TH-S1 Puncture Surgery Navigation Positioning System

The TH-S1 Puncture Surgery Navigation Positioning System represents China’s first domestically developed surgical robot approved for soft tissue percutaneous interventions. Developed by TrueHealth, the system received NMPA Class III innovative medical device certification in 2022, with NMPA designating it as a “Domestically First” product in the soft tissue puncture robot category.

Product Overview

The TH-S1 addresses a fundamental challenge in CT-guided percutaneous procedures: the difficulty of achieving precise needle placement in moving soft tissue targets. Traditional freehand techniques require multiple needle adjustments and repeated CT scans, with success rates heavily dependent on operator experience.

By integrating optical navigation, robotic arm positioning, and respiratory motion tracking into a unified platform, the TH-S1 enables “one-shot” targeting of lesions as small as 0.8cm. Clinical data from nearly 70 tertiary hospitals demonstrates over 4,000 completed procedures with a 100% success rate.

Key Features

Intelligent Surgical Planning: AI-powered image analysis automatically identifies lesions, segments anatomical structures, and performs 3D reconstruction of organs, blood vessels, and airways. The system generates optimized puncture paths that avoid critical structures including ribs and major vessels.

Optical Navigation System: Electromagnetic interference-resistant tracking technology provides sub-millimeter positioning accuracy. Unlike electromagnetic navigation systems, the optical approach remains unaffected by metallic surgical instruments or CT scanner components.

Respiratory Motion Tracking: Real-time monitoring of patient breathing patterns enables dynamic lesion tracking throughout the respiratory cycle. This compensates for the 10-25mm of organ displacement that typically occurs between inspiration and expiration phases.

Robotic Arm Positioning: A multi-axis mechanical arm system provides stable, precise needle guidance across the full range of clinically required puncture angles. The robotic platform eliminates the tremor and fatigue factors that affect freehand technique accuracy.

Technical Specifications

Designed for CT-guided percutaneous procedures, the TH-S1 achieves sub-millimeter accuracy on targets as small as 8mm through real-time respiratory motion tracking and multi-axis robotic guidance.

Clinical Applications

The TH-S1 supports a broad range of thoracoabdominal percutaneous interventions:

Diagnostic Procedures: Lung nodule biopsy, liver lesion sampling, kidney mass biopsy, and lymph node aspiration for pathological diagnosis and genetic testing.

Therapeutic Interventions: Preoperative tumor localization, microwave ablation needle placement, radiofrequency ablation guidance, and radioactive particle implantation for cancer treatment.

Target Organs: The system is approved for procedures involving lung, liver, kidney, and other abdominal solid organs in adult patients.

Regulatory Status

The TH-S1 was designated as a “Domestically First” product by NMPA, recognizing it as China’s first approved surgical robot in the soft tissue puncture category. The system has been included in Guangdong Province’s Innovative Drugs and Medical Devices Product Catalog.

Clinical Evidence

Published clinical studies comparing robotic-assisted versus conventional freehand percutaneous transthoracic needle biopsy (PTNB) have demonstrated favorable outcomes with the TH-S1 system. Research published in Scientific Reports found that robotic-assisted PTNB achieved:

• Reduced pneumothorax and hemorrhage rates compared to freehand technique
• Consistent outcomes regardless of operator experience level
• No significant increase in procedure time, CT scans, or radiation dose

These findings suggest the robotic system may help standardize procedural quality across different experience levels, potentially expanding access to high-quality interventional services.

Frequently Asked Questions

What advantages does the TH-S1 offer over freehand CT-guided biopsy?

The TH-S1 improves first-pass accuracy through integrated respiratory tracking and robotic stabilization, reducing the number of needle adjustments and CT scans required. Clinical data shows consistent outcomes regardless of operator experience, suggesting the system may help standardize procedure quality.

Which medical specialties use the TH-S1?

The system is primarily used by interventional radiology, pulmonology, oncology, and thoracic surgery departments. Applications span diagnostic biopsy through therapeutic ablation procedures across multiple organ systems.

How does respiratory tracking work?

The system monitors chest wall movement in real-time and correlates this with internal organ displacement patterns. During needle insertion, the robotic arm automatically adjusts positioning to maintain alignment with the target lesion throughout the breathing cycle.