Inflatable Bone Tamp Flow Control Balloon Inflation
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Solution Overview
Problem
Conventional spinal fracture treatment procedures lack control over the inflation rate of balloons used in kyphoplasty, leading to uneven inflation, balloon ruptures, and suboptimal performance, which can result in unpredictable patient outcomes.
Innovation Solution
The development of an inflatable bone tamp (IBT) with a flow control device that regulates the inflation of balloons, ensuring a steady and uniform inflation rate by controlling the flow of material through a shaft and into the balloon, preventing rapid inflation and promoting gradual compression of bone.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional spinal fracture treatment procedures are used without flow control, then the procedure can be performed quickly, but the balloon inflation becomes uneven and unpredictable leading to suboptimal outcomes
Solution Approach 1:
A flow controller is introduced as an intermediary component between the inflation source and the balloon. This flow controller regulates and controls the material flow into the balloon, ensuring steady and uniform inflation. The flow controller acts as a mediator that translates uncontrolled inflation pressure into controlled, gradual balloon expansion, thereby achieving predictable treatment outcomes without requiring complex external monitoring systems.
2Productivity
If the balloon is inflated rapidly to reduce procedure time, then the procedure becomes more efficient, but the bone compression is insufficient and cavity formation is suboptimal
Solution Approach 1:
The flow controller dynamically adjusts the inflation parameters by controlling the flow rate of material into the balloon. Instead of using a fixed high inflation rate, the system modifies the flow parameters to achieve an optimal balance between speed and precision. The controller ensures that the balloon inflates at a controlled rate that allows bone material to be gradually compressed and redistributed, forming precise cavities while maintaining acceptable procedure time.
3Manufacturing precision
If the balloon is inflated slowly to achieve gradual bone compression, then the bone deformation is optimal, but the procedure time increases significantly
Solution Approach 1:
The flow controller maintains continuous and steady material flow into the balloon throughout the inflation process. This continuous controlled action ensures that the balloon expands uniformly and consistently applies compression force to the bone. By eliminating interruptions and maintaining steady progression, the system achieves high-quality bone compression more efficiently than intermittent or manually controlled inflation, thereby reducing overall procedure time while maintaining compression quality.
4Reliability
If no flow control device is used, then the device structure remains simple, but balloon rupture and uneven inflation occur leading to unpredictable outcomes
Solution Approach 1:
A flow controller is introduced as an intermediary component between the inflation source and the balloon. This flow controller regulates and controls the material flow into the balloon, ensuring steady and uniform inflation. The flow controller acts as a mediator that translates uncontrolled inflation pressure into controlled, gradual balloon expansion, thereby achieving predictable treatment outcomes without requiring complex external monitoring systems.
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 solution allows for more predictable and effective treatment of vertebral compression fractures by ensuring gradual inflation of balloons, creating a stable cavity within the vertebral body, which can be filled with bone cement, thereby improving patient outcomes and reducing procedure time.
Implementation Method 1
The IBT comprises a flow control device that controls the flow of the material through the shaft and into the balloon
Implementation Method 2
The balloon or balloons are inflated within the fractured vertebral body such that the cancellous bone of the vertebral body is pushed towards cortical walls
Implementation Method 3
the cancellous bone of the vertebral body is pushed towards cortical walls of the vertebral body to form a cavity within the vertebral body
Data Source
AI summary
An inflatable bone tamp is provided that includes a shaft with proximal and distal portions and a central longitudinal axis. A balloon is attached to the shaft such that a material can flow through the shaft and into the balloon to inflate the balloon. A flow controller controls the flow of the material through the shaft and into the balloon. Kits, systems and methods are disclosed.