Timothy Dillingham, M.D., M.S. presents at the Johns Hopkins Department of PM&R’s Grand Rounds on March 13, 2018.
Yeah. All right, folks. Uh we're gonna get started in just a minute. So um those of you who uh want CME, please uh sign in on the uh the, there's a message board back there. I guess we got one slide ahead of ourselves um uh text into the system. So um the text number is on the uh back table there if you need it. Um A couple of announcements about some upcoming talks. Uh So we're excited to have a couple of other speakers coming in the next uh week. So, on Friday, uh particularly for the residents, um We have a speaker from University of Texas in Houston. Um Doctor uh Barraco. I hope I pronounced that right. But anyway, she is their vice chair for quality and safety and she's going to be talking about social media and utilizing that to build your academic career. So I think it will be a really enjoyable talk that's in the Myer One conference room back in our clinic offices. Um So please come to that. And then um next Wednesday, the 21st, we're gonna have uh Eric Wazowski, uh who's director of cancer rehab at uh nrh, and he's going to be giving a talk at noon also. Um, and then it'll be INPs 2 40 cancer rehab and it will be an interactive talk. So we're looking forward to that. Um, so I have a pleasure to, uh, introduce to you all. Uh, somebody who's very familiar to those of us that have been in hops a while. Uh, because, uh, Doctor Gillingham spent 10 years here back in the 19 nineties and early two thousands and he hasn't been back in 15 years. So we're happy to have him finally back. And uh talking to us, he's uh uh chair of the Department of uh Physical Medicine and rehab at U Penn, which is the oldest rehab department in the country. Um He's a world leading expert on amputee care and he's going to be talking to us about a neat new adventure that he's been on developing a new type of prosthesis that will hopefully reduce cost and make it much more efficient to provide amputee care. So, with that, Tim Well, thank you. Um I'm, I'm really delighted to be here. I, I remember talking with Marise and uh uh Doctor Gonzalez was worked with me many years ago on one of my research projects and um she uh uh got Doctor Mayer to invite me to this talk and I'm, I'm just delighted to be here. Um It's nice seeing uh uh some of my old mentors. I don't know the residents. It familiarity sometimes makes you not realize that you have a giant in our field in, in your midst. Dr Barbara de La tour has just been uh tremendous. She was a mentor for me and um having her around, you should cherish every, every moment that you get to work with there. Um Pablo, uh I remember when we hired him as a resident, I thought to myself, I look over at and I thought, wow, I couldn't get in this residency program. And um I said he's going to be a superstar and now he's your, your chairman. Uh you know, Sam is your residency program director now. And uh he was a former Elkins Award winner and uh so he knows the way for you and um listen to your, to your mentors. Um I'm really pleased that you came here and I'm gonna talk to you about and, and I usually walk around. I went to a, a course on how to teach and they said you never stand behind the podium, but I'm told I have to be in the focus line here for the camera. So, um I'll try to uh make do with that. I'm gonna talk to you today about a project that's been going on for about eight years for me. And um it's developing an immediate fit prosthesis. The goals will be to this lecture will be to learn some of the global needs and the US needs um learn how this sort of came about its key features. And I'm also going to present some preliminary research on um this uh device. Um can't do that. No, no. Nowadays, it's really team science. Nobody can really do anything by themselves. You have to have collaborators and I have a really terrific engineering team at at um in Milwaukee, Pewaukee Wisconsin, um Dr Marshall and Connor Duo and Sarah. Um we do most of our patient research and patient testing at University of Pennsylvania and then um I have business development, uh Josh Mullins marketing uh Michelle Brass. And so you have to kind of bring this whole team together to make this work. Now, this is the first lecture I've ever ever given where I have disclaimers. Um This was funded by the National Institutes of Health um for a phase 12 and two B and then a commercialization project is what we're funded for now. Um I'm the P I but I also founded the company and I'm the major owner of the company as well. Um All conflict of interest was signed with the University of Pennsylvania as a primary investigator by the provost. Um all of the amputees you see in here signed consent forms were very hi a conscious and there are several patents associated with this work. So why, why do this, why do we need a new state of the art and prosthetics? Well, there's a huge and unmet need out there. Um This is according to the uh actually, Doctor mckenzie here, about 1.6 million amputees are living in the US with an amputation with a limb loss. And because they of the survival rates, they're, this is going to double in the next several decades. You, about 100 and 50 160 new 1000 new amputations occur each year in the United States. And as we all know, these are the major causes of limb loss, dysvascular traumatic malignancy and congenital. And um we did a study here a long time ago that actually hasn't been duplicated. Um It's hard to get funding to just do epidemiological studies. But we showed back in 1996 that this vascular out outweighed um traumatic by about eight fold, cancer was way down and congenital deficiencies were pretty constant over a period of time. What we found was that the dysvascular rates were going up and this was from 88 to 96 trauma had gone down and this was probably due to better work place safety, less manufacturing, industrial labor in the United States and cancer was going down as well. That was a very, you know, 1 100 th the overall magnitude. Now, I did find some articles recently looking particularly at diabetes. Now, the the fact the figures I just quoted you were for the general population, but for diabetes, there was a big push to reduce amputations. And by um better health system performance guidelines. Um Clinical care issues like inspecting your feet and what um some of these researchers found was that indeed, um the rates were going down. So you see the rates in diabetes and my rate, the overall population is about 46. So tenfold difference diabetics have a tenfold increase, greater risk of limb loss. It dropped pretty precipitously over this period of time. One of the important things to note though is if you have end stage renal disease, you have about 100 times greater likelihood of losing your limb, then if you don't have diabetes or renal disease. Um and some other uh uh play in the Scottish registry showed decrease as well. And the this new England Journal article was quite strong. They use a lot of data uh sources and found that the date, the there was a 50% reduction in amputations and they thought it was mostly due to advances in health care, medical homes and overall better health system performance, not the uh uh any change in the diseases. This is my crew up skiing. So worldwide, it's an uh fairly bleak story. Um 80% of the world's population live in developing countries. And um it's estimated about 25 million need some prosthetic or orthotic. Um and 75% of developing countries lack any prosthetic or orthotic training programs. So they don't have the educational infrastructure to meet the needs of their, their countries this is from the