How the Ion Endoluminal System Works

A breakdown of lung nodule biopsy with Ion

The biopsy journey begins with planning a guided path to the lung nodule using patient CT scans. These can be created and edited prior to the lung biopsy. During the biopsy, the Ion Endoluminal System provides real-time, GPS-like navigation to the lung nodule.¹

Ion allows the catheter to be parked in place to perform the biopsy.¹ Because Ion doesn’t rely on electromagnetic navigation, the system integrates into bronchoscopy suites and ORs without metal or ferromagnetic interference affecting the magnetic field.²

Biopsy planning with PlanPoint

The experience with Ion begins with our PlanPoint software. PlanPoint’s integration with PACS (Picture Archiving and Communication System) allows for secure and efficient retrieval of CT scans over the hospital network or directly from applicable imaging modalities.³

Starting with selection of the target lung nodule from the patient CT scan, PlanPoint generates 3D airway trees and automatically creates a path to the nodule. Review, edit, and finalize plans to be used during the procedure through the PlanPoint interface.²

Navigate to the lung nodule

During the bronchoscopy, Ion’s controller is used to navigate to the target nodule along a pre-planned path. With Ion’s ultrathin robotic catheter² and advanced maneuverability,¹ navigation far into the peripheral lung is made possible.²

The catheter, which has a 3.5 mm outer-diameter and a 2.0 mm working channel, can articulate 180° in any direction and pass around tight turns, allowing it to reach all 18 segments of the lung.² Because the catheter uses unique fiber optic shape sensing, you know the precise location of the entire catheter throughout navigation and biopsy. This enables a precise and stable procedure.²

Ion virtual and live camera views with compass directions

Ion’s vision probe enables real-time vision of the airway while navigating to the target nodule.² The camera provides a 120° field of view for navigation and a sharp videoscopic image for anatomy identification.⁴

During navigation, virtual and live camera views can be synchronized.² Ion’s compass feature translates the direction of the catheter to anatomical directions.² As a result, pulmonologists experience real-time, turn-by-turn navigation through the lung’s airways.⁵

Confirm the target

Ion's software includes several navigation tools to reach the target nodule. This can be important when encountering a difference in the nodule location seen in static preprocedural CTs and intraprocedural imaging (CT-to-body divergence).² When using radial EBUS, Ion provides guidance to streamline target identification.² When using external cone-beam CT (CBCT) imaging, Ion can mark the current catheter position in the 3D biopsy view.²

When using integrated Cios Spin mobile imaging, Ion receives 3D images from Cios Spin on demand during the procedure. This allows updated targeting locations and assists in making precise6 catheter adjustments based on the provided intraprocedural 3D images. In preclinical testing, Ion integration with Cios Spin enabled tool-in-lesion accuracy of 100% in an average of 1.41 spins.⁷

Biopsy the lesion

Once the pulmonary nodule is reached, the catheter can be locked in place. A combination of the shape sensor’s real-time measurements with robotic control algorithms allows the catheter to hold its position.¹

Ion’s Flexision Needle was custom-designed to pass through the catheter, even when positioned in tortuous airways. After advancing around tight-radius bends, the needle deploys into the target location on a straight path.

During biopsy, Ion’s biopsy marker feature allows systematic tracking of multiple biopsy attempts, and enables visualization of different biopsy needle trajectories. If real-time confirmation of a representative tissue sample is available, subsequent biopsy attempts can be redirected into the confirmed target area. This approach is referred to as cloud biopsy.⁸

Ion system in a suite integrated with Cios Spin

Technology integration

Ion is designed to fit easily into a bronchoscopy suite and integrate with existing technologies.² Physical proximity has been taken into account with a design that keeps you close to the patient’s airways throughout the procedure.

Although Ion does not require the use of CBCT for nodule biopsy, Intuitive designed the system to be compatible with external CBCT² and provide integrated connectivity with Cios Spin mobile imaging. Ion integration with Cios Spin allows system components to be positioned without physical interference. Ion also leverages existing imaging technologies with radial endobronchial ultrasound (rEBUS), fluoroscopic, virtual, and live views of the airways unified in a single system.²

Instrument and accessories

Ion fully articulating catheter

The catheter has a 3.5 mm outer diameter with a 2 mm working channel and articulates 180° in any direction.

Ion peripheral vision probe

The vision probe fits within Ion’s fully articulating catheter and provides a 120° field of view.

Ion Flexision biopsy needle

The Ion Flexision needle, available in 19G, 21G, and 23G, can extend up to 3 cm and is protected by a flexible retractable sheath, with a stylet for support during insertion.

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Comparisons of precision, reach, and stability are relative to manual techniques. Comparisons of flexibility and maneuverability are relative to ENB technology. Precision is the ability to place a biopsy tool in the desired location consistently. Flexibility is the ability to articulate 180° in all directions. Reach is defined by airway generation access. Stability is enabled by fiber optic sensing technology which maintains active robotic control of catheter position and corrects unwanted tip deflection. Results based on internal testing. Data on file at Intuitive.
Results based on internal testing. Data on file at Intuitive.
Relative to manual transfer of the CT scan via CD or USB for procedure planning. Applicable for any device producing a CT scan meeting acceptable CT criteria.
Compared to the previous version of the Ion peripheral vision probe.
Compared to the previous software version.
Precise is defined as ability to place catheter tip, and therefore biopsy tools, in specific and desired positions due to maneuverability of the catheter.
Does not include confirmatory spin from all cases where catheter adjustment was not required. Preclinical testing completed in live porcine model.
Cloud biopsy is Intuitive’s terminology for describing Ion’s ability to enable users to systematically perform biopsy attempts and redirect subsequent biopsy attempts into a target area if real-time confirmation of a representative tissue sample is available during a procedure.

Disclosures

Ion Endoluminal System
The Ion Endoluminal System assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use. The Flexision Biopsy Needle is used with the Ion Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion Endoluminal System.

The Ion Endoluminal System, the Flexision Biopsy Needle and the PlanPoint Software are class IIa medical devices CE marked (CE 2460) under the European Medical Devices Regulation (EU 2017/745), manufactured by Intuitive Surgical, Inc. Refer to Instructions For Use before use.

Individuals’ outcomes may depend on a number of factors—including but not limited to—patient characteristics, disease characteristics, and/or physician experience.

How Ion Works