Thank you, Tomas. First my disclosures, I am a founder and stakeholder of Obvious Robotics, which is the maker of the SIRTA robot, which I'll talk about. But I'll actually begin by saying that I arrived in Phoenix Friday afternoon with the intention of spending the evening with my brother, who lives here. Took an Uber en route to his house. My Uber driver went right through a stop sign, and a large Cadillac SUV crashed right into the side of the car I was on. And so I survived the crash. I temporarily lost my sunglasses, but I did find them. And I got out of the car, and I called my brother and said, I was in a car crash. Can you pick me up? And he actually stepped out of his house, out of his door, and waved to me from about a block away. So fast forward to Saturday, I was staying at the Sheraton, and I noticed all these auto driving vehicles throughout town. And I could really relate on automating this procedure of driving for greater safety. So instead of that event on Friday being traumatic, I've come to think of it in my imagination as propitious. So without further ado, I'll talk to you about my outline. And I'll tell the story of the development of this device from a bedside clinician's view. That's me. I'm a bedside clinician. I'm not an engineer. And I'll walk you through its evolution over the last dozen years. OK. So the origin story started a dozen years ago at 2 a.m. in the bedside of my hospital's ICU, where I got a 25-year-old acute liver patient, life flighted in. And he was on high-dose pressers, peripheral IV, also needed blood products. He was bleeding. And so one of the first orders of business was, in fact, to place a central line. So actually, in the process of placing the central line with the standard ultrasound-guided technique that we all use, I actually did not hit the central line on first pass. I instead created this pretty significant hematoma, liver patient, coagulopathy. So not only did I not get the line, but it injured the patient. That really created delay in getting a good, solid line. Eventually, two hours later, was able to get a line in and moved along. And fortunately, that did not hurt this patient's outcome. But the next morning, I made it home. I got a couple hours of sleep. But the next day, I woke up, and I said, you know, it would be so great to have a device that would do this more automatically so as to achieve greater safety in placing these lines, greater reliability in placing these lines, and frankly, for a guy putting lines in the middle of the night, easier to put these lines in. So that really started this journey. So some context. Central venous catheters is about 7 million placed in the United States a year. We don't have data on the ones that don't get placed. Those of you who work in an urban medical center have seen plenty of patients who come in from a peripheral hospital, usually at night or on the weekends, with little IVs, with a lot of pressures going, or blood products. And these community hospitals can't get someone to come in in the middle of the night to place these lines. It takes a lot of training and experience, actually, to be good at placing central lines, to be able to place them with facilities. You have to gain facility with ultrasound first. Typically, we train on a gel block or a mannequin. We have to have quite a few proctored lines. Really, you don't get good until you have about 100 lines under your belt. So there's a lot of investment and years and time to get facile at placing central lines safely and effectively. And those of you who place lines know that it takes generally at least 30 minutes to get a line in, especially in a chaotic emergent situation. And the failure to place rate is actually pretty high. So in a recent study, a 2015 study, multi-center study, it was almost 10% failure to place a line. The best recent study of lines was actually a big Swedish study published in British Anesthesia in 2022. And in that study, with very experienced line placers, almost all the lines were placed with ultrasound, not surface technique. About 15% of those lines had multiple, multiple sticks to actually get that line. In emergency rooms, in urgent situations, only about 60% to 65% of the lines are actually placed in those EDs in emergent situations when they're needed. Complication rates. So studies vary, but the best, again, recent studies, about a 7% complication rate to placing central venous catheters. But those are significant complications, hemothorax, bleeding, et cetera. And the back story of the technology of placing central venous catheters is this. The first central venous catheter was placed by Werner Frostman in New York City. He placed a catheter in his antecubital vein and advanced it, went to the x-ray department, and situated it in his right atrium. That's actually a picture from his original paper. 1953, came along Steldinger with his technology, his technique. That's actually an original drawing from his paper. 