Pedicle Access Clip and Frame Assembly for Trajectory Stability
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Solution Overview
Problem
Current methods for positioning pedicle screws during spinal procedures are inefficient due to the difficulty in accurately aligning the trajectory of needles and devices to avoid damaging the nervous system, often requiring multiple x-rays and manual stabilization, which can expose practitioners to radiation and lead to instability in the alignment.
Innovation Solution
A system comprising a clip and frame assembly that secures the device for pedicle access, allowing for adjustable positioning and imaging to determine the proper trajectory, with a clip that has jaws that can be closed to securely hold the device, reducing the need for manual stabilization and minimizing radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual positioning of the needle is used, then the practitioner can adjust the trajectory, but the alignment stability deteriorates and radiation exposure increases
Solution Approach 1:
The patent introduces a specialized holder device as an intermediary between the practitioner's manual control and the needle positioning. This holder includes a clamp mechanism with adjustable jaws that securely grip the needle, providing stable positioning while allowing controlled adjustment of the trajectory. The holder acts as a mediator that maintains alignment stability during imaging and procedure execution, reducing the need for repeated manual repositioning and radiation exposure.
2Measurement precision
If multiple x-rays are taken to verify trajectory, then positioning accuracy improves, but radiation exposure increases
Solution Approach 1:
The patent implements preliminary action by using the holder device to pre-establish and secure the needle trajectory before final insertion and before taking verification x-rays. The holder maintains the estimated trajectory during the initial positioning phase, allowing practitioners to take fewer verification x-rays since the holder itself provides visual confirmation of proper alignment and prevents trajectory drift between imaging attempts.
3Object-affected harmful factors
If the handle is positioned far from the needle edge, then practitioner safety improves, but trajectory control precision deteriorates
Solution Approach 1:
The holder device serves as an intermediary that decouples the practitioner's hand position from the needle tip position. The practitioner manipulates the holder from a safe distance, and the holder's rigid structure and secure clamping mechanism ensure that this distal manipulation is accurately transmitted to the needle without loss of precision. This allows the practitioner to maintain safe distance while the holder maintains precise trajectory control.
Data Source
AI summary
A method of positioning a device for pedicle access includes securing a clip in an adjustable frame assembly and securing the device in the clip. The method also includes positioning the device at an initial position having a trajectory estimated to allow the device to penetrate a pedicle without damaging the nervous system, and determining whether the trajectory of the initial position is proper to avoid damage. Further, the method includes re-positioning the device to a new position if the trajectory of the initial position is not proper to avoid damage to the nervous system, and determining whether the trajectory of the new position is proper to avoid damage. The method also includes repeating the steps of re-positioning the device and determining whether the trajectory of the new position is proper as required until a proper trajectory is obtained.