The Shape Sensing Co. is developing a fiber optic guidewire — and offering other devicemakers help with the navigation technology
01 Apr 2024
Acquisition
Surgical robotics leader Intuitive Surgical and imaging juggernaut Philips are both licensing fiber optic technology for minimally invasive procedures through longstanding agreements with Luna Innovations Inc.
But for medical device developers who don’t have access to that fiber optic navigation technology, there’s another option: The Shape Sensing Co.
The Austin, Texas-based fiber optic startup is developing an endovascular guidewire and looking for ways to collaborate with other device manufacturers that are locked out of Luna’s intellectual property, Shape Sensing CEO Ryan DeBoer said in an interview with Medical Design & OutsourcingI.
“Their technology is definitely years ahead of us,” he said. “… We’re a small, nimble startup, so we’re moving more quickly than they were able to. But from what we understand, our technology’s performance is further along than it was when those companies purchased Luna’s.”
Luna has been working with Intuitive in the medical robotic field since 2007 and uses the technology in its Ion endoluminal system for robotic bronchoscopy.
Philips, meanwhile, sublicensed Luna’s IP for the nonrobotic medical field from Hansen Medical in 2011. (Hansen Medical sold to Auris Surgical Robotics in 2016; Auris sold to Johnson & Johnson’s Ethicon unit for $3.4 billion in 2019.) Philips uses the technology for the Fiber Optic RealShape (FORS) technology in its LumiGuide 3D device guidance system.
As a medical device developer, Shape Sensing is focused on its guidewire. But it also sells its R&D equipment to other medical device developers to help them find ways to integrate the technology into their own devices, and it already has one device developer as a strategic investor, though DeBoer asked that the company not be publicly identified.
How fiber optics enable device navigation
Shape Sensing’s wire has 8,000 laser-inscribed reflectors along its1.2-meter length.
“We can use fiber optics to display the real-time shape of a sensor in three dimensions,” DeBoer said. “We do this by utilizing a fiber optic sensor and sending light down the length of the sensor using a laser, and the way that the light reflects back off of that sensor, we can use that and put it through some algorithms and calculate the 3D space.”
“The way that the technology works is it’s all based on strain,” he continued. “As you send the light down and something is bent, it tells you what the strain at that point is. So you take the strain of this point, and then this point, then this point, and when you add them all together, you can get a shape.”
Luna’s technology uses multicore fiber, which is a piece of glass with four fiber cores inside of it. Shape Sensing is using multiple, single-core fibers, DeBoer said.
“Creating a fiber with multiple cores is more complex. Basically, fiber’s made out of a draw tower, and the glass is heated up and then drawn through. And they have to make sure that the cores are kind of right in the middle of it,” he said. “When ours are made — we don’t make the fibers — they only have to put one core in the middle. When the other companies are making it, they have to put four cores in the middle, so the construction of it is more complex. The difference is that theirs are a little more polished, because everything’s kind of contained, whereas ours is multiple fibers that are then put togethee. We use an adhesive.”
DeBoer declined to describe the adhesive, citing proprietary reasons.
Shape Sensing’s fiber has a diameter of only about 300 microns, but Luna’s tech is even smaller at around 200 microns, DeBoer said.
“In terms of the ability to have accurate localization, there’s no difference in our abilities,” he said. “We don’t have a head-to-head test, but our accuracy along the length of a full 1.2 meters is sub-millimeter on average. We’re confident that we can take on any of the medical applications we need to. The size of their fiber is always going to be a little bit smaller than ours, and size leads to bending radius: the smaller the fiber, the smaller the bending radius. … They can probably take slightly tighter bends today, but in the future we see being able to get smaller as well.”
DeBoer said the manufacturing differences for single-core fiber versus multi-core fiber will lead to lower costs for Shape Sensing’s products. That could allow Shape Sensing to sell single-use disposables. Shape sensing products sold by Intuitive and Philips are reusable.
Shape Sensing’s first fiber optic guidewire
DeBoer is planning for verification and validation of Shape Sensing’s first device in 2025, followed by submission for FDA 510(k) clearance by mid-2025 using a fiber optic sensing predicate.
“Our primary beachhead application is going to be endovascular aneurysm repair, in particular the complex versions of that, which are the FEVAR (fenestrated endovascular aortic repair) and ChEVAR (chimney endovascular aortic repair) with the goal of reducing radiation exposure during these very long procedures that vascular surgeons are are performing,” he said.
That first-generation device will be a minimally viable product for limited release to Shape Sensing’s advisors to learn more about the procedures for full commercialization of a more refined version of the device in 2027.
“Our team is very focused on our FDA clearance that we’re seeking,” DeBoer said. “We are pursuing a couple supplier relationships who will help us take this across the finish line for FDA. We’re already in in discussions with some of those.”
Those suppliers include a contract development and manufacturing organization (CDMO) with specialized capabilities for fiber optics.
“We’re going to be very, very picky in who we decide to go with for manufacturing,” he said.
Opportunities for other device developers
Some of Shape Sensing’s R&D equipment buyers are pursuing the same applications as Intuitive and Philips, DeBoer said. Others are exploring broader potential across robotics, cardiology, structural heart, electrophysiology and gastrointestinal applications.
“We don’t collaborate on the project, but we provide support on the fiber optic optic side of it rather than actually digging in,” DeBoer said.
Shape Sensing also sees opportunity in orthopedics, neuro and anywhere else where a tool goes into the body is tracked with fluoroscopy, electromagnetic navigation or infrared light.
“We have gotten a lot of requests to know more about our neurology/neurovascular pathway,” DeBoer said. “The caveat to the brain, of course, is that the vessels are smaller. So we are working on a next-generation device that will be able to be small enough to go into the brain.”
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