Definition and Core FunctionsThe zero-profile fusion device instrument package is a specialized toolset for spinal surgery, particularly designed for anterior cervical procedures. Its key features include:
- Minimally invasive implantation: Enables small-incision operations to reduce muscle and soft tissue damage.
- Zero-profile effect: The implanted fusion device aligns flush with the anterior vertebral edge, eliminating esophageal compression and reducing postoperative complications like dysphagia.
- Stability assurance: Integrates the fusion device with self-locking screws and torque-limited tools to ensure immediate stability and long-term bone fusion.
Core Components and ApplicationsThe package includes four categories of tools:
- Measurement Tools
- Sizing trials: Used intraoperatively to measure disc space height and select appropriate fusion device dimensions (e.g., parallel, wedge, or curved trials), with X-ray guidance for positioning.
- Access Tools
- Retractors/hooks: Blunt, sharp, or fenestrated retractors to expose the surgical field and establish minimally invasive pathways.
- Working cannulas: Assist in bone grafting or device insertion, especially in lumbar minimally invasive procedures.
- Implantation Tools
- Graspers/aiming devices: Ensure precise device placement and endplate contact.
- Torque wrench: Limits screw tightening to 1.2Nm to prevent breakage or loosenin.
- Drills/reamers: Prepare bone grooves or endplates, some with anti-slip designs.
- Auxiliary Tools
- Distractors/curettes: Expand disc spaces or remove pathological tissues for bone grafting.
- Bone graft fillers: Load autograft or synthetic bone into the fusion device cavity to promote fusion.
Materials and Sterilization Requirements- Materials:
- Tool bodies: Stainless steel (e.g., 30Cr13, 06Cr19Ni10) or titanium alloys compliant with GB/T1220-2007.
- Fusion devices: Titanium alloys or biocompatible materials (e.g., 3D-printed porous titanium) for optimal osseointegration.
- Sterilization: Non-sterile upon delivery; requires hospital sterilization (high-temperature autoclaving or chemical methods) per guidelines.
Key Features and Clinical Advantages- Minimally invasive efficiency: Reduces blood loss and enables early ambulation (1-2 days postoperatively).
- Enhanced stability: Serrated device surfaces and self-locking screws minimize migration risks.
- Superior biocompatibility: 3D-printed porous structures achieve >95% bone fusion rates.
- Broad compatibility: Adapts to systems like Zero-P and anti-migration trabecular fusion devices.
