Shape metal alloy implant

[dw_william]

I am thinking of going the implant route. Even though they are still working on it, this seems like a much better solution. It's in one piece apparently and is a much simpler surgery than the inflatable device with no pumping to boot.

http://www.sj-r.com/article/20160309/NEWS/160309525

http://www.medscape.com/viewarticle/845706

Has anyone heard of any clinical trials or more recent news about the status of this device?

[Lost Sheep]

Interesting. The article did not appear to mention if this device will prevent one from having MRI (Magnetic Resonance Imaging). And what about the TSA?

Still, a simpler device, even if it takes an external device (and electric power) to activate (and deactivate?) is intriguing.

Thanks for bringing it to our notice.

Lost Sheep

[Boulder]

I can't get into the medscape article but would love to read about it. Is it possible for you to cut and past it here? Thanks?

[dw_william]

A pump-free and touchless method of activating a nonhydraulic penile prosthesis seems to perform as well as any hydraulic inflatable prosthesis, and would be much easier for the patient to use and for urologists to implant, an ex vivo study suggests.

"Mechanical devices can malfunction and require revision, which is a negative event for patients," said Kevin McVary, MD, from the Southern Illinois School of Medicine in Springfield.

"Our plan is to prevent such malfunctions," he told Medscape Medical News. And the new device "would make one of the more complex procedures that urologists do one of the easiest, so it could actually be transformative."

In their study, Dr McVary and his colleagues demonstrated that they could repeatedly activate the penile prostheses without pumps or reservoirs.

He presented the results at the American Urological Association 2015 Annual Meeting in New Orleans.

The team used a nonhydraulic shape-memory alloy 22 cm (8.6 inch)-penile prosthesis made out of nitinol, a metal alloy of nickel and titanium commonly used in medical devices. A 1000 W Mini-Ductor II (Induction Innovations, Inc.) and a coil 2.5 cm (1 inch) in diameter was used to activate the prosthesis.

The perpendicular force required to induce the prosthesis to transition from the flaccid to erect configuration was 0.3 kgf, which is comparable to the force required for an inflatable prostheses, Dr McVary reported.

The fully activated device resisted buckling forces of 2.66 kgf, meaning that on penetration, the prosthesis will not buckle or bend and should remain as rigid as current inflatable devices, he explained.

The final temperature reached by the prosthesis at maximum force was 42 °C (108 °F).

"Using a handheld magnetic inductor, we were able to successfully activate the shape-memory alloy penile prosthesis with no direct contract," the investigators report. "The time needed to reach a straight, erect configuration using this 1000 watt magnetic inductor was approximately 120 seconds."

"We have to do some animal studies testing the same technology," said Dr McVary. "We're in the midst of getting that arranged."

"But we found that the operating-force parameters are consistent with current market devices, and future use of a variable power generator could improve response times," he added.

It's long been known that 40% to 50% of men do not respond to any of the PD-5 inhibitors, suggesting that alternative options are needed to improve the treatment of erectile dysfunction.

We know that there's a large population of men who are good candidates for an implant, yet it's a big step.
The number of men who could benefit from a penile implant is much greater than the number who end up undergoing the procedure, said session comoderator Natan Chaim Bar-Chama, MD, from the Icahn School of Medicine at Mount Sinai in New York City.

"We know that there's a large population of men who are good candidates for an implant, yet it's a big step," he told Medscape Medical News.

Having said that, the satisfaction rate for all other therapies use to treat erectile dysfunction is relatively low, at about 50% to 60%. However, if you survey men who've had implants, 80% to 90% say they would do it again, Dr Bar-Chama reported.

Currently, any form of hydraulic prosthesis involves the implantation of several different pieces, along with tubing connecting those pieces.

"Once you increase the number of pieces you put in, you have the potential for malfunction over time and, because of that, there is hesitancy on the part of urologists to proceed with implantation," said Dr Bar-Chama.

Even if malfunction rates with the hydraulic implants are quite low, "the data from this abstract show that when rigidity is achieved, the level of hardness that this implant provides is as good as or better than what we currently have," he said.

"My hope is that because it's a simple unit, it will be embraced by many urologists who are using the multicomponent implants now," he explained. If it is, "more patients who are good candidates for this procedure would be able to benefit from an easy-to-use cosmetically appealing prosthesis that would enhance their quality of life dramatically."

[Lost Sheep]

Thanks for going to the effort to copy/paste the text of the article,dw_william.

The final temperature reached by the prosthesis at maximum force was 42 °C (108 °F).

Kind of brings a new meaning to the phrase "hot rod".

What I did not find in the article or the videos on the web site is any reference to the flaccid state. Does the penis "hang" as it did before implantation? One of the problems with implants is that none on the market today let the flaccid penis be as unobtrusive as it was before implantation. A tradeoff I am willing to accept in return for a working erection, but it is still a tradeoff.

Apparently you activate it by heating with the induction device to 108*F or so. How do you deactivate it?

If the stiffness fades as the temperature drops that might be disappointing. Too fast a drop means one might have to stop in the middle of coitus and "recharge" (if friction did not keep the temperature high ) Too slow a temperature drop might mean extended erection time. And what about a guy who works in a high-temperature environment (foundry, etc)? Could he have unwanted hardness?

Do you (as in thermoplastics) just re-heat and reposition to an equally stiff neutral position? A penis that is equally stiff in a downward pointing direction as it is in the upward direction is barely an improvement over current semi-rigid/malleable implants.

If the rod is loose and flexible and turns straight and stiff when activated and returns to loose and flexible upon some second magnetic induction in the opposite direction, that would be a big improvement. And if there is an increase in girth and/or length when activated, even better.

Then you just have to worry about power outages or losing the induction device.

Would your wife/partner consent to having the induction device implanted? Please forgive my making jokes at the expense of the device. I REALLY DO appreciate advances in technology and do not disparage these scientists' work. Besides, I am sure they have an inventory of even weirder thoughts in their journals.

Lost Sheep

[cumstein]

This device and technology looks promising. If successful, it should be a viable alternative in the future. The issues of MRI, TSA are good questions. I already have a pacemaker so not being able to do MRI's as one gets older, is a real issue. That said, can people with artificial knees etc have an MRI?

I don't have 5 years to wait, so for me its not viable.

[Boulder]

I've heard rumors about this devise for years, I'm glad somebody is doing it! Wouldn't that be nice! Thanks for posting it! Now can you post the video? Sorry, but I can't log in for some reason.q

[densal07]

Are there any news about this?

The last article I saw mentioning this was this one: https://www.mddionline.com/business/som ... rects-heat

However, in 2017 and nothing new since. Anything I missed?

Eitherway I think Lost Sheep has raised some good concerns about this, I really wonder "how long" does it stay heated, as well as how does it behave in warm/hot environments.

[Waqas007]

Same nitinol core is present in tactra

[densal07]

Same nitinol core is present in tactra

That's a different implant. It's not the one that "remembers the shape". Also Tactra is malleable implant, this one is supposed to be inflatable-like, so being different in flaccid and erect state (and requiring induction heat to get erect).

So I wonder if there are any news about this "nitinol implant which gets expanded when heated"?