1986, there was a paper from an interventional radiologist on using ultrasound to guide placement. And that's really the technique that we use today. It really gained standardization technique by the mid-2000s. And from that time, for over the last 20 years or so, there's been a number of investigators around the world, Stanford, Japan, there's a group in Germany, that have been trying to automate this procedure. It would seem simple, right? You have an ultrasound technique. You have a robot that can advance a needle. We should be able to automate this technique. We should have done this 20 years ago. But we actually have been stuck here. And I'll go over why we've been stuck and what we've done to overcome those barriers. So if you think about placing a central venous catheter, if you really think about it, there are some real challenges to placing this catheter. First you have to visualize the vessel, of course. And then mentally, you path plan where your needle's going to go and get into that vessel. So there's variability in that. There's obviously fail points in that. And then, I don't know what your experience is, but I often can't see the needle tip when I'm advancing that needle tip into that catheter, another potential fail point. I think most of you will admit that it takes a lot of muscle memory and experience to guide that needle into that vessel, something we don't talk about much. And importantly, as you advance that needle, that needle actually pushes structures out of the way, pushes that vessel into a different position. And I'll talk more in depth about that later. And then finally, when you get to that vessel wall, I think everybody's had the experience of trying to get through that vessel wall. The vessel wall often compresses. Sometimes in the act of trying to get into the lumina of that vessel, you compress that vessel when you go right through the other side into the pleural cavity or into a vessel. So those are some challenges when placing a central line that we thought a lot about. So one of the best things I did is recruit a couple of people who were smarter than me early on in this journey. Wayne Reddix is an ICU nurse, very innovative. Billy Cohn is a very accomplished cardiovascular surgeon. In fact, at the end of this week, he'll win the Lifetime Achievement Award from the STS for many of the innovations he's developed over the years. So our first move was actually to develop a mechanical device. And this is a picture of our initial mechanical device. We bought an off-the-shelf software app to design the device. And then we actually 3D printed this device. And in this, I don't have a pointer, but in the picture there, you can see the ultrasound. The hand is holding the ultrasound. And what you see is a tract along which we would advance a standard needle. Thank you. OK. So here is an ultrasound. Here's an ultrasound. This is a tract along which we advance a standard needle. And this thing is an arc that basically keeps that needle along this line, along the visualization line. So no matter what angle you advance that needle from, you would actually hit the target vessel. So, we then mechanized this mechanical device. Again, we computer designed it. I'll stick the banana with the standard needle, no out of. Actually, I need to go back one slide here. Vibration. There we go this early prototypes designed to demonstrate some of the potential value of image-guided handheld robotic instruments There is a needle with a catheter over the top and a guide wire The difference of course being that the elements are arranged in this disposable unit in such a way that they can be actuated by the robotic console Handheld surgical robot allows all those things to be done at the push of a button The idea is that when this module is popped into the surgical robot Each of those mechanisms the two linear sliders and the rotating spool on which the O35 guide wires coiled Lock and registration with motors that will provide that actuation So by pushing one button, you can advance the needle in the catheter Roll out the J wire and then advance the catheter This is what it looks like from slightly further away again Advance the needle in the catheter Roll out the J wire and advance the catheter. Basically all the steps required to place a central line This is a model that emulates some of the challenges associated with placing a catheter in the central vein Becomes a small matter to place our crosshairs on the structure that we wish to cannulate whether it's a vein, an artery, pericardial effusion, the gallbladder, the dilated renal pelvis, perhaps pleural fluid Push the button and in so doing Atrematically advance the catheter using the tried-and-true sublinger technique. When the device is actuated The robotic module will advance the needle Advance the guide wire and place the catheter over the guide wire into that loom And because the relationship of the echo probe and the device are fixed Much of the scope and arrivals positions are fixed The wire and subsequently the catheter will always be placed safely in the central portion of the lumen of our vein This early prototypes Okay, so this is this is again an early prototype of our device and it worked very well in gel blocks but we took this into our animal lab and the problem we ran into Was the problem that had gotten everybody stuck in the world trying to develop an automated central venous catheter device and that was a problem of tissue deformity again when you advance a Needle through tissue you displace The tissue and ultimately as you're advancing towards the vessel, you'll displace the vessel Pardon me, so Coupling an image as a target to linear actuation Has been the problem for the last 20 years So there's been a lot of work on well how to solve that problem We did a lot of work on how to solve that problem. We use different Insertion speeds doesn't different insertion angles. We use different needle tip designs we we worked with laser for a little bit, but ultimately I'll show you stick the banana with a standard needle. No added vibration