Universal Trial for Lateral Cages with Adjustable Angulation
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Solution Overview
Problem
Conventional trial systems for lateral spine surgeries are limited in adjusting and measuring the angle of trial insertion, particularly in posterior approach surgeries, leading to inefficiencies and increased costs due to the need for multiple specialized instruments.
Innovation Solution
Development of continuously adjustable trials that allow for flexible angulation within single or multi-planes, enabling precise measurement and adaptation to patient anatomy and surgical preferences, using mechanisms like pivoting heads and universal joints with incremental measurement and locking features.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple specialized trial systems are developed for different lateral approaches, then each approach can be optimized for its specific angle, but the number of surgical instruments increases and overall procedure cost increases
Solution Approach 1:
The trial system incorporates a universal adjustment mechanism that allows a single trial to be used for multiple lateral approaches by enabling continuous angle adjustment. The trial head can be rotated to various angles and locked in place, allowing one instrument to replace multiple specialized trials for different approaches (direct lateral, anterior-lateral, superior/inferior lateral).
Solution Approach 2:
The trial system transitions from fixed-angle designs to a dynamic, continuously adjustable angle system. The trial head can be rotated through a full range of motion and locked at any desired angle, providing adaptability for different surgical approaches while maintaining the reliability of optimized angular positioning for each approach type.
2Device complexity
If fixed-angle trials are used for specific lateral approaches, then the trial angle is predetermined and simplified, but the ability to adapt to patient anatomy and surgical preferences is limited
Solution Approach 1:
The trial system incorporates a dynamic adjustment mechanism that allows the trial head angle to be continuously modified during the surgical procedure. The surgeon can rotate the trial head to various angles and lock it in place, enabling real-time adaptation to patient anatomy and surgical preferences while maintaining a relatively simple overall device structure.
3Device complexity
If conventional trial systems are used without angle measurement capability, then the device structure remains simple, but the ability to measure and ensure consistent insertion angle is lost
Solution Approach 1:
The trial system incorporates radiopaque markers or indicators that can be visualized on fluoroscopic or radiographic imaging. These markers provide visual feedback about the trial's angular orientation, allowing the surgeon to measure and verify the insertion angle without adding complex mechanical measurement devices. The markers appear as distinct radiopaque features on imaging that can be used to determine angular positioning.
4Adaptability or versatility
If adjustable trials with multiple adjustment mechanisms are developed, then flexibility and adaptability are improved, but the device complexity and surgical complexity increase
Solution Approach 1:
The trial system uses a simple rotational mechanism that allows the trial head to be rotated to various angles and locked in place. This single-degree-of-freedom adjustment provides the necessary flexibility for different lateral approaches without introducing multiple complex adjustment mechanisms. The rotation and lock function achieves adaptability while maintaining relatively simple device and surgical complexity.
Data Source
AI summary
A method of trialing an intervertebral disc space, comprising the steps of :a) creating the disc space,b) inserting a trial into the disc space, the trial having i) a distal head having an upper surface and a lower surface connected by a pair of side walls, the side walls defining planes, and ii) a proximal rod,wherein the head and rod form an obtuse angle, andwherein the rod extends through at least one of the planes defined by the side walls of the head.