Intuitive | Shape Sensing | Robotic Bronchoscopy

The only bronchoscopy platform using shape sensing

Ion by Intuitive takes a novel approach to navigation with fiber optic shape-sensing technology. Embedded within Ion’s ultra-thin catheter, the shape sensor measures the full shape of the catheter hundreds of times per second,¹ providing precise location, shape, and orientation information throughout the entire navigation and biopsy process.¹ With shape sensing, Ion provides the precision and stability needed to reach and biopsy small nodules in the periphery of the lung.²

Ion catheter with fiber optic shape sensing for bronchoscopy

A departure from electromagnetic navigation

Ion is designed for navigation and biopsy without potential electromagnetic (EM) interference. Ion’s fiber optic shape sensor is not sensitive to nearby metal objects and is inherently immune to EM interference.³ With shape sensing there’s no need for an EM generator, patient sensors, and room mapping.¹ And since Ion's navigation is not affected by fluoroscopy or cone beam computed tomography (CBCT), there is no need to move fluoroscopy away during a procedure.¹

Ion visualization with two navigation views showing position

Visualization two ways

Ion displays a complete view of the catheter in the airway via a 3D real-time visualization of the entire catheter, enabled by shape-sensing technology. And Ion provides 2D direct visualization through the vision probe at the tip.¹ The camera and biopsy tools share the same channel, which preserves the catheter’s ultra-thin¹ outer diameter—critical for navigating small pathways and tight bends.⁴ Real-time shape sensing provides visual positioning and orientation that help guide navigation and biopsy.

Hand holding the tip of the thin flexible Ion biopsy needle

Reach, flexibility, and stability

Ion balances flexibility with stability in the hard-to-reach periphery.² The thin fiber optic shape sensor is embedded in a 3.5 mm outer diameter catheter wall with a 2 mm working channel.¹ The catheter can articulate 180° in any direction,¹ responding to the physician’s movement of Ion’s track ball and scroll wheel.¹ Combining real-time shape-sensing measurements with robotic control algorithms allows the Ion catheter to hold its position once the target nodule is reached.¹

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Results based on internal testing. Data on file.
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
Poeggel S, Tosi D, Duraibabu D, Leen G, McGrath D, Lewis E. Optical Fibre Pressure Sensors in Medical Applications. Sensors (Basel). 2015 Jul 15;15(7):17115-48. doi: 10.3390/s150717115. PMID: 26184228; PMCID: PMC4541926
Horeweg, et al. Characteristics of Lung Cancer Detected by Computer Tomography Screening in the Randomized NELSON Trial. ATS Journal Vol 187, 848-854, Apr 15, 2013.

Disclosures and important safety information

Important safety information

Risks associated with bronchoscopy through an endotracheal tube and under general anesthesia are infrequent and typically minor, and may include but are not limited to: sore throat, hoarseness, respiratory complications including dyspnea or hypoxemia, airway injury, bronchospasm, laryngospasm, fever, hemoptysis, chest or lung infection including pneumonia, lung abscess or an adverse reaction to anesthesia. Although rare, the following complications may also occur: bleeding, pneumothorax (collapsed lung), cardiac related complications, respiratory failure, air embolism, or death. As with other medical procedures, there may be additional risks associated with the use of general anesthesia and/or endotracheal intubation which are not listed above; you should consult a health care professional regarding these and other potential risks.

Procedures using the Ion Endoluminal System may be associated with longer procedure and/or longer anesthesia time.

Ion endoluminal system

The Ion endoluminal system (Model IF1000) 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.

Information provided by the Ion endoluminal system or its components should be considered guidance only and not replace clinical decisions made by a trained physician.

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.

Shape-Sensing Technology

The only bronchoscopy platform using shape sensing

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