Inflatable Bone Tamp Flow Control and Pressure Damping
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Solution Overview
Problem
Conventional spinal fracture treatment procedures lack a means to control 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
An inflatable bone tamp with a flow control device and a damper is introduced, allowing for controlled inflation of the balloon by regulating the flow of inflation material and managing pressure to ensure a steady and uniform expansion, thereby facilitating gradual bone compression and vertebral height restoration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the balloon is inflated quickly to reduce procedure time, then productivity is improved, but the inflation becomes uneven and may cause balloon rupture, worsening reliability
Solution Approach 1:
A flow control device is introduced as an intermediary component between the inflation material source and the balloon. This device actively regulates the flow rate of inflation material, ensuring it remains within an optimal range to prevent both过快 inflation (which causes rupture) and过慢 inflation (which extends procedure time unnecessarily), thus resolving the contradiction between productivity and reliability
Solution Approach 2:
The system dynamically adjusts the flow rate parameter of inflation material based on real-time balloon expansion state. By changing the flow rate parameter adaptively during the inflation process, the system maintains optimal inflation speed that balances procedure efficiency with balloon safety, preventing rupture while avoiding unnecessary delays
2Reliability
If the balloon is inflated slowly to ensure uniform expansion, then reliability is improved, but procedure time increases, worsening productivity
Solution Approach 1:
The flow control device serves as a mediator that actively manages the inflation material flow, providing just the right amount of material at just the right speed. This active regulation ensures uniform balloon expansion (improving reliability) while preventing excessive procedure time (maintaining productivity), resolving the contradiction between these two parameters
Solution Approach 2:
The system incorporates feedback mechanisms that monitor balloon expansion progress and adjust the inflation material flow rate accordingly. This closed-loop control ensures uniform expansion by responding to real-time conditions, while the intelligent adjustment prevents unnecessary delays, thus resolving the contradiction between reliability and productivity
3Device complexity
If manual control of inflation rate is used by the physician, then device complexity is reduced, but manufacturing precision of inflation rate is insufficient
Solution Approach 1:
The flow control device is designed to automatically regulate the inflation material flow rate without requiring continuous manual intervention. The device self-adjusts based on pre-set parameters and real-time feedback, providing precise inflation rate control (improving manufacturing precision) while maintaining relatively simple device architecture (managing complexity), thus resolving the contradiction
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 controlled inflation system ensures more predictable and effective vertebral body expansion, reducing the risk of balloon rupture and improving procedural outcomes by allowing for a more consistent and controlled expansion of the vertebral body, leading to better patient results.
Implementation Method 1
A flow control device is coupled to the first port. The flow control device controls flow of the material through the first port and into the lumen.
Implementation Method 2
A damper is coupled to the second port. The damper controls pressure within the inflatable bone tamp when pressure within the inflatable bone tamp reaches a threshold.
Implementation Method 3
A balloon is coupled to the shaft such that a material can flow through the lumen and into the balloon to inflate the balloon.
Data Source
Figure 1
Figure 1A~1D
Figure 2
AI summary
An inflatable bone tamp is provided that includes a shaft defining a lumen. A balloon is coupled to the shaft such that a material can flow through the lumen and into the balloon to inflate the balloon. A connector is coupled to the shaft. The connector includes a first port and a second port. The ports are in communication with the lumen. A flow control device is coupled to the first port. The flow control device controls flow of the material through the first port and into the lumen. A damper is coupled to the second port. The damper controls pressure within the inflatable bone tamp when pressure within the inflatable bone tamp reaches a threshold. Kits, systems and methods are disclosed.