World Health Organization Traumatic Injuries. This is a study in, out of Pakistan and um the problem with developing countries is not so much that the accidents are worse than here. It's that you don't have the trauma care system that can then pick up the pieces and what would otherwise end up in an external fixator of vascular repair. And a stint on rehab ends up in an amputation. Land mines are another um source of uh uh limb loss in other countries. And the takeaway with this is that less than one in four landmine victims are fitted with a proper prosthesis. And this was from some of the uh World Health uh and Foreign Policy Agency, this vascular disease much like in the United States. It's also going up in developing countries and I know this is hard to see, but you can see there's sort of a diabetes belt here where the prevalence is going up in these areas and correspondingly leading to more amputations. Diabetic foot care is also lacking so that when you get an ulcer, it more often leads to an amputation as opposed to being able to be healed, barefoot, walking, lack of awareness of pathogens. Um And just by the time somebody gets to a medical facility, um it's already infected and you have osteomyelitis and and subsequent amputation. This is an uh uh insightful um uh study and it was from the International Diabetes Federation showing that in developing countries, the rates of diabetes are going up for the middle aged folks as opposed to uh developed countries where the diabetes is going up more in, in the elderly. Well, by the way, feel free to just shout out a question if you want, I don't want, should have to wait till the end of the lecture. Um You have to have training programs for prosthetics and orthotist and so for developing countries, access labs, materials and time. Um And making a prosthesis is, is time consuming. It takes weeks to fabricate it with molding as we'll see in a moment. And as you all know that first year after amputation, you need several different socket changes because the limb matures and changes. Can everyone hear me by the way? Ok. Um And it's a particularly problem when you, if you don't have a prosthesis because many countries are not wheelchair accessible, you'll be wearing crutches. And so you really need that um prosthetic to help you get around. Now, how many people have um watched a prosthesis get made? Yeah. So um it's time consuming and often technician intense. Um It relies on craftsmanship. So it varies the the it varies based on the prosthetic. As much as the uh person. You have to make a positive mold, build a socket over it, do a check socket, sometimes a final hard socket and you have to do different adjustments to make it work. Um This is what you typically see in a lab. So you have to take a positive mold, cast of someone's limb or digitize it and then create a positive mold and you have grinders and you have mandrels and you grind the plaster where you may think the patient has a, a pressure sensitive area. And um if you go into these labs, um a lot of times you smell dust, um dried plaster, it sort of gets my sinuses all plugged up, but this is kind of the state of the art at this point. Now, there's some new things. This is, this is my family that we had a meeting in Hawaii. And um if you ever get a chance to go to Hawaii meeting, it was really fun. Um I was the keynote speaker at the A anem that year and um my, my kids still talk about how much fun it was. Um So the fundamental problem I think not only the um manufacturing of the prostheses um and how time consuming it is, but, and even when I was running the amputee clinic here many years ago, the fundamental problem is trying to make a hard rigid socket, fit a soft uh limb with bony prominences. So whatever you digitize and make and create in that hard socket, the minute you walk on it, it's different. Um Many things are done. You can grind out the inside, you can make cutouts. Um And I, I imagine most of you have seen this, uh, uh, done in the, uh, prosthetic Clinic, um, socks, an increase and decrease socks. So it's really time, I think for a fundamental change in how we approach these patients. Now, there are some other things going on. 3D, gets a lot of press. Um, it's not bad. You can digitize images, have it printed and as you'll see what we used to with our engineering folks would make 3d parts when we'd want to make a design change, they'd make a 3d part, but they had to laminate it with epoxies and make sure that it was strong enough. And so you can make 3D printing pretty strong if you do the right uh right things. But again, it leads to a hard socket about the, the same problem, but it is, it is. But um with the upper limb, you don't have to weight there. So you don't need it as strong as you would have um for the lower limb so much, it's not as much of a problem. And frankly 3D printing has a great role. I think growing kids, I think, you know, being able to 3d print and mail something to a, to another country. You know, it's, I'm just sort of going through, I'm not trying to disparage any of this other technology. I'm just sort of imparting knowledge um and showing you what, what, what else is out there. So a lot of people have used PV C for these third world country prosthetics. And again, relies on a lot of craftsmanship and sort of one off manufacturing. Um, a lot of these materials aren't durable. Um, you, as you'll see, you have to have a bloody strong set of materials to withstand a £300 guy walking around. And that's why you have international standards for, for testing. Um, they often have a high probability of breakage. Um, The other thing is this is really, you can get a socket that fits pretty well, but you gotta get the alignment right or it's very uncomfortable. Um And can be uh just not working well. The other thing is you have to think about suspension systems and there are a lot of them out there, um pin sleeve magnet suction automated section, you know, the little machine. Um but you have to think about it and how it fits in the overall system. Um This was the pediatric uh folks and um probably a very good thing to do. Orthotics, I think are not bad for this because people grow quite a bit and um the ability to rapidly give a patient what they need at that time, I think is really, really critical. We actually know that our rapid prototypes would work when I tested them in the lab because our engineers would make the 3D print, we would make several of them and they would break one. And so they could tell us and we would ask the engineers if we're trying a new design, as we'll see in a moment, um We would ask the engineers, we want the socket a little bit bigger for this particular set of people and um will it withstand the rigors? Can I let that part out of the lab? And that's a key um concept that you have to keep in mind as I present this talk is this is not like general research because we're developing the product in parallel with having to test it and determine it. So there's these key milestones like is that part ready to go home? Do I feel comfortable letting somebody take it out of the lab? And you have to have a lot of engineering behind that um to, to uh uh determine that whole bunch of international efforts have looked at low cost prostheses. And uh Oser has a modular cast system that's uh fairly common in, in Europe where you actually cast right on the limb problem is it's very hard to get pressure there. They have this vacuum device that puts pressure and makes the cas squeeze it. And again, you end up with a hard socket. Um This was an effort uh that this reporter was from the New York Times, um went and looked at one of these fitting