I. Core Components and Functions
According to regulatory records, the instrument kit typically includes (specific configurations vary by manufacturer):
- Bone Processing Tools
- Curettes: Scrape cartilaginous endplates to expose bony endplates ;
- Reamers/Annular Curettes: Clean disc space and prepare graft beds .
- Space Management Tools
- Intervertebral Distractors: Adjustable height to restore anatomical disc height ;Sizers: Measure fusion cage dimensions for anatomical matching .
- Neural Protection Instruments
- Nerve Probes/Nerve Root Retractors: Gently retract nerve roots and dura to prevent intraoperative injury .
Implantation Assist Tools- Cage Holders: Grip and guide fusion cages into position ;
- Impactors/Mallets: Tap cages to predetermined depth ;
- Graft Funnels/Bone Packers: Fill cage cavities or disc space with bone graft .
Note: Some kits include quick-release wrenches and tray locking components to enhance efficiency and prevent instrument displacement .
II. Performance and Design Features
- Materials and Manufacturing
- Medical-grade stainless steel with passivation or coating (Ni plating ≥7μm, Cr plating ≥0.5μm), corrosion resistance meets YY/T0149 standard boiling water test Grade B;
- Ergonomic handles with silicone anti-slip grips reduce surgeon fatigue.
- Precision Requirements
- Surface roughness Ra ≤1.6μm (external) and ≤6.3μm (holes/grooves) ;
- Impactor threads must precisely match cage threads to prevent disengagement or jamming .
- Safety Assurance
- Heat-treated parts hardness: 37~55 HRC for mechanical strength ;
- Smooth edges on neural instruments minimize nerve injury risk .
III. Clinical Applications
- Surgical Indications
- Primarily for PLIF procedures (Posterior Lumbar Interbody Fusion), treating degenerative disc disease, discogenic low back pain, Grade I-II spondylolisthesis ;
- Requires supplemental pedicle screw-rod systems for spinal stability .
- Operational Pros and Cons
- Advantages: Single-kit workflow reduces instrument changes; minimally invasive design minimizes muscle stripping ;
- Limitations: Bilateral cage implantation increases nerve retraction risks compared to TLIF .
IV. Usage Precautions
- Preoperative: Non-sterile supply—strict sterilization required; endplate preparation quality directly affects fusion rates ;
- Intraoperative:
- Avoid over-distraction causing endplate fractures;
- Ensure sufficient graft volume (autograft/allograft mix recommended) 11;
- Postoperative Maintenance: Dedicated cleaning protocols to prevent coating damage/corrosion .
