Multi-Balloon Catheter Inflation Sequencing for Vertebral Lift
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Solution Overview
Problem
Existing balloon kyphoplasty devices often create circular cavities that result in high-pressure areas, leading to weakened bone structure and inadequate cement support, and lack the ability to evenly distribute lift and stabilization forces during vertebral reconstruction.
Innovation Solution
A balloon catheter device with multiple inner and outer balloons, each with independent inflation capabilities, forming a cubic shape to distribute lift evenly and create a larger, structurally sound cavity for bone cement, using a multichambered port system and a stylet wire for controlled deployment and retraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a single circular balloon is used for vertebral reconstruction, then the procedure is simple to perform, but high-pressure areas are created leading to weakened bone structure and inadequate cement support
Solution Approach 1:
The single circular balloon is divided into multiple separate balloons (typically four quadrants) that can be independently inflated. Each balloon segment creates a more distributed pressure profile, eliminating the high-pressure concentration point of a single circular balloon while maintaining procedural simplicity through coordinated inflation of multiple segments.
2Device complexity
If a single circular balloon is used, then the device structure is simple, but lift forces are not evenly distributed during vertebral reconstruction
Solution Approach 1:
The balloon structure is segmented into multiple independent balloons arranged in a pattern (such as quadrants) that collectively provide evenly distributed lift forces. Each segment can be independently controlled, allowing precise distribution of lifting forces across the vertebral body while maintaining a relatively simple overall device architecture.
Solution Approach 2:
Each balloon segment can be inflated to different pressures or volumes based on local requirements of the vertebral structure. This allows tailored lift distribution where specific areas may require more or less support, achieving homogeneous overall stabilization while accommodating local variations in bone density and fracture patterns.
3Volume of stationary object
If a single circular balloon is used, then the cavity formed is small, but the device configuration is simple
Solution Approach 1:
Multiple balloon segments are arranged to collectively form a larger cavity when inflated, providing more volume for bone cement injection. The segmented design allows the balloons to be packed more efficiently within the catheter delivery system, achieving larger expansion volume while maintaining manageable device configuration through modular arrangement.
Solution Approach 2:
The multiple balloon segments are nested within the catheter structure in a compact configuration for delivery, then expand outward to form a larger cavity. This nesting approach allows the device to transition from a compact deliverable state to a large-volume expanded state, maximizing cavity volume while minimizing delivery profile complexity.
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 device achieves more effective vertebral stabilization by distributing lift forces evenly, allowing for a larger cavity filled with bone cement, reducing the risk of bone weakness and enhancing the structural integrity of the vertebral reconstruction.
Implementation Method 1
The balloons are inflated to a desired pressure, volume, and/or size
Data Source
AI summary
A balloon catheter-type device and method of using the same. The device includes a balloon structure supported at a distal end of an extension tube. The balloon structure is configured for advancement through an incision in a patient to a target location within the patient, and has at least first and second inner balloons retained within an outer balloon. First and second fluid channels extend along the extension tube and are coupled to the respective first and second inner balloons. An inflation sequence can be used in which the first balloon is inflated followed by inflation of the second balloon. The outer balloon can remain uninflated or can be further inflated as well. Orientation indicia made of contrast response material can be used to identify a major or minor axis of the deployed balloon structure. A stylet wire can be used to deploy and retract the balloon structure.