centers in India and you know, I don't want to disparage and, and please don't think I'm doing that disparaging efforts to help people. It's all good just pointing out some of the shortcomings is that um many of these folks, once they got the limb, it was so uncomfortable that they went back to crutches or, or discarded because if you don't get the alignment right. And, and that's very hard to do with prosthesis like this, that have no just ability between the socket and the foot. Um In Haiti, for instance, very well meaning efforts donated a lot of component which then had to be retooled Andrea uh to, to make prosthetic uh components. Um This was a quote that said most practitioners in the United States, this was from humanitarian relief. Um see 700 amputees patients in a lifetime and they serve that many in just nine months. So it really illustrates where you have an earthquake and um a lot of crush injuries and crush injuries can't be saved. You have a lot of uh limb amputations. So how, how do you address this? Well, um you have to, in some way, you have a high need internationally, you have a cost pressure, you have a pressure to get devices to the right place. You have a need to make them quickly. And so mass production really offers a great alternative to some of these problems and particularly injection molding as we'll see. Um with, with those types of manufacturing, you can automate and optimize the design and control the quality you can build in, adjust ability, you can have very high strength materials. As we'll see, the materials we're using are called aluminum substitutes. So they're plastic injection molded, but they're as strong as aluminum, not as strong as steel, but they're as strong as aluminum and they have great properties, but the properties are a little bit different. So they're not exactly like metals. You have to look at how many stresses and repetitive stresses they, they will take. We also incorporated um commercial feet and component tree. And it was very interesting. Initially, I started this at the medical college trying to get a very low cost prosthesis. And I, I initially set with my resident, a cap of um $300. And the problem with that is, is it constrained your thinking too much if you try and set these um a priority cost pressures, if you're designing a product or something like this, it keeps you from thinking outside the box and doing things that would get a better product. So I came up and, and we just sort of um looked into the paradigm that get the right design and then drive down the cost through economies of scale manufacturing and things like that. Um Even here, prosthetics are very expensive and um there's a patchwork of insurance, I'm sure you deal with that quite frequently about who will fund prosthetics. So where do we go from here? So start. So I started I at prosthetics um about seven years ago, mostly as a vehicle to apply for an S TT R grant. And um it's been quite an adventure. Um So many failures. Uh But as you, as I'll, I'll convey in a moment, those failures are the most important thing you get and you have to have those failures be quick, cheap and fixable. Um We initially tried rapid casting, we tried different materials. We finally coalesced and I spared you all the uh uh mishaps that we had for this talk um because it was only an hour. Um And we have to, what? One o'clock or 1 15? What's the 1 30? Great? We finally call off list around the device that, that you'll see. Um It's very important when you're doing this. It's not like traditional research. You have a paradigm, you collect data, you analyze it, you write it up here, you're collecting data, but you're also designing and changing the product. And so you want things to fail quickly. And um the, the kiss of death for this is when you, you cannot wait for the next semester and a new grad student to come and help you, you need it done in weeks rather than in months or, or a semester. I strongly urge if you ever do this to get a for profit company working with you advanced design engineering that we work with in Pewaukee is absolutely terrific. As Josh can attest, we have twice a week, go to meetings where everybody sees each other, it's video conferencing and we problem solve and we, and if there's something wrong, like we recently had a buckle break, so we had to retool that we retested it, we re prototype it and we did that literally in about two weeks, you can't wait a year for this or, or things will just never progress. Um Then there's the issue of when are you ready to finish the product? That's always a very challenging thing to know. When is it good enough? When is it good enough that you can take this and give it to someone and be confident it's not gonna break, they're gonna fall and they're gonna in the hospital with the hip fracture. I mean, this is real stuff and um it is what keeps, you know, keeps us awake. And so what you have to do is you have to have an engineering arm that can test and give you quantitative information. Does it work? Is it strong enough? Will it work for the first three years? We've been just at the lab at Penn and then it was in my lab in Milwaukee working with patients and making sure in parallel bars and in the lab that they were safe, then what you have to do. So you, it does have a lot of design iterations. Then the, the way we're making this product is with injection molding. It's this, it's state of the art, injection molding, you melt these glass filled nylons under 1200 degrees, you eject them under high pressure and you can make things mass produce very consistent parts. The problem is, is, is for every part on the prosthesis, you have to make an injection mold and they're very expensive. So, when have you, when are you at the point where you can say yes, we have the design and I can now spend $25,000. Um you know, the grant money to have uh these molds made. So you really, that's that big step where you hum and haw and you get more data and you try to test patients and at every step of this, you can't test 100 patients or collect data on 100 patients. It's really a handful. So those handful of patients that you're seeing in your lab that you can recruit from advertisements are the ones that are actually driving your design decisions. So it's, it's a bit free wheeling. Um I was going to talk a little bit. I didn't want to talk too much about it. But if anybody is interested, I'm happy to answer questions. Um After uh this lecture on S TT R grants, they are like SBIR Grants, but they have some nuances. The primary investigator can be employed by the academic institution as opposed to the business concern. It's designed for testing and developing devices like this. And the university gets about 30% of the effort the company uses the remainder. Um And there's a, a series of phases, phase one is this proof of concept and it's usually a one year grant and where you can write and um uh get funding to see if it works, test it out. Phase two is, and to apply for phase two, you had to have gotten a phase one. So the, so the um the group that's applying for this is pretty rarified and you have a much better chance of getting it if you've done a phase one and you get a proof of concept. This is about, I think it's up to 200,000. Now, this is up to two or three years at about a half million. So it's a considerable chunk of money that you can use to do it. You think you're going to get it ready but you're not. And by the time you get to the end of this, you think jeez this is not going anywhere. And so they have a phase two B or a phase three, you gotta watch the agency because the NCMRR didn't have any phase two B. So I had to go