This was what really helped us to overcome that barrier so Let me let me play this and I'll comment on it First I'll stick the banana with the standard needle no added vibration Gentle sharps micro vibrations help the lancet puncture more smoothly This allows you greater control while minimizing discomfort and stress for your subjects So this this this video and this technology was from a company in Pennsylvania. These were Engineers from Penn State University and they like several other investigative groups were working on vibration and specifically axial down needle vibration to overcome Tissue deformity and very interestingly the inspiration for this work actually came from the mosquito so one of the ways the mosquito gets through your skin is it it actually Vibrates its nose through your skin and it helps decrease resistance and decrease tissue deformity So we incorporated that into our device again another computer animation and This was again one of our original prototypes now with this vibration and this illustrates how that That innovation helps us to overcome tissue deformity This is a silly looking but instructive demonstration the significant impact that low-frequency small amplitude vibration can have on the dynamics of needle insertion In this video, we've attached a 16 gauge needle to the vibration module That's a large enough needle to pass an 035 guide wire to emulate our patient To emulate our patient we have a slab of bacon sitting in this toy truck on a track that abuts this digital strain gauge Basically a digital scale the readout of the scale will give us a metric to assess the resistance the needle encounters moving through the tissue We're gonna adjust the amplitude of the vibration to zero. This is our control This is how a needle normally passes through tissue watch the numbers on the digital strain gauge When the needle advances the numbers rapidly climb to a maximum of about 254 grams that's about half a pound. That's without the needle vibrating Let's move the tissue find a fresh area to stick and try again again with no vibration once again as the needle advances the numbers rapidly rise to a maximum of 286 grams this time again roughly half a pound as the needle goes through the tissue Let's try once again, but this time let's turn the vibrations on we've got a frequency of a hundred and thirty three Hertz 133 cycles per second and you'll see that as the needle passes through tissue. It's a completely different dynamic There the numbers rise to a maximum of 22 grams Roughly 1 10th the resistance. Let's move the tissue and try once again Again this time as the needle advances it only goes to 17 grams Again, less than 1 10th the resistance 1 10th the force It's long been known that the main challenge with automating needle insertion is tissue deformation Collapsing of hollow structures and needle bending reducing the force and the resistance of the tissue will have a dramatic impact on these factors This is a silly This is a silly looking Sorry Okay, so again We we made a substantial step forward when we started using needle vibration particularly axial needle vibration overcome this tissue deformity and that was really a key to Reliably linking the targeted vessel to our needle actuation or needle drive. The other issue was the problem of Advancing a guide wire in a vessel and again once we started working with animals We realized how difficult it is to detect downstream obstruction in that vessel Automatically, so the typical guide wire we all use is a soft guide wire when it hits an obstruction it bends so trying to translate that into Detection of resistance downstream is a problem that actually we've not overcome yet so we backed off a little bit and instead of Developing the device that places the the needle the guide wire and the catheter we backed it off to a device that simply gets into the vessel and makes it very very easy to Manually place that guide wire and use that tactile feedback to determine if you're hitting downstream resistance So I'll fast forward through the years where we collected some Venture backing for stood up a company got some fantastic leaders of the company and now that company is called obvious robotics And this is actually the this is schematic of the current device that we've developed which which again has which incorporates many of the Innovations that we've talked about it has an ultrasound. It has a control handle This is the linear actuator and here is a tear drop needle. So this needle Is designed to show a flash of blood when it enters the vessel and actually provide easy access manual access to a guide wire this our device also comes with a Tablet which has a targeting program you place the target right on the vessel and you You move you Move the gantry up and down target the vessel and then simply press a button and I'll show you that So we actually spent about two years in the lab with with sheep The Texas Heart Institute animal lab and and I'll show you some of that work, right? So here's the draped server robot. Everything I'm holding is sterile. All the non-sterile components are inside Here's the needle guide the vibe motor here's the Serta needle the teardrop needle It's got a magnetic coupler on the back and this unique teardrop basin It's going to allow us to insert the guide wire without disconnecting the needle The prescriptive behavior is to take the needles and do this to tuck in the drape here I'm going to put the tip of the needle carefully through the walk needle guide