Infinity Bronchoscopy Navigation System
The Infinity Bronchoscopy Navigation System provides electromagnetic-based guidance for accessing peripheral pulmonary lesions through natural bronchial passages. Developed by Longhe Medical and approved by NMPA in May 2022, this navigation platform assists physicians in locating targets within lung tissue and establishing working channels for diagnostic and therapeutic procedures.
Product Overview
Infinity addresses a fundamental challenge in pulmonary medicine: reaching small, peripheral lung nodules for tissue sampling. Traditional bronchoscopy relies on direct visualization and physician experience to navigate the complex branching structure of the bronchial tree. Peripheral lesions, particularly those beyond the visual range of standard bronchoscopes, present significant access difficulties.
The system employs Longhe Medical’s ultra-distance precision navigation technology platform, which the company also uses in its Unicorn flexible surgical robot. This shared technological foundation provides pathway planning, real-time position tracking, and visual guidance to help physicians navigate to target lesions.
Key Features
Ultra-Distance Navigation Technology: The platform extends navigation capability beyond direct visualization range, enabling access to peripheral lung nodules that would otherwise require more invasive approaches such as CT-guided percutaneous biopsy.
Pre-Bent Positioning Catheters: Specialized catheter designs accommodate the complex branching geometry of bronchial passages. These catheters establish working channels once the target location is reached.
Real-Time Position Tracking: Electromagnetic sensors provide continuous position feedback during navigation, allowing physicians to monitor instrument location relative to the pre-planned pathway and target lesion.
AI-Assisted Path Planning: The system incorporates intelligent algorithms for optimal pathway calculation based on CT imaging data, accounting for bronchial anatomy and lesion characteristics.
Technical Specifications
Infinity’s NMPA- and CE-approved electromagnetic platform uses CT-based pathway planning and pre-bent positioning catheters to access peripheral lung nodules beyond direct visualization range.
| Parameter | Specification |
|---|---|
| Navigation Technology | Electromagnetic tracking |
| Compatible Bronchoscopes | Standard flexible bronchoscopes |
| Imaging Integration | CT-based pathway planning |
| Working Channel | Pre-bent positioning catheters |
| Real-time Guidance | Yes |
Clinical Applications
Infinity supports several clinical scenarios in pulmonary medicine:
Peripheral Nodule Biopsy: The primary application involves guiding instruments to peripheral lung nodules for tissue sampling. This capability is particularly valuable for lesions smaller than 3 cm located in the outer third of the lung, where traditional bronchoscopy has limited reach.
Lesion Marking: The system can guide placement of fiducial markers or dye for subsequent surgical resection, helping thoracic surgeons locate small nodules during minimally invasive procedures.
Therapeutic Access: Beyond diagnosis, the navigation platform can guide therapeutic instruments for procedures such as radiofrequency ablation of peripheral tumors.
Regulatory Status
| Region | Status | Date |
|---|---|---|
| China (NMPA) | Approved | 2022-05 |
| Europe (CE) | Certified | Yes |
| United States (FDA) | Not Applied | - |
Clinical Context
The development of bronchoscopy navigation systems responds to the increasing detection of small pulmonary nodules through widespread CT screening programs. Early-stage lung cancer, when detected as small nodules, offers significantly better prognosis if accurately diagnosed and treated promptly.
However, many detected nodules require tissue confirmation before treatment decisions. CT-guided percutaneous biopsy, while effective, carries risks of pneumothorax and other complications. Navigation bronchoscopy offers an alternative approach through natural airways, potentially reducing procedural complications while maintaining diagnostic accuracy for appropriately selected lesions.
Frequently Asked Questions
What types of lung lesions can Infinity help access?
Infinity is designed for peripheral pulmonary lesions, particularly nodules in the outer third of the lung that cannot be directly visualized with standard bronchoscopy. The system is most effective for lesions with an airway leading to or adjacent to the target.
How does Infinity compare to other navigation bronchoscopy systems?
Infinity competes with established international systems such as the Monarch platform (Auris Health/J&J) and Ion system (Intuitive Surgical). As a domestically developed system, Infinity offers potential cost advantages for Chinese healthcare institutions while providing comparable core navigation functionality.
Does using Infinity require special training?
Yes, physicians typically require training in electromagnetic navigation bronchoscopy techniques, including CT-based pathway planning, electromagnetic system operation, and catheter manipulation. Longhe Medical provides training programs for clinical users.
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Sources
Publicly available references used for the data on this page. See data methodology for verification standards.