to the National Institute on Aging and um they subsequently funded them, my research assistant found a commercialization grant that was a pilot grant by the National Institute on aging. We slipped in two years ago and, and got funded by it and now it's no longer in existence which is really, um, really lucky. Um, and what people refer to when you, when you read about this is this value of death. You can have a product where you or your final design, where you think. Yeah, this works pretty well. But then it never goes anywhere because the field, the processors don't like it. And I could go for an hour talking about how I had made this really neat design that I thought was just great. The processor hated it. So we had to, we had to change it. But um this is really the problem in getting a product from the bench to, to people. Um So the SCTR, you have to have a small business for profit company. Um it has to be wholly a or the majority American owned. They ask you a whole bunch of questions, you know, are you doing business here? You doing business there? Um All manufacturing has to be done in the US. Uh If you're funded by this grant and the grant really, the goal is to go from bedside to not bench and back again, but you know, bedside bench out the door to meet somebody's needs. They want to build American small businesses. And it's interesting because um as we're getting more and more producing this, people want to send everything to China. I said, no, no, you can't do it. You know, we're making America great here. Um So uh it's very different and I tell you, um it was a good uh project for my time and my career because I'd already made a tenure and, and had advanced. But if you're going down this pathway for S TT R product development, it's not traditional, you don't get publications. The traditional coin of the realm for public for promotions takes a long time. Um You need rapid turnaround. And again, don't rely on the academic timetable. If you have an idea partner with a business who's, who's motivated to do it with you. Um Again, you want quick failures. Um you make designs with limited data and uh it's very challenging and we're at a point right now where I'm now confident when someone comes in our lab for, for either the study or their meeting with Josh, I don't have this sort of angst that, oh my gosh, are we going to be able to fit them? We're getting pretty confident we can, we can fit them and fit them pretty comfortably. And so now is kind of the time when as part of this grant I have, we have to do a comparative effectiveness trial and that's where we're at right now. Um As a researcher, you know, it's hard to wear different hats. You have to be dispassionate and an academician as an adventure, you have to kind of be a bit free wheeling and um you, you have to be a salesman when you and you have to tout the product or the concept before the science is caught up with it. So, you know, it, it's a, it's a very interesting um uh uh academic paradigm. In fact, um the bioengineer chair at Penn and I want to are pushing to try and get an inventor track for um young engineers or young faculty so that you can have a set of requirements to get promoted, that brings that embraces this sort of concept of innovation. So how do you even begin to decide how to fit a new product to residual limbs? We need some data. And in Milwaukee and in Pennsylvania, we went to labs and we got their old casts, the positive molds and used that to take measurements and figure out how big a socket you need to make. Well, a couple of years later, we bought a digitized image database from Willowood Prosthetic Company and this has been just wonderful because um these digitized images give us quantitative data that we can make design decisions. So the our missions produce the highest quality affordable prosthetic device with a key on affordable um One stop fitting for non stop. That was what our marketing people came up with. Uh the right fit right now is another one, you know, you get, you gotta have it and any, any of, you know, when you have a grant or a center grant, you gotta put a catchy name by it. You know, the leap study or um some fit study. So you have to do that same thing here. Um It's based in Milwaukee and the engineering team, as I said, um the idea is really to grow businesses and to bring small businesses into the fore. Now, I just show this because there are other people in this, this space that are working there. This is the limb innovations. Um They have an adjustable uh brim here and they still have to use 3D um imaging and it's pretty high cost for for what you get. The other fundamental problem. I think that that other people in the market are forgetting is when you make a socket, what do you want that socket to do any of the residents fit correctly? But in that is total contact, there's sort of two ways that the there's schools of thought that, you know, you put a patella tendon bar and you put much of your weight on your patella tendon on the medial tibial flare. And then there's a lot of very good studies showing that total contact will get you just as good as suspension and prevent skin breakdowns and problems with that patella tendon bar. There's some other people trying to trying to really minimalist approach to this again, you know, is this gonna stand up to iso testing standards? This is actually an interesting device. It's a revolt limb where they parts of the socket and then have a boa system to adjust it And, um, and uh in fact, one of my patients, I've actually ordered this on him because he's an above and we don't have a bug product obviously. But, um, it, it works pretty well. You still have the hard socket here that um limits you in, in opening up and accommodating uh edema changes. So, um, here's what we developed that it's designed to be in a box and there's boxes here that you can come see later. Um It's a prosthesis in a box. I had an idea of, you know, be able to mass airlift this to um uh impoverished area and somebody who's not a prosthetic, maybe a, a, a fitter who's been trained in how to fit this can, you know, fit a whole bunch of people and get them taken care of. It's made of high strength polymer materials. It's mass produced. Now that we have the molds for this, you can make 5,505,000 very cheaply. Once the molds are made, the individual parts are 3 to $5. So it's much easier to make those. Here's uh the, the device and um we'll, we'll see some of this here. It's uh buckles. Um I borrowed heavily from the uh recreational industry. Um These, these concepts, it has a blocking buckle system and cables, there's different cables, different sizes and a lock here. It has a padded inner liner and we put the uh pin lock, it's a pin suspension. System right here, we recessed it. One of the problems with other amputees that they told us was a lot of times you have a pin suspension system, it sticks out kind of like Frankenstein and, and they bump it on furniture and it will come undone. So that's how it's kind of packaged up. We have everything in there except the foot and the silicone liner. So you have the pylon and the cables and the device. Um Here's the kit um uh that it comes with and uh it's weighs about £2.9. We weigh everybody's a prosthesis that comes in as part of our study. I did, I didn't present the data but ours is pretty comparable. But I'll tell you the range in, in private, conventionally made prosthetics is huge. We had our biggest one. We just had a guy come in an £8 prosthesis. I mean, it's, it's almost like a bowling ball. Um You can throw that thing out and it'll pull you forward. Um So ours fits uh weight wise pretty, pretty uh uh well within