Standalone Interbody Implants with Integrated Fixation Inserts
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Solution Overview
Problem
Current fixation devices for spinal stabilization, particularly in intervertebral spaces, face challenges such as insufficient strength when made from non-metallic materials like PEEK, and protrude anteriorly, obstructing anatomy, necessitating a solution that provides additional support and minimizes profile protrusion.
Innovation Solution
The development of stand-alone interbody fusion implants with a spacer and insert or member design, featuring apertures for fixation elements like screws, and a frame with endplates that enhance strength and stability, while integrating seamlessly with the spacer to secure vertebrae without increasing profile.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the spacer is made from non-metallic materials like PEEK, then the biocompatibility and flexibility are improved, but the strength to support fixation elements deteriorates
Solution Approach 1:
The implant combines PEEK spacer material with titanium insert elements to create a composite structure that leverages the biocompatibility and flexibility of PEEK while utilizing the high strength of titanium to support fixation elements like screws and anchors
2Reliability
If a plate is provided for fixation, then the stabilization is improved, but the profile protruding anteriorly worsens
Solution Approach 1:
The invention extracts the fixation function from a separate anterior plate and integrates it into the interbody spacer itself through inserts with apertures, eliminating the need for a protruding anterior plate while maintaining stabilization capability
Solution Approach 2:
The fixation elements (inserts with apertures for screws, staples, pins, or anchors) are merged directly into the spacer structure, combining the spacer and fixation functions into a single integrated device that minimizes anterior profile
3Strength
If fixation elements are added to the spacer, then the strength and stabilization are improved, but the device complexity increases
Solution Approach 1:
The inserts containing apertures for fixation elements are nested within the spacer structure, allowing the fixation components to be housed inside the spacer volume rather than adding external complexity, thus minimizing the overall device profile
Data Source
Figure 1A~1C
Figure 1D~1E
Figure 2A~2B
AI summary
Stand-alone interbody fusion devices for engagement between adjacent vertebrae. The stand-alone interbody fusion devices may include a spacer or endplates and one or more inserts, members, or frames coupled to the spacer or endplates. The inserts, members, or frames may be configured and designed to provide the apertures which are designed to retain bone fasteners, such as screws or anchors, and secure the implant to the adjacent vertebrae.