Bstent: A Tiny Device With a Huge Impact on Rhinoplasty Recovery [Bahman Guyuron, MD]

Eva Sheie (00:00):
You're listening to Where Before Meets After. Okay, we're back today to talk about your invention, the Bstent, conjoined nasal stent. What is the Bstent?

Dr. Guyuron (00:13):
Whenever we do rhinoplasty, that includes surgery on the septum, we need to eliminate the space between the layers of the septum. There are available stents that serve that purpose and we've been using them for decades. But the problem is that those stents have to be sutured in place, otherwise they can migrate, the patient can swallow it and also obviously the purpose would be lost. And it got to a point that it kept think about what is that I can do differently to prevent that? So I came up with this idea of Bstent, which the number one advantage of it is that it doesn't need to be sutured in place. And it really in a way has revolutionized my postoperative care of the rhinoplasty patients that need septum surgery, which is overwhelming majority of the patients who undergo rhinoplasty because we do septoplasty to improve the breathing, we also, even on patients who do not have deviated septum, need some cartilage. That cartilage comes from the septum and if we don't eliminate the space between the layers of the septum, the patient is going to accumulate blood and that will convert to the scar tissue. So it can actually cause breathing problems or if it can get infected, it can cause perforated septum. So we need to eliminate the dead space by some means. And this is the best way.

Eva Sheie (02:23):
How long did that take from the beginning until having something you could use?

Dr. Guyuron (02:28):
From the time that I started thinking until the device was on the market was close to two years. Because this is something that FDA doesn't need to be approved, it has to be registered by the FDA. And also in order to do that, we have to make sure that sterilization is proper, even packing is proper. Where the device is being built is American and the manufacturer is registered with the FDA. So it is medical device invention it is extremely complicated.

Eva Sheie (03:22):
What does it look like? Can you show it to us?

Dr. Guyuron (03:25):
This is the device. So there is something like in the market that we've been using it for decades, but this device has this, it has also this component. Then the two sides are joined in the center with this bar that sits on the right over the base of the nose and doesn't let the stent to migrate deeper. And because of this connection, we don't need to suture it in place. And the reason that I added this segment to it is to be able to take away any dead space or unused space between the skin and deeper layers in the tip area. While this part takes away the dead space in the septum, it doesn't take away the dead space in the nostril area or the tip area. When the blood accumulates in the tip area under the skin, it can be problematic. It can turn into scar tissues and cause what we call super tip deformity, fullness, cause excessive swelling, delayed healing, and delayed absorption of the swelling.

(05:09):
This part serves to eliminate any dead space between the skin and underlying layers. We have just finished a study looking into any adverse effects or any problems, any issues. And none of our patients had any problems, out of 112 patients that we included in this study, four patients had it removed by somebody else and that somebody else happened to be the family member who was plastic surgeon brother, their spouse or something like that, close family member. And since they were together, they just removed it. The rest for out of town patients, they removed it. That's over 60 patients that were from out of town, out of country, they removed this without any problems. As you can imagine, it saves a lot for the patients also. They have to make an appointment, go to see another doctor to remove it. It takes literally 10 seconds to remove. All they do is just catch this end and slide it out. And because of the silicone nature and moisture inside the nose, there's no resistance. There's nothing is going to keep it from coming out. But on the other hand, there are enough connection between this device and the internal structures. There's enough contact that doesn't get dislodged by sneezing, coughing. And even if it does, it can just gently be pushed back, which is extremely unlikely.

Eva Sheie (07:15):
Are you using it on pretty much every nose surgery now?

Dr. Guyuron (07:22):
Essentially, yes. Unless we doing just some minor refinements on the outside of the nose and we don't need harvest cartilage from the septum and we don't need this device. And even on the majority of those patients that I need to do just some minor refinements, I actually use this part to control the nostrils, keep the nostrils open so that it doesn't, it helps the nostrils, so the valves do not collapse, the cartilages heal nicely. I have designed the end of these, the shape of the nostrils. So they actually emulate the shape of the nostril very closely and they control shape of the nostril while it is healing,

Eva Sheie (08:12):
Does it prevent any kind of complications that are common after surgery? Does it have any kind of preventative aspect to it?

Dr. Guyuron (08:22):
The biggest issue that this device can prevent in terms of design, I have designed in such a way that it has angulation because the nostril orientation with where this should end up being are not on the same plane. One is more of a, like nostril is like this, but the space inside the nose is curved. So this flexible joint allows the internal stent go exactly where we want. And also if you look carefully, the top portion of this is wider than the bottom portion. So it creates then facilitates that hinge effect so that again, the internal portion of the stent follows the natural anatomy and doesn't get stuck somewhere. And also the front portion, this leading portion is beveled so that it can go in the nostril easier. The other devices that we used to use, they have the leading opening like this that it is cut off and it requires a little bit forcing pushing and it can also damage some of the walls. But ours is beveled. The one that is done is beveled so that it slides in very nicely.

Eva Sheie (10:22):
What is it made out of?

Dr. Guyuron (10:23):
Essentially every device that we use in a surgery medical field that is going to be stay in the body for a short period of time made out of silicone. Silicone is the most inert material that doesn't cause any reaction but doesn't promote infection. And in fact, in a way facilitates healing. And we use actually silicone on the scars that they don't heal properly because again, it improves the healing. So this is all medical grade silicone. One of the enormous benefits of this stent, which is again, unlike the stents that they were in the market, is this portion that after the stent is removed, following the course of healing, seven, eight days or whatever the surgeon decides and the stent is extracted, pulled out, it can be washed and this part can be detached from this part. So these will be used as the nostril support, nostril dilator, nostril, conformer. And that is the part that actually a good deal, more attractive actually to some of the surgeons who are using this. And they tell us that actually I really like this part. And obviously this is worn in the evenings on the weekends or as many hours as the surgeon chooses. It's not around the clock, but it can be removed, cleaned, and put back in. So that creates a major, major advantage to this device.

Eva Sheie (12:29):
What were they using as a spacer instead of that piece?

Dr. Guyuron (12:34):
There are some things that are on the market that they are actually not anatomical. They haven't been designed the way these are designed, they're actually circular. The nostril is not circular, but this is again an oval shaped wider at the base portion, the bottom portion. Pretty soon we are going to have this part on the market separately, sterilized packaged, for patients who do not need a septoplasty, the surgeon is working on the nostrils and would like to keep the shape of the nostril in a certain way. And it is again called nostril conformer, nostril dilator. And it is going to come in two sizes also.

Eva Sheie (13:31):
Thanks for listening. I'm your host, Eva Sheie. Follow the show and submit questions for our experts at wherebeforemeetsafter.com. Where Before Meets After is a production of The Axis.