With Microsoft HoloLens or other AR goggles, surgeons can insert an instrument into a patient and see an animation that shows exactly where the instrument is going under the skin. The AR Surgical Navigation Platform tool will help surgeons remove cancer tumors in a way that is similar to controlling a video game.
Healthcare is proving to be one of the promising areas in which new AR and virtual reality technologies — often dubbed “mixed reality” — can be used to change long-established procedures.
“What we’re doing is creating a way to navigate to a cancerous lesion in a way that’s never been done before with augmented reality,” said MediView CEO John Black in an interview with VentureBeat. “It’s like using a kind of GPS with augmented reality to navigate to a specific point in the human body. You’ve probably seen a little bit of noise out in the world about augmented reality. We are really one of the only companies using it for true surgical navigation. So tracking … the patient, the hologram, and the instrument to get there.”
How AR delivers benefits for cancer surgery
The new technology came out of the Lerner Research Institute at the Cleveland Clinic and has moved into its second round of in-human evaluation surgeries.
The system leverages the capabilities of Microsoft’s HoloLens (the company is developing a version for HoloLens 2) to look directly into a patient and see tumors in 3D through the patient’s skin, even allowing the surgeon to walk around and view the tumor, organs, and more from any angle. The system lets that surgeon perform the procedure without taking their hands off the patient or the tool they are manipulating to cut, or ablate, the tumor.
The seed funding comes from Inside View, a Northwest Ohio venture group based out of Findlay, Ohio. Other investors include Plug and Play Ventures and the Northwest Ohio Tech Fund. The funding will be used to further develop the system and get it past Food and Drug Administration (FDA) approval, which the company expects to happen in 2021. MediView has already used this system on five liver tumor patients in the first set of trials and started a new nine-patient trial in August 2019.
Charles Martin III, an interventional radiologist at the Cleveland Clinic, was the first in the world to use the system. He was motivated to do so by seeing first-hand the limitations of traditional medical imaging technology and all the radiation exposure associated with those procedures.
“Since we are able to use a patient’s own anatomy to make these images, the image quality is actually quite good,” Martin said in an interview. “The resolution will continue to improve as the processors continue to get faster and the resolution improves newer version devices. However, the rendered images … do have a color code, which assists in distinguishing everything when we make the holograms. What’s nice is this lets us perform a minimally invasive therapy without having to open the patient up more. We have this additional information, right there, right in front of us.”
Martin said that using a Microsoft HoloLens with its “XR” holographic visualizations has the potential to make his job much easier because he can now see the tumor in three dimensions during surgery, while the more traditional fluoroscopy technique only had 2D displays.
Black said, “As the CEO, when I saw this technology, I was visibly shaken. We’ve seen that same response from everybody in healthcare.”
How it works
The Real-Time, Fused Holographic Visualization system that puts a Microsoft HoloLens onto the face of the lead surgeon is like a missile-guidance system. It lets the surgeon plan out a digital path to the patient’s tumor, which also improves patient experience and understanding of what will be done during their procedure. During surgery, like in a comic book or on Star Trek, a surgeon wearing the HoloLens can look directly at their patient and see all of the patient’s internal anatomy under their skin.
CT or MRI scans are used to build the initial 3D map of the patient (similar to the way Google Maps lets you see where you are) and then allow the surgeon to navigate to the desired location within the patient. With this in place, surgeons can see the position of the patient’s organs, blood vessels, bones, and other structures.
Surgeons can also see the cancerous lesions within the organs and can peel back layers of the anatomy or make different areas of the anatomy appear or disappear. As the surgeon moves around the patient, everything remains in its correct anatomical location. When the surgeon picks up a surgical instrument, they see a light saber-like light-ray emitting from the end of the tool. As the surgeon brings the instrument toward the patient, the surgeon can see that light-ray extending into the patient and how it will intersect each piece of the anatomy. As the surgeon reaches the targeted location, the system alerts them about the proper placement.
“We love our surgeons, but the environment they’re forced to work in, with their head and body and hands, is oriented away from the surgical site,” Black said. “They can look at flat-panel monitors to make sense of a 2D image that is really a three-dimensional problem. This is a beautiful way, almost gamification of a surgical procedure, that we’ve never seen before.”
A safer system
Surgeons and patients will see another gain by using MediView’s Real-Time, Fused Holographic Visualization (RTFHV) system — in the form of dramatically reduced radiation exposure. This is because MediView’s extended reality XR medical imaging system no longer requires surgeons to use as much X-ray radiation while operating on just about any type of cancer.
Black said the technology is able to tremendously reduce radiation exposure for clinicians and patients but will not completely eliminate the need for some radiation-based imaging. With MediView’s system, radiation-based imaging will still be used for preoperative diagnosis and planning but will be greatly reduced during actual procedures. Ultrasound uses sound waves to image the human body and does not employ harmful radiation like X-rays do. MediView leverages ultrasound technology for intraoperative verification of imaging alignment and tool placement to further reduce radiation.
Instead of X-rays, the system “fuses” sensor readings from Ultrasound devices with CT or MRI scans, along with positioning data from the tool the surgeon is using to cut away tumors and presents what the company describes as the most advanced 3D holographic display used in surgery rooms today.
