No OR Time, No Problem: In-Office Pediatric Ear Tube Placement with the Tula System

[Dr. Ashley Agan]
Can we back up a little bit when we were preparing to first do this talk, I had to just Google and look up the Tula system and what it looks like and what it's about. Can you just talk a little bit about the technology that they have to anesthetize the eardrum and how the device itself works just to allow people to visualize what it looks like and what the device is?

[Dr. Jordan Schramm]
Sure, yes. I'd be happy to. It is a two-part system like you mentioned, and that I think sets it apart from the other device. The local anesthetic is part of the whole system, and so most of the time of the case is actually getting the topical anesthetic to work, and get through that process. For Tula, it uses a process called iontophoresis, which we describe it to the families as a gentle electric current. You place a plug into the ear, very similar in feel and shape to the plugs you would use for tympanometry or otoacoustic emissions, but it's connected to an ear set and you fill that ear canal with local anesthetic with epinephrine.

For the families, we tell them, this is basically the same medicine that they would use to numb your mouth at the dentist, but we're not injecting it with a needle. We're having it absorbed into the eardrum. The nuances of the setup are you got to get the ear set up so that it cannot leak out that local anesthetic from the canal. Then it's connected to a little control unit that's all self-contained. They're single-use, they're pretty straightforward, user-friendly, and you go ahead and start the iontophoresis.

The electric current slowly ramps up to the goal target and assuming there's no interruptions, it runs for 10 minutes. After 10 minutes, the entire surface of the tympanic membrane is anesthetized. I usually tell families that's like 90, 95% of the procedure time is just getting that to go. As you're running this iontophoresis, on occasion it may be a little bit uncomfortable, most patients tolerate it fine, but if it is a little uncomfortable, you can slow down the rate and it'll run for about 15 minutes instead of 10 minutes.

So far in the cases I've done, that has been just fine as far as tolerability of that process. Once all that complete, you remove all of that, and then I go under the microscope and you actually do the tube insertion, which is the cool piece. The second part, it's a tube delivery system that is all prepackaged and ready to go. It has essentially what looks like a little catheter attached to a handle and in that catheter is a tube already loaded.

This device you place it has a silicone tip so it's somewhat gentle. You place that up on the tympanic membrane and you click a button from the time you click the button, it's a half a second. There are actually four things that happen. There's a little blade that goes in and out through the tympanic membrane making the myringotomy followed right after by a little dilation device that dilates the myringotomy.

Then the third piece is a small little sheath that goes through that tympanic membrane and the tube gets inserted through that sheath. Everything pulls back and the tube is left in the drum. There's a cool little video on the teaching sessions we show where it shows that in really slow motion on a synthetic tympanic membrane from the underside as if you were looking from the middle ear space and it just shows all those things happen.

Then in real time with less than a half a second, you just see these tubes just pop into the drum. That's, I think the fun part of the technology, but most of the work, like I mentioned, is just getting through the iontophoresis.

[Dr. Ashley Agan]
After you get the tube in, are you doing a lot of suctioning? If you have a kid that's got that thick mucoid effusion, glue ear, you're trying to work quickly because maybe they're upset. How much time do you spend trying to suck all that stuff out?

[Dr. Jordan Schramm]
The short answer is zero. I don't do it at all anymore. Very early on, the first mucoid effusion or two that I did that sort of glue ear, I tried to suction it out with a three suction a little bit, which as you know, is completely futile. Even a five suction, if you're in the OR with those cases often is inadequate, you've got to irrigate, and or even you go to the seven or whatever. The other thing about these tubes, they're silicone and they're malleable.

If you grab onto them, you can actually pull them out of the drum pretty easily because they come out about as easy as a T-tube. If you suction with a five suction, you're going to be wider than the diameter of the tube. I've heard of cases where the tube has been suctioned out by the suction. I haven't done that myself, but you could pretty easily suction the tube out. This is where I really had to force my mindset to change because when you're in the operating room, of course, you're going to suction.

You have to, because when you make the myringotomy, often it obscures your visualization just to get the tubes in, you need to suction. Even if you didn't need to suction, there's fluid there, of course, you're going to suction. Even still when I'm in the OR, I still suction. Even if I don't, conceptually, I definitely know I don't have to suction out all that fluid, but it's hard not to and you just don't have that luxury in the clinic.

This is where it's been useful to follow some of my outcomes from the Tula tubes in the clinic where I'm not doing any suctioning and looking at rates of obstructed tubes that are bad enough that I need to go back to the OR for those mucoid effusions. I actually recently looked at this data to update one of these presentations. About 15% of them were obstructed if it was classified as a mucoid effusion, at least in our internal data.

This is of about, let's see, 53 ears that had a mucoid effusion at the time of placement. Only three of those tubes needed to have something done in the operating room. Two of them were on one patient that ended up having large adenoids and actually, that one had a lot of drainage, it just wouldn't stop. One was removed and replaced because the obstruction, we just couldn't get it cleared. I haven't looked at my data for the OR tubes placed under those circumstances, but it's not unheard of for those also to have the same problem.

You just got to rely on the fact that they're pressure-equalizing tubes and once you equalize that pressure, everything should get better. That was hard to do for me mentally, but I think I'm finally to a place where I just put the tube in and let the tube do what it needs to do.