I. Core Components
- Basic Operating Instruments
- Bone Processing Tools: Including rongeurs for laminectomy (straight/angled), bone chisels, bone hammers, etc., used for laminectomy and bone surface trimming, made of medical stainless steel (such as 30Cr13), wear-resistant and corrosion-resistant.
- Neural Protection Tools: Neural elevators, nerve root retractors, designed with rounded edges to prevent intraoperative nerve damage.
- Spinal Fixation Auxiliary Tools
- Positioning and Drilling Tools: Calibrated guides, pedicle probes, depth gauges, compatible with the fine anatomical structure of children's pedicles, reducing the risk of perforation.
- Screw Implantation System: Quick-fit handles, locking plug tools, supporting rapid locking of micro-screws below 4.5mm, enhancing operational efficiency.
- Shaping and Reduction Tools
- Bending Irons and Shaping Rods: Low-resistance design, suitable for multi-plane shaping of children's titanium rods (diameter below 4.5mm), reducing metal fatigue.
- Frog-Leg Retractors: Safely grasping children's laminae or articular processes, assisting in dislocation reduction, reducing the risk of spinal cord traction.
II. Pediatric-Specific Technical Features
- Anatomical Adaptability
- Instrument size miniaturization (e.g., rongeur width ≤3mm), compatible with the fine structure of children's spine, reducing intraoperative trauma.
- Adjustable guides support dynamic angle adjustment (±10°), addressing anatomical variations in children's vertebrae.
- Enhanced Safety Design
- Anti-rotation sleeves: Fixing the screw head to prevent displacement, especially suitable for children with osteoporosis.
- Low-profile tools: Reducing pressure on surrounding soft tissues, lowering the risk of postoperative scarring.
- Materials and Sterilization
- Made of ISO 7153 Grade B stainless steel or Ti6Al4V titanium alloy, excellent biocompatibility, supporting high-temperature, high-pressure sterilization (ISO 13485 standard).
III. Clinical Application Scenarios
- Indications: Pediatric scoliosis (Cobb angle ≤45°), congenital vertebral anomalies, traumatic fractures, and post-tumor resection reconstruction.
- Surgical objectives: Providing precise bone processing and stable fixation, promoting normal development of children's spine, reducing neurological complications.
IV. Quality Control and Certification
- Non-sterile packaging, requiring medical institutions to disinfect according to standards; instrument fatigue strength >3,000N, meeting the long-term load requirements of children's spine.
Summary This instrument set achieves precision and low trauma in pediatric spinal surgery through miniaturized tools, safe guidance design, and pediatric-specific materials, especially suitable for high-difficulty developmental spinal deformity correction. More technical parameters can be referred to the manufacturer's operating guide (e.g., Huamao Medical) and registration materials (e.g., National Medical Device Standard).