at the end and Magnetically couple the back of the needle to the vibe motor as I rotate it it clicks into position There's one position and that's this 45 degree angle It needs to be in 45 degree angle relative to the base of the device I then put the ultrasound on the patient. I'm going to unlock the gantry So now you can see I'm moving the gantry up and down here. I'm pointing for a superficial target here I'm pointing for a deep target as I articulate the gantry The reticle is Bluetooth to the ultrasound image and shows me exactly where I'm going to hit You can see the dotted line goes right between two blood vessels The one on the left is thicker walled smaller diameter and it's pulsating gently kind of hard to see but it is The one on the right is thin walled much larger and perhaps more importantly when I mash down It completely compresses and you can see the left vessel didn't at all that way. I know it's a low-pressure vein I put my aiming reticle now move the dotted line to the right. So it's centered on that vein I put my aiming reticle on the vein And lock it in a position and you can see when I locked it it turned green that shows I'm ready to fire I take my guide wire and get it at the ready Ready to insert because I have high confidence. I'm gonna hit And push the button I wait for blood to start coming back from the teardrop needle. I insert my guide wire and the guide wire Goes effortlessly into this five millimeter vessel because I know my needle tip is right in the very center I then back off the certain robot and I'm ready to insert my line All right, so here's the game Okay, so again we we worked on The sheep model for two and a half years and and actually presented some of the results of those experiments Last spring in Porto at the Vascular Access Society Bottom line it it was very successful. We got to a point where we could hit five seven millimeter vessels very very reliably and Then we we actually last May we did our first human study was a small study there was 19 patients and This is a feasibility study to just get it get a sense of can we do the safely reliably? And I'll show you a video from one of those one of those patients I'm gonna put the ultrasound on the patient and find the vein there it is And I can adjust my gantry make it go deeper or more superficial, but I line it right up With the vein, so I'm compressing the vein a little bit. So I'm gonna lift up a little too superficial So I'm gonna go a little deeper Okay Now I have the wire at the ready because I'm fairly confident. I'm gonna hit it And I push the button And there I am in the vessel blood's coming back There goes the guide wire And it goes effortlessly because the needles right in the center Okay, so in our trial in in Paraguay again 19 patients we have 100% success rate At first stick we had an 84% success rate and it was very very fast I mean once you put that ultrasound in set your target and press the button you're in So this is a this is a very encouraging trial And so what's next and to wrap up my talk a little bit of it. We're currently Working with the FDA to gain approval. The device needs further study in a broader population This study in Paraguay was for patients who need a hemodialysis temporary hemodialysis Access and catheters, so obviously we need to study this in a broader range of patients. So that's really our next step with this But I'll come to this my last slide final thoughts and and and musings so The society is and we're all about getting to more reliable critical care practice We do that by standardizing our practice through evidence based Standards and protocols we use clinical analytics to look see how we're doing in terms of compliance with best practice we have evolving decision support live time the AI Innovation is going to really really help us at the bedside to make a live time decisions and help make good decisions But one of the things I just haven't seen that much in our space is automating procedures at the bedside I mean if you think about it in our world that we manually intubate we manually place a lines you mean place central So I think this maybe is an area of focus for us With the opportunity to be more reliable to be more safe and more reliable in these procedures We we also here in the society talk a lot about sustainable critical care practice for our providers staffing models, etc, but One of the things again, we don't talk so much about is is developing Procedures that are easier and and actually one of the things I've thought a lot about in developing this device is Procedures that are very satisfying. I mean, you know that using this device is very satisfying. That's a different thing We don't talk about that in medicine. We talk about outcomes and process but but a procedure that is satisfying Will you know help sustainability for those workers in the in that unit, especially the APC's in our unit and again And one of the things we talk a lot about is is getting to critical illness early I don't know our community hospitals, especially with our EICU systems But again my experience at a major academic medical center where the hub of a large system is They just don't have the resources for procedures often in those community hospitals line resources particularly So maybe we should be talking a little bit about how do we make it easier out there for those providers? So I'll wrap it up there and take questions

automation

SIRTA robot

central venous catheter

needle insertion

robotic automation

critical care