Nested Balloon Spacer for Spinal Alignment
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Solution Overview
Problem
Existing methods for inserting a spacer between spinous processes to treat lumbar spinal canal stenosis are invasive and prone to displacement due to uneven dilation of balloons used, leading to misalignment and potential detachment from the space between bones.
Innovation Solution
A spacer design featuring an inner and outer balloon, where the inner balloon dilates with a lower viscosity fluid first, ensuring simultaneous expansion and preventing side-specific dilation, and an outflow portion to maintain the dilated state and facilitate removal, reducing displacement and ensuring proper positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a filling material having a relatively high viscosity is introduced into the balloon, then the balloon can be pressed against surrounding tissues, but the spacer is displaced to the side that starts to dilate earlier
Solution Approach 1:
The balloon is divided into multiple independent chambers (first balloon, second balloon, third balloon, fourth balloon) arranged at different positions. Each chamber can be filled with filling material independently through separate injection holes, allowing controlled sequential dilation from different directions to prevent displacement while maintaining tissue pressure.
2Ease of operation
If the balloon dilates from one side earlier than the other, then the spacer is displaced to that side, but the center of the spacer becomes misaligned with the center of interspinous ligaments
Solution Approach 1:
The balloon structure employs asymmetric positioning of multiple chambers and injection holes. The first and second balloons are positioned on one side while the third and fourth balloons are positioned on the other side, with injection holes arranged to enable sequential filling that compensates for gravitational and pressure imbalances, ensuring the spacer remains centered between spinous processes.
Solution Approach 2:
The design anticipates the displacement problem by pre-positioning multiple balloons and injection holes to counteract the tendency of filling material to flow to one side. By having injection holes at strategic locations and balloons arranged to apply pressure from multiple directions, the system preemptively prevents misalignment before it occurs.
3Device complexity
If a single balloon is used for spacer insertion, then the structure is simple, but the spacer cannot maintain stable positioning and may detach from the space between spinous processes
Solution Approach 1:
Instead of a single balloon, the invention uses multiple independent balloons (first, second, third, and fourth balloons) positioned at different locations between the spinous processes. This segmented approach distributes the retention force across multiple contact points, significantly improving the reliability of spacer retention while reducing the risk of detachment.
Solution Approach 2:
The multiple balloons are nested within the same anatomical space between spinous processes, with each balloon contributing to the overall retention mechanism. The balloons can be filled sequentially and work together as an integrated system, combining the simplicity of individual balloon structures with the reliability of a multi-component retention system.
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
The spacer effectively prevents displacement and ensures accurate positioning between spinous processes, maintaining a stable dilated state and facilitating easy insertion and removal, thereby reducing surgical invasiveness and improving treatment efficacy.
Implementation Method 1
The inner balloon dilates in response to the introduction of a dilating fluid, which has a lower viscosity than a viscosity of a filling material introduced into the outer balloon. The outer balloon dilates in response to the dilation of the inner balloon.
Implementation Method 2
a dilating fluid, which has a lower viscosity than a viscosity of a filling material introduced into the outer balloon
Implementation Method 3
an outflow portion to maintain the dilated state and facilitate removal
Data Source
AI summary
A spacer and implant assembly are disclosed, the spacer including an outer balloon that is folded so as to be dilatable, and an inner balloon that is folded so as to be dilatable, and that is removably inserted into the outer balloon. The inner balloon dilates in response to introduction of a dilating fluid having a lower viscosity than a viscosity of a filling material inserted into the outer balloon, and the outer balloon dilates in response to the dilation of the inner balloon.