]
SeanaTG Offline
Top 10 Contributor

Registered: 08/13/13
Posts: 988
Loc: The Great White North eh
unless you have a patented working prototype, you have nothing. Most folks here are intereated in proven technologies. Have you done a patent search to see if applesonix patented their technology? There is likely to be legal questions in peoples minds as well. That, and is the device proven to function without causing damage? FDA approval is a HUGE hurdle. I think this is out of scope for most people here honestly.

Seana

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#110150 - 10/26/13 03:52 PM Re: Beyond the Selectif Pro – viability of ultrasound [Re: SeanaTG]
korkskrew Offline
Contributor

Registered: 12/30/10
Posts: 39
Well, that was pretty much the point of my posting. It's going to take everything I have to pursue this to the point where I have a prototype that I can test. I don't want to put my family at that kind of risk if there is no potential for it in the market place.

I have already consulted with a patent attorney, and I don't see any risk of running afoul of the Applisonix patent. As I said, they chose a method of using ultrasonic that I think has a serious flaw. I inte3nd to use a different approach. I don't see much value in trying to patent my idea, first because I'm intending to do this out in the open, so that will invalidate a patent application right there. I won't be able to get crowd sourced funding if I don't though. Second, I don't see a patent having very much value on this project. The thing with the engineering company will keep that part of the design secret, and the rest is pretty much commonly known anyway.

FDA approval may or may not be an issue. I can get a class A approval in about 18 months after I have a prototype. This is pretty easy because there is no proof of efficacy required. I just have to show it does no harm. I think Applisonix ran into FDA problems because they were from Israel and didn't really understand the FDA system.

A class B approval will take longer to get because I would have to show proof of efficacy. I imagine that will take about three or four years to compile all of the data an d get the approval. I don't know if it's worth it to go that route.

You're probably right about this being kind of out of scope here, but I don't know where would be a better place. For now, I'm just trying to gauge the interest to see if it's worth the risk. So far, it looks like it isn't.


Edited by korkskrew (10/26/13 03:56 PM)

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#110151 - 10/26/13 04:04 PM Re: Beyond the Selectif Pro – viability of ultrasound [Re: korkskrew]
SeanaTG Offline
Top 10 Contributor

Registered: 08/13/13
Posts: 988
Loc: The Great White North eh
For about two years, I worked technical support for pfizer ( a drug company) . One of the most severe classifications of cases we would get, involved applications for FDA approval. These applications, would have to be submitted using a particular template. It literally cost them upwards of 20 million dollars EVERY TIME they made one whether or not it was successful. They were extremely specific. A lot of these cases, would end up on my desk as senior technician. It was so particular, that even for example having a margin changed by 1/10th of an inch in a document template, was enough to invalidate a 20 million dollar FDA application and it COULD NOT be resubmitted if they got it wrong. And this was a company that made applications for the FDA on a daily basis, and were good at it and knew EXACTLY how to proceed.I worked with doctors and clinical scientists on such projects on a daily basis. So forgive me when I hear you say that you can learn to do this, in 3 years, 5 years, or even a lifetime, I take such an assertion with a grain of salt.
Save yourself, and your family, a lot of heartache.

Seana


Edited by SeanaTG (10/26/13 04:08 PM)

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#110236 - 10/30/13 07:38 PM Re: Beyond the Selectif Pro – viability of ultrasound [Re: SeanaTG]
korkskrew Offline
Contributor

Registered: 12/30/10
Posts: 39
@Seana
Sorry about taking so long to reply, but I wanted to go over my FDA research again to make sure I wasn’t as mistaken as you seem to think.

Drug applications, such as those Pfizer would be doing, are necessarily subject to an extremely long, strict, and rigorous approval process, but that is not the only process the FDA uses. Their various processes generally reflect the magnitude of the consequences if they are wrong to approve it. “Medical devices” fall into a variety of classes depending on their intended use. Implantable devices, and things like defibrillators are subject to a process almost as stringent as that for drugs.

Devices like tweezers, or electric clippers, or substances like lotions or cosmetics are subject to a much less strict and much faster process. This is the class (called class A in the FDA regulations) that I would think would apply to my idea because it is completely nonintrusive in its function and operation. There is some risk that class B regs would apply since there is a possibility of a permanent effect on hair regrowth. If so, the process is longer and more rigorous, but still nothing like that needed for drugs or implantable devices. I’ve gone over this with a colleague who has worked extensively with the most stringent of medical device approvals (that for implantable devices), and he agreed with my reading of the FDA regs without even having to reread them.

I should say, I don’t consider the FDA approval a no-brainer. It will require work and attention, but it’s nothing like the approval process for drugs that you described.

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