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Inspire Device Brings Life-Changing Sleep – In-Depth Doctor’s Interview

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Dr. Joshua Dunklebarger, otolaryngologist and head & neck surgeon at WellSpan Health, talks about the difference between the CPAP machine and new device called Inspire for better breathing during sleep.

Interview conducted by Ivanhoe Broadcast News in 2023.

What do you hear from patients who at first are excited about CPAPs and then dread them?

Dunklebarger: People hate CPAP because of the fact that it keeps them confined to their bed. They have a mask on their face and they have tubing and it makes it really difficult for people to live their life anytime that they move or adjust some things pulling on their face. And so what the Inspire does is it allows people to basically be freed from those shackles. And so it helps people to sleep better, it gets their bed partner back in bed with them if they’re bothered by the CPAP device and it really gives them freedom.

Roger and Linda Schwalm happens to be a couple, one on CPAP and one on in Inspire. Do you see a lot of that?

Dunklebarger: No. This is the first time that we’ve actually had the opportunity to do a couple like this. And it was one of the things that was really inspirational to me. Linda, his wife, Roger, who we just implanted two weeks ago. Came to us first and we went through the whole process with her and Roger and then Roger witnessed what the improvement was in her quality of life. And after we activated her, shortly thereafter, he came in knocking at our door wanting to see if he was a candidate as well.

One thing is, sometimes, the CPAP keeps you up at night. It goes against the very things its designed to do. The noise and the hose falling out, so, is that a justification for most people for getting the Inspire?

Dunklebarger: Anything that makes you intolerant of the CPAP. So claustrophobia, pressure settings, the disruption of your quality of life, I talked about the bed partner earlier. Sometimes bed partners leave the bedroom because they can’t stand the noise of the device or the whistling that people have to deal with. So that’s absolutely one of the reasons why people go forward with it. The other reason is when people travel, they don’t want to take their CPAP device with them. It’s a nuisance. It’s another bag that they have to carry with them. A lot of folks just want the freedom. They want to be able to breathe better, sleep better, get an improvement in quality of life and have less busyness with all the other stuff that goes along with CPAP.

So, from the medical and scientific standpoint, when you’re actually conducting the surgery, can you explain that?

Dunklebarger: So when we do the surgery, before the patient is even a candidate for the surgery, we do what they call a drug induced sleep endoscopy or DICE, D-I-C-E. And so what that is, is we look at the anatomy of the patient by giving them sedation and watching what their throat in the back of the nasal cavity does. And so when they have the appropriate level of collapse, meaning that the airway closes front-to-back, we know that they would do well with the Inspire device. And so then they move on to the next step. And the technical features of the surgery itself are basically there’s a battery pack or a power pack that gets implanted between the second and third rib on the right side of the chest. And then there’s two wires. Wire number 1 goes into the chest and senses when you go to breathe in or Inspire. And the second wire then goes up into the neck where it implants and has three electrodes that surround the nerve that make the tongue basically extend out of the mouth. So the nerve that goes into the tongue has two different functions. One is to pull back, one is to go out. And so we separate that nerve into those two functions and put the implant and the electrode around the portion of the nerve which extends the tongue. So then when you get the impulse to breathe, the battery pack sends a signal up into the tongue, and the tongue sticks out.

Did you say you separate the nerve?

Dunklebarger: Yeah. It’s completely against everything we learned when we were training. So from a technology standpoint, you’d never did this before. So we actually use a nerve stimulating device, where we said, we actually use a nerve stimulating device, which you can tease out the different branches. And so you touch the branch on the top, that pulls the tongue back, that one’s excluded. You don’t use that as part of your inclusion for the device. And then you just keep marching your way down. And then there’s a point when there’s actually a blood vessel that runs right through the center. And then you separate that area and then these ones stay away, these ones are included and the cuff goes right around that. And that’s how you get the tongue stick out of the mouth.

Can you spread those things apart, what are you doing?

Dunklebarger: We spread them apart. We tease them apart and they’re very, very thin. We use magnification when we’re looking at the nerve. And so we’re actually looking at it under about three times magnification and then just teasing the different fibers away until we get to fibers that are only stick their tongue out.

Pretty amazing. And we mentioned before it’s not for central, which is really forgetting to breathe.

Dunklebarger: Yeah. Central sleep apnea is a problem with the brain telling the body that it needs to breathe. And this whole apparatus with the Inspire works by having that impulse to breathe. You have to start breathing by contracting the muscles of the chest in order for the signal to be sent to the tongue.

How long does the entire surgery take and what is the level of intrusiveness from this advocate?

Dunklebarger: So the battery pack is typically underneath the fat and on top of the muscle in the chest. So depending on what your body habitus is, there’s times where it’s very palpable and you can feel it. Other times you can’t feel it at all. So it really depends on the person. It’s not very intrusive. The pocket itself is very small and the wire and incision we make for up in the neck is also very small. So it’s a very minimalistic surgery as far as the extensiveness of it, or at least the invasiveness of it. From a technical standpoint, it’s extremely technical surgery. There’s things that we’re doing that basically we’re combining techniques that we hadn’t done before. And so it was really amazing to go through the process of learning how to implant it and get to the point where we were able to perfect it here locally.

Did you have to take a special training?

Dunklebarger: Yeah. So the training occurred down in Washington and so we went to a course and then a cadaver lab. And so practiced on cadavers first to learn how to do it. And then I trained with one of my colleagues over at WellSpan York Hospital who had been doing it for a few years. And so we got with him as well and then trained with him on an actual live patients.

