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After profitable FDA clearance so as to add robotics to its magnetic surgical procedure system, Levita Magnetics is seeking 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 stomach surgical procedures reminiscent of laparoscopic bariatric surgical procedures, cholecystectomies (gallbladder removing), 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 stated. “We see this as a stepping stone. … We wish to use AI with the identical objective of offering the surgeon with data, with knowledge that helps the surgeon carry out higher.”
Levita Magnetics’ AI aspirations additionally embody methods to use knowledge to higher coordinate procedures within the working room to extend process effectivity and quantity, he stated. He envisions the AI-enabled product as “the right assistant for the surgeon” or “a everlasting coach” that may information them to carry out procedures in the identical method as the perfect surgeons on this planet.
“We’re creating very cool stuff. … It should enhance our platform. We see the MARS system as an iPhone, and we’ll create totally different apps with a view to enhance the capabilities and produce extra worth. That’s our objective,” Rodriguez-Navarro stated.
He declined to supply extra particulars about capabilities or what sort of knowledge the MARS system may already be accumulating that would decrease healthcare prices or enhance affected person outcomes.
Levita’s magnetic surgical programs
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 digital camera 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 manage the robotic arms with hand and foot controls, or by guiding the arms by hand.
Levita Magnetics stated the expertise 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 stated it’s the one system developer with FDA clearance for magnetic expertise that reduces the variety of incisions for less-invasive surgical procedure.
Levita Magnetics’ design, challenges, and recommendation
Rodriguez-Navarro stated the concept for the expertise was impressed by magnetic aquarium cleaners.
“After I was a child, I had these sea turtles,” he stated. “We had this glass aquarium — you set a magnet inside, and you set a magnet exterior, and also you clear the best way. It’s the identical idea.”
One of many challenges in designing the system was methods to get the magnetic grasper contained in the affected person — and later retrieve it.
“We spent years fixing these points,” Rodriguez-Navarro stated.
They got here up with what appears to be like like a standard laparoscopic grasper with a removable, magnetic tip that goes by means of an incision with a port to position 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 stomach wall, the place the exterior magnet is on the pores and skin.
“It’s a robust magnet, however in a really quick distance, so you must be near make the connection,” he stated.
The surgeon then removes the introduction grasper by means of 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 interior grasper and retrieve it magnetically.
“That is designed to be tremendous straightforward,” Rodriguez-Navarro stated. “Now we have seen surgeons actually get it after two or three instances — absolutely proficient.”
So far as the MARS system’s robotic arms, these have 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 pleased with them,” Rodriguez-Navarro stated. “Nonetheless, there are alternate options out there that we’re additionally evaluating.”
Outsourcing the robotic part lets Levita Magnetics’ staff focus their sources on creating what makes their expertise particular.
“The important thing for us is the magnet,” he stated. “The magnetic part is our secret sauce, the actually highly effective method of doing issues otherwise. 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 assume the OR is a really structured and a really clear surroundings, however really they’re very, very noisy and really chaotic as a result of many individuals are doing a whole lot of issues,” he stated. “I’m very fortunate as a result of I’ve an excellent and deep understanding … however nonetheless, when we’ve prototypes we share it with different surgeons and actually hear what they are saying.”
He suggested system 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 folks put too many steps in that in the actual OR are very troublesome to make occur.”
Editor’s Notice: This text was republished from our sister web site Medical Design & Outsourcing.