Spinous Laminar Clamp for Cervical Stabilization
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Solution Overview
Problem
Current spinal stabilization and fixation methods for cervical spine fractures, particularly Type-II Odontoid Fractures, are associated with high morbidity, mortality, and complications such as infection, poor fusion rates, and vascular injuries, with existing devices like halo orthosis, anterior dens screws, and Harms pedicle screws being poorly tolerated by elderly patients and having low success rates.
Innovation Solution
A spinous laminar clamp system with adjustable and offset hooks that provide three-point or four-point fixation to the vertebral laminae, using biocompatible materials and an insertion tool for secure attachment to complex geometries, allowing for easy adaptation to various spinal levels and fracture types, with components designed for easy removal if necessary.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If halo orthosis device is used for cervical immobilization, then surgical intervention is avoided, but the success rate for fusion is low and complication rate is high
Solution Approach 1:
The patent introduces a halo-vest system as an intermediary device that provides cervical immobilization without direct surgical intervention on the spine. The halo ring attaches to the skull and connects to a vest, creating a mechanical bridge that stabilizes the cervical spine while avoiding direct bone contact and associated surgical risks
Solution Approach 2:
The invention replaces the need for surgical fixation devices (screws, rods, cages) with an external mechanical immobilization system. The halo orthosis uses external mechanical forces through the halo ring and vest connection to achieve spinal stabilization, substituting invasive mechanical systems with non-invasive external mechanics
2Reliability
If anterior dens screws are used for fixation, then direct spinal stabilization is achieved, but esophageal injury and swallowing disorder complications occur
Solution Approach 1:
The patent extracts the fixation mechanism from the anterior approach and relocates it to the posterior skull and cervical spine. By removing the need for anterior surgical access, the harmful effects on the esophagus and surrounding structures are eliminated while maintaining spinal stabilization through posterior halo ring attachment
Solution Approach 2:
The halo ring serves as an intermediary structure that provides spinal stabilization without direct contact with vulnerable anterior structures. It attaches to the skull and connects to the vest, creating a mechanical bridge that bypasses the esophagus and trachea entirely
3Reliability
If Harms pedicle screws are used for fixation, then cervical spine stabilization is achieved, but vascular injury and nerve damage risks increase
Solution Approach 1:
The patent extracts the stabilization mechanism from the invasive pedicle screw approach and relocates it to the posterior skull. By removing the need for deep bone penetration near the vertebral artery and spinal cord, the risks of vascular and nerve injury are eliminated while maintaining cervical spine stabilization through external halo-vest connection
4Reliability
If Brooks technique with wires and screws is used, then C1-C2 fixation is achieved, but wire dislodgement and fusion failure occur
Solution Approach 1:
The patent replaces the unstable wire and screw mechanical system with a more reliable external halo-vest mechanical system. The halo ring provides a stable attachment point on the skull that connects to the vest, creating a more robust immobilization mechanism that prevents dislodgement and fusion failure
Data Source
AI summary
A spinous laminar clamp system is disclosed herein. The preferred embodiments are either a three or a four-point fixation system at a particular vertebral level. For example, a two-point adjustable fixation below a vertebrae and a single-point non-adjustable point above the vertebrae exemplifies the three-point fixation. Multiple level and further stabilizing is provided by fixation to subjacent vertebrae above and/or below with a connecting rod providing unitization between levels. Specific designs are applicable to the cervical spine; however, fixation at all levels and regions of the human spine are contemplated.


