Surgical Angulation Measurement for Precise Pedicle Screw Alignment
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Solution Overview
Problem
Existing pedicle screw fixation procedures in spine surgery are prone to misalignment due to operator-dependent orientation determination, leading to potential spinal cord injury, increased surgical time, and excessive fluoroscopy exposure, which is costly and risky.
Innovation Solution
A surgical angulation measurement instrument with a positioning measurer and reader that attaches to orthopedic tools, providing precise angle measurements and alignment notifications for pedicle screws, reducing misalignment and fluoroscopy use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy guidance is used to determine pedicle screw orientation, then measurement precision is improved, but loss of time and use of energy increase due to multiple images and long surgical time
Solution Approach 1:
The surgical template is prepared in advance with pre-calculated drill hole positions and orientations based on the patient's anatomy. During surgery, the template is simply positioned on the vertebrae surface, and the pre-marked guide holes provide immediate orientation guidance without requiring multiple fluoroscopic images or complex intraoperative measurements.
Solution Approach 2:
The invention creates a physical copy or model of the patient's vertebral anatomy using the surgical template that replicates the optimal screw trajectories. This template copy contains pre-determined guide holes that mirror the desired screw paths, allowing direct transfer of the planned orientation to the actual surgery without repeated imaging.
2Reliability
If fluoroscopy guidance is used to ensure pedicle screw alignment, then reliability is improved, but object-affected harmful factors increase due to excessive fluoroscopy exposure
Solution Approach 1:
The optimal screw trajectories and drill guide orientations are calculated and incorporated into the surgical template before the surgery begins. This preliminary preparation eliminates the need for repeated fluoroscopic imaging during the procedure, as the template itself provides all necessary alignment guidance through its pre-configured guide holes.
Solution Approach 2:
The surgical template acts as an intermediary device between the surgical plan and the actual screw insertion. It translates the planned trajectory into physical guide holes that directly guide the drill and screw, serving as a mediator that eliminates the need for continuous fluoroscopic verification and reduces radiation exposure.
3Device complexity
If operator experience is used to determine pedicle screw orientation, then device complexity is reduced, but manufacturing precision deteriorates due to operator-dependent determination
Solution Approach 1:
The surgical template is designed to be self-aligning and self-guiding. It automatically positions itself on the vertebrae surface and provides pre-determined guide holes that self-correct for anatomical variations. The template itself performs the function of determining optimal orientation without requiring operator interpretation or experience-based judgment.
Solution Approach 2:
The template incorporates adjustable parameters and customizable guide hole configurations that can be adapted to different vertebral anatomies. By changing the physical parameters of the template (such as guide hole positions and angles) based on pre-operative planning, the system achieves high precision without requiring complex real-time adjustment by the operator.
4Measurement precision
If multiple fluoroscopic images are obtained to confirm screw placement, then measurement precision is improved, but loss of time and productivity decrease
Solution Approach 1:
The surgical template provides pre-determined guide holes with correct orientations and positions before surgery begins. This preliminary preparation ensures that the first screw placement is correct without requiring multiple fluoroscopic confirmations, thereby improving both precision and surgical efficiency simultaneously.
Solution Approach 2:
The template provides immediate visual and tactile feedback through its physical structure - the guide holes clearly indicate the correct drill path and angle. This built-in feedback mechanism eliminates the need for repeated imaging to confirm placement, as the template itself continuously guides the operator throughout the procedure.
Data Source
AI summary
A surgical angulation measurement instrument of the instant invention includes a positioning measurer and a positioning reader linked to the positioning measurer. The positioning measurer detachably couples with a tool which is used to implant the pedicle screw. In response to the orientation of the tool, the orientation of the pedicle screw is measured by the positioning measurer with respect to a pedicle axis of screw placement. The positioning reader indicates the orientation of the pedicle screw and notifies the orientation of the pedicle screw being aligned with the pedicle axis of screw placement.