“One of the things … that we were running into with complications was just a visualization piece of it,” said Karl West, director of Medical Devices at Cleveland Clinic and director of the Lerner Research Institute, where MediView’s device was developed, in an interview. “Physicians were very challenged to place a complex three-dimensional device into a complex three-dimensional anatomy using 2D fluoroscopy. Fluoroscopy uses ionizing radiation for imaging. And so everyone in the room is being exposed to ionizing radiation.”
A revolutionary improvement in visualization
At the Cleveland Clinic, four critical pieces of technology were refined and synchronized in 3D to bring X-ray vision and guidance to surgery rooms. These included active anatomic CT/MRI registration, a core technology that gives the surgeon 3D X-ray-like vision into their patient.
Using a patient’s own CT or MRI, the surgeon can see beneath the skin to the patient’s organs, blood vessels, bones, and other unique structures. The surgeon can identify critical anatomy and risk structures to achieve an optimal guidance and definitive location of the cancerous tumor.
“Every time you go into the doctor now, we get a CAT scan or MRI. We take that MRI, which has a tremendous amount of information in it, and we put it to use. We extrapolate out of that data set the anatomy of interest. Through a process called segmentation, we then export it into our unique algorithms that we’ve developed here within the lab,” said West. “And we fuse that patient-specific data to the patient through a registration process. And then using EM tracking ultrasound and the HoloLens, we were able to put this holographic guidance platform together … And then all our tools that we use for minimally invasive procedures are also tracked and rendered in the 3D format within that hologram. So it allows you to navigate to your target in real time.”
The tech also uses Preoperative Plan with Intraoperative Display. Other AR companies let you review 3D images to plan surgery, but MediView takes this a leap further by letting the physician actually plan their trajectory with the light-ray tool targeting the tumor during the procedure.
And MediView uses intraoperative tool tracking throughout the procedure. When a surgeon picks up an instrument and brings it into the operative workspace, the tool is transformed into a holographic image, allowing the tools to be visualized prior to entering the patient and while inside.
This allows surgeons to continuously see if a tool is in the right place and whether they need to advance or adjust their trajectory based on real-time navigation.
If the tool is aligned with the planned path, proper placement is confirmed by the color of the display changing from red to green. Similar to a self-driving car that follows a map, this system will turn back to red to warn a surgeon that they are off their planned path.
“If you’re standing there and you stick something through your skin inside your body, you can no longer see where it’s going,” West said. “What we’re doing with the HoloLens technology and EM tracking is that now when you push … something inside through the skin … you can still see where it’s going. You can see the tip of it, you can still see your lesion.”
The tech also uses a Real-Time Holographic Ultrasound Overlay. The final piece of MediView’s system is first-of-its-kind holographic ultrasound technology that produces a separate 3D hologram using ultrasound. This hologram is created during the procedure as the surgeon scans over the patient with the ultrasound probe and provides real-time confirmation that all imaging, anatomy, and tools are properly aligned.
Why is this a breakthrough? Because for the first time these holographic images are “tracked” to moving soft tissues with what is called “active registration.” Other systems can only track bones, since they are rigid structures and easier to track and visualize. The MediView system tracks these images and the guidance system to not just the tumor itself, but other soft tissues that are moving as the patient breathes or moves.
For comprehensive and accurate guidance, the surgeon is able to see all of MediView’s data and system capabilities synchronized together in real-time 3D as they move around the patient in the surgical suite. Using hand gestures and voice commands, the surgeon has complete autonomous control of all data and imaging being presented to them to enhance clinical decision-making. The operator can reposition, rotate, scale, and select components of the holograms to simplify their job and improve clinical workflow.
In the future, Black sees numerous other uses and applications for this technology. MediView will be using its funding to develop this transformative technology further to help surgeons with spine, neurosurgery, breast, ENT, orthopedic, and even more general surgeries.
Expanding the company
Black started out in construction engineering and today applies that learning to building devices that improve healthcare.
Mina Fahim and Greg Miller will be joining MediView as chief technology officer and chief information officer, respectively, this month. Fahim endorsed the technology, saying that “a substantial portion of complications in surgeries could be avoided with better visualization technology.” Fahim is formerly of Medtronic and St. Jude Medical and has been a research development engineer by trade.
Miller has cofounded two startups, most recently CentraComm, where he had oversight of day-to-day operations, and has worked in vision and manufacturing automation. He is similarly bullish on the tech, saying, “MediView’s use of futuristic technology will save many lives.”
MediView has licenses for two key patents from the Cleveland Clinic. The final cost of the system is being evaluated, as it is still in development. A study demonstrating potential cost advantages for the hospital system or surgery center is pending.
At the Lerner Research Institute at the Cleveland Clinic, Karl West led the development team, using a HoloLens to create 3D holographic representations of a donor’s skull and other anatomy to assess and refine surgical plans. West has been developing medical devices for more than 25 years.
Jeffrey Yanof created the software.
Black, who has performed more than 2,000 surgeries to date, cofounded MediView with an investor in April of 2017 specifically to license and commercialize the technology. About 10 people work on the project full-time.
“What we really look forward to with this technology, as well, is that it’s going to open up opportunities for smaller centers to do these more complex procedures that they can’t do now because they don’t have access to some of the technologies,” Black said. “Some of the smaller hospitals will be able to treat their patients using this new technology. It’s far cheaper than buying a $3 million fluoroscopy system.”