So my name is Laura Miller. I am a prosthetist who works as part of this team. So as a prosthetist, my job is after Dr. Demanian does the surgery, they will come to me and work with me and my colleagues, specifically one to acknowledge is Robert Lipschutz. And our job is to now fit these individuals with a prosthetic device. So what I'm going to do is talk a little bit about prosthetic fitting and what I care about as a prosthetist about the surgery, and then also show you a few videos of some of our successes in fitting and the steps to achieve that. So as a prosthetist, what I care about, Dr. Demanian has gone over some of the surgery, but I'm going to specifically hit on some of the things that, in terms of the fitting, are important to me. Length. Looking at the transhumeral population, whenever you can keep length, residual limb length, that's always going to be beneficial to the fitting. You have a longer lever arm. You have more muscle mass. So we're looking for mid to long transhumeral amputees as the best candidates for targeted muscle reintervention. It's also beneficial, like we've talked about, to minimize the redundant tissue because it's going to make a more secure fitting, as well as the fat issues related to the signal. With respect to the shoulder disarticulation level fittings, you can do it with true shoulder disarticulation level amputees. Individuals who have a humeral neck amputation, in which case they are going to be fit as if they had a shoulder disarticulation level fitting. There have been cases of four-quarter level amputations having some version of targeted muscle reintervention, but often at that level, really for targeted muscle reintervention to work, you need the nerve, you need the muscle. And at that level, you may or may not have nerve and or muscle, so you might have to do some of the creative types of things that Dr. Demanian was talking about. And again, minimizing the redundant tissue. Muscle management. This is a case of one of our shoulder disarticulation level patients that you've already seen the video of. And Dr. Demanian showed this video just showing, look, we have good reintervention because we can see that tissue moving. From the prosthetist's point of view, this is very challenging because for the prosthetic fitting to work, we have to have EMG sensors placed over those muscles, and they have to stay on those muscles. So as you watch all that tissue movement, the prosthetic fitting can be very challenging because we're trying to keep sensors in contact with the skin as that skin is moving around. So the pros and cons of removing the humeral head. In that previous picture, I showed the person that had the humeral head. That was a female patient. We could have created a much more cosmetic fitting if that humeral head had been removed because then we could have gotten the shoulder a little bit closer. It just would have been a little bit less bulky. But with that humeral head in place, that pectoralis was held at its insertion up on the humeral head, so all that muscle stayed intact. We didn't have all that muscle wiggle. And also for her, because that muscle was held intact, that muscle was much higher. So you can see on this case, all that muscle movement is down here. And if that muscle had been able to retract, it would have retracted down underneath her breast tissue, requiring a much more aggressive mastectomy to remove that tissue so we could get good EMG, and also just would have made a much more challenging fitting. This shows a similar case of muscle management without good myodesis. Again, making it a much more challenging fitting where that muscle was actually migrating outside of the socket as it contracted. So that might be a case where the person would want to go in later and have the origin cut so that that muscle didn't want to retract up inside. Instead, it would stay down inside of the socket. Scarring and its location. So scar tissue actually isn't that bad in terms of EMG. It doesn't impede the EMG signal. But there does need to be care about where it is placed, and specifically, again, whether those sensors are going to be able to stay in contact with the skin. If that scar tissue is very fragile, like some of the original split thickness skin graft, if there's a lot of HO on it, then we might not be able to keep those sensors in place without compromising the integrity of that scar tissue. Fat. Again, we've really kind of gone over that, that it's beneficial to remove as much fat as possible. And then post-op. So what do we look at in terms of prosthetic fitting post-op? So Dr. Demanian has done the surgery. As he mentioned, you can start to refit the existing prosthesis around four to six weeks. You have to wait for the stitches to be removed, and there might need to be some revisions, but they would probably be able to start wearing their prosthesis around four to six weeks later. Usually we begin evaluating them for the TMR prosthesis around three months, maybe a little bit longer, because those sites are going to continue to change. So as those nerves continue to re-innervate that muscle, the best sites are going to move around. So usually we don't start aggressively doing the fitting until around three to six months. And it is necessary as part of this post-op process to reinforce how the control has changed, especially if they were fit with a prosthesis before where they did need to do some of that switching, to really reinforce what they need to do and to start strengthening those muscles, because those muscles were de-innervated as part of the TMR procedure, so basically they have been paralyzed for months. So there needs to be an exercise regimen to start to build back that muscle mass and muscle strength so that we can get a usable EMG signal. And then, again, there needs to continue to have physician follow-up for pain, psychological issues, and then working on issues of co-activation, because we do tend to get a lot of co-activation with elbow flexion and hand close and elbow extension and hand open. So, again, it is intuitive, but they're not easy fittings. We do have additional electrodes. So on the left it shows one of our shoulder disarticulation users, and the red outline shows kind of some of the more traditional, advanced prosthetic socket trim lines. So this is about where the socket would normally fit, and you can see where we have all the different sensors. That's outside. So now our sockets have to be a lot more aggressive and contain a lot more of the tissue, and a lot more