Spinal Bone Fastener with Navigation for Stable Fixation
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Solution Overview
Problem
Current spinal implant systems for treating musculoskeletal disorders, such as degenerative disc disease and spondylolisthesis, often require complex surgical procedures and may not provide stable fixation, leading to issues like pseudoarthrosis and loss of sagittal correction.
Innovation Solution
A spinal implant system with a bone fastener having a proximal and distal portion configured for fixation on opposite cortical surfaces of a vertebra, utilizing a surgical driver with navigation components for precise placement, allowing for bi-cortical fixation and reducing the need for additional implants, while enabling anterior approaches that minimize morbidity and radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional spinal implant systems are used, then surgical procedures can be performed, but fixation stability is insufficient leading to pseudoarthrosis and loss of sagittal correction
Solution Approach 1:
The bone fastener is divided into distinct proximal and distal portions that engage separate cortical surfaces, with intermediate sections for bone engagement. This segmentation allows each portion to perform its specific function optimally while maintaining overall fixation stability through distributed load bearing across multiple vertebral surfaces.
Solution Approach 2:
The surgical navigation system performs preliminary planning and guidance before implant placement, allowing precise trajectory determination and cavity preparation. This preliminary action ensures accurate positioning of the bone fastener portions relative to cortical surfaces, eliminating the need for complex intraoperative adjustments and reducing surgical procedure complexity.
2Reliability
If multiple implants are used to ensure stable fixation, then fixation reliability improves, but surgical complexity and radiation exposure increase
Solution Approach 1:
The single bone fastener is designed with multi-functionality, incorporating both proximal and distal fixation portions that can engage different cortical surfaces. This universal design allows one implant to perform the fixation function that traditionally required multiple separate implants, reducing radiation exposure from repeated imaging while maintaining fixation reliability.
Solution Approach 2:
The patent replaces the mechanical trial-and-error implant placement method with a surgical navigation system that uses optical or electromagnetic fields to guide implant positioning. This substitution eliminates the need for multiple fluoroscopic images to verify placement, significantly reducing radiation exposure while ensuring accurate positioning for reliable fixation.
3Reliability
If posterior approaches are used for spinal fixation, then stable fixation can be achieved, but surgical complexity and patient morbidity increase
Solution Approach 1:
Instead of using the traditional posterior approach to achieve stable fixation, the patent inverts the approach by using an anterior trajectory with a bone fastener designed to engage cortical surfaces from the front. This inversion maintains fixation stability while improving surgical accessibility and reducing patient morbidity associated with posterior approaches.
Solution Approach 2:
The bone fastener is designed with different local qualities in its proximal and distal portions, with specific geometries optimized for engagement with anterior cortical surfaces. This local quality differentiation allows the implant to achieve stable fixation through the anterior approach, making the surgery easier to perform while maintaining fixation reliability.
4Reliability
If precise implant placement is achieved through navigation, then fixation reliability improves, but device complexity increases
Solution Approach 1:
The surgical navigation system acts as an intermediary between the surgeon and the implant placement process, providing real-time guidance without requiring complex manual measurements or trial placements. This intermediary system simplifies the overall process by integrating tracking, visualization, and guidance functions into a unified platform that improves placement precision while managing device complexity through systematic integration.
Data Source
AI summary
A spinal implant comprises at least one bone fastener including a proximal portion configured for fixation with a first anterior cortical surface of a vertebra and a distal portion configured for fixation with a second cortical surface of the vertebra. The proximal portion is engageable with a surgical driver having a surgical navigation component that generates data for display of an image representing position of the spinal implant relative to the vertebra. The spinal implant can be employed with cervical, thoracic, lumbar and/or sacral regions of a spine. Systems, surgical instruments and methods are disclosed.