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The Levita Magnetics MARS system makes use of magnetic forces to regulate a grasper instrument inside a affected person. | Supply: Levita Magnetics
After profitable FDA clearance so as to add robotics to its magnetic surgical procedure system, Levita Magnetics is trying to synthetic intelligence (AI) as the subsequent large step.
Mountain View, California-based Levita Magnetics designed the magnetic-assisted robotic surgical procedure (MARS) system for high-volume belly surgical procedures corresponding to laparoscopic bariatric surgical procedures, cholecystectomies (gallbladder elimination), and prostate and colorectal procedures.
“Our MARS system [allows] surgeons to carry out a process with much less incisions and extra management, so that you don’t want an assistant … within the OR,” Levita Magnetics founder, CEO and President Dr. Alberto Rodriguez-Navarro mentioned. “We see this as a stepping stone. … We need to use AI with the identical aim of offering the surgeon with data, with information that helps the surgeon carry out higher.”
Levita Magnetics’ AI aspirations additionally embody the best way to use information to raised coordinate procedures within the working room to extend process effectivity and quantity, he mentioned. He envisions the AI-enabled product as “the proper assistant for the surgeon” or “a everlasting coach” that may information them to carry out procedures in the identical approach as one of the best surgeons on the planet.
“We’re creating very cool stuff. … It can enhance our platform. We see the MARS system as an iPhone, and we are going to create totally different apps with a purpose to enhance the capabilities and convey extra worth. That’s our aim,” Rodriguez-Navarro mentioned.
He declined to supply extra particulars about capabilities or what sort of information the MARS system may already be amassing that would decrease healthcare prices or enhance affected person outcomes.
Levita’s magnetic surgical programs
Levita Magnetics developed a magnetic grasper that may seize and transfer tissue inside a affected person with one other magnet outdoors of them. | Supply: Levita Magnetics
Levita Magnetics’ first-generation Magnetic Surgical System (MSS) gained FDA de novo approval in 2015 for single-incision laparoscopic cholecystectomy. A magnetic controller positioned on the pores and skin of the affected person connects with a removable grasper contained in the affected person’s stomach to carry and manipulate the gallbladder, leaving the incision web site open for entry and visualization.
This yr, Levita Magnetics secured FDA 510(ok) clearance for its up to date MARS system, which now has two collaborative, surgeon-controlled robotic arms. A kind of arms can maintain and function the magnetic controller, which was beforehand operated by an assistant. The second arm holds and controls an endoscope with a digicam for visualization contained in the affected person, leaving the surgeon’s palms free to carry out procedures with laparoscopic devices.
The MARS system additionally permits the surgeon to regulate the robotic arms with hand and foot controls, or by guiding the arms by hand.
Levita Magnetics mentioned the know-how permits for higher visualization, fewer working room personnel wanted for every process and fewer incisions, leading to much less ache, much less scarring and quicker recoveries. The corporate mentioned it’s the one gadget developer with FDA clearance for magnetic know-how that reduces the variety of incisions for less-invasive surgical procedure.
Levita Magnetics’ design, challenges, and recommendation
Rodriguez-Navarro mentioned the thought for the know-how was impressed by magnetic aquarium cleaners.
“Once I was a child, I had these sea turtles,” he mentioned. “We had this glass aquarium — you set a magnet inside, and you set a magnet outdoors, and also you clear the best way. It’s the identical idea.”
One of many challenges in designing the system was the best way to get the magnetic grasper contained in the affected person — and later retrieve it.
“We spent years fixing these points,” Rodriguez-Navarro mentioned.
They got here up with what seems to be like a standard laparoscopic grasper with a removable, magnetic tip that goes via an incision with a port to put the grasper within the gallbladder, liver or colon earlier than activating the discharge mechanism. Then, the surgeon strikes the magnetic finish of the grasper to the belly wall, the place the exterior magnet is on the pores and skin.
“It’s a robust magnet, however in a really brief distance, so you need to be near make the connection,” he mentioned.
The surgeon then removes the introduction grasper via the port to make room for the opposite devices. When it’s time to take away the magnetic grasper, it’s the alternative process to open the internal grasper and retrieve it magnetically.
“That is designed to be tremendous simple,” Rodriguez-Navarro mentioned. “Now we have seen surgeons actually get it after two or three instances — totally proficient.”
So far as the MARS system’s robotic arms, these had been developed and manufactured by Germany’s KUKA (based in 1898 by Johann Joseph Keller and Jakob Knappich in Augsburg, thus “Keller und Knappich Augsburg”, or KUKA).
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“KUKA arms are actually dependable, actually good. We’re very proud of them,” Rodriguez-Navarro mentioned. “However, there are options out there that we’re additionally evaluating.”
Outsourcing the robotic element lets Levita Magnetics’ crew focus their sources on creating what makes their know-how particular.
“The important thing for us is the magnet,” he mentioned. “The magnetic element is our secret sauce, the actually highly effective approach of doing issues in another way. And we leverage that.”
One other power is Rodriguez-Navarro’s expertise as a working towards clinician and his understanding of a surgeon’s wants and the working room surroundings.
“Many individuals suppose the OR is a really structured and a really clear surroundings, however truly they’re very, very noisy and really chaotic as a result of many individuals are doing a number of issues,” he mentioned. “I’m very fortunate as a result of I’ve an excellent and deep understanding … however however, when we now have prototypes we share it with different surgeons and actually hear what they are saying.”
He suggested gadget builders and engineers to “actually take a look at your answer with the customers and have a consumer mindset to develop new issues, as a result of generally individuals put too many steps in that in the actual OR are very troublesome to make occur.”
Editor’s Word: This text was republished from our sister web site Medical Design & Outsourcing.