As a doctor, how do you feel about it?

Dunklebarger: I love it. I love new technology. I love working with patients to try to cure things. It’s not often you get the chance to take new technology and incorporate into your practice. So for me, it’s something that keeps me inspired. It keeps me passionate about what I do. I love working with patients. I love interacting with patients. And just like Linda and Roger, they’re the type of people that make you get up in the morning and do what you do because they are so appreciative of the improvement in their quality of life.

Have you seen a difference in Linda?

Dunklebarger: Yes, for sure. Absolutely. Yeah she went from a very high apnea-hypopnea index, which is the severity of her sleep apnea, and we got it to the point where she’s off the CPAP device completely and breathes well and sleeps well and doesn’t have to wear the mask anymore.

The CPAP, like I said, it’s designed to help fix the sleeping, sometimes it doesn’t. And as you said, it’s really bulky and cumbersome. What she had, was that planted and then she used a remote. What does that device do?

Dunklebarger: So, during the day, if this device were on, every time she would breathe, her tongue would contract. It makes it difficult to talk, you can’t swallow as well, so you’ve got to turn it off. And so when you turn it off, the electrical signal to make the tongue contract goes away. So that’s why they have the remote control.

How many of this device have you put in and what did you think the first time you did it?

Dunklebarger: Yeah. So, I think now that we’re to 10 here at this specific hospital, they’ve done hundreds at York WellSpan. And so when I first put it in, it was obviously something that was new. With everything that goes along with a new procedure and technology sits inside of you and you prepare and you work, and you practice, and you think the surgery through your head many times before you do it. And then once we put it in, I was like, “Okay, this was pretty amazing. This is new technology that we hadn’t done before, that we’ve never offered here.” And I was really excited to see what would happen when the device turned on. And Linda was one of our early patients and she had another person that we did that same day. And when we both- activated both of them. Linda did really well and the other patient actually went to zero sleep apnea. So it was absolutely amazing to see the change. And so I think that it’s one of those things that when you see someone’s life changed that much because sleep is a big component of our quality of life. I mean, we spend what, at least a third of our life. And so it’s a huge part of what we do and how refreshed we feel and how we approach the day when we wake up the next morning. And so to see those folks go through that change and to see how welcoming and happy they were and how much energy they had that they weren’t struggling to sleep or struggling to breathe anymore was really just amazing. And so once I did the first few, I was like, this is going to be incredible and so it has just grown from there.

And others who have defects and all that. But it seems to me like this is the time for this device to get them straightened out.

Dunklebarger: Yeah. It’s very important to keep in mind that this device doesn’t work for everyone. You have to be within a certain weight criteria because the tongue itself deposits fat. And if the tongue is too heavy, the device can’t create enough contraction to move it out of the way. So that’s one of the considerations is the severity of the sleep apnea, the weight of the patient, the age of the patient, and then also their CPAP usage. All of those things go into the process of determining who’s going to be a good candidate. Because when you’re implanting something, this device stays there for 12 years before we have to change the battery pack out. So when you’re implanting something like this, you don’t want to do it and not be successful. And I think the reason we’ve been so successful is because of the fact that you have a very strict criteria for who you select as far as patients. And so those patients that are not in criteria for the device, we try to counsel them on how they can get into criteria, whether it be weight loss or certain things with the CPAP device. And sometimes patients come in and there’s something else that we can do for them that doesn’t require the implant, that’s still improves your quality of life.

So, one thing you said that stuck with me is that you walked it through your head a lot of times before you did it. What kind of process is that for you?

Dunklebarger: Yeah. So, you think about the steps before you do the surgery. Now, they’ve got videos and things like that that you can watch. But you actually, mentally, play the surgery through your head before you do it.

Are you moving your hand?

Dunklebarger: No, it’s all slow. It’s like I’ll be laying in bed and I’ll think about it. So I think about like how I make this incision. Then I have to move this muscle, then I got to get this fat out of the way. Move the gland a certain direction because the biggest thing about surgery is retraction view. Because the body doesn’t just like it. So you don’t make decisions just there that’d be great. But I was trained to never enter this area because there’s these small blood vessels that crisscross over top of the nerve to protect it. And it’s like a danger zone. And so when like when you go through residency training, you’re told don’t go here because it’s bad. You don’t want to touch the nerve, you don’t mess with the nerve. A typical training or teaching was that this is a really bad area and when you get into this, you can have severe bleeding and bad complications. And so this went against everything that we were trained to do.

How did they get?

Dunklebarger: So just a different approach. Different approach, different traction, moving things different directions. And so that was one of the things that I would think about is like, how am I going to get the view I need to get to do the surgery I want to do safely without getting a bloody mess. The veins are called Raining veins and they’re very thin-walled and like rain down on us raining. And they are there because I think it’s like a warning sign that you’re getting close to the nerve and so it starts to bleed, you get away from it. But we just developed ways to basically stop those bleeders and push them out of the way. And then I need to get about three-quarters of an inch of the nerve exposed where it branches. Because this- this is the craziest part, when it branches, it’s almost like God told us like, here’s this blood vessel, follow this blood vessel and then his blood vessel goes right here and you got to separate the nerve, which we never did before. It’s insane. And so these branches, you get up out of the way and these branches you push down and then you have this prong with three electrodes that you literally wrap around the nerve.

END OF INTERVIEW

This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.

If you would like more information, please contact:

Ryan Coyle

rcoyle@wellspan.org

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