the range. And it's interesting because the engineers every time I want it strengthened up, they say, well, we're gonna add, you know, 1/10 of an ounce. I said, go ahead, be bold. It's fine. I would rather have it be very, very strong than, than break. Um works with a lot of commercially available feet. We, we use a silicone liner now we had a, a mishap in the lab one time where we used to use a, um, a, uh, what was it? Lock? The, not the sh lock, but the, we used, we used an older type of lock that was a ratchet and it, we had a patient in the lab that didn't get down into it and you couldn't hear when it went click, click, click. So they didn't get down into it and ended up having a fall in the lab. Fortunately, it was very well controlled. But, you know, um uh after your blood pressure comes down and you realize that that that's a problem. We actually redesigned the whole prosthesis so that we could use a shuttle lock, the bulldog lock, which is pretty standard in the industry. We actually pulled a paper and found out that someone had actually written about that's a probably safer, mechanically, simpler, less prone to failure lock. Um You don't need a full prosthetic lab. That's kind of what you need um to branch and, and be sure to torque these things. You know, you have to make sure that you have to do everything the process would you have to put locking solution on it and torque these down to what the manufacturers say. And uh here's a gonna get the mouse working here. There we go. Hi. Excellent, excellent. After he used this for an hour, um his, he was so swollen that his limb um decreased So there's marked volume fluctuations, your patients with real disease, heart disease, um, maybe hypertension problems. We all know how many um, uh socks they have to change throughout the day, the different ply of socks. And so the ability to just kind of re squeeze. This is very helpful. This is a woman who is in our study and she had sepsis and lost some fingers and her baloney bilaterally. And um we were able to fit her. This was actually pretty remarkable. And the one thing that you have to watch their hand function and people have to have enough dexterity and hand function to use the locks and to close the buckles. And when she came in, I thought there's no way she's going to be able to do it, but she ended up being able to, one of our studies early on when I was here at, at Hopkins was that we looked at a large database and people that had to wait more than 60 days to get a prosthesis had less satisfaction, long term use and satisfaction. There's sort of this golden hour and, you know, for trauma, there's sort of this golden period for fitting prosthetics when people tend to adapt to them better. We're starting to do some international stuff. Um This was, there's a woman who works with one of my colleagues in Jamaica and she's a, um she's a physical therapist with the Catholic Ministries down there. And um we she actually Michelle's lab is right next to mine. So I talked to um, Beth uh Wolf, the, the therapist and I said, you want to take one of these down there and just try it out and give us some feedback. And, um, she went and we showed her how to fit it and I lost my mouth. There you go. The bar. Then that's prominent when she, after she fit him, he said she sent us the full story on him. He had been injured in a traumatic accident and hadn't walked in eight years. He was on, he was saving his money to buy a prosthesis because it's about $2000 in Jamaica. And um he was just delighted with this. In fact, we, we're conversing with him, we're going to send him different iterations and let him try it out. But I think this illustrates how a therapist can, you know, learn how to use, put this on and, and get people in, in, in, in other countries. And we're also, we're constantly looking at how to drive down the price of this with a component tree. Maybe we take that shut lock out because that's $100 piece. And we put a little cost for, for some of these efforts, um, advanced design concept. This is the engineering firm I've been speaking about and they are terrific. They can do machining, they can do limited production, which is really nice if you're working with an engineering group that can not only do the rapid prototyping, the changing but the limited production. So they've got the molds, they made the molds and then they can spit out the products. Now, what's good enough? When is a prosthetic component? Good enough that it can be sold? Turns out there's this international standards testing. Has anybody heard of that or know about it? It's, it's, it's to test component and component manufacturers. It's typically not to test sockets, but we put our socket and our connectors on this has to withstand about 3 million cycles and they have some static failure levels and, and the static levels depend on the weight limits you want to impose on it. So um typically it's about £900 and um this is muo expensive. If you send it some place, if you try and buy a commercial um machine, it's about a quarter million. I just eat up your whole grant budget. So what we did is we made our own. And the thing about advanced design concepts and Jim Marshall is this is an engineering team with a huge bandwidth. I mean, they can do everything from, you know, software to prototyping to if we got a machine they can build it. And so we have a load cell and a cyclic loader here and a lot of times the pylon and the parts bend before the plastic here and you wouldn't think so. But this plastic is advanced glass filled nylon. It's an aluminum substitute. It's very, very strong. And so we, um, we even put offsets on it and test it in an offset load because if you have an offset load, any load here is going to put a, a higher torque on there and load it even more. But you know, if you're lining it right, every process is going to have to put an offset to get it right. And so you want your device to withstand those loads. So there's the the device I find this just really neat. Um And we, we ended up making a steel plate and um we've tested as I'm gonna show you, this is aluminum, they bend. So we now have a steel pipe that the engineers made so we can put the maximum load here. And we found that our standard size pro prosthesis went up to 15 £84 and the plastic did fine. We made these new extra wide cups with the idea, Josh has been out working with prosthetic groups and he said, look your prosthesis only fit a certain amount of people. We need, we need, we have bigger people that need to be fit. So, you know, responding to the market, um we designed an extra wide cup and we've got examples here and, but before you want to put it on somebody who weighs £300 you better be damn sure it's gonna be strong enough and we're actually doing as we speak. Um Well, actually it will be in about a month because we have to send the load cells to be calibrated at another company. But um, we broke this at maximum and it went over £2000 when it, when it had that um offset when it was just a straight up force, it went to £2600. Now, the iso standards say you need about 900. So we think, wow, this is a great factor of safety for engineering. You know, you're in a plane or something. You want your ribs and your mechanics to have a factor of safety. The problem with this is that plastics do some funny things. You know, they creep, they have different changes over time. So we wanted to make sure it was very, very strong. We even tested it. We put it in the freezer and tested it a cold and then we tested it at hot about 110 degrees and the properties changed a little bit, but not very much. We had some problems with our buckle and you