Inflatable Disc Space Trial Balloon for Accurate Implant Sizing
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Solution Overview
Problem
Current methods for determining the size, location, and geometry of the disc space after discectomy are limited, leading to potential improper placement and securement of intervertebral devices, which can result in device migration, expulsion, and continued pain.
Innovation Solution
An inflatable, intra-operative trial balloon is inserted into the disc space, inflated with a radiographic material to visualize the cleared space, allowing for accurate determination of size, location, and geometry, enabling precise placement of intervertebral implants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional discectomy is performed without trial device, then surgical procedure is simpler and faster, but implant placement accuracy deteriorates leading to migration or expulsion
Solution Approach 1:
The trial balloon is inflated within the disc space before final implant placement to preliminarily determine the optimal implant size, position, and geometry. This preliminary measurement action allows surgeons to verify disc space dimensions and implant fit before committing to the final implant, thereby improving placement accuracy without requiring complex post-operative adjustments
Solution Approach 2:
The trial balloon serves as an intermediary device between the disc space preparation and final implant placement. It provides a radiopaque template that mediates the determination of implant parameters, allowing indirect measurement and verification of disc space geometry before the actual implant is inserted
2Manufacturing precision
If trial balloon with radiographic material is used, then implant placement accuracy is improved, but surgical time and procedure complexity increase
Solution Approach 1:
The surgical procedure is segmented into distinct phases: disc space preparation, trial balloon insertion and inflation, radiographic imaging for measurement, and final implant placement. This segmentation allows for systematic verification of implant parameters at the appropriate stage, improving precision without significantly extending total surgical time by enabling parallel preparation activities
3Reliability
If accurate disc space determination is made, then implant fit and biomechanical loading are optimized, but measurement and detection difficulty increases due to limited intraoperative imaging
Solution Approach 1:
The trial balloon incorporates radiopaque materials that appear as distinct radiographic densities on fluoroscopic images, enabling clear visualization of the balloon's position, size, and shape within the disc space. This radiographic 'color change' or density contrast allows accurate measurement of disc space geometry without requiring complex imaging equipment or techniques
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method improves the accuracy of implant sizing and placement, enhancing procedure safety and effectiveness by ensuring a proper fit and biomechanical loading of the disc space.
Implementation Method 1
In order to visualize the shape of the balloon, the balloon is comprised of, or is inflated with, a radiographic material. Next, an imaging technique is used to visualize the inflated trial balloon
Data Source
AI summary
A nucleus pulposus trial device for assessing the size, shape and location of a disc space.