Single-Access Balloon Vertebral Augmentation
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Solution Overview
Problem
Current bone stabilization and height restoration techniques, such as vertebroplasty, often require bipedicular approaches that are complex, time-consuming, and may not provide symmetrical bone augmentation, especially for fractured vertebral bodies, which can be challenging due to varying bone geometries and fracture types.
Innovation Solution
A method and system utilizing a single balloon that can be inflated and deflated multiple times through a single access point to create cavities within a bone structure, allowing for targeted placement of curable material to restore height and stabilize the bone, potentially reducing the need for multiple puncture sites and enhancing symmetry.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a bipedicular approach is used for vertebroplasty, then bone stabilization is achieved, but procedure complexity and time increase
Solution Approach 1:
The patent combines multiple balloon inflations and curable material deliveries through a single access point, merging what were previously separate procedural steps into one integrated process. This reduces the number of puncture sites needed while maintaining effective bone stabilization through cumulative balloon expansions that create and fill cavities within the vertebral body.
Solution Approach 2:
The single access point serves multiple functions: it allows insertion of the balloon for cavity formation, enables curable material delivery, and permits repeated inflation/deflation cycles. This multi-functional approach eliminates the need for separate access points for each procedural step, reducing overall procedure complexity.
2Reliability
If a bipedicular approach is used for vertebroplasty, then bone stabilization is achieved, but procedure time increases
Solution Approach 1:
The procedure maintains continuous useful action by performing multiple balloon inflations and curable material deliveries through the same access point without requiring patient repositioning or additional puncture procedures. The sequential inflation-deflation-delivery cycles continue uninterrupted, reducing overall procedure time while achieving effective bone stabilization.
Solution Approach 2:
The balloon is inserted and positioned within the vertebral body before any inflation occurs, preparing the access pathway in advance. This preliminary positioning allows subsequent rapid inflation and material delivery cycles to proceed efficiently without requiring repeated instrument insertion, thereby reducing procedure time.
3Area of stationary object
If multiple puncture sites are used, then bone augmentation coverage is improved, but symmetry and bone-centralization are compromised
Solution Approach 1:
The procedure segments the bone augmentation process into multiple sequential balloon inflations that progressively expand to create cavities throughout the vertebral body. Each inflation targets a specific region, and the cumulative effect achieves comprehensive coverage while maintaining central symmetry through controlled, sequential expansion from a single central access point.
Solution Approach 2:
The balloon dynamically expands and contracts in controlled cycles, allowing progressive cavity formation and curable material delivery. This dynamic approach enables the operator to adapt the expansion pattern to achieve symmetrical, centralized bone augmentation while covering the entire vertebral body through sequential adjustments in balloon size and position.
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 approach allows for more efficient and minimally invasive bone stabilization and height restoration, reducing procedure complexity and time while providing symmetrical augmentation and improved bone-centralization, suitable for various bone types and fractures.
Implementation Method 1
utilizing a single balloon that can be inflated and deflated multiple times through a single access point to create cavities within a bone structure
Data Source
AI summary
An expandable member bone augmentation system and single-access-point methods for bone augmentation using same are provided. In certain embodiments, a pre-curved stylet with an overlying delivery tube may be used to target an approximately centered target site within a bone structure, facilitating direction thereto of an expandable member useful for creating a cavity that may receive curable material to restore bone height and/or to reinforce the bone structure. An expandable member such as, for example, a balloon can be used to create a plurality of voids by displacing bone material, where the voids can be filled with curable material to augment the bone.