would think a buckle. We, we initially tried to take ski boot buckles and I ordered them, they hurt your hands. And even after I'm using it through the day, the ski boot buckles were just didn't work. So we had to design our own that were longer that had a better lever arm that wouldn't hurt your hand, but we had to figure out how to make them, how to make him strong enough. And so to 25,000 give up three. What is the, yeah, that's the pressure. So, how many, how many cycles do you need a buckle to not break? And, you know, and this, it may seem sort of, kind of funny. I'm testing buckles but that buckle breaks, somebody falls. That's the bottom line is when you're held together by buckles and cables and, and you're walking around, you want that buckle locked and you want to make damn sure it doesn't break this withstood 100 and 30 100 and £73. And we, we figured somebody really strong is gonna put about £50 of torque. If you put any more than that, it's gonna torque the prosthesis on your limb. Um This is another gentleman that, yeah, it's hard to find the mouse. There we go. That I fit. Um, just about a month ago, he has a knee friction contracture standing up straight. So, um, here was that, uh, we decided to go with this component tree. Now, everybody asked, well, can it, can it be used with suction suspension? No, it can't. It's a, it's a, it's like a ski boot. It has overlapping, it's not vacuum, um, uh, vacuum tolerant. So, um, we use a shut lock. It's pretty standard in the industry. It's very tough. It's not waterproof. We found out. So, if we want a water prosthesis, you got to do something different here. But incidentally all of our components are waterproof. I mean, you can throw them in the ocean and go goofing around. We've now tried a few people. We've given it to them and let them try it out and they find it's pretty nice. Um, this person, we, we decided to try a few different things and I'd like to get the suspension system. Uh, where's the, there we go, the, the lock suspension system, although very good is expensive. So we're trying to, and so we're trying a little different types of suspension, this suspension sleeve, these are a little cumbersome, but I think we can probably make it work. The advantage to that is, is we could make a very low cost device to mass produce and send to third world countries. We've, we've experimented with a Lanyard and um, we have this little, this is a prototype. We haven't got a real part for this. We're just, we're still kind of mucking around with how to make that work. And most people, the, the two people that we've sent out with lanyards, they don't like it because they have to sit down, they have to thread that thread through their pull it, it on. People really are really are liking the um, the pin. So they just go click, click, click, they can hear it. They get that feedback and know they're safely in it, you have to get it safely on. Um, because you don't want to buckle the buckles and not have that pin engaged or going out the back and then they're really not doing the prosthesis. Now, um, we have padding and we use neoprene padding, um, and it makes a very comfortable socket. It's not a hard socket. Um, we've been able to fit limbs with all kinds of shapes like that, mostly due to the uh the soft inner liner that although the prosthesis socket is one shape, it can accommodate these minor differences and geometric differences across limbs. This is probably we, this is probably the best advancement we've had in, in years. And um, there's a ski boot company called Sure Fit that makes a, um uh a custom ski boot liner. Does anybody know about that? Yeah, they're really comfortable. And um, we called the company and said, hey, can you help us with this? And it turns out there's a lot of thermal molded foams that change at different temperatures that can mold exactly to the limb. And so we're using an oven and you have to heat it for about 4 to 8 minutes. It's not hot, it's just warm to the touch. You put it in the socket and it molds exactly to the geometry of the residual limb. We're just on a call with them and we are trying to push this to where you don't have to have the heater it can be pressure and sort of body temperature over time. This is one of our, you know where the mouse is at. Can you hand me the? I, I can't, it's not uh the mouse is. Oh, there we go. All right. As a safety check. Now, try the, the pins right here in the front. You like that man. Ain't no worry about this. Ok? At the end you can hear it go click, click, click. I know. And it all to be tight now, make sure that always go like this, make sure they're tight now. Push the prosthesis off to make sure it's always stuck on it. OK? Stand up. So you heard several things that the clicking, I'll tell you that audio, a lot of people don't have vision, they, they have diabetic retinopathy. They can't see that little, the other little shuttle lock or the, the, the pin lock, it had to turn and you had to see it and they couldn't see it. So having that um auditory feedback is really, really helpful. Every Yeah, that, that's what I'm thinking. So um sort of continuing here, the prosthetic technology is certainly advancing, but there's a catch for most people, these state of the art devices are neither obtainable nor well suited to day to day life. And so at the high end of the spectrum for technology, it's not always practical. So um we went kind of through this. So we have an adjustable socket. The liner is a neoprene suspension is pin alignment mechanism is your standard pyramid connector. And um uh there we go, we have uh sizing charts that have been developed. Um There's a standard, a wide, an extra wide and a tall. So we can fit most of the people of varying uh dimensions um and heights using these uh different four different sockets. Um This is a standard, here's the wide, it has some extra um spacers here and incidentally every single one of these parts has to have an injection mold. So that flap and it took just months and months and months to get this flap right? You know what's the geometry? Because once you make a mold, it sunk costs um the uh wide prosthesis. Um Again, you have that we designed the flap so it could be cut down and you can adjust it if people shrunk. Um we have, we now have the extra wide to accommodate people just like this. And you see this a lot of times in different centers, they'll have a residual limb wrapping that chokes the limb off or they dangle their foot over the edge of the bed and then they get a bulbous limb. Um It would be great to show this, but let's give it a try. This is a someone fit, we could fit him in like two hours. This is the Boston va va this patient has, this is the furthest this patient has walked within you based on what the physicians, the physicians are here, the head of here, the lead clinicians here. And he's a, he's a but we were able to get up and go and he was able to get into rehab immediately the next day and we were able to set something up just because there's a lot of change. That's why it's traditional. So then um we have a tall device. Um We use these casts. This was this repository of 6000 digitized images ended up being just a gold mine. So we analyzed these digitized images and looked at how much what the range this black bar is. 80% of the population. This would be 50%. So we had some realistic quantitative ways to build into the sockets, what would fit and what wouldn't fit. Um That same thing for males. This was a circumference and so we knew what ranges the, the what design parameters you had to put into the prosthesis. This is much better than when we first started this with the cas from