 Next up will be Sam Thomas, who comes from Utah. He's going to be presenting on corneal transplants, the global need, and an innovative solution and some work that he's done here with Dr. Embodio. Thank you. So as was said, my name is Samuel Thomas, fourth year medical student on a neuro-optimology rotation right now. I had the great opportunity of working with Dr. Embodio on this project last year. I had the opportunity to do a year of bio-innovation and engineering, and this was one of the great projects that I got to work on. As well as I worked with Alexis Johnson, Blair Garrett, Kevin Bryant, and Thomas Newell, who are undergraduate students in the bio-engineering department. And so excited to tell you a little bit more about what innovative solutions we're trying to come up with for corneal transplants in the global sphere. So three things that I had. Three questions I helped to address in this talk is, first, I'll address what kind of impact does corneal bias have in the world. Number two, how is it treated in the US and Europe? And number three, how do we expand that treatment to have a global impact? And so here is just a diagram showing that the impact of corneal blindness in the world. This comes from the WHO. I had it ranked in order of most common causes of corneal blindness to least. You can see the cataracts is 48% is a large part of corneal blindness, or a large part of just blindness worldwide. Corneal opacities come up at four, but I highlighted six, seven, and eight as well, because they also have a component of corneal blindness associated with them. And so I kind of grouped them together, and they kind of add up to be about 15% of the world blindness can be attributed to corneal disease. If you look through the literature, you can find varying numbers on all of these statistics is highly dependent on what the epidemic of disease is in that area. Some places in Africa said that 90% of their blindness was due to corneal disease. And so you can see that this is from the WHO, but it can vary pretty drastically. One thing that WHO did say was that corneal disease is the most common cause of bilateral blindness is the most important cause of bilateral blindness, second only to cataracts. This is because it is a preventable and treatable cause as well. And here's just an image of a child with bilateral corneal disease. And so looking at corneal blindness specifically, looking at three different areas, India, Tanzania, and China, I've listed just the top three reasons for corneal disease in those specific areas. And you can see that they vary pretty differently. So we're not talking about just one type of disease. And here to talk about the numbers, there's about 45 million people who were blind worldwide. About 8 million of those people estimated have corneal disease. And the main state treatment for these patients is the definitive treatment is a corneal transplant. And so treatment for corneal blindness, the first being corneal transplants. There's obviously corneal transplants are where the disease cornea is removed and the donor cornea is brought in and sutured to the eye. There's about 47,000 of these done in the US, cost about $12,000 for the tissue to do it. It's about $16,000 to do the full procedure was what one study told me. If in the United States, if a patient fails this once, twice, and it's considered not smart to do it again, that's when you go to this carotoprosthesis or an artificial cornea. The most popular being this Boston Capro. And this is the one I wanna focus on with you because the solution that we have is kind of a variation of this Boston Capro. There's about 500 done each year. It costs about $5,000 for this device and it involves a front part that transmits the light, the corneal graft, the back plate, which is something that I'll emphasize later on, and then a locking steering in the back. Other artificial corneas include this afacore in the OOKP, but we'll focus on this one for now. The other technology just for completeness for treating corneal blindness can be this, phototherapeutic caretectomy. So not feasible for the developing world at this point. So we won't talk too much about it, but I wanna highlight again that transplant tissue obviously requires donor tissue, but so does this Boston Capro, requires donor tissue for the most part. And so this is where we kind of address the issue of treating corneal transplants in the global sphere. So going and trying to find some data on iBanks, I found this report, 2014 statistical report from the iBank Association of America, noted that out of the 76 iBanks in the US, they got a total of 1,028,000 eyes collected and they used 76,000 of those. And so we have almost a surplus of eyes. Internationally, the only data that I could find from this report was that there was 10 institutions that reported having collected 6,000 and using 5,000 of those. It was obvious in trying to do this search and find these numbers that there's a severe lack of infrastructure for iBanks that can provide this donor tissue. And so my big take home point for this is that the places with the greatest burden of disease are the ones that have the least availability of treatment. And so the need statement, so understanding those aspects, we kind of came up with a need statement that there's a need for a better artificial cornea for the developing world. And our main goal was to eliminate the need for or eliminate the dependence on the donor tissue. Other secondary goals would be things like, and ways that we will talk about doing that is a minimal incision to avoid sutures, reducing surgery time, maintaining and extending the lifetime of device for better tissue integration. These are all other things that we have to keep in mind. And there's quite a long list of specific requirements that we need to meet to actually make a good solution to this problem. But the main thing that we were trying to tackle is how can we eliminate the dependence on donor tissue? And so again to reset the problem, here's the Boston Cape Row, requires donor tissue. The incision usually involves an eight millimeter incision of the cornea in the surface. That's because that back plate that I showed you is eight millimeters in diameter. And it often takes months to years sometimes to recover from this surgery. It is obviously very invasive, very involved. And there's been issues with poor tissue incorporation and tissue longevity. Oftentimes we'll have corneal melt and things like that. I don't have those numbers for you, but this is something that we just wanted to keep in mind. We don't want to make this issue worse. If we can make it better, that would be great. And so what we designed, what we tried to figure out is how can we solve these problems? First, we're gonna try and eliminate the need for the graph. And I'll talk about how we do that in the next slide. We're gonna try and do it through a smaller incision, a three millimeter incision. That won't require any sutures. We'll hopefully try and decrease the recovery time by having a less invasive surgery. And we can hopefully improve the device incorporation and device longevity again with a less invasive procedure. And with maybe doing some interesting biologic work with what this backplate might look like. So this is the solution that we came up with. So shape memory potential, or so shape memory. A lot of