Spinal Plate Inserter with Integrated Awl for Faster Fixation
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Solution Overview
Problem
Existing spinal plate insertion procedures are time-consuming and lack adequate visualization and control during spinal plate fixation to the spine, necessitating improved instruments and methods to reduce procedural time and enhance surgical precision.
Innovation Solution
An inserter instrument comprising a housing, an inner sleeve, and an awl, which allows for the releasable engagement of a spinal plate and the formation of pilot holes in vertebrae for secure fixation, utilizing a mechanism that includes a handle, outer sleeve, and knob for precise manipulation and alignment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional spinal plate insertion methods are used, then the procedure can be completed, but the procedural time is excessive and visualization is inadequate
Solution Approach 1:
The patent combines multiple functions (plate engagement, pilot hole formation, and bone fastener insertion) into a single integrated inserter instrument. The housing contains both the inner sleeve for plate engagement and the awl for hole formation, allowing these operations to be performed sequentially without removing the instrument, thereby reducing procedural time while maintaining manageable complexity through functional integration
Solution Approach 2:
The inserter instrument is designed as a multi-functional device that can engage the spinal plate, form pilot holes in vertebrae, and facilitate bone fastener insertion through a single instrument. This universal design eliminates the need for multiple separate tools, improving productivity by reducing the number of instrument changes and steps required during the procedure
2Measurement precision
If traditional insertion methods are used, then the procedure can be completed, but visualization and control during fixation are insufficient
Solution Approach 1:
The instrument employs a nested structure where the inner sleeve is disposed within the housing and the awl is disposed within the housing. This nesting arrangement allows compact storage of multiple functional components while enabling sequential deployment during the procedure, providing precise control over each operation step while maintaining adequate visualization of the surgical site
Solution Approach 2:
The inner sleeve is pre-configured with engagement features that align with the spinal plate apertures before insertion. This preliminary configuration ensures precise positioning and engagement of the plate without requiring complex adjustments during the procedure, improving measurement precision while keeping the device mechanism relatively simple
3Productivity
If multiple separate instruments are used for plate insertion and pilot hole formation, then each function can be performed, but the procedural time increases
Solution Approach 1:
The patent merges the functions of plate engagement (inner sleeve) and pilot hole formation (awl) into a single housing structure. This allows the surgeon to perform both operations without removing or changing instruments, significantly improving insertion speed and productivity while the integrated design provides straightforward manipulation through a single handle
4Adaptability or versatility
If the awl extends beyond the inner sleeve, then pilot hole formation is enabled, but the risk of inaccurate positioning increases
Solution Approach 1:
The awl is nested within the housing and can extend distally beyond the inner sleeve when needed for pilot hole formation. The nested arrangement ensures that the awl maintains proper alignment with the engagement aperture and the spinal plate position, providing accurate positioning despite the extended reach required for bone engagement
Solution Approach 2:
The housing acts as an intermediary structure that guides and positions the awl during extension. This intermediary mechanism ensures that the awl extends along the correct trajectory and maintains accurate positioning relative to the spinal plate and vertebra, enabling versatile function while preserving manufacturing precision
Data Source
AI summary
Disclosed herein are an inserter instrument, a system including the inserter, a spinal implant, and fasteners for affixing the implant to the spine of a subject, and related methods for performing spinal procedures including insertion of spinal plates. The inserter includes a housing, an inner sleeve slidably disposed within the housing, and an awl slidably disposed within the housing and inner sleeve. The housing includes a rotatable portion configured to actuate translation of the inner sleeve proximally or distally relative to the housing along a central axis to releasably engage the spinal implant using a distal engagement portion of the inner sleeve. The awl is configured to form a pilot hole in a vertebra at the surgical site, which is configured to receive a fastener to fix the spinal plate to the spine.