Prosthetics labs. Um I'm not sure we need to see. Well, this guy walked in. Um We, we don't need to see if we have time who's been walking with. Part of the thing is we have um He came in with a crutch. He's been walking for over a year with a crutch. Now, at the end of this video, we, we cut it but you'll see emotionally. Uh this, this guy has had tremendous success with the guys. It got very emotional. Now, this is how we, we looked at a distribution of um uh measurements circumferences and we know that our three here will cover most of the waterfront, both for males and females. So here's the beautiful city of Philadelphia, um fitting it. Um who, who needs this? Well, it's kind of like fitting any prosthesis. You know, you gotta have some with well heeled surgical limb, no evidence of skin infections. They have to have some sense. We like people to have some touch or intact sensory ability or you need some hand dexterity. You really need people who can kind of uh use that, but most people have been able to, to use it. Um You need some with good judgment. I mean, we all have seen patients that and there's some in our study that, you know, you really have to slow them down and um say you don't fit people with poor judgment. Now, poor hand function and eye function. That was a, we've now fit some people who have some real vision problems. You have to work with them a lot. We've kind of worked it so that they can um can use this and uh uh uh count up the number of slots on the hook so that they hook it at the right place for when they, when they get up. Um Sure. So on that. Um, you know, eye or dexterity issue. If they have an assistant or a helper, it actually makes that helper's job a lot easier to adjust the buckle versus having to try to figure out where Mr Smith is in relation to his compliance or for example, so it makes it a little easier. So, you know, um, don't fit some of the skin abrasions and that, um, our standard, why we now can go up to £330 because believe me, the industry demanded that um here's what your answer to your question. We have spacers that go in here and the sweet spot for this socket is the patella sits about right there. And why did we design that? Well, a lot of prosthesis and you, you'll look at them in clinic, they come up to about here. They really don't go super condor. You can have super condo or suspension, you can have a, you know, a medial brim type of things in the old days. But we put the patella right here. Now, you patella can be down here. I'd rather have it be down here than up here, but it has to be down in this little V notch. And so you have grip above the thermal condal and so it gives a lot of stability here. And you use these spacers so that you put a spacer in to get someone who has a shorter limb to be in that particular area, we can fit people down to about 13, 14 centimeters pretty well. So you cut the pylon. Now, this is one of your questions here. Look at that, you know what that is? Hey, buddy, it's an offset plate. This guy is a huge knee flexion contracture and um, so that you can get him up walking and he, he got up walking quite, quite well. And we now, now you know why we did that testing for offset plates because that really force multiplies your, your torque here. And so you have to have a very, very strong uh uh device there. Um What else buckling? We tell people to um, buckle with their hand open like that, you know, the experience you get leads to the design changes. We had one guy, one person cut, their finger, got a finger cut on the metal part. So he had to go back to the engineering, go back to the people that manufactured that little steel plate and say we have to coin all of the edges so that they're not just the ones that are sticking up. So, you know, you learn this, fortunately he healed very well and he, he liked the prosthesis, but every time that happens, you've got to have that cycle of going back to your lab and saying, jeez, we need to fix this. Now um the buckles go here. Now we have six different cables. So the cables, you can change the cables and you can change where it fits inside the slot. And what I usually do is I'll mark this slot for people after we fit them and say, you know, that's probably the sweet spot here. You can go one or, you know, maybe one notch either way. Um, we have a wearing schedule. I'll tell you the people that have broke down their skin are the ones that said Jesus was so comfortable that they went out and walked way, way beyond what they should have. Um, I mean, if I have a new boots and I go, hi, five miles, I'm going to get a blister. So we really try to make sure that they get used to this. Have a wearing schedule. Um, how will they, uh, accommodate that? I don't know, here's another sizing chart that shows how the spacers, socket and cables. We tried to put this together. It seems to work pretty well for the majority of people we use. Um, again, component sizing, we now have this extra wide version that goes, um, goes even higher, um, to about 50. So we can fit people who are pretty big. Um, yeah. Ok. Go ahead. Mhm. The foam? It's not, but you remember the foam? You've got what? You actually, you can't, you can take it out and wash it. Um, so the neoprene you can take out and wash it. The people have a, the silicone sleeve that goes up their leg with a pin on the bottom every day. They have to wash it with some soap and water. That's pretty much what all of the manufacturers, um, recommend and what we've found is now, we have some long term use. We have people use this for, you know, nine months and, and we're finding about every quarter you have to replace that liner. In fact, we just got on the phone to the company that makes it and we want to sew a little better edge at the top. So it doesn't, uh, delaminating and can last even longer. So something like this can be sent, you know, to 3rd, 3rd world countries or other countries. Um, we kind of went through that, oh, this sort of shows that, um, the differences between traditional and I fit much less time, much less casting, much less visits, um, time to getting prostheses. Um, it is, uh, go easily fit, we can do it in about an hour. I can fit them now in about an hour. Um, and this is probably the last video kind of, this is one of our sub research subjects. Can you hear that? We don't have a, why don't you plug the volume cable in for this? Because this kind of just brings it home here. I should be done another five minutes. So there, or come back, I tell you what. Never mind. Yeah. I don't know. It's, it's, where's your, I didn't know what I did right there. I think it looks fair enough. And, uh, I, yes, cross the line, the line and I transport still. I never know how. Yes. Yeah, that it is. Yeah. This name. Mhm. Scandal. Yeah, for this one this gives me more support and you, you kind of people like I can understand. Mhm. The other way. And so this one track I, I, mhm. Not aware of this process. OK. So uh the last part of this is so what does this even work is this sort of some flim flam? And um uh part of the S TT R grant is you have to do research. That's where it's not just, you know, giving money to industry, to build something, you have to test it and make sure it works. So this is my son, many of you know, him, he was here at two years old when I was here, they won the State Pennsylvania State Soccer Championship. So we did a pilot study, an efficacy study. And um the goal was to determine comfort, fit stability and ease of use. We selected transtibial amputees. Um who could ambulate already. We didn't want to try it being the first prosthesis. They had to be six months beyond amputation and they were due