you might be familiar with night and all and the shape memory idea. If you ever want to know how night and all works, you can YouTube night and all paperclip and you kind of see how it works. It's kind of interesting. I'm gonna try and upload it here but from all the medical school lectures that I saw with people trying to upload videos, it never works. And so I'll let you kind of do it at home. But it's basically, you can have a shape, either a metal or a plastic polyurethane that has a specific shape. You can then warm it up or bend it into whatever shape you want it to. And it will return to that cured state if you would heat it up to that specific temperature. So it has these transition points and you can, by the way that you make this night and all, which is just an alloy of nickel and titanium, or by the way that you make this polyurethane, you can pick at what temperature you want this shape to regain its form. So you cure it at a specific shape that you want to keep it in. You can change its shape to make it more compact, which is what we're gonna try and do. And then you can warm it back up, cool it so it stays that way. Warm it back up and it will take that original shape. And so it's a really interesting way to compact things and to have them reform wherever you need it to just based solely on the temperature of its environment. And so we first started with this shaped memory polyurethane. The reason we did that was because it's easier to work with. We wanted to test the idea. Can we make a device with this shaped memory polyurethane that works? And then I'll talk about this nickel, or this night and all later. The huge advantage of this, highly biocompatible, seen in stents, a lot of orthopedic devices. And it's actually similar to the latest Boston K-Pro that uses titanium. So we know that this type of metal has worked for similar devices in the past. So that was our approach. And this is the image of what that back plate looks like. So you can see that it's this eight millimeter device. Again, what we're gonna do is we're gonna try and warm it up so we can shape it, taco it, freeze it so that it keeps that shape, ship it as needed like that. And then once it goes back in the eye in a small incision, you could put warm saline in the eye to 39 degrees Celsius and it would retake that shape. And then you could assemble it while it's in the eye. And so that's what we tried to do. So you can see here is the engineering that we did to do that, to talk about that front part, clear part of the Boston K-Pro, the searing and then that back plate that I talked about. This was the product. So this is something that was made out of that polyurethane, this shape memory. So this is what we warmed up, tacoed, put into a minimal incision and then warmed back up with warm saline so that we could put these three pieces together. And so, again, how it works, warm it up, able to shape it, pull it out, cool it and it can keep that, it will maintain that shape as long as it's not warmed back up. If you put it back in warm water, it will reform its original shape. And so what we decided to do is we're gonna test this in pig eyes. And so we did exactly what I just mentioned. And again, made the small incision, had the tacoed back piece, put it in the eye. And again, the only thing so that the Boston K-Pro, the front piece comes in from the front, the only thing that you get in from the side is that tacoed back plate as well as the searing. Both that will fit within that minimal three millimeter incision. And then you warm, you send warm saline through the eye up to 39 degrees Celsius and it will unfold that back plate. And then from there, it's just a simple assembly where you get the back plate on and you get the searing on. You can see that this was, that it has appropriately unfolded. You can't really see it too well here. I apologize for the quality of that image. You can see how we were able to assemble that device, making a minimal incision and just using warm saline to reshape that eye. And so the next step for us will be to try and machine night and all to do the similar thing. The issue with this polyurethane, it was a great idea to test how this works. But it's not completely, it wouldn't pass FDA approval for being a device in the eye necessarily. But night and all definitely would. And so we're working now to machine night and all and work with some of the night and all experts here at the U to be able to do this. We have all the specifications that we need, what it needs to include. And then we'll do a similar testing with the night and all. Acknowledgements, I wanna thank Dr. Imboddy for all that he's done to pull me onto this project and to give his time and energy to sharing his ideas on this and being a good mentor there. I also wanna thank Dr. Roscoe who's able to mentor me on my engineering year last year. I couldn't have had two better mentors. And with that, I'll move to questions. Right, from the research that I saw, I think it, and I could be wrong on this, but I thought that you could warm it up to about 40, 41 degrees before you start having some damage. And so we thought that putting it at 38 degrees would be appropriate because you could get a little bit warmer than what it needs to transform but not warm enough to hurt the eye. So that's a great question. Yes, Dr. Warner. So the way that they use the Boston caper right now is they will assemble the Boston caper on donor tissue and then they will transplant that back onto the patient. And so instead, if I go back a few slides, you can see how, with how the Boston caper is used right now, is they'll remove the diseased tissue and they'll have donor tissue that they assemble the Boston caper onto outside the body, they'll assemble it, and then they'll suture it back onto the patient. And so there are some instances in developing countries where if the person has bilateral corneal abrasions, what they can do is they can, and they don't have donor tissue, they can remove tissue from one eye to be used for the other. But currently the Boston caper does need that corneal tissue, that donor to be sandwiched in between the two pieces on the Boston caper. So we're hoping to be able to keep that diseased corneal in place, create the hole for the top piece, and be able to get that back piece in without having to compromise the structure of the existing corneal as is. Because the kind of the cool idea about this as well is that with these diseased corneas, a lot of times the issue is that you just lose the opacity. The structure of the corneal oftentimes is still there. And so we can kind of utilize that to keep our Boston caper out in place without having to use the donor tissue. So that's a great question. And the interesting thing about night and all to me is when I first heard about night and all being used in the body, I know that there is an issue with nickel being biocompatible in the body. But for some reason this combination of nickel and titanium has been used in stents and other orthopedic devices. And I don't know the exact, the rates, but I know that the FDA is completely fine with using night and all in these devices. But that's a good question. I don't know exactly how many times there's a compromise. All right, I think we should thank Sam and move on to the next talk to everyone. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.