area has to stay in contact with the socket in order to get EMG. Also, this is a case of one of our female patients where the surgery was done, so one of the sites was the serratus anterior, so it was right down on the side, and the site actually ended up being the best site for her hand open signal was directly underneath the bra strap. So that ended up being a little bit tricky. Of course, all the male doctors who were a part of this process, well, just cut a hole in it. And I'm sure any of the women in here or if any of the men have shopped for their wives, when a bra costs potentially up to $80, you really don't want to be cutting holes in it. So just a little bit of creativity in the prosthetic fitting. And again, that time to strengthen and isolate the contractions, this just shows some of that co-contraction that we might see with elbow extension and hand open, and that makes the fitting a little bit tricky as they continue to do that. And then again, the soft tissue that I mentioned, so at the transhumeral level and also at the shoulder level. And then also, it is intuitive, but there still is significant occupational therapy that's required. As they progress from working on isolating those contractions so they can move the elbow independent of the hand, and then starting to integrate that into activities of daily living. So this just shows one of our transhumeral patients. And also, a little plug for our website. On the RIC website, through the Center for Bionic Medicine, there's also a video of the TMR surgery, a more traditional TMR surgery for the transhumeral level that you can view, that Dr. Damanian and Dr. Akai can put together. And this is one of the first individuals who had that transhumeral targeted muscle re-innervation. So on the left-hand side, he's having to switch between the elbow and the hand. And then on the right-hand side, he's able to simultaneously control the elbow and the hand with that targeted muscle re-innervation. This just shows another one of our shoulder disarticulation level amputees using her prosthesis. And it shows both her doing some functional tasks in the lab, moving some plates around, but you can also see a little bit more of the simultaneous function as she does some different things. Moving cups, picking up tissues, moving her elbow, and obviously this isn't a functional task. So you can see she still has to manually position her shoulder and manually position her femoral rotation. So if someone has not had a prosthesis before or hasn't worn it very frequently, you know, there's still is also going to be a lot of occupational therapy just related to learning to use a prosthesis in general. And if they are familiar with using a prosthesis, then the therapy can focus more specifically on the control. So things that can help the outcome. So we've had some very, very successful fittings and surgeries. But really for targeted muscle re-innervation to really be optimized and optimize its success, there does need to be good team communication during the fitting. So Dr. DeMine, you mentioned, oh, it doesn't really matter where the nerves go. And it doesn't. But it is very helpful for the prosthetist to know where the nerves went. So if a surgical report can be sent to the prosthetist. Because we're trying to figure out where the EMG is. The person's maybe not familiar with those movements. We're not really sure maybe what aspect of the median nerve might have innervated the certain muscle. And it does sort of help us focus their contractions and what we're asking of them. And our search for the best EMG location. If we know what the surgery was. So sharing that. But then also it helps if there's good communication before the surgery. Not only after the surgery, oh, here I did TMR on this individual. But it does help when there's a good team communication before the surgery to plan what the options might be. For example, the woman with the shoulder disarticulation, you know, to discuss the pros and the cons of removing her humeral head or leaving it in place in terms of the prosthetic cosmesis versus that cosmesis of her remaining breast tissue. And as part of that before the surgery, obviously there is the need to evaluate physically individuals before the surgery. You know, Tonell's sign, limb condition, brachial plexopathy. But I think it's also valuable to evaluate the person prosthetically for surgery. You know, whether or not this person would even be a candidate for a prosthesis. You know, if they're like, no, I just really don't see how a prosthesis is going to help me, you know, they may not choose to wear a prosthesis. And it will be the same or a similar prosthesis to what they could have been fit with before the surgery. So, you know, it really wasn't brought up too much as part of Dr. Demya's talk or Dr. Kuyken's. I know he mentioned it. But we are using commercially available prosthetic components. In the next talk, Levi is going to talk, Dr. Hargrove is going to talk a lot about some of the more advanced stuff that we're working on. But really right now, people will be fit with commercially available components. So if they're not happy or satisfied with commercially available components, what TMR does is makes it easier for them to control those commercially available components. But at least for right now, the components are going to be the same. So, you know, if they have not had success in a conventional prosthesis, you know, due to socket challenges, all the stuff is just way too heavy, I'm never going to wear that, it's still going to be just as heavy. Or if they're not able to understand how the device works and not able to figure out how to make it work, you know, again, that's not going to be changed as well. It is a long process. You know, we talked about the TMR surgery, that it's going to be, you know, three to six months before we do the fitting. So they must be motivated, because it is going to be a long process, and they need to have realistic expectations about what that process is. But with that, we can have really good success, you know, we've had multiple fittings, and good surgical success and good prosthetic fittings clinically. And with that, I want to thank my entire team and all the people, we've already shown a lot of their pictures, so I left it out. But I would like to now introduce Dr. Hargrove, who's going to talk about where we're going with it from here.

prosthetic fitting process

residual limb length

muscle management

occupational therapy

future developments in prosthetics