Balloon Kyphoplasty Device with Nested Balloons for Vertebral Reconstruction
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Solution Overview
Problem
Existing balloon kyphoplasty devices struggle to create a larger bony void with a more structurally sound cement structure, leading to potential weaknesses in the vertebral bone due to high single-point pressure areas and inadequate cement distribution.
Innovation Solution
The balloon kyphoplasty surgical device features a balloon arrangement with inner and outer balloons that inflate to form a cubic shape, providing a larger cavity and a more evenly distributed cement structure upon deflation and cement filling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of stationary object
If a traditional balloon is used in kyphoplasty, then the procedure is simple, but the bony void created is small and cement distribution is poor
Solution Approach 1:
The patent employs nested balloons where inner balloons are positioned inside outer balloons. The inner balloons inflate first to create initial lift and begin forming the bony void, then the outer balloons inflate to expand the void further. This nested configuration allows progressive cavity creation while maintaining structural control, achieving larger bony void volume without excessive complexity.
Solution Approach 2:
The balloon system is divided into multiple segmented balloons (inner and outer balloons) rather than a single balloon. Each balloon can be inflated independently through separate fluid channels, allowing staged inflation that progressively creates and shapes the bony void. This segmentation enables better cement distribution by creating a more uniform cavity structure.
2Force
If high pressure is applied to inflate the balloon, then the vertebral height is restored effectively, but high single-point pressure areas weaken the bone
Solution Approach 1:
The force application is segmented across multiple balloons (inner and outer) rather than concentrated in a single balloon. Each balloon applies restoration force at different locations and magnitudes, distributing the mechanical stress across the vertebral body. This prevents high single-point pressure areas that would weaken the bone while still achieving effective vertebral height restoration.
Solution Approach 2:
Different balloons are positioned to apply force at different locations within the vertebral body. The inner balloons address central regions while outer balloons address peripheral regions, creating a heterogeneous force distribution pattern. This local quality approach ensures that no single point experiences excessive pressure that would compromise bone strength.
3Stability of the object's composition
If a single balloon is used, then the device is simple to operate, but cement distribution is inadequate and structural soundness is reduced
Solution Approach 1:
The balloon system is segmented into multiple independently controllable balloons with separate fluid channels. This allows the operator to inflate balloons in a specific sequence (typically inner first, then outer) to progressively shape the bony void. The segmented design improves cement structure stability by creating a more uniform cavity, while the systematic inflation protocol maintains reasonable operational simplicity.
Solution Approach 2:
The inner balloons are inflated in advance before the outer balloons to pre-establish the basic cavity structure and provide initial lift. This preliminary action creates a foundation that guides subsequent outer balloon inflation and cement injection, ensuring better structural soundness while maintaining a logical, manageable operational sequence.
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 configuration allows for a more structurally sound vertebral body reconstruction by creating a larger bony void with a flat surface area for better cement packing, reducing the risk of bone weakening and improving the stability of the vertebral body.
Implementation Method 1
Positioned on a distal end 15a of the extrusion tube 15 is a balloon arrangement 30 in fluid communication with the at least two fluid channels 21a, 22
Data Source
AI summary
Apparatus and associated methods relate to a balloon kyphoplasty surgical device comprising an extrusion tube having internal fluid channels and a support wire, a port arrangement positioned on a proximal end of the extrusion tube and a balloon arrangement positioned on a distal end of the extrusion tube, the balloon arrangement resulting in a cubic shape when inflated by the port arrangement.