to a variety of causes and um they had to have intact sensation uh where they were excluded, they had skin ulcerations or other central nervous system problems. Um The study was approved by the Pen IRB. And um we had two visits. It was a two week study. We brought them in. We rated their own prosthesis when they came in and I had my research assistant rate it. So I was not present when they rated it. And then they took it, we fit our prosthesis, the I fit device and then they took it home. They rated their current device at the first visit. At the second visit. They rated our device, they did pressure analysis and we did biomechanical studies on them. So we use self reported outcome measures, biomechanics, intra socket pressures and monitored for problems. This is our uh gate biomechanics lab. We use this fuji film to monitor the maximum pressures and um found that uh this is how it kind of works. It's low tech, but it's also low cost for the comparative effect of the study. We're gonna buy a device that's about $10,000. Um They rated it on seven questions. We Eva we took this from the prosthetic evaluation questionnaire. Well, a very common uh instrument but it is just huge and long and we didn't think we really needed it. 26 participants entered the study, four were lost to follow up due to challenges in transportation, no falls, no li ischemia and all the subjects afterwards wanted to keep the device. The mean age was 51 there were three females, 19 males, dysvascular and traumatic and there were three persons with bilateral amputations. Um We did statistical analysis, we also did a, a worst case scenario. So we assumed that those people lost to follow up did worse by one standard deviation compared to everyone else. We assume they're all just worse. This is the um data. So with a self reported questionnaire, assuming those people were worse off, it was still significantly better in favor of I fit uh device. Um All of the biomechanical parameters, there were no significant differences, which is kind of what we wanted. We didn't want them limping, we didn't want them having excessive uh stance, phase and stability. And so this was very uh reassuring here with the peak pressures. Um The red is I fit the other is conventional. It was significantly better on overall and for the Tibby and the lateral uh leg. And um it's not surprising because you have a padded uh liner that protects the, the limb, but the pressures intra socket pressures were less. Two people had minor skin breakdown, which we were addressed with changing the padding and it readily healed up. If you look at the literature, about 40% of amputees have skin issues at some time or another, we changed the geometry of our bottom plate and did a few things that seemed to resolve that um we had one buckle breakage. And so that's why you're seeing a lot about the buckles. We made it from a two rib to a three rib buckle. And engineering wise, the engineers tell me it made it much, much stronger. So, in conclusion, in this very small pilot trial, it compared favorably to the other person's devices. There are no biomechanical differences. There were less pressures and slightly better self reported fit and function. It was a small sample though. And so, um it was a short term and persons entering it, we found may not have been fully satisfied with their conventional devices. Maybe they're more prompted to go into a study because doc this thing hurts. We find that a lot. There's a guy that came in and he had been in a device and it was the most awful thing I've ever seen. He rated at once. He got in ours, he rated RS fours and fives and he said, boy, I like those for the study, but it doesn't tell me how well you're going to compare to a really good, uh, conventionally made prosthesis. Um, the study strengths, however, we had objective information, not just my subjective information, pressures and biomechanics. Um, this, the fact that we had significant differences with the small sample size is more compelling that maybe there's some real effects there. The biggest problem that people have complained is it appears too bulky, can't get over their pants, they can't wear. But, you know, we're addressing that. But I think the safety and reliability of the buckle over time, sort of means that's kind of the way it is and they probably have to get bigger pants at this point. Um, we're trying a boa system. Uh, we'll see how it works. I'm not that convinced does look a little bit lower profile though when you get the buckles out of there and you put the boa crank on the back. Um, it does look a little more streamlined. There's my boys. Um, so where are we now? As I was saying, um and Peggy there, that's what uh those are my boys. So cool. Um We're at a point where we're, we have the product we're working on the above knee sockets, but we need to have a comparative effectiveness study in the next two years and are looking for uh partners and Hopkins would be a lovely place to partner with. So there's some early users now and um what we hope is the value cost proposition, we increase quality and decrease cost at the same time. It does work in the water. We actually got it in the water and it flows. So it's not gonna be an anchor on somebody's leg. That's what we fished for in uh Wisconsin. Um That's my son kind of large Northern pike. Um The above knee, we're going through that again. We have the same analysis. Um We're looking at an IPO so in the hospital, they can move from this socket, you can build the component tree and they can start going. I gotta go. So thank you for attending. It wasn't my fault though. We had, we had I Yes. Yeah, I was just curious, judging complications and agents have good judgment on that. No, I think your clinical insight in the lab, we have AAA pathway. They go, they have to demonstrate that they can put it on in the office safely. We have to go up some stairs. You'd be surprised at how many people in prosthetics are taught and proper going up and down stairs. So we have a pathway for them to go any questions. Sorry. Yes, you talk that. They said they were bulky, et cetera. How about appearance in general? They just bulky one. Oh, the last guy he will, he doesn't wear a prosthesis outside. He wears his old one until I wrap foam around and he puts a black sock over so cosmetically it looks good. We're gonna, we're gonna try and get a cosmetic cover. I think that will make a difference. You know, most people don't want it to be like said, at least I have so many patients and, and again, it's a select sample. That's why we need other people working with us on that. But people say, you know, I'll trade off the bulkiness for being really comfortable doc, I walked all day long. I had no problems. And, um, uh, so there are some tradeoffs there now that was that they tend to be terms of shape. They, they look comfy, but people seem to like that. I think with like the Terminator and Transformers, people are very comfortable with the machine looking, it's much different than 20 years ago. And in fact, one of our patients said, man, I really like the buckles, it looks cool and we experimented with different colors. And initially, I thought, you know, it's gonna be like a Nike line where you have all the different stuff. Finally, we just said, let's do one color and then maybe, you know, later on because I think people just, um, get, they, they, they, the technology is not scary to them anymore. Even the buckle stuff, people used to ski boots and, you know, uh, shoes, you know, hiking shoes have bows on them. So it's not that scary. A technology. Mhm. That's all I have.
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