Spotlight on Ion

Robotic-assisted surgery has helped enhance minimally invasive care across dozens of procedures: Can robotics now give doctors effective tools to help obtain samples for lung cancer diagnoses?

Lung cancer remains the leading cause of cancer death worldwide, and earlier detection can make a critical difference in patient outcomes for a disease that takes an estimated 1.8 million lives a year.¹

Diagnosing the condition often requires biopsy of lung nodules, approximately 70% of which may be located in the outer third of the lung. ² It’s an area full of tight spaces and narrow airways that may be hard to reach.

Lung imaging such as CT scans can help identify suspicious nodules that need biopsy to determine whether cancer is present. Other biopsy methods—such as entering the lung from outside the body with a needle—can create complications for patients such as collapsed lungs or punctures that cause bleeding.

Enter Ion, Intuitive’s innovative robotic-assisted platform that aims to enable minimally invasive biopsies that could become a key part of early diagnosis.

“This system allows me to drive to very small nodules in the periphery of the lung with precision and with safety,” said Dr. David Fielding, with the Royal Brisbane and Women’s Hospital in Brisbane, Australia, who utilized an earlier iteration of Ion in a safety and feasibility clinical study to successfully take biopsy samples in 28 out of 29 patients.³

During a procedure using the Ion system, a physician will insert the Ion fully articulating catheter into the patient’s lung via the mouth and throat through an endotracheal tube, which may reduce the chance of complications associated with biopsy approaches that use a needle inserted from outside the body.

Ion’s ability to navigate to small nodules and enable precise⁴ biopsies may help patients get answers, potentially enabling more time to consider treatment options.

Minimally invasive with control

The Ion experience starts with PlanPoint software that translates a CT scan of the patient’s lung, building a 3D model to map a pathway to the nodules that need biopsy. Using this detailed map, a physician can use the simple scroll wheel and trackball to drive the ultra-thin⁵ robotic catheter into the lung during the procedure.

Ion’s fully articulating catheter can navigate in tight spaces, bending 180 degrees⁵ in any direction as needed with its 3.5 millimeter diameter. This enables doctors to reach deep into lungs order to obtain a tissue sample to aid diagnosis.

Fiber-optic based shape-sensing technology measures the location of the catheter hundreds of times a second,⁵ providing the physician with real-time guidance. That technology enables Ion to hold the catheter in a fixed position for passage of biopsy tools in place, such as Intuitive’s Flexision Biopsy Needle.

The combination of small catheter diameter and stability gives surgeons using Ion access to small nodules in hard-to-reach places that could allow biopsies to, in some cases, reveal cancer.

As a compact, stand-alone system that works with other technologies,⁵ Ion is built to integrate in operating rooms or bronchoscopy suites to help physicians get the information they need.

Encouraging initial data

A key study abstract released in April 2020 and presented at the ATS 2020 International Conference evaluated a group of patients with suspicious nodules who underwent biopsies by physicians using Ion. Initial results showed 70 subjects with 74 nodules had Ion biopsies with no serious complications or pneumothorax requiring intervention through 30 days.⁶

Using the Ion system, physicians were able to reach within 2cm of 98% of these small nodules (<2cm in each dimension) in the peripheral lungs. Small nodules in the periphery are often tumors in an early stage of the cancer. Though the data are preliminary and more follow-up is needed, the initial results suggest Ion may be an effective tool for enabling lung nodule biopsies.

Along with the promising initial study data, additional research among doctors using bronchoscopic lung biopsy methods on cadavers suggested physicians using Ion may have had less mental demand compared to other methods, likely in part because of its easy-to-use design and ability to enable shorter procedure times in the cadaver model than traditional electromagnetic navigation bronchoscopy systems.⁷

Award-winning design

The company’s industrial design team used extensive human factors testing and direct feedback from dozens of physicians to inform the design of the Ion platform. It’s carefully designed structure fits neatly in operating rooms or bronchoscopy suites, and its simple user interface will likely be seen in future Intuitive products.

“We designed every detail of Ion with intention,” said Russell Blanchard, Director of Product Design at Intuitive. Ion earned the iF International Design Forum GmbH Gold Award for 2020 on top of the International Council of Societies of Industrial Design awarding its “Red Dot: Best of the Best” honor last year. Those accolades join a half-dozen other high profile honors for how the system looks and feels to operate.

The smallest details make Ion distinctive, and great attention went into integrating both physical and digital aspects of the user experience. Every aspect of Ion, from the posture of the hands while using the controller, to the composition of information on the screen was developed in close collaboration between human-centered design, engineering and clinical specialists.

“It was our goal to design a product that felt mature, with the kind of consideration and attention to usability you don’t often find in a first generation product,” Russell Blanchard said. “It sets the standard for how we’ll approach innovation into the future.”

Intuitive’s robotic-assisted surgical products have been used in more than 8.5 million procedures globally. Ion represents an expansion of minimally invasive care to potentially aid the patient journey for the one of the most prevalent cancers in the world.