Steerable Spinal Spacer Off-Axis Positioning
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Solution Overview
Problem
Existing spinal implant devices lack the ability to be precisely positioned off-axis, leading to suboptimal placement and reduced effectiveness in promoting lordosis and minimizing patient invasiveness during interbody fusion surgery, resulting in prolonged recovery times and potential complications.
Innovation Solution
A steerable spinal implant spacer with off-axis and on-axis contact sites, allowing for minimally invasive positioning and alteration in size and shape, enabled by a positioning tool that can move the spacer at angles other than straight-line insertion, facilitating precise placement between vertebrae.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If existing IF techniques are used to insert spinal implant devices, then the implant can be placed in the intervertebral space, but the implant cannot be precisely positioned off-axis, resulting in suboptimal placement that fails to promote lordosis and may cause subsidence
Solution Approach 1:
A positioning tool is introduced as an intermediary device between the surgeon and the spinal implant. The positioning tool includes a shaft with a tip that can engage with the implant's tip, allowing the surgeon to manipulate and position the implant with precision. The positioning tool features a longitudinal axis that can be aligned with the desired insertion path, and the implant can be rotated or steered relative to this axis to achieve off-axis positioning. This intermediary tool enables precise control of implant placement without requiring complex surgical techniques.
Solution Approach 2:
The invention introduces rotational freedom around the longitudinal axis of the positioning tool, adding a rotational dimension to the traditional linear insertion approach. The implant can be rotated relative to the positioning tool's axis, and the tool itself can be oriented at different angles during insertion. This dimensional addition allows the implant to be positioned off-axis and steered to optimal locations that promote lordosis, transforming the insertion process from simple linear advancement to controlled multi-dimensional placement.
2Ease of operation
If existing IF techniques are used with on-axis implant insertion, then the procedure is simpler, but the implant placement is suboptimal, leading to reduced effectiveness in promoting lordosis and potential complications
Solution Approach 1:
The positioning tool and implant system incorporates dynamic adjustability during the insertion process. The implant can be rotated and steered relative to the positioning tool's longitudinal axis, allowing real-time adjustment of the insertion angle and final position. The system transitions from a static, fixed-axis insertion to a dynamic, adjustable placement process. This dynamic capability enables the surgeon to optimize implant positioning for promoting lordosis while maintaining procedural simplicity through the intuitive design of the positioning tool.
3Reliability
If precise off-axis positioning of spinal implants is achieved, then surgical effectiveness is improved, but the device complexity increases due to the need for steerable mechanisms and positioning tools
Solution Approach 1:
The system is divided into distinct functional components: the positioning tool (with shaft and tip) and the spinal implant (with engagement features). The positioning tool can be disengaged from the implant after placement, allowing each component to be optimized independently. The implant includes specific engagement features that interface with the positioning tool, enabling controlled manipulation without requiring the implant itself to be complex. This segmentation allows precise off-axis positioning capability while keeping the implant design relatively simple and the positioning tool reusable.
Data Source
AI summary
A method of inserting and positioning an intervertebral spacer is provided. The spacer includes a longitudinal axis, an on-axis interface coincident with or parallel to the longitudinal axis, and an off-axis interface angled to the longitudinal axis. The spacer's front end may be curved. The method may include inserting the spacer into the disc space utilizing a tool to engage an on-axis interface and then to engage one or more of the off-axis interfaces, which may be used for further modification of the spacer. The tool is moved substantially along a single insertion direction, which may be substantially parallel to a posterior-anterior axis of the disc space. The method may result in the longitudinal axis of the spacer being perpendicular to the insertion direction, or substantially parallel to a medial-lateral axis of the disc space. The spacer may also be positioned in an anterior aspect of the disc space.


